Tweet
Whistle Blower Suit Reveals Ugly Side To Medical Devices
Are Physicians Being Bribed?
(January 31, 2006 - ICN Staff)
Would you agree to have a medical implant if you knew that your surgeon was receiving large payments from the company as an incentive for using their product? Could you be sure that you’re getting a balanced viewpoint on the best products on the market today if your doctors’ opinion had been bought??
Patients who have struggled with the decision of whether to have a spinal implant should take note of a Whistleblower lawsuit filed against Medtronic now sending ripples through the medical device industry. Initially filed two years ago in the United States District Court (Memphis), it was placed under seal until January 13, 2006. With the now public release of the details of the lawsuit, the accusations made by plaintiff and former employee Jacqueline Kay Poteet reveal a more controversial side to the device industry, the alleged compensation to physicians for doing implant surgery.
The suit suggests that Medtronic, one of the largest medical device makers in the USA, made payments of $50 million in just four years to physicians doing implant surgery as part of a “bribery program.” One surgeon in Wisconsin was paid $400,000 for just 8 days of work. A surgeon in Virginia was compensated with nearly $700,000 in fees for nine months of work in 2005.
While some industry and medical experts suggest that this is unethical and potentially illegal, representatives of medical device makers contend that the financial relationship is proper and necessary to help in the development of new products. US law is clear. Federal law forbids a payment that is intended to encourage a physician to use a company’s product.
However, there is a loophole. The use of gifts and consulting arrangements are unregulated and, in the past ten years, may have escalated dramatically. In a recent article in the New York Times, author Gardiner Harris said, “The drug industry spends tens of billions of dollars a year to woo doctors, far more than it spends on research or consumer advertising. Some doctors receive a significant part of their income from consulting… other take regular vacations or golfing trips that are paid for by companies.”
The questionable nature of these relationships has also attracted government scrutiny as well. Last year, US attorneys in Massachusetts and New Jersey issued subpoenas to eight device manufacturers (including Medtronic) in an ongoing investigation about the financial relationship between the companies and physicians.
As a former employee, Jacquelyn Kay Poteet had access to a number of internal documents that may help her case. An e-mail message by a Medtronic lawyer in 2003 was submitted in the lawsuit that appears to confirm that company may have engaged in this practice. It said “When we are sending scores of doctors to a nice resort like this under the guise of training and education on our products, I think we need to be more careful and stick to the limits of our rules as best as we can.” In addition, Medtronic apparently kept detailed records of physicians who attended their events and created plans to target physicians who were not using their devices.
Industry response has been lackluster and, apparently, temporary. According to a new filing in the lawsuit, payments made by Medtronic to physicians apparently slowed down in 2004 but resumed last year. One physician in Virginia made $300,000 in consulting fees in 2003, $75,000 in 2004 and a whopping $700,000 for consulting work in the first three quarters of 2005.
Ironically, a group of physicians led by Dr. David Blumenthal (Harvard Medical School) suggested in this Month’s issue of the Journal of the American Medical Association that all gifts over a “modest value” to physicians be banned because they could have “negative results on clinical care.” They believe, however, that few will listen to their suggestions.
One success story is Kaiser Permanente, which has implemented nearly all of the recommendations suggested by the article. Dr. Sharon Levine, associated executive director of Kaiser Permanente Northern California, was recently quoted in the New York Times: “We thought it was critical for us that our patients never had a doubt that the decision made about a drug or a device was based on the best interests of the patient and not the financial interest of the physician.”
As a patient considering the use of a medical device, it makes sense to be aware of this issue. You certainly have the right to ask your doctor if he or she receives any industry money for doing this surgery. You can ask about their training in the use of the device and the number of procedures they’ve done previously. It’s also important to ask about other products available and what the pros and cons of each device may be. You can also ask about the role of the sales representative and if they will be present in the operating room. Are you comfortable with that prospect??
We believe that you must also educate yourself about the device not only from company materials (such as videos) but also from other patients who have had the procedure. Ask your doctor if you can talk with other patients who have had success stories.. Take the time to search the internet for other patients who have had that device implanted, particularly those who have experienced complications. The FDA maintains an extensive database of medical devices that have malfunctioned or caused a serious injury. The MAUDE database is easy to use and searchable by company, product name and date at: http://www.fda.gov/cdrh/maude.html
REFERENCES:
Abelson, Reed. “Whistle-Blower Suit Says Device Maker Generously Rewards Doctors” New York Times, January 24, 2006.
Harris, Gardiner. “In Article, Doctors Ban on Gifts From Drug Makers” New York Times, January 25, 2006
Are Physicians Being Bribed?
