The Department of Justice has announced that medical device company Aesculap Implant Systems in Pennsylvania has agred to pay $38.5 million to settle allegations under the False Claims act that it sold knee replacement devices that it knew would fail prematurely at higher than acceptable rate resulting in false claims to Medicare and Medicaid. Allegations were also settled that the company paid unlawful remuneration to a physician to induce him to use the knee implants.
. The United States alleged that the Vega was prone to becoming loose from patient’s bone prematurely, often shortly after surgery. Patients experiencing loosening could have pain, instability, and difficulty walking, and such patients required a revision surgery to remove and replace the Vega implant. The United States alleged that Aesculap knew shortly after the Vega was released in the United States that bone cement did not properly adhere to the implant. Despite this knowledge, Aesculap sold the Vega to physicians and hospitals in the United States without disclosing this known problem with the device. The United States also alleged that Aesculap failed to take steps to record, track, or report adverse events for the Vega and did not take adequate steps to remediate the problem.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by John Marien, Michael McGee, and Brad Stafford. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam cases are captioned United States ex rel. Marien & McGee v. Aesculap Inc., et al., no. 5:19-cv-1618 (E.D. Pa.) and United States ex rel. Stafford v. B. Braun Medical Inc., et al., no. 4:19-cv-4108 (E.D. Pa.). Counsel for the whistleblowers were Michael McGee and Kevin Kasper.
Jeffrey Newman is a whistleblower lawyer, whose law firm represents whistleblowers revealing violations of export controls, tariff evasions, money laundering, healthcare fraud and other kinds of WB cases. The firm represents individuals both in the United States and other countries. Mr. Newman and his firm also represent physicians and other healthcare providers who become whistleblowers in healthcare fraud cases. Whistleblower laws in the U.S. allow individuals anywhere with information about export control violations or tariff fraud to reveal the information under The False Claims act or through the Securities and Exchange Commission’s Whistleblower Program. The Firm’s website is at www.JeffNewmanLaw.com and attorney Newman can be reached at Jeff@Jeffnewmanlaw.com or at 978-880-4758
