The final months of 2021 saw a flurry of noteworthy False Claims Act (FCA) activity. Among other developments, appellate courts issued important decisions concerning materiality, the government’s qui tam dismissal authority, and the application of the Eighth Amendment’s Excessive Fines Clause. The fourth quarter also brought news of several significant settlements, including a group of eight- and nine-figure resolutions of alleged Anti-Kickback Statute violations by pharmaceutical manufacturers and the latest example of a private equity firm paying a substantial sum to resolve FCA allegations leveled against one of its portfolio companies.

This post summarizes key developments from the year’s final quarter and identifies important takeaways for healthcare providers and government contractors.Continue Reading False Claims Act Decisions and Settlements to Know from Q4 2021

Two partnerships and infighting between relators recently produced a series of difficult questions addressed by the U.S. Court of Appeals for the Third Circuit in In re Plavix Mktg., Sales Practices & Prod. Liab. Litig. (No. II). Three individuals formed a limited liability partnership, JKJ, to bring a qui tam action against Sanofi-Aventis and Bristol-Myers Squibb, pharmaceutical companies that developed and marketed the anti-clotting drug Plavix.

After JKJ filed its qui tam complaint, however, its members had a falling out. One member left the partnership, and the two remaining members created a new partnership, also named JKJ, with a new third member. The old JKJ partnership was dissolved, and the new JKJ partnership filed an amended qui tam complaint.

The defendants moved to dismiss the amended qui tam complaint based on the False Claims Act’s (FCA) first-to-file bar. The first-to-file bar provides that “[w]hen a person brings an action under this subsection, no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.” The defendants argued that filing the amended complaint violated the first-to-file bar because the new JKJ partnership was a new party to the action.
Continue Reading Corporate Maneuvering Leads to Thorny First-to-File Bar Issues

On July 19, 2019, Myriad Genetics disclosed a $9.1 million settlement agreement to resolve a False Claims Act (FCA) qui tam lawsuit alleging that it engaged in a scheme to fraudulently bill Medicare for certain hereditary cancer tests.

Notably, the qui tam relator in the case was not a Myriad corporate insider, but rather a medical director for Palmetto GBA, the Medicare Administrative Contractor (MAC) responsible for overseeing the program through which Myriad’s tests are covered by Medicare.  In this way, the settlement illustrates the often overlooked risk that individuals other than conventional corporate whistleblowers—including even government employees or employees of government administrative contractors—may serve as FCA relators.Continue Reading Myriad Genetics Settlement Illustrates FCA Risks Posed by Government and Other Non-Traditional Relators

The U.S. Court of Appeals for the Sixth Circuit recently upheld a district court’s grant of summary judgment in favor of Abbott Laboratories in an action alleging that Abbott terminated a sales representative in retaliation for reporting a potential FCA violation. The appeals court held that the case should not proceed because the sales representative failed to show she reasonably believed an FCA violation had occurred. The holding potentially is helpful to FCA defendants facing retaliation allegations, but its precedential value may be limited because the court issued the unpublished opinion per curiam and with one judge dissenting.
Continue Reading Sixth Circuit Upholds Summary Judgment on FCA Retaliation Claim

In addition to the most common grounds upon which dismissal is sought in FCA actions, Mount Sinai Hospital and Mount Sinai Radiology Associates recently requested that the district court throw out FCA claims based on their argument that relators relied on improperly obtained patient records in support of their allegations.  Relators, who were employed in various positions with defendants, alleged FCA violations based upon false and fraudulent billing in connection with physician services and attached patient medical records to their complaint in support of their FCA claims. Defendants argued that relators should be precluded from relying on the medical records attached to their complaint because allegedly relators obtained those records without authorization following an internal investigation at the Hospital.  Relators countered that there were no facts before the district court to support any assertion that the medical records were obtained improperly and cited HIPAA’s exception for whistleblowers to reveal information to government authorities and private counsel if those whistleblowers have a good faith belief that their employer engaged in unlawful conduct.
Continue Reading Relator’s Use of Medical Records Insufficient to Warrant Dismissal of FCA Complaint

The Ninth Circuit affirmed the district court’s dismissal of a relator who pleaded guilty to a felony that involved the same fraudulent conduct that gave rise to the relator’s qui tam suit in U.S. ex rel. Schroeder v. CH2M Hill. The FCA’s § 3730(d)(3) requires dismissal of a relator from a qui tam lawsuit and precludes the relator from any recovery in the lawsuit, “[i]f the relator has been convicted of criminal conduct arising from his or her role in the violation of section 3729.” In Schroeder, the Ninth Circuit concluded that this provision applied even to minor participants in the underlying alleged misconduct, who neither planned nor initiated the fraudulent scheme.

The relator, who was employed by the defendant government contractor, was involved in an underlying fraudulent scheme to bill the Department of Energy (DOE) by submitting false time cards to DOE for hourly work. After his interview by investigators, the relator pleaded guilty to a felony count of conspiracy to commit fraud. After his interview, but before pleading guilty, the relator filed suit under the FCA against his employer concerning the DOE fraud scheme. The United States intervened and moved to dismiss the relator from the lawsuit under § 3730(d)(3) as a result of his felony conviction.Continue Reading Ninth Circuit Takes Hard Line against Relators Involved in FCA Wrongdoing

In recent months, relators’ qui tam complaints have been subject to increased scrutiny by criminal prosecutors. In addition to civil FCA liability, individuals doing business with the federal government face potential criminal liability under various criminal fraud-related statutes. Potential charges for fraudulent activities are not limited to a criminal fraud charge, but also include bribery, false statements, conspiracy to defraud, wire fraud, mail fraud, and identity theft, among others. Most of these crimes are felonies and carry substantial penalties, including fines, freezing of assets and imprisonment. Especially in the healthcare industry and defense procurement space, many criminal investigations originate as civil qui tam filings only later adopting a criminal component. These parallel investigations typically involve the DOJ and may include other enforcement agencies.

Recent DOJ rhetoric encourages an increased use of such parallel investigations. In September 2014, Assistant Attorney General for the Criminal Division of the DOJ, Leslie Caldwell, announced that the Criminal Division would be “stepping up” its review to look for potential criminal liability in qui tam complaints, noting that such complaints “are a vital part of the Criminal Divisions’ future efforts.”[1] Consistent with this message, Caldwell encouraged the relator’s bar to notify the Criminal Division directly when a complaint is filed instead of coordinating only with the local U.S. Attorney’s Office. As part of the new process, the Criminal Division will receive and review new complaints so that prosecutors may determine the nature and extent of any criminal exposure.Continue Reading New DOJ Qui Tam Protocols Likely to Lead to Increased Parallel Criminal Investigations