Guttman and Buschner Represent Key Whistleblower in Justice Dept.’s $1.04 Billion Civil Settlement with GlaxoSmithKline

Reuben Guttman Articles, Traci Buschner Articles, Whistleblower News

Reuben Guttman led team on behalf of a former GlaxoSmithKline Therapeutic Sales Manager who alleged misrepresentation in promotion of company’s asthma/COPD drug Advair; firm’s third major whistleblower recovery in 2012, following Abbott Labs’ $1.6 billion settlement and banks’ $25 billion payment over ‘robo-signing’ mortgage fraud. 

BOSTON and WASHINGTON (July 2, 2012) — Reuben Guttman of Guttman, Buschner and Brooks PLLC has represented one of several key whistleblowers behind a $1.04 billion settlement announced today between drug maker GlaxoSmithKline and the U.S. Department of Justice stemming from alleged marketing abuses of various GSK medications. Lois Graydon, is a nursing professional and former GSK Therapeutic Sales Manager.

The U.S. Attorney’s office in Boston led the investigation into promotional tactics behind a total of nine GSK drugs. An accompanying criminal component of the case is expected to substantially increase the sum of the recovery.

Reuben Guttman and Traci Buschner are counsel to Lois Graydon, a registered nurse. She is one of the “relators” who alleged that GSK made false and misleading statements about Advair’s safety and efficacy, thus enabling false or fraudulent claims to Medicare, Medicaid, and other reimbursement programs.

Advair’s share of the recovery – more than $700 million – amounts to over half of the total civil settlement of $1.04 billion.

“The False Claims Act plays an important role in health industry compliance enforcement; health care is an issue that touches everyone and oversight, diligence and transparency are critical,” said Mr. Guttman, one of the country’s leading whistleblower attorneys.

“It is important that the medical community pays attention to this settlement and others and asks critical questions about the scientific support for the use of prescription drugs,” he added.

“In this election year, the safety of pharmaceuticals and their cost to the health care system should be front and center,” Mr. Guttman said.

He added, “Whistleblowers play an important role in compliance enforcement of our laws. We were proud to have represented one of the whistleblowers on this important case under the False Claims Act.”

 

Guttman and Buschner Represents Lead Whistleblower in $1.6 Billion Settlement with Abbott Laboratories

Reuben Guttman Articles, Traci Buschner Articles, Whistleblower News

Payment may be largest ever in single-drug case in history of False Claims Act; 4 ½ year investigation revealed Depakote was illegally marketed for children and geriatric patients; doctors given kickbacks

WASHINGTON, DC (May 7, 2012) – U.S. Justice Department and several state Attorneys General, has reached a $1.6 billion settlement with Abbott Laboratories over its illegal marketing of antiepileptic medication Depakote to children and geriatric patients.

The settlement was reached between Abbott (NYST: ABT) and the Justice Department, along with attorneys general in numerous states who have been conducting a 4 ½ year investigation into the Chicago-based pharmaceutical manufacturer. Prosecutors accused Abbott of violating federal FDA regulations and federal and state false claims act laws in its marketing of Depakote, a powerful anti-seizure medicine.

Abbott’s payment is one of the largest ever in the history of the False Claims Act, which includes $800 million in civil payments, along with a $700 million criminal penalty, and an additional $100 million to settle state consumer protection claims, for a total of $1.6 billion. Meredith McCoyd, a former top-performing Abbott sales representative based in Atlanta, who was the first to come forward with allegations regarding Depakote. Ms. McCoyd is the lead whistleblower relator, whose complaint initiated the government’s investigation of Abbott. The Justice Department intervened in her case last year.

Ms. McCoyd’s case, originally filed under seal in 2007 in the U.S. District Court for the Western District of Virginia, alleged use of illicit incentive payments by Abbott to physicians to encourage prescription writing of Depakote, as well as misrepresentations of the drug’s safety and efficacy, and off-label marketing. Abbott reportedly generated over $1.4 billion per year in sales of Depakote throughout the 2000s before the drug went off-patent.

