It is not hard to imagine the reaction of various liability attorneys upon reading over this week's report from the independent panel that was charged with looking into the device recall processes that were used - or, in this case, generally not used - by Guidant (Indianapolis). Probably something very much like the reaction of a roulette player who has put all of his or her money on a number that has just “hit.“
As the New York Times noted on Tuesday, the report offers the legal sector a very clear “road map“ concerning the company's failure to consider the impact of flaws in its devices on patients and, ultimately, on the company's fortunes.
But we would say that rather than a road map, the report provides a mine shaft that has drilled down into the company's inner workings and will reap plenty of gold for plaintiffs.
That drill-down investigation has even more impact as a result of the company's insistence that the panel doing the study was to be entirely independent and then was peopled with a very high-level group of physicians and medical researchers.
But aside from the effect that the revelations of this report will have on Guidant, and then on its pending acquirer, Boston Scientific (Natick, Massachusetts), the issues that the report focuses on are likely to have a wide-ranging impact on the companies that make implantable devices and that make the components of those devices.
This issue is likely to add one more important item to the list of differences between drugs and medical devices.
Drug manufacturers, of course, must bend over backwards to include warnings concerning the possible side effects that their products have. In taking any drug, they have learned to emphasize to patients that some inevitably will suffer adverse side effects, and they must say so in multiple labeling protocols and advertising.
In contrast, the makers of implantable devices generally have not had to jump through or over comparable hoops and hurdles.
Yes, of course, they must include labeling that indicates how and in what applications their devices should or may be used (and are even somewhat exempt from this in the case of “off-label“ uses). But these warnings, of course, are for the physicians and clinicians. They hardly ever, if ever, reach the patient.
Again, of course, the vast majority of physicians are likely to inform their patients that there are risks involved in the implantation process, as there are in any surgical procedure.
But the current comments from physicians surrounding the Guidant issues indicate that they were not warned concerning the defects in the company's devices and so they had no opportunity to pass this information along (assuming that they would have done so if the information is available - and you know what they say about “assume“).
But the Guidant story adds even more to the “adverse event“ disclosure scenario.
The adverse events caused by drugs are the result of an interaction between the patient and the active agent of the drug, not, ordinarily, as the result of a material, manufacturing or engineering flaw.
And this is how devices are very different.
Yes, certainly, a patient may have an adverse reaction to a device material, but not usually. The adverse events that the impending legal battles will focus on are, quite exactly, material, manufacturing and engineering flaws that Guidant did not reveal to physicians.
And so the game is likely now to change, and must change.
Besides informing patients about the possibilities of infections and other problems related to surgery, implantable device manufacturers are going to have to be very clear in explaining that there may be potential adverse reactions that are an inevitable result of the flaws in the device itself - the product of human inability to make mechanical and electrical products that are entirely fail-safe.
This presents to the industry a problem, of course, since such information may put a company at a competitive disadvantage. And it is going to mean a much heavier increase in postmarketing surveillance and reporting - efforts which are clearly already ramping up by both the companies themselves and regulators
All of this will likely greatly expand what must be said in product labeling, and even more greatly expand the efforts required in seeing that this information gets communicated to patients.
And the new panel report refers to the processes of imparting this information more aggressively as “active transparency“ and “forced transparency.“
This is what the industry must live with. Its patented drumbeat concerning the great benefits of its implantable products will have to be accompanied with greater responsibility for reporting their downsides.
Another point: News reports of the panel conclusions have generally emphasized the recommendation to move flaw assessment from engineers to medical experts. But the report also emphasizes the need for participation of a third player - those who know how to develop improved and consistent communication.
The report says: “There is no general policy governing how [Guidant] crafts an announcement of product reliability deviations,“ and “There is no Guidant Corporation policy that defines what should be communicated and how and when it should be presented, as reflect in the case of the announcements of device malfunctions during the spring and summer of 2005.“
It says that the company's external communication policy was “restrictive“ and, internally, “weak and conflict-ridden.“
In the long run, expanded efforts at communication will slow the roulette wheel of legal liability, and it may even produce an excruciating guessing game for some patients - “Should I or should I not be implanted with this or that device, from this or that manufacturer?“
But it will result in fewer deaths and follow-on morbidities and hospitalizations. And it will make the industry stronger.
Or, as the report puts the issue, “Product quality alone is insufficient to protect and preserve business positions. The public demands greater transparency when product flaws are identified and mitigated.“