Monies Set Aside for Pinnacle and ASR Hip Implant Lawsuits Continues to Increase

As the number of lawsuits against DePuy and its parent company Johnson & Johnson increase, one can only wonder if this increased litigation is responsible for the huge amount of money Johnson & Johnson continues to set aside. The DePuy ASR hip implant was recalled in 2010 after it was found the metal components were rubbing against one another, causing tiny metal ions to shear away from the hip implant and become lodged in the surrounding tissue or enter the bloodstream. The cobalt and chromium ions in the tissues led to hip failure, necrosis, bone loss, inflammation and chronic pain in many recipients of the ASR and Pinnacle systems.

Other recipients of the hip implants develed metal toxicity from the cobalt and chromium which migrated to the bloodstream. Symptoms of metal toxicity are serious, and the heavy metals can build up to dangerous levels in a recipient’s body before without their realizing it. Once the damage has been done by these toxic metals, there is little way to undo it other than have the implant recipient undergo a revision surgery to remove the metal parts which are causing the adverse health problems. 

As of a few short months ago over 6,000 people across the United States filed lawsuits against DePuy and Johnson & Johnson regarding the ASR while another 1,800 have filed suit claiming the DePuy Pinnacle hip implant to be defective as well. Following the recall, DePuy indicated it might consider reimbursement for medical expenses the company deemed “reasonable,” however in order to receive this nominal compensation, hip implant victims were forced to sign away very important rights. 

The DePuy metal-on-metal hip implants which have caused the problems—the Pinnacle and ASR—could lead to many recipients having to undergo a second surgical procedure to remove the defective hip. This past August, DePuy and Johnson & Johnson entered into the first agreement to settle an ASR lawsuit, ending a case brought by three people in Nevada state court. Another state court case is scheduled to begin in early 2013 in Maryland, and the combined multi-district litigation ASR cases will begin in May, 2013, with the second round starting in July, 2013. 

Relevant FDA Communications on Urogynecologic Mesh

The following article will give the reader a comprehensive overview of the FDA’s communications to date concerning surgical mesh when used transvaginally in pelvic organ prolapse surgeries. The article An Appraisal of the Food and Drug Administration Warning and Urogynecologic Surgical Mesh, published in the Current Urology Reports (2012, 13:231-239) gives an overview of the FDA’s conclusions regarding the use of surgical mesh in POP surgeries. The first Public Health Notification issued by the FDA came out in 2008 after over a thousand women submitted adverse health reports following transvaginal surgery using gynecologic mesh. Three years later the FDA issued an update to that report regarding the safety and effectiveness of mesh in POP surgery. At this time the agency reviewed the currently available safety data and scientific research on gynecologic mesh.

This article states that it is estimated that over a third of pelvic organ prolapse surgeries implement surgical mesh and that 75% of all these surgeries were done transvaginally. These numbers come from the over 300,000 women who undergo pelvic organ prolapse surgery annually in the U.S. and over 260,000 who undergo a surgical procedure for stress urinary incontinence. The FDA states that as far as SUI surgeries go, “more than 80% were done transvaginally with mesh.” The FDA’s conclusion is that although POP surgery done transvaginally may restore the woman’s body anatomically, there are few if any benefits over surgeries which do not implement urogynecologic mesh. 

How Effective have the FDA’s Warnings on Urogynecologic Mesh Been?

This article will detail the relative effectiveness of warnings issued by the FDA regarding Urogynecologic mesh use. According to the article, An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh, published in Current Urology Reports (2012, 13:231-239) manufacturers market surgical mesh kits with a goal of increasing speed and ease of placement. The FDA reports over the past few years have sought to increase the awareness of the potential risks of surgical mesh when used in a transvaginal surgical procedure despite manufacturer’s claims.

More and more often reports are coming out which emphasize the fact that surgeons who use these mesh kits must have specialized training which enables them to “recognize and manage the complications of surgical mesh implants.” Governmental regulation of these mesh devices has also come under fire; while there are many different agencies in charge of regulation and reporting, women have nevertheless been harmed by transvaginally placed mesh implants. 

FDA Warnings on Urogynecologic Mesh: An Overview

This article will detail the original warnings the FDA issued regarding urogynecologic mesh when used in pelvic organ prolapse surgical applications. According to an article titled An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh published in Current Urology Reports (2012 13:231-239), permanent surgical mesh has been used in various applications for several decades, having been used in the repair of hernias since the 1950’s.

The FDA’s July 2011 report on Urogynecologic Surgical Mesh defines surgical mesh as “a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.” Beginning in the 1970’s surgical mesh made its appearance in abdominal surgeries for pelvic organ prolapse, then in the 1980’s surgeons began using synthetic slings in the treatment of stress urinary incontinence. It was not until 1996, however, that the FDA approved a type of mesh particularly for use in stress urinary incontinence surgical procedures. Some six years later, in 2002, the Federal Drug Administration approved surgical mesh as an application for the treatment of pelvic organ prolapse. 

Consolidation of Stryker Rejuvenate Hip Lawsuits Placed in New Jersey

The state of New Jersey is expected to consolidate at least ten Stryker Rejuvenate and ABGII hip implant lawsuits before one judge in order to expedite the handling of these cases. Multi-district and multi-county litigation is described by Class Action Litigation website as a procedure utilized by federal and state courts to transfer all pending cases which are very similar in nature before one judge. This procedure allows lawsuits to move in a more expeditious manner through the discovery phase while still allowing the injured party to seek an individual trial and have their settlement adjusted based on the degree of injury. This is unlike class action lawsuits which dictate that all members share equally in the settlement even though it is unlikely that all injuries would be equal. The first ten cases are coming from Florida, Minnesota, New Jersey and Arizona. Hackensack, NJ was chosen as the consolidation point because it is close to Stryker headquarters.

Sales Dip for Stryker Following Hip Implant Recalls

Stryker sales have shown a definite dip in the quart since the recall of the Stryker Rejuvenate and ABGII hip implants in July. The hip implant recall came just months after Stryker issued an Urgent Field Safety Notice to hospitals and physicians in April of 2012 citing the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release. Stryker’s hip implant sales dropped nearly 10 percent while its knee implant sales dropped 4.3 percent.

Why the Dip in Revenues?

A Stryker company official stated the recalls of the Rejuvenate and ABGII had only a “modest impact” on the company’s third quarter drop in sales. While the recalls certainly would have impacted Stryker’s revenues, the overall economy may also have played a part. Joint replacement surgical procedures are considered elective most of the time. Those with insurance may delay the surgery to avoid missing work while those without insurance likely cannot afford the procedure. Stryker’s CFO, Curt Hartman also stepped down after two decades at the helm. He reportedly received a 1.5 million dollar separation package although he will remain as an adviser to Stryker through February, 2013. 

Why Diagnosing Problems in Stryker Rejuvenate Hip Implants is So Difficult

When the Stryker Rejuvenate and ABGII were recalled in July of 2012, citing potential risk of fretting and corrosion at the neck juncture, many of the implants had already been removed during revision surgeries. Unfortunately, since most physicians were unaware of the problems with the implants, the operative reports were unlikely to list this corrosion. In other words, since the doctors hadn’t been told what issues to look for, there were few records stating that corrosion was a factor in the revision surgery. When Stryker originally told hospitals and surgeons (in an Urgent Field Safety Report in April of 2012) that there could be corrosion or fretting and release of metal ions, there was still no mention of that corrosion occurring anywhere except at the neck juncture.

Therefore, the neck juncture would likely have been the only place physicians would have examined when taking out the implant. In the same vein, when implant recipients came to their doctor complaining of pain or other symptoms, the doctor would have ordered x-rays, an MRI and a bone scan. Again, without clear information regarding what to look for, many physicians might have attributed their patient’s complaints to external issues such as the aging process.  The Rejuvenate, unlike former metal-on-metal hip implants, is a four-part device with a ceramic ball and a plastic liner in the cup. Because of these improvements, it was believed there would be no metal parts rubbing against one another causing metal ion shear. 

Stryker Rejuvenate Hip Implant: What is the Real Problem?

