By Independent Staff Writer
In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.
What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.
DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.
Overview of the Statute of Limitations for Recalled DePuy Implants
If you received a DePuy hip implant and have suffered medical issues as a result, you must be aware of how the legal statute of limitations may affect your right to pursue legal action for the harm done to you. It is urged that potential claimants exercise a measure of urgency in obtaining legal representation for a potential recovery suit. The DePuy hip implant recall occurred in August of 2010, and it is estimated it affected more than 90,000 devices worldwide. In most states—including Texas—personal injury and product liability statute of limitations are only two years, therefore those who reside in a state where a two-year product liability statute exists may only have until August of 2012 to file a DePuy hip implant suit. In order to ensure you preserve your rights, it is a good idea for any hip implant recipient who has experienced painful side effects to seek prompt legal action in the event revision surgery becomes necessary.
Has the Statute of Limitations Been Extended for DePuy Lawsuits?
The date the injury occurred often governs when the statutes begin, which could be construed, in the case of the DePuy hip implant, to mean the exact time the DePuy implant was received. This would mean victims had a narrow window of time to seek recovery against the company and could be stuck DePuy’s vague compensation offer. The potentially advantageous news for victims of the defective hip implant is that the damage caused by hip implant could be considered a continuing tort for the amount of time the implant remains in the body of the recipient. The theory is that the defective device is continuously harming the person it was implanted into. If this theory is deemed applicable in this particular case, then the statute of limitations would begin from the date of hip revision surgery. Any person who has had a hip revision surgery and was implanted with a DePuy device should not leave the statute of limitations to chance, rather should seek the immediate advice of a qualified personal injury attorney in your area.
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Showing posts with label 000 hip replacement recipients worldwide were notified that their DePuy hip implant devices were not only defective. Show all posts
Showing posts with label 000 hip replacement recipients worldwide were notified that their DePuy hip implant devices were not only defective. Show all posts
Pioglitazone Receives New Warnings Due to Slight Increase in Bladder Cancer Risk
The health review of the Type 2 diabetic drug, pioglitazone, performed by the European Medicines Agency, confirmed the drug remains a valid treatment option for certain patients while acknowledging a minimal increase in bladder cancer risk. The caveat in the conclusions of the health review centered upon advising physicians to use care and caution when prescribing the drug. The results further stated that those who are prescribed pioglitazone—especially those who take relatively high doses or have taken the drug for longer than a year—must have their overall health monitored closely. Exclusion of certain higher risk groups, such as the elderly is also recommended.
Assessing Risk Factors in Potential Patients
Physicians are warned to screen patients carefully, and avoid prescribing pioglitazone to those who have a history of bladder cancer or who currently have bladder cancer. Patients with uninvestigated macroscopic haematuria are also advised against taking pioglitazone. As stated, age carries a specific risk, as the elderly are already more likely to develop bladder cancer based solely on age. Because of this an alternative diabetes medication with less risk in this area should be prescribed. Patients taking Actos should undergo regular 3-6 month reviews to assess and monitor benefit vs. risk.
Sources of Information
In making its safety recommendations, the Committee for Medicinal Products for Human Use considered results of pre-clinical and clinical studies as well as spontaneous reports and epidemiological studies. The Scientific Advisory Group on Diabetes also weighed in with advice regarding pioglitazone. The CHMP concluded from this array of evidence that while there is a slight increase in bladder cancer among those taking pioglitazone, this risk exists primarily in those who take the drug for long periods of time or in relatively high doses. That being said, those who take the drug for a short amount of time cannot be excluded from the risks.
Further Research Indicated
The CHMP has indicated that further research and controlled studies are necessary to fully explore the risk of bladder cancer in those taking pioglitazone as compared to those who take other diabetic drugs or those who take no diabetic drugs. It is expected that the issue of whether prolonged use or high cumulative doses are more likely to cause bladder cancer will be more clearly addressed in subsequent studies.
The Bottom Line
Both the SAG and CHMP agree that among patients who will not receive adequate treatment from other diabetic drugs—and who are neither elderly nor have a history of bladder cancer—pioglitazone is still considered the best therapy. While patients must be carefully screened and monitored, the benefits of pioglitazone still outweigh the potential risks.
Assessing Risk Factors in Potential Patients
Physicians are warned to screen patients carefully, and avoid prescribing pioglitazone to those who have a history of bladder cancer or who currently have bladder cancer. Patients with uninvestigated macroscopic haematuria are also advised against taking pioglitazone. As stated, age carries a specific risk, as the elderly are already more likely to develop bladder cancer based solely on age. Because of this an alternative diabetes medication with less risk in this area should be prescribed. Patients taking Actos should undergo regular 3-6 month reviews to assess and monitor benefit vs. risk.
Sources of Information
In making its safety recommendations, the Committee for Medicinal Products for Human Use considered results of pre-clinical and clinical studies as well as spontaneous reports and epidemiological studies. The Scientific Advisory Group on Diabetes also weighed in with advice regarding pioglitazone. The CHMP concluded from this array of evidence that while there is a slight increase in bladder cancer among those taking pioglitazone, this risk exists primarily in those who take the drug for long periods of time or in relatively high doses. That being said, those who take the drug for a short amount of time cannot be excluded from the risks.
Further Research Indicated
The CHMP has indicated that further research and controlled studies are necessary to fully explore the risk of bladder cancer in those taking pioglitazone as compared to those who take other diabetic drugs or those who take no diabetic drugs. It is expected that the issue of whether prolonged use or high cumulative doses are more likely to cause bladder cancer will be more clearly addressed in subsequent studies.
The Bottom Line
Both the SAG and CHMP agree that among patients who will not receive adequate treatment from other diabetic drugs—and who are neither elderly nor have a history of bladder cancer—pioglitazone is still considered the best therapy. While patients must be carefully screened and monitored, the benefits of pioglitazone still outweigh the potential risks.
Takeda Pharmaceuticals Received FDA Instructions for Diabetic Drug Actos
The drug Actos, also known as pioglitazone, has recently come under fire due to studies showing a slight increased risk of bladder cancer in those taking high doses of the drug or those who have taken Actos for longer than two years. Manufactured by Takeda Pharmaceuticals of Japan, the drug has shown huge gains in popularity in the past few years as it quickly replaced the drug Avandia which suffered under claims of increased risk of heart attack and death. Actos is Takeda’s tenth best-selling drug, making over $3.4 billion dollars in the past year alone. While the recent safety reviews have alarmed many who are currently taking the drug, in fact there have been safety concerns regarding Actos for several years.
Warnings are Not New
As far back as 2006, the FDA issued instructions to Takeda regarding Actos and ActoPlus Met, advising the company to make specific label changes to the drug’s precautionary statements. These label changes were to specifically include information regarding reports of bladder cancer in those taking Actos. Takeda’s supplemental drug applications regarding Actos were approved conditionally, so long as the agreed-upon text was included in the drug’s labeling.
The FDA stipulated that the final printed label be identical to the proposed labeling changes, and required Takeda to submit an electronic version of the proposed label as well as 20 paper copies and fifteen copies mounted on heavy-weight paper, however final approval was not mandated prior to using the labels. Although these FDA instructions took place nearly five years ago, it was only recently that more stringent warnings regarding Actos were issued.
Letters Issued to Health Care Professionals Prescribing Actos
At the same time the FDA asked for better warning labels, they requested that any letters sent to health care professionals regarding safety concerns of Actos also be sent to the NDA and FDA. Actos is prescribed for Type 2 diabetes, along with a nutritious diet and regular exercise, and is also found in a combination drug with Metformin to control the amount of sugar in the blood and help the body use insulin normally.
Recent Health Reviews
While the more recent health reviews of Actos have led to France and Germany pulling the drug from the market, the fnial recommendations state that Actos continues to offer significant benefits in carefully screened patients. Actos should not be used in those with a history of bladder cancer or in the elderly population, and those taking the drug should be monitored carefully, and kept at the lowest effective dosage.
Warnings are Not New
As far back as 2006, the FDA issued instructions to Takeda regarding Actos and ActoPlus Met, advising the company to make specific label changes to the drug’s precautionary statements. These label changes were to specifically include information regarding reports of bladder cancer in those taking Actos. Takeda’s supplemental drug applications regarding Actos were approved conditionally, so long as the agreed-upon text was included in the drug’s labeling.
The FDA stipulated that the final printed label be identical to the proposed labeling changes, and required Takeda to submit an electronic version of the proposed label as well as 20 paper copies and fifteen copies mounted on heavy-weight paper, however final approval was not mandated prior to using the labels. Although these FDA instructions took place nearly five years ago, it was only recently that more stringent warnings regarding Actos were issued.
Letters Issued to Health Care Professionals Prescribing Actos
At the same time the FDA asked for better warning labels, they requested that any letters sent to health care professionals regarding safety concerns of Actos also be sent to the NDA and FDA. Actos is prescribed for Type 2 diabetes, along with a nutritious diet and regular exercise, and is also found in a combination drug with Metformin to control the amount of sugar in the blood and help the body use insulin normally.
Recent Health Reviews
While the more recent health reviews of Actos have led to France and Germany pulling the drug from the market, the fnial recommendations state that Actos continues to offer significant benefits in carefully screened patients. Actos should not be used in those with a history of bladder cancer or in the elderly population, and those taking the drug should be monitored carefully, and kept at the lowest effective dosage.
Cobalt and Chromium Blood Toxicity in Hip Replacement Patients?
DECEMBER 15, 2010 - HOUSTON — DePuy hip replacement recall by DePuy Orthopedics, Inc.’s metal-on-metal hip replacement system sent shockwaves through the international medical community. Given the fact that these devices have gained great popularity in recent years among orthopedic surgeons and patients alike, reports that the ASR XL Acetabular System and ASR Hip Resurfacing System were prone to early failure were met with great fear and unease.
Since the DePuy hip replacement recall, many of the 93,000 people worldwide who received an ASR hip implant have been scrambling to find answers to pressing health-related questions, especially as stories of blood toxicity, metallosis, chromium poisoning, cobalt poisoning, and other metal poisoning issues in patients have reached the public. And while countless studies have confirmed the consequences of metal wear debris from faulty orthopedics, many people are still left with grave concerns regarding the the DePuy hip replacement recall.
