Michael Lee KoonvCard
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For more than 35 years, Michael's practice has been focused on the defense of organizations and individuals subject to regulation by the United States Food and Drug Administration.
This work has included the representation of prescription drug and medical device manufacturers in a variety of investigations and litigation. In the context of civil litigation, Michael has served as regional and national counsel for a number of major pharmaceutical and medical device companies in product liability, class actions and other complex litigation. In the last decade and a half, Michael has expanded his practice in the area of government enforcement defense. In that role he has served as counsel for FDA-regulated companies involved in civil and criminal government investigations throughout the United States.
Michael has been recognized for his outstanding work on behalf of clients in a number of ways, including being named to successive "Super Lawyers" listings. He was named by The Legal 500 as a standout U.S. lawyer for his "skill, experience and overall client responsiveness."
JD, with distinction, University of Iowa College of Law, 1981
BA, University of Iowa, 1978
- District of Columbia Bar
- Kansas State Bar
- Missouri State Bar
In representing his clients in civil litigation, Michael has appeared before federal and state trial and appellate courts in all but three states. His work in defending his clients in government enforcement matters includes proceedings involving the U.S. Department of Justice, the Securities and Exchange Commission and the Federal Trade Commission. He has also defended clients in qui tam matters in more than a dozen locales, and in investigations and prosecutions by state Attorneys General. Noteworthy representations have included the following:
- National counsel for Sanofi US and its predecessors in its pharmaceutical pricing and marketing practices litigation and government investigations.
- National Counsel for Boston Scientific in connection with defense of qui tam matters and investigations by state Attorneys General.
- National Counsel for GlaxoSmithKline in defense of actions alleging violation of antitrust laws in the operation of consumer coupon programs.
- Counsel for Coloplast Corporation in defense of its litigation involving female pelvic mesh products.
- Counsel for a major academic medical center in defense of a qui tam matter alleging Medicaid billing irregularities.
- Counsel for Astellas Pharmaceuticals in connection with actions by a state Attorney General.
- National counsel for American Home Products in its Duract® product liability litigation. Among the achievements of this work was obtaining a reversal of a nationwide class certification order. Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315 (5th Cir. 2002)
- National counsel for Hoechst Marion Roussel in defending both private antitrust actions and litigation by the FTC involving the company's Cardizem® CD product.
- National counsel for Marion Merrell Dow in its Norpramin® product liability litigation.
- National counsel for Kraft General Foods in its defense of mass tort claims of birth defects based on in utero exposures at a Mexican factory.
- Regional counsel for the Dalkon Shield Claimants Trust in its product liability litigation.
- Regional counsel for G.D. Searle in its Copper®-7 IUD product liability litigation.
- Representation of Bristol-Myers Squibb in defense of claims by plastic surgeons for reputational and other damages based on their use of silicone gel-filled breast implants.
- Legal 500 US, recommended lawyer, Healthcare: Life Sciences, The Legal 500, 2015-2016
- Co-author, "Drugmakers liable for improper copay coupon use," Norton Rose Fulbright - Legal update, September 22, 2014
- "Industrywide Litigation by Definition," For The Defense, October 2005
- "Fleeing the System: A Product Liability Attorney's Perspective," The Metropolitan Corporate Counsel, August 2005
Michael is a frequent speaker on issues of moment to the pharmaceutical and medical device industry. Recent appearances include the following:
- Speaker, American Conference Institute's 10th Anniversary In-House Counsel Forum on Government Regulation of Prescription Drug Pricing, June 2012, New York, New York
- Speaker, 10th National Forum on Fraud and Abuse in the Sale and Marketing of Drugs, March 2010, New York, New York
- Speaker, The Foreign Corrupt Practices Act and Global Corruption, May 2009, Geneva, Switzerland
- Speaker, 6th Annual Forum on Government Regulation of Prescription Drug Pricing, March 2008, New York, New York
- Speaker, 5th Annual In House Counsel Forum on Government Regulation of Prescription Drug Pricing, March 2007, New York, New York
Michael is a member of the American Bar Association, the Defense Research Institute, The Missouri Bar, the Missouri Organization of Defense Lawyers, and the Kansas City Metropolitan Bar Association. He has been active in the DRI's White Collar, Drug and Device and Trial Techniques Committees.