Well, now, thanks to Kim Schmid and her team at Bowman & Brooke, we're quite pleased to report on another - this time from Ohio. Krumpelbeck v. Breg, Inc., ___ F. Supp.2d ___, 2010 WL 5475616 (S.D.
Turns out - not much. Even the turncoat prescriber (we hate it when that happens) had to admit that, at the time he didn't know anything about it until two years later, and that the pump seemed to help his patients. 2010 WL 5475616, at *1-2 ¶¶4, 16. It seems that the first public disclosure of this risk occurred on March 23, 2006. Id. at *2 ¶12. Nobody could find any medical literature from the 2005 era linking chrondolysis and pain pumps. Id. at *2-3 ¶¶19-21.
Ohio, like most states doesn't impose any duty to warn of scientifically unknown information:
There is no duty to warn of unknown and unknowable hazards. The test focuses on the state of knowledge at the time the product left the manufacturer's hands and at the time the product was used.
Plaintiff tried every trick in the book - short of producing competent evidence of prior scientific knowledge - to get around the Ohio state-of-the-art rule, but to no avail.
First, her lawyers claimed there were prior articles, but if that were true, plaintiff inexplicably didn't give them to her expert. Here's some great language for the next time plaintiff's counsel tries to argue in place of an expert:
[T]he Court is not a medical expert, and while it may rely on a medical expert's interpretation of the literature, the Court is not willing to rely on counsel's interpretation of the literature. Plaintiff's counsel have not been designated as experts or completed expert reports. . . . Therefore, their allegations are necessarily limited to legal issues and cannot touch upon an analysis or conclusion regarding the interpretation of medical literature.2010 WL 5475616, at *7 (citation omitted).
Second, the internal emails plaintiff cited also post-dated her surgery. Id. at *8. In any event, they discussed only "possibilities" and "speculation." Id. Fail!
Third, plaintiff's claim of "FDA violations" - purported promotion of off-label use - even if true, were entirely irrelevant. More good language:
2010 WL 5475616, at *10 (citations and quotation marks omitted).[T]he FDA regulations do not affect or preclude summary judgment because they are immaterial to Plaintiffs claims under
law. A manufacturer’s claimed violations of FDA regulations would not be dispositive of the germane issues and would not be relevant in helping the jury determine the adequacy of the warning. . . . No private right of action exists for such a claim. . . [t]herefore, this Court need not reach any conclusion on the alleged FDA violations because . . . they are immaterial. Ohio
Fourth, plaintiff cannot get around the state of the art rule by claiming a failure to test. Plaintiff couldn't convert Class II devices to Class III - and argue that more testing would have been required by the FDA - because plaintiff was "simply wrong." These were Class II devices. Id. at *11. Given what was known, or more precisely not known, under the state of the art, "there was simply no reason for Defendant to have developed specific testing protocols to uncover the supposed link" at any relevant time. Id. at *12.
Fifth, the defendant did not do too much testing. 2010 WL 5475616, at *12. Talk about inconsistency - see our prior post concerning Joan dePucelle. "[T]here is nothing “illegal” about Defendant's field trials. Indeed, had the FDA determined that Defendant's field trials violated IDE regulations . . . [it] could have initiated action to enforce the regulations. That has never been done or even suggested." Id.
Sixth, a design defect claim does not avoid the state of the art either. The "foreseeable risks" did not exceed the design's benefits because the risk in question was unknown at the time. "Plaintiff's design-defect claims fail for the same reason Plaintiff cannot prove her warnings claims-there is no evidence that Defendant knew or had reason to know of a purported risk." Id. at *14.
State of the art, no FDCA private enforcement, and no duty to test all in the same opinion. All in all a most excellent result.