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Teva Pharmaceuticals to pay nearly US$520M in record-breaking FCPA settlement

The world’s largest manufacturer of generic pharmaceuticals, Israeli-based Teva Pharmaceutical Industries Ltd. (“Teva International”), and certain of its global subsidiaries agreed to pay nearly US$520 million and enter into a Deferred Prosecution Agreement (“DPA”) to resolve allegations that the companies bribed government officials in Russia, Ukraine, and Mexico, in violation of the U.S. Foreign Corrupt … Continue reading

DOJ recovers $4.7 billion in 2016, third highest in FCA history

The Department of Justice (“DOJ”) announced yesterday that it recovered over $4.7 billion in fiscal year 2016 in civil cases involving claims of fraud against the government under the False Claims Act (“FCA”).  This is the third largest annual recovery in FCA history and one of the largest in recent years, easily surpassing last year’s … Continue reading

First and Fourth Circuit Courts of Appeal hear oral arguments in two key FCA cases

Last week, the Fourth Circuit and First Circuit heard oral argument in two separate cases dealing with key False Claims Act (“FCA”) issues. First, the Fourth Circuit Court of Appeals heard oral arguments for the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community Inc., Nos. 15-2145 and 15-2147.  Second, in the … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time … Continue reading

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

Physicians’ compensation structure results in $17M Stark Law fine and CIA for hospital

Lexington Medical Center (“LMC”), a 428-bed hospital in South Carolina, has agreed to pay $17 million to resolve allegations that it violated the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729 et seq., and Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn, by allegedly providing improper financial incentives to 28 physicians for referrals.… Continue reading

DOJ charges over 300 people in largest healthcare fraud “takedown” in U.S. history

On Wednesday, the Justice Department announced that it had brought criminal and civil charges against 301 healthcare professionals as part of the largest national healthcare fraud “takedown” in history. A nationwide investigation spearheaded by the Medicare Fraud Strike Force revealed claims amounting to $900 million in the form of alleged kickbacks, money laundering, and other … Continue reading

SCOTUS endorses “implied certification” FCA claims

In a closely watched decision, the U.S. Supreme Court has unanimously endorsed a version of the “implied false certification” theory of liability under the False Claims Act (“FCA”).  In a decision that leaves almost as many questions unanswered as it resolved, the Court held that a material omission on a claim for payment may give … Continue reading

FCA civil penalties to increase substantially under proposed rule

Earlier this week, the Railroad Retirement Board (RRB) became the first federal agency to promulgate an interim final rule implementing provisions of the Bipartisan Budget Act of 2015 intended to index civil penalties assessed under certain statutes to inflation. The RRB’s proposed final rule would double civil penalties assessed under the False Claims Act (FCA). … Continue reading

Ninth Circuit approves enhanced sentences for “abuse of trust” in health care fraud case

In a decision that could have wider ramifications for sentencing in health care fraud cases, a Ninth Circuit panel last week affirmed a lower court’s sentencing enhancement, applied because the defendants were found to have abused a “position of trust” by submitting false information in Medicare claims. The case involves owners of a California-based DME … Continue reading

New OIG exclusion guidance places value on self-disclosure

The OIG has issued updated guidance on the agency’s exclusion authority, as announced by Inspector General Daniel Levinson at the HCCA’s 2016 Compliance Institute. According to the new guidance, good-faith self-disclosures will place providers at the lower-risk end of the spectrum for an exclusion release without integrity obligations.  As a result, providers have additional support … Continue reading

Paxil birth defect lawsuit cannot survive exclusion of evidence of later FDA warnings

Last week, the first of nine Paxil birth defect lawsuits in line for trial in Pennsylvania was dismissed after a judge excluded evidence of the drug’s later heightened FDA warning. Judge Kenneth Powell of the Philadelphia County Court of Common Pleas granted a compulsory nonsuit in favor of defendant GlaxoSmithKline PLC (“GSK”) after portions of … Continue reading

DOJ launches pilot program for FCPA cases

On April 5, 2016, the DOJ announced a new Foreign Corrupt Practices Act (FCPA) enforcement pilot program with the goal of motivating companies to voluntarily self-disclose FCPA-related violations, to fully cooperate with the DOJ during investigations, and to promote greater accountability for individuals and corporations who violate the FCPA and related laws. Under the program, … Continue reading
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