USCS Blocks Certain Labeling Suits Against Generic Drug Manufacturers

November 03, 2011

The U.S. Supreme Court recently handed down a decision that will have disastrous effects on patient and drug safety. The decision effectively grants generic drug companies immunity when they fail to warn about the dangerous side effects of the drugs that they produce. In a 5-4 decision written by Justice Clarence Thomas, the court held that federal regulations, which require generic drugs to have the same warning labels as brand-name drugs, override state laws that allow people to sue drug manufacturers for inadequate labeling.

Background of the Case

The case, Pliva v. Mensing, began when Gladys Mensing and Julie Demahy, the plaintiffs, claimed that they developed tardive dyskinesia, a permanent neurological condition, after using metoclopramide to treat acid reflux disease. Metoclopramide is a generic version of the brand-name drug Reglan. The plaintiffs sued the manufacturer of the generic drug, claiming that the manufacturer failed to warn them of the serious long-term risks associated with long-term usage of the dangerous prescription drug on the drug's label, as required by state law.

The drug manufacturers argued that federal law, which does not require additional warnings on labels for generics, overrules the plaintiffs' state-law claims for two reasons:
- It was impossible for the drug manufacturers to add the warnings because federal regulations prevent generic drug manufacturers from adding warnings that are different from the brand-name drugs
- The plaintiffs' claims conflicted with congressional objectives which apply to generic drug manufacturers under federal law

The Federal Court of Appeals disagreed with the drug manufacturer's first argument, concluding that the manufacturers did not show that it was impossible to add the additional warnings because they could have:
- Proposed a label change for both generic and brand-name drugs to the Food and Drug Administration (FDA) under the "changes being effected" (CBE) process
- Asked the FDA to send out a letter to health care professionals warning them of the risks of taking the drug

The court also rejected the plaintiffs' second argument, holding that the plaintiffs' claims did not conflict with congressional objectives applicable to generic drug manufacturers. The manufacturers appealed the decision to the U.S. Supreme Court.

The Supreme Court Decision

The Supreme Court rejected the plaintiffs' argument that the generic drug manufacturers could have added the additional warnings by proposing a label change to the FDA. The Court deferred to the FDA's interpretation of its own federal regulations. In a brief submitted to the court, the FDA had argued that, contrary to what the Court of Appeals had concluded, the CBE process was not available to generic drug manufacturers. The FDA explained that generic drug manufacturers may use the CBE process only to conform to an updated brand-name label. The court accepted this argument at face value.

The Supreme Court again heavily deferred to the FDA's interpretation of its own regulations and rejected the plaintiffs' argument that generic manufacturers could have asked the FDA to send warning letters to health care professionals, or "Dear Doctor" letters. Based on the FDA's interpretation of its own regulations, the court determined that such letters would constitute product labeling. As federal regulations do not allow product labeling to contradict the warnings that are already on the drug's labeling, generic drug manufacturers could not provide additional warnings by sending a warning letter to health care providers.

The court concluded that federal law overrules the plaintiffs' state-law claims based on impossibility of compliance. In other words, since it was impossible for the generic drug manufacturers to comply simultaneously with state law, which requires additional warnings on the label, and federal law, which does not require the additional warnings, federal law applies, since federal law trumps state law when the laws are in direct conflict. Since the plaintiffs' sued under state law, which does not apply when federal law overrules it, the court dismissed the lawsuit.

Implications of the Decision

The most obvious effect of this decision is that it will eliminate failure-to-warn claims against generic drug manufacturers. By removing the threat of a lawsuit, this decision removes an incentive for generic drug manufacturers to ensure the safety of their drugs and warn consumers of dangerous side effects as they discover them.

This decision also ensures that brand-name drug manufacturers will be held to a different and safer standard than generic manufacturers, as federal regulations require that brand-name drug manufacturers update warnings on their drugs' label as information on new risks becomes available. "Patients will now be taking generic drugs as their own risk," said Gibson Vance of the American Association for Justice.

The lack of safeguards for generic drugs is troubling, as pharmacists fill 70 percent of prescription drugs in the United States with generic drugs. Additionally, the generic drug industry continues to expand as brand-name drugs go off-patent. Finally, some states have laws which require pharmacists to fill prescriptions for brand-name drugs with their less costly generic equivalent. Congress may ultimately act to reverse the impact of this Supreme Court decision, but whether it has the necessary votes to do so is questionable.

An Attorney Can Help

The full impact of this decision is yet unknown. If you or someone you know has been injured after taking a prescription drug, you may be entitled to monetary damages. An experienced personal injury attorney can assess your case and help you get the compensation you deserve.

Article provided by Thomas Q. Keefe, Jr., P.C.
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