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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

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New Data from Britain about DePuy ASR Acetabular Hip Replacement Devices

Is Johnson and Johnson Telling the Truth About the Failure Rate?

Johnson and Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson and Johnson started using the device in the United States in 2005 and based its failure rate on five years of research. However, England has a hip registry dating back well before 2005.

This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson and Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.

Here are the real facts:

- August 2010 - Johnson and Johnson recalled the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a revision.

- April 2011 - Johnson and Johnson agreed to pay $70 million in civil and criminal fines for bribing European doctors to induce them to prescribe their drugs or implant medical devices in patients unaware of their doctors' financial incentives, according to The New York Times.

- May 2011 - The British Orthopedic Association and British Hip Society released data that the DePuy ASR XL hip replacement unit fails as often as 49% of the time - four times more than reported by Johnson and Johnson in 2010.

Based on the evidence there are thousands of patients that appear to be healthy now, yet likely will have complications in the next 3-5 years as a result of the ASR XL device.

U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
The levels of serum and chromium in patients prior to THR.
The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
The number of patients with pain and biological and psychological symptoms associated with the THR.
The quantity of harmful reaction of body tissues in patients who did not have a revision.
How differences in revisions vary over time after the initial implant?
What demographics have higher metal ion concentrations in their blood?
What demographics have higher risks of needing revisions?
What causes the THRs to fail?

Defective DePuy ASR Hip Implants Should Consider The ARP Wave

Patients With Defective DePuy ASR Hip Implants Should Consider The ARP Wave

By Andre Sullo

SULLO & SULLO, LLP

HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.

Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body’s natural recuperative ability.

The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.

To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.

A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”.

These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.

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 skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

Combating Chromium and Cobalt Blood Toxicity After An ASR Hip Replacement

By Megan Breckenridge, Staff Writer

SULLO & SULLO, LLP

HOUSTON > If you are one of more than 93,000 people worldwide affected by the recent recall of DuPuy, Inc.’s ASR Hip Replacement System, you may be in more danger than you realize. Countless patients have already come forward with horrific stories of pain and suffering as a result of the defective devices; the most common of which are related to metal poisoning, or metallosis, which is a reaction to the chromium and cobalt metal debris that is shed when components of the device rub together.

If you have experienced symptoms of chromium and cobalt toxicity, which include pain, inflammation, tumors and difficulty walking, it is imperative that you seek medical attention immediately. Specialized blood tests can be used to detect levels of these toxic metals in ASR Hip Replacement patients. In some cases, patients with DePuy ASR implants have been found with 100 times the normal levels chromium and cobalt in their bodies.

One method of treating ASR Hip Replacement patients with high levels of chromium and cobalt in their blood is chelation therapy. The process involves the administration of chelating agents—the most common of which is ethylenediaminetetraacetic acid (EDTA)—to remove the poisonous metals from the body.

Chelating agents may be administered intravenously, intramuscularly, or orally, depending on the agent and the type of poisoning. They bind to heavy metals in the body and prevent them from binding to other agents, creating a compound that can then be excreted from the body.

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.

At present, the Food and Drug Administration (FDA) has not approved chelation therapy, though both traditional doctors and alternative medicine practitioners do offer this service. A single chelation treatment usually lasts from two to four hours and costs between $50 and $100. In the first month, patients receive between five and 30 treatments (with 30 being most common), and are often advised to continue preventive treatment once a month.

Individuals must pay for the treatment themselves. Because chelation therapy isn’t a medically accepted procedure, standard medical insurance and Medicare do not cover it. It is believed to be safe for patients of all ages, including children and the elderly, but no scientific data currently exists to support this claim.

Side effects of chelation therapy include a burning sensation at the injection site, fever, a sudden drop in blood pressure, headache, nausea, vomiting, inability to create new blood cells, and mineral deficiencies. Some patients have experienced permanent kidney damage or failure, and deaths have occurred in some chelation studies. Because of the known risks and unknown benefits of chelation therapy, talk to your doctor before trying it as a treatment chromium and cobalt poisoning.

Although a full recovery from chromium and cobalt toxicity is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of metallosis 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 the full compensation that you deserve. Call us at 800.730.7607 for a free legal consultation today.

Chromium Poisoning Just as Dangerous as Cobalt Poisoning

Early this year, DePuy issued their recall for the ASR XL Acetabular System sold in the United States. Doctors began recommending revision surgery to those of their patients who reported pain or an overall failure of the DePuy hip implant. In many cases, the doctor was wise enough to run a blood test to determine whether there was excess metal in the bloodstream, as many medical studies have shown that elevated levels of metal are common for patients with metal-on-metal hip implants.

Patient after patient with the ASR Acetabular DePuy hip implant began turning up with cobalt and chromium levels that were well over 100 times normal.

