Source: https://www.kirkland.com/lawyers/l/lefkowitz-jay-p-pc
Timestamp: 2019-04-21 19:00:14+00:00

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Jay Lefkowitz is a senior litigation partner at Kirkland. He is also an adjunct professor at Columbia Law School, where he teaches a seminar on Supreme Court advocacy. Jay has served as lead trial and appellate counsel in a wide variety of substantive areas, including shareholder disputes, antitrust, product liability, litigation against the FDA and False Claims Act matters. He has also conducted numerous internal investigations for public companies and audit committees.
In its 2013 release of “The 100 Most Influential Lawyers in America,” The National Law Journal describes Jay as “a leading voice on school choice issues” and “a no-nonsense appellate and antitrust lawyer for an array of blue-chip clients.” The Legal 500 U.S. noted that Jay “provides a depth of understanding and influence in some of the highest courts of our country,” and in Chambers USA, America’s Leading Lawyers for Business, clients say, “‘Jay is brilliant; there is no other way to put it.’” Jay was also named a Law360 “MVP of the Year” in 2011 for his Appellate practice, and in 2012, 2013, 2014 and 2015 for his Life Sciences work. Jay is one of only three of the 189 MVPs named to the list five years in a row. The American Lawyer named him its “Lawyer of the Week” in December 2012 for his role in winning an antitrust lawsuit in the pharmaceutical industry.
Jay takes on groundbreaking work for high-profile clients, representing more than a dozen major pharmaceutical, medical device and health care companies in important and frequently precedent-setting matters. Jay has won two landmark 5-4 decisions at the U.S. Supreme Court in favor of the pharmaceutical industry overturning the decision of three Circuit Courts of Appeal. In Pliva v. Mensing in 2011, on behalf of Teva and Actavis, Jay convinced the Court to reject the views of the FDA and the Solicitor General and establish that generic drug companies may no longer be sued for “failure to warn claims,” finding that federal law preempts state law under the Constitution’s supremacy clause. His victory in Mutual v. Bartlett in 2013, overturned a $21 million verdict on behalf of Sun Pharmaceuticals, and extended the Mensing ruling to cover design defect claims.
Mylan Pharms. Inc. v. Sebelius et al.
Jay currently serves on Advisory Boards for many organizations, including Columbia Law School, NYU Alexander Hamilton Center and Barnard College, and his public service career includes serving as a senior White House advisor to two presidents, and as United States Special Envoy on Human Rights in North Korea.
Upsher-Smith Laboratories, Inc. v. Louisiana Wholesale Drug Company, Inc., et al.
Represented Upsher-Smith Laboratories in a petition for certiorari to the U.S. Supreme Court regarding antitrust challenges to Upsher-Smith’s patent settlement regarding the drug K-Dur. This case highlighted the circuit split regarding whether patent litigation settlements — so-called “reverse payment” cases — violate antitrust laws, and argued that the Third Circuit applied an incorrect legal standard in holding that such settlements were presumptively unlawful. The Supreme Court granted certiorari in June 2013, vacated the Third Circuit decision, and remanded the case to be adjudicated in light of the Supreme Court’s ruling in the companion case, FTC v. Actavis.
Represented Mutual Pharmaceutical Company in a successful appeal before the U.S. Supreme Court in a preemption case. The Court’s decision overturned a $21 million products-liability verdict, and held that conflict preemption cannot be avoided by asserting that the defendant should not have sold its product. The Court’s decision not only extends Kirkland’s prior win for the generic industry in PLIVA, Inc. v. Mensing, but shields manufacturers of all products from what potentially was the single greatest threat to conflict preemption that the Supreme Court has ever considered.
Sincoskie v. West-Ward Pharmaceuticals, Inc. et al.; Yamane v. Wyeth, Inc.; Wiley v. Wyeth, Inc.
Represented Baxter Healthcare in three products liability victories in state courts in New Jersey, Hawaii and Alabama. In each case, Baxter argued that because federal law requires generic drug labeling and design to be “the same as” the labeling and design of the corresponding brand-name drug, any and all state-law tort claims that seek to hold generic drug manufacturers liable for failing to unilaterally alter their product warnings or design are preempted under the U.S. Supreme Court ruling in Pliva v. Mensing.
