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Long ago we realized we were out of our depth when it came to video games.  By the time he was five, the Drug and Device Law Son was thumping us in Super Mario.  Now the DDLS is heading off to college, leaving us proud and a bit terrified.  From our empty nest we will pray that he spends as much time hitting the books as hitting the A button in feverish Call of Duty  online battles.  We rather doubt he will be playing any of the new “empathy” games that we read about recently.  As opposed to, say, first-person shooters, games such as That Dragon, Cancer and Depression Quest place players in complex situations where they must deal with real-life dilemmas.  Why would anyone want to do this?  Where’s the fun?  Maybe the theory is similar to what Shelley argued in his “Defense of Poetry” – that empathy prepares us to be better people and better citizens.  Or maybe it is schadenfreude.

You might think from our breezy recitation of the case law that very little empathy is going on here.  You would be wrong.  It is hard to read some of these cases without feeling the pain of the players.  But if we express any sympathy for injured plaintiffs, we are sure to get clobbered in the comments section for alleged insincerity or for being capitalist lackeys.  On a couple of occasions we have even expressed some sympathy for plaintiff lawyers.  We try to keep that to a minimum.  Mostly, of course, we put ourselves in the position of the defense lawyers and consider how difficult or awful it must have been to receive a ruling that was crazy or inconsistent or obviously indifferent to what the law actually says.  That feeling of there-but-for-the-grace-of-God crops up frequently with Daubert rulings.  If a judge simply does not feel comfortable playing the role of gatekeeper, junk science creeps in.  Sometimes Dr. Parisian isn’t even involved.

The opinion in Newman v. McNeil Consumer Healthcare, 2013 U.S. Dist. LEXIS 113438 (N.D. Ill. March 29, 2013), was issued some months back, but we found it on LEXIS only a couple of days ago.  It is another dreaded SJS/TEN case, and it presents a mixed bag of Daubert rulings.  In summary, the defense succeeded in excluding the omnipresent Laura Plunkett on FDA compliance issues under Daubert, but she was allowed to testify as to causation and adequacy of warnings (even though she is not a medical doctor) and partially on alternative design.  Significantly, the court ruled that comparing the number of adverse event reports between different drugs was not sufficiently rigorous to satisfy Daubert.  Plunkett was allowed to criticize the FDA.  Other medical causation experts were partially excluded, but never enough to make much of a difference.  The plaintiffs’ Daubert motions against the defense experts were thoroughly denied.

The details might make you nod or wince.  Parts of the ruling might even end up being useful.

Plunkett approaches Parisian-like heights (lows?) in offering opinions on all matters under the sun.  Let’s just say that we are mighty familiar with Plunkett.  It is possible that we even cross-examined her in a case far away and long ago.  She studied zoology, then toxicology, and now testifies for plaintiffs wherever and whenever.  Think of a Parisian minus the FDA experience and minus the MD.  In Newman, Plunkett was willing to provide opinions regarding general and specific causation, safer alternative drugs to ibuprofen, the adequacy of the labeling on Motrin products, the requirements of FDA regulations, and the defendants’ compliance with FDA regulations.  The issues were the usual ones under Daubert: whether Plunkett was qualified by knowledge, skill, experience, training or education to offer her opinions, and whether her methodologies were reliable.

The court was not bothered that Dr. Plunkett was not a medical doctor, because she was not offering a medical opinion.  Instead, her causation opinion was based on her expertise as a pharmacologist and toxicologist.  Maybe it looked like she was playing doctor when she considered the plaintiffs’ medical histories, but that “does not mean that her opinion is not a pharmacological or toxicological one; indeed, disregarding such information would likely guarantee errors.”  Newman, 2013 U.S. Dist. LEXIS 113438 at *7.  While it is true that Plunkett’s experience with SJS/TEN outside of litigation was, er, “limited,” that (all together now) goes to “weight” not admissibility.  Plunkett was allowed to opine about general causation based on this sort of blathering:  “we have some information about the biological plausibility of the underpinnings for how SJS and TEN can develop.  But we don’t know exactly what happens.  So we have pieces of the puzzle, but we don’t have all of the answers at this point in time.”  Id. at *10.  Apparently this delightful puzzle can be plopped down in front of a jury.  (The plaintiffs do still have the burden of
proof, right?  Right?)

Plunkett was permitted to opine that only one percent of adverse events are reported, basing that number on studies that many of you have seen before.  Plunklett conceded that the one percent figure is an average for all drugs and all events, and that more serious events like SJS/TEN are more likely to be reported than less serious events.  How to deal with that rather pesky fact?  Plunkett magnanimously applied a ten percent figure.  The court thought that was “reasonable.”  Id. at *20.  Sounds like guesswork to us.  No worries, though.  “Defendants are free to cross-examine Dr. Plunkett.”  Id.   Thanks.

Further, Plunkett’s familiarity with the FDA and its regulatory capacities, work as a lecturer, study of FDA regulations, and authorship of a book chapter on FDA pharmacovigilance practices made her “qualified to opine on the limitations of the FDA’s ability to monitor the safety of drugs.”  Id. at *21.  So now the jury will be treated to the GAO conclusions “that the FDA lacked access to critical postmarketing surveillance information for OTC drugs.”  Id. And Plunkett gets to tell the jury how really bad that is, because what the GAO said “likely means very little to a layperson, but potentially quite a lot to an expert.”  Id.  Did we mention that Plunkett “did not interview anyone from the FDA or conduct her own investigation into the alleged limitations of the FDA”?  Id. at *22.  That didn’t bother the court, so why should it bother you?  In addition, Plunkett would be permitted to opine on whether Children’s Motrin should have been marketed over the counter.  Id. at *15-16.  Hmmm.  Shouldn’t the FDA decision on that fairly significant fact be the last word?

