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When most of us think of the First Amendment, commercial speech is probably not what springs to mind.  A business talking about its products doesn’t fit our classic perception of free speech.  It will never equal the “I Have a Dream” speech or stir inspiration in your soul.  But it’s important.  It really is.  The Supreme Court says so:
Advertising, though entirely commercial, may often carry information of import to significant issues of the day.  And commercial speech serves to inform the public of the availability, nature, and prices of products and services, and thus performs an indispensable role in the allocation of resources in a free enterprise system.  In short, such speech serves individual and societal interests in assuring informed and reliable decision-making.
Bates v. State Bar, 433 U.S. 350, 364 (1977).
And, generally, the worth of the information that is put into the commercial marketplace should be determined by the speakers and the audience hearing it, not the government:
The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented.
Edenfield v. Fane, 507 U.S. 761, 767 (1993).  This means that the government should not quiet commercial speech simply for paternalistic reasons: “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996).
Given its importance, we have discussed the FDA and its regulation of commercial speech often, and we recently saw yet another interesting opinion in this area, Fleminger, Inc. v. U.S. Dep’t of Health & Human Servs., No. 3:10cv855 (VLB), 2012 U.S. Dist. LEXIS 22892 (D. Conn. Feb. 23, 2102).  The Fleminger case involved green tea.  Its maker petitioned the FDA for authorization to make a “health claim,” which is a claim that relates nutrients in the product with a positive health effect.  Here, the particular health claim was that the green tea may reduce the risk of breast and prostate cancers.  Id. at *25.
Generally, the FDA will allow such a health claim if there is (i) “significant scientific agreement” supporting the claim or (ii) “credible evidence” (a lower level of evidence) supporting the claim, but then only if the claim is accompanied by an appropriate disclaimer on the lower level of the scientific evidence.  The FDA calls this second category “qualified” health claims and readily admits that it arose from court rulings against the FDA in First Amendment cases.  See, e.g., Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. 
Fleminger involved a “qualified health claim.”  It was “qualified” because the FDA found that the scientific evidence supporting it was “the lowest level” that could still allow such a claim.  Id. at *26-28.  Hardly a ringing endorsement from the FDA, but this is where the First Amendment steps in.  The FDA can’t stop a company from making such a claim since it has sufficient supporting evidence.  The FDA, instead, can require the company to include an appropriate disclaimer, but only one that doesn’t violate the company’s First Amendment rights.
The controversy in Fleminger did not involve the company’s health claim – that “Green tea may reduce the risk of breast and prostate cancers.”  That is good.  The FDA has recognized that the First Amendment does not allow it to simply strike down a health claim that has some support.  The controversy in Flemering, instead, involved the disclaimer.  The company wanted:
“The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.”
Id. at *34-35.  The FDA believed that this disclaimer overstated the scientific evidence.  It wanted:
“FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.”
Id. at *33-34.  The company balked and took the issue to court on First Amendment grounds.
The Fleminger opinion detailed the history of decisional law on the FDA’s regulation of commercial speech and, if interested, you should read the entirety of the opinion.  We will limit our discussion, however, to the court’s consideration of whether the FDA’s rejection of the company’s disclaimer and imposition of its own disclaimer was a “reasonable fit” with the government’s interest in preventing confusion about health claims and advancing the public health.
First, the court addressed the company’s proposed disclaimer – “FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.”  The court struck this down as misleading and inaccurate, basing its decision on its deference to the FDA’s finding that there was “very little scientific evidence” to support the company’s health claim.  Id. at *50-62.  The court considered the FDA’s ranking of the evidence to be very different from the company’s claim that it was “credible . . . although . . . limited.”  What is interesting, though, is that the FDA’s own guidelines define a “qualified health claim” as one that is supported by “credible but limited evidence.”   Id. at *57.  That language is very familiar.  It’s almost the same language that the company used in its disclaimer.  So how can the company’s disclaimer be inaccurate if it essentially tracks the description of qualified health claims found in the FDA guidelines?
Well, the court found a difference between consumers’ everyday understanding of the word “credible” and its unique and technical meaning within the FDA guidelines.  The court determined that a member of the public reading a disclaimer was more likely to understand “credible” to mean “offering reasonable grounds for being believed,” which is how Webster’s dictionary defines it, than to mean the lowest level of evidence, which is how it applied under the FDA guidelines in this case.  Id. at *53-54, 57-58.  This reasoning didn’t help the company.  But it could help the defense in other products and device cases.  We’ve seen plaintiffs’ counsel try to use technical terms from FDA regulations and guidelines, such as “adulterated” or “misbranded,” to create a false or overly negative impression with a jury.  The reasoning of the Fleminger court, however, can possibly be used to block such efforts or get a curative instruction from the judge.Next, the court addressed the FDA’s proposed disclaimer and upheld the portion stating that “very little scientific evidence” supported the company’s health claim.  Id. at *67-70.  This was sheer deference to the FDA’s findings.  This ruling, however, is not surprising.  The history of this case reveals that the FDA contoured the language of its proposed disclaimers to the case law as it developed.  The FDA has been chastened over the years by previous losses in First Amendment litigation.  The FDA has finally reacted and adjusted.  “[T]he First Amendment requires that the FDA allow Fleminger’s claim,” but the FDA can require “the addition of short, succinct and accurate disclaimers as to the level of scientific support of the proposed health claim.”  Id. at *68-69.  Here, the FDA provided the court with the details of its analysis and findings on the level of scientific evidence and proposed a short, succinct clause to describe those findings.
But the court did not uphold the FDA’s entire disclaimer.  The court struck down the FDA’s proposed language that “FDA does not agree that green tea may reduce that risk.”  That is not a disclaimer.  It’s an explicit announcement of the FDA’s own opinion that was to be inserted into the Company’s speech immediately after the company’s health claim.  It would have had the impermissible  “effect of negating any relationship between green tea and the reduction of breast or prostate cancer and therefore effectively swallow[ed] the entire claim.”  Id. at *71.  In essence, it was a way around the prohibitions of the First Amendment, and the court properly did not allow it.
The story ended fairly well.  The company was allowed to exercise its First Amendment rights and state its health claim about green tea, and the FDA was not allowed to inject its own opinion into that claim.  It’s probably not inspirational or moving.  But it’s another step in what has become a very interesting area of the law.
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We’ve mentioned before how preemption is the strongest defense because (unlike Daubert or the learned intermediary rule) it bars claims without regard to their substantive merit.  When preemption applies in mass torts, such dismissals may occur on a wholesale basis.  In our prior post, “The New One-Two,” we described how potent preemption can be in generic drug cases when teamed with the traditional requirement of product identification as applicable to branded manufacturers.
The other day this “new one-two” scored a knockout in the heavyweight division, that is to say a federal multi-district litigation (“MDL”) – specifically the Darvon/ Propoxyphene MDL.  In two simultaneously issued opinions, the court disposed of what are likely to be the great bulk of the claims in the MDL.  Darvon is a drug that’s been around for decades, and which the FDA eventually decided to take off the market because newer drugs were, the agency believed, both safer and more effective.  That doesn’t mean that Darvon was any less safe than before, but anytime there’s a recall, it seems somebody takes a shot at a mass tort.
No longer – at least for Darvon.
First, preemption. In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, MDL No. 2226, slip op. (E.D. Ky. Feb. 5, 2012), the court dismissed a comprehensive set of claims against generic makers of propoxyphene (the generic equivalent of Darvon), finding that all of the claims are either preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), or inadequately pleaded. Specifically:

