Overview

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.

Jay has also successfully challenged several FDA decisions under the Hatch-Waxman Act in the D.C. District Court and D.C. Circuit Court of Appeals. These cases generated hundreds of millions of dollars in “first filer” exclusivity revenues for his clients:

  • Teva Pharmaceuticals USA, Inc. v. Sebelius

  • Apotex, Inc. v. Food and Drug Administration

  • Ranbaxy Labs & Teva Pharmaceuticals USA, Inc. v. Leavitt

  • Biovail Corp. v. FDA

  • 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.

More

Thought Leadership

Publications

Brett Kavanaugh Is a Mensch,” National Review, August 29, 2018

“A North Korea Strategy for the Next U.S. President,” Wall Street Journal, September 29, 2016

“Shifting Daylight — Review of ‘Doomed to Succeed: The U.S.-Israel Relationship from Truman to Obama,’” Jewish Review of Books, Winter 2016

“A Symposium — The Jewish Future,” Commentary, November 2015

“The Dangers of Inaction in North Korea,” The Wall Street Journal, October 14, 2015

The Rise of Social Orthodoxy: A Personal Account,” Commentary, April 2014

"Director Independence: Interplay Between Delaware Law and Exchange Rules," The Harvard Law School Forum on Corporate Governance and Financial Regulation, October 7, 2013

"U.S. Response to North Korea is Dangerously Naive," The Washington Post, April 13, 2013

"Drones Are No Substitute for Detention," Financial Times, March 4, 2013

"Symposium - What Is the Future of Conservatism in the Wake of the 2012 Election?" Commentary, January 2013

"Escaping from the North Korean Stalemate," Commentary, December 2012

"Fate of Financial Crisis Litigation Hangs on Knotty Legal Question," New York Law Journal, July 19, 2012

"A Question Of Belonging," The Wall Street Journal, March 22, 2012

"Court Paints with Broad Brush, Upends U.S. Stem Cell Policy," The Hill, September 15, 2010

"Obama Embraces the 'Pre-emption' Doctrine," The Wall Street Journal, September 14, 2010

"Bookshelf: Judaism: A Way of Being, by David Gelernter, The Genesis of a People," The Wall Street Journal, March 29, 2010

"Obama vs. the Regulators," The Washington Post, August 6, 2009

"AIDS and the President - An Inside Account," Commentary, January 2009

" Let's Confront North Korea on Human Rights," The Wall Street Journal, December 23, 2008

"Why North Koreans Need Us," The New York Sun, May 5, 2008

"Truth in Advertising," The Wall Street Journal, January 25, 2008

"Stem Cells and the President - An Inside Account," Commentary, January 2008

"Science Obviates Politics," The New York Sun, January 11, 2007

"For A Few Dollars More," The Wall Street Journal, January 10, 2007

"Homes Away from Home," The Wall Street Journal, March 17, 2005

"The Election and the Jewish Vote," Commentary, February 2005

"It's Time to Lengthen Strides in Tort Reform," Investor's Business Daily, August 31, 2004

"Houses of Worship - Singled Out," The Wall Street Journal, July 30, 2004

"A Spectrum of Abuse at FCC?," The Washington Times, July 25, 2004

"Telecommons Turf Tango," The Washington Times, June 24, 2004

Testimony before the Commission on Security and Cooperation in Europe (the Helsinki Commission), "Government Actions to Combat Anti-Semitism in the OSCE Region," June 16, 2004

Testimony at the OSCE Conference on Anti-Semitism, "Workshop on Promoting Tolerance: Media, i.a., Internet, NGOs and Religious Leaders," April 28, 2004

"Three Strikes for the FCC - Government Regulation Stifles the Telecom Industry," National Review, March 18, 2004

"Strike Up the Broadband," The Weekly Standard, January 26, 2004

"Bookshelf - Ugly and Venomous," The Wall Street Journal, January 22, 2004

"The 9/11 Deadline," The Wall Street Journal, December 16, 2003

"Malarkey And Stem Cells," The Washington Post, November 8, 2003

"The Facts on Stem Cells," The Washington Post, October 30, 2003

"Does the Jewish Vote Count?," Commentary, March 2001

"A Critique of the FCC's Decision to Retain Limits on National Television Station Ownership," Telecommunications & Electronic Media News, Fall 2000

