Print Friendly, PDF & Email

On June 23, 2011, in a 5-4 decision, the United States Supreme Court held that federal statutes and FDA regulations governing the labeling of generic drugs preempt state law tort claims against generic drug manufacturers for failure to provide adequate warning labels.  In Pliva, Inc., v. Mensing the court determined that it was impossible for the generic drug manufacturers to comply with both the state and federal law requirements regarding the labels on their drugs.

The plaintiffs, Gladys Mensing and Julie Demahy, claimed to have developed tardive dyskinesia, a severe neurological disorder, after long-term use of metoclopramide, which is a generic form of Reglan.  Both the plaintiffs had been given a prescription for Reglan, but had received the generic form of the drug from their respective pharmacists.  The plaintiffs, in separate state court actions, sued the generic drug manufacturers that produced the metoclopramide, alleging failure to provide adequate warning labels.  The plaintiffs argued that the applicable state laws required the manufacturers to update their labels to accurately reflect the risks of using the drug.

The manufacturers argued that the plaintiffs’ state law claims were preempted by federal statutes and FDA regulations, which require generic drug manufacturers to use identical labeling on their products, as is used on their brand-name counterparts.  The manufacturers argued that it was impossible for them to comply with both state laws requiring them to change their labels and with federal laws prohibiting such a change.

The court rejected the plaintiffs’ argument that the manufacturers could have changed their labels through the FDA’s changes-being-effected (CBE) process, which permits them to change their labels when necessary.  The court deferred to the FDA’s interpretation of the generic labeling regulations, namely that the CBE process only allows changes to be made in order to match the updated brand-name label or to follow FDA instructions.  The court concluded that the CBE process was unavailable to the manufacturers to make the changes as required by state law.

The court also rejected the plaintiffs’ argument that the manufacturers could have sent “Dear Doctor” letters to provide additional warnings to prescribing physicians.  The court again deferred to the FDA, which indicated that the “Dear Doctor” letters would have qualified as labeling, and thus must be consistent with the drug’s approved labeling.  The court, therefore, concluded that federal law does not permit the manufacturers to issue additional warnings in the form of “Dear Doctor” letters.

The plaintiffs’ final argument was that preemption should not apply in this case because the manufacturers should have proposed stronger warning labels to the FDA if they thought it necessary.  If the FDA agreed with the manufacturers, then the FDA would have worked with the brand-name manufacturers to create a new label for the drug.  The court rejected the argument and determined that even if the manufacturers had requested a change in labeling, the proposal itself would not comply with state law, which required an actual new label.

In its decision, the court pointed out that conjectures on what a third party or the Federal Government might have done would make most conflicts between state and federal law “illusory.”  In this case, for example, the manufacturers could have requested that the FDA change the warning labels, or could have requested that the FDA reinterpret or rewrite its regulations, or could have requested that Congress amend its laws.  The court found that the Supremacy Clause would be eroded if such conjectures were sufficient to prevent state and federal laws from conflicting.

The court also stated that the question for determining impossibility is whether the party could independently do under federal law what state law requires of it.  Since the manufacturers cannot change their labels without the approval and assistance of the FDA, the court believed it impossible for them to comply with state and federal laws.  In this case, the court agreed with the arguments of the manufacturers and held that the manufacturers were unable to comply with both the state and federal laws because the state laws would have required the manufacturers to change their labels, while the federal laws prohibit unilateral labeling changes by generic drug manufacturers.

The court further pointed out that its holding is not contrary to the holding in Wyeth v. Levine, 555 U.S. 555, decided two years earlier.  In that case, the court allowed a state tort action against a brand-name drug manufacturer for failure to provide an adequate warning label.  The court held that federal law did not preempt the state court action because it was possible for the manufacturer to comply with both state and federal law.  Federal regulations permit brand-name manufacturers, unlike generic manufacturers, to unilaterally strengthen their warnings without prior FDA approval.

In delivering its holding in the Pliva case, the court recognized the “unfortunate hand” that federal regulations have dealt the plaintiffs and others who are similarly situated.  A person who takes a brand-name drug is allowed to sue for inadequate labeling under state law, whereas a person who is provided with the generic version of the drug cannot.

Pliva is an important decision for generic drug manufacturers, who are now armed with a significant defense against state law failure to warn claims.