Birth defects are scary.  We suspect most parents among our readers can remember their relief upon hearing the pronouncement “normal” during a sonogram and when the post-birth count of fingers and toes came up as expected.  When there is a child born with birth defects, parents search for reasons.  On possible explanation may be a drug the mother took while pregnant.  For more than fifty years, the vast majority of people in this country who have hit or passed childbearing age have understood that some drugs are associated with (or, more conventionally, “cause”) birth defects.  The FDA’s familiar regulatory framework for drugs dates to 1962, when it was revamped because of concern over birth defects with a drug approved in other countries.  Patient information for drugs, prescription and over-the-counter, is read unevenly, but the risks of use by pregnant women tends to get more attention in the real world.  Not surprisingly, there has been quite a bit of litigation involving allegations of birth defects with drugs for many years, some of which has been detailed in various posts here (not to mention Daubert itself).  Plaintiffs and their contentions have inherent jury appeal.  The child (regardless of age at trial) is faultless and juries are disinclined to hold anything the mother (or father) did against the child.  Although birth defects occur in the general population without regard to drug usage, the tendency of jurors to put themselves in the shoes of the parents of the child with birth defects can impede rationality and shift burdens to defendant drug manufacturers—after all, every knows that some drugs can cause birth defects and women are supposed to avoid taking them while pregnant for a reason.

So, it takes a brave judge and strong record to get rid of the general causation opinions of a well-qualified epidemiologist across all cases in an MDL about birth defects with a drug.  That is what came together in In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, 2014 WL 2921648, __ F. Supp. 2d __ (E.D. Pa. June 27, 2014).  The expert, Dr. Berard, holds a Ph.D. and is a professor in a relevant discipline—Canadian schools count here—and actually had done research outside of litigation on birth defects with this the relevant class of drugs, SSRI antidepressants.  The lack of research outside of litigation can be a major Daubert attack on an expert, but Dr. Berard’s non-litigation work was inconsistent with her opinions here.  In addition, her work for plaintiffs suing over birth defects with another SSRI produced inconsistent opinions, which leads to the whole petard hoisting thing.  (We are not suggesting Dr. Berard actually injured herself with an explosive device.  A petard, given the context of the expression, sounds to us like an article of French clothing or perhaps an uncomfortable chair.)Continue Reading Hoisted By Her Own Petard: A Qualified Epidemiologist’s Causation Opinions Get Tossed Across An MDL