1511, 2013

FDA Officially Proposes Rule Permitting Generic Drug Injury Lawsuits Once Again

November 15th, 2013|Dangerous Drugs, Reglan|Comments Off on FDA Officially Proposes Rule Permitting Generic Drug Injury Lawsuits Once Again

I’ve written much on this blog about the terrible consequences of the U.S. Supreme Court’s ruling in PLIVA v. Mensing. In that case, the Court found that victims of injuries from generic drugs may not sue the drug makers for failure to warn, because the drug makers are not permitted under federal regulations to change their labels unilaterally. That’s true no matter how blatantly the science showed that a warning was needed; as long as the drug maker followed the rule conforming its label to the name-brand drug’s label, there could be no liability. This made generic drugs makers not liable for injuries to their customers, even though the name-brand maker of the exact same substance would be liable for the same injury. Now, the Wall Street Journal reported last week, the FDA has announced a proposed rule that would fix this dangerous situation.
The FDA’s rule would permit generic drug companies to change their labels if they have had reports of injuries or illnesses that warrant a label change. That would be true even though the resulting label might not be exactly the same as the name-brand drug’s label. This would remove the quandary found by the U.S. Supreme Court in Mensing, where the majority said it was impossible for generic drug makers to comply with both federal regulations and state-court decisions. If a state court finds that a drug maker failed to warn the patient, the logic goes, it is making a state law saying the drug maker must change its label. But because federal regulations require generic drugs to have exactly the same labels as their name-brand counterparts, the court said, it would be impossible to comply with both. As always in cases of such conflict, the federal law must prevail.
This foreclosed all generic drug injury lawsuits alleging failure to warn. A U.S. Supreme Court decision earlier this year, Bartlett v. Mutual Pharmaceutical, added that negligence claims and others that were at heart about the label are also forbidden. The new rule would remove the “impossibility” problem that the court found, restoring injured people’s ability to get fair compensation regardless of whether the drug was generic or name-brand. This is important; as the Wall Street Journal notes, generics account for about 84 percent of the drugs sold in the United States. An FDA official noted that this would also level the playing field. Sen. Patrick Leahy, D-VT, praised the move; he had previously introduced legislation seeking the same outcome. Not surprisingly, however, big-business advocate the U.S. Chamber of Commerce criticized the move for driving up businesses’ costs by enabling more lawsuits.
Of course the change would enable more lawsuits, but as an attorney for people injured by defective drugs, I fail to see the problem with that. If drug makers have a chance to adequately warn patients of new and important research on safety, they should be able to make the labels adequate in the first place. This is the best outcome for everyone: it would create fewer injuries, requiring fewer lawsuits to make the victims whole, and thus lower costs. By giving generic drug makers the ability to change their labels, the FDA would do nothing more than put them on the same footing as their name-brand counterparts. And for the victims of generic drug injuries—which can be quite serious, as the Mensing and Bartlett plaintiffs can attest—it represents a chance to get financial relief that has been denied to them for reasons outside their control. I look forward to hearing more about this rule.


1110, 2013

Glass Particles Force Reglan Recall

October 11th, 2013|Reglan|Comments Off on Glass Particles Force Reglan Recall

Hospira, the manufacturers of a generic version of the acid reflux drug Reglan, has issued a recall of the pills after it was discovered that the drug contained strands of glass. The recall was announced by the FDA on October 1.
While no adverse events reports […]

509, 2013

Alabama Supreme Court Set to Reconsider ‘Innovator Liability’ in Prescription Drug Cases

September 5th, 2013|Dangerous Drugs, Reglan|Comments Off on Alabama Supreme Court Set to Reconsider ‘Innovator Liability’ in Prescription Drug Cases

Because I practice pharmaceutical injury law nationwide, I’ve been very interested in the debate over “innovator liability” in Alabama. That’s the name for the legal theory the Alabama Supreme Court has come up with in order to hold name-brand drug manufacturers legally liable for injuries caused by the generic equivalents to their drugs. The U.S. Supreme Court has ruled that generic manufacturers cannot be held responsible for failure to warn patients about their drugs’ risks because any such decision would contradict federal regulations requiring them to have the exact same labels as the name-brand equivalent drug. The Alabama court reasoned that this makes name-brand manufacturers, who do have control over their labels, liable for failure to warn even when the drug that injured the plaintiff was a generic. That decision is being reconsidered this week by the high court, and observers on both sides are watching closely.
The case under consideration is Wyeth v. Weeks, in which Danny Weeks and his wife, Vicki Weeks, sued both generic and name-brand manufacturers for failure to warn about problems with the drug Reglan (metoclopramide). Danny Weeks took generic Reglan and eventually developed tardive dyskinesia, an irreversible nervous-system problem in which the patient has uncontrollable head or facial movements. The Weekses conceded that Danny never used name-brand Reglan. A federal district court concluded that they might have a case and certified a question of Alabama law to the state Supreme Court. That court surprised observers by ruling that people like Weeks may have a case against a name-brand manufacturer if it made statements that materially misinformed their doctors. It said U.S. Supreme Court precedent makes manufacturers responsible for labels on generics, making it reasonably foreseeable that their safety communications might lead to liability.
The Alabama court is in the minority of courts that have considered this issue. Most courts (with exceptions in California and Vermont) have concluded that the tort laws of various states require them to dismiss claims against any manufacturer whose drugs the defendant didn’t actually use. As a result of that—and a loud outcry from the pharmaceutical industry and other business interests—the Alabama high court took the unusual step of agreeing to rehear its decisions. Oral arguments on that were scheduled for Sept. 4. A dissenting justice in the original Alabama case pointed out that there was no good decision for the court; U.S. Supreme Court precedent essentially denies any relief to people like Weeks. The FDA is reportedly addressing the issue through its rulemaking process, but that process is glacial and may be interrupted by a change in presidents.
I applauded the Weeks case at the time it came out, and I still do. When you’re a lawyer representing people hurt by dangerous drugs, you start to see how much we all rely on pharmaceutical companies and doctors to provide us with good information. When drug companies knowingly withhold important safety information, as alleged in this case, patients and doctors who trust those companies are put at risk. And that risk is not small; tardive dyskinesia is a permanent disability. In other high-profile defective drug litigation, the states can be a woman’s ability to have children—as in the Mirena IUD lawsuits—or even death, as in the series of Vioxx cases. Even opponents of “innovator liability” agree that the situation is unfair.