Represented Teva, Abbott, and 20 other Pharmaceutical companies in a False Claims Act case in the U.S. District Court for the District of Massachusetts. The relator plaintiff alleged that the defendants violated the Act by causing Medicaid to reimburse the companies for unapproved drugs, vitamins and dietary supplements that were not Medicaid eligible and sought more than $2 billion in total damages. The court granted the defendants’ joint motion to dismiss, adopting the argument that the court lacked subject matter jurisdiction over the action.
PLIVA, Inc. et al. v. Mensing et al.
Represented Teva before the U.S. Court of Appeals for the Eleventh Circuit in a case that alleged that Teva could be held liable under Florida law for negligently failing to communicate its labeling changes directly to health care professionals. The Court rejected the plaintiffs’ argument on both federal and state law grounds.
Represents Teva and several other pharmaceutical companies in appeals pending throughout the nation in product liability cases. All these appeals raise preemption issues that are related to the Supreme Court’s decision in PLIVA v. Mensing. Already on Jay’s docket for the coming year are appeals in the Third, Fourth and Sixth Circuits, as well as the Pennsylvania and California Supreme courts.
Represents Abbott Laboratories in the U.S. Court of Appeals for the Fifth Circuit in a case involving a Texas statute that provides drug manufacturers with a rebuttable presumption that FDA-approved drug warnings are adequate in products liability actions.
Lesh, MD, et al v. eV3 Inc.
Represented the former shareholders of Appriva Medical, Inc. in a securities case convincing a jury in the Superior Court of the State of Delaware to award approximately $250 million in damages as a result of eV3 Inc.’s breach of the parties’ 2002 merger agreement. Initially filed in 2005, Kirkland took the lead of this litigation in 2009.
Buettgen, et al. v. Harless, et al.
Represented SuperMedia Inc. (f.k.a. Idearc Inc.) in a class action lawsuit in the United States District Court for the Northern District of Texas, alleging that the defendant misrepresented its bad debt expense with fraudulent intent and thereby caused investors to suffer hundreds of millions of dollars in losses. In June 2013, on the eve of trial and after failed attempts at mediation, the parties reached a settlement.
Represented a German company against a suit brought by several hedge funds and Merrill Lynch International claiming that the company breached the terms of a “Payment-in-Kind” loan. The plaintiffs also sued the directors of the company on an alter ego liability theory and bringing additional claims for intentional and constructive fraudulent conveyances. The court granted defendants’ motion to dismiss in 2010. Plaintiffs appealed to the New York Supreme Court but the parties reached a settlement and the appeal was voluntarily dismissed in June 2011.
Represented three individual directors of Loral Space & Communications, Inc., including its CEO, in a derivative suit and a shareholder class action case arising from a $300 million financing transaction between Loral and its controlling shareholder. The lawsuits, filed in Delaware Chancery Court, alleged that the Loral directors had breached their fiduciary duties by giving the controlling shareholder a preferential deal. After a one-week trial in March 2008, the court did not find that the directors had breached their fiduciary duties and refused to impose liability.
Randy Kopp, et al. v. Klein, et al.; Bruce Fulmer, et al. v. Klein, et al.
Represented Idearc (now, Supermedia, Inc.) and its former ERISA plan fiduciaries defending against an ERISA class action alleging that it was imprudent for Company ERISA plans to hold Idearc stock. In March 2012, the Northern District of Texas granted Idearc’s motion to dismiss all claims. Affirmed by the Fifth Circuit in July 2013.
Straily v. UBS Financial Services Inc.
Represented UBS in a successful defense of an action brought in the United States District Court for the District of Colorado, in which the court granted summary judgment in favor of UBS in a putative class action seeking more than $650 million in damages on behalf of the class. The suit alleged that UBS had breached fiduciary duties and the implied covenant of good faith and fair dealing when it implemented a new program under which uninvested cash, which had previously been automatically swept from customers’ brokerage accounts to UBS money market funds, was swept instead into FDIC-insured deposit accounts at a UBS affiliate, UBS Bank USA.
