Product Liability

August 5, 2009

Yasmin / Yaz Defective Drug Lawsuit Consolidation

It is common in defective drugs claims, when a large group of people file lawsuits against a drug maker to have similar allegations that an injury was caused by a side effect of a particular drug.

The plaintiffs are seeking to consolidate all Yasmin and Yaz birth control lawsuits in an MDL, or Multidistrict Litigation, where the individual cases would be assigned to one judge and handled in a manner similar to how a Yasmin / Yaz class action lawsuit would be managed during pretrial litigation.

The Yaz / Yasmin lawyers are reviewing potential lawsuits involving serious and life-threatening injuries caused by these popular birth control pills, and support the formation of an MDL, as it will benefit the women who have experienced Yasmin / Yaz problems.

The motion was filed in July with the U.S. Judicial Panel on Multidistrict Litigation asking that an MDL be formed for the Yasmin / Yaz litigation, and that all of the cases filed in different federal district courts throughout the United States be transferred to the Northern District of Ohio for coordinated handling.

August 5, 2009

CBS News Investigation Finds 59 Deaths, Hundreds Of Injuries Linked To Yamaha’s Off-Road Vehicle

by Dr. Shezad Malik

In the swath of Kentucky called the Land Between The Lakes, the Turkey Bay Off-Highway Vehicle Area is a rugged expanse of hills and woodlands crisscrossed by 100 miles of trails. Test drivers came here in July, 2002, to try out the Yamaha Rhino, a new breed of off-road vehicle then in development, and had a mishap that would resonate years later.

Keisuke “Casey” Yoshida, president of a U.S. subsidiary of Yamaha Motor Co. Ltd., was behind the wheel of a Rhino prototype. Ike Miyachi, a company vice president in charge of Rhino development, rode beside him in the passenger seat. After descending a long hill to flat ground, the Rhino tipped over, giving Miyachi a foot injury.

At a meeting weeks later, Yoshida raised a question that now seems prophetic. “Casey wants update on instability of vehicle for future liability cases,” according to minutes obtained by CBS News.

August 5, 2009

Defective Drugs: Neurontin Lawsuits and Suicide

by Dr. Shezad Malik

Pfizer Inc.’s Warner-Lambert unit created a list of 13 ailments that its epilepsy medicine Neurontin could treat as part of its promotion of the drug for unapproved uses, a former employee testified.

“I was trained from day one” to market the drug illegally, David Franklin testified. Franklin, who worked as a medical liaison at the Parke-Davis division of Warner-Lambert, said he encouraged doctors to prescribe Neurontin for uses beyond those approved by the U.S. Food and Drug Administration.

“My job was to promote Neurontin and motivate doctors to experiment” on patients, he said today in federal court in Boston. After being hired as a medical liaison, “I was selling drugs,” he said. The uses promoted were from the “snake-oil list” of 13 medical conditions, said Franklin, a microbiologist.

August 4, 2009

FDA: Arthritis Drugs Linked to Cancer Risk in children

by Dr. Shezad Malik

Federal regulators on Tuesday added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents.

After more than a year of review, Food and Drug Administration scientists said the drugs appear to increase the risk of cancer after they are used beyond 2 1/2 years. The agency studied several dozen reports of cancer in children taking the drugs, some of which were fatal. Half of the cases were lymphomas, a cancer that attacks the immune system.

The drugs are known as tumor necrosis factor blockers and work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue. The drugs are prescribed to children with rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease.

August 4, 2009

Yaz and Yasmin and Increased Risk of Cardiovascular Side Effects

by Dr. Shezad Malik

Four Yaz and Yasmin lawsuits have been filed in Pennsylvania state court against Bayer, claiming that the company failed to warn consumers that the birth control pills increase the risk of a variety of cardiovascular health problems.

The complaints were filed on July 29 in the Philadelphia Court of Common Pleas on behalf of plaintiffs Rae Anne Bailor, Felicia R. Hill, and couples Erin and Daniel Shae, and Heather and Chris Karabin. The plaintiffs allege that they suffered a variety of ailments after taking the birth control pills, including pulmonary embolisms and health complications that required gallbladder removal for two of the plaintiffs.

August 4, 2009

No Punitive Damages Against Merck in Fosamax Trial

by Dr. Shezad Malik

Merck & Co., facing more than 850 lawsuits over claims that its osteoporosis drug Fosamax may cause irreversible “jaw rot,” won’t face punitive damages in the first trial, a federal judge said.

U.S. District Judge John Keenan said at a hearing today in New York that he’ll release a decision as early as July 31 knocking out the possibility of punitive damages in the case. He’ll deny Merck’s request to rule in its favor on liability, which means the case will go to trial Aug. 11, he said.

Keenan has scheduled three so-called bellwether trials through January to show each side the other’s strategy and possibly point the way to settlements. The judge earlier denied the plaintiffs’ request to treat the litigation as a class, or group, lawsuit allowing them to ask for court-ordered medical monitoring of all Fosamax users.

August 3, 2009

Carcinogens and Poisons Found in Electronic Cigarettes

by Dr. Shezad Malik

The Food and Drug Administration on Wednesday released an analysis of 19 varieties of electronic cigarettes that said half contained nitrosamines (the same carcinogen found in real cigarettes) and many contained diethylene glycol, the poisonous ingredient in antifreeze. Some that claimed to have no nicotine were found to have low levels of the drug.

E-cigarettes are promoted by their manufacturers as safer than traditional cigarettes because they do not burn tobacco. Instead, a lithium battery in the cigarette-shaped device heats a solution of nicotine in propylene glycol, producing a fine mist that can be inhaled to deliver nicotine directly to the lungs.

August 3, 2009

Neurontin Pfizer Product Liability Lawsuit Dropped

by Dr. Shezad Malik

After her family dropped its lawsuit in the midst of trial, Pfizer Inc. won’t face a lawsuit over claims its epilepsy drug Neurontin helped lead a Massachusetts woman to commit suicide,
Susan Bulger’s family agreed to dismiss the suit after an anonymous donor offered to put money in a trust for her 10-year- old daughter, Regina, said Mark Lanier, the family’s lawyer. The trial began July 27 and was scheduled to run three weeks in federal court in Boston.

The suit was the first of about 1,200 involving Neurontin. The family claimed Pfizer, the world’s largest drug company, promoted the medication for unapproved uses and didn’t warn it could increase the risk of suicide until forced to do so by the government. Pfizer said Bulger had a history of drug abuse and had made six suicide attempts before taking her life in 2004.

August 2, 2009

Defective Drugs: Levaquin Lawsuits and Tendon Rupture

by Dr. Shezad Malik

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

FDA agrees to Public Citizen’s request to issue a “black box” warning in the product label and a guide for patients warning of the dangers of tendinitis and tendon rupture with the fluoroquinolone antibiotics, but fails to send a letter to doctors warning of these dangers.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

August 2, 2009

FDA Warning: NJOY Firm Continues to Sell E-Cigarettes

by Dr. Shezad Malik

NJOY, the electronic cigarette brand based in Scottsdale, will continue to market the tobacco-less devices despite a warning from the Food and Drug Administration that it could pose health risks.

Public health officials said last week that electronic cigarettes, or “e-cigarettes,” may not be such a healthy alternative to traditional cigarettes.

The FDA tested NJOY and another brand. Results showed some of the samples in both brands contained human carcinogens and tobacco impurities suspected of being harmful to humans.