Generic Drugs: Exempt from Lawsuits?
In a previous blog last year, I spoke to you about how generic drug labels do not have the same requirements as brand name drugs. So, how does this affect you if you have been injured by a generic drug?
Previously, I covered the Supreme Court case Pliva, Inc. v. Mensing, which held that federal law regarding the labeling of generic drugs preempts state law on this subject matter. Federal law only requires that a generic brand’s label match that of the brand name drug. That is the duty of the generic drug maker. If the label meets those requirements the manufacturer has not failed in its duty to inform consumers. However, the majority of the consumer base get generic drugs because they are more conveniently priced then brand-named drugs. In fact, according to the FDA, nearly 8 out of 10 of all prescriptions in the U.S. are filled with generic drugs. Unfortunately, the current structure of the law prevents many consumers from being compensated for injuries due to serious side effects from a harmful drug.
As mentioned in the previous blog, the FDA has been seeking changes that would let generic drug makers unilaterally change drug labels. The FDA now intends to release in July a final rule that would allow generic drug companies to update their labels with new safety information on their own, instead of matching the brand name label. If the rule is finalized, it would permit a generic drug maker to immediately issue a labeling change for any “safety-related change,” and thus intending to allow differences to exist between the label of the generic drug and the brand-name product and other generic drugs on a “temporary basis.” This may provide for a new legal standard in which the courts will not see a preemption issue between federal laws requiring the labels to match. Therefore, if a generic drug manufacturer is aware of the harms a drug poses and fails to make consumers aware of this risk, then there may be the possibility of bringing a lawsuit against the maker in this context.
Additionally, there is a recent Illinois opinion, Guvenoz v. Target Corp., Inc., No. 12-L-005162 (Mar. 27, 2015), regarding a man who allegedly died as a result of taking the generic version of the drug Darvocet (propoxyphene). In 2009 the FDA Advisory Committee had voted against the continued marketing of the drug due to adverse side effects including cardiac effects. Months before the FDA ordered the withdrawal of the drug off the market, the plaintiff took the drug and experienced cardiac arrest which led to his death. The court reasoned that the facts in this case were different from Mensing and another case Mutual Pharmaceutical Co. v. Bartlett. In its opinion, the court stated that the drugs in those cases were “safe for the vast majority of patients taking it.” In this case, the plaintiff alleged that “the drug was simply unsafe and should not have been sold at all.” This is of course an Illinois state court opinion, but it suggests that there may still be options out there for those who have been harmed by a generic drug.
If you were seriously injured by a generic drug, you should speak with an experienced attorney today as you may have options in the future. However, it is important to note that as the law changes there are still statute of limitations that may bar your claim after a certain period of time. Even under the rules of the Mensing decision, it’s important to at least preserve you right to seek compensation in the future.Back to the Blog