But the Newman opinion is not all bad news.   The court held that Plunkett’s reliance on a comparison of ibuprofen-related and acetaminophen-related SJS/TEN adverse events “lacks scientific rigor.”  Id. at *14.  Further, her reliance on an alleged company witness admission from 1984 was “problematic from a scientific point of view.”   Also, Plunkett’s alleged expertise added nothing to the statements themselves that the jurors could not figure out on their own.  Id.  The court also shut down Plunkett’s opinion “about what FDA regulations require and whether Defendants violated them.”  Id. at *16.  Shouldn’t the court decide questions that are, um, legal?  Also, Plunkett relied on company witness deposition testimony to establish the alleged noncompliance, and such evidence would be available to the jury to decide for themselves.  But plaintiffs did not want the jury to decide for themselves.  They wanted Plunkett to cherry-pick from the deposition testimony, focusing on “out-of-context answers given in depositions that are amenable to different interpretations and that were offered in response to questions that, more often than not, lacked clarity themselves.”  Id. at *19.  Sound familiar?

The plaintiff’s other expert, Dr. Lowitt, did not fare as well as Plunkett.  The court agreed with the defendants that determining how the “average person” understands OTC Motrin labeling is “the type of question a jury can resolve without Dr. Lowitt’s help.”  Id. at *24.  He was also foreclosed from opining that there was evidence of a genetic component in drug-induced TEN in some populations.  The problem was that the plaintiffs admitted that the relevance and helpfulness of the information “was conditioned on the discovery of a genetic link, which may not happen.”  Id. at *28.   Lowitt also volunteered to testify about the plaintiffs’ increased risk of skin cancer.  The plaintiffs wanted to be paid now for the possibility that they might get skin cancer later.  The court rejected this proffer, reasoning that “any award on this particular element of damages must reflect the probability of the occurrence of future injury, and so any such award will be problematic because there is no evidence concerning the probability of cancer.” Id. at *30.

When it came to the defendants’ Daubert motions, it was win some, lose some.  As we mentioned above, we feel empathy for the defendants, and share what must be their frustration that Plunkett would be allowed to spin a dismal web of nonsense.  The problem with a Plunkett, as with a Parisian, is that once they take the witness stand, they invariably find all sorts of ways to tuck in as many opinions as possible.  They are wind-up witnesses — highly paid Trojan horses who transform paper credentials into regurgitated plaintiff closing arguments.

Perhaps it is bad form for us to grouse too much over the Newman opinion.  For if the defendants lost some of their Daubert arguments, the plaintiffs lost all of their Daubert challenges to the defense experts.  For example, the plaintiffs argued that a defense expert’s theory that infections can cause SJS/TEN was insufficiently supported by epidemiological studies.  The court held that epidemiological studies are important, but that “an alternative methodology is acceptable so long as the methodology is sound and the underlying data is reliable.”  Id. at *35.  The defense expert, who was a medical doctor, performed a “differential etiology” (which is a more accurate phrase  than the usually misapplied “differential diagnosis”) and that it was properly grounded on medical records, as well as the deposition testimony of treating physicians.  Id. at *37.

Another defense expert was proffered to articulate the following opinions:  (1) “because the mechanism of action through which SJS/Ten is caused maintains unknown, it is extremely difficult, if not impossible, to identify a causative agent responsible for inducing [SIS/TEN] in an individual, especially because there are no laboratory tests that can be performed to provide a definitive assessment,” (2) infections are associated with SJS/TEN; and (3) not enough people have been exposed to dexibuprofen to establish whether it is causally related to SJS/TEN or not.”  Id. at *39.  The plaintiffs attacked these opinions for being speculative, but the court saw this testimony as being admissible to “cast doubt” on the plaintiff’s specific causation theories.  Id. at * 41.  After all, the defense does not bear the burden of proof.  Doubt can be enough.  That same expert also opined that that infections are associated with SJS/TEN and constitute  a potential cause of SJS/TEN.  There are a variety of published, peer-reviewed articles that suggest or have identified a potential association between infection and SJS/TEN.  The plaintiffs seized upon the expert’s admission that he did not believe that causation can be definitively established in the absence of a known mechanism.  But the expert was merely opining about possible alternate causes.  That possibility was a legitimate defense, and that possibility was supported by the literature.

The expert also opined that not enough people had been exposed to dexibuprofen to establish whether it was causally related to SJS/TEN.  To estimate extent of usage, the defense expert relied on his general understanding of the market size.  He did not review sales data.  That failure to review sales data did not mean the opinion was inadmissible; it merely meant that it was something the plaintiffs lawyers could cross examine the expert about.  Id. at *45.  (Nice to see that the ‘go ahead and cross examine the expert’ formula works both ways).

The plaintiffs attacked the methodologies of other defense experts.  Inasmuch as those experts actually were experts, and actually employed sound methodologies (certainly sounder than anything Plunkett brought to the table), it is no surprise that the court rejected the plaintiffs’ Daubert challenges.