We recently posted about H.R. 1215: Protecting Access to Care Act of 2017. The bill, which masquerades as a way to decrease costs for healthcare, but is really just short-sighted tort reform, includes a small section about class-action lawsuits:
“A health care provider who prescribes, or who dispenses pursuant to a prescription, a medical product approved, licensed, or cleared by the Food and Drug Administration shall not be named as a party to a product liability lawsuit involving such product and shall not be liable to a claimant in a class action lawsuit against the manufacturer, distributor, or seller of such product.”
(You can read the full text of the bill here.)
We see a number of potentially devastating problems arising from this bill in general, but we want to focus on this part today. In order to understand why this is such a mistake, however, you’ll need to understand how the Food & Drug Administration (FDA) process for approving a drug or product actually works.
FDA approval for drugs and medical devices
It can take more than a decade for a new drug or device to make it to the market, and multiple clinical trials. If a new product makes it through the initial testing phase, and then three rounds of volunteer trials, the manufacturer must then apply for FDA approval. If it is approved, doctors can prescribe the drug. Overall, it is an in-depth and detailed process unique to the FDA.
But there is a “loophole” that drug and medical device manufacturers take advantage of whenever they can: the 510(k) submission process. In the most basic of terms, it allows a company to bypass the normally-required testing and trials for products that are similar to, or updates of, existing products. While this bypass might work for companies that build smartphones, or want to use real sugar instead of corn syrup in their cereal, there is an established pattern of problems when it comes to updating medical devices. You need look no further than the issues with transvaginal mesh, or Stryker’s hip implants, to see the devastating effects of the 510(k) process of submission.
But what happens when one of those defective products or drugs “breezed” through the approval process because they were fast-tracked in a 510(k)? If a hospital knows that such products exist – and they should be able to access that information from the FDA itself, if not the rep – and chooses to use them anyway, then they are complicit in prescribing a dangerous or defective drug or device.
Other ways hospitals and doctors can be liable for defective medical products
Let’s set the FDA approval process aside for a moment. Consider this: earlier this year, Sorin 3T Heater-Coolers were implicated in a number of deaths, thanks to contamination in their plant by infectious bacteria. Using these heater-coolers put thousands of people at risk of developing a deadly bacterial infection themselves. It is perfectly understandable, perhaps, that the first patient on whom the device was used might be infected: after all, hospitals would have no reason to assume that a device was contaminated. But if the devices had been properly sterilized, or if hospitals employees had taken the appropriate precautions to ensure that they followed protocols for sanitation, then there would be no reason for all of those other people to be exposed to the bacteria. In this case, just like those with transvaginal mesh and Stryker’s hip replacement, the hospital bears some responsibility for exposing its patients to potential harm by these devices.
Doctors also owe their patients a duty of care, which includes informing them about potential side effects or concerns. It should be a part of hospital policy, too. Therefore, if a person takes a medication, or has a medical device implanted in him or her, and the doctor fails to warn the patient about potential effects because of A) negligence, or B) no clear-cut policy dictating this rule, the both the doctor and the hospital may be liable if the patient sustains an injury or develops an illness.
How does this apply to class action lawsuits?
Pharmaceutical companies lobby doctors all the time; so do drug and medical device manufacturers. Hospitals and doctors are constantly begged and cajoled (and sometimes bribed) to prescribe their products. Certain products become all but mandatory for use at hospitals, here in South Carolina and across the country. Sometimes, those products and drugs are found to be defective, or found to have side effects that were not discovered before they went to market.
In the end, thousands of people are either harmed, or put at risk, every single day because of defective devices and dangerous drugs. Hospital administrators, doctors and personnel share liability with the manufacturers. In the cases we discussed, there were thousands of plaintiffs. Trying to take each one to court individually would tie up our system for decades. Class-actions, then, become a necessary tool for moving these cases forward efficiently and effectively.
Class-actions also tend to result in significant, multi-million dollar verdicts or settlements because of the sheer number of people involved. These awards do more than help compensate victims: they send a clear message that such behaviors will not be tolerated. Hospitals, specifically private and, ironically, non-profits, earn hundreds of millions of dollars each year. Pharmaceutical companies and manufacturers earn billions. One verdict for $150, 000 is not going to stop them from making and using defective products, because recalls are less expensive than the lawsuits. But multiple class-action lawsuits than result in $1.5 billion awards, like Endo International was forced to pay over transvaginal mesh? That makes a statement.
The Seventh Amendment guarantees you the right to a jury trial in civil court. H.R. 1215 wants to take away that right, all so that hospitals and manufacturers can continue to line their pockets with money taken out of yours.
At McGowan, Hood & Felder, LLC, we will not take this lying down. We will fight against this bill with the same passion and dedication we always do, as we seek justice for those who need it. Our team of attorneys here in South Carolina knows how effective class-action lawsuits can be, because we have successfully represented mast tort clients for decades. We will fight; we hope you join us.