Articles Posted in Product Liability

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According to a report by Bloomberg News, Johnson & Johnson sold their Gynecare Prolift mesh for several years before obtaining FDA approval. Johnson & Johnson has been subjected to product liability lawsuits brought by women who suffered complications allegedly caused by design defects with the vaginal surgical mesh.


Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008.

Johnson & Johnson sold the Gynecare Prolift mesh without approval, and claimed that it was substantially similar to the Gynecare Gynemesh, which was already on the market.

The Ethicon Gynecare Prolift mesh is one of a number of surgical mesh products manufactured by Johnson & Johnson, that are the subject product liability lawsuits nationwide.

Thousand of Lawsuits

Thousands of women are filing lawsuits, claiming that they suffered painful and debilitating complications after the vaginal mesh was implanted, such as pelvic pain, infection and erosion of the mesh through the vagina.

All vaginal mesh lawsuits involve similar allegations that the manufacturers failed to adequately research and test their products. Furthermore they claim, rushing the products to the market through the FDA’s controversial fast-track approval system, known as the 510 (k) process, which allows the agency to approve medical devices without rigorous pre-market testing when they feature a substantially similar design to other previously approved products.

FDA 510 (k) Process

Johnson & Johnson reportedly failed to obtain 510(k) approval before marketing the Gynecare Prolift mesh.

FDA Warning

In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

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Canadian health regulators have added new label warnings to Pradaxa, the new blood thinner. In Canada it is known as Pradax. The regulators are warning that the risk of bleeding events may be increased among patients with kidney problems.


The Pradaxa warnings were announced on March 16, and recommend that all patients should have their renal function assessed before starting Pradaxa, and that doctors should assess any changes in renal function while on the treatment, especially among patients over 75 years old.

Health Canada indicated that use of Pradaxa was not recommended for patients with rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves, as the safety and efficacy of Pradaxa has not been studied among those patients.

Pradaxa (dabigatran) is a new blood thinner, which was touted by Boehringer Ingelheim as a superior alternative to Coumadin (warfarin) for prevention of strokes among patients with atrial fibrillation.

There are concerns about the risk of serious and potentially fatal bleeding events from Pradaxa among the medical community in the United States. Since the medication was introduced in the U.S. in October 2010, hundreds of deaths have been reported among Pradaxa users who experienced internal bleeding or hemorrhages that doctors were unable to stop.

No Antidote for Pradaxa

There is no antidote to the bleeding side effects of Pradaxa, short of dialysis.

Institute for Safe Medication Practices Report

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa hemorrhages were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

FDA Investigates

In December 2011, the FDA announced that it was evaluating post-marketing reports on the Pradaxa bleeding events to determine if there is anything abnormal about the side effects of Pradaxa, and whether the anticoagulant may pose an unreasonable risk for certain consumers.

Pradaxa Lawsuits

Some lawsuits have been filed throughout the United States after patients have experienced severe bleeding problems. The lawsuits allege that Boehringer Ingelheim failed to adequately research the side effects of their medication. When it became apparent that the risk of bleeding events were causing a number of serious injuries throughout the United States, the drug maker should have provided stronger warnings or issued a Pradaxa recall, according to many of the complaints filed.

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New medical research suggest that the popular diabetes drugs Byetta and Januvia could increase the risk of pancreatitis and pancreatic cancer.


In a study published this summer in the medical journal Gastroenterology, researchers from the University of California, Los Angeles (UCLA) found a nearly threefold increase in reported cases of pancreatic cancer and a sixfold increase in reported cases of pancreatitis among Byetta and Januvia users.

Researchers also found an increase in thyroid cancer among Byetta users.

The study used data from the FDA’s adverse event reporting system from 2004-2009 to find reports of problems with Januvia and Byetta submitted by doctors and patients who took the drugs.

Prior studies done on rats have also suggested a potential link between the two drugs and pancreatitis, which is an inflammation of the pancreas. Severe cases, involving necrotizing pancreatitis or hemorrhagic pancreatitis, can cause severe bleeding, multi-organ failure or death.

Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.

Concerns about pancreatitis from Byetta first arose in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.

Amylin and Eli Lilly currently face a number of Byetta lawsuits involving allegations that they failed to adequately research their medication and warn about the risk of pancreatitis or other side effects of the diabetes drug.

Januvia is a newer drug approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Januvia has rapidly become a strong selling medication for Merck.

