Patients Assume the Risk with Generic Drugs

The United States Supreme Court issued 2 opinions in the past 2 years that address pharmaceutical manufacturers liability for name brand and generic drugs in Wyeth v Levine and Pliva Inc. v. Mensing, respectively. In 2010 in Wyeth v Levine, the Court held that state tort laws do not conflict with federal law and can be used to hold the brand name pharmaceutical manufacturers (innovator) accountable for the serious injuries and damages caused by their brand name dangerous drugs. In June, 2011, the Court in Pliva Inc. v. Mensing held just the opposite for the manufacturers of the generic forms of these dangerous drugs. The Court found that state tort claims are inconsistent with and are preempted by federal law and are not permitted. While these two opinions seem consistent, they created a middle-ground ambiguity and disconnect for the determination of responsibility for serious injuries caused by generic drugs.

These opinions came out of failure to warn litigation where it was alleged that the drug’s warnings did not provide full, complete and accurate disclosure of all know risks of serious side effects associated with the drug. The legal issue presented in these opinions is referred to as preemption, and asks the question whether state tort laws duty to warn are inconsistent with and are, therefore, preempted by federal law.

When these two cases are read together, they are just as significant and troublesome for what they did not say. Since generic manufacturers cannot be held responsible if the generic drug’s warnings fail to provide full, complete and accurate disclosure of all know risks of serious side effects associated with that drug, who will be? The Court found in Levine that that duty rests solely on the innovator to conduct the required safety and efficacy testing and change the warnings where necessary. That being said, neither opinion specifically stated, however, that the innovator’s duty extends past its original brand name drug to all generics, even though it is the only entity charged with those responsibilities. So charged, the innovators are and must be held responsible and accountable for undisclosed risks associated with the name brand and its generic cousin.

While the United States Supreme Court put the Levine and Mensing bookends in place, it avoided the middle ground of innovator responsibility for serious injuries from generic drugs. The thousands of lower courts were left to fill in the gap on their own. As of September, 2011, no less than 41 federal district courts and 3 federal appeals courts have issued opinions citing Mensing and upholding the bar of any responsibility on generic drug failure to warn cases for both the brand name and generic manufacturers and dismissing failure to warn cases against generic manufacturers.

So while we have seemingly consistent rulings, this resulting ambiguity and disconnect is left to the lower courts to figure out. The lower courts are seeing it as a black-or-white issue, following the 2 opinions and ruling that the innovators are not responsible for the warnings on generic drugs. This puts the patient between the proverbial rock and a hard place, with no remedy when they suffer a serious yet unwarned about side effect. Further, while doctors will prescribe brand name drugs, insurance companies often only pay for generics. So what is the patient to do? Protect your self by asking your prescribing physician to prescribe and specify that your prescription be filled with brand name drugs.