"Bookshelf: The Supreme Court and Its Most Famous Justice, Law Without Values," by Albert W. Alschuler, The Wall Street Journal, December 14, 2000

"It's The Law, Stupid, How many lawyers does it take to win an election?," The Weekly Standard, November 20, 2000

"Books in Review: Jew vs. Jew: The Struggle for the Soul of American Jewry," by Samuel G. Freedman, Commentary, October 2000

"Clinton, Not the Courts, Is Condemning Elian," The Wall Street Journal, June 2, 2000

"Bookshelf: The Warren Court and American Politics, by Lucas A. Powe, Jr., If the Legislature Won't Do It, We Will," The Wall Street Journal, March 20, 2000

"A Modest Tort Proposal," The Weekly Standard, August 16, 1999

"Bookshelf: The Lord Will Gather Me In, by David Klinghoffer, Torah and Truth," The Wall Street Journal, December 15, 1998

"Supreme Court on School Choice: 50 Years of Precedents," The Wall Street Journal, November 23, 1998

"Treason of a Clerk, On the Vast, Right-Wing Conspiracy at the Supreme Court," The Weekly Standard, April 27, 1998

"The NPR Log Book, No: All Opinions Are Not Entitled To Equal Air Time," ABA Journal, June 1996

"Decade of Greed?," The Public Interest, No. 124, Summer 1996

"Books in Review: Ultimate Answers, Think A Second Time, by Dennis Prager," Commentary, Vol. 101, No. 5, May 1996

"Overcoming Posner," The Public Interest, No. 120, Summer 1995

"The Paradox of a Great Ethnic Success," The Wall Street Journal, May 10, 1995

"Managed Competition Is Unhealthy – for Baseball," The Washington Times, August 2, 1994

"Books in Review: Romancing the State, The Fatal Embrace,: Jews and The State," by Benjamin Ginsberg, Commentary, January 1994

"Books in Review:  The Baseball Business, Play Ball:  The Life and Troubled Times of Major League Baseball," by John Feinstein, Commentary, Vol. 96, No. 3, September 1993

"GOP Jujitsu Strategy," The Washington Post, June 23, 1993

"Where Dad Belongs," The Wall Street Journal, June 18, 1993

"Our Students, Still at Risk," The New York Times, May 3, 1993

"The Next Rebellion: Parents vs. The Liberals," The Washington Times, April 23, 1993

"Jewish Voters & the Democrats," Commentary, April 1993

"The Missing Linkage," The Jerusalem Report, March 14, 1991

"Law Review Errs With Affirmative-Action Plan," Manhattan Lawyer, May 23, 1989

"Affirmative Action Can Hurt Those It Is Intended to Help," The Times Union, February 7, 1989

"Shultz Had Legal Right to Bar Arafat," The Jewish Week, Inc., December 9, 1988

Press Coverage

"2015 Life Sciences MVP: Jay Lefkowitz," Law360, November 23, 2015

"2014 Practice Group of the Year: Product Liability," Law360, January 21, 2015

"Kirkland & Ellis; The 2014 Appellate Hot List," The National Law Journal, November 17, 2014

"Pro Bono Firm of 2014: Kirkland & Ellis," Law360, October 10, 2014

"2014 Life Sciences MVP: Jay Lefkowitz," Law360, December 3, 2014

"2 Firms Steal GC Hearts In Health, Pharma," Law360, March 26, 2014

"New York City Strikes Deal with Hassidic Williamsburg Businesses," The Jerusalem Post, January 27, 2014

"Hasidic Merchants Won't Have to Pay Fines for Dress-Code Signs," ABA Journal, January 22, 2014

"Williamsburg Stores Agree To Revise Modesty Signs," The Jewish Week, January 22, 2014

"City Settles with Hasidic Businesses Over Dress Codes," The New York Daily News, January 21, 2014

"Hasidic Stores Win Fight with City Human Rights Commission," The New York Post, January 21, 2014

"No Fines for Stores Displaying a Dress Code," The New York Times, January 21, 2014

"NYC Settles With Hasidic Stores Over Modesty Dress Codes," Gothamist, January 21, 2014

"2013 Practice Group of the Year: Product Liability," Law360, January 15, 2014

"2013 Life Sciences MVP: Jay Lefkowitz," Law360, December 16, 2013

"The 4 Firms In-House Counsel Fear the Most," Law360, September 9, 2013

"Eleventh Circuit Upholds Dismissal of Generic Reglan Suit," The Am Law Litigation Daily, June 26, 2013