(January 31, 2006 - ICN Staff)
Would you agree to have a medical implant if you knew that your surgeon was receiving large payments from the company as an incentive for using their product? Could you be sure that you’re getting a balanced viewpoint on the best products on the market today if your doctors’ opinion had been bought??
Patients who have struggled with the decision of whether to have a spinal implant should take note of a Whistleblower lawsuit filed against Medtronic now sending ripples through the medical device industry. Initially filed two years ago in the United States District Court (Memphis), it was placed under seal until January 13, 2006. With the now public release of the details of the lawsuit, the accusations made by plaintiff and former employee Jacqueline Kay Poteet reveal a more controversial side to the device industry, the alleged compensation to physicians for doing implant surgery.
The suit suggests that Medtronic, one of the largest medical device makers in the USA, made payments of $50 million in just four years to physicians doing implant surgery as part of a “bribery program.” One surgeon in Wisconsin was paid $400,000 for just 8 days of work. A surgeon in Virginia was compensated with nearly $700,000 in fees for nine months of work in 2005.
While some industry and medical experts suggest that this is unethical and potentially illegal, representatives of medical device makers contend that the financial relationship is proper and necessary to help in the development of new products. US law is clear. Federal law forbids a payment that is intended to encourage a physician to use a company’s product.
However, there is a loophole. The use of gifts and consulting arrangements are unregulated and, in the past ten years, may have escalated dramatically. In a recent article in the New York Times, author Gardiner Harris said, “The drug industry spends tens of billions of dollars a year to woo doctors, far more than it spends on research or consumer advertising. Some doctors receive a significant part of their income from consulting… other take regular vacations or golfing trips that are paid for by companies.”
The questionable nature of these relationships has also attracted government scrutiny as well. Last year, US attorneys in Massachusetts and New Jersey issued subpoenas to eight device manufacturers (including Medtronic) in an ongoing investigation about the financial relationship between the companies and physicians.
As a former employee, Jacquelyn Kay Poteet had access to a number of internal documents that may help her case. An e-mail message by a Medtronic lawyer in 2003 was submitted in the lawsuit that appears to confirm that company may have engaged in this practice. It said “When we are sending scores of doctors to a nice resort like this under the guise of training and education on our products, I think we need to be more careful and stick to the limits of our rules as best as we can.” In addition, Medtronic apparently kept detailed records of physicians who attended their events and created plans to target physicians who were not using their devices.
Industry response has been lackluster and, apparently, temporary. According to a new filing in the lawsuit, payments made by Medtronic to physicians apparently slowed down in 2004 but resumed last year. One physician in Virginia made $300,000 in consulting fees in 2003, $75,000 in 2004 and a whopping $700,000 for consulting work in the first three quarters of 2005.
Ironically, a group of physicians led by Dr. David Blumenthal (Harvard Medical School) suggested in this Month’s issue of the Journal of the American Medical Association that all gifts over a “modest value” to physicians be banned because they could have “negative results on clinical care.” They believe, however, that few will listen to their suggestions.
One success story is Kaiser Permanente, which has implemented nearly all of the recommendations suggested by the article. Dr. Sharon Levine, associated executive director of Kaiser Permanente Northern California, was recently quoted in the New York Times: “We thought it was critical for us that our patients never had a doubt that the decision made about a drug or a device was based on the best interests of the patient and not the financial interest of the physician.”
As a patient considering the use of a medical device, it makes sense to be aware of this issue. You certainly have the right to ask your doctor if he or she receives any industry money for doing this surgery. You can ask about their training in the use of the device and the number of procedures they’ve done previously. It’s also important to ask about other products available and what the pros and cons of each device may be. You can also ask about the role of the sales representative and if they will be present in the operating room. Are you comfortable with that prospect??
We believe that you must also educate yourself about the device not only from company materials (such as videos) but also from other patients who have had the procedure. Ask your doctor if you can talk with other patients who have had success stories.. Take the time to search the internet for other patients who have had that device implanted, particularly those who have experienced complications. The FDA maintains an extensive database of medical devices that have malfunctioned or caused a serious injury. The MAUDE database is easy to use and searchable by company, product name and date at: http://www.fda.gov/cdrh/maude.html
REFERENCES:
Abelson, Reed. “Whistle-Blower Suit Says Device Maker Generously Rewards Doctors” New York Times, January 24, 2006.
Harris, Gardiner. “In Article, Doctors Ban on Gifts From Drug Makers” New York Times, January 25, 2006
In Memory of My Father (Lawerence) 1/25/2007
, 
It makes me very unhappy though.
Comment