Articles Posted in Product Liability

After a much publicized hearing, federal health experts said that drug labeling for Yaz and other drospirenone containing birth control pills should be updated to highlight recent data suggesting a higher risk of blood clots with these drugs than older contraceptive pills.

Expectations were heightened and many experts felt that the FDA may put a restriction on the sale of these drugs, but according to many, the FDA’s findings was very disappointing.

The FDA’s panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs, known as deep vein thrombosis and pulmonary embolism.

Medical research has demonstrated that newer birth control formulations containing a synthetic new progestin, Drospirenone, are more likely to cause venous thromboembolism (VTE) blood clots than older drugs. This data has lead the Food and Drug Administration (FDA) to consider new safety measures in meetings later this week. The increased risk is significant because VTE can cause heart attacks, strokes and blockages in lungs, (pulmonary embolism PE) or blood vessels, (deep vein thrombosis DVT) which can be deadly.

Yaz, Yasmin (manufactured by Bayer) and generic versions of the drugs use drospirenone which appears to reduce side effects found in older drugs, including bloating and mood swings. Evaluating the VTE risk of birth control drugs is difficult because all hormone-based contraceptive drugs increase the risk of VTE. Furthermore VTE risk can be increased by smoking, obesity or family history (genetic blood clotting defects).

Yaz, Yasmin and other generic pills containing drospirenone are the focus of a FDA discussion this week. Bayer says its studies have shown no difference in VTE risk between its drospirenone drugs and the older birth control drugs. But several large, independent studies suggest the risk with Yaz and similar medications is slightly higher. The latest analysis by the FDA estimates the risk of VTE with drospirenone-containing pills is 1.5-fold higher than other hormone-based contraceptives.

The Trans Vaginal Mesh (TVM) saga continues and another Multidistrict litigation is pending. American Medical Systems (AMS), a pelvic mesh manufacturer, is filing motions for the centralization and consolidation of all transvaginal mesh lawsuits filed in federal district courts throughout the United States.

There are currently at least 85 AMS mesh lawsuits filed on behalf of 133 different people, which are pending in 20 different federal district courts. The complaints all involve allegations of design defects associated with various AMS surgical mesh products, including the AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC and Straight-In mesh. The medical devices are implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

On November 23, AMS filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to consolidate all of the cases for pretrial proceedings in the U.S. District Court for the Eastern District of Minnesota. In the alternative, the medical device manufacturer has proposed that the cases be centralized in the Southern District of West Virginia.

Another generic birth control pill based on Yaz has been approved by the FDA, despite concerns that the pill may increase the risk of blood clots including deep vein thrombosis, pulmonary embolism, strokes and heart attacks when compared with older birth control pills.

Vestura, is manufactured by Watson Pharmaceuticals, containing ethinyl estradiol and drospirenone, a newer “fourth” generation progestin that is only found in the Yaz-family of contraceptives.

Yaz, and an older version known as Yasmin, are two of the most popular birth control pills on the market. Gianvi is a generic Yaz version and Ocella is a generic Yasmin version. Bayer also introduced Beyaz, a newer version, which is not available as a generic, which includes a folate supplement.

The use of Actos, a popular diabetic drug, is associated with an increased risk of bladder cancer. If you have developed bladder cancer as a result of using the drug Actos, then you need to consider the time you have to file a lawsuit for the injuries you have suffered. The right to file a lawsuit is not indefinite and is time limited, this is known as the statute of limitations. You have a certain amount of time to file a personal injury lawsuit, or the claim will expire irrespective of how strong your case is.

In the United States, personal injury statute of limitations vary from the state to state. Most states have a statute of limitations that runs for two years after the date of the injury. But, it is hard to pin down the starting date of the injury. For example, did the injury occur when the patient first began taking Actos, or was it when the bladder cancer was first diagnosed, or when the victim first realised the link between the bladder cancer and Actos or when the patient had surgery for his bladder cancer?

Typically, the court rules that the statute of limitations starts when the victim should have known about the dangerous side effects of the drug. Sometimes the drug manufacturer makes a public announcement that their drug is causing side effects; then the plaintiff should know about the danger, starting the statute of limitations. Sometimes, the court rules that the statute of limitations begins after the Food and Drug Administration issues a warning about the danger of the drug or makes a “black box warning.” At this point, the drug manufacturer’s dangerous drug is public knowledge. In the case of Actos, the FDA went public in June of 2011, and issued a warning.

Federal judge, Judge Keenan has appointed a law professor to oversee settlement talks in hundreds of Fosamax jaw decay lawsuits filed throughout the United States.

John Feerick, of the Fordham University School of law was appointed Special Settlement Master on November 22, in the federal multidistrict ligitation (MDL) for all federal lawsuits involving jaw problems from Fosamax.

Feerick will attempt to facilitate a Fosamax settlement agreement between Merck and plaintiffs who claim that the osteoporosis drug caused them to suffer decay of the jaw bone, known as osteonecrosis of the jaw (ONJ).

According to a new medical study and analysis, irrespective of the implant material, all types of hip replacement devices appear to work the same. The researchers said, the newer, metal-on-metal implants seem to be no more effective than older implants and may sometimes even be more problematic.

“Metal-on-metal and ceramic-on-ceramic hip implants might not be associated with any advantage, compared with traditional bearings such as metal-on-polyethylene or ceramic-on-polyethylene,” said lead researcher Dr. Art Sedrakyan, director of the Patient-Centered Comparative Effectiveness Program at Weill Cornell Medical College in New York City.

Sedrakyan said there is some medical evidence from three large national registries that higher rates of replacement surgery are associated with metal-on-metal implants, compared with metal-on-polyethylene implants. Even for newer implants such as metal-on-metal or ceramic-on-ceramic bearings, their advantage over traditional implants is not clear, Sedrakyan added.

U.S. District Judge James Beaty has rejected an attempt by Novartis to overturn the verdict in a Zometa jaw decay lawsuit. The trial unearthed evidence that suggests the drug maker’s employees intentionally covered up medical evidence of the bone drug’s side effects.

Novartis was trying to obtain a new trial in a defective drug product liability lawsuit brought by the family of Rita Fussman. The plaintiffs alleged in their lawsuit that the company failed to adequately warn consumers that side effects of Zometa could cause a condition known as osteonecrosis of the jaw (ONJ), where the jaw bone decays and dies.

Last year, a North Carolina jury awarded Fussman’s estate $13 million in compensatory and punitive damages, finding that the company intentionally withheld vital safety information from consumers.

It has now been eighteen months (August 2010) since the DePuy Acetabular Hip Replacement System (ASR Hip) was recalled. Approximately 37,000 DePuy Acetabular Hip Replacement Systems were implanted in the United States.There are many folks who had hip replacement surgery with these one of these devices but remain unaware of the recall or whether or not their hip is defective. It is important for all those who may have been affected—and their family members—to understand the DePuy hip recall and its potential affect on their life.

The DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.

The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Physicians have been warning about problems with metal-on-metal hip implants, which can release metal particles into the body, known as metallosis. The metal particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

A panel of federal judges is scheduled to meet in Savannah, Georgia to hear oral arguments over whether all federal Actos bladder cancer lawsuits should be consolidated under one judge for pretrial proceedings as part of an MDL, or multidistrict litigation.

All of complaints allege that the plaintiffs developed bladder cancer from Actos. The lawsuits allege that Takeda Pharmaceuticals failed to adequately research their type 2 diabetes drug or warn about the potential bladder cancer side effects of Actos.

The first Actos bladder cancer lawsuit was filed on July 29, 2011, but recently the number of cases has increased over the past four months.