Imagine if lights, kitchen equipment, and home electronics didn’t need to be tested for electrical shock and fire hazards, and that no one ever certified that the devices were safe. Would you put them in your home?
What about a car that had just one crash test, at low speed, and Congress had passed a special law making it impossible for anyone to sue the car company, so the company couldn’t be held responsible for people’s injuries? Would you put your family in one?
Yet, those examples above describe the state of the $156 billion American medical device market. Most medical devices aren’t tested with clinical trials. The medical devices which are tested can pass with a minimal showing, and Congress passed a special law that says that this minimal showing is enough to shut the courthouse doors on victims.
The Bleeding Edge, a documentary just released on Netflix, details the many problems with medical devices today, with an emphasis on the suffering of thousands of people due to Bayer’s Essure contraceptive, DePuy’s ASR hip implant, Johnson & Johnson’s transvaginal mesh, and the Da Vinci surgical robot. I know these awful products well; most of my law practice is representing victims of medical devices and pharmaceuticals.
If no one ever watched The Bleeding Edge, the film would still be a remarkable success: soon after it premiered, Bayer announced it will discontinue sales of Essure.
But everyone should watch it. Essure was just one part of a broken regulatory system and a corrupted market, and medical device companies often lobbying Congress to make it even worse.
It doesn’t have to be this way.
The Broken Regulation Of Medical Devices
As The Bleeding Edge points out, one key problem is the 510(k) loophole, which I’ve written about many times before, and which the Institutes of Medicine long ago recommended be abolished. Most medical devices need not undergo any testing because they are approved under a provision that only requires the manufacturer to show “substantial similarity” to some other approved medical device. The FDA’s interpretation of “substantial similarity,” however, has gone so far off the rails that the FDA regularly approves medical implants with different designs, different materials, and different purposes. The DePuy ASR hip implant used never-before-tested components, and transvaginal mesh was used for a never-before-tested purpose—yet both sailed through the 510(k) loophole.
If a medical manufacturer doesn’t want to or can’t use the 510(k) loophole, then they go through the “premarket approval” (“PMA”) process for “Class III” medical devices. As the FDA says, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” We can already see one obvious problem: there’s no doubt a complete hip replacement (like the DePuy ASR) or the surgical implantation of a foreign object (like transvaginal mesh) “present a potential, unreasonable risk of illness or injury,” and so should have to go through the premarket approval process. But the FDA doesn’t see things that way, and so routinely allows inherently risky devices to glide through the 510(k) loophole without any studies.
Essure went through this “PMA” process, which, as we’ll discuss in a minute, is often referred to as “rigorous.” You can read the “safety and effectiveness data” used to approve it. As The Bleeding Edge points out through interviews of clinical trial participants, this data was inaccurate, and the researchers routinely changed the participants’ answers to make the device look safer than it was. Yet, even the data taken at face value isn’t much: Essure was approved and sold to the public after a single “Phase II” clinical trial (a trial designed mostly to look at whether the implant can function, rather than if it is safe) of 227 women and a single “Phase III” clinical trial of 518 women.
Look carefully at page 8 of that summary of Essure safety data: that table of “adverse events” only includes those events the clinical trial investigator (who was paid by the manufacturer) said were “possibly” related to the Essure and only those events that occurred in the first year after the implantation. If something terrible happened to a woman but the investigator didn’t think or didn’t want to say it was “possibly” related to the Essure—such as autoimmune disorders and inflammatory reactions to the toxic metals in Essure—then it wasn’t included. If something terrible happened to a woman more than a year after implantation, it wasn’t included.
The FDA thought this sham of a report was good enough. The FDA panel meeting on Essure approval was videotaped and has to be seen to be believed; I won’t spoil it, I’ll just urge you again to watch The Bleeding Edge, which includes clips from it.
The regulatory process for medical devices is, in a word, indefensible. Even when the products are subject to a clinical trial, like DePuy’s Pinnacle hip implant, the manufacturers manipulate the trial results and then viciously attack anyone who calls them out for it. But the problems don’t stop there. Another reason why America is now awash in dangerous medical devices is money.
How Medical Devices Use Money To Control Medicine, And How They Make You Pay For Their Negligence
The Bleeding Edge pulls back the curtain on the unholy alliance between doctors, sales representatives, medical organizations, and medical device manufacturers. For example, several members from the Essure Problems group go to a conference for the American College of Obstetricians and Gynecologists (“ACOG”), where they are dismissed and ignored by members. ACOG is hardly a friend to patients: when they’re not helping shuttle along dangerous medical devices so their member OB/GYNs can make an extra buck, they’re writing unscientific “guidelines” to help negligence doctors evade responsibility for malpractice.
One issue The Bleeding Edge did not go into, however, was the many legal hurdles put in place to prevent patients injured by defective medical devices from bringing lawsuits. The Bleeding Edge follows several women whose lives were destroyed by Essure. They likely qualify for lawsuits and probably have them—but Bayer has still refused to settle Essure lawsuits and among the reasons why are the many dubious legal defenses available to them.
