Alan Klein

Areas of Practice

• Products Liability and Toxic Torts
• Generic Drugs, Biosimilars and Life Sciences
• Commercial Litigation

Representative Matters

• Counsel for pharmaceutical companies in China and India in their acquisition of drug manufacturing facilities in the U.S.

• Counsel for a major brand and generic drug company in establishing an acceptable, science-based allowable daily limit for nitrosamine in certain of its prescription drug products.

• Lead counsel for a China-based pharmaceutical manufacturer in the defense of class actions, personal injury cases and regulatory compliance issues emanating from a 22-country recall of a major cardiovascular medication.

• Defended major brand and generic pharmaceutical manufacturers in failure to warn personal injury litigation in state and federal courts, in both individual and consolidated proceedings.

• Represented a major China-based generic drug manufacturer and its U.S. affiliates in successfully opposing significant new U.S. tariffs upon medicines and related products.

• Regional counsel and MDL liaison counsel for fenfluramine manufacturer in diet drug (fen-phen) individual and consolidated cases.

• Defended a former manufacturer of asbestos products in state and federal MDL proceedings as its senior national trial counsel.

• Regional counsel for a major manufacturer of implantable Class III medical devices in personal injury and death cases in state and federal courts.

• Counseled domestic and European product manufacturers on labeling, packaging and warnings issues.

• Defended a major pharmaceutical manufacturer and its subsidiaries in drug pricing litigation.

Admissions

• Pennsylvania
• Supreme Court of Pennsylvania
• Supreme Court of the United States
• U.S. District Court for the Eastern District of Pennsylvania
• U.S. Court of Appeals for the Third Circuit
• U.S. Court of Appeals for the Sixth Circuit

Education

• Vanderbilt University Law School, J.D.
• Drexel Institute of Technology, B.S.

Experience

• Duane Morris LLP, Philadelphia, Pennsylvania
  - Partner, 2003-present
  - Past Coordinating Partner, Current Member, Products Liability and Toxic Torts Practice Group
  - Member, Generic Drugs, Biosimilars and Life Sciences Practice Groups
  - Member, China Practice Group
  - Member, E-Discovery Practice Group

• Hangley Aronchick Segal & Pudlin, Philadelphia, Pennsylvania
  - Shareholder, 1995-2003
• Cohen, Shapiro, Polisher, Shiekman and Cohen, Philadelphia, Pennsylvania
  - Partner, 1989-1995
• Drinker, Biddle & Reath, Philadelphia, Pennsylvania
  - Partner, 1977-1988
  - Associate, 1969-1971; 1972-1976
• Office of the Philadelphia District Attorney
  - Assistant District Attorney, Major Trials Division, 1971-1972
• United States Court of Appeals for the Sixth Circuit
  - Judicial Clerk, Honorable George Edwards, 1968-1969

Professional Activities

• Defense Research Institute
  - Drug and Medical Device Committee
  - Lawyers' Professionalism and Ethics Committee
• American Bar Association
  - Section of Litigation
• Pennsylvania Bar Association
• Philadelphia Bar Association
  - Former Member, Fee Disputes Committee
  - Former Member, Civil Rights Committee
  - Former Member, Ethics Committee
• American Trial Lawyers Association
• Pennsylvania Trial Lawyers Association
• Philadelphia Trial Lawyers Association
• Philadelphia Court of Common Pleas
  - Settlement Master and Arbitrator
• United States District Court for the Eastern District of Pennsylvania
  - Mediator and Arbitrator

• Hearing Committee Member, Disciplinary Board of the Supreme Court of Pennsylvania

Honors and Awards

• AV Preeminent® Peer Review Rated by Martindale-Hubbell®

Board Memberships

• Public Interest Law Center of Philadelphia
  - Former Board Member
  - Member, Advisory Board, 1990-2000
• Oak Lane Day School, Blue Bell, Pennsylvania
  - Board President, 1997-2005