  • “Wrongful marketing” – that is, claims that the generic defendants should be liable for not removing their products from the markets altogether – are preempted because such allegations prove too much: “the idea that [defendants] should have simply stopped selling [the generic drug] is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether.”  Slip op. at 7-8.
  • Failure to warn claims based upon alleged “failure to timely change the labeling” after the FDA ordered it strengthened were barred because plaintiffs had no facts to support “purely conjectural” “information and belief” pleading.  Slip op. at 8-10.
  • Likewise, no facts were alleged to support “Dear Doctor” letter-based claims.  In any event, such letters would involve new information, and thus labeling that was no longer the “same” as required by federal law.  Slip op. at 10 & n.9.
  • That certain defendants were designated by the FDA as “reference listed drug” holders did not prevent preemption, because “the FDA, not the RLD holder, controls label changes” once such a designation is made.  Slip op. at 10-11.
  • Claims for misrepresentation, fraud, consumer protection, and express warranty, were all preempted because they demanded labeling changes that were impossible under the federal “sameness” requirement.  Slip op. at 11-12.
  • Plaintiff’s “statutory negligence” claims were based solely on allegations of FDCA violations (“mostly relating to labeling or ‘misbranding’”) and were thus preempted under Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), because there is no private FDCA right of action.  Slip op. at 12.

Because the MDL complaints had already been amended, and plaintiffs were not entitled to speculative discovery under TwIqbal, all of the generic complaints were dismissed with prejudice and without leave to amend.  Slip op. at 12-13.
That’s one.
Continue Reading The New One-Two – Heavyweight Division

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            It was the best of times . . . . No, our story isn’t nearly as significant as that classic.  Rather, it is a tale of two medical device cases that we thought offered an interesting comparison for their numerous similarities and one key difference – the result.  This brings to mind vague memories of a popular book series of our youth, Choose Your Own Adventure.  The books were written with the reader as the protagonist.  After a few pages of a story such as Who Killed Harlowe Thrombey?, the reader is offered two or three options, each of which leads to more options and then to one of about 40 different endings.  For an avid reader, it meant a lot of mileage out of one book.  Now, it reminds us how changing one or two small facts can make a huge difference in the outcome.
            Both cases start out pretty much the same.  Two surgically implanted medical devices.  Two product failures.  Two alleged injuries.  Two explanted medical devices.  Two devices that were lost, discarded, missing – here you can choose your own adjective without it impacting the story – the devices were unavailable for inspection, they were gone.  Two lawsuits filed alleging product defects.
            Without the devices, both plaintiffs were going to have to rely on the doctrine of res ipsa loquitur.  For those who haven’t thought about res ipsa loquitur in awhile, it is an evidentiary doctrine providing that a prima facie case of negligence exists where (1) the event is of a kind that ordinarily does not occur in the absence of someone’s negligence; (2) the event is caused by an instrumentality within the exclusive control of the defendant; and (3) the event must not have been due to any voluntary action of the plaintiff.  Think plummeting elevator, dead mouse in a soda bottle, or the classic left behind scalpel.  
            But this is where our stories diverge and the major plot difference is preemption.  Viserta v. St. Jude Medical, Inc., 2012 U.S. Dist. LEXIS 26084 (D.S.C. Feb. 29, 2012) involved a Class III medical device that had received premarket approval from the FDA.  Id. at *1.   So, we know this story by heart.  Plaintiff’s claims are preempted – except where plaintiff pleads a parallel violation claim, which is what they tried here.  Specifically, plaintiff alleged that the defendant’s manufacturing materials and/or procedures “did not meet Current Good Manufacturing Practices (“CGMPs”) promulgated by the FDA, and/or they deviated from the FDA’s approval for the [device].”  Id. at *2.  While the court agreed that plaintiff was attempting to assert a non-preempted parallel claim, it also found that they failed to do so:

[A] plaintiff must allege specific facts as to how a manufacturer violated federal requirements and the causal connection between such violations and the plaintiff’s injuries to survive a motion to dismiss. . .  In this case, [plaintiff] makes conclusory allegations concerning defects in [the] manufacturing process, but does not include any factual support as to how [defendant] failed to manufacture the [device] in the manner required by the PMA process.