"Lefkowitz Scores for Generics in Supreme Court Preemption Ruling," The Am Law Litigation Daily, June 24, 2013

"In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs," The New York Times, June 24, 2013

"High Court Further Limits Generic-Drug Suits," The Wall Street Journal, June 24, 2013

"High Court Overturns Landmark Generic-Drug Liability Ruling," Law360, June 24, 2013

"Frum Dress Codes V. Human Rights?," The Jewish Week, April 17, 2013

"The 100 Most Influential Lawyers in America: Jay Lefkowitz," The National Law Journal, March 25, 2013

"Court Weighs Drug Liability," The Wall Street Journal, March 20, 2013

"Justices Explore Fine Line on Generic Drug Injuries," The New York Times, March 20, 2013

"Supreme Court Weighs Future Of Generic-Drug Defect Suits," Law360, March 19, 2013

"Top Court to Hear Arguments Over Generic Drugmaker Liability," Reuters, March 18, 2013

"K&E's Lefkowitz Strikes Again for Defendants in Medicaid Fraud Case," The Am Law Litigation Daily, February 28, 2013

"Q&A with Kirkland's Jay Lefkowitz," Law360, February 27, 2013

"Eye Med Distributor's $100M Suit Barred By Deal, Akorn Says," Law360, January 28, 2013

"Appellate Group Of The Year: Kirkland & Ellis," Law360, January 10, 2013

"Litigator of the Week: Jay Lefkowitz of Kirkland & Ellis," The Am Law Litigation Daily, December 14, 2012

"Life Sciences MVP: Kirkland & Ellis' Jay Lefkowitz," Law360, December 3, 2012

"Six Kirkland Partners Named to Law360's "MVPs of the Year" List," Law360, November 30, 2012

"Generic Drugs Proving Resistant to Damage Suits," The New York Times, March 20, 2012

"Charter School Dispute had a Strategic Angle," Florida Business Review, January 13, 2012

"Pro Bono Hotlist," The National Law Journal, January 2, 2012

"Focus: The Litigation Top 50 - Wars of the World," The Lawyer, December 5, 2011

"Appellate MVP: Kirkland & Ellis' Jay Lefkowitz," Law360, November 18, 2011

"Law360 Names 2011 MVPs," Law360, November 10, 2011

"Palestinian Move Hits Obama Vote Base," Financial Times, September 21, 2011

"Supreme Court Delivers Big Win to Generic-Drug Makers," Inside Counsel, September 1, 2011

"In Trio of Big Business Cases, Justices Sharply Divide," The National Law Journal, June 24, 2011

"Court: Generic Drug Makers not Liable for Warnings," The Associated Press, June 23, 2011

"Supreme Court Sides with Generics, Rules State Law Failure-To-Warn Claims Preempted by Federal Law," The Am Law Litigation Daily, June 23, 2011

"For Generics' Lawyers, Landmark Ruling was Years in the Making," Thomson Reuters News & Insight, June 23, 2011

"Generic-Drug Makers Shielded From Lawsuits, Top Court Says," Bloomberg News, June 23, 2011

"Lefkowitz Drops Bid to Run 9/11 Fund," Metropolis, April 14, 2011

"Star Litigator Jay Lefkowitz Goes Pro Bono in California School Reform Case," Lawyers and Settlements.com, February 22, 2011

"First-of-its-Kind Lawsuit Seeks to Improve Los Angeles School," The National Law Journal, February 7, 2011

"How Policy Can Often Trump Politics in the White House," Columbia Law School, September 23, 2010

"Corp. Counsel Name Product Liability Standout Firms," Law360, September 7, 2010

"The 4 Firms In-House Counsel Fear The Most," Law360, September 3, 2010

"Litigation Department of the Year: Finalist: Not Afraid to Litigate - or Negotiate," The American Lawyer, January 1, 2010

"4 Firms Lead Pack In Legal Skills," Law360, November 16, 2009

"Kirkland Wins Appeal for Tenet in RICO Case," The Am Law Daily, September 9, 2009

"Inside the Ring: Korea Rights Report," The Washington Times, January 29, 2009

"Kosher in the White House," AISH.com, December 28, 2008

"Daddy Track; Paid Paternity Leave is Now Standard at Am Law 100 Firms," The American Lawyer, July 2008

