Jay Lefkowitz
Official Website
Notable Cases
Over more than three decades in practice, Jay Lefkowitz served as lead trial and appellate counsel in matters spanning securities litigation, antitrust, product liability, constitutional law, and litigation against the FDA.
Jay Lefkowitz has represented more than a dozen major pharmaceutical, medical device, and health care companies in frequently precedent-setting matters, and argued and won landmark cases before the United States Supreme Court.
United States
Supreme Court
PLIVA, Inc. v. Mensing (2011).
Landmark 5–4 victory for Teva and PLIVA establishing that federal law preempts state failure-to-warn claims against generic drug manufacturers, overturning rulings of the Fifth and Eighth Circuits and rejecting the position of the FDA and the Solicitor General.
Mutual Pharmaceutical Co. v. Bartlett (2013).
Second 5–4 Supreme Court win for the generic industry, overturning a $21 million products-liability verdict and extending Mensing to design-defect claims.
Teva Pharmaceuticals USA v. Sandoz (2015).
Secured a ruling vacating a Federal Circuit decision that had invalidated patents covering Teva's multiple sclerosis therapy Copaxone, with the case remanded in Teva's favor.
State of Wisconsin School Voucher Litigation.
Argued for the State of Wisconsin in the successful defense of the nation's first school voucher program before the Wisconsin Supreme Court, with certiorari subsequently denied by the U.S. Supreme Court.
Securities &
Financial Litigation
Lesh v. eV3 Inc.
Persuaded a Delaware jury to award the former shareholders of Appriva Medical approximately $250 million for eV3's breach of the parties' merger agreement.
Fernandez v. Knight Capital Group
Defended Knight Capital and its officers in a securities fraud class action arising from a software malfunction that produced a $460 million loss; the case settled on favorable terms, funded entirely by insurers.
In re Loral Space & Communications
Represented three Loral directors, including its CEO, in Delaware Chancery litigation over a $300 million financing transaction; after trial, the court declined to find any breach of fiduciary duty.
Straily v. UBS Financial Services
Won summary judgment for UBS in a putative class action seeking more than $650 million over changes to the firm's cash-sweep program.
Park Employees' Fund v. Smith (BioScrip)
Won dismissal of a derivative action in a seminal ruling — the first to hold that demand excusal must be evaluated against a board reconstituted after the complaint was filed.
Pharmaceutical & FDA Litigation
FTC v. AbbVie
Won dismissal for Teva in the first "reverse payment" antitrust case brought by the FTC after FTC v. Actavis, an important precedent for the pharmaceutical industry.
Post-Mensing Appellate Campaign
Led the nationwide defense of preemption rulings for Teva, Baxter Healthcare, and other manufacturers in the Third, Fourth, Sixth, Ninth, and Eleventh Circuits and in state supreme courts, winning affirmance of dismissals across the country.
Hatch-Waxman Exclusivity Disputes
In a series of cases against the FDA, secured rulings preserving Teva's 180-day generic marketing exclusivity for major drugs, including a D.C. Circuit holding that the agency's conduct violated the plain language of the Hatch-Waxman Act.
In re Budeprion Litigation
Defended Teva in a nationwide consumer class action involving more than 2.1 million putative class members seeking over $12 billion; the matter settled with Teva paying no cash compensation to any class member.
Commercial & Product Liability
Boca Raton Community Hospital v. Tenet Healthcare
Defeated a purported nationwide RICO class action over Medicare outlier payments, winning summary judgment and affirmance at the Eleventh Circuit.
General Motors C/K Pickup Truck Litigation
Represented GM in more than a dozen product liability suits nationwide, and served as trial counsel in the highly publicized Washington Square Park case, reaching a favorable settlement after six weeks of trial.
United States v. Stein
Defended an investment manager in the KPMG tax shelter prosecution, described by the Justice Department as the largest criminal tax case ever filed.
Constitutional & Religious Liberty
McCall v. Scott
Represented parents whose children benefit from the Florida Tax Credit Scholarship Program, persuading the court to dismiss a constitutional challenge in 2015, affirmed on appeal in 2016
NYC Hasidic Merchants Matter
Represented Williamsburg merchants pro bono in a dispute with the New York City Commission on Human Rights over modesty dress-code signage, reaching a 2014 settlement under which the merchants paid no fines.
Concerned Citizens of Carderock v. Hubbard
Successfully defended the Adat Shalom Reconstructionist Congregation against a constitutional challenge to a Maryland zoning ordinance, winning dismissal in federal court.