Id. at *9. 
Plaintiff intended to rely on res ipsa loquitur – the device was defective because she suffered an injury.  Id. at *10.  But, in discussing the need to plead a causal connection, the court focused in on the missing device:

The Amended Complaint is further devoid of any factual allegations concerning the actual condition or observation of the device upon its removal which may possibly provide the required causal connection.

Id.  Preemption thus added another step.  Plaintiff is required to prove an FDCA violation, not just a device malfunction.  Res ipsa doesn’t allow the inference of the latter.  Thus, without the device, plaintiff had not pled facts necessary to establish a causal link.  Without a causal link, plaintiff failed to state a claim and the court dismissed the complaint.
By contrast, the device at issue in Banks v. Coloplast Corp., 2012 U.S. Dist. LEXIS 26112 (E.D. Pa. Feb. 28, 2012) was not a PMA device and therefore, preemption was not in play.  So, instead of a “parallel claim”, the plaintiff was pursuing a garden variety “malfunction theory” case.  Under Pennsylvania law, when the product is unavailable, a plaintiff is allowed to use circumstantial evidence to establish a product defect.  But the plaintiff must also offer proof of the absence of other reasonable secondary causes for the malfunction.  Id. at *6-8.
This case had also advanced a few more chapters and was at the summary judgment stage.  So, the court considered evidence that the device had in fact malfunctioned (didn’t perform as intended), that the malfunction occurred shortly after implantation (allowing an inference that the device was defective when it left defendant’s control), and the lack of evidence of abnormal or unintended use of the device.  Id. at *8-9.  The court also considered arguments about the possibility of surgical error or damage during implant, but found those only gave rise to genuine issues of material fact for the jury and did not warrant summary judgment on plaintiff’s strict liability claim.  Id. at *10.      
Two cases with similar facts but vastly different outcomes and it looks like we have our old favorite preemption to thank for it.  If given a choice in our adventures, we’ll pick the preemption ending every time.
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Over a decade ago, Bexis convinced the Fourth Circuit to predict that Virginia would reject cross-jurisdictional class action tolling – the notion that a meritless class action filed in one jurisdiction could suspend the running of the statute of limitations in another jurisdiction.  See Wade v. Danek Medical, Inc., 182 F.3d 281 (4th Cir.1999).  But what was won in Wade had a hard time staying won.  Some federal courts, deviating from their federalist duty to construe state law conservatively, nonetheless made conflicting predictions that, maybe Virginia law (despite not recognizing class actions at all) would allow cross-jurisdictional tolling.  See Torkie-Tork v. Wyeth, 739 F. Supp.2d 887 (E.D. Va. 2010); Shimari v. CACI International, Inc., 2008 WL 7348184 (E.D. Va. Nov. 25, 2008).
But not all courts.  In In re Fosamax Products Liability Litigation, 694 F. Supp.2d 253 (S.D.N.Y. 2010), the court followed Wade in another multidistrict litigation (Wade had followed an MDL remand).  The plaintiffs appealed, and the Second Circuit certified the question to the Virginia Supreme Court, which accepted the appeal.
Virginia’s highest court has now killed cross-jurisdictional class action tolling dead in that jurisdiction.  Casey v. Merck & Co., No. 111438, slip op. (Va. Mar. 2, 2012).  Good riddance, we say.  It was a long enough time coming – as was the underlying Fosamax class action decision.  The plaintiffs wanted over two years of tolling – just for filing a meritless complaint – because it took various courts (it was an MDL, after all) from September 15, 2005 until January 28, 2008 to dismiss the patently bogus personal injury class action.
Continue Reading At Long Last – Virginia Definitively Rejects Class Action Tolling

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Those of us who graduated from the University of Chicago are just a wee bit tired of the “place where fun goes to die” epithet. It’s true that U of C is an intensely intellectual place, and it’s true that Hyde Park is a long way from Chicago’s hot spots, and it’s true that the Cubs will continue to disappoint, and it’s true that when the Winter wind (“the Hawk”) blows in off Lake Michigan one prays for death, but … what was our point, anyway? Right – intellectual combat can be a fascinating spectator sport. It can be a moveable feast. It can even be, yes, fun.
In mid-February, the Law School put on a “Manhood in Law and Literature” conference. Here is part of what the conference announcement promised: “The conference will include two dramatic performances by members of the University of Chicago law School. The first scene, from the Caine Mutiny Court Martial by Herman Wouk, will feature Judge Richard Posner as Lt. Commander Queeg … and Judge Diane Wood as Captain Blakely. The second scene, from The Little Foxes by Lillian Hellman, will feature Professor Martha Nussbaum as Regina Hubbard Giddens and Professor Douglas Baird as her husband Horace. A musical interlude will be provided by Jajah Wu, Gary de Turck, and Martha Nussbaum.”
Sounds like fun, right? It gets better. An article describing the conference reveals that Professor Nussbaum sang “Can’t Help Lovin’ Dat Man” from Show Boat. Mind you, this is the same Martha Nussbaum who is one of the country’s most daring and creative philosophers, who is a hero to the Drug and Device Law Daughter because of her position on animal rights, and whose analysis of Plato’s Symposium has been stuck to our brain for over 25 years. We are genuinely sorry we missed this performance. Author Joyce Carol Oates also spoke (but did not sing) at the conference. She talked about Hemingway and boxing. Oates’s writings on boxing have given it an unexpected intellectual heft.
Continue Reading There’ll Always Be Posner: Hemingway, Boxing, and Sanctions

