A few days ago we concluded the litigation strategy class we co-teach at Penn Law School.  This year’s students were the best yet at understanding the importance of reducing any case to its most basic story bits.  One of the case studies we teach is a drug/device lawsuit.  Big surprise there.  It contains the usual medical cartload of science/causation issues.  The students quickly figured out that any plaintiff case would need to be constructed around the failure to warn claim which, in turn, was premised on accusations of lies, laziness, and greed.  Those would not necessarily be accurate or fair accusations.  Indeed, their strength resides in their ability to steamroll over pesky things like facts and complexity.
 
Plaintiffs toss theories of failure to warn around like nickels, and with just about the same degree of care.  What makes a warning adequate?  Does a warning get assessed in terms of whether it is noticed?  Or is remembered?  Or is persuasive?  We’ve seen all of those theories at one time or another.  That last one – alleging a warning is inadequate simply because the injury happened – is obviously nonsensical.  Recently, we heard someone describe the process of assembling a child’s playground toy.  The instructions were a page long, then followed by four pages of warnings.  First there was a picture of how the parts fit together, then there was a picture of the toy on fire, with little stick-figure children shown fleeing the area.  It is as if the first instruction was how to put it together, but the second was “Do Not Do This.”  We suspect that enterprising plaintiff lawyers would still file a failure to warn claim even if the product insert said, “Do Not Take This!”
 
Most of the failure to warn cases involve some alleged deficiency in content.  These theories are wholly retrospective and opportunistic. It is always possible after the fact to find something, perhaps to some level of detail or drama, that was missing.  We are reminded of the evolution-creationism debate, where a pro-evolution scientist complained that every time new fossil evidence is found, the critics inevitably carp that now there are two more gaps in the story.  What is exasperating about most failure to warn claims is how much they are at odds with reality.   Talk to any real live consumer (at least before they have filed a complaint) about the effect of drug or device warnings, and they will tell you that they do not pay any attention to them or that they find them hilarious.  The warnings, in terms of length and ghoulishness, end up making much more of an impression than assertions of benefit.  The reality is that patients pay attention to the advice from their doctors.
 
Hence, we have the learned intermediary in almost every jurisdiction.  The issue is whether the doctor was adequately warned and, if not, whether the warning’s inadequacy made any difference.  When those questions are presented to a jury, there is a concern about how well equipped those fact-finders are to resolve those issues.  The odds of a real live doctor being on the jury are infinitesimally small.  (The truth is that the prospect of such a juror would likely terrify both sides.  The six or twelve person jury might effectively become a one-person jury.)  The jury is dependent on the testimony of competing paid experts and, most critically, the testimony of the prescribing doctors.  Rarely, but sometimes, a prescribing doctor will say that he or she now feels misled by the label, and that more information would have changed the prescribing decision.  Those are Very Bad Cases for the defense.  Much more commonly, the doctor will testify that the allegedly missing information was already known, or that it would not have made much of a difference.  Those are Very Good Cases for the defense.  In fact, they should never come within sniffing distance of a jury, as they should be poured out on summary judgment. 
 
Many cases are in-between.  They are messy.  They are messy because somehow the plaintiff has been permitted to waltz all the way up to, and maybe even through, trial without ever specifying what the warning should have been.   Or occasionally the plaintiffs manage to create a messy record by getting the prescriber to admit to the feel-good notion that doctors would always like to know more rather than less.  A doctor might hesitate to testify that “No no no – I would not care about hearing more studies or internal company documents, etc.” because it might make them sound dogmatic or indolent or simply incurious, even though the new 'information' really would not matter.  Further, an especially modest doctor (they do exist) might allow that it would be hard to step back in time and predict what the doctor would have done in a different information environment.  We would say that such a fact scenario manifests a failure of proof on the plaintiff’s part, and the case should not be pushed along for further speculation, this time for a jury.  Here’s the point:  failure to warn claims can be effective precisely because they are imprecise, and courts need to step in sooner rather than later.        
 
