The Medical Device Safety Act of 2008 would overturn the “federal preemption” clause in the 1976 Medical Device Amendments that allowed Medtronic to win a Supreme Court case earlier this year. AdvaMed late yesterday issued a statement against it. “A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients,” said AdvaMed President Stephen J. Ubl.
The case, Riegel v. Medtronic, concerned a patient who was injured by a Medtronic catheter in 1996. The 1976 law stated that makers of PMA products cannot be sued in state courts if the products did not violate federal laws and regulations. It established FDA as the sole arbiter of safety and effectiveness of PMA products. This “preemption” of lawsuits in state courts does not apply to 510(k) products, nor to PMA products that are found to be adulterated or misbranded. (The Medtronic catheter was neither. Instead, it was misused by the patient’s doctor.)
The consequences of allowing such cases to proceed in state courts could allow states to set their own standards for safety and effectiveness of PMA products, which would be chaotic, Ubl said. “The Supreme Court’s 8-1 decision in Riegel v. Medtronic re-affirmed what most Federal courts have regarded as settled law since 1976 — that the FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology,” he said. “This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.â€
July 7th, 2008 at 11:35 pm
Obviously AdvaMed President Stephen J. Ubl has not bothered to read the Medical Device Act of 1976. He needs to educate himself before he makes these ridiculous statements.
Federal Pre-emption by the FDA was a phrase in a preamble to an FDA document written by Daniel Troy, then Chief Counsel of the FDA. He worked for pharmaceuticals before his stint at the FDA and works for them again. Conflict of interest here?
“what most Federal courts have regarded as settled law since 1976″ Are you kidding? What cases is he reading? Does he read cases regarding pre-emption? If he is reading any of those cases, he is wearing “Pharmaceutical” colored glasses.
It would be much better if President Stephen J. Ubl said nothing as opposed to showing such ignorance of the facts.
“in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.â€
What “essential medical technologies”? Big Pharma has not invested in R&D in so long, they don’t know what R&D means.
“More lawsuits”…maybe Big Pharma should produce drugs and devices that are actually safe and effective to stop harming people and the lawsuits would stop.
“Ultimately higher health care costs”…Big Pharma should stop spending $1 Billion on advertising to launch each of their “new” products and then charging these advertising costs on their books to their non-existent R&D Departments.
Lana Keeton