• Multicultural Academy Charter School, Philadelphia, Pennsylvania
  - Member, Board of Directors, 2002-2017
  - President, Board of Directors, 2011-2017

Civic and Charitable Activities

• Philadelphia Diversity Law Group, 2004-2018
• Leadership Council on Legal Diversity 2015-2019, mentor/mock interviewer
• Community Legal Services, 1969-1989
• Volunteer Lawyers for the Arts, 1969-1985
• Philadelphia Reads/Achieve Now
  - Reading Coach of Philadelphia elementary school students, 1998-present
• Duane Morris Pro Bono Program, 2013-present

• University of Pennsylvania Quaker Classic Mock Trial Competition
  - Presiding Judge

• Drexel/Villanova Law Schools, National Mock Trial Competition
  - Presiding Judge
• Drexel University and U.C.L.A. Law Schools, “Trial by Combat” Mock Trial Competition, Presiding Judge

Selected Publications

• Co-author, "Updated Federal Rules Can Improve Product Liability MDLs," Law360, June 11, 2024
• Author, "FDA Seeks Input from Life Sciences Industry on Controlling Nitrosamine Impurities," Duane Morris Alert, June 13, 2023
• Co-author, "Pa. Supreme Court Can Finally Set Proper Venue Standards," Law360, April 10, 2023
• Co-author, "On the Horizon: The Continued Viability of Restatement (Second)'s Strict Liability Jurisprudence in Pennsylvania," Mealey's Personal Injury Report, July 2022
• Quoted, "$8B Philly Risperdal Verdict Ripe For Reduction, Experts Say," Law 360, October 9, 2019

• Quoted, "Product Liability Cases To Watch: Midyear Review," Law360, July 3, 2019

• Co-author, "Supreme Court Rules That Judges Must Decide Preemption of Failure-to-Warn Claims," Duane Morris Alert, May 24, 2019

• Quoted, "J&J Win Shows Potential Limit To Mesh Injury Claims," Law360, April 19, 2019

• Quoted, "Punitives Promise Fiercer Fight In Philly Risperdal Trial," Law360, January 28, 2019

• Co-author, "FDA Withdraws Proposed Generic Drug Labeling Rule," Duane Morris Alert, December 17, 2018

• Co-author, "Should Juries Try To Predict FDA Drug Labeling Decisions?" Law360, November 13, 2018

• Quoted, "Accutane Ruling Raises Bar For Garden State Labeling Claims," Law360, October 5, 2018

• Quoted, "Merck Fosamax Appeal Faces Uncertain Odds In High Court," Law360, June 29, 2018

• Quoted, "Stakes High As GSK Takes Generics Liability Row To 7th Circ." Law360, May 25, 2018

• Co-author, "Getting Your Expert's Testimony Through Daubert's Goalposts," Defense Research Institute, Medlaw Update, Vol. 23, Issue 1, March 2018

• Quoted, "Mass. Court Ruling Eases Way For Brand Drug Label Claims," Law360, March 19, 2018