Represented Tenet Healthcare Corporation and certain current and former officers and directors in a formal SEC investigation concerning whether Tenet’s public disclosures of Medicare outlier and stop-loss payments under managed care contracts were misleading or otherwise inadequate, as well as whether certain former and current Tenet officers and directors engaged in insider trading. The matter was settled for a small financial penalty with no imposition of a monitor.
Conducted an internal investigation of a NASDAQ-listed broker-dealer that was the subject of an SEC fraud investigation. Kirkland interviewed numerous witnesses here and throughout Europe and made numerous findings and recommendations regarding the company’s sales practices, accounting practices, public disclosures, financial controls, records retention practices and personnel decisions. Kirkland worked with and appeared before the SEC, the DOJ, the NASD and the NASDAQ Listing Qualifications Panel.
Represented a New York-based hedge fund and its principal in connection with a SEC investigation of the fund’s short trading related to its investments in PIPEs (Private Investments in Public Equity). The fund had been one of the largest investors in PIPEs, with several hundred transactions. After a two-year investigation involving testimony and expert analysis, in June 2008, the SEC agreed to close its investigation without bringing any charges against any of the parties involved.
Defended UBS in a putative class action alleging that the firm’s prime brokerage unit violated antitrust laws by fixing prices for the interest charged on short sales, particularly naked short sales. The successful defense was upheld on appeal.
Represents several foreign entities in relation to the liquidation of Bernard L. Madoff Investment Securities LLC. These representations have included filing claims on each client’s behalf, objecting to claim determinations and responding to document subpoenas.
Represents BioScrip, Inc. in connection with the company’s 19 percent stock drop case following the company’s announcement of a government investigation initiated by Department of Justice and the New York Attorney General’s Medicaid Control Fraud Unit.
Represents a major investment bank in several cases nationwide challenging the client’s prime brokerage practices and interest charges on naked short sales under California law.
Represents Herald Fund SPC in an adversary proceeding brought by the Trustee overseeing the liquidation of Bernard L. Madoff Investment Securities LLC, pending in the United States Bankruptcy Court for the Southern District of New York. The lawsuit seeks avoidance of more than $550 million in alleged preferences and fraudulent conveyances. After the Fund filed a motion to dismiss all claims, the Trustee voluntarily dismissed nearly half of his claims against the Fund.
Represented Teva in the U.S. District Court for the District of New Jersey in a Sherman Act case arising out of a patent litigation settlement between Teva and GlaxoSmithKline (GSK). The plaintiffs alleged that, through the litigation settlement, Teva and GSK conspired to delay the marketing of Teva’s generic version (Lamotrigine) of GSK’s branded epilepsy drug Lamictal®. The Court granted a motion to dismiss all claims.
Represented Teva in a multi-district nationwide consumer fraud class action brought in the Eastern District of Pennsylvania (Schiller, J.) by more than 2.1 million putative class members seeking more than $12 billion in damages. While our motion for summary judgment and opposition to class certification was pending, the plaintiffs agreed at mediation to settle on a class wide basis; under the settlement, Teva paid no cash compensation to any class members and reimbursed the plaintiffs’ counsel for $2.25 million of its $8 million in fees and expenses (an amount matched by Teva’s co-defendant). Final settlement was approved over objections that it was too favorable to the defendant.
Represented Teva in a case in Southern Nevada (D. Nev. 2011) (Mahon, J.), in which more than 3,000 individual consumers brought separate actions in Nevada state court against Kirkland clients asserting product liability, breach of warranty and infliction of emotional distress claims. Plaintiffs moved in state court to have the individual cases consolidated for a single trial, and Kirkland removed the claims to federal court as a “mass action” under the Class Action Fairness Act. After Kirkland successfully defeated the subsequent motion to remand the cases to state court, the plaintiffs voluntarily dismissed all of the cases (for zero dollars).