"Supreme Court Pharma Fight," CNBC Video, February 27, 2008

"Subprime Crisis Stirring up New Wave of Litigation, Says Kirkland's Lefkowitz," Global Forensics, February 2008

"Foggy Bottom Apostate," The Wall Street Journal, January 25, 2008

"K&E Wins AmLaw's Litigation Dep't of the Year," Wall Street Journal Law Blog, January 2, 2008

"Litigation Department of the Year: Winner: Top Guns," The American Lawyer, January 2008

"Bush Envoy Argues for Accountability," Yale Daily News, October 10, 2007

"Shuttle Diplomat," Columbia College Today, September 1, 2006

"European Closing Bell," CNBC Europe, March 22, 2004

"A Hard-Nosed Litigator Becomes Bush's Policy Point Man," The Washington Post, April 30, 2002

"Blackboard Jungle," The American Lawyer, May 1, 2000

"Republican, Connected and Rising," The National Law Journal, March 11, 1996

Seminars

Aspen Ideas Festival - Panelist, “North Korea: The Threat Assessment, Seismic Shifts,” June 2018

Concordia 2016 Summit - Speaker and Panelist, “Strategic Stability: Deterring Provocations and Escalation in North Korea,” September 2016

Harvard, Princeton, and Stanford Conference - “American Conservatism in a Generous and Caring Country” - Moderator and Panelist, “American Conservatism and Faith Based America: A Productive or Troublesome Relationship,” April 2016

Catalent Pharma Solutions Event – Speaker, “Recent Legal Issues in the Pharmaceutical Industry,” December 2015

2015 Jewish Review of Books Symposium – Speaker and Panel Moderator, “The United States and Israel: The Future of a Relationship,” October 2015

United States Committee on Foreign Relations – Testified before US Congress, “Assessing the North Korea Threat and U.S. Policy: Strategic Patience or Effective Deterrence?” October 2015

Washington Legal Foundation Media Briefing – Speaker and Panel Moderator, “FEDERAL PREEMPTION: New Developments and Notable Trends for Drugs and Medical Devices,” September 2015

Columbia University’s Political Science Student’s Association and Columbia Political Union Event – Speaker and Panelist, “Columbia University Alumni Panel,” focusing on political service, December 2014

ACI Legal and Regulatory Summit on Generic Drugs – Speaker, “Operating in the Post-Bartlett Landscape in Light of New Decisions and FDA Rulemaking,” July 2014

Ramaz Upper School Event, “We The People, Understanding the Relationship Between United States Law & Religion” – Featured Speaker, “Religion in the Public Square: Walking a Very Fine Line,” January 2014

The Tikvah Fellowship’s “In the Arena” – Speaker, “A conversation with Jay Lefkowitz," December 2013

George Mason University School of Law’s Eighth Annual Judicial Symposium on Civil Justice Issues – Panelist, “Brand Name Drug Liability,” November 2013

The American Lawyer’s New Partner Forum – Panelist, “New Partners as Career Planners - Setting Targets,” November 2013

Baxter Pharmaceuticals CLE Program – Speaker, "FTC v Actavis: Litigation Implications and Impact on Patent Settlements" and "Wyeth and Beyond: Developments in Product Liability Law and Preemption," July 2013

ACI Legal and Regulatory Summit on Generic Drugs – Panelist, "How Generic Companies are Weighing the Newfound Risk of Exposure for Increased Suits Product Liability Based on Evolving Theories of Law," July 2013

Bristol-Myers Squibb CLE Double Header Program: Recent Developments in Patent Settlements & Antitrust Issues, and Product Liability Law & Preemption – Speaker, "FTC v Actavis: Litigation Implications and Impact on Patent Settlements" and "Wyeth and Beyond: Developments in Product Liability Law and Preemption," July 2013

Columbia Law's Center for Constitutional Governance Conference – Domestic Policy Panelist, "The Next Four Years: Major Issues in Constitutional Governance," April 2013

American Conference Institute – Speaker, "Asserting a Successful Preemption Defense and Managing Parallel Plaintiff Claims in a Post-Mensing World," December 2012

AJC's Learned Hand Award Dinner – Moot Court Advocate Headliner, "Civil Liberties in a Post-911 World," November 2012

PhRMA Law Section Event – Speaker, "Review of the 2011-2012 Supreme Court Term and Preview of the 2012-2013 Term," October 2012