The settlement stems from charges that over a period of years Abbott instructed its national sales team to market Depakote for treatments outside the FDA’s approved usage, which includes use for treating epileptic seizures, migraines and bipolar mania in adults. Among other illegal ploys, Abbott was accused of heavily marketing the drug to nursing homes as a method of sedating elderly residents, including those with Alzheimer’s and dementia and, in the process, allowing nursing home facilities to maintain lower staff-to-patient ratios. Abbott was also charged with encouraging doctors to prescribe the drug to young children outside of its FDA approved label for epilepsy and migraines.

Abbott was further accused of misrepresenting the safety and efficacy of Depakote, which can have serious side effects, including somnolence and increased risk of falls in the elderly and polycystic ovary syndrome in teenage girls. The company was charged with providing kickbacks to doctors and making misrepresentations to nursing homes about the reporting requirements for Depakote under the Omnibus Reconciliation Act.

According to Ms. McCoyd’s complaint: “This case is about a company – Abbott Laboratories – that methodically and recklessly endangered this vulnerable population – those with Alzheimer’s and other forms of dementia – through the illegal marketing of a drug that Abbott knew was unapproved for the treatment of Alzheimer’s, did not work to treat the disease, and was actually dangerous for use by the elderly. Incredibly, Abbott did not limit its wrongful conduct to preying upon the elderly; it also unlawfully marketed Depakote, to an array of patient populations, including children, placing them at risk for life altering injury or illness.”

“The size of this settlement demonstrates the seriousness of Abbott’s illegal actions. The company placed vulnerable elderly and pediatric patients at extreme risk by marketing Depakote for purposes not approved by the FDA and by paying kickbacks to induce doctors to write prescriptions,” said Reuben Guttman. Mr. Guttman and Traci Buschner, of Guttman, Buschner and Brooks PLLC, served as lead counsel for Ms. McCoyd.

“Abbott’s unlawful practices showed how the company elevated aggressive sales and marketing of Depakote over medical decision-making, violating basic norms of health care and ethics. Abbott essentially preyed on two of the most helpless patient populations in children and Alzheimer’s patients,” Mr. Guttman added.

“Abbott directed its sales force to get Depakote widely used in nursing homes, principally to neutralize older patients as a substitute for proper staffing,” Mr. Guttman said. “We are extremely gratified that the Justice Department and participating state AGs ensured that Abbott would pay a significant penalty for its rampant off-label practices.”

“With health care fraud projected to top $60 billion annually, cases such as this should serve as a catalyst for lawmakers to take a hard look at the pharmaceutical industry,” Mr. Guttman continued. “What happened here with Abbott was a train wreck. Now is the time for Congress to create a pharmaceutical and medical device safety and investigation board, which would conduct investigations with an eye toward providing honest information and analysis to practitioners.”

Medicare Decides It Takes a Thief to Catch a Thief

Reuben Guttman Articles, Whistleblower Articles

With Medicare fraud costing the federal government an estimated $60 billion a year, it makes perfect sense that the Centers for Medicare and Medicaid Services has tapped aerospace innovator Northrop Grumman to create a predictive model that will detect fraud. Or does it?

With all the great technology and healthcare companies out there, Northrop Grumman may not be the obvious choice, but in some ways it is perfect for this role. After all, Northrop is one of the worst perpetrators of fraud against the U.S. government. While some could see this as an unfortunate decision to reward a chronic offender, maybe the government is using a “takes a thief to catch a thief” model.

The reality is that the government’s decision to call on Northrop as its designated fraud detector shows a complete unwillingness to punish wrongdoers. A quick perusal of Northrop’s rap sheet shows how little the company respects the law. Indeed, the Project on Government Oversight—a Washington, D.C.-based public interest watchdog—has identified 33 instances where Northrop Grumman has had ugly dust-ups with the law, from False Claims Act violations to derelictions in environmental compliance and the failure to pay workers in accordance with regulatory and contractual requirements.

And the company has had to pay for its transgressions. That includes a $325 million penalty that Northrop paid on behalf of its aerospace subsidiary to settle claims that defective parts were used for a satellite project. Or the $700,000 in fines the company paid to settle claims that it submitted improper invoices to the Defense Department for lodging expenses. Northrop also settled claims that it installed substandard parts in military drones and even misled the Air Force about paint used on aircrafts.

