December 9, 2016 / 10:47 PM / a year ago

Who can challenge FDA label decisions? Not plaintiffs' firm with drug cases - 3rd Circuit

(Reuters) - The Philadelphia plaintiffs’ firm Sheller is at the center of a novel case that raises a rather disturbing prospect: Does anyone have legal standing to challenge FDA decisions based on citizen petitions?

Sheller represents hundreds of children who claim to have suffered grievous side effects from the Johnson & Johnson antipsychotic Risperdal. Among those ill consequences, according to dozens of suits Sheller has filed in Pennsylvania and California state courts, is the development of abnormally large breasts in young men. The breast tissue does not shrink after patients stop using Risperdal, the suits allege, so the abnormal enlargement can only be reversed through surgery.

In 2012, after obtaining Risperdal documents through discovery, the Sheller firm filed a citizen’s petition with the Food and Drug Administration. The petition asked the FDA either to revoke approval for Risperdal’s use in children and adolescents or to require Risperdal labels to include a black-box warning about the drug’s alleged side effects in young people. The plaintiffs’ firm also asked the FDA to review the drugmaker’s Risperdal files. (Sheller could not provide discovery documents to the government because the materials were subject to a confidentiality provision.)

The FDA denied Sheller’s requests for a ban or a black-box warning in 2014, after Johnson & Johnson responded to a government demand for all of its previously unproduced data on Risperdal and children. Sheller sued the Department of Health and Human Services, challenging the FDA’s decision not to revise its warnings about Risperdal or to take the drug off the market for young patients.

U.S. District Judge Legrome Davis of Philadelphia found that Sheller did not have standing to bring the challenge. Sheller had argued that as a result of the FDA’s decision, J&J was able to present stronger arguments that plaintiffs’ claims in the firm’s ongoing personal injury cases were pre-empted by the federal government’s labeling of Risperdal. Countering those beefed-up pre-emption arguments in contingency fee litigation, Sheller said, costs the firm money - an economic injury that confers standing. The judge said Sheller’s theory was fundamentally flawed because the causation chain included J&J. “That a third party - plaintiff’s adversaries in the Risperdal drug cases - has ostensibly caused and would need to rectify plaintiff’s injury undermines plaintiff’s position as to both causation and redressibility in its suit against the FDA,” the judge said.

Sheller appealed. In July, a three-judge panel at the 3rd U.S. Circuit Court of Appeals agreed with Judge Davis that the law firm’s theory of standing was “tortuous” and, ultimately, unpersuasive. “Put simply, Sheller’s injury - increased Risperdal litigation costs - depends heavily on the actions of both (J&J) and Sheller, not the FDA, and granting the petition produces only a ‘chain of contingencies which amounts to mere speculation’ about how (J&J) and Sheller will conduct the Risperdal litigation and accrue associated litigation costs,” wrote 3rd Circuit judges Julio Fuentes, Patty Shwartz and Felipe Restrepo.

Sheller brought in appellate litigator Howard Bashman (author of the How Appealing blog) to petition the 3rd Circuit for a rehearing. Bashman argued that the FDA decision did cause Sheller’s injury. Any defendant in J&J’s position would have taken advantage of the FDA’s position to boost its pre-emption argument, Bashman said, so J&J’s beefed-up defense was an inevitable link in the causation chain. But for the FDA decision, the Sheller brief said, the law firm would not have had to spend extra time and money to counter defense arguments.

On Thursday, the 3rd Circuit denied the petition for rehearing, but in an interview Friday, Bashman said the Sheller firm plans to ask the U.S. Supreme Court to take the case. As you might imagine, there is no split among the federal circuits on the specific issue of whether personal injury law firms have standing to challenge FDA responses to citizen petitions on drug labeling. In fact, Bashman said his research turned up no other case directly on point. But Bashman said the justices have proven themselves to be very interesting in questions of constitutional standing, and this case could be an opportunity for the Supreme Court to consider who has a constitutional right to challenge a government action.

Think about it. Young patients who already take Risperdal wouldn’t have standing to challenge the FDA’s decision not to revoke approval or require re-labeling because they (or, more likely, their parents) opted to use the drug under its existing labels. Prospective Risperdal users, meanwhile, are probably too ill to wait around for a challenge to the FDA’s decision to be litigated. If they or their parents were concerned about Risperdal’s use in children, Bashman said, they’d likely just turn to an alternative medication. So their standing is also questionable.

Bashman said he’s going to do additional research on whether cases outside of the 3rd Circuit have confronted the question of who has standing to challenge the FDA’s denial of a citizen’s petition. He has found an instance of an expert witness who learned about problems with a particular drug bringing a successful citizen’s petition for relabeling, but he continues to believe that Sheller and other plaintiffs’ firms actually may be the best-situated challengers.

I also asked Bashman to explain his brief’s final point, in which he told the 3rd Circuit that Sheller didn’t file its citizen’s petition as a strategy in the underlying personal injury litigation. I’d wondered about that: If Sheller had persuaded the FDA to bar or warn against Risperdal’s use in children, wouldn’t that have made it easier for firm clients to win cases against J&J? Bashman told me that because those cases are based on alleged shortcomings in labels in place when Sheller clients were taking Risperdal, the FDA’s subsequent action would not be conclusive and might not matter. Besides, Bashman said, plaintiffs have been able to win Risperdal suits despite the FDA’s denial of Sheller’s citizen’s petition.

According to Bashman, Sheller’s founder, Steven Sheller, filed the petition because he was genuinely concerned about other boys and young men developing the side effects he has accused Risperdal of causing. “He’s in a position to try to do things to help others,” Bashman said. “This was one thing he thought would be a useful way to expend the firm’s resources.”

I left a message with a spokeswoman for the J&J subsidiary that sells Risperdal but did not hear back.

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