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?
I wonder.
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.
-Wes
Wes,
ReplyDeleteIn this post you write:
"What I do know is an incredible amount of good has come to the medical device industry since this story broke."
Let's look at this a little closer.
Since the Prizm story broke, double digit annual ICD growth has nearly flattened out. Objective data and personal experience still shows that there is a large pool of patients who have well established indications for ICD implant that do not have devices.
I think we can all agree that the negative press that followed the Prizm story had some contribution to the industry fall in ICD growth. I recognize that it is impossible to quantify this and that there have been other factors that have contributed to declining growth.
I rarely have found attention given to the tragic deaths of patients with established ICD indications who have never been offered ICD therapy. If ICD growth had not leveled off several years ago, many of those people would still be alive today. I would argue that this type of death occurs orders of magnitude more often than deaths due to ICD dysfunction.
I fully recognize the tragedy of a death when an ICD is ineffective, but we should all be doing what we can to get ICDs in more (appropriate) patients, not less. Scare articles about "defective" ICDs, promote underutilization of ICDs at least as much as they pressure industry to create better products.
The real question is whether more people are alive today because ICDs are "better," or whether more people have died because they and their doctors are reluctant to have them implanted.
I suspect the latter argument is the case and that the reaction to Prizm was more harmful than the product defect itself.
Jay
I dunno, from my very non-medical point of view, it sounds like the docs (who are constantly the prey of malpractice litigators) are righteously mad at the obvious malfeasance of the DME manufacturers.
ReplyDeleteHow many medical "malpractice" suits go against docs every year, when they were at best victims of bad luck? Let alone ambulance companies who get sued for $10MM over a kid who was born with CP. When someone is actually suppressing bad outcomes for monetary gain they should indeed be screwed harder than the normal, but unlucky, docs.
Then again, I'm just a humble computer programmer/medical groupie. What do I know?
Why not sue the FDA. Aren't they the ones approving these devices?
ReplyDeleteGranted, this is a criminal action rather than a civil action, but why wouldn't physicians be qualified to give their opinions as to the damages? They're voters, and thus qualified to sit as jurors.
ReplyDeleteWe'd let them decide damages in a car wreck case, sentence someone to jail and in some states even allow them as part of a jury to sentence someone to death. There is no reason they aren't qualified to do what every other juror in America is asked to do.
" 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."
This correlation is often used by defendants - don't sue us or costs will go up. But typically it's an insurer covering these damages and the defense, so it's not a dollar for dollar cost to the manufacturer. And, insurance rates are far more complex than dollar out in settlements/judgments v. dollar in of premium.
Anony-
ReplyDeleteAs I said, I have no problem with doctors expressing their disagreement with the proposed settlement, but as physicians and doctors who cared for one of the plaintiffs, they are not, by definition, a third party to the proceedings who should be deciding damages in my view.
Further, there are other interesting issues not disclosed by the article's author, like the potential conflict that might be inherent to one of the letter's authors being the former President and Chief Executive Officer of Cardiac Pacemakers, Inc., a division of Eli Lilly and Company, prior to its merger with Guidant, Inc.
Dr. Wes,
ReplyDeleteI appreciate your comments regarding Dr. Hauser. However, you need to dig deeper into his motivations to interject his opinions into this debate. Particularly the fact that he was once highly involved with CPI/GUIDANT. As I understand he was fired by the company. Is there some bias here.
Furthermore, I would argue that not all companies have taken to improve their product performance reports. There needs to be a standard that applies to everyone equally. Also, the return rate for each company in the CRM space varies greatly. There is no data that records this.
Just some random thoughts.
Thank you for your informative blog.
" they are not, by definition, a third party to the proceedings who should be deciding damages in my view."
ReplyDeleteThey aren't really "deciding" damages as they would in a civil trial. In criminal cases, particularly white collar cases, you'll often see letters from both victims and supporters of the defendants to the court. The judge will almost certainly read them and consider them in rendering sentence. But he/she has the absolute right to ignore them.
Because a criminal case is SOCIETY punishing someone, as opposed to an individual plaintiff recovering their individual losses, I see no problem with any member of society letting the judge know their feelings on the subject, if expressed properly that is.
I would question any results surrounding device malfunctions and recalls recently as beneficial. Before we indict the device companies, one should note that all of the device "defects" that Guidant identified had failure rates significantly below the rates of contemporary devices. It should also be noted that physician programming and (mis)management results in more deaths than device failures every year. It is not even close. Finally the device companies actually find these defects and report every one of them to the FDA.
ReplyDeleteThe sensationalist method of publishing these failures is akin to yelling fire in a crowded auditorium.
Reporting every defect leads many physicians to act precipitously to remove devices which often pose less risk in place than the procedure to remove them. Typically, more patients are killed by physician actions to correct the defect than the problem would cause.
There has always be the recommendation to return any explanted device. There is nothing to force physicians to do this and many (most) do not. I have routinely returned my explanted devices and insisted on an analysis even when the device appeared to have function normally.
I will further ask anyone the question, if you know the expected failure rate of 1 in 5,000 devices would you explant the device with a risk of infection of 1 per 100 procedures?
The doctors who are the subject of this article have suggested that they would have removed their patients device had they known all of the facts. I then ask, where do they stand on the lead recall ongoing at Medtronic? Did they take every one of these leads out of service given the failure rate approaching 10%? If not, they are merely media opportunists and are exploiting the untimely death of their patient. I suggest that even if they knew ALL of the details of the Prism issues, it is unlikely they would have truly explanted the device. Shame on them for stating otherwise. I had many patients with this device and even knowing the issues did NOT remove the device prematurely.