December 5, 2017 / 9:04 PM / 2 years ago

Merck to Supreme Court: The rules are different in pharma cases

(Reuters) - The pharmaceutical industry, which is not at all happy about how lower courts have interpreted U.S. Supreme Court precedent on federal preemption of state law claims by people alleging injuries from pharma products, got a jolt of good news Monday from the high court. The justices asked the U.S. solicitor general to weigh in on Merck’s petition for Supreme Court review of a ruling from the 3rd U.S. Circuit Court of Appeals that makes it “virtually impossible,” in Merck’s words, for drug companies to win dismissal of personal injury suits by citing the Food and Drug Administration’s oversight of drug labeling.

The Supreme Court’s request for a brief from the Justice Department is already a win for the pharma industry, considering that the last time a drug company asked the justices to review a preemption case, the court denied the petition without asking the government for its views. Merck, at least, will have an opportunity to ask the solicitor general’s office to endorse its argument that appellate courts have been way too lenient in allowing plaintiffs to sue pharma companies.

Merck’s lawyers at Jones Day used a quite unusual strategy to get their case this far. (The underlying litigation involves multidistrict litigation by more than 1,000 women who claim they suffered femoral fractures as a side effect of Merck’s osteoporosis drug Fosamax; the 3rd Circuit vacated the trial court’s grant of summary judgment to Merck on preemption grounds.) Instead of positing the classic argument that the Supreme Court must step in to resolve division in the lower courts, Merck is arguing that the lower courts are united – and uniformly wrong - in their application of the justices’ preemption precedent. The company is calling on the Supreme Court to recalibrate preemption law, using the 3rd Circuit’s Merck decision as a vehicle because, according to Merck, it provides an “extreme illustration” of how the lower courts have gone wrong.

As you know, it’s ordinarily a bad bet to ask the Supreme Court to take your case just because you don’t like how the lower court decided it, especially if the decision aligns with precedent from other appellate courts. Merck and Jones Day are trying to confront that truism head on: They contend the Supreme Court should depart from its usual rules because pharma cases are uniquely important.

“When it comes to policing the boundary between state tort law and federal regulation of prescription drugs, this court has recognized the overwhelming importance of getting it right,” the company’s petition said. “In its recent cases in this area, it has generally granted review because of the ‘importance of the pre-emption issue,’ – and sometimes based on the FDA’s request - not because of disagreement amongst lower courts.”

That’s bold. (Depending on your perspective, you may choose other adjectives.) Even Merck’s fellow pharma companies haven’t signed on to the strategy. The Pharmaceutical Research and Manufacturers of America’s amicus brief backing Merck posits the more traditional argument that lower courts need help from the Supreme Court because they can’t agree on how to interpret its precedent.

The plaintiffs suing Merck over Fosamax, who are represented by Kellogg Hansen Todd Figel & Frederick, threw Merck’s argument back at the company in their brief opposing Supreme Court review. Merck “admits that no circuit split exists,” the opposition brief said. “No reason exists to depart from this court's general practice of … ‘waiting for a conflict to develop’ before granting review.” The plaintiffs’ counsel of record, Kellogg Hansen partner David Frederick, has a particular interest in how lower courts have interpreted the Supreme Court’s 2009 preemption precedent in Wyeth v. Levine: He won the Levine case, in which the Supreme Court established that the FDA’s drug labeling oversight does not automatically preempt state law tort claims.

Of course, Frederick and the Fosamax plaintiffs will also have a chance to lobby the solicitor general’s office now that the justices have requested the Justice Department to brief Merck’s petition. Kellogg Hansen will surely argue, among other things, that Merck’s bald admission of unanimity in the lower courts is a good reason for the solicitor general to oppose Supreme Court review. In fact, when the Supreme Court previously asked the Justice Department to brief a preemption petition by generic drug makers in Pliva v. Mensing, the solicitor general discouraged the justices from taking the case because there was no split in the circuits.

On the other hand, the Supreme Court took the Pliva case despite the Justice Department’s recommendation to the contrary. At the merits stage in the Pliva case, the justices ruled against tort plaintiffs, even though the solicitor general sided with them. And Merck will probably find a more receptive Justice Department audience than generic drugmakers did in the Pliva case, which was litigated during President Obama’s administration.

Merck took a long shot in its Fosamax petition. So far, it seems to have paid off.

The views expressed in this article are not those of Reuters News.

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