The New York Times reported on divergent liabilities by drug manufacturers.Â In comparing the Supreme Court decision in a case by Diana Levine, to a little known case brought by Debbie Schork, the liability factor stands in sharp contrast.Â Both were injected with the same drug (promethazine), both were injected in the arm, both developed gangrene from the drug (an unknown side effect), and both suffered amputations.Â While Ms. Levineâ€™s case proceeded, Ms. Schorkâ€™s case was quietly dismissed.Â The only difference is the intrusion of another Supreme Court decision named PLIVA, Inc. v. Mensing which limits liability by generic manufacturers.Â So while Ms. Levineâ€™s injection was in the branded form of the drug (Phenergan), Ms. Schork received the generic form of the drug. Â The Supreme Court ruling affects potentially millions of people: nearly 80 percent of prescriptions in theUnited States are filled by a generic, and most states permit pharmacists to dispense a generic in place of a brand name.
â€śExplain the difference between the generic and the real one â€” itâ€™s just a different company making the same thing,â€ť Ms. Schork said. â€śYour pharmacists arenâ€™t telling you, hey, when we fill this with your generic, you are giving up all of your legal remedies,â€ť said Michael Johnson, a lawyer who represented Gladys Mensing, one of the patients who sued generic drug companies in last yearâ€™s Supreme Court case, Pliva v. Mensing. â€śYou have a disparate impact between one class of people and another.â€ť
The Supreme Courtâ€™s ruling, has its roots in the Hatch-Waxman Act, the 1984 law that opened the floodgates to generic drugs. That law allowed companies to skip the lengthy process required to approve new drugs if they could prove that the generic drug was equivalent to its brand-name counterpart.Â With few exceptions, it also required generic manufacturers to use the same labels â€” the lengthy list of a drugâ€™s uses, dosages and risks â€” used by the brand names.Â If a problem develops, the brand-name companies are responsible for changing the label, and the generic companies must follow their lead. As a result, the courtâ€™s majority ruled, generic companies cannot be held responsible for failing to alert patients to problems with their drug if the brands do not.Â However, the reverse has not held true.Â Brand manufacturers have not been held liable when their generics have failed to warn consumers (via the brand labels) and consumers have been harmed.Â 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.
The Supreme Court recognized that its decision must make â€ślittle senseâ€ť to plaintiffs who sue generic drug companies. However, Justice Clarence Thomas wrote for the court, â€śCongress and the F.D.A. retain the authority to change the law and regulations if they so desire.â€ťÂ Public Citizen, a consumer advocacy group, has petitioned the FDA to give generic companies greater control over their labels, but the agency said earlier this month that it needed more time to decide. â€śCongress can make this problem go away, and the F.D.A. could, too,â€ť said Allison Zieve, the director of Public Citizen Litigation Group. â€śBut we havenâ€™t seen signs that either of them is paying much attention.â€ť A spokeswoman for the F.D.A. declined to comment.Â 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.