Jay P. Lefkowitz, P.C.

Securities Litigation

Chester County Retirement System v. Collins, et al.

• Represented two senior executives of Blount International, Inc. in a putative shareholder class action arising from the 'take-private' acquisition of Blount by American Securities and P2 Capital Partners. The plaintiff alleged breaches of fiduciary duties and disclosure violations in connection with Blount's sale price. In 2016, the court granted the defendants' motion to dismiss with prejudice.

St. Denis J. Villere & Company LLC, et al. v. Epiq Systems, Inc., et al.

• Represented Epiq Systems, Inc. in a shareholder lawsuit arising from Epiq’s sale to OMERS Private Equity and funds managed by Harvest Partners, LP. St. Denis J. Villere & Company, LLC, Epiq’s largest activist shareholder, alleged breach of fiduciary duty following its rejected attempt to nominate candidates of its choice to stand for election to the board of directors of Epiq. In 2016, the parties reached a favorable settlement, paving the way for the $1 billion transaction.

Park Employees' and Retirement Board Employees’ Annuity and Benefit Fund of Chicago, et al. v. Richard Smith, et al.

• Represented BioScrip and certain current and former directors and officers in a derivative action alleging that certain defendants breached their fiduciary duties with respect to BioScrip’s public disclosures, oversight of company operations, secondary stock offerings and stock sales. In 2016, the court dismissed the lawsuit in a seminal ruling in which the court held — for the first time — that a change in a company board shortly after the filing of a derivative complaint required that demand excusal be evaluated as to the composition of the board after the turn over in directors. In 2017, Kirkland prevailed again when the court dismissed the plaintiffs’ amended complaint.

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.

Juan Fernandez, et al. v. Knight Capital Group, Inc.

• Representing Knight Capital Group and its officers in a putative securities fraud class action in the United States District Court for the District of New Jersey arising out of a software glitch that caused Knight Capital to erroneously purchase $7 billion worth of stock and ultimately record a $460 million loss. The SEC censured Knight and imposed a $12 million fine. Thereafter, the plaintiff in the securities litigation moved to compel the production of discovery. Kirkland opposed that motion and, after briefing and argument, the Court denied the motion. On March 2, 2015, the court gave preliminary approval of a settlement, which was affirmed at a settlement hearing on July 1, 2015. Overall, the case settled on very favorable terms with the company’s insurance carriers funding the settlement in full.

Faig v. BioScrip

• 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. In 2015, the court granted in part defendants’ motion to dismiss. A settlement as to the remaining claims was preliminarily approved in 2016.

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.

CMF Cayman, Ltd., et al. v. Heckler and Koch Beteiligungs GmbH

• 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.

In re Loral Space & Communications Consolidated Litigation

• 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.

Tenet Healthcare SEC Investigation

• 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.

NASD Procedural Rule 9800 Et Seq. Litigation

• Represented a broker-dealer that had been the subject of the first-ever application of NASD Procedural Rule 9800 et seq., which permits the NASD to seek “temporary cease and desist orders” under certain conditions. Because the scope of the NASD’s authority to impose affirmative obligations was a matter of “first impression,” the National Adjucatory Council (NAC) agreed to review the Hearing Panel’s decision. The NAC agreed the NASD had overstepped its authority to fashion relief under Rule 9840 when it ordered affirmative action (in this case the unwinding of a transaction and the collection of money from a non-member) that went well beyond the cessation of “ongoing violative conduct.”

NASDAQ-Listed Company SEC Investigation

• 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.

Hedge Fund SEC Investigation

• 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.

Electronic Trading Group v. UBS Warburg

• 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.

In re Bernard L. Madoff

• Represented several foreign entities in relation to the liquidation of Bernard L. Madoff Investment Securities LLC. These representations included filing claims on each client’s behalf, objecting to claim determinations and responding to document subpoenas.

Brokerage Practices California Litigation

• 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.

Picard v. Herald Fund SPC

• Represented 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.

Commercial Litigation

McCall, et al. v. Scott, et al.

