A former compliance supervisor with Maquet Getinge Group has filed a whistleblower lawsuit against the medical device manufacturer in New Jersey state court. The suit claims she was fired about a year ago for objecting to the company’s investigation into a product used in cardiac surgery. The whistleblower, Soila Borrero, alleges in her complaint that she is among several compliance officers terminated by Maquet for whistleblowing conduct related to U.S. Food and Drug Administration (FDA) regulations, claiming that the company “maintains and perpetuates a corporate culture of non-compliance with FDA rules and regulations.” The complaint filed Dec. 9 in Essex County Superior Court states:
Maquet has terminated several other compliance supervisors for their protests and objections to Maquet’s failure to adhere to FDA rules, regulations and laws.
The complaint identifies four such former compliance officers, including Oscar Sanchez, who is pursuing a separate lawsuit against Maquet over similar allegations in the same state court. Sanchez, Maquet’s former chief quality regulatory and compliance officer, has alleged in his lawsuit that the company fired him because he protested regulatory violations and other improper conduct surrounding the company’s products. The Sanchez case was filed in July 2015 and remains pending. The following comes from the new complaint filed by Ms. Borrero:
As a director of Quality Systems at Maquet, Ms. Borrero said she oversaw quality assurance activities to ensure that company products complied with regulatory and legislative requirements. In March 2015, she “objected to Maquet’s improper testing and failure to investigate involving the Ultima Stabilizer, a violation of federal law.” Her objections included that the final investigation involving the product “did not include tests performed on different samples with failed results.”
It’s alleged that after receiving Ms. Borrero’s objections, her supervisor, David Rose – who also is named as a Defendant in the lawsuit – tried to pressure and coerce Borrero to drop her objections and protests. When she refused to do so, Rose removed her from the investigation and stopped providing her with any information related to the inquiry. The complaint alleges a series of actions that were said to be retaliation against the whistleblower for reporting the fraud.
Ms. Borrero said she was terminated on Dec. 27, 2015, because of her whistleblowing activities in violation of New Jersey’s Conscientious Employee Protection Act. Ms. Borrero is represented by Paul S. Foreman. The case is Soila Borrero v. Maquet Getinge Group and David Rose in the Superior Court of New Jersey, County of Essex.