We've all heard about the FBI investigation into manufacturers of power morcellators, and much of the coverage comes across as breathlessness in search of a scandal. This story goes back to at least 2006 when Ethicon, the Johnson & Johnson subsidiary that withdrew its morcellators from the market last year, appended product labels to advise physicians of the potential for the spread of uterine neoplasms during morcellation for hysterectomy or fibroid removal.
There are a number of moving parts to this saga, but the nagging question is still that of what prompted the FBI investigation, and what the answer to that implies about the likely outcome.
Are evil device makers hiding something?
By some estimates, surgeons performed 50,000 morcellations annually before FDA advised the public last year it would "discourage" the procedure, and the agency said it knew of a dozen instances in which morcellation may have spread uterine sarcomas or other cancerous tissues. FDA's latest statement claims that roughly one in 350 women undergoing hysterectomy or myomectomy have undetected/unsuspected disease, but 12 cases would be a lot of under-reporting even if only half such situations led to the spread of a tumor.
Still, we might ask why physicians are slow to abandon morcellation. Good question. According to this information, morcellation is safer than conventional surgical hysterectomy for a large number of women. Funny how nobody in the media is talking about that.
Beyond all that, we have the fact that most doctors will sell out the device maker every time in an effort to sidestep any imputation that patient selection or surgical technique was at fault. Nonetheless, patients are far happier suing some "soulless device maker" rather than "the doctor who saved my life," and there are plenty of attorneys who will go for the deepest pockets even if such a pursuit belies the facts of the case. I've been at this long enough to know that for politicians and the mainstream media, device makers are the default evildoer in this realm, regardless of the facts.
What the beginning tells us about the end
The final piece in this puzzle is how the New Jersey FBI office became involved. I asked FDA about whether it typically forwards such things to the FBI's DoJ overlords rather than the FBI, and all they said was "umm. Errr. Ahhhh." Got the same run-around from the FBI public affairs office when I asked how that agency decides whether to take this kind of case rather than hand it off.
It turns out that the best explanation for the FBI involvement is still that the physician husband of a patient contacted the FBI office in New Jersey persistently, but let's be mindful of something: FDA has yet to allege device makers have been playing games with adverse event data, nor has the agency cited any of them for failure to file medical device reports. Interesting, isn't it?
I make a point of emphasizing this point-of-origin business because there are those who would have the American public believe that FDA's device center is an industry lapdog. Those conspiracy theorists should ask the relatives of the tens of thousands of Americans who are six feet under because of device lag whether they believe the industry lap-dog theory of FDA.
When you add it all up, it's entirely implausible that the FBI field office in New Jersey is taking this up because of any data provided or action taken by FDA. And that, dear reader, tells you everything you need to know about how this story will unwind.