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Sanofi Aventis Can’t Invoke the First Amendment to Escape FCA Liability

Monday, January 23rd, 2017

United States ex rel. Gohil v. Aventis, Inc. is a long-running False Claims Act suit filed in the Eastern District of Pennsylvania by an ex-sales specialist against his former employer, behemoth pharmaceutical company, Sanofi Aventis.  Relator Yoash Gohil filed this qui tam suit in 2002 alleging that his former employer engaged in a fraudulent marketing scheme to promote off-label the chemo-therapy drug, Taxotere.

The Relator alleges that Aventis trained and directed its sales force to misrepresent the safety and effectiveness of the chemotherapy agent in order to expand the market share for Taxotere beyond its FDA approval as a “second line treatment.”  A second line treatment is one that is approved for limited use only after the failure of a prior treatment.  Relator also alleges that Aventis had engaged in a kickback scheme that included sham grants, exorbitant speaking fees, and excessive preceptorship fees paid to physicians in order to incentivize them to prescribe Taxotere.

Aventis moved for a partial judgment on the pleadings and raised two grounds for dismissal.  First, Aventis argued that some of the claims (those from 1996 to 2000) were barred by the statute of limitations.  Federal District Court Judge Lawrence Stengel rejected this argument finding that the pharmaceutical company was given fair notice of the claims when the First and Second Amended Complaints were filed.  The Court accepted Relator’s argument that all of the new claims “related back” to the claims laid out in his original complaint.

Second, Aventis argued that some of Relator’s claims were precluded by the First Amendment.  This argument has been made with increasing frequency by the pharmaceutical industry in trial and appellate courts throughout the United States.  Aventis argued that First Amendment protections extend to commercial speech and that parts of Relator’s claims were based on truthful, non-misleading speech regarding Taxotere.  Judge Stengel rejected this argument as well, finding that Relator’s Complaint had asserted that the off-label promotion was false and/or misleading.  Ultimately, the dispute over the whether the speech was false or misleading is material to the outcome of the case.  Judge Stengel held that the First Amendment issue was not ripe for disposition and denied the motion for partial summary judgment.  He wrote, “This question is better answered by a jury.”

United States ex rel. Gohil v. Aventis, Inc., No. 02-2964, 2017 U.S. Dist. LEXIS 3236 (E.D. Pa. Jan. 9, 2017)

 

Georgia-based Hospital Group to Pay Over $513 Million to Resolve Civil and Criminal Allegations Related to Illegal Payments for Patient Referrals

Wednesday, October 19th, 2016

On Monday, the DOJ announced the resolution of criminal allegations and a False Claims Act (“FCA”) lawsuit a relating to a scheme to defraud the United States and obtain kickbacks in exchange for patient referrals.  A major U.S. hospital chain, Tenet Healthcare Corporation and two subsidiaries, Atlanta Medical Center, Inc. and North Fulton Medical Center, Inc., will pay over $513 million pursuant to a series of agreements, including a civil settlement agreement, non-prosecution agreement, and plea agreements:

FCA settlement:  Tenet Healthcare and related entities – described in the settlement as “the Tenet Entities – agreed to pay $368 million to the federal government and to Georgia and South Carolina to resolve claims brought by a Georgia whistleblower.  The FCA suit was filed in the Middle District of Georgia and claimed that Tenet Healthcare paid bribes and kickbacks to pre-natal clinics to unlawfully refer Medicare and Medicaid patients to its hospitals.  The whistleblower will receive $84 million under the agreement.  The agreement stated that the Tenet Entities denied any liability regarding the false claims allegations.

Non-prosecution agreement:  Tenet HealthSystem Medical Inc., the corporate parent of Tenet Healthcare, entered into a non-prosecution agreement (“NPA”) with DOJ based on similar allegations to those within the FCA case.  The NPA allows the two companies to avoid criminal prosecution in exchange for following the agreed-upon terms.  The criminal allegations at the heart of the NPA focused on an alleged conspiracy to defraud the United States and to violate the Anti-Kickback Statute, which bars illegal payments that induce patient referrals for services paid for by federal health care programs.  Under the NPA, Tenet HealthSystem and Tenet Healthcare will avoid criminal prosecution if they cooperate with the government’s prosecution and strengthen their internal controls, including their compliance and ethics programs.  The NPA is effective for three years, although it may be extended for an additional year if necessary.

Plea agreements:  Two subsidiaries of Tenet Healthcare, Atlantic Medical Center and North Fulton Medical Center, agreed to plead guilty to a criminal information for their role in the conspiracy, as referenced above, to defraud the United States and violate the Anti-Kickback Statute.  Under the plea agreements, the two healthcare will forfeit over $145 million to the United States, collectively representing the amount paid to the two entities by the federal Medicare and Georgia Medicaid programs for services paid to patients referred as part of the conspiracy.

