Sunday, June 06, 2010

St. Jude Medical Settles

We could not let more than a week go by without discussing another legal settlement by a major health care organization.  From the Pioneer Press,
Little Canada-based St. Jude Medical will pay $3.7 million to resolve allegations the medical device company provided kickbacks to hospitals in Kentucky and Ohio to secure sales of heart devices, the U.S. Department of Justice announced Friday.

The government alleged that St. Jude Medical provided rebates that were retroactive and paid based on a hospital's previous purchases of heart device equipment from the company. Prosecutors also charged that St. Jude Medical paid rebates for purchases of heart-device equipment sold by its competitors to induce purchases of similar equipment from St. Jude Medical in the future.

As I understand it, the issue was that the rebates did not amount to a simple volume discount, but were given only if the hospital allowed St. Jude to become its dominant supplier of certain devices, for example,
One such rebate was offered to Parma Community General Hospital in Parma, Ohio, a suburb of Cleveland, according to settlement papers made available by the government on Friday. The medical center could earn discounts on products if it gave St. Jude Medical 90 percent of its annual usage of mechanical heart valves, 80 percent of its annual usage of conventional pacemakers and 50 percent of its annual usage of conventional implantable defibrillators, according to the settlement agreement.

The two-year contract began in April 2003 and St. Jude Medical at the time did not have government approval to sell newer 'biventricular' pacemakers and ICDs. A rival company, however, did have approval for such products, and the settlement agreement asserts that St. Jude agreed to give the Ohio hospital a rebate for each biventricular pacemaker and ICD purchased from the competitor so long as Parma hospital maintained market share targets on St. Jude Medical products.

'The contract also mandated that once (St. Jude Medical) gained Food and Drug Administration approval for its own biventricular devices, the rebates would end, and (Parma) could earn discounts by giving (St. Jude Medical) 80 percent of its annual usage of biventricular pacemakers, and 50 percent of its annual usage of biventricular ICDs,' the settlement agreement states.

What was the problem with this?
'Hospitals should base their purchasing decisions on what is in the best interests of their patients,' Tony West, assistant attorney general for the Justice Department's civil division, said in a statement.

St. Jude's response was that it was all so trivial and so long ago,
In a statement issued Friday, St. Jude Medical said: 'The allegations centered on small, isolated product rebates that the company paid more than five years ago. The company entered into a settlement agreement in order to avoid the potential costs and risks associated with litigation.'

So add another marcher in the parade of legal settlements. While most of the marchers in this parade seem to be pharmaceutical companies, it appears that device manufacturers are trying to catch up.

We have been noting new entrants to this parade for a while mainly as a way to document how often health care organizations, including some of the largest and seemingly most respectable organizations, have been accused of unethical conduct.  Often this conduct seems likely to increase health care costs, by driving up the prices of goods or services, or by encouraging the use of expensive tests or treatments when perhaps something simpler and cheaper would be just as good for the patient.  Sometimes, this conduct seems likely to decrease health care quality, and worsen patient outcomes because the tests or treatments being pushed by the unethical behavior may be less effective, and/or more likely to cause harm than other credible alternatives.

We also have repeatedly said that the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior.  Even large fines (and the one described above would be peanuts to a large health care corporation) can be regarded just as a cost of doing business.   Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.


Wellescent Health Forums said...

These sorts of agreements represent unethical business practices in the first place, but when they alter patient access to the most appropriate care, they can be playing with the health and well-being of these patients. While it is good to see that enforcement has discovered this case, the question is just how much other activity of this nature goes on without being discovered?

Cetamua said...

"Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich."

Given the breakdown of the rule of law in this country, and the rapid cleavage toward a multi-tiered system of justice, (bankers, "I waterboarded KSM", Joe Cassano at AIG, BP etc. etc. etc.) It would be entirely reasonable to expand the above statement:

Real socio-economic reform needs to make leaders accountable, and especially accountable for the bad behavior that helped make them rich, powerful, or both.

Health care is merely a symptom of a much wider problem that is corroding the very foundations of our society.

Ben Franklin admonition was truly prophetic:

"We gave you a Republic...if you can keep it!"