In September 2009, FDA recommended that doctors monitor patients carefully for signs of pancreatitis from Januvia and Janumet after starting treatment or increasing dosage. The agency found that in 58 of the 88 cases of pancreatitis Januvia and Janumet users required hospitalization, and four required treatment in intensive care units (ICU).

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A medical study published in the British medical journal, Lancet, has identified that all-metal on metal artificial hips fail more often than other designs. This confirmation has increased concerns about the implants and the researchers are calling for a ban.


British experts at the world’s biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements, citing an analysis showing they have to be fixed or replaced more often than other implants.

The medical analysis in The Lancet, was published recently after Britain’s medical regulators said nearly 50,000 Britons with metal-on-metal hips needed annual check-ups to monitor for problems, including exposure to toxic metals.

Metal on Metal Hips were supposed to be more durable

Metal-on-metal hips were designed to be more durable than traditional implants, which consisted of a ceramic or metal ball with a plastic socket.

But medical investigation suggests they may actually do worse, leading to the recall of the ASR device made by Johnson & Johnson that experts argue should never have been allowed on the market in the first place.

Women with higher failure rates

According to the researchers, data from the study now reveals that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years – some three times greater than the revision rate seen with older implants.

And to complicate matters further, the rate was particularly high with larger-head implants and those used in women, in whom failure rates were up to four times higher.

Stringent Regulation demanded

Art Sedrakyan of Cornell University said the problem revealed weaknesses in the regulatory systems in both the UK and US due to “outdated and low-threshold regulatory pathways”.

New monitoring guidelines in UK

Under the new guidelines from Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA), doctors are being advised to consider removing and replacing implants if patients have abnormal MRI scans or if metal ion levels in the blood reach worrying levels.

The study follows findings reported last month that hundreds of thousands of people worldwide may have been exposed to high levels of toxic cobalt and chromium ions that can seep into tissues and destroy muscle and bone, leaving some patients with long-term disability, according to an investigation by the British Medical Journal and the British Broadcasting Corp.

Other companies that make metal-on-metal hip implants include Zimmer, Wright, Stryker, Corin and Biomet.

Read more here and visit our website for more information.

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Federal lawsuits against Wright Medical Technology, a manufacturer of metal-on-metal hip-replacement is now being consolidated in Multi district Litigation (MDL). Wright Medical Technology’s Conserve Plus implants are under assault for causing injuries similar to those produced by the DePuy ASR and Pinnacle metal on metal hip system.


This is one of three MDLs organized to consolidate pre-trial proceedings for plaintiffs suing over dangerous and defective metal on metal hip implants. The Wright Conserve MDL has been consolidated in the U.S. District Court for the Northern District of Georgia.


In the United States, more than 3,500 lawsuits have been filed over DePuy ASR hip metal on metal replacement systems, and litigation has been underway over the past 18 months in the U.S. District Court for the Northern District of Ohio. The DePuy ASR hips were recalled by Johnson and Johnson in August 2010.

DePuy Pinnacle MDL

In the Northern District of Texas, Dallas, another MDL has been organized for more than 900 patients filing suits over the DePuy Pinnacle hip replacement metal on metal systems. These DePuy Pinnacle metal on metal hips have yet not been recalled. Johnson and Johnson considers the DePuy Pinnacle to be their flagship product.

Wright Metallosis and Early Replacement

Plaintiffs allege that they were not warned about the real risk of early failure of the medical devices. Additionally, they have suffered from metallosis, a medical condition of high blood levels of chromium and colbalt. This occurs as a result of metal particles produced when the metal ball and metal socket of the hip implant grind against each other. The metal particles also damage local muscle and tissue, and may lead to cancer.

The National Joint Registry for England and Wales released its Eighth Annual Report in September 2011 and found that Wright Conserve’s revision rates were second only to the ASR devices manufactured by DePuy.

Types of Wright Hips Affected

The Wright Conserve hip-replacement system includes the Conserve Femoral Surface Replacement, the Conserve Plus Total Resurfacing Hip System, the Conserve Total A-Class Advanced Metal and the Conserve Total Hip System.

The system was approved by the U.S. Food and Drug Administration (FDA) through its 510(k) process, a fast track to market process.

Concerns over Metal on Metal Hips

Several thousand metal on metal hips have been implanted over the past 10 years and only a fraction of those defective hips are seeing the light of litigation. This means that there are many thousands of defective hips out there, with folks unaware of the litigation, who are having problems. And the manufacturing companies and their implanting doctors are not letting the patients know of these problems. I get calls every day from folks who did not realize that there was a recall with the DePuy ASR or about metallosis in general. The message needs to get out.

