This year, the U.S. Supreme Court made a ruling that will set back the drug injury victims I represent as a defective drug attorney. In PLIVA v. Mensing, the court ruled that generic drug manufacturers can face no liability for the harm their products do, because state-law tort claims are preempted by federal drug laws. That ruling acknowledged the absurdity of the result, which frees generic drug makers from liability that the name-brand drug makers face, but its decision was final. That decision formed a large part of the rationale behind the Sixth U.S. Circuit Court of Appeals ruling in Morris et al. v. Wyeth et al.. In that case, a group of gastroesophageal reflux disease sufferers who had developed a rare neurological disorder sued the makers of the generic drugs they took, as well as the name-brand manufacturer. Both claims were ultimately dismissed.
Kentucky residents Lala Smith, Alice Wilson and Dennis Morris all developed tardive dyskinesia, a slow-onset disorder causing involuntary and repetitive body movements. Sufferers are disabled by a difficulty holding still, rather than an inability to move. Its main causes are psychiatric drugs and gastrointestinal drugs, and there is no cure, just a series of strategies for treating symptoms. The plaintiffs alleged that their disease was brought on by taking metoclopramide, the generic name for the drug Reglan, for GERD. They sued six generic makers whose drugs they had used for failure to warn. They also sued two companies that had previously made name-brand Reglan for fraud, negligent misrepresentation and fraudulent concealment, arguing that the two companies had played down Reglan’s risks in the Physician’s Desk Reference. The federal district court granted summary judgment to the name-brand defendants, saying they cannot make a misrepresentation claim against a manufacturer whose product was not actually used. It later granted summary judgment to generic defendants on federal preemption grounds.
The plaintiffs fought both decisions on appeal, but to no avail. The Sixth Circuit quickly affirmed the ruling about the generic manufacturers, noting that the facts are actually quite similar to those in PLIVA v. Mensing. The same result is compelled in this case, the appeals court said. It took longer to affirm the ruling on the name-brand manufacturers. Under the Kentucky Product Liability Act, it noted, plaintiffs may sue only those whose products actually caused their injuries. The plaintiffs argued that the regulatory structure surrounding name-brand drugs makes it foreseeable that doctors and patients will use name-brand labels as a guide to generic drugs. This has failed in two other federal appeals courts and a federal district court, the Sixth said; only one court, an intermediate appeals court in California, has accepted the argument. The Sixth sided with the majority. Not only did it decline to find a duty of care by name-brand drug makers to non-customers, but it found it unlikely that Kentucky state courts would do differently. Thus, it upheld the dismissal of the case.
Unfortunately, nothing here tells me, as a pharmaceutical liability attorney, that the decision was legally wrong. It is well-established that lower courts must apply Supreme Court precedent, and both common law and common sense underlie the idea that a defendant must be responsible for the plaintiff’s injuries. The problem, as I noted in July, is with the Supreme Court’s bad precedent. Under that split ruling, generic drug makers were essentially given immunity from any lawsuits, regardless of what they have done. Indeed, in this case, the courts never reached the issue of whether the drug makers knew their products could cause tardive dyskinesia. From a legal standpoint, it wouldn’t even matter whether the generic manufacturers took active steps to give patients the disorder, because they face zero responsibility for their actions. As a dangerous drug lawyer, I’m not at all sure this is the result Congress intended.
Based in St. Louis, Carey, Danis & Lowe represents clients across the United States who suffered an illness, injury or death in the family because of a dangerous drug. If that sounds all too familiar to you, give us a call today at 1-877-678-3400 or send us a message through our website.
Similar blog posts:
Supreme Court Rules State Drug Tort Claims Preempted by Federal Drug Regulations – PLIVA Inc. v. Mensing
The Public Citizen Pleas with FDA to Allow Generic Label Updates
U.S. Supreme Court Rules FDA Approval Does Not Bar Pharmaceutical Injury Lawsuits
