Are Medical Device Manufacturers About to Get a Truly Free Ride?
If my reading of an article in the latest New England Journal of Medicine is accurate, then the Supreme Court is about to rule on a case of momentous implications.
The case is Riegel v. Medtronic and it's a big one. Charles Riegel is suing Medtronic over a balloon angioplasty device that malfunctioned necessitating emergency care and ultimately coronary bypass surgery. Medronic is arguing that because their product received premarketing approval by the FDA, it has effectively been "immunized" against lawsuits in any state court arising from the failure of that product and that the suit should be thrown out.
Read more about this extremely important case here.I'm not a attorney and I don't play one on TV. But unless I'm facing the wrong end of a lawsuit (which has happened more than once), I do find the law fascinating and engaging. Every once in a while though, I encounter a legal case that truly cuts at the heart of our day-to-day lives. One such case was Kelo v. City of New London. This case ruled in 2005 by the U.S. Supreme Court gave local municipalities incredibly broad power in exercising eminent domain over private property owners.
Kelo sent shockwaves through society when a previously assumed fundamental right to be secure in one's property suddenly vaporized. A town could now take your home and give it to a real estate developer who could then commercialize it in such a way as to increase tax revenues to that town. People across the country (even people who were not owners but hoped one day to be) instantly felt less secure about their homes and their lives.
If my reading of this article in the latest New England Journal of Medicine is accurate, then the Supreme Court is about to rule on a case with similarly momentous implications.
The case is Riegel v. Medtronic and it's a big one. Charles Riegel is suing Medtronic over a balloon angioplasty device that malfunctioned necessitating emergency care and ultimately coronary bypass surgery. Medronic is arguing that because their product received premarketing approval by the FDA, it has effectively been "immunized" against lawsuits in any state court arising from the failure of that product and that the suit should be thrown out.
Their argument is based on an amendment to the FDA charter voted by Congress in 1976. This amendment granted authority to the FDA to certify the safety of medical devices, a power that had not previously been extended to them. In order to ensure that this new FDA mandate wasn't usurped by laws that individual states might create, a clause (360k(a)) was inserted in the amendment guaranteeing that FDA guidelines would supersede any such state laws.
It is this clause that Medtronic is attempting to exploit in this case. They are arguing that 360k(a) gives the FDA priority over state laws and that this includes state provisions allowing lawsuits against device manufacturers if the FDA certified a product before it went to market. Medtronic's argument then, is that Riegel's lawsuit against them should be completely thrown out.
If the Supreme Court rules for Medtronic, this would open the door to immunizing all medical device manufacturers from lawsuits. The article in the NEJM does an excellent job of describing the implications of such a ruling.
I hate lawsuits as much as the next guy but I'm not so militant that I don't recognize the important social good that they can serve. While lawsuits are a blunt, often misused weapon, they clearly help promote better medical product reliability and safety. To simply eliminate the public's right to sue a company making a faulty device would be extremely damaging to society.
I love medical device companies. I think the products they develop help incredible numbers of people. It is naive to think however, that getting FDA premarket approval is all that's necessary to insure product safety. It is the sword of Damocles in the form of a lawsuit that truly stimulates device manufacturers to "do the right thing".
I differ with the authors in one respect. They claim that the most compelling argument the Supreme Court should be guided by is whether a ruling for Medronic will truly benefit or hurt society. My understanding is that the role of the Supreme Court is simply to adjudicate the law and determine whether or not it conforms with the U.S. Constitution. It is not the Court's job to decide whether a law is stupid or not or whether it does or doesn't achieve a particular objective
In this case, I think that the Court needs to determine whether Congress ever intended clause 360k(a) to prevent product liability lawsuits against device manufacturers. For me, it's inconceivable that that was the case.
I can only hope that for my patients and for society as a whole, nine justices think long and hard about this one.
Any lawyers have an opinion on this?
The case is Riegel v. Medtronic and it's a big one. Charles Riegel is suing Medtronic over a balloon angioplasty device that malfunctioned necessitating emergency care and ultimately coronary bypass surgery. Medronic is arguing that because their product received premarketing approval by the FDA, it has effectively been "immunized" against lawsuits in any state court arising from the failure of that product and that the suit should be thrown out.
Read more about this extremely important case here.I'm not a attorney and I don't play one on TV. But unless I'm facing the wrong end of a lawsuit (which has happened more than once), I do find the law fascinating and engaging. Every once in a while though, I encounter a legal case that truly cuts at the heart of our day-to-day lives. One such case was Kelo v. City of New London. This case ruled in 2005 by the U.S. Supreme Court gave local municipalities incredibly broad power in exercising eminent domain over private property owners.
Kelo sent shockwaves through society when a previously assumed fundamental right to be secure in one's property suddenly vaporized. A town could now take your home and give it to a real estate developer who could then commercialize it in such a way as to increase tax revenues to that town. People across the country (even people who were not owners but hoped one day to be) instantly felt less secure about their homes and their lives.
If my reading of this article in the latest New England Journal of Medicine is accurate, then the Supreme Court is about to rule on a case with similarly momentous implications.
The case is Riegel v. Medtronic and it's a big one. Charles Riegel is suing Medtronic over a balloon angioplasty device that malfunctioned necessitating emergency care and ultimately coronary bypass surgery. Medronic is arguing that because their product received premarketing approval by the FDA, it has effectively been "immunized" against lawsuits in any state court arising from the failure of that product and that the suit should be thrown out.
Their argument is based on an amendment to the FDA charter voted by Congress in 1976. This amendment granted authority to the FDA to certify the safety of medical devices, a power that had not previously been extended to them. In order to ensure that this new FDA mandate wasn't usurped by laws that individual states might create, a clause (360k(a)) was inserted in the amendment guaranteeing that FDA guidelines would supersede any such state laws.
It is this clause that Medtronic is attempting to exploit in this case. They are arguing that 360k(a) gives the FDA priority over state laws and that this includes state provisions allowing lawsuits against device manufacturers if the FDA certified a product before it went to market. Medtronic's argument then, is that Riegel's lawsuit against them should be completely thrown out.
If the Supreme Court rules for Medtronic, this would open the door to immunizing all medical device manufacturers from lawsuits. The article in the NEJM does an excellent job of describing the implications of such a ruling.
I hate lawsuits as much as the next guy but I'm not so militant that I don't recognize the important social good that they can serve. While lawsuits are a blunt, often misused weapon, they clearly help promote better medical product reliability and safety. To simply eliminate the public's right to sue a company making a faulty device would be extremely damaging to society.
I love medical device companies. I think the products they develop help incredible numbers of people. It is naive to think however, that getting FDA premarket approval is all that's necessary to insure product safety. It is the sword of Damocles in the form of a lawsuit that truly stimulates device manufacturers to "do the right thing".
I differ with the authors in one respect. They claim that the most compelling argument the Supreme Court should be guided by is whether a ruling for Medronic will truly benefit or hurt society. My understanding is that the role of the Supreme Court is simply to adjudicate the law and determine whether or not it conforms with the U.S. Constitution. It is not the Court's job to decide whether a law is stupid or not or whether it does or doesn't achieve a particular objective
In this case, I think that the Court needs to determine whether Congress ever intended clause 360k(a) to prevent product liability lawsuits against device manufacturers. For me, it's inconceivable that that was the case.
I can only hope that for my patients and for society as a whole, nine justices think long and hard about this one.
Any lawyers have an opinion on this?
Labels: Law, Medical Technology
posted by The Medicine Man at 1:17 AM
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