Articles Posted in Product Liability

An Arkansas judge fined Johnson & Johnson and a subsidiary more than $1.1 billion for downplaying and concealing risks associated with the antipsychotic drug Risperdal.

Judge Tim Fox ruled that Janssen Pharmaceuticals Inc. and its parent company must pay $5,000 for each of 240,000 Risperdal prescriptions the state Medicaid program paid for during a 3½-year period. He also fined the companies $2,500 for more than 4,500 letters Jannsen sent to Arkansas doctors, about $11 million.

Arkansas sued the companies alleging they misled doctors throughout the state in a letter that downplayed Risperdal’s side effects.

Tylenol is the most popular pain killer in America, with billions of the tablets and capsules sold each year.

Acetaminophen is the generic name for Tylenol, and is found in well over 200 commonly available over the counter medications, including DayQuil® and Tylenol®.

Acetaminophen-related liver injuries (Acetaminophen Injury) result in over 56,000 emergency room visits each year, 26,000 hospitalizations each year, and over 450 deaths.

The FDA made a safety announcement today regarding birth control pills containing Drospirenone and the new label change, that these products may be associated with a higher risk for blood clots.

FDA indicated that it had completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. According to the FDA, drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

What is Drospirenone

Many more Yaz injury plaintiffs are being added to the growing YAZ multidistrict litigation (MDL) against Bayer, but this time it’s not for deadly blood clots or a heart attack.

Plaintiffs are litigating against Bayer Healthcare because they suffered severe gallbladder disease, one of the many side effects from this oral contraceptive.

Plaintiffs are claiming gallstones, cholecystitis (inflammation) and biliary dyskinesia, as disorders that disrupts the emptying and filling of the gallbladder. Most plaintiffs eventually end up get a cholecystectomy or gallbladder removal.

Natazia (estradiol valerate and estradiol valerate/dienogest), a fourth generation oral contraceptive made by pharmaceutical giant Bayer HealthCare Pharmaceuticals, Inc, was FDA-approved on March 15, 2012, for the treatment of heavy menstrual bleeding.

In February 2012, the FDA gave Natazia a Black Box Warning regarding “Thromboembolic Disorders and Other Vascular Problems.” The warning states:

“Data from a large, prospective cohort safety study of various COCs (combined oral contraceptives) suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.”

According to a medical study, patients who received metal-on-metal hip replacements are at no greater risk of developing cancer after a seven-year period than the general population.

The research is published in the British Medical Journal, and recommends that longer-term review is needed of the effect of metal particles released from the implants, because some tumors take many years to develop.

The BMJ and the British Broadcasting Corp. said Feb. 28 that a joint investigation showed patients with the metal-on-metal implants may have been exposed to toxic metals that can cause long-term disability.

The blood thinner Pradaxa, (subject of 6 wrongful death US lawsuits), according to a new FDA report, may have been responsible for another 117 deaths during the second quarter of 2011.

The Institute for Safe Medication Practices (ISMP) published their quarterly report (PDF) earlier this week on adverse event reports between April and June 2011.

Pradaxa (dabigatran) is associated with more adverse reported cases than any other regularly monitored drug, the anticoagulant had been on the market for less than a year at the time.

A New Jersey State court will begin the first bellwether trial for NuvaRing lawsuits in February of 2013. These bellwether trials will reach a jury, out of hundreds of cases brought by women who allege the birth control ring increases the risk of blood clot (venous thromboembolism) injuries.

A group of nine cases are being prepared for trial dates in New Jersey state court, where the NuvaRing litigation has been consolidated for “mass tort” treatment before Judge Brian Martinotti in Bergen County.

According to a case management order, the first trial date is scheduled for February 4, 2013.

There is a new warning from the U.K. health officials, that states patients who received combination DePuy MITCH and Stryker Accolade metal-on-metal hip replacement components are experiencing a high failure rate.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert (pdf) on April 2, stating that there is an increased rate of revision surgery among patients who had a DePuy MITCH acetabular cup/modular head used in combination with uncemented Stryker Accolade femoral stems.

The MHRA is advising orthopedic surgeons not to use the components together and to follow up on all patients implanted with the combination of DePuy and Stryker components as part of a metal-on-metal total hip replacement.

In December of 2011, The U.S. Food and Drug Administration (FDA) issued a safety announcement, that it was “evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate).

Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.”

Pradaxa Side Effects