Product Liability

September 1, 2013

Stryker Oasys Occipito-Cervico-Thoracic System Recalled

Stryker, a well known artificial hip and medical device manufacturer, is recalling devices used in spinal surgeries. The FDA has assigned its most serious warning label to the problem, indicating that using the device could result in serious injury or death. Stryker is already under fire over lawsuits involving its Stryker Rejuvenate and ABG II artificial hips, amid allegations of early failure of the devices and the risk of metallosis. Metallosis occurs when the component parts grind against each other releasing metal ions into the bloodstream and hip joint, leading to loosening of the hip device, bone destruction, pain and swelling.

The device is the Oasys Occipito-Cervico-Thoracic System, which is designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine.

Stryker has received reports that a pin that connects the tulip head to the plate body can fracture, possibly causing blood loss, nerve injury and the need for revision surgery. The FDA put its Class I designation on the recall, a notification for potentially deadly malfunctions.

August 30, 2013

Tylenol Liver Failure and Red Cap Warnings

by Dr. Shezad Malik

As a Texas medical doctor and Dangerous Drugs attorney, I have been warning about the serious and potentially deadly side effects of this commonly used medication. I have had personal experience of the liver damage that this drug can inflict on the young, elderly and sick patients, during my years as working as an ER physician.

Many a night we struggled to save the lives of young kids who would take Tylenol overdoses as a means of committing suicide. In some instances, the children died, some we managed to save with aggressive medical treatments.

According to experts, almost a quarter of patients take more than the recommended dose, which could result in accidental Tylenol overdoses, increasing the risk of liver failure or death.

August 21, 2013

NuvaRing DVT and Pulmonary Embolism Settlement?

by Dr. Shezad Malik

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.