As we noted earlier this week, compounding pharmacies are not regulated by the FDA. Now, it’s possible the New England Compounding Center was acting more like a drug manufacturer than a compounding center in this case. Members of the U.S. House and Senate are currently demanding investigations over those allegations, including whether a crime may have been committed, and Massachusetts Governor Deval Patrick said the Center “may have misled regulators and done work beyond the scope of its state license.” That all may be true, but for the victims of this tragedy, the fact that there was no FDA oversight, while decidedly unhelpful to their health, may be very helpful to their quest for justice.
First, note that the first case has now been filed. It was filed today in Minnesota by a woman who was given a steroid injection for back pain and “has experienced symptoms consistent with meningitis.” As these cases move forward, it will no doubt come up that this company’s owners have some history of negligence and have forced victims to settle confidentially in the past. USA Today reported yesterday,
Long before the current rash of fungal meningitis, the compounding pharmacy suspected in the outbreak settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.. …
A 2004 lawsuit filed in upstate New York's Monroe County claimed New England Compounding Center produced a tainted shot that caused William Koch to contract bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83. …
The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.
That said, it is important to note the following. Had the contaminated steroid been regulated by the FDA and you happen to live in Michigan, no lawsuit would be possible – at all. Had the case involved a misleading label on a generic drug, and the brand name version has been approved by the FDA, no lawsuit would be possible – at all. Had the case involved a Class III medical device approved by the FDA (as opposed to an injected steroid), no lawsuit would be possible – at all. And had the contaminated steroid been regulated by the FDA, and H.R. 5 (the federal medical malpractice/drug immunity bill) were law, a lawsuit might be possible, but the Center might not be liable for any punitive damages - despite how many were sickened and killed. (I only say “might not” because the bill exempts "knowing misrepresentations" to the FDA, which may or may not be provable in this case.)
That’s all to say, while FDA regulation is certainly preferable to no regulation, history shows that many FDA-approved drugs and devices have caused some of the most serious injuries and death. Yet, the fact that a drug or device is regulated, no matter how unsafe, might present legal defenses that could prevent a patient’s legal case from going forward - at all. This legal doctrine is known as “preemption" and fortunately, they don’t apply here.