Corporations lie, and government regulators often let them get away with it.
Not always, of course. But once is too often, and, as medical malpractice lawyers, we see that it happens a lot more than that.
The most recent example comes from ProPublica. They just published blockbuster investigation into HeartWare, a company that sold Ventricular Assist Devices. These were essentially heart pumps, which work by helping to force blood through a tube and into the aorta. Once implanted, a wire runs through the chest cavity and connects to a battery on the patient’s hip. Medtronic bought the company in 2016.
These were supposed to be life-prolonging medical devices, buying valuable time until a transplant becomes available. But the pumps had countless safety concerns, were subject to a litany of recalls, and generated several warning letters from the FDA.
These safety concerns largely went unaddressed. Even after recalls, the company made scant effort to fix known problems in existing inventory. And the FDA basically sat on their hands.
Ultimately, many of the unrepaired pumps were implanted into patients. You can guess what happened next:
“The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.”
Horrifying. How does something like that happen? Don’t we have a robust federal regulatory process — with teeth — to protect our most vulnerable citizens?
Well, no. Not according to the news organization’s research.
“For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database.”
The federal agencies charged with stopping corporations from cutting corners “prefer” for these same companies to “voluntarily” fix problems. Does that sound right to you?
Fixing problems costs money, and if there’s a corporate tug of war between profits and people, you know who’s going to win.
It’s sad, but true. Profits almost always win out.
Remember Boeing’s recent struggles with the 737 Max, the aircraft that crashed twice overseas before being grounded worldwide? A different federal agency — the FAA — had largely relied on Boeing to rigorously evaluate the safety of their own product and self-report all problems. That didn’t happen. And hundreds of people died.
With the HeartWare pump, it was even worse.
“If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.”
So where was the FDA while all this was going on with HeartWare? Well, apparently they were there the whole time, watching misstep after misstep.
In responding to ProPublica, the FDA said it had been “closely monitoring issues with the HVAD,” meeting with the company more than 100 times to resolve problems and review safety concerns. The agency also told ProPublica it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient-focused,” Dr. William Maisel, director of product evaluation and quality at the FDA’s device division, told ProPublica. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
But that did not happen with the HVAD, according to the article:
“In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.”
What good are 100 meetings when the problem never gets fixed? Is a misbehaving child ever going to change his behavior if repeated warnings are never once followed by actual consequences? Why did the FDA never act?
The FDA told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a “complicated device.” It also said it wanted to make sure patients with severe heart failure had access to this treatment option, because there were “very few alternatives.”
But this explanation collapses under minimal scrutiny.
There was a competing device which was available, already in use by a heavy majority of patients who needed a pump, and could easily have bridged the gap.
The FDA wasn’t trying to take care of patients with a failing heart; they were trying to prop up a failing and unsafe company.
Worse yet, most of these endangered patients had no idea the FDA had issued these warning letters. The company didn’t tell them, and the FDA posted their warnings in places patients weren’t advised to check. Their tickers were ticking time bombs, and the agency charged with protecting them instead left them in the dark.
In short, it was a complete regulatory breakdown. And it happens time after time.
So where does this leave patients? Unfortunately, when it comes to suing medical device manufacturers, the United States Supreme Court has made things tough. There is a doctrine known as preemption, which bars any claim that the manufacturer violated state standards which were different from the federal standards.
How’s that for bitterly ironic logic? Because the devices are supposedly subject to rigorous regulatory oversight before coming to market — called the “premarket approval process” — there is a heavy presumption of safety. After all, the FDA signed off on it.
Yes, the same FDA whose passivity helped HeartWare cause thousands of deaths.
But that just means the case is more challenging. At Keefe, Keefe & Unsell, we’re up for that challenge.
A smart and creative lawyer can often get around the preemption doctrine surrounding faulty medical devices. And there are other theories which are outside preemption, such as a failure to act once a company learns of a problem.
When accountability won’t come from the government, it must come from the justice system.
If you, or a loved one, may have been harmed by a faulty medical device, give us a call today, at: 618-236-2221.