In two major cases before the
Supreme Court of the United States,
Pliva Inc. v. Mensing, (564 U.S. 604 (2011) and
Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), Lefkowitz succeeded in persuading the Supreme Court that because federal law absolutely demands that generic drugs precisely follow the
FDA-approved labels of the related brand-name drug produced by another manufacturer, states may not impose liability on
generic manufacturers who do nothing but use the labels federal law requires them to use. In 2007/2008, in the course of serving as a criminal defense lawyer for
Jeffrey Epstein, eventually convicted of sex offences, Lefkowitz negotiated a deal with prosecutor
Alexander Acosta. Acosta would later come under attack for having made this agreement with Epstein's defense lawyers, and pressure connected with whether the deal was in the best interest of the prosecution led Acosta to resign his position as
Secretary of Labor in 2019. In
Corber v. Xanodyne Pharmaceuticals Inc., the
United States Court of Appeals for the Ninth Circuit, sitting
en banc, ruled in favor of Lefkowitz's client,
Teva Pharmaceuticals. Hundreds of plaintiffs had brought actions against Teva in various
California state courts and had asked that the cases be coordinated before one state court judge "for all purposes." The defendants sought to remove the cases to federal court pursuant to the
Class Action Fairness Act ("CAFA"), on the ground that the plaintiffs had proposed a joint trial. But the District Court and a three-judge panel of the Ninth Circuit held that the cases were not removable because the plaintiffs had not explicitly asked that the cases be tried together, which is essential to the definition of a removable "mass action" under CAFA. The Ninth Circuit granted
en banc review and ruled in favor of Lefkowitz's client, that the plaintiffs' request for coordination "for all purposes" necessarily encompassed a request for a joint trial. Hence, the case was properly removed to federal court. In
Association for Accessible Medicines v. Frosh, Lefkowitz secured a major victory on behalf of his client in the
United States Court of Appeals for the Fourth Circuit. During its 2017 legislative session, the
Maryland General Assembly had passed a law prohibiting a manufacturer or wholesale distributor from "engag[ing] in
price gouging in the sale of an essential off-patent or generic drug." Md. Code Ann. Health Genera; § 2-802(a). The Court ruled that the statute violated the
Commerce Clause of the
United States Constitution because a state may not regulate transactions that occur completely out of that state. In the case of the Maryland statute, the state statute was impermissibly regulating transactions between manufacturers and distributors that took place wholly outside of Maryland. ==Representing Jeffrey Epstein in 2006 Florida case==