Cobalt poisoning has been getting a great deal of attention and for good reason: the symptoms of cobalt poisoning include many serious side effects including neurological (brain) damage, heart irregularities, and seizures. Cobalt poisoning has also been linked to cancer. It's small wonder that many people, when they first learn that the DePuy hip implant leaks metal ions into the body, are primarily concerned about cobalt poisoning.

However, chromium poisoning is equally dangerous. And the symptoms are just as troubling.

What is Hexavalent Chromium?

When discussing chromium poisoning, the most significant problems have been linked to a particular compound, hexavalent chromium (Chromium (VI)). Hexavalent chromium is the agent that turned up in the water supply of the California town of Hinkley, later made famous by Erin Brockovich's activism work. Many people remember the Erin Brockovich story - if not for the event itself, certainly for the award-winning movie based on it. They remember that there were many cases of cancer in the town; 196, to be precise.

Few of them remember that the problem with the water was hexavalent chromium.

Hexavalent chromium has been deemed a cancer-causing agent by the World Health Organization, which means that both chromium and cobalt can elevate a DePuy hip implant patient's cancer risk. In fact, studies show that elevated levels of any heavy metal increase the risk of cancer.

Our research indicates that hexavalent chromium is the type of chromium being released by the ASR Acetabular system; it degrades in the body into trivalent chromium, or Chromium (III). Anywhere from 18-30% of a typical metal-on-metal implant is composed of chromium; we do not have current numbers on the amount of chromium included in the DePuy hip implant.

Patients with elevated chromium levels show similar symptoms as those with elevated cobalt levels. There are notable differences; cobalt poisoning can cause cardiomyopathy, for example, while elevated chromium levels do not appear to cause heart problems but can cause problems with the reproductive system. The table below gives an overview of the symptoms shown by patients with elevated chromium levels vs. those with elevated cobalt levels.

If a particular type of chromium or cobalt has been specifically linked to a symptom, it is noted in parentheses next to the symptom. For example, mutated DNA is noted as being linked specifically to Chromium III.

	Elevated Cobalt (Co) Levels	Elevated Chromium (Cr) Level
Genetic Information	Inability to repair DNA, reduce gene expression Co (II)	Can mutate DNA (Cr III) Inability to repair DNA, reduced gene expression Cr (VI)
Localized tissue around the implant	Hypersensitivity Inflammation Infiltration of lymphocytes	Hypersensitivity Inflammation Infiltration of lymphocytes
Liver		Necrosis at high levels of Cr (VI)
Kidney	Co excreted by the liver	Can impair liver function
Respiratory System	Asthma Shortness of breath	Asthma Shortness of breath
Nervous System		Oxidative Damage (Cr VI)
Heart and Vascular Systems	Possible cardiomyopathy
Endocrine System	Potential to alter the production of sex hormones Co (II) Potential to induce hyothyroidism Co(II)	Potential to alter the production of sex hormones Cr (VI)
Visual and Auditory System	Loss of hearing Vision Impairments	Loss of hearing Vision Impairments
Reproductive System		Decreased sperm Cr (VI) Abnormalities in sperm Cr (VI) Reduced number of follicles Cr (VI)
Carcinogenesis	May lead to an increased risk of cancer	May lead to an increased risk of cancer

What Does This Mean for My Health?

Chromium poisoning and cobalt poisoning are both very serious; however, there is no way to tell if you have either problem without getting a blood test to find out what your chromium and cobalt levels are. Even if you have elevated levels, you may still not have chromium or cobalt poisoning; slightly elevated levels are normal for patients who have metal-on-metal hip implants and among the doctors we've consulted, they do not consider slightly elevated levels to be cause for alarm.

For those DePuy hip implant patients who have presented with 100 and 500 times the normal level of these two metals in their systems, however, doctors are quite concerned. Cobalt and chromium can both be retained in the bodily tissues for a long period of time, and if the body is subjected to excess levels, it will have a more difficult time processing the metal ions through the normal elimination process, especially if the kidneys are damaged - a problem sometimes caused by chromium poisoning. Little research has been done on the long-term effects of elevated metal ion concentrations.

When speaking to your doctor, we have a medical crib sheet that may be prove useful if you are uncertain what to ask about or worried you may forget important questions. We would also highly recommend you read this article on DePuy trying to get patients to agree to give the company access to their medical records; if you are thinking of pursuing a legal case against DePuy, signing away your medical records can be severely detrimental to your case.

If you have received a DePuy hip implant and are concerned about the effects chromium and cobalt poisoning may have on your health, please give us a call at 1-800-730-7607 or send us an email through our online system. We're here to answer your questions and help you build a case against DePuy if you think that is the best course of action for you. The health risks you've been asked to shoulder are immense and surely very upsetting; we will do our best to help in any way we can.