Articles Posted in Product Liability

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A new medical study suggests that side effects of Pradaxa, a new blood thinner, may increase the risk of bleeding events even more than warfarin, the drug it was designed to replace.


Kansas researchers tested the use of Pradaxa during radiofrequency ablation of atrial fibrillation and discovered more than double the number of bleeding problems with Pradaxa, when compared to those seen when warfarin was used.

In a study was published in the Journal of the American College of Cardiology.

Pradaxa (dabigatran) is under increased scrutiny from federal health regulators. A large number of post-marketing reports involving severe bleeding events and deaths are reported with Pradaxa.

Pradaxa was introduced by Boehringer Ingelheim in October 2010, as an alternative to Coumadin (warfarin) for prevention of strokes among patients with atrial fibrillation.

The drug was heavily marketed as superior to warfarin, because it is easier to use and requires less monitoring. When serious bleeding events do occur, warfarin can be quickly counteracted by doses of Vitamin K or fresh frozen plasma infusions. There is no such quick fix for bleeding with Pradaxa.

According to a report by the Institute for Safe Medication Practices in January 2012, more episodes of hemorrhages with Pradaxa 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 episodes involving Pradaxa bleeding were reported, compared to 176 cases reported with warfarin, which was second on the list.

A number of patients throughout the United States who have experienced severe bleeding problems are considering a potential Pradaxa lawsuit against Boehringer Ingelheim for failing to adequately research their medication or warn about the risk of internal bleeding.

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New Jersey state court lawsuits over Accutane and generic versions have been consolidated as a mass tort in Atlantic County before Judge Carol Higbee, and the number of complaints filed in the state has more than doubled over the last year.


There are now more than 7,000 Accutane lawsuits pending in New Jersey state court. These complaints allege that the makers of the acne medication failed to adequately warn about the risk of serious and debilitating bowel problems.

All of the complaints involve similar allegations that the acne drug had inadequate warnings and that side effects of Accutane may increase risk of severe inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis.

The drug maker Roche, discontinued Accutane in June 2009, due to the increasing costs associated with the litigation over Accutane, but a number of generic versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

Several Accutane trials have already occurred in New Jersey state court, with a number of multi-million dollar verdicts being returned for damages caused by Accutane.

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The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal Wright Conserve hip replacement lawsuits be transferred to one judge for coordinated pre-trial proceedings as part of an MDL, or multidistrict litigation.


The U.S. JPML centralized the Wright Conserve hip litigation before U.S. District Judge William S. Duffey, Jr. in the U.S. District Court for the Northern District of Georgia.

The complaints allege that Wright Medical Technology manufactured a defective metal-on-metal hip implant, known as the Conserve Plus, and failed to warn patients about the potential risk that the device may fail within a few years of surgery.

According to plaintiffs, the Conserve acetabular cup has a tendency to loosen and fail as metal particles are shed into the body from the metal parts rubbing against each other.

The FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) approval system. More than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a fraction of the total number of problems with Wright hip replacements.

The Wright Conserve hip system is a metal-on-metal design. And consists of cast cobalt chromium molybdenum cup that provides the connection for the cobalt chromium molybdenum femoral head.

The metal femoral head rotates within the metal monoblock Conserve Cup, which does not have a liner, resulting in the release of metal particles that can cause metal toxicity in the blood, soft tissue and bone.

According to the complaints, this can result in metallosis, tissue necrosis, pseudotumors and other problems.

Furthermore, a number of patients have filed complaints over problems with the Wright Profemur hip replacement. These involves a femoral stem that may be prone to fracture, break, degrade and ultimately fail, according to allegations raised in a number of other lawsuits.

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A new medical study has found that the anti-clotting drug Xarelto could have less of a risk of causing a stroke than older blood thinners, but the drug appears to share of the same risks as Pradaxa.


The study, which was funded by Johnson & Johnson, the manufacturers of the new medication Xarelto. According to researchers, users of Xarelto were one-third less likely to experience brain bleeding than patients given warfarin, (Coumadin), when the drug was prescribed for the treatment of atrial fibrillation.

But, Xarelto, like Pradaxa, belongs to a new class of blood thinners that require less monitoring, but may cause severe bleeding problems that are more difficult to treat.

Pradaxa (dabigatran) is a blood thinner that was introduced in October 2010, as an alternative to warfarin for prevention of strokes among patients with atrial fibrillation. The medication has been heavily promoted by the manufacturer, Boehringer Ingelheim.

If severe bleeding problems do occur with warfarin, they can be treated by an injection of Vitamin K, fresh frozen plasma, and blood transfusions. There is no easy fix for bleeding problems with Pradaxa, and similar medications like Xarelto.

In December, the FDA announced that it was launching a safety investigation into reports of severe bleeding events with Pradaxa, after a shocking number of deaths and severe injuries were submitted to the agency’s adverse event reporting system during the first year Pradaxa was on the market.

Experts are alarmed about the safety of the drug, and some researchers have recently questioned the validity of the drug’s pre-approval clinical trials, saying that they were so flawed that the FDA should have never approved Pradaxa for the market.