Read more here and visit my website for more information.

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Bleeding side effects in patients treated with Pradaxa have led a group of New Zealand hematologists to sound the alarm and call for better doctor education.


The hematologists wrote of their concerns in a letter published in the March 1 issue of the New England Journal of Medicine. In a two-month review, they identified 78 bleeding episodes, including 12 major bleeds, one of which might have contributed to a patient’s death,
Many of the bleeding incidents involved older patients and patients with reduced kidney function. Importantly prescriber error occurred in about 25% of the complications, revealing a lack of awareness of the potential risks associated with the drug.

The researchers reported that,”bleeding is an expected complication of dabigatran, especially in the elderly, a risk that is not completely mitigated by a dose reduction: 22 of our patients had a bleeding episode while receiving a reduced dose.”

In reviewing the clinical characteristics of their 44 patients, the authors noted that two-thirds were older than 80, a majority had moderate or severe renal impairment, and half had low body weight (<60 kg).

The patients differed substantially from those in the pivotal trial of dabigatran, whose study population had a median age of 71, median weight of 83 kg, and creatinine clearance that averaged 68 mL/min.

The authors noted that “our audit illustrates the difficulty in extrapolating trial data into clinical practice and emphasizes the need for post-marketing surveillance and adverse-event reporting to detect groups whose risk factors may not be apparent in a clinical-trial setting.”

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According to Cleveland Clinic researchers, Pradaxa patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin.


This finding, from Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients.

According to Uchino and Hernandez, “the risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo.”

Archives of Internal Medicine

The editorial accompanying the study in the Jan. 9 issue of Archives of Internal Medicine, journal editor Rita Redberg, MD, notes that this isn’t the first safety warning issued for Pradaxa.

FDA Is Investigating Pradaxa Side Effects

The FDA is investigating an unusually large number of adverse reports of serious bleeding linked to the drug. Japan and Australia already have issued a safety warning. The European Medicines Agency advises doctors to check patients’ kidney function before prescribing Pradaxa. And last year the FDA warned patients that the drug breaks down quickly when removed from its original container.

According to Kirk Garratt, MD, clinical director of interventional cardiology research at New York’s Lenox Hill Hospital, “that’s still an important added risk for patients who may already be piling up risk factors for heart disease.”

Garrett continues, “if I have a patient on this drug for 10 years, I’d expect a 5% increased lifetime risk of heart attack.”

“The most important aspect of this study is that it allows us to see a consistent risk across studies and types of patients. That speaks to the conclusion that this study is well done and that the risk is real.”

SOURCES:Uchino, K. Archives of Internal Medicine, published online Jan. 9, 2012.Redberg, R.F. Archives of Internal Medicine, published online Jan. 9, 2012.Jacobs, J.M. Archives of Internal Medicine, published online Jan. 9, 2012.Hohnloser, S.H. Circulation, published online Jan. 3, 2012.FDA Safety Communication, March 29, 2011.FDA Safety Communication, Dec. 12, 2011.Institute for Safe Medical Practices, Quarterwatch, Quarter 4, 2010.Ansell, J. Circulation, January 2012.Granger, C.B. Circulation, January 2012.

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U.S. District Judge Danny Reeves, has dismissed generic Darvon and Darvocet lawsuits. A recent US Supreme Court decision shields generic drug makers from responsibility to warn patients and doctors about the dangers of associated with generic copies of brand name medications they manufacture and sell.


The dismissals were based on the U.S. Supreme Court’s 2011 decision in Pliva Inc. v. Mensing, which found that generic drug companies can not be held liable for failing to warn about side effects, so long as their labels are identical to those of the original brand-name product.

Following the recall of Darvon and Darvocet, a number of product liability lawsuits have been brought against manufacturers of the name-brand medications, as well as manufacturers of generic equivalents.

All of the complaints involve similar allegations that the manufacturers failed to properly research their medications, provide adequate warnings or recall the drugs after it became known that there was a large number of fatalities among users.

The June 2011 U.S. Supreme Court decision, ruled that the failure to warn lawsuits against generic drug makers are pre-empted by federal law. Here, the “copycat” medications are to carry the same warning labels as the brand name versions they copy.

The ruling means that if a generic drug maker knew or should have known that their medication causes a dangerous side effect, then the manufacturer is allowed to escape liability for failing to warn consumers or the medical community.