• Co-author, "Spoliation of Electronic Information Under Amended Federal Rule 37(e)," The Legal Intelligencer, Special e-Discovery Issue, February 7, 2017
• Editor and contributor of a monthly featured article in Generics Web INNsight Internet newsletter, 2010-2015
• Co-author, "A New Paradigm For Prescription Drug Labeling?," Law360, November 30, 2015
• Author, "Current Issues for Generics in the U.S. Marketplace," Generics Web INNSight, Sydney, Australia, November 2015
• Author, "The Emerging Biosimilars Marketplace in the U.S.: One Big Step Forward, with Others to Follow in a Complex Playing Field," Generics Web INNSight, Sydney, Australia, May 2015
• Co-author, "Legal Issues Affecting Generic Drugs," Today's General Counsel," April/May 2015
• Author, "FDA's New Guidance on Plant Inspections Provides Industry with a Roadmap to Avoid Agency Sanctions," Generics Web INNSight, Sydney, Australia, December 2014
• Co-author, "Biosimilars in the U.S.: Current Status and Challenges Ahead," Generics Web INNSight, Sydney, Australia, August 2014
• Co-author, "Generic Drugs At 30: Fulfilling The Promise And Path Ahead," Law360, July 24, 2014
• Co-author, "A New Paradigm for Challenges for Cause in Pennsylvania," Pennsylvania Law360, March 27, 2014
• Author, "Generic Pharmaceutical Meeting Airs Key Challenges Facing the Industry," Generics Web INNSight, Sydney, Australia, March 2014
• Co-author, "There May Be A Paradigm Shift In Generic Drug Labeling," published online in Law360, November 12, 2013, and republished in Generics Web INNSight, Sydney, Australia, November 2013
• Co-author, "FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do," Duane Morris Alert, November 12, 2013
• Author, "U.S. Biosimilars Development Continues Notwithstanding Legislative and Regulatory Hurdles," Generics Web INNSight, Sydney, Australia, September 2013
• Author, "U.S. Supreme Court Finds Patent Settlements Subject to Antitrust Scrutiny," Generics Web INNSight, Sydney, Australia, June 2013
• Author, "U.S. Supreme Court to Decide Key Issues in Two Pharma Cases," Generics Web INNSight, Sydney, Australia, December 2012
• Author, "The Validity of Branded Drug Patent Litigation Settlement Agreements Are Primed for U.S. Supreme Court Review," Generics Web INNSight, Sydney, Australia, July 2012
• Author, "Generics Demand Product Samples from Brand Companies for Bioequivalency Tests; Congress Falls Short in Providing a Remedy," Generics Web INNSight, Sydney, Australia, June 2012
• Co-author, "Class Actions Against Pharmaceutical Companies over Off-Label Marketing Claims Have No Leg to Stand on, Third Circuit Rules," Duane Morris Alert, May 24, 2012; republished in Product Liability Law360, June 8, 2012, as "Connecting Off-Label Marketing to Use: Not Quite A to B"
• Author, "Patent Settlement Agreements Remain a Focus in the U.S. Congress," Generics Web INNsight, Sydney, Australia, November 2011
• Co-author, "Supreme Court Orders Ninth Circuit to Revisit Preemption Ruling Against Generic OTC Ibuprofen Manufacturer," Duane Morris Alert, November 2, 2011; republished by Linex Systems, November 3, 2011; republished in Product Liability Law360, November 8, 2011
• Co-author, "Big Win for Drug Companies Under the New Jersey Product Liability Act," Duane Morris Alert, October 4, 2011; republished by Linex Systems, October 2011; republished in Product Liability Law360, November 15, 2011
• Co-author, "Mensing and Its Impact on State-Law-Based Claims Against Generic Drug Manufacturers," Update Magazine, The Food and Drug Law Institute (FDLI), September 2011
• Author, "Big Win for Generics in the U.S. Supreme Court," Generics Web INNsight, Sydney, Australia, July 2011
• Co-author, "Pennsylvania District Court Dismisses Class Action Against Pharmaceutical Giant Johnson & Johnson," Duane Morris Alert, July 26, 2011; republished in Product Liability Law360, September 28, 2011
• Co-author, "New Pennsylvania Law Limits Joint and Several Liability," Duane Morris Alert, June 29, 2011
• Co-author, "U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers," Duane Morris Alert, June 23, 2011
• Co-author, "In Smith v. Bayer Corp., Supreme Court Breathes New Life into Repetitive State Court Class Actions," Duane Morris Alert, June 23, 2011
