Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called “regulatory causation.”  Since we’d only touched upon this type of expert opinion once, we thought we’d take a more in-depth look at this concept.

The first thing we discovered is that “regulatory causation” apparently was invented by the ubiquitous Suzanne Parisian, largely for use in the now-mostly-concluded Aredia/Zometa litigation.  That theory was an attempt to dumb down the usual common-law requirements for both causation (ordinarily “more likely than not”) and expert certainty (a “reasonable degree of medical” either “certainty” or “probability” depending on the jurisdiction).

As we described in more detail, here, the FDA, being a regulatory agency, is able to intervene prophylactically, before actual harm takes place, in order to prevent such harm.  Thus, the FDA is not bound by common-law causation or expert standards in deciding when a warning should appear on the label for a drug or device.  And the Agency doesn’t.  Instead, its regulations governing label changes state the new warnings should be added “as soon as there is reasonable evidence of a causal association [of a risk] with a drug; a causal relationship need not have been definitely established.”  21 C.F.R. §201.57(c)(6)(i).  That’s for drugs approved after mid-2001.  For some older drugs (without an update since 2001), the standard is similar, although the words vary:  “as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”  Id. §201.80(e).  See In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108, 1120 (S.D. Cal. 2015) (describing how these regulations work).  For medical devices, the equivalent standard is harder to locate, since the FDA’s “labeling” regulations for devices does not address when to change a label.  For PMA devices a standard of sorts – “reasonable evidence of a causal association” – in the CBE provisions applicable to such devices.  21 C.F.R. §814.39(d)(2)(i).Continue Reading “Regulatory Causation” Roundup