Additional information, including the FCA settlement agreement, NPA, and criminal information can be found here.

$690,000 Settlement to be Paid Under False Claims Act

Thursday, August 18th, 2016

The U.S. Attorney’s Office in Philadelphia announced that several Lehigh Valley medical facilities and three doctors will pay in excess of $690,000 to settle false health care bill claims to Medicare and other federal benefits programs.  The allegations under the False Claims Act were made by whistleblower Margaret Reynard against Dr. Yasin Khan, Dr. Elizabeth Khan and Dr. Dong Ko.  Also involved were Westfield Hospital and Lehigh Valley Pain Management, an affiliated pain clinic.  Between July 1, 2007 and December 31, 2013, Reynard claimed that the doctors received reimbursement for services performed “incident to” by non-physicians when the doctors were not in the office or clinic, increasing the bills by 15 percent because the “incident to” services required the doctor to supervise the non-physician.  In addition to Medicare, the claims were submitted to government programs such as the Federal Employees Health Benefits Program and Department of Labor Office of Worker’s Compensation programs.

http://www.thelegalintelligencer.com/id=1202765336826/Doctors-Hospital-Settle-Whistleblower-Claims-for-690K?cn=20160817&pt=PM%20Legal%20Alert&src=EMC-Email&et=editorial&bu=The%20Legal%20Intelligencer

Confidentiality Agreement Does Not Curb Former Employee’s Whistleblower Suit

Thursday, May 12th, 2016

A whistleblower’s retention and disclosure of confidential documents did not amount to breach of his employment contract, according to the U.S. District Court for the Northern District of Illinois.

In United States ex rel. Cieszyski v. LifeWatch Services, Case No. 13-cv-4052 (N.D. Ill.), relator and one-time LifeWatch salesperson Matthew Cieszyski alleges that his former employer violated federal and state False Claims Acts (“FCAs”) by submitting for government reimbursement claims for heart monitoring services that violated relevant Medicare and Medicaid regulations. LifeWatch counterclaimed that Cieszyski had breached a confidentiality agreement and privacy policy – both of which, it contended, were components of his employment contract – by retaining and disclosing to the government confidential company documents.

Breach of Contract Must Be Independent from Any Fraud Investigation

The court held that LifeWatch failed to state a claim for breach of contract and thus dismissed the counterclaims. There was no dispute that Cieszyski had signed a confidentiality agreement as a condition of his employment, or that he removed documents from the company’s premises, contrary to the agreement’s terms. But, according to the court, enforcing the agreement would undermine the protections against retaliation afforded relators by the federal and state FCAs.

At root of the dismissal was the court’s conclusion that LifeWatch’s counterclaims derived completely from the FCA claims lodged against it. LifeWatch did not contend that Cieszyski had retained or disclosed the information for any reason other than alleging the company’s FCA violations. There was no evidence that he shared the documents with anyone other than his attorneys or the government. Nor did LifeWatch claim harm beyond its exposure to the FCA suit or damages beyond the fees and costs associated with bringing the counterclaims – “a self-inflicted wound,” in the court’s parlance. Cieszyski had not, for example, revealed trade secrets that could have jeopardized LifeWatch’s standing in the market.

Interest in Confidentiality Subordinate to Anti-Retaliation Protections

Finally, the court rejected LifeWatch’s argument that Cieszyski had collected and shared more information than was needed to support his allegations of fraud. The court declined to burden relators with the obligation to know the precise quantum of evidence necessary to make their FCA cases and to limit their disclosures accordingly. The key question is whether the relator has gathered the evidence for a reason other than furthering an investigation of possible FCA violations. LifeWatch could not persuasively attribute an ulterior motive to Cieszyski. Accordingly, his statutory right to be free from retaliation overwhelmed LifeWatch’s interest in having its confidential information protected.

CFTC Approves Record $10 Million Award to Whistleblower

Thursday, April 7th, 2016

The U.S. Commodities and Futures Trading Commission (“CFTC”) has approved an award of more than $10 million to a tipster through its whistleblower program. The award – only the third in the program’s five-year history – is not only the largest ever approved by the agency, it is more than 30 times larger than its closest competitor, a $290,000 award paid in 2015. The CFTC redacted the tipster’s identity – along with the precise amount of the award and the percentage of total recovery – from the final order, which is available here.