To date, the most widely researched side effect of DePuy’s defective hip replacement devices is the aforementioned metallosis, which the Journal of Bone & Joint Surgery describes as “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the recalled DePuy ASR hip replacement system cause the metal components such as chromium and cobalt to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions and bone loss.
Of particular interest are the remarkably high concentrations of cobalt and chromium that have been found in patients with metal-on-metal hip resurfacings. In some cases, patients with recalled hip replacement implants have been found with 100 times the normal levels chromium and cobalt in their bodies.
The potential adverse effects of systemic cobalt and chromium ion elevation are the subject of ongoing investigation. While their individual implications on the body are somewhat understood, their combined effects are not. Doctors are struggling with patients’ questions because they simply do not have the answers. But based on existing research we do have some insight into the long-term ramifications of blood toxicity, chromium poisoning, cobalt poisoning and metallosis and sadly, it is not promising for DePuy patients.
Research Relating to the hip replacement recall – Metallosis, Chromium Poisoning & Cobalt Poisoning
As early as 2003, researchers at the Municipality of Vienna Gersth of Orthopedics Hospital in Austria found that patients with metal-on-metal total hip replacements had higher cobalt and chromium levels than those in a control group. Their findings, published in the Journal of Orthopedics Research, showed cobalt concentrations up to 50 times higher and chromium concentrations up to 100 times higher, and called for the careful monitoring of patients to ensure that any local or systemic complications are detected early on.
In 2006, a study published in the British Volume of the Journal of Bone and Joint Surgery found a correlation between metal ions from hip resurfacing and reduced T-cell counts. Researchers discovered that elevated cobalt and chromium levels in patients with metal-on-metal hip resurfacings were associated with statistically significant decreases in the level of CD8+ cells (T-cytotoxic/suppressor cells).
In the same publication in 2007, a review by researchers from University of Bristol in Bristol, UK, demonstrated the long-term effects of metal-on-metal arthroplasty. The team compiled data describing the release, dissemination, uptake, biological activity and potential toxicity of chromium and cobalt debris released from alloys currently used in modern orthopedics, which included a list of potential harmful effects on immunity, reproduction, kidney function, development, the nervous system and carcinogenisis.
Doctors from ANCA Medical Center in Ghent, Belgium, released a study in 2008 showing a direct correlation between inclination of the acetabular component and metal ion levels in hip implant patients. Their research found that there were significantly higher levels of metal ions in patients with steeply-inclined components, and that high concentrations of chromium and cobalt are toxic; are known to interfere with a number of biological functions; can result in fluid or mass formation with subsequent destruction of soft tissues; and can result in bone resorption leading to loosening of he implant or fracture of the femoral neck.
Finally, hip replacement patients with metal-on-metal implants have been shown to pass chromium and cobalt ions to their infants during pregnancy, according to research presented at the 2010 Annual Meeting of the American Academy of Orthopedics Surgeons (AAOS). Data showed that there is a correlation between whole blood metal ion levels in the mother and her infant at the time of delivery, which proves that the placenta is not a complete barrier to the transport of these harmful substances.
The known risks of failure of DePuy ASR hip implants are clear, and evidence of their dangerous, long-term health consequences is substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before it is too late. If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The DePuy hip is part of one of the biggest hip replacement recalls in history. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 for a free legal consultation today.
Since the DePuy hip replacement recall, many of the 93,000 people worldwide who received an ASR hip implant have been scrambling to find answers to pressing health-related questions, especially as stories of blood toxicity, metallosis, chromium poisoning, cobalt poisoning, and other metal poisoning issues in patients have reached the public. And while countless studies have confirmed the consequences of metal wear debris from faulty orthopedics, many people are still left with grave concerns regarding the the DePuy hip replacement recall.
To date, the most widely researched side effect of DePuy’s defective hip replacement devices is the aforementioned metallosis, which the Journal of Bone & Joint Surgery describes as “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the recalled DePuy ASR hip replacement system cause the metal components such as chromium and cobalt to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions and bone loss.
Of particular interest are the remarkably high concentrations of cobalt and chromium that have been found in patients with metal-on-metal hip resurfacings. In some cases, patients with recalled hip replacement implants have been found with 100 times the normal levels chromium and cobalt in their bodies.
The potential adverse effects of systemic cobalt and chromium ion elevation are the subject of ongoing investigation. While their individual implications on the body are somewhat understood, their combined effects are not. Doctors are struggling with patients’ questions because they simply do not have the answers. But based on existing research we do have some insight into the long-term ramifications of blood toxicity, chromium poisoning, cobalt poisoning and metallosis and sadly, it is not promising for DePuy patients.
Research Relating to the hip replacement recall – Metallosis, Chromium Poisoning & Cobalt Poisoning
As early as 2003, researchers at the Municipality of Vienna Gersth of Orthopedics Hospital in Austria found that patients with metal-on-metal total hip replacements had higher cobalt and chromium levels than those in a control group. Their findings, published in the Journal of Orthopedics Research, showed cobalt concentrations up to 50 times higher and chromium concentrations up to 100 times higher, and called for the careful monitoring of patients to ensure that any local or systemic complications are detected early on.
In 2006, a study published in the British Volume of the Journal of Bone and Joint Surgery found a correlation between metal ions from hip resurfacing and reduced T-cell counts. Researchers discovered that elevated cobalt and chromium levels in patients with metal-on-metal hip resurfacings were associated with statistically significant decreases in the level of CD8+ cells (T-cytotoxic/suppressor cells).
In the same publication in 2007, a review by researchers from University of Bristol in Bristol, UK, demonstrated the long-term effects of metal-on-metal arthroplasty. The team compiled data describing the release, dissemination, uptake, biological activity and potential toxicity of chromium and cobalt debris released from alloys currently used in modern orthopedics, which included a list of potential harmful effects on immunity, reproduction, kidney function, development, the nervous system and carcinogenisis.
Doctors from ANCA Medical Center in Ghent, Belgium, released a study in 2008 showing a direct correlation between inclination of the acetabular component and metal ion levels in hip implant patients. Their research found that there were significantly higher levels of metal ions in patients with steeply-inclined components, and that high concentrations of chromium and cobalt are toxic; are known to interfere with a number of biological functions; can result in fluid or mass formation with subsequent destruction of soft tissues; and can result in bone resorption leading to loosening of he implant or fracture of the femoral neck.
Finally, hip replacement patients with metal-on-metal implants have been shown to pass chromium and cobalt ions to their infants during pregnancy, according to research presented at the 2010 Annual Meeting of the American Academy of Orthopedics Surgeons (AAOS). Data showed that there is a correlation between whole blood metal ion levels in the mother and her infant at the time of delivery, which proves that the placenta is not a complete barrier to the transport of these harmful substances.
The known risks of failure of DePuy ASR hip implants are clear, and evidence of their dangerous, long-term health consequences is substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before it is too late. If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The DePuy hip is part of one of the biggest hip replacement recalls in history. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 for a free legal consultation today.
We've got several good reasons why you shouldn't do anything of the kind.
After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery.
In exchange, the company wanted just one minor thing: the hip implant.
On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.
Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you.
The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.
Why Your Hip Implant is Valuable to Your Case
When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.
Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.
If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.
The Art of Misdirection
DePuy offered patients a free hip revision surgery as an enticement. For patients who are fearful that their hip implant is faulty and causing problems like metal sensitivity, metallosis, heavy metal poisoning, and bone deterioration, the offer of a no-cost revision is extremely appealing. Worried that the longer they retain the hip implant, the worse off they will be, those patients are likely to sign the consent forms presented to them without reviewing them properly. Even if they do review the forms, it's not likely the full ramifications will become clear until it's too late.
If DePuy lacked sufficient talent to properly design and engineer a functioning implant, they've made up for that shortcoming by perfecting the art of misdirection. Distracting patients with the offer of a free hip revision surgery, DePuy is making the removed hip explants disappear into thin air - or, at the very least, into the hands of their legal defense.
It's a clever con, and it is very easy to be taken in by it. Many patients have already signed away their own hip explants to DePuy in exchange for the free hip revision surgery, and have undermined their case by doing so. However, even if you have already signed the consent forms, there are ways to reverse the trick and bring the faulty hip implant out of the shadows and back into the light.
Bad Intentions
It is entirely possible that DePuy intends to use the explants to improve on their current model and produce a better ASR Acetabular System. However, the evidence thus far is not in favor of that story. Leaving aside the fact that DePuy never put the hip implant through clinical trials in the first place, in previous litigation on another implant case, the company's defense team used the explants to try to prove the plaintiff caused the problems himself.
In one particularly frightening story recounted to us by an attorney who referred a client to us, a hip explant was "lost" after a revision surgery. The hospital and surgeon's staff insisted that the explant was being held at the hospital after surgery. Another staff member said the explant had been thrown out along with other surgical waste, admitting later that a DePuy representative was present at the hospital on the day of the operation.
We cannot offer irrevocable proof of this story and we have no reason to believe that DePuy representatives are actively attempting to scoop up explants immediately after surgery. However, it is a troubling story and we have no reason to disbelieve the word of the attorney who recounted it. If nothing else, it would seem to indicate that DePuy's motives are not as benign as they claim.
Unless, of course, the representative merely wanted the explant to help the company's engineers improve the design. It must be a great comfort to the patient whose personal property was lost to know that her case was undermined for such a worthy cause.
Don't Sign Your Rights Away
You are entitled to a hip revision surgery without submitting your explant to DePuy. We believe you should be compensated for all medical costs related to the faulty hip implant, which would include the revision surgery.
To put it another way, you can allow them to pay for the surgery now and lose a great deal of future compensation in the future - or you can retain your own explant and receive the compensation you are due, including the cost of the revision, after we have used your explant to make a strong case against DePuy in a mass action lawsuit.
If you are asked to sign a document waiving your right to keep your own explant, we strongly advise you not to sign it. If you have already done so, please contact our offices immediately at 1-800-730-7607 or via our online contact form. We may be able to help retrieve the explant or show that DePuy obtained it improperly.