2012 GSK Law Firm Summit – Speaker, "Preemption and the Post-Mensing World," September 2012

Hudson Institute – Speaker and Moderator, "Escape from North Korea," September 2012

DRI's Drug and Medical Device Seminar – Speaker, "Preemption: Where Has the Pendulum Swung After Mensing?" May 2012

General Pharmaceutical Association's Annual Meeting – Featured Speaker, "Drug Liability Litigation Post Mensing: Generic Drug Labels—The Same Only More Defensible," February 2012

Hertog Political Studies Program – Speaker, "Stem Cell Research and Federal Funding," July 2010

Alexander Hamilton Society Dinner – Speaker, "Perspectives on North Korea," July 2010

New York Young Republicans Club – Guest Speaker, April 2010

Republican Jewish Coalition Seminar – Speaker, "Post Election Analysis & the Future of the GOP," January 2009

Young Israel of Century City Scholar in Residence, Weekend of October 24-26, 2008

American Enterprise Institute Conference "The North Korean Problem: Toward a Diplomatic Solution in 2008?" – Keynote Speaker, "North Korean Human Rights & US National Security," January 2008

Columbia Law School Dean's Visiting Speaker Luncheon Series – Speaker, "Perspectives on the Law," February 2007

United States' Mission to the United Nations, Economic and Social Council Presentation – Speaker, "Shining a Light: Human Rights Abuses in North Korea," December 2006

Asia Society Symposium "Can Human Rights Concerns Be Addressed in a Comprehensive Northeast Asia Security Regime" – Keynote Speaker, May 2006

Columbia University's Kraft Lecture Series – Panelist, "Is Religion Political?" March 2006

American Bar Association's Annual National Conference – Presented "Preserving Exclusivity: Navigating What's at Stake Under the Hatch-Waxman Act," January 2006

American Bar Association's Aviation and Space Law Committee Conference – Panelist, "Aviation Security and Privacy and Discrimination," October 2005

Manhattan Institute's Center for Legal Policy Conference "9/11 Victim Compensation Fund: Successes, Failures, and Lessons for Tort Reform" – Opening Remarks, January 2005

UJA Young Leadership Conference "Perspectives on U.S. Policy in the Middle East" – Keynote Speaker, June 2004

Manhattan Institute's Center for a Digital Economy Conference "Avoiding a Tragedy of the Telecommons" – Panelist, "How are Regulatory Incentives Affecting Competition and Investment?" May 2004

U.S. Chamber of Commerce's Alternatives to Litigation Conference – Panelist, "Administrative Compensation Systems," April 2004

Recognition

Jay was recognized by The Best Lawyers in America for Product Liability Litigation - Defendants in 2019.

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.

Communal Activities & Distinctions

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.

Columbia Law School Board of Visitors, Board Member

Congregation Kehilath Jeshurun, Board Member

Foundation for Jewish Camp, Board Member

National Affairs, Board Member

New Citizens Project, Board Member

NYU Alexander Hamilton Center Advisory Board, Board Member

Ramaz, Board Member

The Tikvah Fund, Board Member

Credentials

Admissions & Qualifications

  • 1988New York
  • 1996District of Columbia

Court Experience

  • Supreme Court of the United States
  • United States Court of Appeals for the First Circuit
  • United States Court of Appeals for the Second Circuit
  • United States Court of Appeals for the Third Circuit
  • United States Court of Appeals for the Fourth Circuit
  • United States Court of Appeals for the Fifth Circuit
  • United States Court of Appeals for the Sixth Circuit
  • United States Court of Appeals for the Seventh Circuit
  • United States Court of Appeals for the Eighth Circuit
  • United States Court of Appeals for the Ninth Circuit
  • United States Court of Appeals for the Tenth Circuit
  • United States Court of Appeals for the Eleventh Circuit
  • United States Court of Appeals for the District of Columbia Circuit
  • United States Court of Appeals for the Federal Circuit
  • United States Tax Court
  • United States District Court for the District of Columbia
  • United States District Court for the District of Colorado
  • United States District Court for the Eastern District of New York
  • United States District Court for the Southern District of New York
  • United States District Court for the Eastern District of Michigan
  • United States District Court for the Eastern District of Wisconsin

Education

  • Columbia Law SchoolJ.D.1987
    Harlan Fiske Stone Scholar (1985–1986)
  • Columbia CollegeA.B., History1984
    James A. Beard Political Science Prize, 1984