Scarcely Publicized US Supreme Court Decision Affects Consumers of Over 75% of Pharmaceutical Drugs Dispensed in the Country
As a result of the Supreme Court decision in Pliva v. Mensing, 131 S.Ct. 2567 (2011), causes of action based on failure to warn have been essentially eliminated against manufacturers of generic drugs. The central issue in this case was whether federal drug regulations, concerning drug-label warnings which apply to manufacturers of generic drugs, directly conflicted with duties imposed by individual states’ laws. If there is a conflict between federal and state laws, the federal law supersedes or “preempts” the state law.
Federal drug regulations require that generic drug labels contain the exact same label and warning information as the brand drugs after which they are modeled. State laws on drug regulations require that when a manufacturer of a product has knowledge of a danger which is not listed on the drug’s label, the generic manufacturer has a duty to warn the public of such a danger. One avenue to satisfy this duty to warn the public is through a change in product labeling.
In the narrow 5-4 decision delivered by Justice Clarence Thomas, the U.S. Supreme Court Justices reasoned that it is not possible to comply with federal law, which requires generic manufacturers to have the exact same label as brand manufacturers, and at the same time comply with State law, which requires generic manufacturers to change their labels when they are aware of a label that does not adequately warn of a drug’s side effects. Since it is not possible to comply with both federal law and state law for product labeling, the Court decided that generic drug companies must only comply with federal law due to “federal preemption.” Federal preemption is the concept that a state law is invalid when it conflicts with a federal law.
This decision means that generic drug manufacturers are not legally liable for inadequately labeled drugs, as long as the generic drug label exactly matches the label of the brand drug that the generic drug is modeled after. According to the Supreme Court, since the generic manufacturer cannot alter their label, generic manufacturers do not have to pay damages under state law since the label is required by federal law.
This decision ultimately means that entire cases can potentially hinge upon whether or not a potential plaintiff ingested a brand-name or generic drug. In her dissent Justice Sotomayor remarks, “[a]s a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.”
Justice Sotomayor’s above statement reflects the notion that often whether a consumer ingests a brand-name or generic drug is not even a decision that is actively made by the consumer. Currently, all states have some form of generic substitution law; some of these laws authorize pharmacists to unilaterally substitute generic drugs for brand-name drugs without consulting the patient.
This divergent treatment of brand and generic drugs becomes even more frustrating when examining the composition of brand and generic drugs. The FDA requires generic drugs not just to be similar to the brand name drug after which it is modeled, but bioequivalent. Meaning, the generic drug must be exactly the same as the brand drug in terms of active chemical components as well as the effect the drug has on the consumer.
Though Justice Thomas acknowledges the unfortunate and disparate impact this ruling will have on the consumers of over 75% of American pharmaceutical drugs, he nonetheless leaves no clear avenue for redress for users harmed by usage of generic drugs. Instead, Justice Thomas concludes his opinion by stating that Congress, as well as the FDA, retain the authority to change these laws if they so desire. When, or even if, these legislative changes will take effect continues to remain a mystery to the general public. Meanwhile, many insurance companies continue to require their insured to purchase generic drugs, which come at a fraction of the price of brand drugs for the insurance company, but also deprive consumers of one of their most fundamental rights to seek redress for harms that, for many people, will inevitably come as a result of ingesting pharmaceutical drugs.
However, while the law established in Pliva v. Mensing currently prohibits recovery against generic manufacturers, there is some existing authority supporting alternative theories of liability against manufacturers. The law supporting recovery on behalf of consumers of a generic drug is relatively new, and is not well-established in all parts of the country. At the Maher Law Firm we are currently looking to pursue such avenues for many of our clients, but doing so is a serious uphill battle.
If you would like to further discuss this opinion or our firm’s involvement with generic drug pharmaceutical litigation, contact us toll-free at 866-481-8667.