D. Kyle Sampson

With Monitor appointed by U.S. Attorney's Office for the District of New Jersey under Deferred Prosecution Agreement ("DPA"), oversaw orthopedic device manufacturer's compliance with federal Anti-Kickback Statute and other federal healthcare laws and its implementation of comprehensive compliance program.
Represented manufacturer of medical convenience kits and other medical devices in import dispute with the FDA related to the Agency's implementation of its PREDICT import screening system.
Drafted and submitted to the U.S. Patent and Trademark Office an Application for Extension of Patent Term ("PTE") for radiopharmaceutical product on behalf of medical diagnostics manufacturer.
Assisted pharmaceutical and medical device companies in developing and implementing comprehensive regulatory and healthcare fraud and abuse compliance programs involving federal healthcare program reimbursement and pricing, off-label promotion, anti-kickback violations and false claims actions.
Advised pharmaceutical manufacturer on compliance with state marketing disclosure laws, including developing in-house system to identify, aggregate, and disclose firm's payments to healthcare practitioners in the form of gifts, grants, honoraria, food, consulting fees and travel.
Represented manufacturer of consumer products in negotiations with FDA over recall of manufacturer's over-the-counter ("OTC") drug product, including proper classification of recall, assessment of health hazard, and development and implementation of recall strategy.
Represented foreign cosmetic manufacturer in responding to FDA's detention of imports and placement of firm on Import Alert and successfully negotiated firm's removal from Detention Without Physical Examination ("DWPE").
Helped pharmaceutical and medical device company respond to widespread counterfeiting of company products and unlawful importation by Internet pharmacies and others in violation of the Federal Food, Drug, and Cosmetic Act and Lanham Act.
Provided strategic advice and counsel to multinational pharmaceutical company regarding compliance with Prescription Drug Marketing Act and related FDA regulations and state drug distribution and licensing laws, including pedigree laws.
Advised third-party logistics provider ("3PL") on compliance with federal and state drug distribution laws and regulations.
Represented multinational generic drug manufacturer in responding to FDA inspectional findings related to current good manufacturing practices ("cGMPs") and to Warning Letter raising cGMP and other issues.
Represented multinational generic drug manufacturer in dispute with FDA and competitors over company's "first applicant" status and its maintenance of marketing exclusivity under the Drug Price Competition and Patent Term Restoration Act ("Hatch-Waxman").
Provided advice to manufacturer of oral healthcare drugs and cosmetics regarding compliance with labeling regulations, monographs, and tentative final monographs.
Advised dietary supplement manufacturer on labeling and advertising for dietary supplements, including health claims, nutrient content claims, nutrition labeling, and substantiation issues.
Represented maker of little cigars in declaratory judgment action against the FDA regarding the Agency's interpretation and application of the Family Smoking Prevention and Tobacco Control Act.
Advised medical diagnostics company in connection with investigation by FDA's Division of Drug Marketing, Advertising, and Communications ("DDMAC") and related trade complaint submitted to DDMAC.
Provided advice to two Attorneys General on legal and policy issues, coordinated Justice Department positions in criminal prosecutions and civil litigation, and formulated and implemented policy initiatives and legislative proposals.
As Special Assistant US Attorney, conducted trial and appellate litigation, including arguing three cases in the US Courts of Appeals for the Fourth and Ninth Circuits.

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