In exchange, the company wanted just one minor thing: the hip implant.
On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.
Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you.
The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.
Why Your Hip Implant is Valuable to Your Case
When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.
Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.
If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.
The Art of Misdirection
DePuy offered patients a free hip revision surgery as an enticement. For patients who are fearful that their hip implant is faulty and causing problems like metal sensitivity, metallosis, heavy metal poisoning, and bone deterioration, the offer of a no-cost revision is extremely appealing. Worried that the longer they retain the hip implant, the worse off they will be, those patients are likely to sign the consent forms presented to them without reviewing them properly. Even if they do review the forms, it's not likely the full ramifications will become clear until it's too late.
If DePuy lacked sufficient talent to properly design and engineer a functioning implant, they've made up for that shortcoming by perfecting the art of misdirection. Distracting patients with the offer of a free hip revision surgery, DePuy is making the removed hip explants disappear into thin air - or, at the very least, into the hands of their legal defense.
It's a clever con, and it is very easy to be taken in by it. Many patients have already signed away their own hip explants to DePuy in exchange for the free hip revision surgery, and have undermined their case by doing so. However, even if you have already signed the consent forms, there are ways to reverse the trick and bring the faulty hip implant out of the shadows and back into the light.
Bad Intentions
It is entirely possible that DePuy intends to use the explants to improve on their current model and produce a better ASR Acetabular System. However, the evidence thus far is not in favor of that story. Leaving aside the fact that DePuy never put the hip implant through clinical trials in the first place, in previous litigation on another implant case, the company's defense team used the explants to try to prove the plaintiff caused the problems himself.
In one particularly frightening story recounted to us by an attorney who referred a client to us, a hip explant was "lost" after a revision surgery. The hospital and surgeon's staff insisted that the explant was being held at the hospital after surgery. Another staff member said the explant had been thrown out along with other surgical waste, admitting later that a DePuy representative was present at the hospital on the day of the operation.
We cannot offer irrevocable proof of this story and we have no reason to believe that DePuy representatives are actively attempting to scoop up explants immediately after surgery. However, it is a troubling story and we have no reason to disbelieve the word of the attorney who recounted it. If nothing else, it would seem to indicate that DePuy's motives are not as benign as they claim.
Unless, of course, the representative merely wanted the explant to help the company's engineers improve the design. It must be a great comfort to the patient whose personal property was lost to know that her case was undermined for such a worthy cause.
Don't Sign Your Rights Away
You are entitled to a hip revision surgery without submitting your explant to DePuy. We believe you should be compensated for all medical costs related to the faulty hip implant, which would include the revision surgery.
To put it another way, you can allow them to pay for the surgery now and lose a great deal of future compensation in the future - or you can retain your own explant and receive the compensation you are due, including the cost of the revision, after we have used your explant to make a strong case against DePuy in a mass action lawsuit.
If you are asked to sign a document waiving your right to keep your own explant, we strongly advise you not to sign it. If you have already done so, please contact our offices immediately at 1-800-730-7607 or via our online contact form. We may be able to help retrieve the explant or show that DePuy obtained it improperly.
Soon enough to save thousands of people from revision surgery and severe medical consequences.
Soon enough to save thousands of people from revision surgery and severe medical consequences.
When DePuy issued its recall of the ASR XL Acetabular System and the ASR Hip Resurfacing System, it claimed to be doing so because the revision rates were higher than normal. Surgeons, the company said, needed to be fully informed before making the decision to implant the devices.
Up until this point, the company had consistently blamed the surgeons for implanting the device improperly. The high revision rates were due, DePuy claimed, to surgeons placing the device at the wrong angle.
So it was somewhat surprising that DePuy should suddenly decide to recall a hip implant that it had been planning to "phase out" by the end of 2010 anyway. If the high revision rates were no fault of the company's, surely a recall was unnecessary.
And if a recall was so necessary that the device could not justifiably stay on the market for another nine months, it seems peculiar that DePuy should have waited three years before issuing the recall - considering they had data showing failure rates that were many times the usual for their ASR systems. The ASR hip resurfacing system failed at a 12% rate, over twice the accepted norm of 5%. The ASR XL Acetabular System failed at a 13% rate, topping the average of .5-3% by a hefty margin.
DePuy had the information on those failure rates in 2007. The recall wasn't issued until 2010, and until a month before the recall, the company insisted that its revision rates were equivalent to any other products' on the market.
We believe this timeline proves the company knew otherwise, and allowed the ASR device to stay on the market anyway. We believe they did so for profits: the ASR was an expensive device in both incarnations, and if DePuy had issued a recall in 2007, it would have lost out on several years' worth of device sales.
That said, these are the facts: You can deduce for yourself what DePuy knew, and when, and how despicable it was that they did nothing at all to stop their device from being implanted in thousands upon thousands of people who never suspected what a risk they were really taking.
In 2005, the FDA clears the ASR cup for use in traditional hip replacement through the 510(k) approval process. It claims the product is "substantially equivalent" to several other devices already on the market. None of the products to which the ASR product was claimed to be "substantially equivalent" had ever been clinically tested by the FDA.
(Click above to download our 510K Hierarchy Cart...)
Beginning in 2007, the Australian National Joint Replacement Registry issued seven separate reports to DePuy identifying the problems being reported by surgeons throughout the country with the ASR Hip Resurfacing System, and warning the company of unusually high failure rates.
By the beginning of 2008, the U.S. Food and Drug Administration has received approximately 400 complaints about the failure of the ASR XL Acetabular total hip replacement system.
In early 2009, DePuy sends a brochure to doctors describing the importance of proper acetabular cup positioning for all hip implants. The brochure did not specifically mention the ASR as a point of concern.
In December of 2009, DePuy withdraws the ASR from the Australian market for "commercial reasons" - but does not recall the device.
In February of 2010, DePuy officials grant an interview to the New York Times in which they state that the ASR's performance is equal to that of competing devices.
In a letter dated March 6, 2010, DePuy issues a formal recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System.
In April of 2010, DePuy maintains in the New York Times that the ASR XL Acetabular System is safe, despite the recent recall.
On August 26, 2010, Johnson & Johnson announces that DePuy is issuing a worldwide recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System.
DePuy clearly attempted to get the device off of the market without having to go through the loss of reputation that accompanies a formal recall. It claimed it was taking the ASR system off the Australian market because of declining sales, rather than declining success rates. It claimed to the New York Times that the device performed at equal levels to other competing hip implants, even when it could not possibly have believed that statement to be true.
And most damning at all, even after issuing a recall in the United States in March of 2010, DePuy kept selling the faulty hip implants worldwide for the next five months before extending the recall overseas.
To keep selling a device even when the company was fully aware it was risking one in every eight patients' future health is unconscionable. For the sake of every patient who received a hip implant from DePuy, and every surgeon who placed one in good faith that the product would perform well, we would like to see justice done.
If you have a DePuy hip implant and would like to join the mass action case against the company, we're here to answer your questions. Give our offices a call at 1-800-730-7607 and we'll have you talking directly to one of our lawyers in short order. It's important to us that you get the personal attention you deserve.
When DePuy issued its recall of the ASR XL Acetabular System and the ASR Hip Resurfacing System, it claimed to be doing so because the revision rates were higher than normal. Surgeons, the company said, needed to be fully informed before making the decision to implant the devices.
Up until this point, the company had consistently blamed the surgeons for implanting the device improperly. The high revision rates were due, DePuy claimed, to surgeons placing the device at the wrong angle.
So it was somewhat surprising that DePuy should suddenly decide to recall a hip implant that it had been planning to "phase out" by the end of 2010 anyway. If the high revision rates were no fault of the company's, surely a recall was unnecessary.
And if a recall was so necessary that the device could not justifiably stay on the market for another nine months, it seems peculiar that DePuy should have waited three years before issuing the recall - considering they had data showing failure rates that were many times the usual for their ASR systems. The ASR hip resurfacing system failed at a 12% rate, over twice the accepted norm of 5%. The ASR XL Acetabular System failed at a 13% rate, topping the average of .5-3% by a hefty margin.
DePuy had the information on those failure rates in 2007. The recall wasn't issued until 2010, and until a month before the recall, the company insisted that its revision rates were equivalent to any other products' on the market.
We believe this timeline proves the company knew otherwise, and allowed the ASR device to stay on the market anyway. We believe they did so for profits: the ASR was an expensive device in both incarnations, and if DePuy had issued a recall in 2007, it would have lost out on several years' worth of device sales.
That said, these are the facts: You can deduce for yourself what DePuy knew, and when, and how despicable it was that they did nothing at all to stop their device from being implanted in thousands upon thousands of people who never suspected what a risk they were really taking.
In 2005, the FDA clears the ASR cup for use in traditional hip replacement through the 510(k) approval process. It claims the product is "substantially equivalent" to several other devices already on the market. None of the products to which the ASR product was claimed to be "substantially equivalent" had ever been clinically tested by the FDA.
(Click above to download our 510K Hierarchy Cart...)
Beginning in 2007, the Australian National Joint Replacement Registry issued seven separate reports to DePuy identifying the problems being reported by surgeons throughout the country with the ASR Hip Resurfacing System, and warning the company of unusually high failure rates.
By the beginning of 2008, the U.S. Food and Drug Administration has received approximately 400 complaints about the failure of the ASR XL Acetabular total hip replacement system.
In early 2009, DePuy sends a brochure to doctors describing the importance of proper acetabular cup positioning for all hip implants. The brochure did not specifically mention the ASR as a point of concern.
In December of 2009, DePuy withdraws the ASR from the Australian market for "commercial reasons" - but does not recall the device.
In February of 2010, DePuy officials grant an interview to the New York Times in which they state that the ASR's performance is equal to that of competing devices.
In a letter dated March 6, 2010, DePuy issues a formal recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System.
In April of 2010, DePuy maintains in the New York Times that the ASR XL Acetabular System is safe, despite the recent recall.
On August 26, 2010, Johnson & Johnson announces that DePuy is issuing a worldwide recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System.