• Author, "America's Top Court Rules in Adverse Drug Event Disclosures and Will Next Decide Generic Drug Preemption," Generics Web INNsight, Sydney, Australia, April 2011
• Co-author, "U.S. FDA Proposes User Fees for Applications for New Generic Drug Applications_3984.html," Generics Web INNsight, Sydney, Australia, February 2011
• Co-author, "Federal Government Provides Its Position Regarding Generic Preemption to the Supreme Court," New Jersey State Bar Association's Products Liability and Toxic Tort Law Section Newsletter, Volume 12, Number 2, January 2011
• Co-author, "U.S. Supreme Court to Decide an Important Case for Generics in the U. S. Market," Generics Web INNsight, Sydney, Australia, January 2011
• Co-author, Expert Analysis: "The Government Stance On Generic Preemption," published online in Appellate Law360 and Health Law360 by Portfolio Media, Inc., November 5, 2010
• Co-author, "Acting Solicitor General Gives Government's Position on Generic-Pharma Preemption to U.S. Supreme Court," Duane Morris Alert, November 4, 2010
• Co-author, "Brand and Generic Drugs on Trial Together in U.S. Courts," Generics Web INNsight, Sydney, Australia, October 2010
• Co-author, "Is 'Private' Data on Social Networks Discoverable?" The National Law Journal, August 23, 2010; reprinted in Law Technology News, August 25, 2010; reprinted in The Legal Intelligencer, August 26, 2010
• Co-author, "In Pennsylvania Products Liability Decisions, Pharmaceutical Manufacturers May Lose a Little, but Gain a Lot," Duane Morris Alert, August 10, 2010; reprinted in Health Lawyers Weekly by American Health Lawyers Association, August 27, 2010; Product Liability Law360 and HealthLaw360 by Portfolio Media, Inc., September 1, 2010
• Co-author, "Federal Government to Provide Its Position on Generic Preemption to the U.S. Supreme Court," Duane Morris Alert, August 3, 2010
• Co-author, "False Marking Claims in the U.S: A Different Kind of Patent Litigation," Generics Web INNsight, March 2010
• Interview, "Patience and Preparation are Key to U.S. Preemption," article and interview by Aidan Fry, Generics Bulletin, February 2010
• Co-author, "Federal Preemption: A Complete Defense to American Products Liability Suits," Generics Web INNsight, December 2009
• Co-author, "Viability of the Federal Preemption Defense Post-Levine," Drug and Medical Device, For The Defense, Defense Research Institute, July 2009
• Co-author, "Can Failure-to-Warn Claims Against Generic Drug Manufacturers Be Preempted?" Law Journal Newsletters, June 2009
• Co-author, "Wyeth v. Levine: An Attorney's Perspective," PharmExec.com, March 11, 2009
• Co-author, "Wyeth v. Levine: U.S. Supreme Court Finds That State-Law Failure-to-Warn Claims Are Not Federally Preempted," Duane Morris Alert, March 6, 2009
• Co-author, "Courts Are Divided on Whether Failure-to-Warn Claims Against Generic Drug Manufacturers Can Be Preempted," Generics Web Innsight, March 2009
• Co-author, "Courts Are Divided on Whether Failure-to-Warn Claims Against Generic Drug Manufacturers Can Be Preempted," Strictly Speaking, the newsletter of the DRI Product Liability Committee, Volume 3, Issue 2, February 25, 2009
• Co-author, "Federal Preemption of Failure to Warn Claims Against Generic Drug Companies," Duane Morris Alert, October 7, 2008
• Guest Column, "Key Pharma Preemption Ruling in Third Circuit," published online in Product Liability Law 360 and Health Law 360 by Portfolio Media, Inc., April 18, 2008
• Co-author, "Drug Ads After a Decade: Are Direct-to-Consumer Messages Still a Good Idea?" a physician peer-reviewed article published online by the American Council on Science and Health, June 2007
• Co-author, "What Are Your e-Discovery Obligations Under Revisions to the Federal Rules," Mealey's Publications, March 2006
• Co-author, "The Shifting Landscape of e-Discovery," e-Discovery Law & Strategy, published in July 2006
• "The Impact of Direct To Consumer Pharmaceutical Advertising on the Learned Intermediary Defense In Pennsylvania, and Its Influence on the Traditional Patient-Physician Relationship," published October 2005 in the Philadelphia Legal Intelligencer special litigation supplement
• Co-author, "Toxic Tort Litigation: Theories of Liability and Damages," Environmental Litigation, Vol. 2, Chapter 6, American Bar Association, 1998 and 2000

