Abbott Whistleblower Seeks New Trial In $219M Stent Row

By Y. Peter Kang

The whistleblower who accused Abbott Laboratories of improperly marketing bile duct stents for off-label use asked a Texas federal judge Friday to grant a new trial after a jury in April cleared the medical device maker in a False Claims Act suit that sought $219 million in damages.

Former Abbott salesman and relator Kevin Colquitt said the court improperly excluded evidence showing that health regulators didn’t tacitly approve off-label use of the stents, causing the jury to err when it determined the company did not violate the FCA by making false statements or submitting false records to the Centers for Medicaid and Medicare Services.

Colquitt said U.S. District Judge Barbara M.G. Lynn’s exclusion of certain evidence — correspondence between an Abbott executive and the U.S. Food and Drug Administration —prevented him from countering Abbott’s argument at trial that the company had the FDA’s blessing to use the stents for off-label purposes.

“By not allowing relator to introduce the FDA evidence, the defendants were permitted to give the jury the impression that the FDA tacitly or impliedly approved of, or was simply neutral towards, defendants’ conduct when, in fact, the FDA expressly took action against defendants,” the 27-page filing states.

Colquitt said allowing the jury to get the false impression that health regulators were aware of and accepted the off-label usage caused undue confusion for the jury and resulted in a “miscarriage of justice.”

In addition, the whistleblower said Abbott’s counsel made closing arguments to the jury that were improper under Fifth Circuit case law. Colquitt said Abbott's attorneys presented a “golden rule” argument asking jurors to imagine themselves or a family member in need of an off-label vascular stent procedure. read more »

Another Study Finds Link Between Pharma Money and Brand-Name Prescribing

By: Ryann Grochowski Jones

A group of researchers at Harvard Medical School has found that medical industry payments to physicians in Massachusetts are associated with higher rates of prescribing brand-name drugs that treat high cholesterol.

The study’s finding, published today in JAMA Internal Medicine, is in line with a ProPublica analysis and story from March, which showed that physicians who receive industry money tend to prescribe higher rates of brand-name drugs — and thus, lower rates of similarly effective, more affordable generic drugs — when compared to peers.

An aim of the study, said lead author Dr. James S. Yeh, was to determine and reduce any industry influence that could produce bad behavior.

“You want your doctors to be objective rather than doing something because there is a financial gain, be it subconscious or conscious,” Yeh said. “That’s not the way we should be doing medicine.”

Yeh added that not all industry relationships with physicians are problematic. Often pharmaceutical companies fund large research projects that could produce advances in medical care.

The Harvard study concluded that physicians’ rate of prescribing brand-name statins — the category of drugs that treat high cholesterol — increased by 0.1 percent for every $1,000 in industry money received. Under $2,000 in payments, there was no significant increase in brand-name prescribing.

A 0.1 percent increase in brand-name prescribing might not seem like much, but the study notes that brand-name statins cost two to four times wholesale as much as generics and that cost is an important factor in patient health outcomes. Patients are less likely to keep taking drugs that are more expensive.

Both ProPublica and the Harvard researchers were careful not to assign a causal relationship between payments and brand-name prescribing because there’s a lot that the data alone can’t show — for instance, why a doctor chose a certain drug, or the list of preferred drugs used by a patient’s insurer. It’s also possible that pharmaceutical companies market their drugs more to doctors who are already high brand-name prescribers. read more »