DePuy clearly attempted to get the device off of the market without having to go through the loss of reputation that accompanies a formal recall. It claimed it was taking the ASR system off the Australian market because of declining sales, rather than declining success rates. It claimed to the New York Times that the device performed at equal levels to other competing hip implants, even when it could not possibly have believed that statement to be true.
And most damning at all, even after issuing a recall in the United States in March of 2010, DePuy kept selling the faulty hip implants worldwide for the next five months before extending the recall overseas.
To keep selling a device even when the company was fully aware it was risking one in every eight patients' future health is unconscionable. For the sake of every patient who received a hip implant from DePuy, and every surgeon who placed one in good faith that the product would perform well, we would like to see justice done.
If you have a DePuy hip implant and would like to join the mass action case against the company, we're here to answer your questions. Give our offices a call at 1-800-730-7607 and we'll have you talking directly to one of our lawyers in short order. It's important to us that you get the personal attention you deserve.
DePuy ASR Hip Implants To Blame For Metal Poisoning, Metallosis and Other Long Term Health Effects.
DECEMBER 2, 2010 - HOUSTON — If you have undergone hip replacement surgery and are experiencing any amount of pain as a result, you may be in more danger than you realize. Recent findings concerning certain types of metal-on-metal hip implant devices show that they are prone to early system failure and may even cause metal poisoning, or metallosis, which is a reaction to the metal debris that is shed when components of the device rub together.
On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced it is voluntarily recalling two types of hip implants due to high early failure rates. The recall affects the ASR XL Acetabular System, and the ASR Hip Resurfacing system. To date, more than 93,000 of the devices have been implanted worldwide.
In the wake of the recall, countless patients have come forward with horrific stories of pain and suffering as the result of receiving a faulty DePuy ASR implant. If you or someone you love has been implanted with one of these devices, you must understand the risks and repercussions if you fail to seek medical help immediately.
Among the problems reported, some of the most common are:
Swelling or pain in the effected hip or surrounding areas
Difficulty walking or pain in the hip when doing so
Grinding or popping noises originating in the hip area
Inflammation or infection in the affected hip
Dislocation or improper positioning of the implant
Perhaps the most dangerous side effect of all is metallosis, which, according to the Journal of Bone & Joint Surgery, is “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the devices cause the metal components to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions, blood metal poisoning and bone loss.
Symptoms of metallosis from metal-on-metal hip replacement devices can include pain, inflammation, tumors and difficulty walking. Specialized blood tests can be used to detect levels of toxic metals in patients experiencing these symptoms. In some cases, patients with DePuy implants have been found with 100 times the normal levels chromium and cobalt in their bodies.
Chromium and cobalt toxicity has been linked to cancer, and can affect the nervous system, gastrointestinal system, cardiovascular system, blood production, kidneys, liver and reproductive system.
Symptoms of heavy metal toxicity include confusion, pain in muscles and joints, headaches, short-term memory loss, gastrointestinal upsets, food intolerances/allergies, vision problems, chronic fatigue, and others. The symptoms are so numerous that it is difficult to diagnose based on symptoms alone.
The first step in treating metallosis or heavy metal toxicity is to identify the toxic elements and begin the removal process. With the DePuy ASR hip replacement system, this means a painful, costly “revision” surgery, which about 1 in 8, or 12 percent of those who have received the implants have been shown to require within 5 years. Originally, the devices were predicted to last 15 years before requiring any corrective revision.
For many patients, intravenous Vitamin C and replacement mineral infusions are also recommended to support the body through the metal removal process. Symptoms will often begin to improve within weeks of commencing treatment, but some may linger, indicating residual organ damage. Therapy may last as long as six months to two years.
Although a full recovery from metallosis is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of heavy metal toxicity for extended periods. Some of the damage, for instance to the liver or brain, may not be fully reversible, and many find that their food intolerances are never completely remedied. Unfortunately for those affected, only time will tell.
If you or someone you love received a defective DePuy ASR device, it is imperative that you obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get compensated. Call us at 1-800-730-7607 for a free legal consultation today.
On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced it is voluntarily recalling two types of hip implants due to high early failure rates. The recall affects the ASR XL Acetabular System, and the ASR Hip Resurfacing system. To date, more than 93,000 of the devices have been implanted worldwide.
In the wake of the recall, countless patients have come forward with horrific stories of pain and suffering as the result of receiving a faulty DePuy ASR implant. If you or someone you love has been implanted with one of these devices, you must understand the risks and repercussions if you fail to seek medical help immediately.
Among the problems reported, some of the most common are:
Swelling or pain in the effected hip or surrounding areas
Difficulty walking or pain in the hip when doing so
Grinding or popping noises originating in the hip area
Inflammation or infection in the affected hip
Dislocation or improper positioning of the implant
Perhaps the most dangerous side effect of all is metallosis, which, according to the Journal of Bone & Joint Surgery, is “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the devices cause the metal components to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions, blood metal poisoning and bone loss.
Symptoms of metallosis from metal-on-metal hip replacement devices can include pain, inflammation, tumors and difficulty walking. Specialized blood tests can be used to detect levels of toxic metals in patients experiencing these symptoms. In some cases, patients with DePuy implants have been found with 100 times the normal levels chromium and cobalt in their bodies.
Chromium and cobalt toxicity has been linked to cancer, and can affect the nervous system, gastrointestinal system, cardiovascular system, blood production, kidneys, liver and reproductive system.
Symptoms of heavy metal toxicity include confusion, pain in muscles and joints, headaches, short-term memory loss, gastrointestinal upsets, food intolerances/allergies, vision problems, chronic fatigue, and others. The symptoms are so numerous that it is difficult to diagnose based on symptoms alone.
The first step in treating metallosis or heavy metal toxicity is to identify the toxic elements and begin the removal process. With the DePuy ASR hip replacement system, this means a painful, costly “revision” surgery, which about 1 in 8, or 12 percent of those who have received the implants have been shown to require within 5 years. Originally, the devices were predicted to last 15 years before requiring any corrective revision.
For many patients, intravenous Vitamin C and replacement mineral infusions are also recommended to support the body through the metal removal process. Symptoms will often begin to improve within weeks of commencing treatment, but some may linger, indicating residual organ damage. Therapy may last as long as six months to two years.
Although a full recovery from metallosis is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of heavy metal toxicity for extended periods. Some of the damage, for instance to the liver or brain, may not be fully reversible, and many find that their food intolerances are never completely remedied. Unfortunately for those affected, only time will tell.
If you or someone you love received a defective DePuy ASR device, it is imperative that you obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get compensated. Call us at 1-800-730-7607 for a free legal consultation today.
Becoming part of a mass action lawsuit over the DePuy hip implant gives you an edge that going solo can't afford.
Many different law firms are suing DePuy Orthopaedics over the faulty ASR XL Acetabular System. In a personal, vulnerable situation like this hip implant case, it can be difficult to assess the situation and make the right legal decision for you. In this article, we'd like to break down the difference between mass action, class action, and solo cases so you can make a well-informed choice for yourself.
"One Riot, One Ranger"
When a single person with a single lawyer brings a case against one organization, our firm's Andrew Sullo likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.
Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.
Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.
"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.
So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?
If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.
And in that situation, the math starts to work against the plaintiffs.
Bluffing Without a Hand
Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.
Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.
Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.
Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.
One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.
In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.
Enter the mass action lawsuit.
The Pocket Ace: Mass Action Lawsuit
Every individual client needs personal attention in a case like this. Everyone has different injuries, different changes to their lifestyle that need to be recompensed, and different problems that need to be addressed.
However, there is a great deal of overlap when it comes to researching the case. All of the plaintiffs in the Company X case were struck by the same vehicle, for example. If 200 different lawyers are working each of the plaintiff's individual cases, each of those lawyers has to do their own research on the driver, the vehicle, and the circumstances that led to the accident.
If one lawyer brings a lawsuit on behalf of all of those 200 plaintiffs, he only has to do that research once. That lowers his costs, which means he can start to compete with Company X in the game of who has the most money to bring to the case.
With a single case, it might cost $200,000 to bring the lawsuit even though the client only recovered $200,000.
With ten cases, it might cost $400,000 to bring the lawsuit, but it's now possible to recover $2 million.
With 100 cases, it might cost $1 million to bring the lawsuit, and the recovery might be $20 million.
The more clients a law firm or a collaborative group of law firms has, the better their position when it comes to bargaining with DePuy about how much money his clients should ultimately get. When the potential recovery is quite high, it's still possible for lawyers to stay in the game even though the company is willing to put in a large amount of money defending the case.
These aren't necessarily the numbers for the DePuy hip recall case. The damages we've seen have been widely varied, but they share a single common denominator: it will be easier to get everyone recompensed properly if everyone bands together in a single mass action suit. The more clients a legal partnership has, the better its position when it comes to bargaining with DePuy about how much money their clients should receive.
New Game: DePuy ASR XL Acetabular System
There are a great many lawyers out there billing themselves as a "hip recall lawyer" or a "faulty hip lawyer." We aren't those things. At Sullo & Sullo, we have a history of bringing mass action lawsuits against major corporations and winning. Usually, when a normal, everyday citizen brings a case against a huge corporation with a lot of money to spend on a lawsuit, he's going to lose.
We tip the scales. We gather together the people who have been harmed and we draw power from those numbers. Our firm's history, bringing and winning lawsuits against Shell Chemical, Prudential Bache, Tenet Healthcare, and National Medical Enterprises, shows that this is the most effective way to win cases when thousands were injured.
No company should get away with causing you serious harm simply because they have deeper pockets. If you have questions about your legal rights in the case against DePuy Orthopaedics, we're here to answer them. More than anything, we want to be sure the thousands of people who were harmed by the ASR XL Acetabular System have the legal and medical information they need to move forward.
"One Riot, One Ranger"
When a single person with a single lawyer brings a case against one organization, our firm's Andrew Sullo likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.
Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.
Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.
"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.
So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?
If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.
And in that situation, the math starts to work against the plaintiffs.
Bluffing Without a Hand
Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.
Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.
Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.
Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.
One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.
In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.
Enter the mass action lawsuit.
