Dallas Fort Worth Injury Lawyer Blog

Transvaginal mesh plaintiffs are petitioning for the vaginal mesh litigation pending against 4 different companies to be centralized before one judge in the U.S. District Court for the Southern District of West Virginia.

As described in previous blogs, thousands women throughout the United States are bringing product liability lawsuits against the 4 main medical device manufacturers as a result of injuries with transvaginal bladder mesh systems, which have been associated with reports of infection, vaginal erosion and pelvic pain.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) in November received motions for many Boston Scientific pelvic mesh lawsuits, American Medical Systems (AMS) mesh lawsuits and Ethicon/Gynecare mesh lawsuits to be centralized before Chief Judge Joseph R. Goodwin, who is already presiding over all federal Bard Avaulta mesh lawsuits that were consolidated for pretrial proceedings.

A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous thrombosis embolism (VTE) when compared to using some older oral contraceptives. The panel did not recommend that the FDA issue an Ortho Evra recall due to the potential dangers.

The FDA recently held the advisory committee to review the risk of VTE with the Ortho Evra patch, as well other newer forms of contraceptives, such as Yaz and Yasmin birth control pills and the NuvaRing birth control ring.

The panel voted 19-5 that the benefits of the Ortho Evra outweighed its health risks, and they voted 20 to 3, to recommend that the birth control patch’s blood clot warnings be rewritten.

Another example of a corporation being caught with its hand in the cookie jar. Medtronic has agreed to pay the U.S. Justice Department $23.5 million to settle allegations that the company paid doctors to implant its pacemakers and defibrillators.

The Justice Department investigation alleged that Medtronic paid doctors between $1,000 and $2,000 per patient implanted with a Medtronic pacemaker or defibrillator as part of four post-marking studies.

According to a press release from the Justice Department, the payments were to promote doctors to use a Medtronic device over other competing devices, and to persuade them to be loyal to Medtronic for future cardiac procedures.

This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing.

The FDA advisory panel voted 19-5 that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel members think those risks should be more clearly stated on the label.

The FDA’s Advisory Committee for Reproductive Health Drugs and a drug safety committee voted Friday to recommend that the FDA should allow the patch to remain a contraceptive option.

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).