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PARISIAN TRANSCRIPTS 2.0
We had a number of people send us material after our first post with out list of deposition transcripts (and various other items) concerning the testimony of the extremely active plaintiffs’ side expert, Dr. Suzanne Parisian. We are still awaiting promised materials from certain other folks, who will remain nameless.
One anonymous benefactor sent us a 30-page disclosure list (no transcripts, unfortunately) of Dr. Parisian’s appearances in court or at trial prior to early 2010.
Another anonymous benefactor sent us a Westlaw print out containing additional Parisian-related materials. We’ve added the Westlaw citations, both to new items and to those we’ve already had.  We haven’t looked at them all, but we did review some, and we caution that a lot of the Westlaw materials contain extensive omissions and thus might not be particularly helpful.  The Westlaw materials also included some of Parisian’s expert reports, so we’ve created a second list – after the first – of those.  Those are only on Westlaw; they weren’t included in any materials we received.
We’ve tried to synthesize this material and compile it into a single list.  If you thought our prior Parisian post was boring – well this one’s just as boring, but even longer.  If we have the actual transcript of the testimony, then the item is listed in black, as before, with or without a Westlaw citation. If we don’t have any transcript, then we’ve also listed it, but in red.  A red colored entry with a Westlaw cite means we don’t have a copy of the transcript, but there’s something available on Westlaw.
Continue Reading Parisian Transcripts 2.0

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So The Artist won.  Some of us (maybe only one of us) didn’t even know it was a silent movie.  Imagine going to that movie without knowing it was silent.  That’s failure to warn.  At least when Mel Brooks made Silent Movie you knew what you were getting.  And in his movie the French guy spoke. 
Alright, on to legal stuff.  We found a number of interesting Daubert decisions in the court’s opinion in Hershberger v. Ethicon Endo-Surgery, Inc., No. 2:10-cv-00837, 2012 U.S. Dist. LEXIS 18799 (S.D.W. Va. Feb. 15, 2012), so we thought we’d discuss a few of them here.  This is a device case.  The plaintiff claimed that a stapler used during her colostomy reversal procedure was defectively manufactured because it didn’t contain the staples that it was supposed to contain, requiring a second stapling procedure.  Id. at *2-4.  The defense, on other hand, argued that the stapler did in fact contain staples but one of the surgeons prematurely and negligently discharged the stapler.  Id.  As trial approached, the parties filed a number of motions in limine to exclude testimony from experts and treating physicians related in one way or the other to this issue. 
The attending surgeon sought to testify that no staple was discharged at all during the first firing of the stapler – supporting plaintiff’s claim that it was defective – but rather a staple found in the plaintiff instead got there during a second stapling.  Id. at *16-19.  The defense’s response was based on a simple and seemingly effective argument.  The attending physician had already admitted that he didn’t see any staples inside the plaintiff during the procedures so he could not testify on when it got there.  The court allowed the testimony, however, ruling that the doctor’s opinion was “a product of [the doctor’s] experience and observations in the role of treating physician.”  Id. at *18.  We aren’t too surprised by this.  This ruling falls into a category that we’ve often seen at trial, whether appropriate or not: treating doctors get to testify about an awful lot of things as long as the testimony can be linked to their treatment of the plaintiff.
But in this case the plaintiffs wanted it all.  They not only wanted to be allowed to use the treating surgeon’s testimony to support their claim but also to exclude the defendant from offering testimony from an expert disagreeing with the conclusions and reports of the treating surgeons.  No go, said the Court:
In formulating their opinions, expert witnesses may be called upon to sift through conflicting testimony and data to arrive at an opinion of the most likely course of events. Such determinations of judgment, provided they are well-reasoned and explained, do not render expert testimony inadmissible. . . . [The defense expert’s] choice to credit some facts contained in the treating physicians’ reports and testimony but not other facts is an issue for cross-examination, not a threshold question of admissibility.
Id. at *11.  In fact, the court went on to say that the defense expert’s choices on which testimony and data to credit and which to discredit appeared “well founded.”  Id. at *11 n.5.
Maybe the most interesting decision contained in this opinion, however, was on the defense’s motion to exclude a plaintiff’s expert from testifying that “based upon the lack of staples in the stapler [reported by the treating physicians], the stapler was defective.”  Id. at *22.  Defendant’s argument to exclude this opinion was simple and one we like: this is no expert opinion at all.  The testimony would simply credit or parrot the treating surgeons’ testimony on the absence of staples and use that to then give an opinion that a stapler without staples is defective, which calls upon no specialized expertise.  Id. at *23.  In fact, the plaintiffs inadvertently conceded this point.  They defended this opinion by arguing that it was “a matter of common sense.”  Id. at *23.  Exactly.  Jurors have common sense and no need for an expert to help them with it. 
As we have often had to argue at trial, expert opinion is not meant to parrot or cheerlead the testimony of others, and it isn’t needed to tell jurors things that they can figure out themselves.  And this court got it right.  It ordered the expert to remain silent.  Id. at *24.  That’s the kind of silent movie we like.
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            Suspicion.  It is the stuff of great movies.  We could name just about any Hitchcock movie here, but why not go with the aptly titled Suspicion starring Cary Grant and Joan Fontaine (who by the way won the Best Lead Actress Oscar for her role in this film).  After a chance meeting on a train, Johnnie Aysgarth, reckless gambler and playboy, and Lina McLaidlaw, shy heiress, have a whirlwind romance and are married.  It is only after the honeymoon that Lina discovers her new husband’s true character and she starts to become suspicious that he is a murderer and she is his next intended victim.  Cue eerie music. 
It is also the stuff of great songs.  And here we could quote any of a number of country hits about cheating spouses and double-crossing gamblers.  But, again, why not go straight for the most obvious.  Suspicious Minds was Elvis Presley’s seventeenth and last number one hit single.  Written and originally recorded by Mark James (who also wrote Grammy-winning “Always on My Mind”), the song is about two people whose suspicions of one another are ruining their relationship.
Which brings us to today’s case – Messina v. Amylin Pharmaceuticals, Inc., 2011 U.S. Dist. LEXIS 153392 (W.D. Pa. Dec. 30, 2011) — which is all about suspicions.  While we typically don’t spend much time on statute of limitations cases, we liked the message of this case which is rooted less in state law and more in general common sense. 
Plaintiff was prescribed Exenatide, commonly known as Byetta, for treatment of her diabetes.  The Byetta warning label included acute pancreatitis as a possible adverse reaction.  Id. at *3.  Plaintiff was diagnosed with pancreatitis in March 2007 and hospitalized for treatment for almost two months.  Shortly after her discharge in June 2007, she retained her attorney to investigate the matter.  Id. at *2.  Her attorney filed suit against the drug manufacturers on November 18, 2009 – more than two years after being retained.  Id.
Pennsylvania has a two year personal injury statute of limitations.  Like many states, Pennsylvania has also adopted the discovery rule – meaning the “running of the statute is tolled until the injured party is reasonably aware that her injury has been caused by another’s conduct.”  Id. at *5 (citation omitted).  A party must also exercise “due diligence” in becoming aware.  Id. at *7.   To the lay person, the answer to when someone knew something may seem fairly straightforward and due diligence can be as easy as asking your wife “what year did we vacation in the Keys?”  In the legal arena, however, what constitutes “reasonably aware” is the question most often at the heart of drug and device statute of limitations cases.  And, as with the Messina case, plaintiffs often want to argue that their own suspicions are trumped by medical certainty.  Fortunately, this court didn’t agree.
Plaintiff testified “that she believed Byetta caused her injury when she was discharged from the hospital in June, 2007.”  Id. at *7  This would be enough for us and it was enough for the court too:

Given Plaintiff’s testimony that she subjectively attributed her injury to Byetta at that time, she was clearly on at least inquiry notice, i.e., her belief was sufficient to trigger running of her two-year statutory period to investigate.

Id.  Plaintiff’s counsel tried to muddy the waters with testimony from plaintiff’s mother that while her daughter was in a coma “her physicians did not tell [plaintiff’s mother] that Byetta did not cause her daughter’s pancreatitis and she did not know if [the doctors] were sure what caused it.  Id. at *8-9.  That’s a lot of double negatives.  Her doctor’s certainty wasn’t the trigger.  Plaintiff’s suspicions were.  Whether that suspicion was specifically that Byetta caused her injury or a more general suspicion that “something went wrong with her care” – the time for plaintiff to investigate started to run.  And because plaintiff had retained counsel, that duty to investigate applied equally (if not more so) to her counsel:

[Plaintiff] and [her] counsel on [her] behalf were obliged to make adequate inquiry during the two (2) year period applicable under Pennsylvania law, to form/substantiate reasonable beliefs as to the cause of Plaintiff’s injuries and any resultant potential legal liability, and to file the appropriate actions in the appropriate courts. Counsel’s failure to file the Complaint against Defendants within the statutory period leaves this Court no alternative but to hold the action time barred.

Id. at *9.
Pennsylvania actually has a fairly long history of cases that support the proposition that, absent an affirmative diagnosis to the contrary, the plaintiff’s subjective suspicion satisfies the discovery rule.  See Danysh v. Eli Lilly & Co., 2011 U.S. Dist. Lexis 104997 (Mag. M.D. Pa. July 13, 2011) (summary judgment granted on statute of limitations grounds, holding that knowledge of the precise cause of injury is unnecessary to the discovery rule); Debiec v. Cabot Corp., 352 F.3d 117 (3d Cir. 2003) (summary judgment affirmed in one of four consolidated cases; a definitive medical diagnosis is not necessary to start the statute running when a plaintiff suspects he or she has been injured and believes he or she knows the cause of her injury; where plaintiff did not receive a definitive negative diagnosis, he should have investigated his condition further and had additional tests);  Russo v. Cabot Corp., 2002 U.S. Dist. Lexis 12134 (E.D. Pa. Apr. 22, 2002) (summary judgment granted where decedent was suspicious and began collecting newspaper clippings about possible links to beryllium disease; suspicions obligated her to investigate her potential claim); Love v. Raymark Industries, Inc., 633 A.2d 1185 (Pa. Super. 1993) (knowledge of a “dirty lung” and a diagnosis of lung cancer, combined with the plaintiff’s suspicion that both were related to occupational exposure to asbestos, satisfies the discovery rule; even if plaintiff was not informed of the cause by his physicians, it was unreasonable as a matter of law for him not to make inquiry); McD v. Rosen, 621 A.2d 128 (Pa. Super. 1993) (the statute begins to run when the injured party possesses sufficient critical facts to put him on notice that a wrong has been committed and that he need investigate to determine whether he is entitled to redress);  Stauffer v. Ebersole, 560 A.2d 816 (Pa. Super. 1989) (while a speculative diagnosis may have been insufficient in and of itself to satisfy the discovery rule, it activated a duty on plaintiffs’ part to pursue whether the injury was caused by an outside act or otherwise a potential plaintiff with a tentative diagnosis could wait indefinitely).