The Pocket Ace: Mass Action Lawsuit
Every individual client needs personal attention in a case like this. Everyone has different injuries, different changes to their lifestyle that need to be recompensed, and different problems that need to be addressed.
However, there is a great deal of overlap when it comes to researching the case. All of the plaintiffs in the Company X case were struck by the same vehicle, for example. If 200 different lawyers are working each of the plaintiff's individual cases, each of those lawyers has to do their own research on the driver, the vehicle, and the circumstances that led to the accident.
If one lawyer brings a lawsuit on behalf of all of those 200 plaintiffs, he only has to do that research once. That lowers his costs, which means he can start to compete with Company X in the game of who has the most money to bring to the case.
With a single case, it might cost $200,000 to bring the lawsuit even though the client only recovered $200,000.
With ten cases, it might cost $400,000 to bring the lawsuit, but it's now possible to recover $2 million.
With 100 cases, it might cost $1 million to bring the lawsuit, and the recovery might be $20 million.
The more clients a law firm or a collaborative group of law firms has, the better their position when it comes to bargaining with DePuy about how much money his clients should ultimately get. When the potential recovery is quite high, it's still possible for lawyers to stay in the game even though the company is willing to put in a large amount of money defending the case.
These aren't necessarily the numbers for the DePuy hip recall case. The damages we've seen have been widely varied, but they share a single common denominator: it will be easier to get everyone recompensed properly if everyone bands together in a single mass action suit. The more clients a legal partnership has, the better its position when it comes to bargaining with DePuy about how much money their clients should receive.
New Game: DePuy ASR XL Acetabular System
There are a great many lawyers out there billing themselves as a "hip recall lawyer" or a "faulty hip lawyer." We aren't those things. At Sullo & Sullo, we have a history of bringing mass action lawsuits against major corporations and winning. Usually, when a normal, everyday citizen brings a case against a huge corporation with a lot of money to spend on a lawsuit, he's going to lose.
We tip the scales. We gather together the people who have been harmed and we draw power from those numbers. Our firm's history, bringing and winning lawsuits against Shell Chemical, Prudential Bache, Tenet Healthcare, and National Medical Enterprises, shows that this is the most effective way to win cases when thousands were injured.
No company should get away with causing you serious harm simply because they have deeper pockets. If you have questions about your legal rights in the case against DePuy Orthopaedics, we're here to answer them. More than anything, we want to be sure the thousands of people who were harmed by the ASR XL Acetabular System have the legal and medical information they need to move forward.
Women have a disproportionally larger number of problems with hip implant surgery than men do. Especially with the ASR XL Acetabular System.
Several news sources, among them the New York Times, have already commented on the mounting data that more women than men are reporting problems with the ASR XL Acetabular System. We'd like to explain exactly why that is.
Problem: Hip Implant Not Designed Ideally for Wider Hip Sockets
Women, as you may have heard, are structured differently anatomically than men. The differences aren't merely on the surface, however; they extend into the skeletal structure and particularly in the pelvis region. Women have wider hips with bigger hip sockets to accommodate the process of giving birth, which means they often have more problems in hip implant surgery because those large hip sockets allow the implant to dislocate more easily.
In the DePuy ASR XL Acetabular System, however, the problems go beyond the norm. One of the reasons is that the hip implant was designed to be extremely shallow, exacerbating the problems women already have with hip implants.
Problem: Women More Likely to Require Hip Implants
Women are more prone to osteopenia, osteoporosis, and often have weaker bones overall than men, particularly as they age. The onset of menopause, and the subsequent drop in estrogen, have been linked to rapid bone deterioration. Because of all of these factors, women are more likely than men overall to require a hip implant because of a hip fracture.
Problem: Small, Shallow Hip Implant
The DePuy ASR XL Acetabular System was designed to give patients a greater range of motion. If you'll recall, the design of the hip implant included two parts: an implant inserted into the femur bone with a rounded top that fit into a cup placed in the hip bone.
In the design of the ASR XL Acetabular System, the cup was made very shallow, which meant that the patient could move their leg in a wider arc before the other part of the implant might dislocate.
Good in theory. And if DePuy had tested their product properly, it might have worked quite well. In real life, it went a little differently.
The shallow hip implants meant that all of the friction caused by everyday movement was focused on a much smaller area. There was more force on a smaller amount of material. The hip implant was under more stress and was more prone to the friction that caused small metal ions to break off into the bloodstream. It was also more likely to break altogether.
Especially in women. Their smaller, shallower hip implants meant there was even more strain on the material. Women who have an ASR XL Acetabular System are reporting problems in greater numbers than men in part because their hip implants are simply breaking down faster. They have the same problems, forced upon a smaller area.
Our consulting doctor offered some sobering statistics for smaller hip implants in general: the risk of a hip revision surgery for a hip implant with a head size of 44 mm is five times that of a hip implant with a head size of 55 mm.
Problem: Bone Deterioration Exacerbated in Women's Hip Implants
Because women are more prone to bone deterioration in general and have less bone density than men, the problems caused by the ASR XL Acetabular System are multiplied. We've explained the problem of bone deterioration at length, but here's the issue in a nutshell:
For a non-cemented hip implant like the ASR XL Acetabular System to work properly, the surrounding hip bone needs to be healthy and growing. DePuy's hip implant design caused an inordinate number of metal ions to be released into the bloodstream, causing problems with metallosis, heavy metal poisoning, and metal sensitivity - all of which adversely affect the bone.
One reason why women may be reporting problems with their hip implants sooner than men is because they have less bone to sacrifice to the effects of the metal ions floating in their bloodstream. The symptoms become painful more quickly, and more women are going to their doctor with concerns about the hip implant.
Handicapped with less dense, weaker bones, women now face the additional problem of attempting a hip revision with severely damaged hip bones from the previous DePuy hip implant.
It is already more difficult for a woman to have a successful hip replacement surgery than a man. DePuy's ASR XL Acetabular System made it even more difficult - not to say dangerous.
If you have any questions about your hip replacement surgery or your options moving forward, we'd like to help. Give us a call at 800-730-7607 or fill out our online form and we'll explain your legal options and try to answer any of your questions about the DePuy hip implant and how it's affecting your health.
Problem: Hip Implant Not Designed Ideally for Wider Hip Sockets
Women, as you may have heard, are structured differently anatomically than men. The differences aren't merely on the surface, however; they extend into the skeletal structure and particularly in the pelvis region. Women have wider hips with bigger hip sockets to accommodate the process of giving birth, which means they often have more problems in hip implant surgery because those large hip sockets allow the implant to dislocate more easily.
In the DePuy ASR XL Acetabular System, however, the problems go beyond the norm. One of the reasons is that the hip implant was designed to be extremely shallow, exacerbating the problems women already have with hip implants.
Problem: Women More Likely to Require Hip Implants
Women are more prone to osteopenia, osteoporosis, and often have weaker bones overall than men, particularly as they age. The onset of menopause, and the subsequent drop in estrogen, have been linked to rapid bone deterioration. Because of all of these factors, women are more likely than men overall to require a hip implant because of a hip fracture.
Problem: Small, Shallow Hip Implant
The DePuy ASR XL Acetabular System was designed to give patients a greater range of motion. If you'll recall, the design of the hip implant included two parts: an implant inserted into the femur bone with a rounded top that fit into a cup placed in the hip bone.
In the design of the ASR XL Acetabular System, the cup was made very shallow, which meant that the patient could move their leg in a wider arc before the other part of the implant might dislocate.
Good in theory. And if DePuy had tested their product properly, it might have worked quite well. In real life, it went a little differently.
The shallow hip implants meant that all of the friction caused by everyday movement was focused on a much smaller area. There was more force on a smaller amount of material. The hip implant was under more stress and was more prone to the friction that caused small metal ions to break off into the bloodstream. It was also more likely to break altogether.
Especially in women. Their smaller, shallower hip implants meant there was even more strain on the material. Women who have an ASR XL Acetabular System are reporting problems in greater numbers than men in part because their hip implants are simply breaking down faster. They have the same problems, forced upon a smaller area.
Our consulting doctor offered some sobering statistics for smaller hip implants in general: the risk of a hip revision surgery for a hip implant with a head size of 44 mm is five times that of a hip implant with a head size of 55 mm.
Problem: Bone Deterioration Exacerbated in Women's Hip Implants
Because women are more prone to bone deterioration in general and have less bone density than men, the problems caused by the ASR XL Acetabular System are multiplied. We've explained the problem of bone deterioration at length, but here's the issue in a nutshell:
For a non-cemented hip implant like the ASR XL Acetabular System to work properly, the surrounding hip bone needs to be healthy and growing. DePuy's hip implant design caused an inordinate number of metal ions to be released into the bloodstream, causing problems with metallosis, heavy metal poisoning, and metal sensitivity - all of which adversely affect the bone.
One reason why women may be reporting problems with their hip implants sooner than men is because they have less bone to sacrifice to the effects of the metal ions floating in their bloodstream. The symptoms become painful more quickly, and more women are going to their doctor with concerns about the hip implant.
Handicapped with less dense, weaker bones, women now face the additional problem of attempting a hip revision with severely damaged hip bones from the previous DePuy hip implant.
It is already more difficult for a woman to have a successful hip replacement surgery than a man. DePuy's ASR XL Acetabular System made it even more difficult - not to say dangerous.
If you have any questions about your hip replacement surgery or your options moving forward, we'd like to help. Give us a call at 800-730-7607 or fill out our online form and we'll explain your legal options and try to answer any of your questions about the DePuy hip implant and how it's affecting your health.
Could the DePuy ASR™ XL Acetabular System recall have been avoided? Looks like it.
In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.
But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.
How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States?
The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.
The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market.
Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word.
Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.
The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.
Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.
Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market.
The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.
Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product's safety and effectiveness without strong clinical data?
If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might've been avoided. Tens of thousands of patients might've been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first.
Critics have long argued that companies use the 510(k) process is a loophole that allows companies to get around the more arduous premarket approval process otherwise required by the FDA. While it's true that the 510(k) process saves companies a lot of time and money, the cost is merely passed on to the patients, who pay with their money, pain, and quality of life.