The CFTC’s whistleblower program arose from the Dodd-Frank Act in 2010, and it exists to reward tipsters who voluntary provide information that leads to successful enforcement actions for violations of the Commodity Exchange Act (“CEA”). Such tipsters are eligible to receive between 10 to 30% of the CFTC’s recovery where sanctions imposed exceed $1 million. The awards are paid through the CFTC Customer Protection Fund, which is financed wholly from sanctions paid by violators of the CEA.

Eligibility to receive a reward, however, does not amount to a guarantee. Indeed, the CFTC has issued 38 denial orders, as compared to the three orders approving awards. Participants in the U.S. Securities and Exchange Commission’s (“SEC’s”) whistleblower program – also a product of Dodd-Frank – have a much higher batting average. The SEC has approved 21 applications for awards, while denying 33.

In a press release announcing the award, Aitan Goelman, CFTC’s Director of Enforcement said, “By providing robust financial incentives and enhanced protections to whistleblowers, the Commission incentivizes people to come forward with high quality information about serious violations of the law that we might not otherwise uncover. An award this size shows the importance that the Commission places on incentivizing future whistleblowers.” Encouraging participation in the program is one thing. Would-be tipsters are left to hope that the award also signals the CFTC’s new-found dedication to compensating those individuals who provide information that leads the agency to significant recoveries.

Naming Additional Defendants and Identifying Their Fraudulent Conduct Defeats Operation of First-to-File Bar

Wednesday, March 30th, 2016

On March 28, the U.S. District Court for the District of South Carolina advanced a plaintiff-friendly interpretation of the False Claims Act’s (“FCA’s”) first-to-file rule. It recognized that naming new defendants who are related to defendants named in previously filed complaint and complicit in the alleged fraud renders the subsequent complaint sufficiently different to pass muster under the rule.

The first-to-file rule, 31 U.S.C. § 3730(b)(5), provides that “no other person than the Government may intervene or bring a related action based on the facts underlying the pending action.” In many U.S. Circuits, including the Fourth, where the District of South Carolina sits, courts apply the “same material elements” test, meaning that a relator is not “first to file” if his complaint describes the same material elements of a fraud documented in a previously filed complaint.

United States ex rel. Lutz v. Berkeley HeartLab, Inc., et al., No. 9:14-cv-230 (D.S.C.), is an FCA case in which three separate qui tam actions were consolidated for government intervention. The three complaints – one filed by relators Scarlett Lutz and Kayla Webster, one filed by relator Michael Mayes, and one filed by relator Chris Reidel – allege a nationwide scheme in which physicians were offered and paid kickbacks to order often-medically-unnecessary tests from diagnostic laboratories (Berkeley HeartLab, Health Diagnostic Laboratory, Inc. [“HDL”], and Singulex, Inc.), through a marketing agent (BlueWave Healthcare Consultants), in violation of the FCA. Government healthcare programs then reimbursed the laboratories for those impermissible payments. Mayes filed his complaint first, Reidel’s complaint followed, and Lutz and Webster filed their complaint thereafter. Unlike Mayes and Reidel, Lutz and Webster named the individuals who concocted, directed, and implemented the scheme – as opposed to only the corporate entities they represent – as defendants.

Those individual defendants – HDL’s Latonya Mallory and BlueWave’s Floyd Calhoun Dent and Robert Bradford Johnson – moved to dismiss the Lutz-Webster action, arguing that the first-to-file rule divested the court of subject matter jurisdiction because the Lutz-Webster complaint alleged the same general fraudulent scheme as that alleged in the Mayes complaint and the Reidel complaint. The court rejected the argument, holding that Lutz and Webster were first-filed as to the individual defendants. Put differently, “a later-filed action is not based on the facts of a pending action when it identifies a new defendant who is not a subsidiary of an already-named defendant.”  Because Lutz and Webster were the only relators to name the individual defendants and allege that they personally committed fraudulent conduct, their complaint “contains different material elements of fraud than the pending action[s].”

Notably for future relators, the court’s analysis suggests that the addition of any defendant – except for a subsidiary of a previously named defendant – will defeat the first-to-file rule, as long as their involvement in fraud can be documented with particularity. Each relator should thus draft her complaint as broadly as the facts allow, in order to support the identification and naming of all parties involved in the fraud alleged. Doing so will increase the odds that the relator’s complaint names and inculpates different defendants – and thus, under the Lutz court’s analysis, alleges different material elements – than any potentially related and previously filed complaint.

