Jay Lefkowitz of Kirkland & Ellis LLP defied expectations when he convinced the U.S. Supreme Court to rule in Pliva v. Mensing that federal laws shielded generic-drug makers from state failure-to-warn claims, earning him a spot on Law360's list of Appellate MVPs.
In one of the most closely followed product liability cases this year, Lefkowitz persuaded the high court to reverse two federal appeal court decisions, surprising many experts who expected the court to come down in favor of permitting state product liability claims against generics makers.
The Supreme Court found in its decision that state-law tort claims against generics manufacturers were preempted because the federal Hatch-Waxman Amendments required generics to use the same warning label as brand-name companies.
Lefkowitz represented Teva Pharmaceuticals USA Inc. against claims the generic-drug maker failed to adequately warn consumers of the risks associated with generic prescriptions, in violation of state failure-to-warn statutes.
Both the Fifth and Eighth Circuit courts had allowed state-law tort claims against several generics makers in consolidated suits claiming they failed to warn consumers that generic versions of Wyeth Inc.'s Reglan were tied to tardive dyskinesia, a neurological disorder.
"It was a big challenge just to get the court to take the case, because of the lack of a circuit split," Lefkowitz said.
But Lefkowitz, in his first time arguing in front of the Supreme Court, contended that the language of the Hatch-Waxman Act required generic drugs to carry the same warnings as their brand-name equivalents, meaning that under the Constitution's supremacy clause, state laws could not require generic drugs to use different warnings.
As a result of the Supreme Court's ruling that effectively shielded generics manufacturers from state liability laws, a large number of drug liability cases pending in state and federal courts have been thrown out or severely reduced, as most drugs prescribed in the U.S. country are generics.
In the months following the high court's June decision, courts in Alabama, Georgia, Indiana and Louisiana, as well as the Fifth, Sixth and Eighth Circuit Courts of Appeals have all dismissed such cases.
Although the decision was a game-changer, it came as a surprise to many, especially in light of the high court's 2009 decision in Wyeth v. Levine allowing state claims against name-brand companies and the absence of a split in the circuit courts.
"Given the dozens of courts post-Wyeth that had ruled the other way, and the fact that the solicitor general weighed in on the plaintiffs' side, not a lot of commentators thought we had much chance of winning," Lefkowitz said.
Although it was a tough fight, Lefkowitz, who works out of Kirkland & Ellis' New York office, said the case was the most "exciting and satisfying" he has handled so far in his career.
"When I was an intern at the Supreme Court in 1983, I dreamed of one day arguing before the court," Lefkowitz said.
Lefkowitz said he prepared extensively for the case, holding several moot courts to practice his oral arguments and legal strategies. The practice runs were organized for Lefkowitz by the deans of Harvard University and Columbia University, where he is currently an adjunct professor of administrative law.
"I prepared for it the way I prepare for every argument — by reading every single case again, and again and again — and by doing countless moot courts," Lefkowitz said.
Since the Pliva case, Lefkowitz said he has been busy defending drug companies in cases where opponents seek to place limits on the Pliva decision.
He is also currently leading the appellate team involved in defending Baxter Healthcare and affiliates of Teva Pharmaceuticals in 250 separate lawsuits stemming from a hepatitis outbreak in Las Vegas in 2008.
Patients have filed suits against the drug companies alleging the drugmakers sold the injectable anesthetic Propofol to endoscopy clinics in vials so large that they could be used for more than one patient, which led many doctors to reuse them at the risk of contamination.
Several jury verdicts have already come down in the first few cases in favor of the exposed plaintiffs. Most recently, in October, a Nevada jury awarded $104 million in damages to a colonoscopy patient who claimed he contracted hepatitis from a reusable vial of Propofol.
Lefkowitz, a senior litigation partner with the firm's litigation, securities, product liability and appellate practices specializes in prominent federal and state court appeals.
Prior to rejoining Kirkland & Ellis in 2003, Lefkowitz served several terms at the White House under both Bush administrations — first as director of cabinet affairs and deputy executive secretary to the domestic policy council under President George H.W. Bush, and later as an adviser to President George W. Bush.
Lefkowitz acted as one of George W. Bush's senior advisers on domestic policy, legal and international issues as head of the White House's Domestic Policy Council, in addition to his time spent serving as general counsel in the Office of Management and Budget.
"I've been involved with preemption issues for a long time — both during my time in government and as a litigator," Lefkowitz said.
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