We can only hope that the proposed reforms to the current process take effect soon and prevent more tragedy from prematurely approved devices like the DePuy ASRTM XL Acetabular System.
But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.
How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States?
The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.
The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market.
Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word.
Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.
The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.
Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.
Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market.
The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.
Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product's safety and effectiveness without strong clinical data?
If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might've been avoided. Tens of thousands of patients might've been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first.
Critics have long argued that companies use the 510(k) process is a loophole that allows companies to get around the more arduous premarket approval process otherwise required by the FDA. While it's true that the 510(k) process saves companies a lot of time and money, the cost is merely passed on to the patients, who pay with their money, pain, and quality of life.
We can only hope that the proposed reforms to the current process take effect soon and prevent more tragedy from prematurely approved devices like the DePuy ASRTM XL Acetabular System.
Too many ASR XL Acetabular Systems causing problems in first three years.
In 2003, DePuy released the ASRTM XL Acetabular System, a hip implant that was touted to last up to 20 years with a stronger, more durable metal-on-metal design. Approximately 93,000 people around the world weighed the risks of surgery against their current level of pain and discomfort and chose to receive a hip implant that they believed would give them 15 to 20 years of pain-free movement.
DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule.
With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%
The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.
The major flaw, as we've said in other articles about the problems with the XL Acetabular System, is the engineering. The two pieces of the implant rub together as the patient moves, releasing microscopic particles of chromium and cobalt into the bloodstream. Some patients experience pain when this happens; others have no idea of the damage being done to the bone and tissue surrounding the hip implant. Some patients and doctors have reported a loosening of the joints in the hip implant, fracturing of the surrounding bone, and full-out dislocation.
Every hip implant releases small particles of the device's materials into the bloodstream, but the quantities are so small that the body can release them from the bloodstream as waste. In the ASR XL Acetabular System, the quantities being released are sometimes so great that the body can't get rid of them efficiently, causing metallosis.
According to DePuy's website, "the patients who reported problems in the first five years and had revision surgery reported a variety of symptoms." So far, DePuy hasn't listed those symptoms on their website, but the current evidence reveals metal poisoning, bone deterioration, and tissue necrosis, as well as metallosis.
Before any surgery, the surgeon is required to meet with the patient and go over the potential risks. Most people are familiar with the idea of informed consent, which essentially states that patients should understand the facts, implications, and future consequences of any medical decision they're being asked to make.
With hip implant surgery, the potential problems include malignant hyperthermia, infections, respiratory issues, and blood clots that can cause strokes. These are the basic risks for any major surgery; a hip implant patient would've been informed of that fact. The recovery process also has risks, as does refusing to have the surgery. Risks are part of the decision to receive or not receive a hip implant.
However, DePuy never informed the patients who were receiving the ASR XL Acetabular System that their hip implant might have a number of risks above and beyond those of major surgery. DePuy never informed the surgeon performing the procedure that the hip implant's engineering hadn't been tested by the FDA-or that many patients, especially women, had already reported problems only a few years into the life of their hip implant.
DePuy certainly failed to inform both the surgeons and the patients that their product could mean a revision surgery in less than three years-a fraction of the 15- to 20-year time frame their advertising campaign promised. The hip implants recall issued by DePuy was voluntary-but it was too little too late. According to their website, "DePuy intends to cover reasonable and customary costs of testing and treatment associated with the ASR recall, including revision surgery if it is necessary... This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis."
"Out-of-pocket costs" means everything that's not covered by the insurance company-and insurance companies haven't exactly developed a reputation for being forthcoming with treatments that keep the patient's health at the forefront of considering factors. They're more likely to choose the least costly option, which means that many of these patients will find themselves in a lawsuit over what is and is not a necessary medical procedure.
This is the last thing any of these patients with failing hip implants needs. They needed a hip implant-not costly procedures and legal battles to make sure they get the care they need to replace the damage that was done. They also need full compensation for all their losses and damages, not just out-of-pocket costs.
Every patient who undergoes major surgery takes a risk. Those who received a DePuy ASR XL Acetabular System weren't merely asked to take a risk, however-they're being asked to take the fall.
DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule.
With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%
The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.
The major flaw, as we've said in other articles about the problems with the XL Acetabular System, is the engineering. The two pieces of the implant rub together as the patient moves, releasing microscopic particles of chromium and cobalt into the bloodstream. Some patients experience pain when this happens; others have no idea of the damage being done to the bone and tissue surrounding the hip implant. Some patients and doctors have reported a loosening of the joints in the hip implant, fracturing of the surrounding bone, and full-out dislocation.
Every hip implant releases small particles of the device's materials into the bloodstream, but the quantities are so small that the body can release them from the bloodstream as waste. In the ASR XL Acetabular System, the quantities being released are sometimes so great that the body can't get rid of them efficiently, causing metallosis.
According to DePuy's website, "the patients who reported problems in the first five years and had revision surgery reported a variety of symptoms." So far, DePuy hasn't listed those symptoms on their website, but the current evidence reveals metal poisoning, bone deterioration, and tissue necrosis, as well as metallosis.
Before any surgery, the surgeon is required to meet with the patient and go over the potential risks. Most people are familiar with the idea of informed consent, which essentially states that patients should understand the facts, implications, and future consequences of any medical decision they're being asked to make.
With hip implant surgery, the potential problems include malignant hyperthermia, infections, respiratory issues, and blood clots that can cause strokes. These are the basic risks for any major surgery; a hip implant patient would've been informed of that fact. The recovery process also has risks, as does refusing to have the surgery. Risks are part of the decision to receive or not receive a hip implant.
However, DePuy never informed the patients who were receiving the ASR XL Acetabular System that their hip implant might have a number of risks above and beyond those of major surgery. DePuy never informed the surgeon performing the procedure that the hip implant's engineering hadn't been tested by the FDA-or that many patients, especially women, had already reported problems only a few years into the life of their hip implant.
DePuy certainly failed to inform both the surgeons and the patients that their product could mean a revision surgery in less than three years-a fraction of the 15- to 20-year time frame their advertising campaign promised. The hip implants recall issued by DePuy was voluntary-but it was too little too late. According to their website, "DePuy intends to cover reasonable and customary costs of testing and treatment associated with the ASR recall, including revision surgery if it is necessary... This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis."
"Out-of-pocket costs" means everything that's not covered by the insurance company-and insurance companies haven't exactly developed a reputation for being forthcoming with treatments that keep the patient's health at the forefront of considering factors. They're more likely to choose the least costly option, which means that many of these patients will find themselves in a lawsuit over what is and is not a necessary medical procedure.
This is the last thing any of these patients with failing hip implants needs. They needed a hip implant-not costly procedures and legal battles to make sure they get the care they need to replace the damage that was done. They also need full compensation for all their losses and damages, not just out-of-pocket costs.
Every patient who undergoes major surgery takes a risk. Those who received a DePuy ASR XL Acetabular System weren't merely asked to take a risk, however-they're being asked to take the fall.
Choosing a good lawyer isn't as difficult as you might imagine; it's just a matter of asking the right questions.
With so many lawyers out there, how should you go about finding a good one? How can you tell a strong lawyer from a weak one? You need solid legal advice, and you want the right attorney. Do not, we repeat, DO NOT just open the phone book, close your eyes, and point to a name. Here are some guideposts to help you.
A good lawyer is ethical. You're probably laughing right now. Can the words "ethics" and "lawyer" exist in the same sentence? Actually, it is possible, and you should absolutely insist on it. But how can you tell if a lawyer is ethical? There are some pretty good indicators.
What types of cases does he take? Lawyers have a choice about which cases they take. Look at her winning cases as well as the losing ones. No lawyer wants to lose a case, but an ethical lawyer will often be willing to take a case because it is the right thing to do and fight to the very end.
Look at whether the lawyer actually tries the cases he takes in court or whether he just gathers cases for others. Ask the attorney when he last went to trial. Ask him how often his cases settle and how often his cases make it to a jury.
Be sure that the lawyer specializes in your type of case. You really don't want a tax attorney to represent you in your personal injury case. An ethical attorney will only take cases in her area of expertise.
What types of clients does he represent? Does he represent big corporations or everyday people? Does he fight for the underdog? Does he hold wrongdoers accountable for their behavior?
Is he honest? Is she candid about the strengths and weaknesses of your case? A good lawyer will almost never tell her clients that the case is a "slam dunk." Those types of cases are extremely rare. Moreover, is he honest about his own strengths and weaknesses as an attorney? A good lawyer will tell you if he's particularly good in one area, but that he may ask his partner to help out in another area. He knows that two heads are better than one, and he can be honest about it. Is the lawyer truthful about his fees and costs? He should tell you what his services will cost, and there should not be any hidden fees.
What is the lawyer's reputation in the community? Is he known for his honesty, his pro bono work, his strong relationships in the legal and general community? Google the lawyer's name. See what comes up. Look for newspaper articles, websites and blogs. Make sure the attorney is in good standing with the state. Any sort of disciplinary action is a red flag. Ask around the community. Does the lawyer have a good name around town? Have any of your friends or acquaintances had experiences with him? Check his references.
A good lawyer values you as a person. Does he look you in the eye when he's talking with you? Are you treated as a person or as just some client? Does the lawyer remember personal information about you, including your spouse's or children's names? Do you actually get to meet with him personally, or are you always sent to talk with a secretary? A good lawyer will make time for you and will return your phone calls quickly. Does he show that he understands that you have a unique situation that is quite unlike anyone else's? Has he shown that he respects your time and obligations, or does he talk on and on? Remember, a good lawyer will listen at least as much as he speaks.
Trust your gut. It all really comes down to trusting yourself. Ask yourself: Do I like the guy? How does he treat his office staff? Do I trust this guy? Does it feel like he's trying to sell me the Brooklyn Bridge? If you don't like how you feel at that first meeting, chances are that it's not going to get any better. Listen to that little voice inside - odds are, you're exactly right.
How do I know if Sullo & Sullo is right for me? Please browse our site and give us a call. We'd like to answer any questions you may have. Give your gut a chance to test our ethics and people skills.