The Supreme Court Endorses Statistical Sampling to Prove Liability

Monday, March 28th, 2016

Last week, in Tyson Foods v. Bouaphakeo, — S. Ct. —-, 2016 WL 1092414, the U.S. Supreme Court affirmed a district court decision certifying a class of workers who sued Tyson Foods under the Fair Labor Standards Act (“FLSA”) and Iowa state labor law for short-changing them the time it took to change in and out of their protective gear, thus unlawfully depriving them of overtime pay.  To establish that the “donning” and “doffing” of protective gear pushed them over the 40-hour overtime threshold, the workers used sampling evidence.  An expert videotaped a representative number of employees donning and doffing the gear, calculated the average time that the process lasted, and applied that number on a class-wide basis.

Tyson appealed the order granting certification, contending that the time it took employees to change in and out of protective gear was an individual question that substantially predominated the class-wide issues, and that the use of sampling evidence “assum[ed] away the very differences that make the case inappropriate for classwide resolution.” Tyson sought a ruling not only that the use of sampling evidence was inappropriate in this case, but also that it was necessarily an improper means of establishing liability in a class action.

The Court, in a 6-2 opinion, rejected Tyson’s arguments. “A representative or statistical sample,” it concluded, “is a means to establish or defend against liability. Its permissibility turns not on the form a proceeding takes—be it a class or individual action—but on the degree to which the evidence is reliable in proving or disproving the elements of the relevant cause of action. Indeed, “[i]n many cases, a representative sample is the only practicable means to collect and present relevant data establishing a defendant’s liability.”  This, the Court held, was one such case.

While Boutaphakeo involves a class action and labor law, its language – the Court’s most definitive statement on the propriety of statistical samples as a means of proving liability – suggests broad applicability. In the False Claims Act (“FCA”) context, courts often permit statistical sampling to prove damages once liability is established, but cases permitting such evidence to prove liability exclusively based on representative evidence are far fewer in number.  Perhaps most notably, in United States ex rel. Martin v. Life Care Centers of America, 2014 WL 4816006 (E.D. Tenn. Sept. 29, 2014), the government alleged that skilled nursing facilities submitted false claims to Medicare for medically unnecessary services. The government sought to establish its case by identifying a small sample of these claims and extrapolating to the more than 154,000 claims alleged to be at issue.  The court permitted the sampling over Life Care Centers’ objection, concluding that “limiting FCA enforcement to individual claim-by-claim review would open the door to more fraudulent activity because the deterrent effect of the threat of prosecution would be circumscribed.”

Thus, in Boutaphakeo, the Supreme Court seemingly endorsed the proposition set forth in Martin: where it is impractical to “collect and present” all of the false claims at issue, presenting a “representative sample” may suffice in establishing a defendant’s liability.

$34.8 Million to be Paid by Respironics for False Claims Related to Sale of Sleep Apnea Masks

Thursday, March 24th, 2016

Respironics is to pay $34.8 million for alleged False Claims Act violations related to the sale of sleep masks designed to treat sleep apnea.  Allegedly Respironics, a Murrysville, PA based company, paid kickbacks in the form of free call center services to durable medical equipment (DME) companies that purchased the masks.  The DME companies; otherwise, would have had to pay a monthly fee based upon the number of patients who used the masks manufactured by a Respironics competitor.  The alleged conduct occurred between April 2012 and November 2015.  Approximately $34.14 million will be paid to the federal government and about $660,000 will be paid to various state governments based on their Medicaid program participation.

Dr. Gibran Ameer initially brought the lawsuit under the False Claims Act qui tam provisions.  Dr. Ameer had worked for different DME companies.  He will receive $5.38 million out of the federal government’s share of the settlement.  The Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s office of the District of South Carolina, and HHS Office of Counsel to the Inspector General and Office of Investigations and the National Association of Medicaid Fraud Control Units all worked together to bring about the settlement in this lawsuit.

https://www.justice.gov/opa/pr/respironics-pay-348-million-allegedly-causing-false-claims-medicare-medicaid-and-tricare

Lockheed Martin Agrees to Pay $5 Million to Settle Alleged Violations of the FCA and the Resource Conservation and Recovery Act

Monday, March 14th, 2016

On Monday, February 29, 2016, the Justice Department announced that the Lockheed Martin Corporation and its subsidiaries Lockheed Martin Energy Systems and Lockheed Martin Utility Services (collectively, Lockheed Martin) agreed to pay the United States $5 million to resolve allegations that they violated the Resource Conservation and Recovery Act (RCRA).  By misrepresenting their compliance with RCRA to the Department of Energy (DOE), Lockheed Martin knowingly submitted false claims for payment under its contracts with DOE to operate the Paducah Gaseous Diffusion Plant in Paducah, Kentucky.  Lockheed Martin is a global security, aerospace, and information technology corporation that provides environmental services to the government and commercial customers.

