The U.S. Supreme Court just delivered a crushing blow to consumers harmed by generic drugs. Mass tort attorneys at Pintas & Mullins Law Firm are disappointed in the Court’s ruling, which strips innocent victims of their legal right to sue generic drug-makers. Consumers may still sue brand name drug makers for failing to warn them of possible side effects, but generic manufacturers are essentially shielded from liability. We believe that this decision fails to adequately protect public health and safety, and encourages negligence by generic drug-makers.
Federal law requires that generic drugs carry the same labeling and warnings as their brand name counterparts. On June 23, 2011, in a sharply divided, 5-4 decision, the high court held that generic drug makers who comply with federal law and carry the same labeling as their brand name equivalents cannot be sued for failing to warn of dangerous side effects. Unfortunately, this leaves injured generic drug patients without any legal recourse for the injuries and medical expenses they suffer.
Pila v. Mensing and two other consolidated cases before the Court were brought by women who took generic Reglan to treat stomach problems and developed serious neurological disorders. The drastic side effects these women experienced illustrate the dangers of inadequate label warnings. One of the plaintiffs, Julie de Mahy, was perfectly healthy when she started taking generic Reglan. Over time she began twitching and jerking, and is no longer able to work or drive. She also requires thousands of dollars in drugs to treat her current condition. Sadly, she will not be compensated for these losses.
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Writing for the majority, Justice Clarence Thomas admits that this decision deals injured generic drug consumers a difficult hand. But he reasoned that federal law blocks the state tort-law product liability claims. Because federal regulations require generic drugs to have the same warning labels as their brand name versions, generic drug-makers cannot independently change their labels. Federal law overrides any state law requirement that generic drug makers update their warning labels with new safety risks.
In 2009, the U.S. Supreme Court held in Wyeth v. Levine that brand name manufacturers have a legal duty to warn consumers of potential side effects. The distinction, according to the Court, is that brand name drug-makers can sometimes change their product labels without FDA permission. Unlike generic drugs victims, patients injured by brand name drugs can sue brand name manufacturers for inadequate labeling.
This double legal standard was criticized by Justice Sonia Sotomayor, writing for the dissent. She argued that consumer’s rights should not turn on whether a pharmacist fills a prescription with a brand-name or generic drug. We agree with the dissent that this case will create uncertainty about the safety of generic drugs, and negatively impact doctors and patients who rely on drug-makers to provide accurate information about serious side effects.
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Patients injured by drug-makers who fail to warn of dangerous side effects should be held accountable, regardless of whether the drugs are prescription or brand name. According to the New York Times, generic drugs account for more than 75 percent of prescriptions nationwide, and many insurance companies require the use of generic drugs when available. As the law stands, generic drug makers cannot be sued for negligence, even if they know of dangerous side effects and fail to take steps to warn the public. This decision seriously undermines the legal rights of thousands of injured generic drug victims.
The U.S. Supreme Court also sided with drug manufacturers in another unfortunate decision handed down the same day. There, the Court struck down a Vermont law that banned drug manufacturers from buying patient’s prescription drug records and using them as a marketing tool. Now drug companies in every state can use this information to persuade physicians to prescribe brand name drugs.
Product liability attorneys at Pintas & Mullins Law Firm continue to fight for the rights of all patients harmed by deceptive drug manufacturers. Contrary to the high court, we believe that patients are entitled to keep their prescription drug records private, and we also believe that they deserve a legal remedy when they are harmed by inadequate generic drug labels.