• Represented parents, as intervenor-defendants, whose children benefit from the Florida Tax Credit Scholarship Program, arguing that, unlike state-funded vouchers, the plaintiffs lacked standing to challenge a tax-credit voucher program as unconstitutional. In 2015, Kirkland persuaded the court to dismiss the lawsuit; affirmed on appeal in 2016.

Comcast MO Group Inc. v. Qwest Communications International Inc.

• Represented Qwest Communications Inc. (now part of CenturyLink, Inc.) in litigation stemming from a tax sharing agreement that predecessors of Comcast and Qwest had entered into in connection with the 1998 separation of U S WEST, Inc. into two separate companies, MediaOne and New US WEST. Obtained summary judgment in 2014, dismissing the $120 million claim; affirmed on appeal in 2015.

Unilever-TRESemmé

• Representing Conopco, Inc. d/b/a Unilever in a putative class action complaint, pending in the Eastern District of California, regarding Unilever’s labeling of its TRESemmé Naturals line of shampoos and conditioners. Plaintiffs there have claimed damages in excess of five million dollars. Jay succeeded in persuading the court to dismiss claims based on the consumer protection statutes of 21 states in which no named plaintiff resided. In 2016, the parties reached a preliminary settlement. Awaiting final court approval.

Unilever-Suave

• Representing Conopco, Inc. d/b/a Unilever in a putative class action complaint, pending in the Eastern District of New York, regarding Unilever’s labeling of its Suave Naturals line of shampoos, conditioners, and body washes. Plaintiffs there have claimed damages in excess of five millions dollars. As of February 2015, our motion to dismiss is fully briefed and we are awaiting a decision from the Eastern District of New York.

Unilever-Suave

• Representing Conopco, Inc. d/b/a Unilever in a putative class action complaint, pending in the Western District of Missouri, regarding Unilever’s labeling of its Suave Naturals line of body washes. Jay succeeded in removing the case from state court to federal court by arguing that the potential damages exceeded eight million dollars, thereby satisfying CAFA’s jurisdictional minimum of five million dollars. Motion to dismiss is pending.

Alberto v. Colgate

• Represented Colgate in a putative nationwide class action in the Federal District Court for the Eastern District of New York.  Plaintiffs alleged consumer claims based on Colgate’s iconic Speed Stick line of deodorant and antiperspirant products, seeking damages for a nationwide class and an injunction. In 2015, while Kirkland’s motion to dismiss — which asserted a novel preemption argument — was pending, plaintiffs voluntarily dismissed the complaint.

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.

General Motors C/K Pickup Truck Litigation

• 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.

Washington Square Park Litigation

• 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. Plaintiffs appealed to the Second Circuit but withdrew their appeal prior to argument.

XL Specialty Insurance v. Loral Space & Communications

• 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.

White Collar Litigation & Internal Investigations

Phone Recovery Services, LLC v. Verizon Washington, D.C., et al.

• Represented Verizon Communications, Inc. in False Claims Act litigation asserting that Verizon and every other major telecommunications provider collected an insufficient amount of 911 surcharges from their business clients resulting in more than $200 million in alleged damages. Won dismissal of claims in 2015. Affirmed on appeal in 2018.

Madoff-Related Investigations

• 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.

Fortune 50 Company Investigation

• 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.

Fortune 100 Corporation Investigation

• 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.

United States Supreme Court and Other Appeals

Wagner v. Teva Pharmaceuticals USA, Inc., et al.

• Represented Teva Pharmaceuticals USA, Inc. and its affiliates, Barr Pharmaceuticals, LLC and Barr Laboratories, Inc., in the appeal of a favorable judgment in a product liability case alleging “failure-to-warn” claims regarding generic hormone therapy drugs. In 2016, the appellate court affirmed the underlying judgment, finding that the Federal Food, Drug, and Cosmetic Act preempted the plaintiff’s Wisconsin state-law claims.

Drager v. PLIVA, Inc.

