A whistleblower who sued medical device manufacturer Stryker Corp. and two other companies under the False Claims Act is seeking to have his lawsuit reopened after it had been tossed out by a federal judge in June. The plaintiff argues that the Affordable Care Act changes the terms on which his lawsuit was dismissed.
Lonnie Paulos, an orthopedic surgeon and former Stryker consultant, alleged in his 2011 whistleblower lawsuit that Stryker, I-Flow Corp., and Orthofix International marketed their pain pumps for off-label purposes unapproved by the U.S. Food and Drug Administration (FDA) and then billed Medicare and other government-funded health care programs. Dr. Paulos claims the illegal, off-label marketing of these pain pumps resulted in more than $12 million in false claims submissions to the government.
U.S. District Judge Ortrie D. Smith tossed the lawsuit after it was unsealed in December, saying that Dr. Paulos’ claims were largely based on publicly disclosed information and thus not a valid whistleblower claim against the companies. In his appeal, however, the plaintiff argues that the 2010 Affordable Care Act created changes to whistleblower laws that invalidate the judge’s basis for dismissing the lawsuit.
“Before the new health care law, the public disclosure bar was jurisdictional in nature, but now, it’s an affirmative defense that must be pleaded and proved,” Law 360 said of the case.
Dr. Paulos, who maintains that his lawsuit’s claims are based upon his personal knowledge and not something he learned on “60 Minutes,” argues the Affordable Care Act’s changes to whistleblower laws require defendants to prove that they have already publicly disclosed “substantially the same allegations.”
Among Dr. Paulos’ allegations were that the pain pump manufacturers marketed pain pumps for unapproved in-joint use, which caused a “startling number” of post-arthroscopic glenohumeral chondrolysis complications among patients, requiring them to have additional treatments and surgeries.
Judge Smith said that those or similar allegations already had been publicized to some degree by media reports, lawsuits, and other publicly available materials.
According to Law 360, Dr. Paulos “refuted Judge Smith’s assertion that he didn’t really learn of a connection between the pain pumps and chondrolysis until he read published studies, saying he made the discovery months and years before the studies were issued, and gained his knowledge from working in the field.”