Selected Speaking Engagements

• Presenter, 2019 China Attorney Tour Study Group, "Case Study: Working with Chinese Companies in the U.S.," New York City, October 4, 2019

• Speaker, "Innovation Across Borders: Strategies for U.S. and Chinese Companies in the Health Sciences Industry," Duane Morris LLP and Chinese Biopharmaceutical Association (USA), January 8, 2019

• Moderator, "Upcoming Regulatory Changes and Their Impact on Pharmaceutical Portfolio Management," Pharmaceutical Portfolio Management Optimization Conference, Philadelphia, July 23-24, 2018

• Moderator and Presenter, Duane Morris' Generic Drugs and Biosimilars Summit, Princeton, New Jersey, 2011, 2012, 2013, 2014, 2015, 2016 and 2017

• Co-Presenter, "Spoliation Under Amended Federal Rule 37(e): Takeaways for Litigators," Duane Morris LLP, Continuing Legal Education, October 13, 2017
• Moderator and Presenter, "Ethical Obligations Relating to Metadata," 2017 South Central Information Governance Retreat, San Antonio, TX, May 22, 2017
• Panelist, "Data Management, Preservation and Production in the 21st Century," Ingenious E-Discovery Conference, Wequasset Resort, Massachusetts, September 25-26, 2016
• Seminar Presentation, "Preparing for Pharmacovigilance, Labeling and Potential Federal Preemption Issues," America Conference Institute's "Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process," Boston, Massachusetts, November 2012
• Panelist, "The New Pennsylvania Joint and Several Liability Act," Pennsylvania Bar Institute Conference, Mechanicsburg, Pennsylvania, October 2011
• Seminar Presentation, "Data Governance: Managing Information for Compliance," IQPC's eDiscovery for Pharma Conference, Philadelphia, October 2011
• Seminar Presentation, "Defending Generic Pharmaceuticals," American Conference Institute's 14th Annual Drug and Medical Device Litigation Conference, New York, December 2009
• Seminar Presentation, "Establishing Lack of Causation," American Conference Institute's Annual Conference on "Preventing and Defending Chemical Products Liability Litigation," Chicago, November 2007
• Panelist, "Subclassing, Bifurcation and Avoiding Individualized Issues Preventing Certification," American Bar Association's "The Future of Class Action Litigation in America," Washington, D.C., October 2007
• Seminar Presentation, "Hormone Replacement Therapy Litigation Update and Defenses," Mealey's Drug and Medical Device Litigation Conference, La Costa, California, May 2007
• Panelist, "Confronting the Science Issues in Benzene, Welding Rod and Toxic Tort Cases," American Conference Institute's "Preventing and Defending Chemical Products Liability Litigation" Conference, Chicago, Illinois, October 2006
• Seminar Presentation, "Privacy Laws and Their Impact on Colleges and Universities," University Risk Management and Insurance Association's "Risk, Recovery and Rewards" Conference, San Antonio, Texas, September 2006
• Panelist, "Unconventional Wisdom on Products Liability Defense," Insurance Society of Philadelphia CLE Seminar, August 11, 2006
• Seminar presentation, Mealey's Lexis/Nexis Conference "Defense Strategies in Pharmaceutical Litigation," on "New Age Handling of Mass Torts in the Electronic Era," Laguna Niguel, California, January 2006
• National webcast on "Coast to Coast" about the Vioxx trials, November 2005