Just this past July Stryker Orthopedics issued a voluntary recall of their Rejuvenate and ABGII hip implant systems citing a potential for fretting and corrosion at the metal neck junction. The FDA convened a panel shortly before this recall to discuss the merits of continuing to use metal-on-metal hip implants due to the high number of complications suffered from recipients. The design of the Rejuvenate was believed to overcome most issues associated with the all-metal hip implants as it allowed surgeons to custom-fit the stems and necks of the implants to the size and relative activity level of the patient.

The Rejuvenate Design

The Stryker Rejuvenate consists of a ceramic ball which fits into a plastic-lined socket. Because there was no metal-on-metal ball and socket it was believed there were no metal surfaces which could potentially rub against one another, causing metal ion debris to enter the surrounding tissue or bloodstream. The Rejuvenate is essentially a two-piece system in that the properly sized metal stem and neck connect to one another then connect to the ceramic ball. The neck is made of chromium and cobalt, just like the all-metal implants and the stem is coated with titanium. Even so, by using a ceramic ball and a plastic-lined socket, it was believed there would be no issues regarding metal ion debris.

Motorcycle Accidents in the State of Texas

As motorcycle riding has grown in popularity over the past decade it might surprise some to realize that a large portion of these additional motorcyclists are comprised of the “over-fifty crowd.” Contrary to the stereotype of the motorcyclist who drives recklessly and too fast, this group of motorcyclists generally drive their bike in the same manner they drive their automobile—safely and respectful of the other drivers on the road.

Texas Motorcycle Facts

Although the nation has seen a decline in the overall number of motorcycle fatalities, the state of Texas has actually had an increase in motorcycle deaths, with the majority of these deaths occurring in those between the ages of 20 and 29. It can be traumatic for anyone involved in an accident of any type however those who are injured in a motorcycle accident are much more likely to suffer death or serious injury.  There is little to no protection for the motorcycle rider when he is hit by a three-thousand (or more) pound hunk of metal, steel and glass.

What Happens Following a Trucking Accident?

There are nearly half a million collisions involving large commercial trucks each year; as many as 5000 of those involve fatalities with the state of Texas having between 250 and 450 trucking fatalities annually. In fact, the fatal crash rate for large trucks is 2.4 deaths per 100 million vehicle miles traveled which is fifty percent higher than the rate for other vehicles on the road. Because of the great disparity in size between a loaded commercial truck and a passenger vehicle 98 percent of these trucking fatalities are occupants of the smaller vehicle. A normally loaded 18-wheeler can take up to 350 feet to come to a stop while an overloaded truck will take an even longer distance.

Factors in Trucking Accidents

Trucking accidents are the result of a variety of factors including truck driver error, distraction or fatigue, mistakes on the part of the driver of the passenger vehicle, and mechanical failures which are common to 18-wheelers. The scores of victims of trucking accidents may wonder how the system which is meant to keep us safe has failed time after time. Those who survive a trucking accident likely find themselves totally immersed in the health of those involved in the accident, particularly in instances where injuries are extremely serious. The focus is on medical care and the ongoing treatments required leaving little time or energy to contemplate the medical bills stacking up, the lost wages which are resulting in regular bills going unpaid and the long-term effects resulting from the trucking accident. Those involved in a trucking accident may have wondered what the “other side” was doing in the days and weeks following the collision. 

When Trucking Accidents Occur in the State of Texas

The City of Houston is well-known for the number of large commercial trucks which share the roadways with other vehicles. Because the Houston area is a primary shipping route, with over three million residents in Houston and outlying areas, it is considered one of the busiest thoroughfares in America. There is also considerable truck traffic resulting from the surrounding petroleum-transport areas as well as the many 18-wheelers from out of state which continuously travel through the Houston area. When you factor in the amount of truck traffic in the area you can see that accidents are much more likely to happen simply due to the sheer volume of truck traffic.  In 2008 Houston saw 421 fatalities involving large commercial trucks and although that number was down to 284 fatalities by 2010, the numbers are still sobering.

Why 18-Wheelers are Dangerous to Smaller Vehicles

The Houston area accounted for approximately 8 percent of all fatalities associated with trucking accidents in the entire United States. Considering the sheer size of an 18-wheeler—particularly when it is fully loaded—in the event a truck crashes into a passenger vehicle, those in the smaller vehicle are obviously at a clear disadvantage. Even though trucks are now required to have under-ride bars at the rear, when a passenger car runs into the back of an 18-wheeler the impact is four times as likely to cause death than when the reverse is true (when the 18-wheeler rear-ends a passenger vehicle). A loaded truck easily weighs 20-30 times as much as a passenger vehicle meaning it takes a good forty percent longer distance to come to a complete stop. In the end, when an 18-wheeler collides with a smaller vehicle it is highly likely there will be serious injuries or death.

When Truckers Take to the Road Do They Look Out for Your Safety?

You’ve probably noticed drivers who are texting, talking on their phones, applying makeup, eating, or any number of other activities which distract them from driving and put other drivers and passengers at risk. Now, imagine that person who is not paying attention to the road is a truck driver. When you consider that a fully loaded truck needs the length of a football field to come to a complete stop—assuming it is traveling 60 mph on a totally dry road--you can see that when a truck driver is distracted, even for a moment, a tragic accident can result. The most recent federal regulations mandate shorter braking distances for commercial trucks however don’t affect existing 18-wheelers, only newly manufactured trucks.

While all drivers should avoid distractions which can lead to accidents, there is a large disparity between a crash between passenger vehicles and a crash involving a commercial truck and a passenger vehicle. A fully loaded truck is 20-30 times as heavy as a passenger vehicle and in a collision between the two the passengers in the smaller vehicle rarely fare well. Of the half a million trucking accidents in the United States each year approximately 5,000 of those will result in fatalities and a large percentage of the remainder will result in very serious injury to those in the passenger vehicle. Truck drivers are constantly under pressure to get their loads delivered; both from their employers and even from their own family members as their paycheck depends on the time they spend behind the wheel of the truck.

Miss the Filing Deadline for Your DePuy ASR Hip Case? There May Still Be Hope

Despite the fact that the August, 2010 recall of the DePuy ASR metal-on-metal hip implant caused a significant stir among the medical community, thousands of recipients of the metal implant remained unaware of recall and subsequent warnings. Due to the initial FDA notice which was issued July 17, 2010 and the recall of the implant on August 24, 2010, all those who live in a state which operates under a two-year statute of limitations may have already lost their right to file suit against DePuy and Johnson and Johnson. Over half of the states do operate under that two year SOL, while others extend that time limit to three, four, six or even ten years. A handful of states have a one-year statute of limitations.  If you are the recipient of a DePuy metal hip implant it’s important that you determine your state’s statute of limitations for defective medical products even if you are currently having no problems with your implant.

Although DePuy originally set their metal implant’s failure rate at approximately 5%, they increased that number to 12% at the time of the 2010 recall. Independent studies place the likelihood of a DePuy ASR implant failure much higher—50% at five years following implant surgery and 80% at eight years following implant surgery. Statistically speaking, even those patients who have not yet experienced failure of their hip implant or adverse health effects from metal toxicity will do so in the very near future. It is extremely important that all DePuy ASR implant recipients at least be aware of their options prior to the date the statute of limitations will run.

In some states the statute of limitations begins at the time the “injury” actually occurs, however in the case of a hip implant this date can be impossible to determine since the recipient may not experience problems for months or years following the implant.  In such cases the statute of limitations begins to run when the injured person should have known there could be an issue with their hip implant, which is likely when the recall was issued in August of 2010 or when the FDA warnings were issued in July of 2010. The problem with metal hip implants is that most of the harm and adverse health effects associated with the DePuy ASR hip implant do not fully manifest for three to six years following implantation.

The DePuy ASR Metal-on-Metal Hip Implant: A Scientific Analysis of its Problems

The last ten years have seen surgical replacement of hip joints with an artificial prosthesis increase significantly. The main reason for this surge in hip replacement surgeries is our aging population. With people living longer, more active lives, degenerating hip joints can put a halt to that activity. From 1997 through 2004, the number of hip replacement surgeries increased nearly 50% and if the trend continues it is estimated that the annual number of hip replacements in the United States will reach 600,000 by 2015.

Factors in Hip Replacement Surgery

Primary reasons for patients undergoing hip replacement surgery include chronic pain, impairment of daily functions and severe arthritis in the hip joint. The most common type of arthritis leading to total hip replacement is osteoarthritis and is generally seen with aging or trauma to the hip joint. In some instances necrosis of the hip can be present, usually caused by a fracture, alcoholism, lupus, or taking steroid drugs such as prednisone. Patients may experience progressively worsening chronic pain which prohibits them from walking, climbing stairs or even getting up from a sitting position.

