File this under Catch 22. A study released this week found that only a fraction of the devices recalled by the FDA had been approved under the more stringent pre-market approval, or PMA process, which requires clinical tests and inspections. The PMA is usually reserved for higher risk devices, as opposed to the less stringent 510K standard for other devices.
The findings were bleak: Of 113 devices recalled between 2005 and 2009, only 21 had been approved through PMA, while 80 were cleared by the 510K process (the remaining eight were exempt from FDA review). The upshot: most devices that were recalled for life-threatening or very serious problems were originally cleared by the lower standard, suggesting a "reform" of the review process is needed.
However, the findings, which were published in the Archives of Internal Medicine (see here), bring to mind an interesting 2008 ruling by the US Supreme Court, which decided that patients can't file lawsuits against device makers when their products were approved by the FDA using the PMA process.
The court reviewed a lawsuit that pitted Medtronic against a woman whose deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts, or supercedes, state law claims brought by patients who were hurt by devices that received premarket FDA approval.
The ruling gave device makers a defense in product-liability lawsuits (here is the ruling and the back story). [You may recall, however, the Supreme Court also ruled that FDA approval does not preempt state lawsuits for drugs (some background here)].
And so this suggests something of a conundrum for patients. If harm is alleged by a device that was endorsed under the more rigorous PMA process, the patient can not file a lawsuit under state law - and state courts are, generally, believed to be more sympathetic venues for product-liability litigation. Yet if a device was not reviewed under PMA, a patient can file a state lawsuit. In other words, if more devices are eventually reviewed under the PMA process, patients who allegedly suffer harm may have less recourse.
photo thx to walknboston on flickr
27 Comments
The Medical Device Safety Act of 2009 was a bill that would have overturned Riegel v. Medtronic. Unfortunately, I don't think such legislation has much chance of passing in the current political climate.
The entire archives article is suspect in my opinion. The author first characterizes these as FDA ordered recalls. I don't believe FDA has that authority yet. Also, is it really surprising that the majority of device recalls were 510(k) devices when 99.9% of devices on the market go through the 510(k) process?
The FDA does have statutory ability to recall devices, although it is more of a two step process. Please refer to "Current Statutory Authority for Mandatory Recalls" page 6.
http://www.nationalaglawcenter.org/assets/crs/RL34167.pdf
The second of the 4 categories - Medical Devices - is on pg 7.
The SC ruling effectively incentivized device-makers to seek PMA, which is probably what FDA would prefer. The plantiffs' bar may not be so happy, though.
OK... to be specific, FDA does not have mandatory recall authority. It coerces device makers into recalling a product. The procedure you describe John is never used.
Patients go to hospitals to be made well. They do not go there to file a lawsuit.
They have the expectation that ALL products in use in hospitals are proven safe and effective when allowed to be sold by the FDA. Which is not true!!!
Who needs recourse if you are not harmed? No one! I vote for PMA every time!!!!
What patient knows some classes of medical devices are not proven safe and effective when "cleared" through the FDA's flawed 510(k) Premarket Notification process?
What patient knows a lawsuit may fall under federal pre-emption?
What patient knows they are under two regulatory authorities while the doctor is operating on them...The product potentially federally pre-empted and the doctor under the states' authority?
All patients in hospitals undergoing surgeries are in regulatory blackholes.
They are exceptionally lucky if they are not seriously harmed or killed.
Hospitals and doctors and bad medicines and medical products kill literally hundreds of thousands of people a year.
The whole regulatory process is flawed as there is always more concern for profit than for patient safety. Even by the FDA with the user fees and their ongoing desire to speed things up for industry, always at the potential expense of harm to patients.
This is the wrong discussion about this study...not whether the study is flawed but whether patients are protected by the FDA's regulatory process.
Lana Keeton Truth in Medicine Incorporated lanakeeton@truthinmedicine.us.com www.truthinmedicine.us.com
p.s.
Sven...so what pharmaceutical company do you work for? The whole article is suspect? Please. Check the facts for yourself and then report the article is suspect.
FDA has the statutory authority to make manditory recalls under the Food Drug and Costmetic Act Sec. 518(e). Manditory recalls are used a lot, just look at the CDRH website (there is usually a recall at least once a month).
A PMA is an application in which FDA approves a device to market. A PMA is a very long and costly application reserved for only those devices that have significant safety and/or efficacy risks.
A 510(k) (NOT 501(k)) is a clearance for a company to market a device (not an approval).
FDA preemption has taken away the right of victims (or their survivors) to hold a medical device or drug company accountable when their products harm or kill.
Most Americans have no idea what FDA preemption is and how it will impact their lives. And the media has not been doing their job of informing us.
It is time Americans became aware of this threat to our health, safety and democracy.
I must say I completely agree with FDA Preemption.
I am also convinced that all medical device manufacturers are completely infallible, completely above board and in every case utterly trustworthy. And because the FDA is so well funded and properly manned and equipped, there is no chance at all that a shady CEO could ever put one over on them. Don’t you agree?