The RCRA is a statute that establishes how hazardous wastes are managed.  The government’s lawsuit alleged that Lockheed Martin violated the RCRA by failing to identify and report hazardous waste produced and stored at the facility, and failing to properly handle and dispose of the waste.  Furthermore, the government alleged that this conduct resulted in false claims for payment under Lockheed Martin’s contracts with the DOE.

Of the $5 million settlement, Lockheed Martin will pay $4 million to resolve the government’s False Claims Act allegations and its subsidiaries will pay $500,000 each in RCRA civil penalties.

From 1984 to 1999, Lockheed Martin operated the Paducah Gaseous Diffusion Plant under contracts with the DOE and a government corporation, the U.S. Enrichment Corporation.  Lockheed was responsible for the facility’s uranium enrichment operations.  Uranium enrichment, through a process called “gaseous diffusion,” increases the proportion of uranium atoms that can be used to produce nuclear fuel for weapons and civilian energy production.

In addition to uranium enrichment, Lockheed Martin was responsible for the environmental restoration, waste management, and custodial care of the site, which operates 3,500 acres in McCracken County, Kentucky.  Uranium operations concluded at the plant in 2013.  The government is working to remediate any contamination at and near the site consistent with the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

The lawsuit resolves two lawsuits filed under the qui tam provision of the False Claims Act.  The lawsuits were filed by the Natural Resources Defense Council, Inc. and several former employees of Lockheed Martin who worked at the Paducah facility. The United States partially intervened in the lawsuits, which were then consolidated into one action.  The whistleblowers will collectively receive $920,000 from the United States’ portion of the settlement.

The case was a coordination effort between the U.S. Attorney’s Office for the Western District of Kentucky, the Civil Division’s Commercial Litigation Branch, the Environment and Natural Resources Division’s Environmental Enforcement Section, the U.S. Environmental Protection Agency, the Department of Energy and the Department of Energy Office of the Inspector General.

The case caption is: United States, ex rel. John David Tillson, Natural Resources Defense Council, Inc., et al. v. Lockheed Martin Corp., et al., Civil Action No. 5:99CV00170-GNS (W.D. Ky.).  The claims resolved in this settlement are allegations only; there has been no determination of liability.

Ninth Circuit Endorses Relator-Friendly Interpretation of Public Disclosure Bar

Friday, March 11th, 2016

The U.S. Court of Appeals for the Ninth Circuit reversed a district court order dismissing the False Claims Act (“FCA”) lawsuit brought by Relator Steven Mateski against his former employer, Raytheon. The suit, which potentially exposes Raytheon to more than $1 billion in damages, is based on allegations that the company failed to comply with provisions of its contract with the government to develop a sensor for a meteorological satellite, covered up its noncompliance, and improperly billed the government for incomplete work.

The district court dismissed the case for lack of subject matter jurisdiction under the Public Disclosure Bar, 31 U.S.C. § 3730(e)(4)(A), which prohibits FCA suits that are “based upon the public disclosure of allegations or transactions.” Specifically, the court found that public documents, such as reports from the Government Accountability Office and various newspaper articles, described the rampant mismanagement and deviations from protocol that characterized the sensor project. The district court conceded that Mateski added detail to the publicly available information, but concluded that such amplification did not render the allegations sufficiently distinct to survive scrutiny under § 3730(e)(4)(A).

The Ninth Circuit Court of Appeals, however, held that the lower court had erroneously compared the Mateski complaint with the public documents at “the highest level of generality.” While the complaint and the documents both described problems with the project, Mateski provided the government with useful, “infinitely more precise” details that were lacking from the public documents, including numerous false waivers and certifications, as well as documentation of the use of substandard materials in production of the sensor. Barring his action, according to the Court, would upset the FCA’s carefully struck balance between encouraging private litigants to discover fraud, yet stifling parasitic lawsuits.

In deciding the matter, the Mateski Court expressly endorsed and adopted the “levels-of-generality” approach employed by the Seventh Circuit Court of Appeals. But Mateski also shares analytical common ground with the U.S. Court of Appeals for the Third Circuit’s recent decision in Moore & Company (also discussed on this blog). There, the Court held that the operative question under the Public Disclosure Bar was whether the relator’s allegations materially added to the “who, what, when, where, and how” of the events set forth in public documents. Although they frame the issue differently, both Mateski and Moore & Company strictly construe the Public Disclosure Bar to ensure that relators who add significant relevant details to fraud generally described in newspapers and other public documents retain the ability to pursue FCA claims on behalf of the federal government.

 

 
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