Types of Hip Implants

There are many different types of hip replacement implant including the metal-on metal, metal-on-polyethylene and metal-on-ceramic as well as the implants which are 100% ceramic or polyethylene. Other than the materials the implant is constructed with, the only other major difference is in how the implant is affixed—it can be cemented to the bone or attached in such a manner that it grows into the patient’s remaining bone. The idea behind the cobalt and chromium metal-on-metal hip implant was to create an implant which would not have to be re-done for fifteen to twenty years—unlike the ceramic and polyethylene hip implants which last approximately 8-12 years.

While metal-on-metal hip implants were actually used as far back as 1955, they were not FDA approved until 1999. Crude attempts at implanting stainless steel devices in the hip joint actually first occurred in 1937 using stainless steel components fitted to the bone with bolts and screws.  According to an article by John M. Restaino titled The Science, Medicine, Epidemiology and Liability Analysis of the DePuy ASR Metal-on-Metal ProstheticImplants, between October 1, 2005 and December 31, 2006 approximately 35% of the hip replacement surgeries implemented a metal-on-metal implant.

First Three DePuy Cases settled by Johnson & Johnson for over $600,000

The DePuy metal-on-metal hip implant, approved by the FDA a mere seven years ago—has been inundated with over 8,000 lawsuits claiming the implant is inherently defective and can lead to costly and painful revision surgery as well as a myriad of other serious health issues. DePuy initially claimed the failure rate of the ASR metal hip implant to be between 4-5%. When DePuy voluntarily recalled the implant in 2010, they upgraded the failure rate to approximately 12% within the first five years. Studies independent of DePuy or Johnson & Johnson place the failure rate of the ASR metal implant at 50% within six years and 80% within eight years. These staggering numbers almost guarantee that this particular metal-on-metal hip implant will fail at some point in the majority of recipients.

Nearly a hundred thousand ASR devices were implanted worldwide prior to the recall with nearly forty thousand in the United States alone. The propensity of the implant to loosen and detach as well as the thousands of reports regarding adverse health effects from high levels of chromium and cobalt have led to over 6,000 lawsuits filed in federal court an another 2,000 filed at the state level in Maryland, California, Nevada and other states. Johnson & Johnson recently settled three Nevada cases for $600,000—an amount considered to be at the low end of the expected $200,000-$500,000 to settle each case. 

“ASR” type Chromium and Cobalt Poisoning also being seen in Pinnacle Hip Implant Recipients

The DePuy ASR metal-on-metal hip implant has repeatedly made the news following a voluntary recall on August 26, 2010. While DePuy’s Pinnacle metal hip implant has not suffered under the recall stigma, many feel that it offers the same risks to implant recipients as the ASR. And, in fact, many attorneys are constantly asked by their clients about the differences between the ASR and the Pinnacle. The primary distinction between the two metal hip devices lies in the fact that the Pinnacle uses an insert liner between the acetabular cup and the femoral head while the ASR does not. It has been theorized that the ASR cup was too shallow for the head, leading to the ball hitting the edge of the cup and metal shavings to shear off into the body, also know as edge-loading.

While the Pinnacle’s cup was designed to give greater depth and allow the femoral head to move more freely within the socket, in some cases it still has been know to cause metallosis in implant recipients when the cobalt and chromium ions migrate around the body. Metal poisoning can cause a wide variety of adverse medical events. Many ASR recipients have had cardiovascular, renal, neurological and thyroid issues although studies done in the 70’s do not definitively tie these metals to cancer. Unfortunately, due to the lack of comprehensive studies on safe levels of cobalt and chromium in the body and the effects of toxic levels, nobody really knows just how dangerous these metals can be should they migrate to the bloodstream. The metal shards can also lodge into the surrounding tissues causing degeneration and destruction. 

Attorneys of Sullo & Sullo Seeing DePuy Hip Implant Lawsuits Increasing

While many other firms have seen a drop in the number of metal hip implant clients, Sullo and Sullo attorneys have actually seen those numbers climb. Andrew Sullo, Class Action Lead Counsel & Managing Partner notes that “Although many firms have noticed a slowdown in the number of clients hiring them for DePuy ASR and Pinnacle lawsuits, our firm has not. I believe that is because we are constantly offering our clients new and updated information. Our job is to inform all metal-on-metal hip recipients that even though their hip may not have failed yet, it could and after August 26^th they may lose rights to recover compensation from Johnson and Johnson.”

With the statute of limitations coming up soon on the ASR metal-on-metal hip implant lawsuits, Sullo & Sullo is experiencing an increase in the ASR recipients who are coming forward and asking to be a part of the lawsuit. Many clients in the lawsuit have experienced adverse health effects as a direct result of having an ASR all metal hip implant put into their body.  On the other hand, many have experienced little or no pain with their ASR hip implant but have elected to join the lawsuit that they can be financial protected at a point in the future should their ASR device fail. Through no fault of their own, these people have become victims of a heavily flawed system which allows harmful medical devices to be sold to the public. The ASR was approved in 2005 by the FDA under the controversial 510(k) process which allows medical devices to essentially ride in on the coattails of other medical devices which have come before them. In some cases approval is granted based on a device which has actually been discontinued because of the number of problems associated with it.

Current Updates on the DePuy ASR Hip Recall

The DePuy ASR metal-on-metal hip implant was approved in 2005 by the FDA, but soon thereafter both DePuy and the FDA began receiving reports of adverse health events. Some believe that the much less rigorous 510(k) approval process which allows manufacturers to skip clinical trials could be at least partially responsible for the adverse health effects in the thousands of ASR recipients. Following a flurry of complaints, DePuy voluntarily recalled the ASR on August 26, 2010. At present there are approximately 4000 DePuy ASR lawsuits consolidated into an MDL in Ohio as well as a smaller mini-state consolidation in Chicago with approximately 600 plaintiffs and another in California containing 1500 or so plaintiffs. Since California is experiencing so many financial problems, the plaintiffs and their attorneys are expected to face problems in getting a trial setting.

The MDL, or multi-district litigation system is meant to streamline the litigation process, taking advantage of the fact that there are similar allegations from all plaintiffs made against the defendants—in this case DePuy and Johnson and Johnson. The first trial regarding the ASR was scheduled to begin in state court in Las Vegas in mid-December although it has been rumored the case settled prior to trial. Should this be true, it would be a positive precedent for all other ASR lawsuits to follow. The metal-on-metal design came about due to its ability to last significantly longer than the metal-on-ceramic or metal-on-plastic hip implants. Unfortunately, the metal-on-metal design allowed the cobalt and chromium ball and cup to shave off microscopic metal ions into the body, entering the surrounding tissues or even the bloodstream. The FDA recently held a two-day panel to discuss the safety of the metal hip implant.

Is Joining the DePuy ASR Class Action Lawsuit still an Option for Recalled DePuy ASR Hip Implant Recipients With No Pain?

Andrew Sullo, Class Action Lead Counsel & Managing Partner at Sullo & Sullo is working hard to ensure that every single recipient of the DePuy ASR metal-on-metal hip implant is fully aware of both the recall on August 26, 2010 and the upcoming statute of limitations expiration for those who reside in states which implement the two-year statute. There are over 40,000 people who have received an ASR implant in the United States. The ASR was approved by the FDA in 2005 and began being widely used by surgeons who believed the metal-on-metal design would last much longer than the metal-on-ceramic or metal-on-polyethylene models.

Unfortunately, adverse health reports began pouring in with over 17,000 such reports received by the FDA regarding these all metal hip implants. Of those thousands of recipients, there are only approximately 6,000 who have joined into the MDL lawsuits against DePuy. While this might cause some to wonder if the risks of the ASR have been exaggerated, there are other factors involved. First of all, many recipients may not have heard the device was recalled or may truly have no idea what type of implant was used in their surgery. Second, many recipients of the ASR and other hip implant devices are senior citizens who may believe the symptoms they are experiencing are related to advancing age rather than attributing them to the ASR implant.