A good lawyer is ethical. You're probably laughing right now. Can the words "ethics" and "lawyer" exist in the same sentence? Actually, it is possible, and you should absolutely insist on it. But how can you tell if a lawyer is ethical? There are some pretty good indicators.
What types of cases does he take? Lawyers have a choice about which cases they take. Look at her winning cases as well as the losing ones. No lawyer wants to lose a case, but an ethical lawyer will often be willing to take a case because it is the right thing to do and fight to the very end.
Look at whether the lawyer actually tries the cases he takes in court or whether he just gathers cases for others. Ask the attorney when he last went to trial. Ask him how often his cases settle and how often his cases make it to a jury.
Be sure that the lawyer specializes in your type of case. You really don't want a tax attorney to represent you in your personal injury case. An ethical attorney will only take cases in her area of expertise.
What types of clients does he represent? Does he represent big corporations or everyday people? Does he fight for the underdog? Does he hold wrongdoers accountable for their behavior?
Is he honest? Is she candid about the strengths and weaknesses of your case? A good lawyer will almost never tell her clients that the case is a "slam dunk." Those types of cases are extremely rare. Moreover, is he honest about his own strengths and weaknesses as an attorney? A good lawyer will tell you if he's particularly good in one area, but that he may ask his partner to help out in another area. He knows that two heads are better than one, and he can be honest about it. Is the lawyer truthful about his fees and costs? He should tell you what his services will cost, and there should not be any hidden fees.
What is the lawyer's reputation in the community? Is he known for his honesty, his pro bono work, his strong relationships in the legal and general community? Google the lawyer's name. See what comes up. Look for newspaper articles, websites and blogs. Make sure the attorney is in good standing with the state. Any sort of disciplinary action is a red flag. Ask around the community. Does the lawyer have a good name around town? Have any of your friends or acquaintances had experiences with him? Check his references.
A good lawyer values you as a person. Does he look you in the eye when he's talking with you? Are you treated as a person or as just some client? Does the lawyer remember personal information about you, including your spouse's or children's names? Do you actually get to meet with him personally, or are you always sent to talk with a secretary? A good lawyer will make time for you and will return your phone calls quickly. Does he show that he understands that you have a unique situation that is quite unlike anyone else's? Has he shown that he respects your time and obligations, or does he talk on and on? Remember, a good lawyer will listen at least as much as he speaks.
Trust your gut. It all really comes down to trusting yourself. Ask yourself: Do I like the guy? How does he treat his office staff? Do I trust this guy? Does it feel like he's trying to sell me the Brooklyn Bridge? If you don't like how you feel at that first meeting, chances are that it's not going to get any better. Listen to that little voice inside - odds are, you're exactly right.
How do I know if Sullo & Sullo is right for me? Please browse our site and give us a call. We'd like to answer any questions you may have. Give your gut a chance to test our ethics and people skills.
Much of the pain and problems behind the DePuy ASR total hip implant were caused by metallosis. But what does that really mean?
Johnson & Johnson has announced that its subsidiary company DePuy issued a voluntarily recall of their ASR hip implant due to a number of patients who required a second hip replacement procedure, called a revision surgery."
No mention was made of metallosis in the Johnson & Johnson press release. In fact, Johnson & Johnson didn't mention any of the more significant symptoms patients are suffering after receiving a DePuy ASR XL hip implant. They would prefer that the public believed the revision surgery process is simple and fixes the problem of a faulty hip implant with absolutely no long-term effects.
We're recommending you get a second opinion - and a blood test. Metal-on-metal hip replacement bearings like the DuPuy ASR XL Acetabular System total hip replacement were originally reintroduced as an alternative to metal-on-plastic or ceramic hip replacement systems. Metal-on-metal implants (for a hip implant, this is a design that involves both a metal ball and a metal socket) have certain advantages over plastic or ceramic when the design is properly engineered. They last longer, have high resistance to wear and tear, and can withstand more vigorous activity, making metal-on-metal the usual choice for surgeons with younger, more active patients who are going to put more strain on their implants.
However, a poorly engineered metal-on-metal hip resurfacing system has considerable complications, many of them more serious than their ceramic or plastic counterparts.
The Blue Cross Blue Shield Association Technology Evaluation Center report on metal-on-metal total hip resurfacing notes that metal-on-metal systems have risks of elevated heavy metal ion levels, delayed hypersensitivity to metals, and even carcinogenesis - cancer, to the layman.
All hip replacement systems release tiny particles of the implant's material into the body when the two parts of the hip replacement rub against one another. In metal-on-metal implants, a small amount of friction and metallosis is predictable and part of the considered risks when the surgeon recommends a certain type of hip implant.
However, when the metal parts are improperly made or installed, the friction releases much more metal into the bloodstream, causing serious metallosis and metal poisoning.
Engineers who have examined the DuPuy ASR hip replacement system noted several design flaws that contributed to increased metallosis and metal poisoning in patients. The implant is shallower than most other hip replacement systems, which made it much more challenging to implant than other systems. DePuy was fully aware of this setback; their instructions to the surgeon recommended a much more precise placement than other implants.
One engineer we consulted with went on to note that the requirements for placement were so specific that only about 3% surgeons would be able to place the hip implant properly. This is not a comment on the surgeon's skill; the engineer was quick to note that the placement demands would be impossible for all but the most skilled and experienced surgeons, and even then the surgeon would have to be fully informed of the importance of precise placement.
What's more, even with proper placement, the DePuy ASR hip replacement was made with a poorly designed cup and socket that did not fit together properly. If they had, friction would have been minimal and the metallosis risk would have been akin to other metal-on-metal hip implants. That said, a study by The Journal of Bone and Joint Surgery on metal-on-metal hip implants (not specifically DePuy implants) showed that patients had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times normal. Read more ....
No mention was made of metallosis in the Johnson & Johnson press release. In fact, Johnson & Johnson didn't mention any of the more significant symptoms patients are suffering after receiving a DePuy ASR XL hip implant. They would prefer that the public believed the revision surgery process is simple and fixes the problem of a faulty hip implant with absolutely no long-term effects.
We're recommending you get a second opinion - and a blood test. Metal-on-metal hip replacement bearings like the DuPuy ASR XL Acetabular System total hip replacement were originally reintroduced as an alternative to metal-on-plastic or ceramic hip replacement systems. Metal-on-metal implants (for a hip implant, this is a design that involves both a metal ball and a metal socket) have certain advantages over plastic or ceramic when the design is properly engineered. They last longer, have high resistance to wear and tear, and can withstand more vigorous activity, making metal-on-metal the usual choice for surgeons with younger, more active patients who are going to put more strain on their implants.
However, a poorly engineered metal-on-metal hip resurfacing system has considerable complications, many of them more serious than their ceramic or plastic counterparts.
The Blue Cross Blue Shield Association Technology Evaluation Center report on metal-on-metal total hip resurfacing notes that metal-on-metal systems have risks of elevated heavy metal ion levels, delayed hypersensitivity to metals, and even carcinogenesis - cancer, to the layman.
All hip replacement systems release tiny particles of the implant's material into the body when the two parts of the hip replacement rub against one another. In metal-on-metal implants, a small amount of friction and metallosis is predictable and part of the considered risks when the surgeon recommends a certain type of hip implant.
However, when the metal parts are improperly made or installed, the friction releases much more metal into the bloodstream, causing serious metallosis and metal poisoning.
Engineers who have examined the DuPuy ASR hip replacement system noted several design flaws that contributed to increased metallosis and metal poisoning in patients. The implant is shallower than most other hip replacement systems, which made it much more challenging to implant than other systems. DePuy was fully aware of this setback; their instructions to the surgeon recommended a much more precise placement than other implants.
One engineer we consulted with went on to note that the requirements for placement were so specific that only about 3% surgeons would be able to place the hip implant properly. This is not a comment on the surgeon's skill; the engineer was quick to note that the placement demands would be impossible for all but the most skilled and experienced surgeons, and even then the surgeon would have to be fully informed of the importance of precise placement.
What's more, even with proper placement, the DePuy ASR hip replacement was made with a poorly designed cup and socket that did not fit together properly. If they had, friction would have been minimal and the metallosis risk would have been akin to other metal-on-metal hip implants. That said, a study by The Journal of Bone and Joint Surgery on metal-on-metal hip implants (not specifically DePuy implants) showed that patients had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times normal. Read more ....
The surgeon recommended a DePuy hip implant to his patient thinking the device was fully tested by the FDA for safety. He was wrong.
A 30-year-old man needs a hip replacement. His surgeon recommends a DePuy ASR XL Acetabular system because its metal-on-metal design is more durable and allows for a more active life. Following the doctor's recommendations, the young man gets the DePuy hip implant.
Then the hip implant fails. The young man is in extraordinary pain. His revision surgery reveals dead tissue and deteriorated bone, making it extremely difficult for his new implant to take hold. He takes a blood test that reveals extremely elevated levels of cobalt and chromium. He is now hypersensitive to metal and the surgeon warns him he may contract early-onset osteolysis.
The young man blames the surgeon for recommending the ASR XL Acetabular system in the first place? But the surgeon isn't the culprit in this scenario; he made the best recommendation he could for his patient. The surgeon is simply another victim of the real culprit: an FDA approval loophole called "substantial equivalence."
A surgeon has countless medical devices to choose from. In the world of hip implants, he's looking at numerous options. The surgeon naturally wants to give his patients the best implant possible for their situation, so he chooses only FDA-approved devices that have been rigorously tested for safety.
Or so he thinks. Does an FDA Endorsement Guarantee Hip Implants' Safety? The FDA has two processes for approving a new medical device: the premarket approval process,, and the premarket notification approval process. Similar as their names are, there is a world of difference between those two processes.
In the case of the patients who received an ASR XL Acetabular system, it may have been the difference between an improved quality of life with a working hip implant - or a drastically reduced quality of life with a faulty one. The premarket notification process is also known as the 510(k) process, and it includes the loophole of "substantial equivalence." The 510(k) process allows a product to go directly to market without full clinical testing if the manufacturer claims the medical device is "substantially equivalent" to another device already on the market.
