The United States Supreme Court's recent decision in Pliva v. Mensing was a watershed moment in the world of pharmaceutical products liability (1). In short, the majority in Mensing held that state tort law claims for inadequate warnings against manufacturers of generic prescription drugs are preempted by the provisions of the Food, Drug, and Cosmetic Act (FD&C Act), which require the product safety information for generic drugs to be identical to their branded equivalents. The primary distinction between Mensing and the Court's prior opinion in Wyeth v. Levine, which came to the opposite conclusion on the preemption question for branded drugs, is the branded manufacturers' ability to change the safety information for its products through the changes being effected (CBE) provisions of the Act (2).
The significance of this decision for drug manufacturers and potential plaintiffs is difficult to overemphasize because of the ever-expanding use of generic drugs in the United States. As the dissent in Mensing noted, generic drugs constituted 75% of all dispensed prescription drugs in the US in 2009. That number is expected to grow as the cost savings provided by generic drugs continue to mount.
The history of generic-drug benefitsCongress essentially created the modern generic-drug industry in 1984 with the passage of the Hatch–Waxman Amendments to the FD&C Act. The goals of Hatch– Waxman were to make drugs less expensive, while maintaining safety standards and incentives for new drug innovation. They achieved those goals by providing extended patent protection for new drugs hitting the market, while at the same time reducing the regulatory burdens on generic-drug manufacturers, thereby allowing them to provide comparable drugs at greatly reduced costs to consumers once a branded drug's patent protection expired.
In 1984, supporters of Hatch–Waxman predicted that the new amendments "would save American consumers $920 million over the next 12 years" (3). But recent studies have shown that Hatch–Waxman saved the American healthcare system more than $824 billion during the decade 2000–2009, including $139.6 billion in 2009 alone, meaning that the originally projected 12-year savings of $920 million are now being achieved every three days (4).
Although these cost savings are unquestionably beneficial for everyone paying for prescription drugs—most notably the US government, which spends hundreds of millions of dollars each year on prescription drugs for Medicare and Medicaid patients—the majority in Mensing took note of the now recognized tradeoff for consumers in the Hatch–Waxman regulatory scheme. That is to say that, post-Mensing, an allegedly injured plaintiff's ability to bring state law tort claims is based solely on whether the drug taken was a generic or its branded equivalent.
"We recognize that from the perspective of Mensing and Demahy, finding pre-emption here but not in Wyeth makes little sense. Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits. We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated" (5).
The dissent put it even more starkly:
"Today's decision introduces a critical distinction between brand-name drugs and generic drugs. Consumers of brand-name drugs can sue manufacturers for inadequate warnings; consumers of generic drugs cannot" (6).
Although plaintiffs are attempting to assert novel and/or nuanced theories against generic-drug manufacturers to side-step Mensing, it is difficult to imagine many, if any, of these cases surviving summary judgment, much less appellate scrutiny. Thus, while some plaintiffs are attempting to plead their way around Mensing's pre-emption of claims against generic-drug manufacturers, others are refocusing on the branded manufacturers by attempting to establish liability for inadequate warnings against the branded manufacturers, even when the plaintiff ingested only the generic drug.