Finally, many of those who have not come forward to take part in the lawsuits state they are not having any problems with the ASR at present, so why would they sue the company? This is very flawed logic in this particular instance. Although the failure rate of the ASR was originally stated by DePuy to be in the 12-13% range—still much higher than the average of .5-5% failure rates—experts in the field have estimated that by six years following the initial surgery nearly 50% of the ASR hip implants will have failed and by eight years following the surgery a staggering 80% will have failed. When you look at those numbers you can see that it is highly likely that at least half of those thousands of people who have not joined into the lawsuit will suffer a hip failure. In fact, Andrew Sullo notes that “More than 50% of our ASR hip recipient docket has already received revisions.”

Problems with the DePuy Pinnacle Hip Implant: Current Reports

As of this date the Pinnacle metal-on-metal hip implant device manufactured by DePuy has not followed in the recall footsteps of DePuy’s other hip implant, the ASR. While Johnson and Johnson and DePuy vigorously deny that the Pinnacle has any problems—and, in fact, call it the best metal-on-metal hip implant on the market today—many recipients of the device feel it has some of the same flaws as the ASR. Both the Pinnacle and the ASR are manufactured by Johnson and Johnson’s subsidiary company, DePuy. The Pinnacle made its debut in 2002 as the predecessor of the ASR which followed in 2005. The ASR is strictly a metal-on-metal hip implant device while the Pinnacle name includes metal-on-ceramic and metal on polyethylene models as well.

Nearly 150,000 Pinnacle all-metal hip replacements have been implanted compared to 93,000 ASR’s worldwide—approximately half of those in the United States alone. Both the Pinnacle and the ASR all-metal hip implants were approved under the controversial 510(k) FDA approval process. This particular process allows the majority of medical devices to get to market quickly by showing they are substantially comparable to a device which has already gained approval. The process also allows a product to get to market without expensive clinical trials however in some cases the approval process has been predicated on a device which is no longer marketed—even due to poor performance.

Chromium and Cobalt Poisoning: What are the Long Term Side Effects of Metallosis?

It is likely that the recipients of a metal-on-metal hip implant have heard about the possible consequences from the metal shavings which can be released into the body when the metal cup and ball rub against one another during normal activities. Tiny ions of cobalt and chromium shear off when the two surfaces meet and those ions can lodge in the surrounding tissues or can end up in the bloodstream. As more and more metal hip implant patients are realizing the seriousness of metal toxicity, blood testing for elevated levels of metals is increasing. In many cases patients have been found to have levels of cobalt and chromium in their bloodstream which are as much as a hundred times normal levels. 

Although slightly elevated levels of these metals are fairly normal for patients with metal-on-metal hip implants, extreme elevations can be very dangerous—and anxiety-producing for the patient. DePuy released a report indicating that concentrations of the metals greater than 7 parts per billion are cause for concern. The Mayo Clinic has set somewhat different reference values, stating that blood serum concentrations of chromium greater than 1ng/mL suggests significant wear of the metal implant while serum concentrations greater than 5.0 ng/mL of cobalt can be considered toxic and also suggest significant wear of the prosthesis. Remember that 1 PPB (part per billion) equals 1.0 ng/mL.

Johnson & Johnson Hip Implant Settlement: Filing Deadlines are Approaching Fast

Many recipients of the ASR metal-on-metal hip implant are unaware of a crucial date which is fast approaching. The ASR was approved by the FDA in 2005 then labored under a flurry of adverse reports regarding early failure rates. Finally, on August 26, 2010, DePuy recalled the ASR, citing failure rates of around 12-13%--as opposed to their initial reports of 4-5% failure rates. What this means is that among the 26 states which operate under the two year statute of limitations, there is less than a month left to join in the multi-district lawsuits against DePuy. Of the more than 40,000 recipients of the ASR in the U.S. alone, only about 6,000 of those have joined in as plaintiffs in the DePuy suit. This means there are over 35,000 ASR recipients out there who have yet to come forward.

There may be several reasons for this including the fact that many of these people may be unaware of the recall. Others may be elderly recipients of the metal ASR and are simply chalking their negative health symptoms up to the aging process. It is believed, however that a large number of those who have not joined in the lawsuit have not done so because they are not yet experiencing problems, therefore believe they have no rights under the current lawsuit. It’s important that this group of people be aware that the actual failure rate of the ASR has been estimated at 50% at six years and 80% at eight years. Considering the ASR metal-on-metal implant has only been on the market since 2005 you can see that the likelihood of thousands more recipients having serious problems from the device is huge.

Texas First Degree Felony Crimes and Consequences

By Independent Staff Writer

What is a First Degree Felony in Texas?

Criminal offenses in Texas are charged under the categories of misdemeanors and felonies.  Felonies are the most serious criminal offenses and carry the most severe penalties.  A felony is generally considered any criminal offense more serious than a misdemeanor, and that is punishable by imprisonment of more than one year.  A felony crime is classified as a State Jail Felony, Third-Degree Felony, Second-Degree Felony, First-Degree Felony, or a Capital Felony, the most serious being a Capital Felony that can bring a penalty of life imprisonment or death.

First Degree Felonies are among the most serious crimes in Texas, second only to capital felonies.  Examples of crimes that are considered First Degree Felonies include but are not limited to the following:

Penalties for Assault and Battery in Texas

By Independent Staff Writer

Assault charges in Texas can result from a simple threat or argument, a fistfight, or a violent attack with a weapon.  Assault charges range from misdemeanors to felony charges depending on the circumstances, and are taken especially seriously if injury occurs or if a weapon was used.  The penalties range from fines to prison terms depending on the severity of the assault and the circumstances of each case. Being faced with assault charges of any kind can have drastic negative consequences both personally and professionally.

Texas law defines assault as intentionally, knowingly, or recklessly:

• Causing bodily injury to another person, including the person’s spouse;
• Threatening someone with imminent bodily injury, including the person’s spouse; or
• Causing physical contact with another when the person knows or should reasonably believe that the other will regard the contact as offensive or provocative.

Classes of Misdemeanor Offenses in Texas

By Independent Staff Writer

Criminal offenses in Texas are divided into two main categories, felonies and misdemeanors.  Misdemeanors are considered lesser crimes than felonies and are divided into three classes based on the degree of seriousness of the offense and the severity of the punishments.  It is important to take misdemeanor charges seriously, because having a misdemeanor conviction on your record can impact your life in many negative ways.  You may have difficult time getting the job you want, being admitted to an institution of higher education, or even obtaining an occupational license.

Texas Driver’s License Fines and Suspensions

By Independent Staff Writer

A. The Texas Driver Responsibility Program and Points on Your License

Texas uses the Texas Driver Responsibility Program (DRP) adopted by the state legislature (TRC §708; Article 10, House Bill 3588, 78^th Legislative Session) to track individuals’ traffic violations, assign points to their records, and assess fines to drivers who receive or exceed a certain number of license points.  Not surprisingly, the point system has been an efficient revenue generator for the state.

Defining Felony Crimes in Texas

By Independent Staff Writer

Texas Felony Criminal Offenses

Criminal offenses in Texas are charged under the categories of misdemeanors and felonies.  Felonies are the most serious criminal offenses and carry the most severe penalties.  A felony is generally considered any criminal offense more serious than a misdemeanor and is classified as a State Jail Felony, Third-Degree Felony, Second-Degree Felony, First-Degree Felony, or a Capital Felony, the most serious being a Capital Felony that can bring a penalty of life imprisonment or death. Criminal felony charges of any kind are a very serious matter.  The penalties for conviction are severe and can have profoundly negative and damaging consequences to one’s personal and professional life for many years.  You may face difficulty in finding employment and may face financial problems.

How Strong is Your Pradaxa Case?

By Independent Staff Writer

If your doctor has prescribed the relatively new drug, Pradaxa, as an alternative to Warfarin, you may have been alarmed to hear of the potential issues with Pradaxa. Pradaxa was approved by the FDA in late 2010 after the manufacturer, Boehringer Ingelheim, presented the drug as a much better alternative to Warfarin, which had been used exclusively since the 1950’s as a treatment for the prevention of systemic embolisms and strokes. Pradaxa is used to treat patients with atrial fibrillation and works primarily by thinning the blood of the patient. While Pradaxa did appear to work slightly better than Warfarin, it has been shown to have serious side effects, some of them fatal.

How Does Pradaxa Work?

