Product Liability

May 1, 2014

J & J Ethicon Stops Hysterectomy Power Morcellators Over Cancer Risk

Johnson & Johnson’s Ethicon subsidiary has announced that it will stop selling its power morcellators used for uterine fibroid removal surgery. Medical research has shown that use of the devices during minimally invasive laparoscopic hysterectomy and myomectomy procedures may carry a risk of spreading sarcoma cancer.

Johnson & Johnson Ethicon: No Recall

The company, which manufactured and sold uterine fibroid surgery morcellators since 1998, has stopped sales, promotion and distributing the medical devices after an April 17 FDA warning. The FDA warned doctors to avoid the devices because of the risk of spreading preexisting uterine sarcomas.

April 30, 2014

FDA: Reclassification of Trans Vaginal Mesh as High Risk Device

by Dr. Shezad Malik

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

https://www.youtube.com/watch?feature=player_embedded&v=0Xvv9cd07G8

What is Pelvic Organ Prolapse?

April 23, 2014

AndroDerm Stroke Testosterone Patch Lawsuit Filed

by Dr. Shezad Malik

Wesley Davis, from New York filed a stroke product liability lawsuit against Actavis and Watson. Davis alleged that the side effects of the testosterone patch AndroDerm caused him to suffer a serious stroke. Furthermore, Davis claimed that the drug manufacturers failed to warn men about the potential risks associated with use of testosterone replacement therapy (TRT).

What is Androderm?

AndroDerm patch is a low testosterone drug approved by the FDA in 1995 for treatment of low testosterone caused by a medical condition, called hypogonadism. The testosterone replacement therapy medication is delivered in permeable skin patches.

April 20, 2014

Pradaxa Uncontrollable Bleeding Death Lawsuit Set for Trial

by Dr. Shezad Malik

U.S. District Judge Herndon, who is presiding over all federal Pradaxa lawsuits has established the pretrial schedule for the first bellwether trial. On September 8, 2014, the first trial will involve the wrongful death lawsuit brought by Suzanne Mackiewicz, on behalf of her mother, Malachy Higgins.

The Higgins case is selected as the first out of several thousand lawsuits on file, involving bleeding problems from Pradaxa.Multidistrict Pradaxa Consolidation

All federal product liability lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation. The MDL is centralized for pre-trial discovery before U.S. District Judge Herndon in the Southern District of Illinois.

April 19, 2014

F.D.A. Warns About Hysterectomy Morcellator Procedure

by Dr. Shezad Malik

According to the FDA, doctors should stop using a procedure performed on thousands of American women a year in the course of hysterectomy uterine surgery, because it increases the risk of spreading cancerous tissue.

The procedure, power morcellation, cuts uterine tissue into pieces that can be pulled out through the incisions made during laparoscopic surgery. The morcellator devices, have been widely used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the entire uterus.

Morcellator Devices: No Clinical Trials

April 17, 2014

Androgel Testosterone Injury Federal Consolidation

by Dr. Shezad Malik

Recently a consolidation motion was filed for all federal Androgel lawsuits to become part of an MDL, or multidistrict litigation.

Hot on the heels of that motion, a second motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that all testostereone therapy lawsuits be centralized before one judge as a single coordinated proceeding.

April 15, 2014

Testim Testosterone Gel Louisiana Wrongful Death Lawsuit

by Dr. Shezad Malik

A Louisiana man, who suffered a deadly heart attack, filed a wrongful death lawsuit against Testim gel manufacturer. The lawsuit claims that the 61 year old died as a result of Testim testosterone replacement therapy side effects.

The lawsuit was filed by the family of John Peuler against Auxilium Pharmaceuticals, Inc. on March 21, in the U.S. District Court for the Eastern District of Louisiana. There are close to 100 similar testosterone replacement therapy lawsuits filed across the United States in recent months.

What is Testim?

April 14, 2014

Texas Benicar Chronic Diarrhea Enteropathy Lawsuit

by Dr. Shezad Malik

Recently a Texas woman has filed a product liability lawsuit against Benicar drug manufacturer. The plaintiff alleged that Benicar side effects caused her to suffer chronic diarrhea problems, and severe weight loss.

Harriet Rubin, and her husband Allen, filed their complaint in the Superior Court of New Jersey. Benicar manufacturer Daiichi Sankyo removed the case to the U.S. District Court for the District of New Jersey on March 14.

There are several Benicar lawsuits pending in New Jersey, all of them have similar allegations that Daiichi Sankyo failed to adequately research their popular blood pressure medication or provide warnings for patients and doctors about the connection between Benicar and diarrhea intestinal disease known as sprue-like enteropathy.

April 13, 2014

Viagra and Melanoma Cancer Risk

by Dr. Shezad Malik

According to the latest medical research, the blockbuster erectile dysfunction drug Viagra may significantly increase men’s risk of developing melanoma. Melanoma is a lethal form of skin cancer, if not treated early.

Viagra Medical Study: 84% Risk Increase in Melanoma

Boston researchers, found that men taking Viagra were up to 84% more likely to be diagnosed with the skin cancer when compared to men who do not use the drug. It is postulated that Viagra has a direct effect on the body’s ability to combat skin cancer.

April 9, 2014

Louisiana Jury Hammers Takeda Actos Bladder Cancer $9 Billion Verdict

by Dr. Shezad Malik

The jury in federal court in Louisiana, sent a loud and clear message on Monday, in rendering a bombshell verdict. Takeda Pharmaceutical Co. and Eli Lilly & Co. were ordered to pay a combined $9 billion in punitive damages. The federal court jury found they hid the cancer risks of their Actos diabetes drug in the first federal U.S. trial.

https://www.youtube.com/watch?v=G4ItYan1QWo&feature=player_detailpage

Takeda, Lilly $9 Billion Punitive DamagesTakeda, based in Osaka, Japan, was ordered to pay $6 billion by the jury yesterday in Lafayette, Louisiana. Indianapolis-based Eli Lilly, Takeda’s partner, was ordered to pay $3 billion. Punitive damages are awarded in these types of cases to punish the companies for their wrongful acts.