Kristin D. Kiehn is a counsel in the firm’s Litigation Department, based in the New York office. Her practice focuses on healthcare-related enforcement, litigation and compliance, including in the areas of white collar and regulatory defense, government and internal investigations, general commercial litigation, and compliance and regulatory advice.
She has broad experience representing pharmaceutical and medical device companies, hospitals, pharmacies, and individuals in a variety of healthcare-related matters, including government investigations relating to sales and marketing practices, manufacturing and distribution issues, clinical trials, healthcare program reporting, and individual Park liability; False Claims Act litigation and consumer and third-party payor class actions alleging deceptive practices; and international disputes relating to drug development, manufacturing, and safety.
Her experience includes healthcare program exclusion matters and Corporate Integrity Agreement negotiation and implementation. She regularly advises clients – including major pharmaceutical and device companies – on corporate compliance standards and best practices in the healthcare industry.
Ms. Kiehn is the co-author of numerous articles, including “A Walk in the Park Shouldn’t Lead to Jail Time: Recent Decisions Explain Why Incarceration is Never Appropriate for ‘Responsible Corporate Officers’ Who Lack Criminal Intent,” Bloomberg BNA’s Pharmaceutical Law & Industry Report (October, 2016); “It’s A Hard-Knock Life: The Rough-And-Tumble Fight Over Orphan Drug Pricing,” Bloomberg BNA’s Pharmaceutical Law & Industry Report (November, 2014); “DOJ Proposal Shows Focus on Individuals in Corporate Crime,” Law360 (September, 2014); “Compliance Corner: The Clock Is Ticking: 60-Day Rule and FCA Liability for Overpayments,” Bloomberg BNA’s Health Care Fraud Report (September, 2014); “Vicarious Criminal Liability in the Executive Suite for Problems on the Manufacturing Floor,” Bloomberg BNA’s Pharmaceutical Law & Industry Report(April, 2014); “GSK’s $3 Billion Settlement Reflects Continued Expansion In Scope Of Pharma Plea Agreements,” Rx Compliance Report (August, 2012) and “An Unprecedented Settlement For FDCA Violation,” Law360 (May, 2012).
Ms. Kiehn joined the firm in 2001, then rejoined the firm in 2003. From 2000 to 2001, she clerked for the Hon. John S. Martin, Jr., Southern District of New York. From 2002 to 2003, she clerked for the Hon. Chester J. Straub, U.S. Court of Appeals for the Second Circuit.
Ms. Kiehn received a J.D. cum laude from Fordham University School of Law in 2000. She was writing & research editor of the Fordham Law Review. Ms. Kiehn received an M.A. from New York University in 1996, and a B.A. from Smith College in 1992.
Prior to coming to the firm, Ms. Kiehn worked in the publishing field.
- A major pharmaceutical company in defeating nine motions to certify classes of consumers and third-party payors and obtaining dismissal of all remaining claims in MDL actions alleging RICO and consumer fraud violations based on alleged fraudulent promotion of antidepressants.
- A major pharmaceutical company in obtaining dismissal of qui tam action under the False Claims Act relating to marketing of prescription drug due to unethical behavior by relator’s counsel. In its dismissal, the district court, in addressing a novel legal issue, admonished counsel for obtaining medical information from physicians by engaging in “an elaborate scheme of deceptive conduct.”
- A major pharmaceutical company in obtaining dismissal of state law claims in First Circuit decision marking the first time since Wyeth v. Levine that a federal appellate court dismissed claims against a brand-name drug manufacturer pursuant to the “impossibility” preemption doctrine.
- A major pharmaceutical company in civil and criminal investigations led by DOJ and the U.S. Attorney’s Office (D. of Mass.), and related qui tam litigation, regarding marketing, promotion, and sale of three drugs.
- A major pharmaceutical company in investigation led by DOJ and the U.S. Attorney’s Office (E.D. of Wisconsin) relating to speaker programs involving three prescription drugs.
- A major pharmaceutical company in investigation led by DOJ and the U.S. Attorney’s Office (D. Mass.) relating to marketing of cardiovascular drugs.
- A national pharmacy chain in investigation led by the U.S. Attorney’s Office (SDNY) relating to billing practices.
- A major pharmaceutical company in obtaining dismissal of qui tam action under the False Claims Act alleging kickbacks paid to physicians in connection with marketing of several drugs.
- A major U.S. hospital network in defending multiple class action complaints filed in several states alleging wrongful billing practices.
- A multinational healthcare company executive in investigations led by DOJ, the U.S. Attorney’s Office (E.D. Pa.), and U.S. Congress arising from consumer product recalls.
A major pharmaceutical company in negotiating, implementing, and facilitating ongoing compliance with Corporate Integrity Agreement.
- A multinational pharmaceutical company’s Board of Directors in conducting several Compliance Program effectiveness reviews to support Corporate Integrity Agreement obligations.
- The Board of Directors of a leading medical device manufacturer in conducting several Compliance Program effectiveness reviews to support obligations under a plea agreement.
- The CEO and Chief Compliance Officer of a global pharmaceutical company in meeting obligations under a Corporate Integrity Agreement.
- A pharmaceutical company in providing compliance advice relating to marketing of drugs for rare diseases.
- Fordham University School of Law, 2000, J.D.
- New York University, 1996, M.A.
- Smith College, 1992, B.A.
- New York
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