The Institute of Safe Medication Practices (ISMP) reported that the FDA received hundreds of complaints about Pradaxa problems just weeks after it was released, related to bleeding events in elderly patients.

A number of individuals throughout the United States are now considering a potential Pradaxa lawsuit against Boehringer Ingelheim after suffering problems like internal bleeding, hemorrhages, heart attacks, strokes and sudden death.

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The U.S. Judicial Panel on Multidistrict Litigation has decided to create three new multidistrict litigations (MDLs) for all vaginal mesh lawsuits.


These lawsuits involve products manufactured by American Medical Systems, Inc. (AMS), Boston Scientific Corp. and Ethicon, Inc. The new MDLs will be centralized in the Southern District of West Virginia, where litigation over Bard Avaulta mesh systems is already consolidated.

According to an order issued this week, all four vaginal mesh MDLs will be assigned to Chief Judge Joseph R. Goodwin.

Recently, a growing number of lawsuits over problems with vaginal mesh and bladder sling products have been filed against manufacturers of the medical devices, which are used transvaginally to treat pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The complaints allege that design defects with the mesh products can cause women to experience painful and debilitating complications, such as infection and erosion of the mesh through the vagina.

The FDA has issued warnings about an increasing number of adverse event reports associated with the products. 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.

There are currently about 84 AMS vaginal mesh lawsuits pending in 19 federal district courts throughout the United States; 23 Boston Scientific pelvic mesh lawsuits pending in 14 different district courts; and 37 Ethicon or Gynecare mesh lawsuits pending in 22 different district courts.

All of these cases will be transferred to the Southern District of West Virginia, where Judge Goodwin will preside over pretrial proceedings. Judge Goodwin was assigned to the three new MDLs, as he already presides over more than 330 Bard Avaulta mesh lawsuits that have been transferred to his court since that MDL was formed in October 2010.

Each of the vaginal mesh MDLs will be kept separate, because they involve different manufacturers. Putting all of the litigation before one judge will help reduce scheduling conflicts, eliminate conflicting pre-trial rulings and serve the convenience of the witnesses, the parties and the courts.

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According to medical experts, a medical study underway is expected to reveal that side effects of metal-on-metal hip replacements can cause genetic damage, which could lead to an increased risk of cancer.


According to the U.K.’s Telegraph newspaper, a study to be presented next month at the British Hip Society conference will include findings that suggest the metal particles released by the grinding of metal-on-metal hip replacements could cause chromosomal changes, which may lead to kidney cancer and bladder cancer.

The findings are the latest nails in the coffin over the safety of the once-popular hip implant designs. These hips have been the subject of massive recalls and product liability lawsuits filed by individuals who allege that they are subject to failure within a few years after surgery.

The most likely cause of the genetic damage is metal debris made up of cobalt and chromium, which is released into the body when metal hip implant parts grind against each other. The particles have been linked to tissue damage, tumors, high metal ion blood counts and metal blood poisoning, known as metallosis.

DePuy Orthopaedics, a division of Johnson & Johnson, already faces a massive number of metal hip implant lawsuits. In August 2010, a DePuy ASR metal hip implant recall affected 93,000 implants worldwide and about 40,000 sold in the United States.

Approximately 3,500, of those victims who received the implant in the U.S. have already filed a DePuy ASR hip lawsuit. As more hip implants fail over time, the number of people filing product liability claims against manufacturers is bound to increase.

Recent data from the National Joint Registry for England and Wales indicates that nearly a third of patients will experience problems within six years and other estimates suggest that as many as half of all individuals who received the recalled hip system may eventually experience loosening or failure of their implant.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and what the potential side effects of metallosis are.

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The litigants in the federal NuvaRing litigation are scheduled to meet with the Court to discuss a plan to settle the lawsuits filed by women who allege that they suffered serious blood clot injuries from side effects of NuvaRing birth control.


All NuvaRing lawsuits filed in federal district courts are consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Rodney W. Sippel in the U.S. District Court for the Eastern District of Missouri.

NuvaRing is a ring birth control device that releases a combination of etonogestrel and ethinyl estradiol and is inserted into the vagina once a month.

The complaints all involve similar allegations that Merck and their Organon Pharmaceuticals subsidiary failed to properly research the birth control ring or adequately warn about the risk of blood clots from NuvaRing.

Plaintiffs claim that they have suffered injuries after taking NuvaRing birth control, including deep vein thrombosis (DVT), pulmonary embolism, heart attacks and strokes.

Following a status conference last week, the Court issued an Order that directed the parties to be prepared to discuss a preliminary plan for alternative dispute resolution at hearing set for February 28.

In January the Court ordered the attorneys to submit proposed plans for alternative dispute resolution, which would be designed to assist the parties in negotiating a potential NuvaRing settlement agreement.

While attorneys for the plaintiffs submitted a plan that calls for the appointment of a special master to oversee the negotiations, attorneys for Merck and Organon have suggested that it is premature to consider such efforts.

The parties are currently preparing a handful of lawsuits, known as “bellwether” cases, for early trial dates. The cases are designed to help the parties gauge how juries are likely to respond to certain evidence that will be introduced throughout other cases in the litigation. In complex pharmaceutical litigation, the results of such trials often factor heavily into settlement negotiations.

