Did you happen to catch the TV show The Good Wife over the weekend? (Full episode here.) “Straight from the headlines” doesn’t half describe it, and I’m not even talking about the listeria-outbreak subplot given what’s gong on with cantaloupes these days (although this story dealt with processed cheese, which seems somehow more fitting for show about food poisoning.)
But the main plot dealt was something equally timely, and kudos to them for tackling it - i.e., the FDA’s highly controversial 510(k) process, which allows manufacturers to put certain medical devices on the market if they submit evidence that the device is “substantially equivalent” to a device already on the market (See Public Citizen’s study on this.) In the show, a spinal cord stimulator – a medical device used to ease chronic pain - was implanted in a patient, a young mother. Turns out that the manufacturer and inventor of the device was the patient’s doctor and he made boatloads of money every time he implanted one. Are these writers clairvoyant or what? Just last week, the Wall St. Journal published a large investigative piece about spine surgeons who do this very thing, writing:
Rather than use spinal implants from third-party manufacturers, scores of surgeons have started their own device makers to churn out similar designs, putting themselves in a position to benefit financially from the hardware they insert into patients.
And just like real life, this Good Wife doctor never put the device through the more rigorous FDA approval process (with clinical trial data) because he paid some “experts” to say the device was “substantially equivalent” to a device already on the market. Writes the WSJ:
The Food and Drug Administration has a less stringent approval process for medical devices nearly identical to ones on the market. Surgeons only have to submit mechanical-testing data attesting that their implants are "substantially equivalent" to existing ones. The FDA usually gives its green light within 90 days.
But like many of these 510(k) devices, this one was defective, it malfunctioned and as a result, the patient was permanently injured. And she sued.
Ironically and as we’ve pointed out many times (here, here ), had the device actually gone through a pre-market approval process, this lawsuit probably would have been impossible. Device manufacturer are completely immune from all responsibility for putting unsafe Class III (i.e. high-risk) devices on the market (yes, plenty of unsafe devices are FDA-approved) and the writers would have had to come up with a whole different storyline.
Actually, here is one new storyline that’s not so different. Wisconsin Governor Scott Walker, not satisfied just with targeting abused and neglected nursing home residents, now wants to do to his residents what Michigan politicians did to theirs almost two decades ago (and which no other state has since replicated). They want to prevent any Wisconsin citizen who is injured by any FDA-approved unsafe drug or device, from ever getting compensated by the negligent drug company. As The Cap Times wrote:
For 15 years Michigan residents and families of loved ones who have been injured or killed by drugs like Rezulin, Accutane and Vioxx have tried to get their day in court. But they've largely been stymied by a state law that shields drug makers from legal liability.
Even the state itself, seeking to recover millions in Medicaid dollars spent on ailments caused by Vioxx, was prevented from doing so by its own appeals court.
Michigan passed the law in 1995, and it remains the only state in the nation with such sweeping legal immunity for drug makers.
But Wisconsin Republicans want to enact similar legislation that would shield drug makers from lawsuits over FDA-approved drugs. And the proposal here would go further, including immunity for makers of FDA-approved medical devices like automatic external defibrillators, heart valves and artificial hips. They also would be granted immunity from lawsuits if their products had inadequate warnings.
"If this becomes law, all of those people who are injured, or the families of people who die, will just be SOL," says Mike End, the president of the trial lawyers group Wisconsin Association for Justice.
Even the conservative U.S. Supreme Court has said that immunizing drug companies is a very bad idea All I have to say is, we once warned Hollywood about great legal class action storylines drying up because of the way our class action system is being decimated. They had better start paying attention to this one, too.