A very good example of a court stepping in is the recent case of Bergstresser v. Bristol-Myers Squibb Co., 2013 U.S. Distr. LEXIS 169138 (M.D. Pa. Dec. 2, 2013).  In that case, the court dismissed a failure to warn claim on the ground that pharmaceutical companies are not obligated to provide details to doctors about how to practice medicine.  Taken seriously, this holding should help courts trim their dockets of sloppy failure to warn claims.  Everyone who is not a plaintiff lawyer should be in favor of such trimming.  Sloppy cases impose enormous costs on court systems, companies, and, eventually, patients.  The fact that sloppiness – or, if you prefer, uncertainty – often translates into a desire to settle is viewed by too many judges as a good thing.  It is not.  Seen from a macro level, it is a pernicious dead-weight loss on society.  Having attended the University of Chicago, we’ve got the graphs to prove it.  But we digress. 
 
After some preliminary procedural skirmishing in Bergstresser(we have written about that skirmishing in Bergstresser before, and not all of it was to our liking), the case boiled down to an amended complaint setting forth a sole claim of negligent failure to warn.  The plaintiff alleged that the defendant’s antipsychotic medication failed to provide instructions to physicians on how to monitor signs and symptoms of any version of dystonia or tardive dyskinesia (movement disorders) so as to prevent contraction of those conditions.  The amended complaint also alleged a failure to provide directions as to how the prescribing physician should increase or decrease the strength or dosage of the medication. 
 
Bergstresser was decided under Pennsylvania law, thus making it a case harboring special interest to those of us who labor in the shadow of Billy Penn’s statue.  Under Pennsylvania’s application of the learned intermediary doctrine, “the determination of whether a warning provided to a prescribing physician is adequate is initially a question of law.” Bergstresser, 2013 U.S. Dist. LEXIS 169138 at *14.   Here, the court resolved that question with an intelligent, bracing analysis. 
 
The plaintiff alleged that “nowhere” in the package insert did the defendant warn of the potential to contract dystonia. Id. at *12. The court points out that “[d]espite this allegation, in the package insert, Section 6, ‘Adverse Reactions,’ sub-section 6.2 ‘Clinical Studies Experience,’ extrapyramidal symptoms are indicated.” Id. That is an important rejoinder to the theory often announced by plaintiff lawyers that an adequate warning must be located in the “Warnings” section. We have always thought that theory was silly. If we saw a sign on a fence saying“Guard Dog” or “300,000 Volts,” we would not need inclusion of the word“Warning” to understand the existence of risk and danger. When plaintiffs do us the rare courtesy of saying exactly what was wrong with the label, they like to pick and choose not only what exact words must be used in a label, but where in the label they should go. In their view, some portions of the label are less equal than others. But doctors are not only literate, they are experienced and careful. They read the label as a whole, and so should the court.
 
The plaintiff’s claims that monitoring and dosing instructions were missing ends up being just as incorrect. The packaging insert did contain such information – certainly enough to get a doctor started on the process of doctoring.  
The plaintiffs harped on the absence in the label of “adequate monitoring instructions to physicians regarding the symptoms of dystonia.” Id. at *21. But according to the court, those allegations “overlook the fact that such judgments as to specific monitoring are better left to the physicians’ discretion, as opposed to the disassociated drug manufacturer.” Id. at *22. Put simply, the law “does not require that the drug manufacturer provide such detailed information or instructions so as to remove the medical judgment of the physicians, who are in the best position to monitor and treat their patients and make medical judgments with respect to their care.” Id.
 
That last point is what will be quoted often in future defense briefs. It is certainly an adequate instruction to courts on how to avoid the maladies of pointless, burdensome trials and runaway juries led more by emotion than law and reality.

But the Bergstresser case does not quite end there.  As with most such failure to warn claims, the plaintiff “failed to indicate what further warning should have been given, or that any alternative warning would have prevented his physician from prescribing” the drug or device at issue.  Id. at *23.  Moreover, the plaintiff has not alleged what “appropriate” monitoring information should have been given, or that any such information would have prevented his doctor from prescribing the medicine.  The court’s conclusion is less conclusory than the plaintiff’s allegations:  “The plaintiff cannot in a conclusory manner simply allege that his injury would not have been resulted if his physician was provided with some unspecified information.  He must provide sufficient factual allegations as to why the information provided to the intermediary was inadequate, what information should have been provided, and how that information would have caused the intermediary to act differently which would have prevented the plaintiff’s injury.”  Id. at *24.

Bergstresser should become a lead paragraph when defense lawyers explain to courts why failure to warn claims must be dismissed.  Maybe citation of Bergstresser does not completely fit into the category of storytelling, but it might greatly increase the chance of a happy ending.