Welcome to the Campaign to Stop Corporate Immunity (CSCI). Our members represent consumer, health, and trade associations fighting to restore the rights of patients injured by faulty medical devices.
Press Release:
For Immediate Release: Thursday, June 11, 2009
Contact: info@stopcorporateimmunity.org
Statement on Report of Department of Defense Ties to the Medical Device Industry
Medtronic Tries to Buy Vets Support – Patients Ask for Sen. Grassley’s Help
Washington, DC—On June 9, 2009, the Center for Public Integrity released a report detailing free travel the drug and device industry has sponsored for the Department of Defense. Although this tactic is technically legal, the Campaign to Stop Corporate Immunity feels this poses a serious conflict of interest and a threat to veterans’ health.
According to the report, medical device manufacturers curry favor with those at the DoD responsible for selecting which brands they will purchase, by paying for trips to exotic locales and covering the cost of expenses. Such undo influence could potentially be a health catastrophe for our military personnel. Studies have shown that health professionals courted by these special interests are more likely to recommend purchase of the product. This could be extremely dangerous for patients.
The medical device industry is lobbying against the Medical Device Safety Act (MDSA), legislation that would restore the rights of victims of faulty class III medical devices to seek justice in state courts. Class III medical devices include heart defibrillators, artificial valves, and prosthetic knees and hips. Currently, the medical device industry enjoys complete immunity for their class III medical devices, even when the devices are found to be defective and dangerous, and have even been recalled. This immunity was granted to device manufacturers following the Supreme Court’s decision in Riegel v. Medtronic last year. Prior to that decision, lawsuits served as a strong deterrent to the release of dangerous and defective medical devices.
Recently, it was revealed that medical device manufacturer Medtronic Inc., sponsored travel for Dr. Timothy Kuklo from Walter Reed, who in turn overstated the effectiveness of a drug manufactured by Medtronic and went so far as to falsify information and commit forgery in order to promote use of their product within the military community.[1] Sen. Charles Grassley (R-IA) is investigating, and the Campaign to Stop Corporate Immunity calls on Sen. Grassley to support the Medical Device Safety Act and further reign in these bad actors.
Congress must act to restore accountability to the medical device industry by removing complete immunity protection enjoyed by no other corporate entity in
[1] New York Times, 5/12/09, “Doctor Falsified Study on Injured G.I.’s, Army Says,” by Duff Wilson and Barry Meier.
Background:
The Supreme Court has ruled that medical device manufacturers are immune from lawsuits if their device received FDA approval, no matter how negligent they were, or how terrible the patient’s injuries. (Riegel v. Medtronic)
The FDA is not responsible for testing the safety of medical devices, but rather, they rely on the manufacturer’s testing data when issuing an approval. If medical device manufacturers can’t be held accountable in a court of law, they have no incentive to produce a reliable product or to be forthright with the FDA about the device’s safety.
The Medical Device Safety Act has been introduced to correct the Supreme Court’s decision in Riegel by reiterating Congressional intent. The Campaign to Stop Corporate Immunity will be working towards passage of this important legislation, but we need your help! Please <"_new"">contact your Senators and Representatives and enlist their support for this measure.
Recently, patients who have a faulty Medtronic Sprint Fidelis Lead in their Implantable Cardiac Defibrillators were kicked out of court because of Riegel. 1,496 people have been denied justice stemming from this single case. Please read about their dire situation. Congress must act to restore their rights.
Tell Congress You Support the Medical Device Safety Act!
Questions? Email: contact@stopcorporateimmunity.org