Another day, another multi-billion-dollar industry looking for a handout.
This time it’s the Wall Street hedge funds and venture capital funds — you know, the ones that talk “free market” but somehow always need government assistance — that have invested heavily in medical device manufacturers:
As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.
“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”
The New York Times found that “people associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years.” Shocking, I know.
Take a look at how thoroughly the Republican-controlled House of Representatives examined the issue:
Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing in the Senate had a more varied witness list. Two weeks ago, four Democratic congressmen wrote to their Republican counterparts about the imbalance in the House testimony and suggested the hearings had failed to address potential dangers “if medical devices are not appropriately regulated.”
Not one. A little over a year ago, Johnson & Johnson and the FDA announced the recall of nearly 100,000 defective DePuy hip replacement implants because the metal-on-metal bearings degrade and release metal shavings into surrounding tissues and patient’s bloodstreams, requiring revision surgery and treatment for blood poisoning, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.
Maybe Congress thought that was an exception and all the other medical implants are totally safe. So what about July of this year, when the FDA reported:
In October 2008, the FDA issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, and to provide recommendations on how to mitigate risks and how to counsel patients. Following the PHN, the FDA continued to monitor the outcomes of urogynecologic use of surgical mesh. A search of the FDA’s Manufacturer and User Device Experience (MAUDE) database from the last 3 years (January 1, 2008 – December 31, 2010), identified 2,874 Medical Device Reports (MDRs) for urogynecologic surgical meshes, including reports of injury, death, and malfunctions. Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs.
Just under 3,000 vaginal mesh problems because the surgical mesh eroded the vaginal wall causing painful sexual intercourse, infection, urinary problems, vaginal shrinkage, bleeding, and organ perforation, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.
Or maybe the Republicans in Congress didn’t want to hear what patients and their advocates might say: the FDA does too little to ensure medical devices are safe. The FDA needs more regulations, not fewer.
The Depuy ASR hip implant and transvaginal mesh implant debacles both had the same cause: the 510(k) clearance loophole. Under that loophole, if a medical device manufacturer can convince the FDA that the implant is “substantially equivalent” to something else on the market, then it’s approved, even without any actual testing to see if it’s safe or even useful.
It’s a bad idea, which is why the Institute of Medicine — which investigated 501(k) clearance at the request of the FDA — recommended the process be abolished. Consider this depressing section from the FDA’s safety update on transvaginal mesh placement:
Surgical mesh products are currently regulated as Class II devices and are reviewed under the 510(k) Premarket Notification Program. The FDA’s premarket review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety. Bench and/or animal testing have been used to confirm that engineering specifications are met and that the mesh material is biocompatible. Clinical performance data typically has not been used to support clearance for POP or SUI urogynecologic mesh products.
In other words, they just checked to make sure the transvaginal surgical mesh was made like normal surgical mesh. The FDA didn’t even bother to review “clinical performance data” on actually implanting the mesh to treat POP or SUI to see if it worked and if it was safe. It just made sure the vaginal mesh looked like surgical mesh and that was that. Those are the ‘overly burdensome’ regulations medical device manufacturers think are too stringent. There are Representatives and Senators who believe we need less FDA regulation?
There’s another important aspect to this debate: medical device manufacturers already have a special exemption from the negligence laws that apply to all the rest of us. Lowering FDA standards will make that special exemption even bigger.
As I’ve written before, it’s already particularly difficult to sue drug makers even for breaking federal law, and some courts are considering eliminating manufacturers’ legal duty to make safe drugs, leaving plaintiffs with a single potential claim, i.e. the “failure to warn” based on the drug maker not honestly describing how dangerous their drugs really are.
To put it another way, in a car accident case, the question is if the defendant driver drove the car in an appropriate manner. In drug cases, though, Congress and the courts change all the rules: in most states you can’t even argue the drug maker was negligent, you can only argue the drug maker didn’t warn you that they were negligent. It’s like if we said you can’t sue someone for driving recklessly, you can only sue them for not giving you enough warning that they were driving recklessly. It’s unreasonable and unfair.
Medical implant companies, however, have all those same special defenses available plus a special gift from Congress and a majority of the Supreme Court: the Medical Devices Amendments to the Food, Drug and Cosmetics Act, which the Supreme Court decided in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008) exempts medical device manufacturers from personal injury claims alleging flaws in a design or label once the application for the design or label has gained premarket approval from the FDA. If one of the hundreds of thousands of people injured by defective medical devices every year wants to sue, their claim must be “premised on a violation of FDA regulations.”
It’s like if you couldn’t sue a licensed driver, even if they were drunk or reckless or speeding away from a robbery, unless you could prove the driver lied on their driving test to get their license. Sometimes even these “fraud on the FDA” claims are dismissed by courts without ever seeing a jury. It’s a sad comment on our Congress’ and Supreme Court’s values.
And that’s why the investors in those medical device companies want fewer FDA regulations: it’s a double-whammy. They can more quickly ship inadequately tested medical implants while also avoiding any legal responsibility when people are inevitably hurt.
As always, we don’t have to sit back and take it. Elections matter. Calls to Representatives and Senators matter. Let them know what you think.