Yeah, about as much as I agree root canals and prostate exams are enjoyable.
I am the senior author on this study. What surprised me was that most of the highest risk recalls -- the ones where device flaws could cause death or permanent harm -- had been cleared through the 510k process and therefore had never been subject to clinical trials, inspections, or post-market studies. 510k devices are supposed to be low or moderate risk, so how is it possible that they are killing patients, causing blindness, etc? 112.6 million of these devices were recalled in 2005-9. By the way, the device industry response was that considering all the devices cleared through the 510k process, these recalls are a tiny minority.
Diana, Consider Genzyme's 510K product - Seprafilm – An implantable membrane for adhesion reduction that is known to cause very severe reactions, including infections and death for some unfortunate patients. It can hardly be called a low risk device since once it is implanted and provided fertile ground for infection, it cannot be retrieved. Low risk? Tell that to the people it has killed. Yet this has been approved by 510K by the FDA.
Strangely enough, I am pretty sure that 510K devices manufacturers are _not_ shielded by preemption as interpreted in Riegel.
JiM-Seems the court felt that only products that went through PMA were worthy of pre-emption. This stands to reason since the standards for 501K are lower.
I think you are correct JiM and it appears that Seprafilm was not 510k approved.
@Diana Zuckerman, can you direct me to a list of 510k approved medical devices? Either my research skills are lacking (and I'm a librarian) or this is not information that medical device companies care to share.
Laura:
I am not Diane but will this link do?
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
The home page for this and other Medical Device related databases is:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm
The House Energy and Commerce Committee held a hearing today on regulation of medical devices. Dr. Nissen, one of the authors of this paper, gave testimony, as did Dr. Redberg, one of the authors of the editorial. Links to testimony here:
http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=8221
After the Riegel decision, the then DDL bloggers wrote a rather sober post under the theme of "big responsibility" provided by the shield on liability over PMA devices. While the devices at issue here are in a different category, I wonder if their conclusions are nevertheless now confirmed:
"If the high regulation, low litigation model can’t deliver the goods, then its failure will discredit the medical device industry, discredit the FDA, and discredit us lawyers who represent the industry."
JiM, I assume that the "goods” that they wanted to deliver are - higher numbers of innovative products funded by higher profits due to less litigation. It seems that this was the main argument that I remember in discussions a few years back.
John English, Thanks, that's exactly what I was looking for.
Hi Jaynesday--I think "the goods" simply meant products with appropriate safety and efficacy within a context of business and regulatory integrity. In other words, the reasonable basics.
Justice, I recall that DDL post, as well. As I recall, they paused for a moment in their celebration in order to present a "good winner" front. They may have truly believed what they wrote at the time but, if you look at DDL today, you see a parade of medical device cases that have been dismissed solely based upon preemption.
There appears to be nothing that a medical device company can do that will allow a victim to hold them accountable in the court of law. The Supreme Court's "parallel requirements", that proponents of preemption lauded as a way to soften the idea that there would be "no-way, no-how" that a medical device lawsuit could succeed, appear to be a big fat lie. Riegel, in combination with Buckman, which preempts fraud on the FDA, pretty much slams the courthouse door in the medical device plaintiff's face.
On Cafepharama, medical device companies' employee boards are available for all to see. On one recent Genzyme post, "Euflexxa will overtake Synvisc",on 2-01-2011 a poster stated, "...Genzyme doesn't have to report adverse events because it's a myth that you made up." A myth...the primary source of information that the FDA uses to collect data on medical devices? The reality is that there is no reason for Genzyme or any other medical device company to inform their employees of their legal obligation to report adverse events because, if they do, a red flag may go up, but if they don't, no foul no fault.
Indeed, Laura. After the Levine decision, DDL was less capable of "nuance." They wrote:
"So we don’t think we’ll be seeing prescription drug litigation vanishing from the face of the earth any time soon.
But we’ll keep trying."
Ah, yes, because hope springs eternal….
After all, something has to be done about all the drug and device victims. Look at Michigan for example, a Hellhole state, where, as “Bexis” of DDL claims, tricky victims of medical drugs and devices reside:
“Michigan plaintiffs have tried every trick in the book to flee their home state for somewhere – anywhere – else. We’re happy to report that most of the time they haven’t been successful in avoiding Michigan law.”
(Whew!! …. Makes me think of the Underground Railroad.)
Bexis ends his posting with this hope for America:
“Now, if we could only convince the other 49 states to follow Michigan’s lead.”
********** Pass the coffee, pass the cake, pass the word for all our sakes. God bless us, everyone.
Another step toward total commercial control.
I wrote this book about a completely corporate-driven procedure called catheter ablation for atrial fibrillation. A risky procedure of dubious merit, it is now a firmly entrenched money maker across the land.
http://collateral-damage.net
Nicotine Patch Alzheimers Patch Fentanyl Patch
All of these things have at least one fundamental thing in common.
And this is the last I will be entering this post.