Articles Posted in Product Liability

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.

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.”

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.

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.

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.

According to a British health agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), millions of people worldwide who have received metal-on-metal hip replacement may need to get blood tests for the rest of their lives.

Many metal hip replacement systems contain chromium and cobalt in the ball-and-socket device, which became popular due to the untested belief that they would be more durable to younger, more active hip patients.

Recently, there has been damaging data to indicate that these types of hip implants not only have a high rate of failure, but also shed metal particles into the body that can cause metallosis.

Bayer Healthcare reports that it has reached agreements to settle Yaz and Yasmin deep vein thrombosis and pulmonary embolism lawsuits brought by at least 70 women.

Earlier in the week, the judge ordered that the bellwether trials been postponed for another 60 days. The bell-wether trial were scheduled for April and now are moved out to June 2012.

Here is a copy of the court transcript. “MINUTE ORDER STAYING DEADLINES AND CONTINUING BELLWETHER TRIAL: All current deadlines related to bellwether matters are extended 60 days and the bellwether trial is continued until further order, due to the courts calendar.. Signed by Chief Judge David R. Herndon on 2/29/2012.”

A panel of federal judges will hear arguments in March on the centralization all Zoloft lawsuits filed in U.S. District Courts.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has set a hearing for March 29. The lawyers will argument whether federal complaints filed against Pfizer by parents of children born with birth defects should be centralized for pretrial proceedings as part of an MDL, or multidistrict litigation.

Pfizer filed a motion seeking that the lawsuits should be consolidated in the U.S. District Court for the Southern District of New York. MDL is designed to avoid potentially conflicting pretrial rulings from different judges, reduce duplicative discovery and to serve the convenience of the witnesses, the parties and the courts.

Dr Shezad Malik Law Firm examines the evidence of risk from metal-on-metal hips, the manufacturers’ inadequate response, and how the regulatory bodies failed.

Thousands of patients around the world may have been exposed to toxic metal substances after being implanted with poorly regulated and potentially dangerous hip devices, according to a BMJ/BBC Newsnight investigation.

The implants are the so called “metal on metal”—the head at the top and the lining of the cup it fits into are made of cobalt-chromium alloy rather than ceramic or polyethylene—and there are both total hip replacement and hip resurfacing designs.

Three women have filed a product liability lawsuit against Forest Laboratories alleging birth defects from the use of Lexapro. Lexapro is an antidepressant that each of the plaintiffs claimed to have used while pregnant.

The Lexapro lawsuits were filed on February 16 in St. Louis Circuit Court, in Missouri.

All three plaintiffs, Kimberlee Fisher, Kristy Hernandez and Leah Scott, allege that they gave birth to children who suffer from congenital defects.