In order to side step the Supreme Court ruling, the Plaintiffs had filed amended complaints alleging defective design, negligent design, strict liability, breach of implied warranty, and negligent marketing.

Reeves said that his interpretation of the decision also bars all of those charges as well, saying that generic manufacturers have a “federal duty of sameness” that requires them to make the drug just like the brand name, thus meaning they cannot be held responsible for those charges, either.

All complaints filed in federal courts throughout the United States have been consolidated for pretrial proceedings before Judge Reeves in the U.S. District Court for the Eastern District of Kentucky.

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Taking Pradaxa, are you playing Russian Roulette with a potentially lethal drug? Is it the case of Head you lose, Tails you lose? Taking your life into your hands should not come down to a flip of the coin.


There is no antidote or treatment to reverse the bleeding side effects of Pradaxa. According to a newly published case study, this lack of treatment is proving deadly to many patients.

The Journal of Neurosurgery has published a report, in which researchers pinpoint the risk associated with hemorrhages from Pradaxa.

Pradaxa, the new blood thinner does not have a “reversing agent” that allows doctors to stop the bleeding.

The University of Utah’s Department of Neurosurgery report the case study of an 83 year-old man who died from a brain hemorrhage caused by Pradaxa. The man was given the blood thinner following a minor head injury sustained in a fall at his home.

Just six hours after Pradaxa was administered, a CT scan showed extensive brain hemorrhaging. The doctors determined there was nothing they could do to save his life due to the lack of a reversal agent for Pradaxa and he died shortly afterward.

Pradaxa (dabigatran) is a blood thinner, which was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillation.

Among users of the older, more widely-used blood thinner Coumadin, known generically as warfarin, bleeding events can be addressed by giving the patient a dose of Vitamin K.

“There is currently no effective antidote to reverse the anticoagulant effect of dabigatran in the event of an emergency,” the researchers wrote. “Dabigatran is only the first of several direct thrombin inhibitors that may enter clinical use and these agents will likely have similar risks for catastrophic progression of traumatic injuries.”
According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa hemorrhages were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

A number of individuals throughout the United States are now considering a Pradaxa lawsuit against the drug maker for failing to adequately research the medication or warning about the risk of serious and potentially life-threatening health risks of Pradaxa.

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The family of a Tennessee woman who died, has filed a wrongful death lawsuit over Pradaxa against Boehringer Ingelheim, alleging that the drug maker failed to adequately warn about the risks associated with the blood thinner.


The lawsuit was brought this week by Bertha Bivens, the daughter of Nancy Brummett, in the U.S. District Court for the Eastern District of Tennessee.

According to allegations in the lawsuit, Brummett was prescribed the new blood thinner in January 2011, for long-term treatment of atrial fibrillation. Atrial fibrillation is a very common cardiac arrhythmia.

Two months after Pradaxa was prescribed, Brummett was hospitalized with a massive gastrointestinal bleed from Pradaxa. Brummett died less than three months after she first used the drug.

Pradaxa (dabigatran) is an anticoagulant, introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillations.

It is the first of a new type of blood thinners known as direct thrombin inhibitors, which also includes Johnson & Johnson’s Xarelto.

There have been a massive number of reports of bleeding events and hemorrhages among users of Pradaxa, including hundreds of deaths.

The Pradaxa wrongful death lawsuit alleges that Boehringer Ingelheim created a defective product that is no safer than older blood thinners, and lacks a reversal agent.

Coumadin (warfarin) is the blood thinner Pradaxa is meant to replace, but bleeding events with that drug can be treated with a dose of Vitamin K or an infusion of fresh frozen plasma.

According to the complaint, Boehringer Ingelheim should have placed a warning on Pradaxa that the drug lacks a quick way to fix bleeding events.

Furthermore, the label warning fail to adequately alert doctors and patients about the Pradaxa gastrointestinal bleed risk, and the company also failed to provide any guidance on how to deal with bleeding events when they arise, the lawsuit claims.

According to the complaint, the drug is defective and recommends that Boehringer Ingelheim should have issued a Pradaxa recall.

As of November 2011, Boehring Ingelheim reported there were 260 confirmed Pradaxa deaths, mostly due to bleeding problems, with 120 of those deaths reported in the U.S.

The drug had only been out in the U.S. for a little more than a year, and had been available worldwide since only 2008. The FDA, European and Canadian health officials, as well as the drug company itself, have all launched investigations into Pradaxa safety risks.

The complaint is believed to be the first Pradaxa lawsuit filed in the United States.