Purepac Preemption Defense Denied

Sep 30, 2008

All eyes may be on the pending Supreme Court case Wyeth v. Levine, but California was making news of its own this week after an appeals court decided that generics manufacturer Purepac Pharmaceutical should be held responsible for warning information on its generic version of Wyeth’s acid reflux drug Reglan—even if the label is FDA approved.

The argument that Purepac made is that because generics companies are federally mandated to use the same label as the drug’s innovators, the court should not blame them for problems stemming from that labeling. The court disagreed, claiming that the generics maker had enough of an opportunity to change the label, and should be independently responsible.

In the case, McKenney v. Purepac, the plaintiff developed a muscle spasm syndrome after taking Purepac’s metoclopramide; the plaintiff asserts that the warnings on the label were not clear enough. The case was originally dismissed because FDA had  approved the label.

The original judgment stated that: “All of Plaintiff’s causes against Purpac are pre-empted by federal law… Defendant Purepac is not the original manufacturer of Reglan. It is a generic[s] manufacturer of metoclopramide and, as such, must obtain approval by the FDA before issuing any label [on] metoclopramide which deviates from the labeling previously approved by the FDA.”

The appeals court disagreed, however, stating that the generics manufacturer could have brought additional label changes to FDA for consideration. “The FDA has stated that its mechanism for compelling labeling revisions ‘applies to both ANDA and NDA drug products’ and that [a]fter approval of an ANDA, if an ANDA holder believes that new safety information should be added, it should provide adequate supporting information to FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised,” Judge William A. Mayhew stated in the appellate ruling.

Now all eyes are on the US Supreme Court, and what will come of Wyeth v. Levine. In that case, Diane Levine lost part of her arm after receiving a dose of Wyeth’s nausea drug Pheneragan. She claims that the FDA-approved label wasn’t firm enough, and that Wyeth could have increased the warning. Levine won $6 million in Vermont, but Wyeth has appealed to the US Supreme Court.

“This is the first time the Supreme Court has looked at drug preemption, so no one knows how long it will take the Supreme Court to decide the appeal. The rule of thumb is that the really hard cases get gummed up forever,” said Mark Herrmann, partner at Jones Day and editor of the Drug and Device Law Blog.

Wyeth will be argued before the high court on November 3. A decision is expected before the last day of June 2009, because that’s when the Court’s term ends, and cases do not carry over from one term to the next. However, Herrmann told Pharm Exec that he doesn’t expect the Presidential election to affect the outcome of the case.

“Emotions run pretty high on this issue,” Herrmann said on Monday. “The people who don’t like preemption say that FDA is imperfect, and people in favor of preemption say that FDA might not be perfect, but its better than lay juries. The question is which system puts more errors in the process.”