We’ll get to those in a moment, but it’s important to recognize that an injured patient’s ability to bring a lawsuit and to have it promptly go to trial are not just a matter of justice. Lawsuits are also a matter of patient safety. If a medical device company can’t be sued, then they won’t be financially responsible for the harm they negligently cause, and they won’t have nearly the same incentive to make a safe product. Fact is, lawsuits made cars safer by making car manufacturers accountable for the damage they caused, and removing the many barriers to lawsuits against medical device manufacturers will help do the same.
Lawsuits are also a way of shifting the costs of the damage—including medical costs—onto the entity responsible for them. The costs of medical care are part of the damages in a lawsuit and, if a plaintiff is successful in a lawsuit, the very first thing that happens is a payment to the plaintiff’s health insurer (or to the government if the plaintiff was on Medicare or Medicaid) reimbursing them for the cost of treatment related to the claim. Right now, for example, because Bayer refuses to settle the Essure lawsuits, the entire cost of treatment for Essure victims is being paid by the victims, their health insurers, and the taxpayers—which means that you are paying for an injury Bayer negligently caused.
To explain the special exemption Congress granted “premarket approved” medical devices like Essure, I’ll just quote a brief Bayer filed in an attempt to dismiss Essure lawsuits as soon as they were filed, before the plaintiffs could even put any Bayer employees under oath:
Congress did not provide plaintiffs with a federal cause of action under the FDCA, either expressly or impliedly. Recognizing the “undu[e] burden” imposed by differing state regulations, Congress also adopted a “general prohibition on non-Federal regulation” of medical devices. H.R. Rep. No. 94-853, at 45 (1976). Therefore, Congress incorporated an express preemption clause – a “general prohibition on non-Federal regulation” (id.) – providing that no state may impose “any requirement” relating to the safety or effectiveness of a medical device that “is different from, or in addition to, any requirement applicable … to the device” under federal law. 21 U.S.C. § 360k(a).
A victim’s state-law negligence lawsuit is considered a state “requirement,” and so they are “preempted” and thus cannot proceed.
Bayer added in a footnote, “This Court should not be swayed by concern that the application of federal preemption would effectively leave Plaintiffs without any recourse.” Bayer doesn’t want the court to be “swayed by concern” that it’s asking the Court to shut the courthouse doors on Essure victims and leave them (and taxpayers) paying for Bayer’s negligence, but Bayer itself routinely tries to “sway” courts, including the United States Supreme Court, by filing amicus briefs on its own behalf or through shadowy corporate advocacy groups, like the Medical Information Working Group and the Product Liability Advisory Council.
Here, for example, is an amicus brief filed by the Product Liability Advisory Council—which includes major medical device manufacturers Bayer, Johnson & Johnson, Medtronic, and St. Jude Medical—trying to “sway” the Supreme Court by complaining about “the profound impact of state law claims seeking to impose obligations on manufacturers regulated by the FDA.” In the brief, those companies argued they should be totally immune from lawsuits even when they violated “the Current Good Manufacturing Practices standards or the general obligation to report to FDA information concerning the occurrence of adverse device-related events.”
There is an extremely narrow way plaintiffs can sometimes still bring a case, if they can show their negligence claim is “parallel” to a violation of FDA regulations—the same regulations medical device companies constantly lobby over and sometimes help write—but most plaintiff cases are dismissed anyway.
It does not have to be this way, and it should not be this way. Congress should eliminate the “preemption” clause contained in the Medical Devices Act, and there’s even a bill pending on this issue, H.R. 2164, the Medical Device Safety Act, but Congress refuses to even hold hearings on it.
What Can Be Done?
First, remember this issue and talk about it. The Bleeding Edge just got a dangerous medical device taken off the market. Congress and corporations will sometimes listen, if you speak loudly enough. Last week, even a small amount of public attention helped correct an injustice against sexual abuse victims who had brought a lawsuit against a State entity.
Second, contact your Representative and Senators in Congress and tell them:
- You saw The Bleeding Edge and you are concerned about medical devices;
- You want them to pass a bill fixing the 510(k) loophole in the Food, Drug, and Cosmetic Act, like what would have been done by H.R. 3847, the SOUND Devices Act of 2012;
- You want them to pass a bill like H.R. 2164 that will allow victims to bring lawsuits against “premarket approved” medical devices;
- You want them to regularly hold hearings about the FDA and its decisions and to invite patient advocates to those hearings, to ensure the FDA is always acting in the best interest of patients; and,
- For Senators, you want them to only confirm judicial nominees that respect your Seventh Amendment right to a jury trial.
In all likelihood, you will get from them a form letter response. That’s okay: the point of contacting your legislators is to let them know that their constituents care about this issue. Three months later, contact them again, and ask them what they’ve done since you last asked them. Keep doing it. The more people who make themselves heard, the more likely it is that we can make medical devices safer.