The primary issue with Pradaxa lies in how it works in the body. While both Pradaxa and Warfarin are used to prevent strokes in patients with atrial fibrillation, Warfarin works through the inhibition of Vitamin K in the body. Vitamin K is a clotting agent, and should Warfarin cause excessive bleeding in a patient, doses of Vitamin K can be administered to slow the bleeding. Pradaxa works by inhibiting an enzyme in the blood known as a thrombin. Thrombins are also responsible for controlling blood clotting, however at this time there is no known reversal agent to Pradaxa and should it cause excessive bleeding physicians have no way of slowing or stopping the bleeding. In the case of excessive bleeding among Pradaxa users they have no choice but to wait 12 to 24 hours until the drug has cleared their system, allowing the blood to clot as it should.
Unfortunately, some patients have bled so excessively they don’t have that amount of time. This has led to the death of several Pradaxa users, particularly those who are over the age of 75 or those with impaired renal function. The Pradaxa drug is also unique in how it gets into the patient’s system. The active ingredient in Pradaxa is actually contained in the outer shell of the drug while the encapsulated portion contains a core of tartaric acid. Scientists believe that this particular type of delivery system allows the drug to be mroe rapidly absorbed by increasing the acidity in the digestive tract. It is theorized that this delivery system can be responsible for major GI bleeds, and those who have experienced minor gastrointestinal symptoms may go on to have a excessive internal bleeding as a fairly minor ulceration turns into a serious or fatal hemorrhage.

Do I Have a Pradaxa Case?

If you have had adverse responses to the drug Pradaxa, your personal injury attorney will want to know whether those responses occurred prior to January, 2012, or after that date. This date is important because the FDA mandated changes in the warning labels of Pradaxa in January after receiving numerous adverse reports of serious side effects related to Pradaxa. It is believed that over 260 deaths have been directly tied to Pradaxa through uncontrollable bleeding incidents. Those who had an adverse response to Pradaxa prior to January of 2012 likely have a bit stronger case than those who had a negative incident after the FDA issued their warning. Those Pradaxa users who ended up with an extended hospital stay or died as a result of taking the drug whether through a gastrointestinal bleed, a hemorrhagic stroke or a trauma-induced atypical bleeding event, will likely hold a strong legal position against Boehringer Ingelheim.

Elderly patients with reduced renal functions are more likely to have experienced a serious side effect from Pradaxa since it builds up more quickly in the body. Any significant bleeding event can be responsible for a lack of blood flow to organs in the body which results in organ damage. While some organ damage can be reversible, others may not be. Pradaxa users have also experienced strokes and heart attacks as a result of taking the drug. Whatever damage you suffered as a result of taking Pradaxa, you have likely racked up significant medical expenses, lost time from work and suffered a substantial level of emotional distress, and may have a cause of action against the manufacturer of Pradaxa.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

Pradaxa (Dabigatran) and the FDA Safety Review

By Independent Staff Writer

Although only on the market for a relatively short period of time, Pradaxa, the blood-thinning drug manufactured by Boehringer Ingelheim—has already suffered under the weight of threatened recalls, lawsuits and warnings by the FDA. Pradaxa is the first FDA-approved drug of its type since the drug Warfarin was approved in 1954. Both Warfarin and Pradaxa are commonly prescribed as blood thinners to reduce the risk of stroke in patients with heart rhythm irregularities.

Warfarin was used almost exclusively until November of 2005 when Boehringer Ingelheim sponsored a clinical trial to determine the long-term safety and effectiveness of their “new kid on the block,” Pradaxa. The Pradaxa blood-thinning drug trial concluded in March of 2009 to rave reviews. More than 18,000 patients were enrolled in the trial across 44 countries. Boehringer announced that Pradaxa was able to significantly reduce the risk of stroke when compared to the older established drug, Warfarin, and that it had similar or even reduced risks of causing major bleeding in the body—depending on the dosage.

Pradaxa Receives FDA Approval
Pradaxa FDA approval came in October of 2010. The FDA approved Pradaxa as the first anti-coagulant drug approved for the prevention of stroke since the approval of Warfarin. The end of 2010 saw Boehringer Ingelhem Pharmaceuticals aggressively marketing Pradaxa across the United States, touting it as a much more effective alternative to Warfarin. Then, merely three months later, the pharmaceutical company saw the first of what was to be a series of blips on the radar of their new drug which was already adding millions of dollars to their coffers. This first snag was a minor one—the FDA issued a fairly benign alert, stating that Pradaxa must be kept in its original packaging in order to avoid the potential of moisture to cause the drug to break down and lose potency.

Boehringer Reports Increase in Sales
Still riding high in August of 2011, Boehringer reported its business had seen a sixty percent increase in net sales since the launch of Pradaxa in Canada, the United States and Japan. In fact, in less than twelve months on the market, over a million prescriptions for Pradaxa were dispensed to Americans, with nearly 400,000 patients receiving a Pradaxa prescription. Apparently Boehringer should have waited for the announcement of success. Three months later, in November of 2011, Boehringer Ingelheim reported that Pradaxa had been linked to 260 deaths worldwide, then the FDA issued a safety review of Pradaxa in December of 2011. At the end of 2011 the FDA reported they were evaluating reports of serious or even fatal uncontrolled internal bleeding incidents among Pradaxa blood-thinning drug patients.

Side Effects of Warfarin vs. Pradaxa
Although Warfarin is well-known by health care professionals to sometimes cause excessive bleeding there is a major—and significant—difference between the drugs. In an emergency which involves excess bleeding there are currently no medications known which can reverse the effects of Pradaxa, while in an emergency involving Warfarin, the effects can be reversed by giving the patient Vitamin K. The downside of Warfarin is that it requires several days to take effect and the patient taking Warfarin must undergo frequent testing to arrive at the proper dosage. Warfarin has also been known to react poorly with specific foods or other medications. While Pradaxa has none of these issues, Pradaxa patients are considered to have a 33% higher risk of a heart attack or other heart disease symptoms than the patient using Warfarin. Most alarming, however, is the potential with Pradaxa for excessive bleeding which cannot be stopped, possibly leading to death.

What is the FDA Doing About Pradaxa?
The FDA is currently conducting studies to determine whether the reports of excessive bleeding among patients who are taking Pradaxa is more common than previously expected. The FDA continues to assert that Pradaxa provides important health benefits when used as directed. These studies become more complicated since a wide variety of factors can influence whether or not adverse side effects are reported. After the FDA announced their intent to study the side effects of Pradaxa prior to making a recall determination, findings from a new study were published in a well-known medical journal which suggested there could be an increased risk of heart disease in patients taking Pradaxa as compared to Warfarin.

To date, the FDA has received over 900 reports of serious negative side effects involving Pradaxa as well as reports of 500 hospitalizations and the permanent disability of twenty-five people as a direct result of Pradaxa use. The Journal of the American College of Cardiology released a study showing Pradaxa users had a 16% increased risk of severe bleeding while Warfarin users had only a 6% increased risk.

No Recall, Lawsuits Filed
Although the FDA has not yet issued a recall, they do strongly advise any person taking Pradaxa who has experienced any negative side effects to see their physician immediately. Side effects can include bruising more easily than normal, dizziness or feelings of lethargy, a serious or prolonged headache, vomiting or coughing up blood, unusual or prolonged nosebleeds or bleeding from the gums, urine which is pink or brown-tinged or a weakness or swelling in the extremities. Just this month, the first three Pradaxa lawsuits have been filed, one of which claims the death of a Tennessee woman who suffered a gastrointestinal bleed while taking Pradaxa.

What You Should Do if You Take Pradaxa
Those patients who have put their belief and trust into a drug which has FDA approval and is physician-prescribed can end up feeling confused and overwhelmed when that same drug turns out to be unsafe and is found to cause serious, life-threatening side effects. Many people have suffered serious health issues as a result of taking Pradaxa—if you or a loved one has also suffered such issues you must take steps now to protect your rights and your future. Drug companies must be held accountable for allowing dangerous drugs to flood the market.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

Pradaxa (Dabigatran) Lawsuits

By Independent Staff Writer

March of 2012 saw the first lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa. This drug was the first of its type to be marketed in over half a century, and Boehringer had high hopes that Pradaxa would knock its only competitor, Warfarin, out of the running in short order. Pradaxa works differently from Warfarin; while both drugs are used to prevent stroke in patients with atrial fibrillation, Warfarin works by inhibiting the production of Vitamin K, a clotting agent in the body. Should there be excessive bleeding in a patient who has taken Warfarin, doses of Vitamin K can be administered to slow the bleeding. Pradaxa, on the other hand, works by inhibiting thrombin, an enzyme in the blood which also controls blood clotting. At this time there is no known antidote to Pradaxa in the event it leads to excessive or uncontrollable bleeding.