Represented business partners Teva Pharmaceuticals USA, Inc. and Impax Laboratories, Inc. in two cases challenging FDA’s approval of Impax’s generic version of Wellbutrin XL antidepressant. In those cases, brand manufacturer Biovail alleged first that the FDA could not approve Impax’s generic version of Wellbutrin XL because Impax’s approved product labeling would have been misleading, and second, that FDA approval of Impax’s ANDA was in any event blocked by a 30-month regulatory stay of approval based on Biovail’s filing of a patent infringement lawsuit against another strength of the product. In the first case, Jay intervened on behalf of Teva and Impax and persuaded the U.S. District Court for the District of Columbia to reject Biovail’s challenges in both TRO and preliminary injunction proceedings. In the latter case, Jay argued for Teva and Impax in emergency TRO proceedings, successfully obtaining an oral ruling from the U.S. District Court for the District of Maryland holding that FDA’s approval was not blocked by the 30-month stay.
Represented Teva, as national counsel, in a products liability litigation in the U.S. District Court for the Eastern District of Arkansas relating to Teva’s generic version (Budeprion) of the antidepressant drug, Wellbutrin. This particular matter involved allegations that ingestion of Teva’s Budeprion product during pregnancy resulted in heart defects and other injuries to a minor child. While Teva's motion to dismiss was pending, the plaintiff voluntarily dismissed the case.
Mylan Pharmaceuticals Inc. v. Sebelius et al.
Represented Teva and Cephalon in a case which involved the 180-day marketing exclusivity provided under the Hatch-Waxman Act. Kirkland successfully convinced the FDA to depart from its “shared exclusivity” policy and award the sole exclusivity. When Mylan — with support from the Federal Trade Commission — sued to overturn the FDA’s decision, Kirkland convinced the U.S. District Court for the District of Columbia to uphold the FDA’s decision.
Ranbaxy Labs & Teva Pharmaceuticals USA, Inc. v. Leavitt, et al.
Represented Teva Pharmaceuticals USA, Inc. in a dispute with the FDA and argued that the FDA acted arbitrarily and capriciously when it denied IVAX Pharmaceuticals (since acquired by Teva) 180 days of marketing exclusivity for its generic version of Merck’s blockbuster drug Zocor following Merck’s request to remove the patents claiming Zocor from the FDA’s Orange Book list of patents. The D.C. Circuit held that the agency’s conduct violated the plain language of the Hatch-Waxman Act and was fundamentally inconsistent with the Act’s incentive scheme.
Mutual Pharmaceutical Co. v. Ivax Pharmaceuticals, Inc.
Represented Ivax Pharmaceuticals in federal district court in California in a case where the plaintiff sought a preliminary injunction under the Lanham Act to preclude marketing forms of a “DESI” drug, Quinine, that had not received formal FDA approval. We successfully fended off the preliminary injunction because we demonstrated that the plaintiff had not shown likelihood of consumer confusion.
Apotex, Inc. v. Food and Drug Administration, et al.
Represented Teva Pharmaceuticals USA, Inc. in its fight against the FDA over the exclusive rights to sell a generic form of Bristol-Myers Squibb Co.’s Pravachol cholesterol drug. The FDA had ruled that a stipulated dismissal of a lawsuit between Bristol-Myers Squibb and Apotex had triggered Teva’s six months of exclusivity. Following argument, the U.S. District Court for the District of Columbia reversed the FDA, instead ruling that a stipulated dismissal is not a “decision of a court” or a “holding” as required by the Act and granted judgment and injunctive relief to Teva. FDA appealed that decision to the D.C. Circuit, which vacated the district court’s decision and remanded the matter to FDA for reconsideration in light of the district court’s analysis. On remand, FDA fully adopted the district court’s position and awarded Teva exclusivity. When another applicant challenged FDA’s post-remand award of exclusivity, Jay successfully defended the agency’s decision in both the district court and D.C. Circuit.
Represents Barr and Teva against claims under the Sherman Act alleging that several generic manufacturers conspired to keep a generic version (modafinil) of the narcolepsy drug Provigil off the market. The case is pending in the U.S. District Court for the Eastern District of Pennsylvania.
Fenwick et al. v. Ranbaxy Pharmaceuticals, Inc., et al.
Represents Ranbaxy Pharmaceuticals Inc. and certain of its affiliates in connection with allegations of consumer fraud and other similar claims arising out of Ranbaxy’s recall of generic atorvastatin tablets. The case was filed on November 29, 2012.
