The Scalpel & The Cash: A Lawsuit Over A Conflict
8 CommentsBy Ed Silverman // June 30th, 2008 // 12:56 pm
Katrina McKenzie was tired of the pain in her hips and took her surgeon’s advice to replace them with experimental implants. And so the 31-year-old New Jersey woman agreed to participate in a clinical study, knowing there was a risk her new hips could fail, The Philadelphia Inquirer writes.
But she didn’t know the manufacturer financing the 2002 study, Smith & Nephew, was also paying her surgeon tens of thousands of dollars a year as a consultant, the paper continues. And she later filed a lawsuit against the University of Pennsylvania Health System and her surgeon, Jonathan Garino, contending he botched her surgery and the consulting fees affected his decisions.
Garino and Penn responded, in court filings, that the payments had no effect on her treatment, according to the paper. Garino was participating in a trial aimed at winning FDA approval for the new implant. In his deposition, Garino said Smith & Nephew sponsored the study, but he didn’t receive any direct financial benefit, and that the device maker paid Penn for his time and expenses.
But under questioning McKenzie’s lawyer, he acknowledged payments for other work by Smith & Nephew, which he didn’t disclose. In 2002, Garino estimated he was making “$20,000 to $50,000 annually” as a company consultant, the paper writes. He was paid $200 to $400 an hour to do “things like instruct other surgeons how to use devices, how to do their surgery better, give lectures at Smith & Nephew-sponsored courses, provide ideas for improvement of products…things of that nature.”
In 2007, Garino got at least $75,000 from Smith & Nephew, according to company disclosures. In response to written questions from The Inquirer, Garino said “the vast majority of payments to me are royalties for joint replacements that I developed.” Asked during a deposition if he had told McKenzie or other patients that he was paid by the company, Garino said “I did not.” His failure to disclose that work was contrary to Penn policy, which says that docs must tell patients about any financial relationship with a company sponsoring a clinical trial, the Penn spokeswoman told the paper.
What do you think?
Should Garino have disclosed the payments to the patient?
- Yes (91%, 102 Votes)
- No (10%, 11 Votes)
Total Voters: 112
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Justice in MI
I think whatever the “right answer” to this question has to be on the level of general policy, if not legally at least by the AMA, rather than for individual instances.
As recently discussed, it is certainly unrealistic to expect the average (or even not-average) patient to ask about this.
And even if the surgeon had mentioned his connections, what would he have said - “Oh yeah, and this is why I’m using this device for you.”
Personally, I believe the information should be accessible for pts who want to know. But I don’t think it is realistic to expect either docs to discuss their ties in individual circumstances or to wait for pts to ask.
Pharma Whore
It is not necessary for the doc’s to disclose to the patinet that they have taken funding. It is up to each individual HCP to hold themselves to that higher standard, we as patients put our lives in their hands.
If we try to hold these surgeons back we are doing all of ourselves a disfavor. I know that I want the most arrogant, agressive, knowledgable surgeon if I have to be operated on. Being a surgeon is about perfection and ego, who is the best, who will have the guts to push the envelope. It doesn’t sound PC but, it is what has to bee.
That is why there is insurance.
dan
My views and opinion are not in regard to a particular case, such as this one. Rather doctors should be obligated to inform patients of any finincial ties with any drug or device maker as it relates to the patient’s treatment options received from a certain doctor.
Drugmakers and managed care companys, along with pharmacy benefit manager payments to doctors should be disclosed to the doctor’s patient, as they have a right to know to ensure a proper doctor-patient relationship.
Jack2
If he works for Penn and Penn has a policy to disclose he should disclose.
Justice in MI
I missed the last part about Penn policy when I first read the piece. Under those circumstances, fully concur with Jack2.
Harry Lewis
The Penn policy dates, I would guess, from after the death of Jesse Gelsinger during a gene therapy clinical trial in 1999. In that scenario, there was no disclosure of a financial interest of the clinical investigator in some of the technology used in the clinical trial. Given the notoriety of that incident, it is shocking that the doctor here failed to disclose his financial ties to the device company.
Former pharma Marketing Exec
I also concur with Jack2 and I believe Harry is making a very appropriate guess, that was a famous case and is still referred to in many bio ethical discussions.
I was thinking however, that patients should be given the full name and descriptions of all drugs and devices they are being treated with and encouraged to at least conduct their own search before consenting. Sometimes a quick “google” search can lead you to published studies. The disclosures listed can give you an idea of the breadth and scope of the work. In the case of Smith & Nephew, it will also point you to the page indicating the amount of money he has received from the company.
It will be a major step forward when all drug companies were required to provide full disclosures of payments for any work to doctors.
However, it may make decision making for patients more difficult - how will you find a doctor not taking any money from anyone?
But lets cross that bridge when we get to it….
kytra
I think that the doctor should have disclosed if that was required by his employer.
Otherwise imagine that you are a well known cardiologist consultant in your 50’s and you want to treat a newly diagnosed patient which has hypertension and coronary heart disease.
Whoa, only the disclosure and the subsequent discussion would take half a day!!