Congress Must Make Generic Drugmakers More Accountable in Wake of ‘Bizarre’ Failure to Warn Decision

The U.S. Supreme Court on June 23, 2011, published a 5-4 decision in favor the generic drugmaker Pliva that many commentators are calling a "pass on side effect warnings."

I lean toward a less dire reading of the Justice Clarence Thomas-penned opinion in Pliva Inc., et al. v. Mensing. But as a Virginia Beach, VA-based personal injury attorney whose law firm has represented clients in dangerous drug and pharmaceutical error cases, I also feel strongly that federal lawmakers and regulators need to act immediately to hold all pharmaceutical manufacturers to the same standards for giving health care providers and patients the most complete information about the potentially life-threatening risks of their medications.

Specifically, the Court’s majority ruled that patients who had developed tardive dyskinesia could not hold the pharmaceutical companies that had made and marketed generic versions of the antinausea medication Reglan (metoclopramide) liable for failure to warn about a disabling or deadly adverse effect the companies knew or should have known about.

The justices who concurred with the Pliva opinion agreed that federal regulations on drug labeling enforced by the U.S. Food and Drug Administration take precedence over states’ safe medical products laws. They also noted that, under FDA rules, every generic metoclopramide product had to carry the same labeling and set of side effects warnings as brand-name Reglan.

Here is part of what the most up-to-date FDA-approved Reglan drug label warns doctors, pharmacists and patients about the serious adverse effect experienced by the women who originally sued generic metoclopramide makers:

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic [uncoordinated muscle] movements may develop in patients treated with metoclopramide. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients are likely to develop the syndrome. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the total cumulative dose.

The potential for metoclopramide use to cause the incurable and largely uncontrollable neuromuscular syndrome was know in 2001. At that time, however, neither the maker of branded Reglan, Sanofi-Aventis (which had earlier acquired the drug portfolio of A.H. Robins), nor any of the companies making unbranded equivalents of the medication were required to state this. Still, because the Supreme Court ruled in 2009 that brand-name drugmakers could be held liable for failure to warn even if FDA had not asked for new labeling, Justice Thomas had no choice but to admit that the Pliva decision was bizarre and, at heart, unfair to gravely harmed patients.

The way to resolve this injustice is to treat both brand-name and generic drug products the same under law. The U.S. Congress needs to clarify in law that any company making any type of FDA-regulated medication is held to the same liability standards for injuries and wrongful deaths their products cause. FDA already has regulations requiring identical labeling for originator and copycat drugs. Interpreting those requirements to include warnings about adverse effects makers of branded and unbranded medications should have known about seems a no-brainer.

If Congress and FDA do not act quickly, however, the nearly three-quarters of U.S. patients who receive generic drugs may be left without a legal means for seeking justice from a pharmaceutical company operating under a reduced obligation to warn about the risks of their products.

EJL

About the Editors: The Shapiro, Cooper, Lewis & Appleton personal injury law firm, which has offices in Virginia (VA) and North Carolina (NC), edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard and Northeast North Carolina Injuryboard as pro bono services.