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Supreme Court Rules Generic Drugmakers Are Shielded from Failure to Warn Suits

The Washington Post reported, “Makers of generic drugs cannot be sued for not warning patients of the drugs’ dangerous side effects, the Supreme Court ruled Thursday, even though brand-name manufacturers can be found liable.” The Post continued, “A five-member majority of the court recognized that it ‘makes little sense’ to bar suits against generic drug-makers while allowing them against brand-name manufacturers, but said federal law gave the justices no other choice.” In dissent Justice Sonia Sotomayor wrote, “As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.” Attorney Louis Bograd of the Center for Constitutional Litigation echoed Sotomayor in noting that “the common use of generics means that ‘three of four patients in America has just lost the right to sue for inadequate warnings.’”

The Los Angeles Times reported Gladys Mensing and Julie Demahy, “developed tardive dyskinesia, a severe neurological disorder, after taking metoclopramide, a generic form of the drug Reglan for digestive problems, including acid reflux. They sued, alleging that the drug maker failed to warn them of the danger of taking this drug for more than 12 weeks. Studies had suggested a potentially increased risk of the condition – and Reglan was eventually required to carry a ‘black box’ warning about it.” Bograd, who represented Mensing, said patients “appear to be left without any legal remedy.”

USA Today reported, “Justice Clarence Thomas, writing for the majority, said federal regulations, which require generic drugs to have the same warning labels as the brand-name prescription, override state personal injury law that lets people sue manufacturers for allegedly inadequate labels. The state laws at issue dictated that drug manufacturers strengthen their labels as they became aware of new risks. Thomas said the court was bound by the principle that federal law trumps the states and by relevant US regulations. Yet he acknowledged it ‘makes little sense’ that, based on court interpretation of varying US regulations, people who are injured by generic drugs have no state failure-to-warn claim but those injured by brand-name drugs do.”

The Wall Street Journal added in her dissent, Sotomayor wrote “Today’s decision leads to so many absurd consequences that I cannot fathom Congress would have intended to pre-empt state law in these cases.”

CNN reported, American Association for Justice President Gibson Vance denounced the ruling saying, “Patients will now be taking generic drugs at their own risk.” Vance added, “It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers — not generics — can be held accountable for their drugs’ dangerous side-effects.”

The Atlantic Wire reported on the AAJ’s press release condemning the decision as “‘disastrous to patient safety’ and claiming a double-standard, as federal law already requires brand-name drugs to list the latest side-effects.”

Bloomberg News reported Bograd said, “The ruling ‘creates an absolutely untenable distinction in the law between name-brand and generic drugs.’” He added that “in some states patients who suffer injuries stemming from generic drugs may be able to sue the brand-name company that manufactured the original medicine. He said 1,000 lawsuits are pending over metoclopramide alone.”

The New York Times explained, “Two years ago, in Wyeth v. Levine, the court decided the same question in the context of brand-name drugs but came to the opposite conclusion. That decision was based in large part on the fact that such drug companies can sometimes change the labels on their products without permission from the Food and Drug Administration.” Justice Thomas wrote that generic drug makers “must use the same warning labels as the corresponding brand-name drugs, and they may not unilaterally alter those labels. That means, Justice Thomas wrote, that makers of generic drugs are caught in an impossible bind: they can comply with a state law requiring them to change their labels or the federal law prohibiting changes, but not both. Given that impossibility, federal law pre-empts state law under the Constitution’s supremacy clause, he wrote.”

The New Orleans Times-Picayune reported, “Noting that the majority opinion said ‘Congress and the FDA retain the authority to change the law and regulations if they so desire,’ Gibson Vance, president of the trial lawyers’ American Association of Justice, called on Congress and the FDA to act quickly to ‘address the huge legal disparity between brand-name and generic drugs.’”

The CNN “Chart Blog” reported AAJ statistics showing that “70% of all prescriptions are filled with generic versions, accounting for about 2.6 billion prescriptions every year.” The blog noted the National Institute of Health “has website called DailyMed where consumers can look up their drug by class and brand name, and find up-to-date information about labeling, package inserts and more.”

The Minneapolis Star Tribune reported the ruing was praised by generic drug makers, including the executive director of the Generic Pharmaceutical Association. Bob Billings said “the court recognized generic makers were “in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing.”

The MedPage Today reported, “The Obama administration, 42 states and the District of Columbia, the American Medical Association (AMA) along with a number of state medical associations, and the American Association of Justice (AAJ) all filed amicus briefs on behalf of the injured women in the case.”

SCOTUS rulings viewed as pro-business. In an overall commentary on the court’s rulings, the Los Angeles Times reported the Supreme Court “has once again shown itself to be highly skeptical of large lawsuits against big business, regardless of whether the suits are intended to protect workers, consumers or the environment.” Robin Conrad of the US Chamber of Commerce called the High Court’s rulings “a ‘mixed bag overall’” but said the ones restricting class actions were business victories. The American Association for Justice “saw no mixed picture,” saying “by knocking out large lawsuits, the court is ‘granting immunity to corporate wrongdoers who cheat customers or abuse employees.’” Noting the court’s Wal-Mart ruling, AAJ President Gibson Vance said “ordinary employees and consumers will have no legal remedy if they cannot band together in a class-action claim. … The Supreme Court has sent a loud and clear message to the American people: ‘You’re out of luck and on your own.’”

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

About This Blog

The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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