Zyprexa

Rulings Clear Way for Product Liability Suit Against Drug Maker Wyeth
The JereBeasley Report
August 2007 - Page 21 to 22

A New Jersey judge who is handling hundreds of lawsuits over Wyeth's hormone replacement drug Prempro has ruled that a federal law does not bar state lawsuits alleging drug makers did not adequately warn about a product's risks. The ruling, released last month by Superior Court Judge Bryan Garruto, is another in a string of rulings by a state or federal judges concluding that such product liability suits against drug makers are not pre-empted by the U.S. Food, Drug, and Cosmetic Act. The ruling came in a lawsuit brought by Ellen Deutsch, who blames Prempro for her breast cancer. Ms. Deutsch's key claim against Wyeth will be allowed to proceed as a result of the decision. I believe the ruling will help plaintiffs across the country suing drug makers in a lawsuit involving other drugs.

Since at least early 2006, drug makers have been claiming that product liability suits are pre-empted, or barred. They argue that federal law gives the FDA the exclusive right to determine whether a drug's label, or detailed package insert, contains adequate warnings about any health risks. The ruling in the Deutsch case backs up earlier ones in New Jersey state court involving Vioxx and in a New York federal court involving Zyprexa. Clearly, just because a drug is approved by the FDA does not protect the drug company from being sued. The FDA regulations are a floor, not a ceiling. Drug companies under the law can strengthen warnings or add new ones at their option. Ms. Deutsch, who took Prempro from 1996 through 2002 and also took an older Wyeth menopause treatment, Premarin, before that, alleges the drugs caused her breast cancer. She is now in treatment for the cancer, which has spread to her bones. The Deutsch lawsuit, which was scheduled for trial on July 16th, would have been the first in New Jersey. However, the case settled just hours before opening statements were to start.

Currently, about 250 Prempro lawsuits are pending in New Jersey and about 10,000 have been filed nationwide. Judge Garruto also issued other pretrial rulings in the Deutsch case; including one stating that a doctor's prescribing a drug does not preclude a patient from suing over alleged harm. This makes sense, and is legally correct, because drug companies advertise directly to patients. People might choose not to take a drug their doctor prescribed if they knew all of its risks. In a third ruling against Wyeth, Judge Garruto also ruled that a plaintiff bringing a product liability suit can separately sue for a fraud or misrepresentation under New Jersey's Consumer Fraud Act. But, in Ms. Deutsch's case, he dismissed her consumer fraud claim because she had not provided evidence of what she paid for the hormone replacement drugs.

To date, there have been nine Hormone Therapy (HT) cases set for trial. Of those, Wyeth has settled three and plaintiffs have received sizeable jury awards in four of the others. Ted Meadows, Russ Abney and Melissa Prickett are the primary lawyers handling the HT cases for our firm.