Devices

Lawyers See Lessons in ACell Criminal, Civil Cases

Civil and criminal penalties in cases involving an ACell medical device deserve further study by other device companies, according to attorneys Anne Walsh and Adrienne Lenz (Hyman, Phelps & McNamara). In a blog post for their firm’s FDA Law Blog, the two first discuss two whistleblower cases alleging that the firm made false and misleading statements in off-label promotion of its MicroMatrix powder wound dressing. The company agreed to pay $15 million, plead guilty to a misdemeanor charge, implement extensive compliance activities, and be subject to a five-year corporate integrity agreement.

According to the post, the criminal plea was based on the company’s failure to report to FDA its decision to remove MicroMatrix from the marketplace, as required by Part 806 of agency regulations. It says that in 2012 ACell learned that some 30,000 units of the powder were contaminated with endotoxin levels that posed a risk to health. The company removed the devices, but concealed the reason for removal from healthcare providers and did not submit an 806 report to FDA.

On 6/11, the post says, the Maryland U.S. attorney charged ACell with a criminal misdemeanor, imposed a $3 million fine, and required the company to enact compliance reforms. The attorneys note that no company individuals were named in the plea, contrary to current Justice Department policy to go after responsible individuals, and the statement of facts both sides agreed the government could prove beyond a reasonable doubt at trial was expanded to include activities well beyond the single 806 reporting violation.“Medical device companies simply need to recognize the potential ramifications of the government’s enforcement of the 806 reporting obligations,” the post says.

On the marketing of the MicroMatrix product, the attorneys say the case turned on the “false and misleading” nature of the off-label promotion because no clinical data existed to support the claims. “Industry should not get too confident that off-label promotion investigations are bygone relics,” they say, “and as always should focus on ensuring there is proper substantiation for all product claims, whether on- or off-label.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome