Articles Posted in Product Liability

Following the lead of the Federal Court ordered mediation in the Yaz/Yasmin litigation, the Pennsylvania state court judge has entered a similar order.

Judge Moss, who is managing thousands of cases in Philadelphia state court, required mediation in an order published on January 6, 2012. Judge Moss’s order comes just one week after a federal judge entered a similar order.

Both judges appointed Professor Stephen Saltzburg of George Washington School of Law, Washington D.C., to assist in the mediation.

Medical side effect concerns about Tekturna, a blood pressure drug sold by Novartis, have arisen after clinical trials were canceled due to a high number of strokes and kidney problems among diabetic patients.

Novartis was running a trial of the drug to see if it could be useful in the treatment of diabetic hypertension. The drug maker found that Tekturna may increase the risk of non-fatal strokes, kidney problems and other health risks.

Read the Safety Warning from Novartis here. Direct Healthcare Professional Communication on potential risks of cardiovascular and renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular disease treated with aliskiren (Tekturna®) tablets and aliskiren-containing combination products.

The federal judge overseeing the thousands of Yaz, Yasmin and Ocella venous thrombo-embolism lawsuits, has delayed the first trial scheduled to begin January 9th. The Court ordered the parties to meet with a special mediator in an attempt to negotiate a settlement for the litigation.

The first Yaz trial was involved a plaintiff who suffered a pulmonary embolism after taking the birth control pill.

Judge Herndon issued the order December 31 and determined that the litigation will be better served by delaying the start of the bellwether trial. This trial was designed to help the parties gauge how juries are likely to respond to evidence that will be presented in many of the cases.

The Judicial Panel on Multidistrict Litigation (JPML) is streamlining litigation for all federal cases alleging injury caused by the diabetes drug ACTOS®. These cases will now be brought under MDL No. 2299.

On the basis of the papers filed and the hearing session held, the JPML found that eleven current actions involve common questions of fact, and that centralization in the Western District of Louisiana will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.

Each of the actions alleges claims arising from the use of Actos, a prescription medication approved by the FDA, for use in the treatment of type 2 diabetes. Plaintiffs allege that individuals who use Actos face an increased risk of developing bladder cancer. Plaintiffs further allege that the defendants concealed their knowledge of this risk and failed to provide adequate warnings to consumers and the health care community.

The human tragedy of the most widespread medical implant failure in decades continues to unfold. These involve thousands of all-metal artificial hips that need to be replaced. And now as the litigation slowly grinds on, it has entered its most important phase of cost, both in financial terms and the cost of human suffering.

Medical and legal experts estimate the hip failures may ultimately cost billions of dollars in coming years. The metal-on-metal hip device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more. The grinding of metal parts against each other is generating metal ions that is damaging tissue and crippling patients. This medical condition known as metallosis.

All-metal hip implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. According to experts, 500,000 patients have received an all-metal replacement hip. According to a new study, no new artificial hip or knee introduced in the last five years were more durable than older devices, and 30 percent were worse.

Three Fosamax jaw decay lawsuits are scheduled to go to trial in 2012, including a new trial on damages in one case that resulted in an $8 million jury award in 2010.

U.S. District Judge John Keenan issued an order calling for additional Fosamax bellwether trials to take place in May, September and November of 2012.

Experts and legal commentators are most interested in the re-trial of the Boles case. In that case, the jury will only evaluate the damages that should be awarded for Boles developing osteonecrosis of the jaw (ONJ) from Fosamax.

The FDA is concerned over new liquid acetaminophen products for infants because of the possibility of accidental Tylenol overdoses and dosing confusion by parents.

The FDA issued a consumer update on December 22, warning parents that several new liquid acetaminophen products for infants have different potency than older liquid acetaminophen medications.

According to the FDA, caregivers of infants and children may give a child too much of the drug because they are used to the dosing sizes of older brands of liquid acetaminophen drops.

A recent Australian study indicates that the newer technology for artificial hips and knees did not perform any better than older, well tested and less expensive designs.

This week, data was published from Australia’s orthopedic registry, which covered implants introduced from 2003 to 2007. The study’s findings are significant for patients in the United States because many of the new designs, like the metal-on-metal hips, are widely used here and have come under increasing scrutiny.

These metal on metal implants, consist of a ball and cup made of metal, and according to experts are expected to fail prematurely in tens of thousands of patients. The artificial joints were marketed to last 15 years or more and provide better mobility and be more durable for the elderly population.

The safety of Bayer’s two blockbuster oral contraceptives, Yaz and Yasmin, have been called into question. These drugs which were the first to contain a progestin known as drospirenone, which is now used in a number of generic versions of the pills.

Yaz and Yasmin have been implicated in the formation of blood clots, a condition known as venous thrombo-embolism (VTE). The FDA recently found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. A number of other independent studies have shown an increased risk of blood clots from Yaz and Yasmin as well.

Newly unsealed documents, revealed during discovery in thousands of Yaz and Yasmin lawsuits being pursued against Bayer, indicate that experts believe that the company kept important safety data from federal regulators. Ex FDA Chief, Kessler gave expert opinion testimony that Bayer purposefully mislead the FDA about Yaz and Yasmin’s safety by selectively presenting data on blood clots and other thromboembolic events to make the drugs appear to be safer than they really were.

Accutane side effects and injuries have prompted 6,634 people to file an Accutane lawsuit in New Jersey against the manufacturer of the controversial acne drug, Hoffman-LaRoche.

A master complaint was filed as more plaintiffs joined the Accutane mass tort lawsuit. The purpose of the master complaint is to centralize the plaintiffs’ common allegations, which include Accutane Crohns disease and Ulcerative Colitis. The master complaint alleges that Hoffman-LaRoche created a defective product and negligently marketed that product to consumers.

Furthermore, the complaint alleges that the company failed to warn consumers about the serious side effects associated with Accutane use; inflammatory bowel disease, (IBD). The complaint also alleges that Hoffman-LaRoche failed to take the product off the market once the bowel side effects, birth defects and suicide were known.