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Plaintiffs from Louisiana have filed a lawsuit against Pfizer that alleges the drug maker intentionally hid the link between their popular antidepressant Zoloft and congenital birth defects when the drug is taken by pregnant women.


The two Zoloft birth defect lawsuits were filed in January in the U.S. District Court for the Eastern District of Louisiana by Terry and Nelda Rolling and Joseph and Meg Mitchell.

The complaints involve children born with congenital birth defects after the mother’s use of Zoloft during pregnancy.

Many families have filed a similar Zoloft lawsuit against the drug maker, with allegations that use of the antidepressant during pregnancy caused children to be born with a variety of birth defects and malformations.

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States. Zoloft belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

In recent years, medical research and adverse event reports have indicated that side effects of Zoloft use during pregnancy may increase the risk of serious and potentially life-threatening health problems, including persistent pulmonary hypertension in newborns (PPHN), spina bifida, heart defects, lung defects, abdominal defects and cranial defects.

Studies have suggested that Zoloft may increase the risk of birth defects when used as early as the first trimester of pregnancy, a time when many women do not even know they are pregnant.

Recently, Swedish researchers published a study suggesting a link between PPHN and all SSRI antidepressants.

The lawsuits allege that data was available to Pfizer as early as 1996 that suggested their SSRI antidepressant may increase the risk of problems for children when taken during pregnancy, yet the drug maker failed to provide adequate warnings to consumers or the medical community.

By 2007, the lawsuits claim, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken by pregnant women due to another New England Journal of Medicine study that year. Those results were confirmed in a 2009 study.

The lawsuits allege that Pfizer willfully failed to warn consumers of the risks in order to maximize profits, resulting in a negligent breach in its duties to the medical community, users of their medication and their unborn children.

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A wrongful death lawsuit has been filed against ALZA Corporation by the family of a Utah woman who died in 2010, after using one of the company’s fentanyl pain patches.


The fentanyl patch lawsuit was filed by the family of Janine Ward last month in Salt Lake City’s 3rd District Court. The complaint names ALZA Corporation, a subsidiary of Johnson & Johnson, as a defendant.

According to the claim, the fentanyl patch, also known as a transdermal patch, was defectively designed and leaked fentanyl gel when applied to Janine Ward’s skin.

Johnson & Johnson, ALZA’s parent company, first developed the first pain patch as the Duragesic patch in 1994. Since it was introduced, the fentanyl patch has been associated with manufactured problems and many wrongful death lawsuits filed by families of individuals who overdosed on fentanyl.

Fentanyl is a painkiller about 100 times more powerful than morphine, and poses a severe risk of overdose and death if the gel contained within the patch leaks out and comes into direct contact with the skin of patient or caregiver.

The gel in the patch is supposed to be contained and delivered in a regulated fashion through a membrane placed on the skin. Over the last several years the FDA has received hundreds of reports of fentanyl overdoses and deaths associated with the use of fentanyl pain patches.

In many of the cases, too much of the fentanyl was delivered through the skin due to manufacturing defects. There have been a number of fentanyl patch recalls due to defective manufacturing.

According to Ward’s family, that is what s killed her in May 2010 after using one of the patches. A toxicology report found she had lethal levels of fentanyl in her blood at the time of death.

The lawsuit claims that ALZA used a reservoir design that failed to protect Ward from a potential overdose. According to the complaint, the death may have been avoided if ALZA had used a much safer matrix design; technology the plaintiffs say was known to the company.

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A Texas plaintiff has filed a federal complaint against Biomet Orthopedics over problems with their M2A Magnum metal-on-metal hip replacement system, which she says failed shortly after being implanted.


The complaint was filed by Carol St. Cyr in January, alleging that the Biomet M2A Magnum hip replacement she received was defectively designed and manufactured.

According to allegations raised in the product liability lawsuit, the metal head and acetabular cup of the Biomet hip replacement grindr against each other, causing premature failure and leading to metal blood poisoning from cobalt and chromium fragments; a condition known as metallosis.

St. Cyr, 69, received the Biomet M2A Magnum hip replacement in May 2009. Shortly afterwards, she began to suffer groin and hip pain, problems walking, sitting and standing, inflammation and other complications.

According to experts, as the metal hip replacement parts rub against each other, microscopic particles of cobalt and chromium may be shed into the body, which can result in metal poisoning. This may result in soft tissue damage, inflammatory reactions, bone loss, asceptic fibrosis, local necrosis and other problems that may lead to the need for a risky hip revision surgery.

Concerns about the safety of all-metal implants increased in 2010, after a DePuy ASR metal hip recall was issued due to higher-than-expected failure rates. More than 90,000 of the recalled implants were sold worldwide before the problems were acknowledged by the manufacturer, and hundreds of individuals in the United States have filed a DePuy ASR hip lawsuitafter experiencing complications with the implant.

In addition to DePuy and Biomet, a number of other artificial hip manufacturers also make all-metal implants, which have also been the subject of similar product liability lawsuits.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.