Inundated with calls about serious heart ailments linked to the prescription painkillers Darvon and Darvocet, the plaintiffs bar once predicted that thousands of claims eventually might be filed against the manufacturers of those drugs. A year later, those cases are on life support.
In March, U.S. District Judge Danny Reeves of Frankfort, Ky., who is overseeing the multidistrict litigation against the drugs’ manufacturers, dismissed the primary defendants from a large number of personal injury cases, which at one point numbered nearly 200.
Reeves on March 5 dismissed all the companies that manufacture the generic equivalent of the drugs, citing a recent U.S. Supreme Court holding that generics couldn’t be held liable for failures to warn about risks associated with their products. In separate rulings, he dismissed Eli Lilly and Co. and Xanodyne Pharmaceuticals Inc., the primary manufacturers of the brand-name drugs Darvon and Darvocet, concluding that most plaintiffs had failed to establish that either company made the drugs they took.
The future of the litigation is now in the hands of the U.S. Court of Appeals for the Sixth Circuit, where plaintiffs attorneys have appealed final judgments in six of their cases in hopes of reversing their devastating losses before Reeves. “I’m not aware of an issue that he’s ruled in our favor,” said Richard Schulte, a partner at Behnke, Martin & Schulte in Vandalia, Ohio, and co-lead counsel on the plaintiffs steering committee. “We’re hoping that the Sixth Circuit will see things differently.”
In 2010, the U.S. Food and Drug Administration recommended removal from the U.S. market of Darvon, Darvocet and their generic equivalents. The action followed the release of clinical data showing that the drugs could put patients at risk for “potentially serious or even fatal heart rhythm abnormalities.” The risks decrease quickly once a patient stops taking the drugs.
Both brand-name drugs had been on the market since the FDA approved propoxyphene in 1957 to treat mild pain. Darvon is the brand name for propoxyphene and Darvocet includes propoxyphene and acetaminophen. Xanodyne, which took over manufacturing the drugs in 2005, voluntarily withdrew them from the U.S. market, prompting the litigation. The multidistrict litigation was coordinated in August before Reeves.
Given the recent unfavorable rulings, and a barrage of additional dismissal orders in recent months, the number of claims against the lead defendants has dwindled substantially. Although most of the cases haven’t technically been dismissed altogether, few are expected to survive.
“He’s been throwing them out so fast, I can’t count them out,” Schulte said. “You don’t have to be a rocket scientist to find out that the vast majority of the cases are dismissed.”
In his March 5 ruling, Reeves cited the Supreme Court’s pre-emption opinion in Pliva Inc. v. Mensing. In that case, the high court ruled on June 23, 2011, that users of generic drugs could not bring state tort suits against manufacturers that failed to warn about any danger from their products if the companies relied on the same labeling approved by the FDA for the brand companies.
“This is one of the biggest and most prominent decisions post-Mensing,” said Mark Cheffo, a partner at New York’s Skadden, Arps, Slate, Meagher & Flom who is co-lead counsel for the generic defendants.
It’s also a significant roadblock to the litigation, since the drugs had been on the market for so long. “Typically, once a drug goes generic, well over 90 percent of the market shifts to generic drugs,” said Louis Bograd, senior litigation counsel at the Center for Constitutional Litigation in Washington, who is working with the plaintiffs steering committee in the Darvon cases and argued on behalf of the users in Mensing. “Because of insurance and company preferences for generic substitution, there aren’t that many people who have taken the brand product.”
In court documents, plaintiffs attorneys sought to distinguish Mensing from their cases, arguing that the generics manufacturers should have withdrawn the drugs even in advance of the FDA’s warning, given earlier indications of the danger. Under state tort laws, in fact, those companies should have stopped selling a defective product once they knew about the risks, they wrote.
“The same argument was made in Mensing,” said Michael Green, a professor and tort law expert at Wake Forest University School of Law. “You can stop selling the drug; you can try to push the brand-name manufacturer to make the change; you can petition the FDA to make the change — and the Court rejected all those alternatives in Mensing.”