• Represented PLIVA, Inc., a subsidiary of Teva Pharmaceuticals, in an appeal involving federal preemption issues arising from a product liability case relating to PLIVA's generic drug metoclopramide. Won the appeal in 2014 when the Fourth Circuit affirmed the entry of judgment for PLIVA.

Romo, et al. v. Teva Pharm. USA Inc.

• Represented Teva Pharmaceuticals in a widely followed appeal concerning removal under the Class Action Fairness Act (CAFA) in a product liability case involving the drug propoxyphene. To avoid removal under CAFA, the plaintiffs filed dozens of cases, each with fewer than the 100 plaintiffs required for removal under CAFA. The plaintiffs thereafter filed a petition seeking coordination of all actions before a single state court judge. On the basis of the plaintiffs’ coordination petition, Teva removed the cases to federal court under CAFA and plaintiffs appealed. In a 2014 en banc decision, the Ninth Circuit affirmed the removal, stating “we hold plaintiffs responsible for what they have said and done,” and “the real substance” of the plaintiffs’ coordination petition triggered removal.

Teva Pharmaceuticals USA Inc., et al. v. Sandoz Inc., et al.

• Represented Teva Pharmaceuticals USA Inc. in an appeal to the United States Supreme Court concerning the Federal Circuit's July 2013 decision that invalidated several patents covering its brand-name multiple sclerosis therapy, Copaxone. The district court ruled in 2012 that the generics makers infringed all nine Teva patents. On appeal, the Federal Circuit overturned part of the district court's ruling, stating that five of the patents in question had ambiguous language and were, therefore, not invalid. Teva filed an application with the United States Supreme Court to recall and stay the Federal Circuit's mandate pending the filing and disposition of a petition for writ of certiorari, but Chief Justice John Roberts denied the application on November 13, 2013. Teva's cert petition seeking United States Supreme Court review of the Federal Circuit's ruling was granted on March 31, 2014. Oral argument took place on October 15, 2014, and on January 20, 2015, the United States Supreme Court vacated the 2013 decision and remanded the case back to the Federal Circuit. In another win for Teva, the high court rejected Mylan and Sandoz's bid to expedite remand on January 27, 2015.

In re Fosamax (Alendronate Sodium) Products Liability Litigation No. II

• Represented Teva Pharmaceuticals North America in an appeal involving federal preemption claims arising from a product liability case relating to Teva’s generic drug alendronate sodium (Fosamax). Won the appeal in 2014 when the Third Circuit affirmed the dismissal of all claims against Teva.

In re Darvocet, Darvon & Propoxyphene Products Liability Litigation

• Represented Teva Pharmaceuticals North America in an appeal involving federal preemption issues arising from a product liability case relating to the generic pain-reliever medication propoxyphene. Won the appeal in 2014 when the Sixth Circuit affirmed the dismissal of all product liability claims brought against Teva and nearly two dozen other generic companies.

Upsher-Smith Laboratories, Inc. v. Louisiana Wholesale Drug Company, Inc., et al.

• Represented Upsher-Smith Laboratories in a petition for certiorari to the United States 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.

Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett

• Represented Mutual Pharmaceutical Company in a successful appeal before the United States 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 United States Supreme Court ruling in Pliva v. Mensing.

United States, ex rel. (Constance A. Conrad) v. Actavis Mid-Atlantic

• Represented Teva and 21 other pharmaceutical companies in a False Claims Act case in the United States 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 Pharmaceuticals USA, Inc. and PLIVA, Inc. in successful appeal to the United States Supreme Court in a case that overturned decisions of the Fifth and Eighth Circuit Courts of Appeal and established that generic drug companies may no longer be sued for “failure to warn claims.”

Andrea Guarino v. Wyeth LLC

• Represented Teva before the United States 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.

Pliva v. Mensing-related Matters

• Represented 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. Jay has handled appeals in the Third, Fourth and Sixth Circuits, as well as the Pennsylvania and California Supreme courts.

Millard Anderson v. Abbott Laboratories

• Represented Abbott Laboratories in the United States 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.

