The Qui Tam Team Blog Join In the Fight Against Fraud

Medtronic is the leading manufacturer of medical devices. Despite repeated investigations by federal and state authorities, the company raked in a whopping $15 billion in 2009 alone. Federal scrutiny of the medical device industry has generally been relatively lax compared to that directed toward the pharmaceutical industry, and sometimes it seems as though medical device manufacturers will stop at nothing to get doctors to use their products. That is, until they run into a doctor like David Gossman, M.D.

From 1987 until September, 2009, Dr. Gossman was a cardiologist at the Lahey Clinic near Boston . He was good at what he did, and was the subject of a 2008 promotional article for the clinic chronicling his successful efforts to help a patient recover from a massive heart attack.

While at the Lahey Clinic, Dr. Gossman observed what he determined to be violations of ethical guidelines concerning the clinic’s financial relationship with Medtronic. Dr. Gossman claims that Medtronic offered the hospital “access to the CoreValve, a new heart valve that will be in clinical trials in the U.S. soon, predicated on the purchase and increased utilization of other products made by Medtronic.” In addition, Dr. Gossman claims that a senior cardiologist at the lab, Dr. Thomas Piemonte, has “significant financial interest in Medtronic” and earns “substantial yearly income” serving on the Medtronic speaker’s bureau, which educates doctors about the company’s products. Furthermore, Dr. Gossman claims that Dr. Piemonte’s wife is both a Medtronic employee and a stockholder, and that Dr. Piemonte and the chair of the cardiology department, Dr. Richard Nesto, put pressure on their fellow doctors to use more Medtronic products. Dr. Gossman determined that these were serious conflicts of interest, and he followed his ethical obligation and raised his concerns.

In September, 2009, Dr. Gossman raised his ethical objections during a lecture on medical ethics, in which he asked a hypothetical question about the very situation he had observed. He asked what the hospital’s position would be on an arrangement in which “a medical device company approaches a hospital offering access to a new investigational device, but predicates access to the device on increased utilization of other products sold by the company.” Dr. Gossman claims that Dr. Piemonte and the chairman of the cardiology department mounted an investigation of Dr. Gossman and sought negative feedback about him from other employees. On September 8th, only a few days after Dr. Gossman had raised his ethical question at the lecture, he was fired.

Determined to stand up for himself and hold the Lahey Clinic accountable for the ethical lapses, Dr. Gossman filed suit seeking damages both for defamation and for violations of the Massachusetts Healthcare Whistleblower Act. Massachusetts’ Healthcare Whistleblower Act prohibits retaliatory action (e.g., firing) against a healthcare employee under a variety of circumstances. For example, a healthcare employee may not be subjected to retaliatory action if he or she

objects to or refuses to participate in any activity, policy or practice of the health care facility or of another health care facility with whom the health care provider’s health care facility has a business relationship which the health care provider reasonably believes is in violation of a law or rule or regulation promulgated pursuant to law or violation of professional standards of practice which the health care provider reasonably believes poses a risk to public health. ALM GL ch. 149, § 187 (b) (3).

Qui tam and whistleblower protections vary from state to state. This map shows which states and cities have False Claim acts; consult with a Qui Tam Team attorney to determine what other state and federal protections may be available to you.

Predictably, both Medtronic and the Lahey Clinic are following the usual tactic of “deny, deny, deny.” A Medtronic spokesman said, “We expect that all of our employees adhere to our very strict policies and code of conduct regarding the sale of our products.” The Lahey Clinic claims that Dr. Gossman caused “severe problems” in his relationships with his colleagues that led to his termination, and that these problems were unrelated to any comments he may have made about ethical issues. One has to wonder, however, about the timing of the decision to fire Dr. Gossman. If Dr. Gossman was so problematic, why would the clinic celebrate Dr. Gossman’s skills and expertise in a promotional document (which as of this blog posting is still available on Lahey’s website) but then fire him a year later?

There are some important lessons to be learned from Dr. Gossman’s case. One is that there are many committed professionals out there who will do what it takes to stand up for their ethical principles. Another is that whistleblowers may be subjected to termination and harassment for following the rules and questioning those who don’t. Fortunately, there are federal and state laws that protect those who stand up for what is right. The Qui Tam Team blog will keep you updated on the progress of Dr. Gossman’s case.