Represents as lead counsel in seven national antitrust cases challenging patent settlements following the Supreme Court’s Actavis decision involving well known drugs such as Lipitor (Ranbaxy), Provigil (Teva), Cipro (Teva), Solydyn (Ranbaxy), Nexium (Teva), and Niaspan (Teva). The cases are in various stages of discovery with one set for trial in early 2014.
Represents Barr Pharmaceuticals in a California class action alleging that Barr and Bayer Corporation colluded to delay the entry of a lower-priced generic version of the antibiotic Cipro®. Kirkland previously defeated federal antitrust challenges to the Bayer-Barr agreement in a parallel action. In the California action, Kirkland won summary judgment on all claims and argued a winning appeal before the California Court of Appeal in this 10-year-long litigation. Plaintiffs then appealed to the California Supreme Court, which agreed to consider the matter in February 2012. The case was stayed pending the outcome of FTC v. Actavis, an unrelated case with similar legal issues. Following the ruling in Actavis, the plaintiffs asked the California Supreme Court to put their appeal on hold in light of a possible settlement agreement. The plaintiffs’ case against Barr and several other generics companies will continue.
Represents Akorn, Inc., which was sued by drug manufacturer Fera in the U.S. District Court for the Southern District of New York, in a case involving allegations of breach of a commercial supply contract, fraud and trade secret theft. The case is in discovery.
Represents Medicis in a case in which the plaintiff asserts that she was injured when injected with Medicis’ Restylane Class III device. A motion to dismiss on federal preemption and insufficient pleading grounds is pending before the U.S. District Court for the District of South Carolina.
Represents Teva in a case before the U.S. District Court for the Southern District of Florida in which the plaintiff alleges that she was injured as a result of both manufacturing and design defects in a Paragard® Intrauterine device.
Avantor Performance Materials v. IBM Corp.
Represented IBM when disgruntled customer, Avantor, alleged that IBM fraudulently induced it into an enterprise resource planning/inventory management contract and then breached that contract by providing a flawed product. After convincing the court to stay discovery subject to resolution of IBM’s dismissal challenge, the parties agreed to dismiss the case with prejudice in June 2013.
Chicago Teachers Union v. K12, Inc. and Chicago Virtual Charter School, et al.
Represented K12, Inc. and Chicago Virtual Charter School (CVCS) in a suit brought against CVCS by the Chicago Teachers Union. The union alleged that the virtual nature of CVCS’ educational model violated the Illinois Charter Schools Law’s requirement that charter schools be “non-home based.” The court ruled in favor of K12 and CVCS and granted summary judgment.
Boca Raton Community Hospital, Inc. v. Tenet Healthcare Corp.
Represented Tenet Healthcare in a case brought by Boca Raton Community Hospital on behalf of a purported nationwide class of hospitals. The plaintiff brought claims in federal court in Miami under the federal RICO statute and California’s unfair competition law alleging that Tenet hospitals, through their charging practices, received “too many” outlier payments from Medicare, and thereby “stole” outlier payments from the plaintiff and other hospitals. Prevailed at class certification stage, won summary judgment, and then upheld the decision at the 11th Circuit.
Represented General Motors in more than one dozen product liability lawsuits nationwide; represented General Motors in several evidentiary proceedings in which plaintiffs sought exceptions to GM’s attorney-client and/or work product privileges under the crime-fraud doctrine; successfully brought mandamus petitions in a variety of federal courts to reverse district court decisions; and led a successful effort to have a plaintiff’s attorney sanctioned with a personal contempt citation for $190,000 for violation of a court order.
Trial counsel for General Motors in a highly publicized case in state court arising out of one of the worst automobile accidents in New York City history. The 24 plaintiffs included six decedents and others with significant brain injuries, burns and loss of limbs. Defect allegation related to the lack of a brake-transmission shift interlock in all GM 1980s vehicles. Plaintiffs sought compensatory and punitive damages. Favorable settlement reached after six weeks of trial.
Serrano v. Cablevison Systems Corp. and CSC Holdings, Inc.
