Federal Court Orders Manufacturer, President To Recall & Stop Making & Distributing Defective Drugs |

Federal Court Orders Manufacturer, President To Recall & Stop Making & Distributing Defective Drugs

Massachusetts based drug company Pharmasol Corporation and its president, Marc L. Badia are enjoined from manufacturing and distributing adulterated drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA) and must take other corrective actions as part of a consent decree entered December 13, 2023. resolving a lawsuit filed by the United States on November 17, 2023.

The decree resolves a lawsuit brought by he United States that alleged that Pharmasol Corporation and Badia violated the FDCA at the company’s facility in South Easton, Massachusetts, by manufacturing and distributing adulterated drugs. Pharmasol manufactured and processed prescription and over-the-counter drugs, including Lexette, which is used to treat itching, redness and swelling of skin, and Dexamethasone, which is used to relieve arthritis inflammation. The United States alleged that the company violated the FDCA by failing to notify its customers about defects in its finished products, failing to establish a complaint procedure or corrective action plan despite receiving, within a 12-month period, 533 customer complaints relating to defects in its drug products, and failing to adequately clean and maintain its equipment. According to the complaint, the Food and Drug Administration (FDA) inspected Pharmasol in 2018, 2021 and 2022, and issued the company several warnings, including a warning letter in 2019, regarding its alleged violations. The United States alleged that many of the violations FDA identified in 2022 were repeat violations identified in earlier inspections.

The current good manufacturing practice regulations for drugs mandate that manufacturers control the processes and procedures by which their drugs are manufactured, processed, packed and held, to ensure that the drugs have the identity, strength, quality, purity and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law.

Under an agreement reached with the United States, Pharmasol Corporation and Badia agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that they stop manufacturing, processing, labeling, holding or distributing adulterated drugs. Further, the company must recall all adulterated prescription drugs that the company manufactured or distributed on or after February 10, 2022.

Justice Department and FDA leaders reiterated the Federal government commitment to enforcing drug quality and safety requirements in their press release on the entry of the injunction.

“Drug manufacturers have a responsibility to comply with requirements designed to ensure drug quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work closely with the FDA and take action against manufacturers who fail to meet this responsibility.”

“When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk. In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Director Jill Furman of the in FDA’s Center for Drug Evaluation and Research’s Office of Compliance. “The FDA plays an important role in protecting consumers, and we will continue to work with our federal partners to pursue and bring into compliance those who do not prioritize the health and safety of the American public.”

For More Information

We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

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About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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This entry was posted on Friday, December 15th, 2023 at 8:31 am and is filed under Health Care. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.