Law

We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins.  And the cat.  (We mostly resisted the all-day live feed of the breed judging.)   Since the Best in Show lineup didn't include a Standard Poodle, our "breed of the heart" (a cute Bulldog named Annabelle beat Ricky, the stunning black Standard Poodle, in the Nonsporting Group), and being nothing if not bandwagon jumpers, we were rooting for "Rumor" a gorgeous German Shepherd who was the top winning show dog of 2015 by many, many points.  And she showed beautifully.  But she was defeated by "C.J.," a German Shorthaired Pointer.  While we don't count ourselves as sporting breed fanciers, C.J. is a cool dog.  And, most interestingly (maybe not, but it gives us a hook to transition to our case in a minute), C. J.'s grandmother, Carlee, was Best in Show in 2005.  Carlee was known for her flawless "free stack" – instead of needing her handler to place her feet in the right positions and stretch out her neck – "stack" her – for the judge's examination, she did it all by herself in the most striking of fashions.   Westminster trivia:  like the Adamses and the Bushes, Westminster can count one example of a father siring his eventual successor:  Robert, the English Springer Spaniel, was Best in Show in 1993.  His daughter, Samantha, "took the Garden" seven years later.  The ostensible point of dog shows is to reward the best specimens of each breed so they will pass their genes to future generations, so it is neat when a judge's good decision is affirmed.  

And so it was recently in the Third Circuit.  In In re Avandia Marketing, Sales Practices and Products Liability Litigation (Linda and John Schatz, appellants), -- Fed. Appx, --, 2016 WL 574074 (3d Cir. Feb. 12, 2016), the panel considered Judge Cynthia Rufe's grant of summary judgment to the defendant manufacturer in a case in the Avandia MDL.   The plaintiff, who had taken Avandia, sustained bone fractures in two accidents and alleged that the manufacturer had failed to adequately warn of the risk of such fractures.  The manufacturer had informed doctors of this risk and, shortly thereafter, updated its warnings to include this information.  While it was not clear whether the plaintiff had already stopped taking the drug at this time, it was undisputed that she resumed taking it for a short time after the "bone fractures" warning was added to the label.

At his deposition, the plaintiff's treating physician testified that an earlier warning would not have made any difference – that he would have prescribed the drug for the plaintiff even if a "bone fractures" warning had been included.   (He couldn't remember whether he read the new warning before he wrote the final prescription, but acknowledged that it was available to him.)  His lawyers asked no questions.  Defendant moved for summary judgment on warnings causation – if a stronger warning wouldn't have changed the prescribing decision, there was no causal link between the allegedly inadequate warning and the plaintiff's injuries.  Whereupon ensued a procedural circus.  Without seeking leave, as the Rules require, the plaintiff filed a sur-reply brief attaching a classic "sham affidavit" in which the doctor changed the sworn warnings causation testimony he had given at his deposition.   The judge struck the sur-reply and granted summary judgment, and the plaintiff appealed both orders to the Third Circuit. 

The panel noted that it was within the trial court's discretion to strike filings for failing to comply with the Rules.  Schatz, 2016 WL 574074 at *2.  Moreover, the panel confirmed: 

When a deponent's post-deposition affidavit conflicts with his prior testimony [without explanation], a district court may disregard the affidavit to prevent a party from creating a material issue of fact to defeat summary judgment . . . ."  Id. (internal punctuation and citations omitted).  The panel explained, "The . . . Affidavit was produced more than seven months after the doctor's deposition.  Moreover, the [plaintiffs] could have, but did not, question [the doctor] at his deposition.  Furthermore, [the doctor] was informed that he had thirty days to review his deposition transcript and submit any changes.  He submitted none, . . . [but authored] his affidavit [without explaining the change in his testimony] the day before [plaintiffs] filed their sur-reply.

Id. at *3.  As such, "the District Court did not abuse its discretion in striking the . . . sur-reply and the . . . Affidavit."  Id. 

In the absence of the sham affidavit, the record was clear.  Though the doctor testified that a black box warning "certainly would have caught his eye," id. at 4, he went on to testify that no warning would have changed his prescribing decision, that he prescribed a new round of the drug to the plaintiff after the new warnings were implemented, and that he would still prescribe the drug today, with full knowledge of the new warnings, to a patient with the same clinical course as the plaintiff.  Id. at *4.  (With respect to the "black box" issue, the panel explained, in a footnote, that "[o]nly the FDA may issue a black box warning," so the manufacturer "could not have included such a warning absent a directive from the FDA."  As such, any argument that the manufacture should have included such a warning was preempted by Pliva v. Mensing.  Id. at *4, n.9.)  The panel affirmed the grant of summary judgment, holding that plaintiffs "failed to adduce evidence sufficient to establish some reasonable likelihood that an adequate warning would have prevented [the plaintiff] from receiving the drug."  Id. (internal punctuation and citations omitted).

We love the "sham affidavit doctrine."  We have had fun, in the past, using it to take apart the cases of unscrupulous plaintiffs' lawyers.  And judges who understand and enforce the "warnings causation" requirement (for not all do) – and understand Mensing preemption to boot – earn our eternal respect.  A clear decision, an easy affirmance, and a satisfying decision all around.  As for Westminster, we love 'em all and we will happily await next year's showdown.