JURIST Guest Columnist, Daniel Perrone, St. John’s University School of Law Class of 2013, discusses the implications of the US Supreme Court decision insulating generic drug manufacturers from liability against failure to warn claims…

In 2011, generic drugs accounted [PDF] for nearly 80 percent of the 3.7 billion prescriptions filled in the US. This staggering figure should come as no surprise considering the cost of a generic drug is, on average, 80 to 85 percent lower than its brand-name equivalent. However, the decision to consume a drug’s cheaper, generic equivalent does come at a price. Thanks to the US Supreme Court’s ruling in PLIVA, Inc. v. Mensing, consumers injured by generic drugs are being, and will continue to be, denied recourse against generic drug manufacturers for their failure to adequately and safely label their products.

In Mensing, two plaintiffs were prescribed the brand name drug Reglan. In its place, they both received and consumed metoclopramide, the generic equivalent of Reglan. Through the years, the warnings for the brand-name version of the drug, which were approved by the Food and Drug Administration (FDA), were strengthened and clarified several times. Nevertheless, the warnings for the generic version of the drug were, at all times, the same as those of the brand name. After taking the drug as prescribed for several years, both plaintiffs developed a severe neurological disorder called tardive dyskinesia. The plaintiffs sued the generic drug manufacturers, alleging that prolonged metoclopramide use caused their tardive dyskinesia. The plaintiffs concluded that the manufacturers were liable under state law for failing to provide adequate warning labels.

In a 5-4 decision, the Court found that state law conflicted with — and was pre-empted by — federal labeling requirements. The Court noted that while state law places an affirmative duty on all drug manufacturers to adequately and safely label their products, federal law places such a duty only on brand name drug manufacturers. That is, under federal law, generic drug manufacturers are not responsible for adequately and safely labeling their products. Instead, generic drug manufacturers are only responsible for ensuring that their products’ warning labels are the same as their brand-name equivalent at all times. In other words, generic drug manufacturers are subject to an ongoing federal duty of “sameness.” As a consequence, generic drug manufacturers cannot independently change their products’ warning labels without violating federal law. This is true even if the generic drug’s warning label is clearly inadequate and, thus, violates state law. Accordingly, the Court dismissed the case, noting that it was not lawful, under federal law, for the generic drug manufacturers to do what state law required of them; namely, to attach a safer label to their generic metoclopramide.

The Mensing rule, which essentially insulates generic drug manufacturers from liability against failure to warn claims, has its roots in the Hatch-Waxman Amendments (HWA). The HWA enables generic drugs to gain FDA approval by showing equivalence — in substance and labeling — to a reference-listed drug that has already been approved by the FDA. This eliminates the need for costly and lengthy clinical testing, thereby allowing manufacturers to develop drugs inexpensively, resulting in a reduced price for consumers.

Undoubtedly, the reduced price of generic drugs benefits numerous Americans each year, but at what cost? The individuals who rely on, and benefit from, the relatively affordable price of generic drugs the most — those who cannot afford expensive brand-name drugs — are the least capable to withstand an uncompensated injury suffered as a result of a manufacturer’s failure to adequately and safely label its product. This leaves millions, if not billions, of Americans contemplating whether their decision, assuming they even have a choice, to save money now by purchasing generic drugs could lead to financial ruin down the line. All the while, generic drug manufacturers continue to reap endless monetary rewards without any fear of repercussion, as long as they comply with their ever so arduous duty of “sameness.” Not to mention the fact that the Mensing ruling eliminates any incentive whatsoever for generic drug manufacturers to ensure the adequacy of their products’ warning labels.

Taking all of this into account, the Mensing ruling seems to make little sense. The Court notes:

We recognize that from the perspective of Mensing, finding pre-emption here but not in Wyeth v. Levine 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.

However, it makes even less sense when the brand-name and generic drug manufacturers are one and the same. To illustrate, in 2011, the FDA announced that women who used the birth control pills Yaz and Yasmin, or their generic equivalents, were 74 percent more likely to experience a blood clot compared to women who were using other birth control pills. Since that time, more than 12,000 lawsuits have been filed against Bayer — the manufacturer of both the brand-name and generic birth control pills — alleging that company failed to warn women of the enhanced risks associated with consuming its birth control pills. The Mensing ruling, under these circumstances, would ostensibly leave those women who consumed the generic versions of Bayer’s Yaz and Yasmin without any recourse. Again, this makes little sense, especially since Bayer is the manufacturer of both the brand-name and generic birth control pills at issue.

To address this injustice, courts should craft an exception to the Mensing ruling and hold generic drug manufacturers liable for their failure to adequately and safely label their products where the brand-name and generic drug manufacturers are one and the same. In Mensing, the Court reasoned that it was impossible for the generic drug manufacturers to comply with their state law duty, which required them to strengthen their warning labels, without violating their federal duty of “sameness.” That simply is not the case when the brand-name and generic drug manufacturers are the same entity. Returning to the above example, Bayer could have simultaneously strengthened the warning labels of both its brand-name and generic birth controls pills to render their use reasonably safe. Had Bayer done so, it would have complied with both its state law duty to adequately and safely label its birth control pills and its federal law duty of “sameness.”

There is no denying the vital role generic drugs play in American society. They enable countless Americans, who cannot afford expensive brand-name drugs, to obtain the medication they so desperately need. Unfortunately, the Mensing ruling has dramatically increased the “cost” associated with generic drugs. The decision to insulate generic drug manufacturers from liability, despite their failure to adequately and safely label their products, is an injustice that disproportionately affects those who cannot afford to purchase expensive brand-name drugs just to preserve their right to receive compensation in the event they suffer a debilitating injury. That is why courts should craft an exception to the Mensing ruling that would hold generic drug manufacturers liable for their failure to adequately and safely label their products where the brand-name and generic drug manufacturers are one and the same.

Daniel Perrone is the Editor-in-Chief of the Journal of Civil Rights and Economic Development. His experience includes internships with Kramer, Dillof, Livingston & Moore, St. John’s University School of Law’s Elder Law Clinic and the New York State Supreme Court. He earned a Bachelor of Arts in political science from St. John’s University in 2010. Currently, Perrone interns for the Honorable A. Kathleen Tomlinson in the US District Court for the Eastern District of New York.

Suggested citation: Daniel Perrone, Crafting an Exception to the Mensing Ruling, JURIST – Dateline, Apr. 11, 2013, http://jurist.org/dateline/2013/04/daniel-perrone-generic-drugs.php