What is Atrial Fibrillation?

Atrial fibrillation affects more than two million Americans and is characterized by rapid, uncoordinated contractions in the upper chambers of the heart. Patients with atrial fibrillation are at a much higher risk of developing blood clots, and since the 1950’s doctors have been using Warfarin—which is also known as Coumadin—to help lessen the likelihood of stroke. The FDA approved Pradaxa for use in patients with atrial fibrillation in October of 2010, yet less than a year later reports were coming in regarding serious side effects and even death among Pradaxa users. In December of 2011, in the face of hundreds of adverse reports, the FDA issued a safety warning to patients and physicians, stating they would taking a hard look at the prior Pradaxa studies.

Pradaxa Timeline

Pradaxa was approved in October, 2010, and aggressively marketed as an alternative to Warfarin, yet between the drug’s approval and December of 2010, over 300 adverse event reports were filed with the FDA. Many of these adverse event reports involved serious bleeding, particularly in older patients. This first FDA review also revealed that Pradaxa was being prescribed for off-label use as a general blood thinner. This off-label use was at least in part attributed to Boehringer’s aggressive marketing techniques and failure to provide accurate prescription and warning information. In August of 2011 Japanese officials demanded that Boehringer notify physicians in their country about the potential for excessive or fatal bleeding in patients taking Pradaxa as well as the fact that there is no antidote to reverse bleeding. In November, 2011 Boehringer announced that at least 260 cases of fatal bleeding have been linked to Pradaxa and the next month the FDA announced it would be evaluating the drug further.

Pradaxa Lawsuits
February of 2012 saw a review of Pradaxa published in the Journal of American College Cardiology regarding patients who had experienced adverse bleeding while taking the drug. Hematologists in Australia and New Zealand noted a total of 78 severe bleeds in Pradaxa users in a relatively short amount of time. Then in March the Journal of Neurosurgery published an article detailing an 83-year old Pradaxa user who fell and bumped his head. Although the man appeared to have only a small hemorrhage in the brain, within six hours of the brain scan he fell into a coma and died. The doctors were unable to slow the bleeding and save the man’s life because there is no antidote to Pradaxa.

The first three landmark federal court Pradaxa lawsuits were filed this last week of March in Louisiana, Kentucky and Tennessee. It is likely that Pradaxa lawsuits will focus on Boehringer’s failure to sufficiently warn Pradaxa users about the potential for excessive bleeding or to provide instructions on what to do in the case of an uncontrollable bleed. A Tennessee woman is bringing one of the first three lawsuits on behalf of her elderly mother who suffered an uncontrollable gastrointestinal bleed following the use of Pradaxa. According to court records, after taking Pradaxa for only two months the woman was hospitalized for a gastrointestinal bleed which eventually caused her death.

Possibility of a Class Action Suit

Drug manufacturers are under strict legal obligation to warn consumers of any potential risks their product could present, and when they fail to issue these warnings they may be held accountable. As of this time there is not yet a Pradaxa class action lawsuit, and all complaints are being pursued as individual claims. As more cases come forward it is possible there may be a consolidation or centralization in one court for pretrial proceedings. Although similar to a class action suit each lawsuit remains an individual claim and will be weighed on its own merits.

No Recall–Yet

While the FDA did require a label change for Pradaxa in January of 2012 which added minimal information regarding the potential of the drug to cause excessive bleeding and the current lack of an antidote to this bleeding no black box warning or FDA recall is yet on the horizon. If you or a loved one has taken Pradaxa and suffered grave injury or death, you may have a product liability case against the manufacturer of Pradaxa.

Getting the Help You Need

Because the statute of limitations in product liability cases is relatively short—2 to 6 years depending on the state you reside in—there is a very limited window of time in which you are allowed to file a suit and obtain compensation for your injuries. Pradaxa victims may be entitled to monetary damages for medical expenses, lost wages and certain other damages the court may decide upon.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

The Dangers of Pradaxa (Dabigatran): Part 1 of 3: Side Effects and Complications

By Independent Staff Writer

The newest drug approved for use in the treatment of heart valve problems or atrial fibrillation among patients with an increased risk of stroke is the drug Pradaxa, manufactured by Boehringer Ingelheim. The drug Boehringer is seeking to replace with its newest arrival is Warfarin—a blood-thinning drug which has been used since the early 1950’s. Boehringer claims that Pradaxa is over 30% better in decreasing the risk of a serious stroke than Warfarin. The FDA initially agreed with Boehringer, granting FDA approval of Pradaxa in October of 2010.

What is Atrial Fibrillation and How Does Pradaxa Help?

Atrial fibrillation affects over two million Americans and involves excessively rapid, uncoordinated contractions of the upper two chambers of the heart. Those with atrial fibrillation are at a much higher risk of developing blood clots which in turn can lead to a disabling stroke should the clot travel to the brain. Pradaxa works by inhibiting thrombin, an enzyme in the blood which controls blood clotting.

Excessive Bleeding as a Pradaxa Side Effect?

In the initial trials, Pradaxa users suffered fewer strokes than patients taking Warfarin. Pradaxa also appeared to have other benefits over Warfarin in that Warfarin users must undergo blood test monitoring and must be more cautious in what foods and other medications they take while on Warfarin. Unfortunately, one of the primary issues with either drug involves Warfarin or Pradaxa internal bleeding. When the patient taking Warfarin experiences excessive bleeding, doctors can reverse the effects of the bleeding through injections of Vitamin K, however no such antidote exists to reverse the effects of Pradaxa when excessive bleeding occurs.

Gastrointestinal Dangers of Pradaxa

As with any prescription drug, side effects are possible and even likely. Pradaxa users may have an uncomfortable feeling in their stomach known as dyspepsia, pain in the stomach, excessive heartburn or nausea or bloating in the stomach. It has been suggested that Pradaxa may cause gastrointestinal effects due to the fact that, unlike most drugs, the active ingredient of Pradaxa is actually on the outside of the capsule, forming a shell around a Tartaric Acid Core. This core, once released, creates an acidic environment in the intestinal tract which allows quick absorption of the Pradaxa active ingredients.

More Serious Pradaxa Complications

More serious Pradaxa complications can include uncontrolled bleeding, potentially leading to death. If you are taking Pradaxa and experience any bruising that is unusual or unexpected, notice a pink or brown tinge to your urine, have unexpected swelling or pain in your joints, have a serious headache which lasts a long time, dizziness or weakness or red or black stools you must see your physician immediately as this can indicate internal bleeding. If you have any unusual bleeding in the gums, recurring nosebleeds, or a heavier than normal period you should also seek advice from your doctor. Those patients who are over the age of 75 or have kidney problems or a stomach ulcer should use caution when taking Pradaxa, as these issues make the likelihood of Pradaxa side effects and risks much more likely. Those whose kidney function is less than optimal could experience a greater incidence of Pradaxa side effects since the kidneys are responsible for flushing out excess Pradaxa from the body.

Fatal Effects of Pradaxa

Intra-articular bleeding, pericardial bleeding, subdural bleeds, intracranial hemorrhage and hemorrhagic stroke are all potential fatal effects of taking Pradaxa. The Pradaxa works as a blood clot inhibitor to prevent clots from forming in a different manner than Warfarin or Coumadin. Warfarin is a Vitamin K adversary which prevents the formation of blood clots by intervening in the body’s Vitamin K production. Pradaxa, on the other hand works by inhibiting thrombins which are naturally occurring proteins in the body which encourage clot formation. With no known antidote to the effects of Pradaxa, bleed-outs can happen so swiftly that death occurs before measures can be taken to prevent it. There also currently exists no known method for measuring the anticoagulant effect of Pradaxa, while Warfarin anticoagulant effects can be tested in those taking the older drug.