Constitutional & Religious Liberty Litigation

State of Wisconsin School Voucher Program Litigation

• 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.

Concerned Citizens of Carderock v. Hubbard

• 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 United States District Court for the District of Maryland granted the defendant’s motion to dismiss.

Pharmaceutical Litigation

FTC v. AbbVie Inc., et al.

• Represented Teva Pharmaceuticals in an antitrust lawsuit alleging that Teva’s patent settlement with Abbott regarding the drug AndroGel® delayed the introduction of a competing product. Won a motion to dismiss in 2015. Teva also prevailed soon thereafter when the court denied plaintiff's bid both for reconsideration of the dismissal and for partial final judgment. This was the first so-called ‘reverse payment’ case brought by the FTC following the Actavis ruling and will set an important precedent for the industry going forward.

In re ACTOS End-Payor Antitrust Litigation

• Represented Teva Pharmaceuticals in an antitrust class action alleging a patent settlement between Teva, other generic drug manufacturers and Takeda regarding the drug ACTOS® delayed the introduction of competing products. Won motion to dismiss the complaint with prejudice in 2015. The plaintiffs voluntarily withdrew their appeal of the ruling in 2016.

Becker v. Cephalon, Inc., et al.

• Represented Teva Pharmaceuticals in product liability litigation arising from the alleged failure to warn of side effects associated with Teva’s drug Treanda®. In 2015, Kirkland won dismissal of all claims. The ruling created helpful precedent for future failure-to-warn suits brought against Teva and other pharmaceutical companies.

In re Lamictal Direct Purchaser Antitrust Litigation

• Represents Teva in the United States 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. The case was remanded back to district court after the Third Circuit overturned the dismissal. Teva's appeal to the United States Supreme Court is pending.

In re Budeprion Litigation

• 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.

In re Endoscopy Center of Southern Nevada

• Represented Teva in a case in Southern Nevada (D. Nev. 2011) (Mahan, 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).

Biovail Corp. v. FDA and Biovail Corp. v. FDA

• 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 United States 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 United States District Court for the District of Maryland holding that FDA’s approval was not blocked by the 30-month stay.

Regions Bank et al. v. GlaxoSmithKline

• Represented Teva, as national counsel, in product liability litigation in the United States 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 United States 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 United States 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.

Modafinil Antitrust Litigation

• Represented 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 United States District Court for the Eastern District of Pennsylvania. Won partial summary judgment in 2014. Favorable settlements were reached in the remaining actions in 2016.

State of Illinois v. Abbott Laboratories

• Leading the defense for Teva and other pharmaceutical manufacturers in an Illinois False Claims and Consumer Protection case in the Circuit Court of Cook County, Illinois that began in 2005. The plaintiffs allege that the defendants’ dissemination of “false and deceptive” average wholesale prices for their drugs caused the state to over-pay pharmacies that dispense these drugs to Medicaid beneficiaries. The case, tried in 2013, is awaiting a verdict.

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. In 2013, defeated plaintiffs' preliminary injunction to extend the recall to the consumer level and successfully limited discovery to class certification-related issues. Class certification was defeated in 2018. Settlement achieved in 2019.

Patent Settlements Antitrust Cases

• 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).

In re Cipro Cases I & II

• 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 case is now expected to go to trial in the fall of 2016.

Fera Pharmaceuticals v. Akorn

• Represents Akorn, Inc., which was sued by drug manufacturer Fera in the United States 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. In 2013, the court dismissed Fera's unfair competition claim, and in 2014, dismissed Fera's claim for injunctive relief. The case is ongoing with respect to the remaining claims.

Wells v. Medicis Pharmaceuticals

• Represented Medicis in a case in which the plaintiff asserts that she was injured when injected with Medicis’ Restylane Class III device. Won motion to dismiss, on grounds of federal preemption and insufficient pleading, before the United States District Court for the District of South Carolina in 2014.

Yolanda Hudson v. Teva

• Represented Teva in a case before the United States 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. A favorable settlement was reached in 2015, and the case was subsequently dismissed.