The legal battles related to labeling for generic drugs rage on.
In 2011, The United States Supreme Court decision, PLIVA, Inc., et al. v. Mensing, gave more power to drug companies – ruling that generic makers cannot be held responsible for failure to warn about a drug’s side-effects, since the generic maker is only making a “copy” of the brand drug and must follow the brand name’s label.
Despite the fact that generics increasingly dominate the drug market – up to 80 percent of consumers now take them – this decision largely took those manufacturers off the hook when it comes to warnings, and may prevent a consumer from bringing a lawsuit against a generic manufacturer.
In an equally controversial ruling last month, Mutual Pharmaceutical v. Bartlett, the U.S. Supreme Court once again gave generic drug companies an edge – further shielding manufacturers from liability for generic medications. The Supreme Court overturned the decision on the grounds that the state consumer-protection law under which Bartlett sued was invalid, as it conflicted with federal law. In basic terms, the majority said that since generic-drug manufacturers are legally mandated to use the same active ingredients and warning labels as name-brand manufacturers, they cannot be sued if the drug is harmful or the warning label insufficient.
The decision reversed a $21 million jury verdict in favor of Karen Bartlett, who suffers from Stevens-Johnson syndrome as the result of taking Sulindac – the generic version of Clinoril – for shoulder pain. The rare and life-threatening skin condition has rendered Bartlett legally blind and caused over 60% of her skin to burn off. She spent months in a coma, a year being tube fed, had 13 eye surgeries, numerous cornea implants, and now has trouble walking as far as out to her own mailbox.
Bartlett sued Mutual Pharmaceutical in New Hampshire Superior Court, asserting design-defect and failure-to-warn claims. Her failure-to-warn claim was dismissed at the trial court level, but the jury awarded her $21 million in damages on her design defect claim. However, the Supreme Court decided that federal law pre-empts state law – nullifying that ruling.
The court majority said the federal Food and Drug Administration had approved this drug for sale – and that federal approval supersedes state law.
According to the ruling, “because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce.” Though Bartlett’s claim was based on a design-defect theory, the Court focused on the adequacy of the warning label. The reasoning for the decision mimicked the reasoning used in PLIVA. Thus, Bartlett was left with permanent injuries and no recourse.
The ruling is without a doubt a loss for consumers and has evoked a backlash of criticism. “It is time for the FDA to address the huge disparity between generic and brand drug makers’ responsibility,” said American Association for Justice President Mary Alice McLarty.
Members of Congress (Senator Leahy and Senator Landrieu) sent letters to the Food and Drug Administration, calling on the agency to address generic drug accountability. “Like the PLIVA v. Mensingcase, this decision creates a troubling inconsistency in the law that penalizes the millions of Americans who take generic medications,” said Leahy in a press release. “A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug.” Consumer Rights
Added the AAJ’s McLarty, “I know of no other industry where the maker of a product has such limited responsibility for the safety of the product they make. Over eighty percent of drugs dispensed are generic; the manufacturers must be held responsible for their drugs’ harmful effects.”
Until the FDA re-evaluates the rules and regulation surrounding generic drug manufacturers’ responsibilities, and therefore, their liability, consumers will continue to pay the price. Karen Bartlett, and others like her, will be left with lifelong permanent injuries, and even though a jury or court validates her claim, federal law will forever have the final word.
The time has come for the laws to be more consistent with reality and fairness.