Negative Reports of Serious Effects of Pradaxa

Agencies outside the United States have taken a harder stance against Pradaxa; in Europe patients whose physicians recommend Pradaxa are advised to first have their kidneys checked since an elderly patient with less-than-optimal kidney function has a much higher risk of suffering from internal bleeding. Europe has reported 21 cases of bleeding deaths related to Pradaxa while Japan has reported 14 cases. Japanese regulators have insisted that the manufacturer of Pradaxa issue strong warnings to physicians regarding the potential for deadly bleeding, especially in older patients.

FDA Stance

A letter which was published in a medical journal, Therapeutics Initiative, stated Boehringer was aware of significant flaws in their initial Pradaxa drug trial but overlooked certain issues in order to gain FDA approval. Despite over 260 deaths worldwide which have been definitively linked to Pradaxa use, the American FDA continues to take a more cautious approach. Although the FDA issued a safety review in December of 2011and is reviewing all reports of serious bleeding in patients using Pradaxa, they continue to state that patients using Pradaxa should continue for now and that Pradaxa offers “an important health benefit when used as directed.”

Lawsuits against Pradaxa Manufacturers

Three lawsuits have been filed against the manufacturers of Pradaxa this month, and it is believed that many more are to come. Many believe that Boehringer should have placed a warning on their “wonder drug,” making physicians and patients aware that there currently exists no quick way to manage a bleed in the body caused by Pradaxa. It is likely that Boehringer will be held responsible for failing to adequately warn those taking Pradaxa of the myriad of potential risks, some of them fatal.

Anyone taking Pradaxa, particularly those who are over the age of 75 or who have a history of kidney problems should be aware of the risks when taking this drug. As more time passes more and more reports are coming in of Pradaxa users who have suffered gastrointestinal bleeding, cerebral bleeds or vascular and cardiovascular health issues. If you have suffered a health issue after using Pradaxa, speak with your physician to determine if Pradaxa was responsible.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

The Dangers of Pradaxa (Dabigatran) Part 2 of 3:

By Independent Staff Writer

Some experts feel that the German pharmaceutical company, Boehringer Ingelheim, rushed their new wonder drug, Pradaxa to the market perhaps a bit too quickly in an attempt to beat the competitors to the mark. Pradaxa subsequently became the first drug to rival Warfarin in over half a century. Boehringer announced that Pradaxa was as much as 35% more efficient in decreasing the risk of serious stroke than Warfarin, and in less than a year there were over a million prescriptions issued for the drug to over 400,000 patients hoping to avoid the negative aspects of Warfarin.

How is Pradaxa Used?

Pradaxa is primarily used for patients suffering from atrial fibrillation and to reduce the risks of stroke. Pradaxa also appeared to offer additional advantages over Warfarin in that there was no need for regular blood level monitoring as well as the fact that Pradaxa users didn’t have to be as concerned with mixing Pradaxa with certain foods and other medications as those taking Warfarin. While Vitamin K antagonists, such as Warfarin, are the mainstay of long-term anti-clotting therapy, there certainly exists a need for newer and safer anticoagulants. Pradaxa and other similar drugs currently undergoing trials use thrombin inhibitors as their primary ingredient; unfortunately the side effects of Dabigatran can be serious or even fatal.
Rushing the Drug to Market

In order to get its drug to market, Boehringer conducted a study of 18,000 patients, however rather than an independent study, this one was paid for by Boehringer, and the doctors who subsequently published glowing reports of the drug in medical journals disclosed at the end of those articles that they received a consulting fee, lecture fee or grant support from Boehringer Ingelheim. Later, doctors began seeing ill effects in Pradaxa users and pointed out that unlike Warfarin no reversal agent existed for the drug. In other words, any patient suffering a catastrophic bleeding event while taking Warfarin would stand a chance of living since Warfarin has an effective antidote. Pradaxa, unfortunately, does not. At this point in time over 260 deaths have been reported in those taking Pradaxa, particularly in older patients or those with a prior history of kidney disease.

Pradaxa and Cardiovascular Risks

While the fact that Pradaxa can cause excessive internal bleeding appears to be the primary risk when taking the drug, there are other potential health risks as well. Recent studies suggest an increased risk of heart attack in patients taking Pradaxa, and one online medical resource, WebMD, reports that when compared to Warfarin Pradaxa posed a 33% increase in the risk of serious heart attack. Even if you believe Boehringer’s statement that there is only a very small increase in the risk of heart attack for those taking Pradaxa, patients who have a history of or prior risk of heart attack may want to reconsider taking the drug.

Another meta-analysis of Pradaxa showed it to be associated with greater odds of myocardial infarction and acute coronary syndrome than control treatments. In fact, in controlled trials, acute coronary syndrome or myocardial infarction occurred at a significantly higher rate in those taking Pradaxa. Although Pradaxa appears to reduce the risk of stroke, for those with any indication or history of cardiovascular incidents, Pradaxa may not be the best choice.

Pradaxa’s Connection to Cerebral Hemorrhage

Bleeding in the brain is also known as a cerebral hemorrhage and is a type of stroke which occurs when a brain artery bursts, leaking blood into the surrounding brain tissues. When this blood comes into contact with brain tissue, it causes those tissues to become irritated and swell up. The blood also disturbs brain cells, in many cases leading to irreparable brain damage. Once the blood pools it can form a hematoma which in turn causes pressure inside the skull. One of the primary causes of a brain hemorrhage is head trauma from a fall. Since falls are common among the elderly, and because nearly half of all people hit their head when they fall, cerebral hemorrhages become more likely.

When an elderly person is taking Pradaxa and hits their head in a fall, the bleeding may become excessive, leading to death. In fact a Journal of Neurosurgery report detailed the death of an 83-year-old Pradaxa patient who suffered a relatively minor fall and later died of a cerebral hemorrhage. When the man arrived at the hospital he was awake and alert, and a CT scan indicated only a small area of bleeding on the brain. The man was given IV fluids and a protein which encourages blood clotting, however the doctors were unaware the man was taking Pradaxa and the protein would be completely useless. Blood soon filled the entire left side of the elderly patient’s brain, causing him to become comatose and die.

How Pradaxa Works

Because the drug Dabigatran is more consistently absorbed in an acidic environment, Boehringer took the unusual stance of applying the Dabigatran coating to the outside of a tartaric acid core to form the tiny pellets which are then placed in a capsule. This ensures that the absorption of theDdabigatran is not dependent on the gastrointestinal acidity of the individual patient rather the tartaric acid core creates its own acidic environment. In theory, this decreases the variable of the individual patient’s gastrointestinal pH environment. Unfortunately the acidic core of the Pradaxa capsule can cause gastrointestinal disturbances among Pradaxa users. Many users experience bloating or an uncomfortable, overly full feeling in their stomach while taking Pradaxa while others suffer heartburn, nausea and diarrhea.

If you or a loved one experience any type of unexpected or unexplained bruising, swelling or pain in the joints, discolored urine (pink or brown), bleeding from the gums or red or black stools, this is definitely cause for alarm and requires a visit to your physician. If you feel you have been harmed from taking Pradaxa, it is important to seek medical help from a qualified physician.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

The Dangers of Pradaxa (Dabigatran) Part 3 of 3: Serious Vascular Risks

By Independent Staff Writer

Pradaxa, the drug which less than a couple of years ago seemed like a dream come true for the hundreds of thousands of patients who were taking Warfarin or Coumadin has had its initial glow tarnished by the ever-increasing number of reports of serious side effects from use of the drug. Although Warfarin has been used as a stroke inhibitor and for those suffering from atrial fibrillation since the 1950’s, it comes with certain restrictions and its own set of side effects. Those who are on a Warfarin regimen must have regular blood tests taken, and must also be very careful of foods and other prescription drugs they mix with Warfarin.
However, there is a significant difference in the way Warfarin and Pradaxa work in the body, most notably the fact that in the event Warfarin causes excessive bleeding, the effects can be reversed by administering a dose of Vitamin K. When Pradaxa causes excessive bleeding there is no known antidote, leaving the patient vulnerable to literally bleeding to death. Pradaxa is a direct thrombin inhibitor which, in the initial 18,000 person trial, showed great promise in reducing strokes and helping those patients with atrial fibrillation lead a healthier life. The manufacturer of the drug, Boehringer Ingelheim, has been accused of rushing through the initial trial in order to get their drug on the market before other potential rivals, ignoring some potential risks in the process.

How Does Pradaxa Work?