          While the suspicion of movies and music makes for good entertainment, plaintiffs in products cases (at least in Pennsylvania) should take their suspicions seriously.

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Last night we watched the Academy Awards presentations. We’re never sure why we do this. Why do we care about the film preferences of a notoriously unreliable, insular group whom you might meet at Nate n’ Al’s, but never at Home Depot? Then again, our whole business is built around other peoples’ opinions — judges, juries, clients. (No comment on their reliability or insularity.) We confess to being utterly riveted by the screen shot of the nominees at the moment the winner is announced. It’s the image of the losers that is most arresting — that flash of disappointment shifting seamlessly into a strained smile. We’re not supposed to think of winners and losers when it comes to the Oscars. In the old days, the presenters would tear open the envelope and say “And the winner is ….” Now they say, “And the Oscar goes to….” The artist will consider the idea of picking winners and losers to be crass. That was the reason given by George C. Scott for declining his Best Actor award for Patton.

We often hear that the real honor is just being nominated. That sounds like a mealy-mouthed rationalization, but it’s true. Nominations recognize merit. Who actually wins can seem a matter of happenstance and caprice. To be sure, we’re not saying the nominations always get it right. For instance, how is it that Gary Oldman has never been nominated until this year? There’s also the embarrassing example of Hoop Dreams, which might have been the best film in 1994, but it wasn’t even nominated as Best Documentary. One theory is that, at almost three hours, it was just too long for the voters (median age 62). They needed bathroom breaks.

But what really stands out over the years are winners and losers that make no sense. When you remember that Ordinary People beat out Raging Bull for Best Picture, that Oliver! beat 2001: A Space Odyssey, that How Green Was My Valley beat Citizen Kane, that the same year Hoop Dreams got stiffed Forrest Gump beat Pulp Fiction, and that Hitchcock never won as Best Director, you merely shake your head. Forget about it; it’s Chinatown. (A well-deserved winner.)

One of the nominated pictures this year was Moneyball, which is about how the general manager of the Oakland A’s adopted new analytical methods and metrics to gain a comparative advantage and win more games than better financed baseball clubs. But it turns out that the comparative advantage could only get the team into the playoffs. Once it all came down to short series, anything could — and did — happen. Maybe Derek Jeter would make an unreal defensive play and snuff out a rally. Ultimately, winning and losing has more of a freak-factor than we want to acknowledge. We Phillies fans are pretty certain we were rooting for the best club in the major leagues the last two years, but we ended up running into so-so teams that happened to get hot at exactly the right time. We’re not sure what to think about the Buffalo Bills. No other team made it to four straight Super Bowls. It is an incredible accomplishment. But to lose all four of them makes you wonder whether it was bad luck (a missed field goal or missing helmet), some fatal deficiency, or, as suggested in an episode of The X-Files, the result of a vast conspiracy headed by the Cigarette Smoking Man.

We’re not Citizen Kane or the Buffalo Bills, but we’re happy that this blog consistently gets nice nominations for being the best at what it does. We’ve never played the game of trolling for the popular votes needed to crown the “winner.” No Weinstein Company Oscar campaign for us. Some blogs do seem to do that, and that’s fine. Honestly, it’s an honor just to be nominated. As Justice Hugo Black said, “It is the paradox of life that the way to miss pleasure is to seek it first.”

But in our day jobs as litigators, we care about winning. Our clients certainly care. We are the help. Good lawyering definitely makes a difference. Still, nothing guarantees winning. Some of the very best trial lawyers out there have experienced horrendous losses. Stuff happens, and not just at midnight in Paris. Every day, courtrooms set the scene for stealth jurors, batty rulings, and unforeseeable witness implosions that steal defeat from the jaws of victory. Sometimes, too, the facts are simply difficult. For whatever reason, something weird and unexpected is bound to show up at trial, like those dinosaurs in Tree of Life.

We know an in-house counsel who likes to ask outside lawyers to name their biggest loss. His theory — and it makes a lot of sense — is that a truly good lawyer has been given some gruesomely tough cases. It’s simply not possible to win them all. When a lawyer brags about an unblemished record, we tend to react with either skepticism or a suspicion that the lawyer shies away from, or isn’t trusted with, the hardest cases.

When we worked at the U.S. Attorney’s office, we frequently sought advice from the head of the Criminal Division. He had been there for decades and was a brilliant curmudgeon. Real old school. A war horse. On the wall behind his desk was a poster of Winston Churchill pointing at you, with the words “Deserve Victory” writ large across the bottom. It was from World War II, but it was the best possible creed for what we were doing on a day-to-day basis. It’s been 20 years since we first stared at that poster, and now we have our own copy of it. We continue to find it inspiring. Winning or losing involves some things you can control and some things you can’t. Immerse yourself in the facts, be diligent and creative in arguing the law, and forge an emotional connection with the audience. If need be, get extremely loud and incredibly close with a witness. You might not win, and you certainly won’t be handed an Oscar, but you will deserve victory.

