• The Gist: Preemption issue is a hot one in civil litigation. Proving malicious conduct against a defendant often requires a thorough records review.
© 2008 The Medical-Legal News
A New Jersey superior court judge has tossed out the first two of 168 lawsuits filed against the makers of the hormone replacement therapy (HRT) drugs Premarin, Prempro and Provera, according to the New Jersey Law Journal (2008-07-15). The ruling throws a pall on any optimism for the other cases in the state.
The two cases, Bailey v. Wyeth Inc. and DeBoard v. Wyeth Inc., were based on an inadequate labeling theory. The plaintiffs claim that the HRT drugs caused breast cancers, according to the article. In such cases the patient has to find a breast cancer treatment center.
The judge found that New Jersey’s Products Liability Act (PLA), passed in 1987, subsumed any other method of suing, such as the Consumer Fraud Act and common law claims, and reasoned that the “rebuttable presumption of adequacy” for the labeling under the PLA could not be refuted since the FDA had approved the labeling. The judge said the PLA was intended to “provide the exclusive remedy for harm caused by a product,” according to the article.
Under this reasoning, it seems that once the FDA has approved a label, and the only avenue to liability is via a law that upholds the FDA decision, the door is effectively shut. According to the article, the only way around the law would be to show some intentional misconduct on the part of a drug maker. The judge said: “The ultimate decision of the FDA to provide or not provide certain information in a prescription drug label cannot be criticized unless a plaintiff has provided evidence of the pharmaceutical company’s deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or if the pharmaceutical company was found to have manipulated the post-market regulatory process.” The judge noted that 37 peer-reviewed articles had been published by Wyeth, lending credence to its defense of full disclosure of any potential problems with its HRT medicines, according to the article.
Product liability claims are usually brought under one of three theories: a manufacturing error, a design defect or faulty labeling (failure-to-warn). The article noted that the design defect route might still avail.
In late July, according to Bloomberg news service, Wyeth confidentially settled with two plaintiffs in Nevada concerning Prempro and Premarin. Wyeth is facing upward of 10,000 suits nationwide.