Winning the cGMP Whistleblower Game
Pharmaceutical Manufacturing Magazine
As one of the first qui tam attorneys to write on the application of False Claims Act to violations of the Current Good Manufacturing Practices (“cGMP“) Nolan Auerbach partner Kenneth Nolan is regularly contacted by the press to explain this use of the False Claims Act. Most recently, in an in-depth cover story, Pharmaceutical Manufacturing Magazine interviewed Nolan about how qui tam whistleblowers can use the False Claims Act to put the brakes on serious pharmaceutical manufacturing deficiencies.
Providers Will Find 2011 Is ‘Big Year’ for Regulations, Recoupment, Whistleblowers
Report on Medicare Compliance
January 17, 2011
In this issue, a respected healthcare trade publication interviewed Nolan Auerbach partner Jeb White about the increased number of qui tam filings against hospitals. “Compliance officers are probably the largest contingency of whistleblowers in the hospital setting,” said White. “It makes sense. Compliance officers raise issues to their bosses, who [sometimes] say ‘stop looking.’ Compliance officers are alienated, isolated, terminated — and then they call me.”
Whistleblower Lawsuit Reveals Unapproved Meds
January 13, 2011
In January 2011, the public was made aware of Nolan Auerbach’s client’s unprecedented qui tam case against two dozen companies for selling unapproved drugs. To date, this case has recovered $100 million for the U.S. Treasury. The article notes that “the lawsuit offers some disturbing details in so far as that unapproved meds have apparently been available for years and, in some cases, the FDA failed to do anything to halt the practice.”
Outlook 2011: Permissive Exclusions, Increase in Oversight Expected in 2011
BNA Health Care Fraud Report
January 12, 2011
In its annual “Outlook” issue, BNA Health Care Fraud Report interviewed Nolan Auerbach partner Jeb White about the issues appearing on his fraud-fighting radar screen. Mr. White said that he was particularly interested in hunting down dishonest medical device manufacturers, including manufactures of durable medical equipment (DME). “DME manufacturers seem to be slow learners when it comes to compliance,” Mr. White said.
GSK’s $750 Mil. DOJ Settlement: When GMP Violations Equal Healthcare Fraud
“The Pink Sheet”
November 1, 2010
After the US Government settled a ground-breaking qui tam action, brought by a very courageous whistleblower involving manufacturing issues at a pharmaceutical plant, the esteemed industry trade publication The Pink Sheet turned to Nolan Auerbach partner Ken Nolan for expert insights. “In this particular case, if you read the facts, they are extreme,” explained Nolan. “And the whistleblower was the most well-positioned whistleblower for this type of case, so it was the perfect storm.”
Are More Pharma cGMP Whistleblower Cases on the Way? Experts Think So
November 17, 2010
Pharmaceutical manufacturers are becoming increasingly aware that serious manufacturing deficiencies might subject them to False Claims Act liability. In turn, the industry is making strides to fully understand cGMPs and the reach of the federal False Claims Act. For example, PharmaManufacturing.com spotlighted this concern and directed the industry to Nolan Auerbach partner Ken Nolan, for his “excellent checklist” on cGMP violations.
Whistle-blower Case That Started in Tampa Results in $422.5 Million Settlement
St Petersburg Times
October 1, 2010
Over 100 publications reported on Nolan Auerbach’s $422.5 million settlement with Novartis. One of the publications, St. Petersburg Times, highlighted the fact that the initial complaint was filed in Florida. Nolan Auerbach partner Kenneth Nolan explained that the U.S. Attorney’s Office in Tampa has a “good reputation” for pursuing cases of healthcare fraud. Explaining his initial interest in the case, Nolan stated, “We knew that the percentage of off-label sales was robust and the damages would be high.”
Novartis Whistleblower Speaks: ‘We Wasted Money’
October 1, 2010
Nolan Auerbach’s clients’ case was part of the recent $422 million recovery from Novartis. The firm granted Pharmalot an exclusive interview with one of its clients. “[M]anagement would say you couldn’t use someone [for the speakers bureau] if they didn’t write a lot [of prescriptions for Novartis products], even if the person was an authority,” said Novartis whistleblower Jeremy Garrity. Three of the key whistleblowers in this case were represented by Nolan Auerbach.
Novartis to Pay $422.5 Million Settlement Charges Range from “Off-Label” Marketing to Kickbacks
Wall Street Journal MarketWatch
September 30, 2010
News about the $422.5 million settlement with Novartis made national headlines. “‘As long as they had a prescription pad and were willing to prescribe our products, they qualified as Novartis speakers,’ Jeremy Garrity, a former Novartis employee, said in a statement from his law firm, Nolan Auerbach ‘The company’s illegal business practices were snowballing and nobody was stepping up to stop them. I had to do something.’”
Forest Labs to pay $313 million in DOJ settlement
Medical Marketing & Media
September 16, 2010
Chronicling Nolan Auerbach’s latest $300 million+ settlement with a pharmaceutical company, Medical Marketing & Media inquired about the key differences between this case and the firm’s other successful pharmaceutical fraud cases. “Unlike other cases involving off-label marketing of drugs,” this case dealt with “illegally marketing a drug that has never been approved,” explained Nolan Auerbach managing partner Marcella Auerbach.