FDA Approval Preempts Inadequate Warning Claims

In an ongoing battle between the FDA and those who desire to hold pharmaceutical companies accountable for their inadequate warnings, two fairly recent cases have been decided declaring FDA approval a preemptive measure against inadequate warning claims. According to the decisions in Abramowitz v. Cephalon Inc. (New Jersey Superior Court decided March 3, 2006) and Colacicco v. Apotex, Inc., (Eastern District of Pennsylvania decided May 25, 2006), if the FDA gives its approval of the drug, no consumer, regardless of the injuries sustained, may bring a failure to warn case against the drug manufacture.

According to Mondaq.com:

On summary judgment, Abramowitz found that Cephalon had discharged its duty to warn under the “learned intermediary doctrine” by informing plaintiff’s treating physician of the risk of tooth decay in “FDA approved package insert[s] and . . . information.” Id. at *2. In reaching this conclusion, the court held that “the New Jersey courts have limited the availability of [failure-to-warn claims] when the warnings have been FDA approved” by presumption, on the basis that “compliance with FDA regulations serves as compelling evidence that a manufacturer satisfied its duty to warn.”

The chilling effect of these cases could leave numerous defective drug victims without recourse against the drug manufacture whose product has drastically affected their lives. Fortunately, most courts have not acknowledged this rationale and realize the FDA’s opinions and recommendations are only minimal standards the drug industry should employ in educating the public about the drugs it introduces into the stream of commerce.