Product Liability

August 21, 2013

NuvaRing DVT and Pulmonary Embolism Settlement?

According to Merck company filings, there are now about 1,500 filed product liability lawsuits involving injuries from NuvaRing blood clots. These women claim that the contraceptive ring increased the risk of blood clots, other serious and potentially deadly side effects.

What is Nuvaring?

NuvaRing is a vaginal contraceptive ring, made by Merck’s Organon subsidiary, which is placed in the vagina. The ring releases a combination of estrogen, ethinyl estradiol and the “third generation” progestin, etonogestrel. The ring is replaced every month.

August 20, 2013

Bard Avaulta Vaginal Mesh Trial $2M Plaintiff’s Verdict

by Dr. Shezad Malik

Last week, a federal jury in West Virginia awarded $2 million in damages in a Bard Avaulta vaginal mesh defective product liability claim. The verdict included punitive damages to punish CR Bard Inc., the manufacturer for selling a defective product that has been linked to severe internal injuries.

This is the first federal Vaginal Mesh verdict, in more than 25,000 vaginal mesh lawsuits pending in the federal court system.

Plaintiff Suffered Serious Injuries

August 19, 2013

Medtronic Infuse Injury Lawsuits Update

by Dr. Shezad Malik

Medtronic Infuse product liability lawsuits involving Medtronic Infuse bone graft surgery, have hit a federal preemption roadblock. Federal preemption law, for medical devices, is based on a 2008 Supreme Court ruling that has been used as an impregnable defense wall by medical device manufacturers.

Medtronic has argued that they can not be held liable for injuries, since the device was approved by the FDA. The medical device maker’s argument was upheld in the Supreme Court decision of Riegel v. Medtronic, involving allegedly defective pacemaker leads and injuries.

What is Medtronic Infuse?

August 15, 2013

Intuitive Surgical’s Da Vinci Robot Lawsuit Update

by Dr. Shezad Malik

The FDA issued a warning letter to Intuitive Surgical, which hammers the makers of the da Vinci surgical robot for failing to notify the federal regulators about information the company sent to doctors using the robotic surgery machine.

The FDA letter was issued after a FDA inspection between April 1 and May 30 of the company’s production facility. Investigators found that Intuitive Surgical had sent out field correction letters to doctors and hospitals in order to correct or prevent da Vinci problems. According to federal regulations, the FDA must be informed within 10 working days of such a notification.

One of the notifications appears to show that Intuitive Surgical knew that the da Vinci had problems with electricity arcing from the tools as early as October 2011.

August 12, 2013

Cancer Risk with Byetta and Januvia Downplayed by FDA

by Dr. Shezad Malik

According to the FDA, there is no scientific evidence to confirm that a group of type 2 diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The FDA decision comes on the heels of the European Medicines Agency, which stated that they have been unable to confirm an increased risk of pancreatic cancer linked to side effects of Byetta, Januvia, Janumet, Victoza and other incretin mimetic drugs.

The FDA has apparently completed its safety review into the new group of medications, known as incretin mimetics, and is preparing to report that it has found no conclusive connection between the medications and pancreatic cancer. According to the EMA, its experts reviewed the data and found “methodological limitations and potential sources of bias” and decided the available data don’t bear out worries about an increased risk of “pancreatic adverse events.”

The report addresses the entire group of incretin mimetics, which comprises GLP-1 agonists, which mimic a key hormone, and DPP-4 inhibitors, which interfere with a protein that breaks down the same hormone.

August 1, 2013

Lipitor and Diabetes Risk

by Dr. Shezad Malik

According to experts, the blockbuster cholesterol drug Lipitor may increase the risk of diabetes.

What is Lipitor?

Lipitor (atorvastatin) is a statin-based cholesterol drug manufactured by the Pfizer subsidiary Warner-Lambert. The cholesterol drug is a best seller and has achieved blockbuster status. Lipitor has produced more than $125 billion in sales before the patent expired in 2011. Now off patent, several generic Lipitor versions are available.

July 31, 2013

Tylenol Bad for the Liver

by Dr. Shezad Malik

In April, the U.S. Judicial Panel on Multidistrict Litigation consolidated all product liability lawsuits involving Tylenol. Plaintiffs allege that Johnson & Johnson failed to adequately warn about the risk of liver failure or liver damage from Tylenol. These Tylenol federal lawsuits are centralized before U.S. District Judge Lawrence F. Stengel in the Eastern District of Pennsylvania.

What is the problem with Tylenol?

Tylenol is a blockbuster medication, used for pain relief, that is available over the counter. Tylenol been used by millions of American adults and children. Tylenol the trade name, contains acetaminophen as the active pharmaceutical ingredient.

July 18, 2013

Bard Avaulta Mesh Trial Ends Abruptly

by Dr. Shezad Malik

U.S. District Judge Joseph Goodwin presiding over the first federal Bard Mesh trial has declared a mistrial. This trial involved complications associated with Bard Avaulta mesh. On the second day of trial, a gynecological expert mentioned that the Bard Avaulta mesh has been removed from the market. In pre-trial rulings, the parties agreed that evidence of the products subsequent withdrawal would be excluded because it may bias the jury.

What is Bard Avaulta Mesh?

Bard Avaulta mesh is used for transvaginal surgical repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). Thousands of women have claimed that Avaulta plastic mesh have caused them to suffer serious and catatrophic injuries when the mesh may eroded through the vagina.

July 17, 2013

Federal DePuy ASR Trial Set For September

by Dr. Shezad Malik

A New York woman, Ann McCracken’s defective hip claim will be the first DePuy ASR hip lawsuit to go to trial in federal court. McCracken’s case is a “bellwether” case, designed to determine how juries will respond to presented evidence and testimony.

7,800 Federal DePuy ASR Lawsuits

More than 7,800 lawsuits have been brought in the federal court system by folks who have problems with the recalled DePuy ASR hip implant. These metal on metal hip cases are consolidated as part of an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Katz in the Northern District of Ohio.

June 14, 2013

Concerns About Byetta, Januvia and Victoza Drug Safety

by Dr. Shezad Malik

The National Institutes of Health held a workshop, addressing the risks associated with the newer diabetic drugs. These medications, known as Incretic Mimetics are coming under fire for alleged increased risk of pancreatic cancer.

Merck & Co., Novo Nordisk A/S and others, the manufacturers of these drugs may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.

The Food and Drug Administration said it is considering setting up a study, either through the agency or the companies, that looks deeper into whether medicines for Type 2 diabetes, including Merck’s Januvia and Bristol Myers-Squibb Co.’s Byetta, cause pancreatic cell growth that could turn cancerous.