Represented Cablevision in a case before the United States District Court for the Eastern District of New York in which the plaintiffs filed a putative consumer class action asserting seven causes of action: (1)-(3) violations of the Computer Fraud and Abuse Act; (4) violation of the New York Deceptive Sales Practices Act; (5) violation of the New Jersey Deceptive Sales Practices Act; (6) fraud; and (7) unjust enrichment. In February 2012, the district court adopted all of Cablevision’s arguments and granted summary judgment. The matter is now on appeal to the Second Circuit.
Represented Loral in a suit brought by its insurance company seeking declaratory judgment that there was no insurance coverage for a $19 million fee award granted to plaintiffs’ counsel in underlying litigation. The parties brought cross motions for summary judgment. After hearing oral argument, the court ruled that under the plain language of the insurance policy there was clear coverage for the $19 million fee award and granted Loral’s summary judgment motion.
Represented two non-profit institutions in New York State in connection with regulatory inquiries related to losses due to Madoff-related investments. Conducted internal investigations and coordinated revision of internal corporate controls and bylaws. Made presentations to regulators.
Represented Fortune 50 Company in connection with SEC investigation into allegations of earnings smoothing. Interviewed dozens of employees and executives and made presentations to regulators.
Represented Fortune 100 Corporation in connection with DOJ and SEC investigations into allegations of fraudulent accounting practices. Developed protocol for internal investigations. Conducted hundreds of interviews of employees and executives and made presentations to regulators.
United States of America v. Jeffrey Stein, et al.
Defended an investment manager in what has been described as the largest criminal tax fraud prosecution in United States history. The client was charged with 17 co-defendants in a wide ranging conspiracy to evade taxes and defraud the IRS through allegedly abusive tax shelters in the Southern District of New York. The indictment charges that the defendants — most of whom were employees of KPMG — developed sham tax shelter transactions and marketed them to hundreds of wealthy individuals, evading roughly $11 billion in taxes.
Represented the State of Wisconsin at the Wisconsin Supreme Court and later the United States Supreme Court in its successful litigation to become the first state in the country to implement a school voucher program.
Defended the Adat Shalom Reconstructionist Congregation in a lawsuit brought by residential owners in the town of Carderock, Maryland challenging the constitutionality of a zoning ordinance, arguing that it amounted to an impermissible endorsement of religion within areas zoned for single-family residential use. The U.S. District Court for the District of Maryland granted the defendant’s motion to dismiss.
Jay was recognized by The Best Lawyers in America for Product Liability Litigation - Defendants in 2019.
In 2019, Jay has been recognized by Benchmark Litigation as a Local Litigation Star and National Practice Area Star for Antitrust; Appellate; General Commercial; Product Liability; Securities. Benchmark Litigation recognized Jay as one of the “Top 100 Trial Lawyers in America” for 2015 and 2016. The list features attorneys known for their trial acumen and is developed after three years of research with peers and clients.
Jay was named one of “The 100 Most Influential Lawyers in America” in 2013 by The National Law Journal and is honored for his pro bono work for the education reform movement under California’s “parent trigger” law.
For four years in a row, Jay was named “Life Sciences MVP” by Law360 in December 2012, November 2013, December 2014, and November 2015.
From 2012–2015, Jay has been recognized by The Legal 500 U.S. for his work in Product Liability and Mass Tort Defense: Pharmaceuticals and Medical Devices. He was also recognized for Supreme Court and Appellate Litigation in 2012 and 2013; and was recognized for his work in Commercial Litigation, Product Liability and Mass Tort Defense: Toxic Tort, Trade Secrets and M&A Litigation Defense in 2015.
Jay has been recognized in New York Super Lawyers every year since 2011.
Jay was named “Litigator of the Week,” The Am Law Litigation Daily, December 2012.
In 2011, Jay was named "Appellate MVP,” Law360, November 2011.
In 2019, Jay was honored with the Judge Joseph M. Proskauer Award from the UJA-Federation of New York.
In 2010, Jay was honored with the Gershom Mendes Seixas Award from Columbia/Barnard Hillel.
In 2004, Jay received the Public Service Award from the Orthodox Union, and also represented the U.S. at the International Conference on Anti-Semitism in Berlin, Germany.
In 1990, Jay served as a member of the U.S. delegation to the United Nations Human Rights Commission in Geneva, Switzerland.

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