In announcing the new contract, Peter Budetti, CMS’s new Medicare anti-fraud czar, noted that Northrop would be able “to translate its experience from the private sector to the public sector.” That statement is dubious. Would the Federal Parks Department hire Yogi Bear to guard picnic baskets at Jellystone Park and announce the appointment by saying that “the government hopes that Yogi will translate his experiences from the private sector to the public sector?” Mr. Budetti’s comment is similarly curious because with whatever private sector origins its constituent companies may have had, with over $20 billion a year in government revenue, Northrup now seems more of a permanent government appendage than a true private company.

Northrop isn’t the only violator to remain on the public take. While the average citizen who commits a crime undoubtedly has a hard time finding a job, the same cannot be said for government contractors.

Take the case of one of Northrop’s top competitors, Boeing, which enjoys more than $20 billion in government business each year even though it has settled multiple claims alleging violations of the False Claims Act, including allegations that it sold defective military hardware to the government.

Booz Allen, a mainstay of the government contracting world, generates more than $3 billion annually in government contracts even after settling two false claims cases involving allegations of overbilling and the submission of false reimbursement claims. SAIC, another large technology and services contractor, averaging more than $6 billion a year in government revenue, has settled or been held liable for more than one violation of the Federal False Claims Act. These are not isolated examples. These days it may actually be easier to find a billion-dollar government contractor that has settled allegations of wrongdoing than it is to find one that has never had an encounter with the law.

While it is bad enough that our government continues to reward wrongdoers with more business, the Northrop contract sets a new low. Does CMS really want to send the message that wrongful conduct can be rewarded with a lucrative contract to help the government detect wrongful conduct?

With a wealth of talent in our nation’s great universities, and with the fantastic work done by so many technology companies, it is hard to fathom that Northrop Grumman has a lock on the design of software to detect fraud. CMS’s Mr. Budetti is right about one thing: there is something to learn from the private sector and perhaps even Northrop Grumman. Rather than continue to reward wrongdoers, government contracting officers need to study them, and their misdeeds, in order to be in a position to exercise adult supervision over them.

It is possible that hiring a thief to catch a thief just might send the wrong message about the government’s seriousness in cracking down on fraud. Hiring Northrop and saying that there is much to be learned from its private sector experiences sends exactly the wrong message to American business.

Pharmaceutical Regulation in the United States: A Confluence of Influences

Reuben Guttman Articles, Whistleblower Articles

Background

Pharmaceuticals, like other consumer products distributed in the United States, are subject to regulation and scrutiny from multiple sources. Legislative oversight and statutory pronouncement, regulatory mandate and oversight, judicial review, and non-governmental organization (NGO) and media oversight directly and/or indirectly impact the conduct of pharmaceutical manufacturers. In addition, stakeholders including pharmaceutical company shareholders, employees of pharmaceutical companies, and those entities that ultimately bear the costs of paying for drugs – known as third-party payors –also influence the conduct of drug manufacturers.

For example, the securities markets that price stock rely, in part, on representations that drug companies make about the integrity of their products. Public misrepresentations to regulatory bodies and/or consumers also play out indirectly as misrepresentations to shareholders resulting in additional liability for companies and those individuals who run them. Accordingly, shareholders – the owners of the pharmaceutical companies – have an interest in ensuring not only the integrity of products sold to consumers, but the integrity of public statements about their products.

Through their retirement plans, Pharmaceutical Regulation in the United States: A Confluence of Influences1 pharmaceutical company employees invest in their employer and, to some degree, stand in the same shoes as shareholders except that they have rights of redress under United States Pension laws. Product recalls result in diminished stock value and lost savings for employees who invest in their companies.

Third-party payors, including labor union health and welfare funds, State Medicaid and employee health and welfare funds, and the federal Medicare system, have also had an immense impact with regard to the conduct of the pharmaceutical industry.

To say that any one of these influences is the real source of regulation would paint an incomplete picture. It is the totality of these influences, and their interplay with each other, that either impact or have the potential to impact manufacturer conduct.

Read the full article . . .

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