When a pharmacy fills a prescription with a generic equivalent, the medication is supposed to be functionally equivalent to the brand-name counterparts, and in most respects they are. However, following a Supreme Court decision last year, manufacturers of generic drugs may not be held liable through a product liability lawsuit for failing to warn about dangerous side effects, even when they are aware that consumers are not being provided with adequate information about the risk.
An article published last week by the New York Times highlights the devastating and almost unimaginable impact of the Supreme Court ruling on generic drug lawsuits in Pliva v. Mensing.
In a 5-4 decision, which was split down purely political lines, the U.S. Supreme Court ruled that generic drug makers can not be held liable for failure to warn, since federal law requires that they provide an exact duplicate of the label warnings provided with the name-brand medication they are copying.
As a result, generic drug makers are allowed to continue to profit from the sale of dangerous medications that they know contain inaccurate or misleading warnings. While a consumer of the name-brand version of the medication may be able to pursue compensation through a product liability lawsuit, individuals who were given the generic equivalent may have no recourse.
What’s more, neither the pharmacist nor a hospital has to warn a patient that they are sacrificing all legal recourse when taking a generic drug, and quite often patients are unaware whether they are being given a generic or brand-name drug.
The New York Times article highlights the unfair impact of this decision, as a growing number of drug lawsuits throughout the United States are being dismissed by trial courts, including those involving generic Accutane, Reglan and Darvocet, among others:
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.
The article later points out:
The Supreme Court recognized that its decision must make ‘little sense’ to plaintiffs who sue generic drug companies. However, Justice Clarence Thomas wrote for the court, ‘Congress and the FDA retain the authority to change the law and regulations if they so desire.
Some attorneys who follow the issue have speculated that Congress and the FDA are reluctant to deal a blow to generic companies, which are responsible for providing cheap drugs to millions of American consumers, especially in an election year when health care is a hot issue.
The ideological split that resulted in the ruling in the Supreme Court is likely to duplicate itself in Congress, with a Republican controlled House likely to side with the majority conservative judges on the court that want to protect the manufacturers and the Democrat-controlled Senate likely to side with the minority liberal judges who want recognize the injustice for consumers, meaning legislation may be difficult to make it through both chambers.
The FDA has said it needs more time to weigh the consequences of the ruling, and refused to comment on the issue when pressed by the New York Times.
In the interim, dozens of lawsuits against generic manufacturers are being dismissed nationwide by judges who feel forced to follow the Supreme Court interpretation. The dismissals come not because the cases do not have merit, not because the injuries are not real and not because generic drug manufacturers provided sufficient warning for dangerous drug side effects; but because until the law is changed they have no legal responsibility to tell consumers about any risk information that is not provided on the name-brand drug label, even if they are aware that current label is inaccurate or inadequate.
To protect yourself, your family and other consumers, contact your representatives in the U.S. House of Representatives and Senate, urging that they change the law and regulations to reverse this unwarranted protection for generic drug makers, which allows them to escape accountability for their actions, or lack of action, when they profit at the expense of consumer safety.