By Reuben Guttman and Traci Buschner. Mr. Guttman is a Senior Fellow and Adjunct Professor at the Emory Law School Center for Advocacy and Dispute Resolution, and a partner at the firm of Grant & Eisenhofer where he heads the firm's whistleblower practice. He is a founder of the website, Whistleblowerlaws. Ms. Buschner is a Senior Counsel with Grant & Eisenhofer. Mr. Guttman and Ms. Buschner were lead counsel for the lead whistleblower, Meredith McCoyd, in U.S. ex rel. McCoyd v. Abbott Labs.
Abbott Labs has agreed to pay $1.6 billion dollars to settle criminal and civil allegations that it engaged in the unlawful marketing of its anti-epileptic drug Depakote.
The settlement arose out of a False Claims Act (FCA) case filed in the fall of 2007. Whistleblower or "Relator" Meredith McCoyd, alleged that the company marketed Depakote to elderly nursing home patients and to children for purposes that had not been approved by the Food and Drug Administration (FDA). Ms. McCoyd also alleged that Abbott made misrepresentations about the safety and efficacy of the drug and paid kickbacks to doctors and others.
This case was not just about lost government dollars. It was about a company that placed money over medicine by marketing unlawfully to vulnerable patient populations. And we still don't know what the long-term consequences are for those patients who took Depakote as a result of marketing improprieties.
Unfortunately, Abbott is not the first pharmaceutical company to face allegations of unlawful marketing tactics. Astra Zeneca, Johnson & Johnson and Pfizer have all paid hefty fines following allegations of marketing derelictions.
False Claims Act whistleblowers have now documented an industry-wide epidemic of unlawful marketing practices. On the heels of multiple settlements, some of which have involved repeat offenders, there is little if any reason to trust “Big Pharma.”
With healthcare fraud projected at $60 billion a year, and with patient safety at issue, Congress must step in.
First, where a company engages in unlawful practices, with regard to the drug or device at issue, the FDA should be required to open its files to practitioners. The regulatory record should be an open book which is currently not the case.
Second, Congress needs to place education about drugs and devices in the hands of entities other than the pharmaceutical industry. The industry can no longer be trusted to dispatch legions of sales representatives to provide accurate information.
Third, Congress needs to create a pharmaceutical and device safety and investigation board. Where, False Claims Act litigation has identified "medical train wrecks," there needs to be an agency akin to the National Transportation Safety Board (NTSB) to report on what happened. Practitioners need this information so that they can make informed decisions about patient treatment.
The Abbott settlement is yet another reminder of why the False Claims Act is so important. With the wrongdoing that FCA whistleblowers have surfaced, now is the time -- especially in this election year -- for Congress to take action.