Supreme Court Protects Generic-Drug Makers from Side-Effect Lawsuits

July 29, 2011 (Press-News.org) A recent decision by the U.S. Supreme Court protects makers of generic medicine from lawsuits by consumers who acquire side effects not adequately represented in warning labels. The ruling further hurts already-suffering individuals and has analysts predicting that a change in the laws will result.

Inadequate Safety Warnings on Generic Drugs

In 2001 and 2002, Gladys Mensing and Julie Demahy were prescribed the drug Reglan to treat digestive-track problems. After receiving the generic version, metoclopramide, from their pharmacists, the women took the medicine for several years. Both eventually developed a severe and irreversible neurological disease called tardive dyskinesia, which causes involuntary movements and can result from taking metoclopramide for extended periods of time.

According to the U.S. Supreme Court opinion, since Reglan was first approved by the U.S. Food and Drug Administration in 1980, evidence has accumulated showing that long-term use of metoclopramide creates a higher risk of developing tardive dyskinesia. In fact, in 2009, the FDA required metoclopramide manufacturers to put its strongest warning -- a black box warning -- on the label, stating that, "Treatment with metoclopramide can cause tardive dyskinesia," and treatment with the drug for longer than 12 weeks "should be avoided in all but rare cases."

Mensing and Demahy filed separate lawsuits against the manufacturers of metoclopramide, asserting that the drug makers failed to provide adequate warning labels that conveyed the true danger of extended use of the medicine, eventually causing them to develop tardive dyskinesia. The lawsuits alleged that, "despite mounting evidence that long-term metoclopramide use carries a risk of tardive dyskinesia far greater than that indicated on the label," the manufacturers did not change their labels to reflect the increased risk as required by state law.

The trial courts ruled in favor of the women, and the drug manufacturers appealed the cases to the Fifth and Eighth Circuit Courts of Appeal. After the appellate courts ruled for the plaintiffs, the drug makers petitioned the U.S. Supreme Court to take the cases together, and it agreed.

Conflict Between State and Federal Laws

The main issue in the case was whether consumers may sue generic-drug makers under state laws or whether federal law intervenes and prevents the lawsuits from going forward. State laws require all drug manufacturers to label their products in a way that renders them reasonably safe and so consumers are adequately warned of any dangers the medicine poses of which the manufacturer is or should be aware. In other words, medicines' warning labels must tell consumers of all potential risks of taking the drug.

However, federal law states that the warning labels on generic drugs must be identical to the warning labels on the brand-name drug. If a generic-drug manufacturer becomes aware of an increased or additional risk of taking the medicine, under federal law it is not supposed to update its warning label. Instead, it is directed to notify the FDA and retain the same warnings as the brand-name drug.

This results in conflict between state laws that require continuous updating of all drugs' warning labels and federal law that prohibits variations from the brand-name medicine's label, even when it is not up to date. But, the Supreme Court reiterated the rule that, whenever there is a direct conflict between state and federal laws, federal law must prevail.

Supreme Court Ruling Protects Generic-Drug Makers

Therefore, the Supreme Court ruled that generic-drug manufacturers cannot be held liable for inadequate warning labels if their labels match the brand-name drug's label. Even though makers of brand-name medicines may be sued for failure to warn of possible side effects, makers of generic drugs cannot be sued as long as the labels are the same.

As even admitted by the author of the Court's majority opinion, Justice Clarence Thomas, the decision "makes little sense" to people suffering side effects after taking generic drugs instead of brand-name drugs. Indeed, people suffering side effects of brand-name medicines may sue the manufacturers for inadequate warnings, but people with the same side effects from the generic version of the same medicine have no recourse.

Considering that 75 percent of all prescriptions are filled with generic drugs, the Court's decision severely limits consumers' abilities to hold generic-drug manufacturers accountable for inadequate warning labels that cause them harm. The Court's ruling stated that this is "the unfortunate hand drug regulations have dealt" consumers, but "As always, Congress and the FDA retain the authority to change law and regulation if they so desire."

As a result of this ruling, it is possible that FDA regulations on generic drug warning labels may change. It also may cause previous court rulings preventing brand-name drug manufacturers from being sued for inadequate warning labels by generic-drug makers to be revisited, reports NewsInferno.

If you or a loved one has suffered harm from a prescription or over-the-counter medicine, contact an attorney with experience in defective-products cases to discuss any legal claims you may have.

Article provided by Miller Law Inc.
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