*Note: This article contains generic information – not legal or medical advice. If you find yourself in a questionable or problematic situation, seek professional counsel.

A long-established cornerstone of American jurisprudence is that knowledge of the law is presumed. While some exceptions apply (e.g., Lambert v. California dealing with city ordinances), the general principle is that even if one is wholly ignorant of the law, one is bound to its substance. The medical-legal landscape in America has undergone significant shifts with respect to patient rights in the last decade. Unfortunately, most physicians and patients are unaware of these weighty transformations to consumer-patient laws. As a result, physicians and patients have been left vulnerable in certain aspects.

Consequently, physicians have an obligation to educate themselves and maintain at least a basic understanding of current laws and regulations pertaining to the practice of medicine. As the Latin aphorism states, “scientia potential est” – knowledge is power. In a series of articles, laws that every physician should be familiar with will be covered.

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011)

Same Rx Drug, Same Injury…Different Legal Rights:

Legal Issue: Brand-name prescription pharmaceutical manufacturers can be held liable in state-law tort claims for failing to adequately warn about newly-discovered side effects or health risks on their drug labels. Can generic prescription pharmaceutical manufacturers be similarly held liable?

SCOTUS Holding: No.

Reasoning: On June 23, 2011, the Supreme Court (“SCOTUS”) held in a 5-4 decision in PLIVA, Inc. v. Mensing that generic prescription drug companies cannot be held liable in state-law tort claims for inadequately warning patients about newly-discovered side effects or health risks on their drug labels.

While brand-name drug companies have the ability and legal duty under federal regulations to alter a drug’s warning label based on newly discovered side-effects or health risks, generic drug companies are only required to match (or copy) the labeling information from their brand-name equivalents.

Discussion: In PLIVA, SCOTUS held that a generic drug manufacturer may avoid state tort liability for failure to warn – even if it can be proven that a generic drug company had newly-discovered information that a drug was dangerous and that patients could potentially die.

Thus, when patients take generic prescription medications they unwittingly and simultaneously forfeit their right to file a state-law tort claim against the pharmaceutical manufacturer for failure to adequately warn on a drug’s label of newly discovered side effects or health risks. This is an immense change for the legal rights of patients when considering that nearly 80% of all prescriptions in the U.S. are filled with the generic version of a drug.[1] Moreover, “half of all black box warnings on drugs introduced after 1975 were added after the drug had received FDA approval and been on the market for seven years.” [2]

Justice Sotomayor – who herself takes prescription medications as a diabetic patient – wrote for the dissent in the Mensing opinion that, “As 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 drug or generic drug. The [Majority] Court gets one thing right: This outcome ‘makes little sense.’” Mensing, 131 S. Ct. at 2583 (dissent opinion) (citations omitted).

Although physicians cannot and should not function as a legal counselor to their patients, they are the ultimate arbiters of prescribing medications. As such, physicians should at least be aware of this monumental ruling and its implications for their patients’ legal rights. As is evident with the Mensing ruling, the relationship between medicine and law has become increasingly symbiotic.

[1] U.S. Food and Drug Administration (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm305896.htm)

[2] The Journal of American Medical Association (http://jama.jamanetwork.com/article.aspx?articleid=194879)