Several medical device manufacturer executives were given long terms for rogue clinical trials.
Four executives in total were sentenced – they each had pleaded guilty to one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce.
Bohner is the last of four executives to be sentenced in the case….On November 21, 2011, Bohner’s former colleagues Thomas Higgins and Michael Huggins received sentences of nine months in prison while former executive John Walsh received a sentence of five months. The defendants, including Bohner, approved rogue clinical trials using the bone void fillers Norian SRS and Norian XR to treat vertebral compression fractures of the spine (“VCFs”) in elderly patients, without the permission of the FDA. Despite known and serious safety concerns that the products could cause fatal blood clots, and despite a warning on the label of XR that the product was not intended for treatment of VCFs, Synthes did not stop the illegal testing until after a third patient had died on the operating table during the space of one year. During a follow-up FDA inspection in May and June 2004, three of the executives – including Bohner – also lied to the FDA investigator.
The district judge apparently told one defendant: "you failed."
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Under Section 301(a) of the FDCA, the “introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded” violates the FDCA. Under Section 301(k) of the FDCA, misbranding also includes: “the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
In the latter case, the government must establish two separate elements: (1) that the act in question occurred while the drug was “held for sale after shipment in interstate commerce;” and (2) that the act resulted in the article being misbranded.
Enforcement actions against manufacturers for misbranding have resulted in substantial civil and criminal penalties.
This includes an agreement by Otsuka Pharmaceutical to pay over $4 million in fines to resolve allegations of off-label marketing (drug approved to treat adult schizophrenia and bi-polar disorder, marketed for geriatric patients suffering from dementia-related psychosis), an agreement by Cephalon to pay $425 million for off-label drug marketing (narcotic drug approved for ppioid-tolerant cancer patients, marketed for migraines, sickle-cell pain crises, injuries, and other uses), a $1.415 billion settlement by Eli Lilly for off-label drug marketing (approved anti-psychotic drug marketed to doctors for patients with sleep orders and dementia), and a $600 million settlement by Allergan for marketing Botox® for headaches and pains.
Anyone involved with a potential "medical device" under the federal Food, Drug & Cosmetic Act should consult an experienced FDA attorney for appropriate food and drug law advice.
Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets. As a corporate and regulatory attorney who has also handled litigation matters, Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek Michael H. Cohen’s legal expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas. Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges. Attorney Michael H. Cohen is admitted to practice in California, Massachusetts New York, and Washington, D.C. Contact attorneys at our Beverly Hills, California law firm today.