(By the way, we thought last night that The Descendants deserved to win, and not just because it involved the Rule Against Perpetuities.)

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In our recent post describing Salvio v. Amgen Inc., 2012 WL 517446 (W.D. Pa. Feb. 15, 2012), we mentioned the standard for punitive damages that the court applied – “punitive damages are unfounded where a manufacturer-defendant warns of the potential danger that resulted in injury to a plaintiff.”  2012 WL 517446, at *8.  Under this view, even if the warning is inadequate in some way, the fact that the defendant gave some warning about the risk defeated the “conscious indifference” (or worse) mental state required for punitive damages:

[E]ven if Plaintiff could show that “[m]ore could have been done or said,” the Defendants did not display indifference toward the public’s safety and therefore punitive damages are not warranted. Defendants’ Motion to Dismiss Plaintiff’s claim for punitive damages will be GRANTED.

Id.  The court observed that “Pennsylvania courts have not addressed this issue,” id., and thus relied on several federal court of appeals decisions.

We think the principle is an interesting one, so we’ve decided to examine it in more depth.  One thing we found was that Salvio had overlooked prior Pennsylvania decisions that made more or less the same rulings.  One such decision is Richetta v. Stanley Fastening Systems, L.P., 661 F. Supp.2d 500 (E.D. Pa. 2009), which involved a nail gun, not a prescription medical product.  Like Salvio, Richetta held that the defendant’s efforts to warn precluded the mental state necessary for punitive damages:

[T]he existence of this warning language substantially undercuts Plaintiffs’ argument and indicates that Defendant was, if anything, attempting to minimize the risk of accidents through this warning language.  As the state of mind of the actor is vital in determining whether punitive damages are appropriate, this conduct cannot be considered recklessly indifferent.

661 F. Supp.2d at 514 (citation and quotation marks omitted).

Then there is Ferguson v. Valero Energy Corp., 2009 WL 1676154 (E.D. Pa. June 15, 2009), which wasn’t a products case at all, but involved injuries to an employee of an independent contractor.  A property owner (and other related defendants) could not have been “recklessly indifferent” because “the defendants undertook several steps to warn against the dangers.”  Id. at *14.

The cases Salvio cited are also on point.  Toole v. McClintock, 999 F.2d 1430, 1436 (11th Cir. 1993), was decided under Alabama law.  Alabama follows a “conscious indifference/deliberate” intent standard for punitive damages.  Id. at 1435.  In Toole, a breast implant case, the defendant had warned about the particular injury that the plaintiff experienced.  The warning might not have been adequate, but it demonstrated that the defendant was not acting consciously or deliberately as required for punitive damages:

[T]he issue of punitive damages should not go to the jury when a manufacturer took steps to warn plaintiff of the potential danger that injured him; those facts bar a finding that defendant was “consciously indifferent.”  The [defendant’s] warning describes the main harms that [plaintiff] has actually suffered . . . and the warning forecasted the way she came to suffer these harms. . . .  More could have been done or said, but [defendant] did not exhibit indifference toward safety.  [Defendant’s] conduct shows regard for recipients of its implants and cannot be viewed as “wanton.”  We conclude that there was insufficient evidence of wantonness in this case to permit the jury to award punitive damages.

Id. at 1436 (citation omitted).  Accord Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1317 (11th Cir. 2000) (“reaffirming” prior decision concerning warnings and punitive damages); Richards v. Michelin Tire Corp., 21 F.3d 1048, 1059 (11th Cir. 1994) (tire manufacturer’s warnings precluded finding of “wantonness”) (applying Alabama law).

Toole relied on an older decision, Kritser v. Beech Aircraft Corp., 479 F.2d 1089 (5th Cir. 1973) (obviously not involving a prescription medical product) of the Fifth Circuit, applying Texas law, that reached the same result.  Texas also defined the mental state required for punitive damages as “conscious indifference.”  Id. at 1097.  Kritser determined that the trial court properly withheld punitive damages from the jury because:

[Defendant] gave [plaintiff] notice of [the risk] under some circumstances and warned him against [it]. The fact that the company took such steps to inform [plaintiff] of potential danger absolved [it] of liability only for punitive but not compensatory damages. The defendant did not exhibit the conscious indifference toward the public which generally typifies gross negligence, and there is no evidence that it committed any willful act or omission.

Id. (citation omitted).

The third case Salvio cited, Dudley v. Bungee International Manufacturing Corp., 1996 WL 36977 (4th Cir. 1996) (in table at 76 F.3d 372), is an unpublished (and therefore non-precedential) decision under Virginia law.  The fact pattern was the same – the defendant gave a warning, albeit inadequate, of the risk involved.  The court held that, while inadequate, that warning precluded a finding of “willful and wanton negligence” sufficient to support punitive damages:

This warning, at least in general terms, warned others of the dangers. . . .  Thus, since [defendant] warned of the potential danger that injured [plaintiff], it exhibited some care for his safety.  Because [defendant]. exercised some care for the safety of others, an award of punitive damages was not warranted under a failure to warn theory

Id. at *3.