According to FDA documents, a substantially equivalent product is one that is created for the same intended use as the previously approved products; has the same design, materials and technology; and raises no new concerns about safety or effectiveness.
Substantial equivalence was designed to prevent the 2-3 year waiting period for testing. If one hip implant is so similar to another device that it could be expected to get the same test results, what was the point of testing it?
One might argue "safety," but one would be naive to do so. Medical device companies pushed for the substantial equivalence loophole for an entirely different and far less altrustic reason: profits. Every year spent in testing is a year that hip implant isn't on the market earning money for the company.
A Pyramid Built on Sand For Johnson & Johnson and its subsidiary DePuy, the priority was on products, not patients. They claimed the ASR XL Acetabular System was "substantially equivalent" to no less than three other devices already on the market that had been tested for safety.
Every part of that statement would prove to be inaccurate. Companies are allowed to claim that their new product is substantially equivalent to more than one other product. For example, since they have to show that they have the same materials and technology as a previously approved product, a company might show that they used the same materials as one product and the same technology as another. For the ASR XL Acetabular system's 510(k) application, DePuy cited three different previously approved products saying that the ASR system was "substantially equivalent"-at least in part-to all three.
By this argument, you could get a safety approval from the FDA for a flying car with submarine without ever testing it - after all, it is "substantially equivalent" - at least in part - to an airplane, a car, and a submarine. What on earth would be the point in testing it again when the basic principles have already been proven safe?
The loophole gets even more absurd: companies are allowed to base their claims of "substantial equivalence" on products that were approved under the same 510(k) process.
One of the devices DuPuy used was approved with one device-that had been approved through another device-that had been approved through a third device-that was approved because it was substantially equivalent to a product grandfathered into the system prior to 1976.
Essentially, DePuy was claiming that their product was substantially equivalent to hip replacements manufactured before the FDA was ever in place
Not a single hip implant in this chain of FDA was ever subjected to clinical trials before it was allowed to go to market. Even if it had been, it seems laughable that a hip implant "substantially equivalent" to a series of pre-1976 implant could ever make it through the FDA. Has technology developed so slowly that the best implants on the market are based on designs from 40 years ago?
Put it into perspective: the ASR XL Acetabular system was marketed to younger people who needed a longer-lasting, more durable hip replacement. That means many of the recipients got a hip implant based on a design older than they were.
Only 10% of applications submitted under the 510(k) process are ever returned with a request for clinical trials. That means that 90% of the Class III hip implants available today were never tested in a clinical setting before being marketed to the public.
It's a wonder there haven't been more problems with these hip implants. How many of us would willingly submit to the medical procedures of 40 years ago?
Testing the DePuy Hip Implant Takes a Backdoor to Profits Had thorough clinical testing been done, it would have become clear long before the product went to market that the ASR XL Acetabular system had a revision rate of at least 15% and possibly more, not to mention a much higher rate of metallosis, metal poisoning, bone deterioration, and tissue damage.
Had DuPuy gone through the more rigorous PMA process with the FDA, it's likely the ASR system would never have been sold to the public. But then again, that was probably why DePuy didn't go through the more rigorous process. The 510(k) process and substantial equivalence meant that DePuy could start making profits off their hip implants much more quickly. Why risk losing the profits just because the device can't be proven safe?
While we acknowledge that companies need to make profits, companies who make medical devices such hip implants must be driven by consumer safety above all else. Willingly causing pain and suffering to thousands of people in exchange for a payoff makes DePuy "substantially equivalent" to a hired thug.
It's a harsh comparison - but one that holds up much better under scrutiny than the ASR XL Acetabular System.
Then the hip implant fails. The young man is in extraordinary pain. His revision surgery reveals dead tissue and deteriorated bone, making it extremely difficult for his new implant to take hold. He takes a blood test that reveals extremely elevated levels of cobalt and chromium. He is now hypersensitive to metal and the surgeon warns him he may contract early-onset osteolysis.
The young man blames the surgeon for recommending the ASR XL Acetabular system in the first place? But the surgeon isn't the culprit in this scenario; he made the best recommendation he could for his patient. The surgeon is simply another victim of the real culprit: an FDA approval loophole called "substantial equivalence."
A surgeon has countless medical devices to choose from. In the world of hip implants, he's looking at numerous options. The surgeon naturally wants to give his patients the best implant possible for their situation, so he chooses only FDA-approved devices that have been rigorously tested for safety.
Or so he thinks. Does an FDA Endorsement Guarantee Hip Implants' Safety? The FDA has two processes for approving a new medical device: the premarket approval process,, and the premarket notification approval process. Similar as their names are, there is a world of difference between those two processes.
In the case of the patients who received an ASR XL Acetabular system, it may have been the difference between an improved quality of life with a working hip implant - or a drastically reduced quality of life with a faulty one. The premarket notification process is also known as the 510(k) process, and it includes the loophole of "substantial equivalence." The 510(k) process allows a product to go directly to market without full clinical testing if the manufacturer claims the medical device is "substantially equivalent" to another device already on the market.
According to FDA documents, a substantially equivalent product is one that is created for the same intended use as the previously approved products; has the same design, materials and technology; and raises no new concerns about safety or effectiveness.
Substantial equivalence was designed to prevent the 2-3 year waiting period for testing. If one hip implant is so similar to another device that it could be expected to get the same test results, what was the point of testing it?
One might argue "safety," but one would be naive to do so. Medical device companies pushed for the substantial equivalence loophole for an entirely different and far less altrustic reason: profits. Every year spent in testing is a year that hip implant isn't on the market earning money for the company.
A Pyramid Built on Sand For Johnson & Johnson and its subsidiary DePuy, the priority was on products, not patients. They claimed the ASR XL Acetabular System was "substantially equivalent" to no less than three other devices already on the market that had been tested for safety.
Every part of that statement would prove to be inaccurate. Companies are allowed to claim that their new product is substantially equivalent to more than one other product. For example, since they have to show that they have the same materials and technology as a previously approved product, a company might show that they used the same materials as one product and the same technology as another. For the ASR XL Acetabular system's 510(k) application, DePuy cited three different previously approved products saying that the ASR system was "substantially equivalent"-at least in part-to all three.
By this argument, you could get a safety approval from the FDA for a flying car with submarine without ever testing it - after all, it is "substantially equivalent" - at least in part - to an airplane, a car, and a submarine. What on earth would be the point in testing it again when the basic principles have already been proven safe?
The loophole gets even more absurd: companies are allowed to base their claims of "substantial equivalence" on products that were approved under the same 510(k) process.
One of the devices DuPuy used was approved with one device-that had been approved through another device-that had been approved through a third device-that was approved because it was substantially equivalent to a product grandfathered into the system prior to 1976.
Essentially, DePuy was claiming that their product was substantially equivalent to hip replacements manufactured before the FDA was ever in place
Not a single hip implant in this chain of FDA was ever subjected to clinical trials before it was allowed to go to market. Even if it had been, it seems laughable that a hip implant "substantially equivalent" to a series of pre-1976 implant could ever make it through the FDA. Has technology developed so slowly that the best implants on the market are based on designs from 40 years ago?
Put it into perspective: the ASR XL Acetabular system was marketed to younger people who needed a longer-lasting, more durable hip replacement. That means many of the recipients got a hip implant based on a design older than they were.
Only 10% of applications submitted under the 510(k) process are ever returned with a request for clinical trials. That means that 90% of the Class III hip implants available today were never tested in a clinical setting before being marketed to the public.
It's a wonder there haven't been more problems with these hip implants. How many of us would willingly submit to the medical procedures of 40 years ago?
Testing the DePuy Hip Implant Takes a Backdoor to Profits Had thorough clinical testing been done, it would have become clear long before the product went to market that the ASR XL Acetabular system had a revision rate of at least 15% and possibly more, not to mention a much higher rate of metallosis, metal poisoning, bone deterioration, and tissue damage.
Had DuPuy gone through the more rigorous PMA process with the FDA, it's likely the ASR system would never have been sold to the public. But then again, that was probably why DePuy didn't go through the more rigorous process. The 510(k) process and substantial equivalence meant that DePuy could start making profits off their hip implants much more quickly. Why risk losing the profits just because the device can't be proven safe?
While we acknowledge that companies need to make profits, companies who make medical devices such hip implants must be driven by consumer safety above all else. Willingly causing pain and suffering to thousands of people in exchange for a payoff makes DePuy "substantially equivalent" to a hired thug.
It's a harsh comparison - but one that holds up much better under scrutiny than the ASR XL Acetabular System.
What is the FDA Approval Process for Hip Implants?
Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
Johnson Takes $3 Billion Hit on Hip Recall
Johnson & Johnson took quarterly charges of more than $3 billion, largely related to the recall of artificial hips, and gave a 2012 earnings forecast below analysts’ estimates on Tuesday.
The company’s DePuy Orthopedics unit issued an extensive recall of its “metal-on-metal” hip replacement devices in 2010 after they shed metal fragments, causing disabling injuries.
The fourth-quarter charges will allow money to be set aside for patients and lawyers involved in product liability litigation.
“The hip recalls worry me because their eventual costs are unknown,” said Jeff Jonas, an analyst at Gabelli & Company, who noted that the fourth-quarter charges included $800 million for medical costs of the recall.
The company forecast 2012 earnings of $5.05 to $5.15 a share, compared with the consensus Wall Street view of $5.21.
William Price, a company spokesman, said most analysts had not factored in damage from the stronger dollar.
Johnson & Johnson reported better-than-expected fourth-quarter earnings, helped by favorable taxes and sales of new prescription drugs. The company earned $218 million, or 8 cents a share, in the quarter. That compares with $1.9 billion, or 70 cents a share, a year earlier, when it also took charges for recalls of hip replacement devices.
Excluding special charges, Johnson & Johnson earned $1.13 a share. Analysts had expected $1.09, Thomson Reuters said.
Johnson & Johnson, which is based in New Brunswick, N.J., said global sales rose 3.9 percent in the quarter, to $16.26 billion, slightly below analysts’ target.
Source : nytimes
Depuy Hip recall attorney | asr hip lawsuit | depuy pinnacle hip replacement dangers | hip recall lawsuit help
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