Mark C. Levy

Overview

Mark Levy is a litigator and trial attorney who has spent most of his career defending manufacturers of consumer products in heavily regulated industries in civil claims brought by private plaintiffs as well as both civil and criminal charges initiated by federal, state, and local law enforcement agencies. Mark regularly handles matters involving threatened or actual enforcement actions undertaken by agencies, commissions, and departments of the United States such as the Food and Drug Administration (“FDA”), Federal Trade Commission (“FTC”), Environmental Protection Agency (“EPA”), Department of Defense (“DOD”), and Consumer Product Safety Commission (“CPSC”) as well as matters initiated by the various state enforcement agencies including state attorneys general.

As an outgrowth of his experience with these government agencies, Mark regularly provides risk-management counseling and regulatory advice to businesses that manufacture and sell products for consumer use. This includes developing, expanding, and implementing corporate compliance programs and assessing the risks of litigation in complex, multi-party litigation.

Mark has also conducted internal investigations, from routine to serious, for dozens of companies in the pharmaceutical, medical device, oil and gas, sports apparel, services, retail goods and manufacturing industries.

After graduating law school, Mark served as law clerk to the Honorable James T. Giles, United States District Court for the Eastern District of Pennsylvania.

Representative Matters

• Regulatory Enforcement | FDA and state agencies: Represented manufacturers and distributors in enforcement actions arising from alleged failure to comply with regulatory requirements including those related to clinical trials, regulatory submissions, registration, marketing and labeling, and manufacturing practices.
• Regulatory Enforcement | FTC and state agencies: Represented consumer goods manufacturers in responding to federal and state enforcers related to alleged false or misleading advertising/labeling claims including “green claims” and “health claims.”
• Regulatory Enforcement | CPSC: Represented consumer goods manufacturers, box store retailers and on-air retailers in reporting and responding to the CPSC.
• Regulatory Enforcement | Environmental: Represented former railroad in one of the largest state investigations into alleged violations of environmental laws; represented contractors in state and federal investigations arising from construction of Revolution and Mariner East Pipelines; represented glass manufacturer in nationwide state and EPA matters.
• Regulatory Enforcement/Proposition 65: Represented manufacturers and sellers of products in allegations by private enforcers under California’s Proposition 65.
• Investigations | Pharmaceutical/Medical Products: Internal investigations for medical device pharmaceutical, nutraceutical and cosmetic manufacturers on alleged illegal marketing practices including off-label use.
• Investigations | Government Contracts: Conducted investigation for waste handling company involving minority contracting issues; Conducted investigation involving billing and mishandling of classified information under various DOD contracts.
• Investigations | Environmental: Conducted investigations for hospitality industry company and transportation company arising from waste disposal issues.
• Compliance | Compliance Programs: Represented medical device manufacturers in developing compliance programs to address recent areas of government enforcement; assisted international aid/health program in revisions to its global compliance program (American Red Cross).
• Compliance | Recalls: Represented medical device, cosmetic, food, specialty oil producer and retailers in evaluating and responding to voluntary and mandatory recalls.
• Trial | Government Contracting: Represented largest public service provider in United Kingdom in arbitration over the provision of services related to the reconstruction of Iraq.
• Trial | Pharmaceutical/Medical Products: Represented pharmaceutical and medical device manufacturers in defense of mass tort claims, class action suits and product liability actions as well as commercial litigation arising from contractual disputes.
• Trial | Products Liability/Environmental: Represented oil and gas producers in products liability cases as well as individual executive of oil and gas company charged under the Park Doctrine.