As you may be aware, ACell recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with ACell’s promotion and sale of several of its products. This letter provides you with additional information about the global settlement, explains ACell’s commitments going forward, and provides you with access to information about those commitments.
ACell agreed to plead guilty to a misdemeanor under the Federal Food, Drug and Cosmetic Act relating to its failure to properly implement a recall in 2012. In addition, ACell entered into a separate civil settlement relating to allegations that ACell engaged in improper sales and marketing practices. To resolve these allegations, ACell agreed to pay approximately $15 million to federal and state health care
More information about this settlement may be found at the following links:
As part of the global settlement, ACell also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The Corporate Integrity Agreement is available at: https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp. Under this agreement, ACell agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by ACell’s representatives to ACell’s Compliance organization or the FDA using the information set out below.
Please call ACell’s Ethics and Integrity Helpline at 1-844-620-0004 or visit us at www.lighthouse-services.com/acell if you have any questions about the settlement referenced above or to report any instances in which you believe that an ACell representative inappropriately promoted a product or engaged in other questionable conduct. You should direct medical questions or concerns about ACell products to 1-844-620-0004 or visit us at www.lighthouse-services.com/acell.
Patrick A. McBrayer
President and CEO