The simplest explanation as to how Pradaxa works is that it thins the blood in those with atrial fibrillation, lowering their chances of having a life-threatening stroke. When a person’s heart beats irregularly, the blood is not pumped through the body as effectively as it should be which in turn causes blood to pool in the upper chambers of the heart. This pooling of blood then causes clots to form in the heart which can break away and travel to the brain, blocking an artery and causing a stroke.

Pradaxa’s active ingredient works by attaching itself to thrombin which are the blood’s central clotting agencies, reducing the ability of the thrombin to cause a clot and forestalling a possible stroke. Pradaxa was considered a good alternative to those patients with atrial fibrillation who were already on Warfarin yet were having trouble managing the necessary monitoring regimen, or patients who were on no regimen at all but were considered at risk for stroke. Pradaxa was not recommended for those with mechanical heart valves, those with severe valvular disease those on long-term treatment for deep vein thrombosis or patients with renal impairment. Patients who indicated chronic use of NSAIDS or those who were pregnant were also warned not to take Pradaxa, however patients were warned against discontinuing Pradaxa due to the elevated risk of stroke.

Perhaps even more alarming is the fact that one missed does of Warfarin does not significantly affect the efficacy of the drug. One missed dose of Pradaxa, however, significantly decreases the anticoagulant effect, putting the patient at serious risk of stroke, pulmonary embolism and the formation of thrombus. For every person who regularly takes prescription drugs—and who has accidentally missed a dose for a variety of reasons—this fact is a bit frightening particularly remembering the often-prescribed twice-daily dosing regimen.

Serious Vascular Risks Associated With Pradaxa

Less than a year after Pradaxa received FDA approval, reports of adverse effects of the drug started coming in. Of the 260 reported deaths related to Pradaxa, most occurred in older patients and came about through excessive internal bleeding which doctors were unable to reverse or control. Vascular disorders include internal bleeding, pericardial bleeding, intra-articular bleeding, subdural bleeding and in some cases, death. Intracranial bleeding from Pradaxa has also been noted in some patients, especially following a fall resulting in a bump on the head.

Over a period of two months, a group of New Zealand hematologists noted a “cluster” of bleeding episodes—78 to be exact—among patients taking Pradaxa. Over a dozen of these episodes were considered major and severe, while one person died from excessive bleeding. It was noted that a large portion of the bleeding incidents involved patients over the age of 75, or those with impaired renal functions. The New Zealand hematologists also stated that prescriber error accounted for about 25% of the bleeding complications citing a lack of physician awareness of the potentially serious side effects associated with Pradaxa use.

Less Serious Risks of Pradaxa

Even in those who don’t suffer serious bleeding events, they may have diarrheas as a side effect of Pradaxa or nausea and heartburn as a side effect of Pradaxa. Many users will have stomach pain or a very uncomfortable feeling in their stomach commonly known as dyspepsia. The stomach may be bloated, and the user may simply feel a general discomfort in the stomach. Because the active ingredient of Pradaxa is actually located on the outside of the capsule, formed around a shell of Tartaric Acid, the likelihood of gastrointestinal issues is fairly high. Since the active ingredient of Pradaxa needs an acidic environment to work, the manufacturers simply added their own source of acid to the drug which allows much quicker absorption of Pradaxa’s active ingredients.

Pradaxa Lawsuits

The first Pradaxa lawsuit was filed just this month against the manufacturer of Pradaxa, Boehringer Ingelheim, by Bertha Bivens who claims her mother died following a gastrointestinal bleed caused by Pradaxa only three months after beginning a Pradaxa regimen. As of November, 2011, over 260 deaths were attributed to Pradaxa, and all of these centered around unexpected and extreme bleeding. Soon after this first lawsuit was filed, five more quickly followed with many more expected.

If you have experienced the less serious gastrointestinal side effects of Pradaxa, you still should discuss the issue with your doctor. If you have experienced any unusual or prolonged bruising, bleeding gums, notice a pink or brown color to your urine, have experienced unexpected swelling or pain in your joints, have suffered a severe headache lasting much longer than normal, have had dizziness, weakness, red or black stools, recurring nosebleeds or heavier than normal periods, see your doctor immediately as these side effects could indicate internal bleeding.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever

DePuy Litigation: Statute of Limitations Depuy Lawsuits

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.

How To Find A Divorce Attorney

HOUSTON—With the national divorce rate estimated at about 50 percent, it’s likely that every American will, either directly or indirectly, experience the dissolution of a marriage at some point in their lives. Dealing with divorce is a difficult process, both emotionally and financially, and decisions made during the process can have long-term effects on many areas of your life. For this reason, selecting the right lawyer may be the most important decision that you make.

Choosing a lawyer to represent you in your divorce is an intricate process. It means establishing a close and sensitive relationship with someone that will continue for months and perhaps even years. It is important to find and hire someone whose philosophy of the proceedings aligns with yours, and as such, you must be prepared to ask questions that reflect your specific concerns.

The first step in selecting a divorce lawyer is to gather names of potential counsel in your area:

From other professionals: Lawyers, accountants, members of the clergy and other professionals meet and work with divorce lawyers in the course of their work and are often good sources of referrals. Ask them for the names of family law specialists with good credentials and reputations and whose qualifications are most appropriate to your case.

From organizations: Your state bar may be able to provide a recommendation for certified family law specialists in your area. To be certified in the field of family law usually requires a certain proven level of experience, study and interest, and specialists must pass an examination in this area of the law.

From your employer: The Employee Assistance (EAP) program provided by your employer may be able to provide confidential referrals to attorneys, and often affords a discount on the services performed. Your employer may also offer access to sponsored legal services, either by subsidizing all or a portion of your legal fees if you use specified legal providers, or by providing the opportunity to join a legal services program in which you pay a set premium in order to receive a certain level of legal services throughout the year.

From friends or relatives: You may know someone personally who has gone through a divorce. They can be a good source of information about lawyers, with two qualifications: First, every client and every case is different, so it is difficult to evaluate the performance of a lawyer in someone else’s case. And second, the lawyer-client relationship is highly personal. So while the impressions of a former client about a lawyer are useful, you should meet the lawyer and make your own judgment.

The second step in the selection process is to interview potential candidates. Most lawyers will offer an initial consultation, and you should use this opportunity to outline your case and ask relevant questions. Listen carefully to the answers given and write them down. This will help you compare your options and determine which lawyer will best be able to represent you.

Some questions you may wish to ask include the following:

How long have you been a lawyer?

What is your primary area of practice?

Do you practice in any other areas?

What percentage of your caseload is dedicated to divorce?

Have you handled cases in the past with issues similar to mine?

What kind of approach do you think is appropriate (aggressive, cooperative, etc.) and why?

What obstacles or issues are likely in a case like mine?

What are my options for resolving these issues?

How long will it take to settle my case?

What costs can I expect?

What are your rates and how often will I be billed?

What other legal fees might I incur?

How will you keep me informed on the progress in my case?

Who else in the office will be assigned to my case and what is their rate?

Are there any steps I can take to reduce my legal fees?

After you have chosen an attorney, it is important to establish ground rules and make sure that you are both on the same page. Take time to discuss your specific objectives and highlight the issues that are important to you. Together you may then outline a plan to resolve those issues.

You should also discuss avenues of communication and determine how best to stay in touch. A common complaint about lawyers is that they are often unavailable and fail to return calls in a timely manner. Perhaps your attorney will suggest contacting his secretary or legal assistant to schedule a telephone conference at a time that is convenient for you both. By setting an appointment, you will be assured of reaching your lawyer at a designated time.

Lastly, be honest with your attorney. Do not withhold pertinent information, even if it seems embarrassing. Your lawyer cannot properly represent you with only a portion of the facts. Nothing has the potential to harm your case more than being surprised at trial by unexpected revelations.

Divorce is an extremely difficult process, and while you may not want the added stress of choosing the right lawyer, in the end it could be the most important decision you make. Above all, you need to find an attorney with experience, for they will not only be able to handle the intricacies of the divorce proceedings, but will also be able to explain the law as it pertains to your case and help you explore your options. At Sullo & Sullo, LLP, we understand the emotional and financial ramifications of divorce and are here to help. If you or someone you know is dealing with the dissolution of a marriage, and would like a consultation, contact the experienced professionals at Sullo & Sullo, LLP at 713-839-9026.