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Thursday, March 22, 2012

The Aftermath of Corporate Court’s Generic Drug Ruling

In PLIVA, Inc. v. Mensing, decided last term, the Supreme Court ruled that a generic-drug manufacturer cannot be held liable in state court for failing to inform the FDA that its label inadequately warns consumers of health risks. As Justice Sotomayor wrote in dissent, the majority’s holding in PLIVA created disparate liability schemes for brand name and generic drugs leading to “absurd consequences.”

AFJ and others noted at the time that the 5-4 ruling was likely to have wide-reaching effects, since generic drugs make up 75-80 percent of the prescription drug market.

Yesterday, the New York Times documented how extensive those effects have been already, including the dismissal of scores of suits by individuals who have suffered grievous physical injury as a result of inadequate warnings. The article also highlights that Congress or the FDA could rectify the Corporate Court’s mistake, but there is little sign that either will do so any time soon.
Now, what once seemed like a trivial detail — whether to take a generic or brand-name drug — has become the deciding factor in whether a patient can seek legal recourse from a drug company. The cases range from that of Ms. Schork, who wasn’t told which type of drug she had been given when she visited the hospital, to people like Camille Baruch, who developed a gastrointestinal disease after taking a generic form of the drug Accutane, as required by her health care plan.
“Your pharmacists aren’t telling you, hey, when we fill this with your generic, you are giving up all of your legal remedies,” said Michael Johnson, a lawyer who represented Gladys Mensing, one of the patients who sued generic drug companies in last year’s Supreme Court case, Pliva v. Mensing. “You have a disparate impact between one class of people and another.”

The Supreme Court ruling affects potentially millions of people: nearly 80 percent of prescriptions in the United States are filled by a generic, and most states permit pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June, including some who dismissed dozens of cases consolidated under one judge.

Public Citizen, a consumer advocacy group, has petitioned the Food and Drug Administration to give generic companies greater control over their labels, a rule change that could allow users of generic drugs to sue, but the agency said earlier this month that it needed more time to decide. “Congress can make this problem go away, and the F.D.A. could, too,” said Allison Zieve, the director of Public Citizen Litigation Group. “But we haven’t seen signs that either of them is paying much attention.” A spokeswoman for the F.D.A. declined to comment.

In a statement last week, Representative Henry A. Waxman, Democrat of California, who co-wrote the Hatch-Waxman Act, said he was exploring ways to address the issue, either through legislation or a rule change.
Mr. Waxman argued in a brief opposing the generic companies in the Supreme Court case last year that Congress had never intended for generic companies to be freed of all responsibility. “Congress did not intend for consumers’ rights to be categorically eliminated simply because they purchased a generic rather than a brand-name drug,” he wrote.

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