We are physicians who cared for Joshua Okrup (eds note: should be "Oukrop"), a 21 year-old college student, who died when his Guidant Prizm 2 implantable cardioverter-defibrillator (ICD) short-circuited and failed to deliver a life-saving shock. His unnecessary death was caused by a product defect that Guidant Inc. had known about for years and failed to inform patients, physicians, and the U.S. Food and Drug Administration. Accordingly, we are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act. On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement.An out-of-court $296 million plea agreement is not enough it seems.
While these doctors have every right to express their opinions on the case (and certainly the actions of the company were egregious), their letter opens an interesting precedent for physicians advocating on behalf of their patients: deciding what is "just" concerning damage awards in legal matters on their behalf.
Should this be the purview of physicians?
What I do know is an incredible amount of good has come to the medical device industry since this story broke. Companies do a much better job of reporting problems with their devices now as evidenced by excellent product performance reports. Companies also raise flags regarding their devices MUCH earlier, perhaps even notifying patients of every advisory condition imaginable (like cosmic radiation could interact with their device memory chips) - suddenly nothing was too small to report. We have also seen the profession have a greater understanding of the need to quantify the incidence of device problems by returning all devices - normally functioning or not - to companies for ongoing quantification of device reliability to better appreciate the level of device performance we should accept as "standard." Device registries now are used routinely to track and better understand the myriad of variables that influence device performance in the real world.
Litigation is always expensive and time-consuming. I am left to wonder if ongoing court litigation versus a hefty out-of-court settlement will really provide additional benefit to to the loved ones who lost their children or, as these doctors suggest in their letter, future patients. I worry that ongoing litigation might just drag this process on for years so that future patients will have to bear the costs in the form of even higher device prices.
I admit that I do not know how much money the plaintiffs would receive with the anticipated settlement and whether that will be enough compensation for all that has happened, but irrespective of the judge's decision in this matter, I hope we can continue to move past this unfortunate incident and continue working with industry and regulators to make sure this never happens again.