One of my previous blogs mentioned that medical device makers could learn something from frozen food manufacturers who seem more concerned about customer safety than about company brand and damage control. I suggested that two ice cream makers caught up in a Listeria crisis last year exhibited more compassion and common sense than most medical device makers when it came time to pull bad products from store shelves.
That was written almost a year ago. The ice cream is back on the shelves but many medical device makers still haven’t admitted their products were bad, and they are still defending their bad products and sleazy practices in courtrooms throughout the country. Let’s take a quick look at how this happened. I will use the metal on metal hip implant controversy as a shining example of a medical device regulatory system that has once again failed the American public.
- A Failed Regulatory System.
I am a relative newcomer to metal on metal hip implant cases, but I am in my fourth decade of working on litigation involving bad medical devices, starting with breast implants and HIV-tainted blood products in the early nineties and continuing with vaginal mesh and metal hip medical devices more recently. I have seen many things change during the 30+ years I have been suing drug and device companies. The FDA has changed. The litigation environment and parts of the court system have even changed. Most of these changes, though not perfect, resulted in a net improvement for patient safety and regulation of drugs and devices. But not all change represents an improvement, and I am here to tell you that the medical device companies I am familiar with have not gotten better when it comes to making safer products or accepting responsibility for making bad ones. The medical device companies have not become more responsible when monitoring and voluntarily reporting to the FDA about their experiences with their bad products. In fact, in my experience the medical device companies have gotten worse not better.
- The Metal on Metal Hip Implant Experience.
Metal hip implants have been in the news recently for many reasons, including ongoing trials over allegedly bad implants nationwide. Recent trials have resulted in mixed results for the implant patients, but that will change in coming months as the issues and bad company conduct become clearer through experience. I predict a steady flow of increasingly large verdicts against hip implant makers in coming months. I will discuss the trials and company defense strategies in more detail in future writings, but I’ll briefly describe here the circumstances that resulted in an American tragedy for hundreds of thousands of people with bad hips who ended up getting bad hip implants.
The FDA quietly issued a “Final Order” last month that finally gave all the manufacturers of artificial hips one last chance to apply for “premarket approval” of their metal on metal hip implants. The Final Order was issued on February 18, 2016, after more than three years of consideration and public comment, and it gave the companies ninety days to submit a plan for proving their metal hip implants are safe and effective. Companies choosing not to stand up for their products in front of the FDA by mid-May of this year have to remove their unproven implants from the market. It looks like the majority of metal on metal hip implant makers will quietly remove most of their products from the market rather than try to prove they are safe. They will pull their products after this 10+ year failed human experiment and leave it to their lawyers to defend their unethical practices of the last decade.
Hundreds of thousands of American patients have suffered serious problems from these bad products without the companies ever having to prove or even address the safety or effectiveness of the new devices. This happened because of a regulatory loophole that permits “grandfathering” of new devices simply by convincing busy FDA regulators that the new devices were substantially similar to the old ones. Any attempt at regulating the metal hip devices that became popular in the last decade proved futile under our existing FDA regulatory framework. Every company that wanted to enter the U.S. metal on metal hip business could do so quite easily, and they all did just that. Most of them are probably going to quietly remove their metal hip implants from the market because they know they cannot prove they are safe and effective.
The companies will probably continue to argue that they did the best they could. They will argue that medical progress and innovation requires some element of experimentation. But that’s not true. They will claim there was a void in technology twenty years ago that made orthopedic surgeons literally beg for a new alternative device which resulted in this failed metal on metal human experiment. Also false. The companies will also argue that their implants really were not that bad, but I know for a fact that at least two of the hip implant companies (Smith & Nephew and DePuy) routinely underreported hip implant failures that they knew about and investigated, but simply chose not to report. This creates a false record of safety that the company then relies upon when selling its products.
It is a sad day in America when makers of medical devices can put their bad products on the market in one decade via a regulatory loophole that focuses on similarity to previous products rather than safety or effectiveness and then remove those problematic devices from the market rather than seek “premarket approval” almost a decade later. But that’s how it is in our country. I will discuss this regulatory loophole in future blogs, but the main point here is that our system of medical device regulation has once again put the cart before the horse – ten years of bad hip implants were unleashed on the American public since the mid-2000s and our regulators are just now catching up with them.
- What happens to the patients?
I have spent the last nine weeks in a Dallas courtroom watching almost every day of a trial involving five unfortunate patients-turned-Plaintiffs suing DePuy/Johnson & Johnson over bad implants they received from 2004 to 2010. The FDA “Final Order” requiring “premarket approval” came out in the middle of this trial. The companies involved will probably quietly remove their bad products rather than try to prove they are safe and effective, but the patients who received these implants can’t remove them so easily. They are stuck with them. Even removing the implants and replacing them with non-metal parts isn’t a sure cure, because many millions of metal debris particles are already in their systems.
Dozens of medical articles about bad metal implants have been published over the past decade and the journals are full of new articles in every issue. The medical community is aware that it let the device companies bamboozle them with their shiny new metal on metal hip implants, and dozens of studies are underway to see how bad the results of this experiment really will be. Companies that were unwilling to study their products before selling them are now finally funding studies about hip implant safety. These new studies are mainly aimed at defending hip implant products that are no longer on the market. I predict much human suffering as a result of the hip implant companies experimenting on the American public. Tens of thousands of people will have to undergo revision surgeries in the next decade to remove these bad products and clean up the toxic metal mess left behind. Many of these patients are much worse off now than when they received these products. I’ll be there watching and taking names and notes, and I’ll tell you all about it right here.