Dudley cited another case for this proposition, the Missouri Supreme Court decision in Bhagvandoss v. Beiersdorf, Inc., 723 S.W.2d 392 (Mo. 1987).  Bhagvandoss involved a non-prescription medical device (a bandage).  The defendant’s warnings precluded a conclusion of “complete indifference” or “conscious disregard of the rights of others” needed for punitive damages:

[Defendant] sought to warn users that the product should not be used in sterile intensive procedures.  We have held that the jury might well find that the letter did not give sufficient warning. . . .  But inadequate communication cannot be equated to conscious disregard. . . .  Here the defendant gave serious attention to the problem and issued a warning.  Even if there are grounds for criticizing its procedures, the finding of complete indifference is not supported by the record.

Id. at 398 (citations and footnote omitted) (emphasis added).  See Drabik v. Stanley-Bostitch, Inc., 997 F.2d 496, 510 (8th Cir. 1993) (warnings negated intent under Missouri law); Jackson v. Leland Health Care LLC, 2008 WL 6049187, at *4 (Mo. App. Nov. 12, 2008) (“not enough to justify submitting a claim for punitive damages to a jury that a defendant inadequately communicated a warning”), transfer denied (Mo. Dec. 18, 2008); Jone v. Coleman Corp., 183 S.W.3d 600, 610-11 (Mo. App. 2005) (“warning indicate[d] that [defendant] did not willfully or consciously disregard the safety of the consumers”), transfer denied (Mo. Feb. 28, 2006).

We went looking to see if we could find anything else.  We found the Texas Supreme Court ruling (in a non drug/device case) that an inadequate warning precluded a finding of the mental state necessary for punitive damages:

The issue in gross negligence is not whether [defendant] developed and used the best warning imaginable.  We believe this warning, standing alone, does not provide a reasonable basis upon which to infer conscious indifference.  After reviewing the evidence . . . we hold the evidence of conscious indifference is not legally sufficient.

General Motors Corp. v. Sanchez, 997 S.W.2d 584, 597-98 (Tex. 1999).  See Agrium U.S., Inc. v. Clark, 179 S.W.3d 765, 767 (Tex. App. 2005) (“an actor’s failure to pursue the safest course available or provide the best warnings imaginable does not necessarily equate to a want of caring”) (reversing punitive damages award), review denied (Tex. April 21, 2006).

There was also law next-door in Arkansas.  In DeLuryea v. Winthrop Laboratories, 697 F.2d 222, 231 (8th Cir. 1983) (applying Arkansas law), a prescription drug case, the court agreed that the defendant “failed to adequately warn of these dangers.”  However, the “evidence establishe[d]” that because “warnings were given,” “there was no evidence to support punitive damages” and “no indication of malice, wantonness, or reckless indifference to the consequences from which malice could be inferred.”  See Lockley v. Deere & Co., 933 F.2d 1378, 1390 (8th Cir. 1991) (belated addition of warning decals may “very well have supported a finding of negligence” but “even gross negligence is not sufficient to justify punitive damages under Arkansas law”).

The West Virginia Supreme Court made a similar ruling that where a manufacturer warns, even if the warning is inadequate, punitive damages will not lie.  In Ilosky v. Michelin Tire Corp., 307 S.E.2d 603 (W. Va. 1983) the court upheld the trial court’s ruling striking punitive damages, stating:

 

The trial court correctly struck the appellee’s claim for punitive damages.  The evidence showed that [defendant] had taken steps to warn the public about [the risk in question].  These efforts included placing warnings and recommendations against such action in literature distributed to consumers and to individual dealers who carried [defendant’s]tires.  The fact that these warnings may have been inadequate to fully warn of the hazards of such use does not obviate the fact that [defendant] made some effort.  This case does not involve a situation where the manufacturer or distributor made no effort to warn about use of the product.  Therefore, the facts do not meet the willfulness, wantonness, or malice standard.

Id. at 619.  Thanks to Tom Hurney at Jackson Kelly for this West Virginia addition.

We also found law in Illinois. In Tyler Enterprises of Elwood, Inc. v. Skiver, 633 N.E.2d 1331 (Ill. App. 1994), the court affirmed dismissal of punitive damages in light of arguably inadequate warnings:

There is a fact question as to the adequacy of the warnings supplied by [defendant]. Nevertheless, [it] did advise [plaintiff] not to [do what the plaintiff did].  In light of the above facts, we cannot conclude that [dft] acted with a conscious disregard for, or indifference to, the safety of [plaintiff].

Id. at 1339.

In a non-precedential decision, the Ninth Circuit, interpreting California law, also held that warnings, “albeit inadequate,” precluded a jury from finding the mental state needed to award punitive damages:

Under California law, punitive damages may be awarded when a plaintiff proves by clear and convincing evidence that a defendant acted with such a conscious and deliberate disregard of the interests of others that his conduct may be called willful or wanton.  Here, [defendant] made efforts, albeit insufficiently, to warn its customers about the risks. . . . While this may amount to negligence, it does not rise to the level willful or wanton conduct.

Heston v. Taser International, Inc., 431 Fed. Appx. 586, 589 (9th Cir. 2011) (applying California law).

Finally, in Turner v. Adaltis U.S.A., Inc., 2005 WL 3335425 (D. Md. Dec. 7, 2005), the court held:

that no reasonable juror could rationally find by clear and convincing evidence that [defendant] acted with “actual malice” such that an award of punitive damages could be sustained . . . because the facts of record, including but not limited to the warning contained in the [product’s] user’s manual, affirmatively undermines any such claim of “actual malice.”

Id. at *4.

There may be more such cases.  Our research was little more than some Shepardizing (tracking cases that cite to one another), and one computer search.  It’s enough, however, to tell us that the defense is a valid one in the punitive damages context and that the Salvio court was on solid ground in making its ruling.

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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