Reeves also disagreed with the argument, dismissing 34 cases. On April 10, he issued an order to show cause why the rest of the cases against the generics shouldn’t also be dismissed. On June 22, he dismissed another 94 cases — all the remaining claims against the generics. A status conference in the case has been scheduled for July 23.
On April 5, plaintiffs attorneys asked Reeves to certify his ruling so that they could file an interlocutory appeal before the Sixth Circuit. Reeves refused. Last month, they told him of a May 2 decision in Bartlett v. Mutual Pharmaceutical Co., in which the U.S. Court of Appeals for the First Circuit found that Mensing did not protect generic manufacturers from design-defect claims.
“The Mensing decision doesn’t reference anything about product-defect claims. It references failure-to-warn claims,” Schulte said.
The generic defendants have responded that Bartlett was an anomaly among the circuit courts.
ELI LILLY AND XANODYNE
In rulings for Xanodyne and Eli Lilly on March 5 and March 7, respectively, Reeves concluded that the plaintiffs hadn’t provided enough evidence that they took a drug manufactured or sold by either of the brand companies, as opposed to a generic or other company. Plaintiffs attorneys had argued it was “plausible” that many users had taken a product made by either company, even though Eli Lilly gave up manufacturing and marketing propoxyphene in 2002. They also argued that rulings in several states have held brand companies liable for risks associated with generic versions of drugs.
Although that argument failed on motions to dismiss, the plaintiffs have sought during the past two months to certify to the high courts of 13 states — Arkansas, Connecticut, Georgia, Louisiana, Massachusetts, Michigan, New Hampshire, Maryland, Kentucky, Oklahoma, Arizona, South Carolina and West Virginia — the question of whether the brand companies could be held liable in circumstances where physicians prescribing the generic versions relied on the brand manufacturers’ misrepresentations about the safety of the drugs. They maintained that the issue is one of first impression in those states.
Reeves rejected all the certification requests, most recently on June 18.
Xanodyne’s attorney, Gina Saelinger, a partner in Ulmer & Berne’s Cincinnati office, praised those decisions in a prepared statement. “We think Judge Reeves’ decisions on Xanodyne’s motions to dismiss and his decisions denying plaintiffs’ motions to certify questions to various state high courts are correct and are in full conformance with the law and in the interest of judicial economy,” she wrote.
Mary Larimore, a partner at Ice Miller in Indianapolis who represents Eli Lilly, did not return a call for comment.
On June 6, plaintiffs attorneys asked the Sixth Circuit to consolidate the appeals of six cases involving 24 plaintiffs. They suggested that a combined opening brief be due on Aug. 17. The Sixth Circuit has yet to rule on that request.
“The bottom line is: The future of this litigation rests with the Sixth Circuit,” Bograd said.
He anticipated that plaintiffs attorneys would rely on Bartlett again on appeal. “The argument is stronger here than it was in Bartlett because the FDA has agreed with the argument that this drug was unreasonably dangerous, because it pulled propoxyphene off the market, announcing the risks outweighed the benefits,” he said.
But Green, the Wake Forest professor, wasn’t convinced that the precedent would help all that much. “I will be surprised if the First Circuit decision distinguishing design defects from warnings gains much traction beyond the First Circuit,” he said.
That said, he agreed that certain tort claims under various state laws might assist the plaintiffs against the brand companies. And he noted another ruling, published on Sept. 22, 2011, on which the defendants have pinned their hopes on appeal. In Smith v. Wyeth Inc., the Sixth Circuit cited Mensing in rejecting claims that a brand-name manufacturer could be held liable for injuries caused to users of the generic versions of its drugs.
“The defense thinks it’s an important case, because what Smith says beyond Mensing is that a generic drug victim cannot sue a brand-name manufacturer,” Green said. Still, the Sixth Circuit’s decision is based on Kentucky law.
“If this is an MDL, you have cases governed by a variety of different state laws,” he said. “That might be significant.”
Amanda Bronstad can be contacted at firstname.lastname@example.org.