Last Friday we had a brief post about the new decision in Bartlett v. Mutual Pharmaceutical Co., 2010 WL 2765358 (D.N.H. July 12, 2010).  That was a tickler; we promised you a more fulsome discussion of the opinion later.

Well, later is now, so here goes.

Briefly, the product involved in Bartlett is generic Sulindac, an anti-inflammatory NSAID.  The plaintiff was prescribed Clinoral – the branded version of the drug – but in an increasingly common scenario, plaintiff’s pharmacist substituted generic Sulindac.  2010 WL 2765358, at *1.  Plaintiff came down with Stevens-Johnson Syndrome (“SJS”), a nasty condition that among other things left her permanently blind.

Plaintiff sued, and we suppose in the course of discovery, discovered FDA-related issues with the generic manufacturer’s ongoing post-marketing research – like there wasn’t any. The following facts were taken as true for purposes of the defendant’s summary judgment motion:

More than a year before these events [that is, plaintiff’s prescription], an international medical journal published a study of the link between NSAIDs and [SJS].  The study revealed that . . . Sulindac had 89 reported cases of [SJS] . . . more than any other NSAID on the market and all but four drugs of any kind.  [Defendant] was not aware of that study, however, because it had not been monitoring the medical literature for information about Sulindac’s safety risks.  [It] believed that the manufacturer of Clinoril, the brand-name version of the drug, was responsible for such monitoring.

2010 WL 2765358, at *2.

At the time of the prescription, the defendant’s FDA-approved label didn’t mention SJS by name, instead describing it as “hypersensitivity” – albeit specifically mentioning “severe skin reactions” and “fatalities.”  Id. Thus, the state of the labeling was something that, on the whole, tended to favor the plaintiff.

However, the defense got a big break when the prescriber testified that he never read that allegedly inadequate warning and that it made no difference in his treatment of the plaintiff:

  • He never read either the defendant’s warnings of those with the brand name product, with respect to the condition plaintiff suffered.  Id.
  • Nothing in the label influenced his prescription of the drug.  Id.
  • He already knew, from medical training that all NSAIDs had some risk of SJS, but “it was not his usual practice” to discuss that risk with patients.  Id.
  • He still prescribes the drug “on rare occasions” even knowing what happened to plaintiff.  Id.

So, while the plaintiff had a decent argument on the adequacy of the warning, the defendant had a much better argument on causation – that nothing wrong with the label made any difference to plaintiff’s prescriber.

Anyway, we’d been watching the Bartlett litigation ever since that case produced a major preemption decision back in September of last year.  We didn’t say much about it then – we’re a defense oriented blog and we make no bones about that – but Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. 2009) (“Bartlett I”), was the first decision that systematically addressed the significant arguments that plaintiffs had developed to counter generic-drug-specific preemption arguments.  It’s no secret that, since Bartlett I, generic drug manufacturers have taken their preemption lumps in a number of decisions. We chronicle the gory details in our drug/vaccine preemption scorecard.

It was that first Bartlett decision that led us to compare Judge Laplante in our minds to the late Hon. Edward R. Becker, from our neck of the woods (the one-time chief judge of the Third Circuit here in Philadelphia).  Even though Bartlett I reached an anti-preemption result in the generic drug context, it was notably thorough and tightly reasoned opinion.  Ed. Becker’s opinions were the same way – long and thorough – but at least in the type of tort cases we litigated – usually pro plaintiff.  Unfortunately, Judge Becker rarely met a novel cause of action (such as medical monitoring or recovery of purely economic loss, to name two) that he didn’t like. We wondered whether Judge Laplante, in addition to sharing Judge Becker’s notable intellect and work ethic, might also have his tendency to lean towards the plaintiff side in tort cases.

Well we’re happy to report, based upon that most recent Bartlett opinion, that this fear appears unfounded.  Unlike Bartlett IBartlett II isn’t entirely pear shaped – not hardly.

It is pretty darn thorough, though – just like Bartlett I.

The court first addresses whether the warning could be held adequate as a matter of law.  On the one hand, it didn’t mention SJS, but on the other hand it expressly warned of potentially fatal “severe skin reactions.”  The court conceded that the defendant had the better of the legal argument based upon prior precedent, but ultimately found a jury question as to adequacy in light of the intervening medical journal article mentioned above, which it held raised the salience of SJS beyond what the older cases had addressed.  2010 WL 2765358, at *4.

But we can’t groan too much because the defendant still won summary judgment on the warning claim.  Bartlett II aligned itself with the majority view that a prescriber’s failure to read an allegedly inadequate warning severs the causal link to the purportedly inadequate information.  Basically, a doctor has to read a warning for it to affect his/her treatment.

[The prescriber] made clear that he never reviewed [the] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug or what he told her about it. . . .  Thus, even assuming arguendo that [defendant] had a duty to strengthen [its warning language], that stronger warning would not have affected [the prescriber’s] decision or prevented [plaintiff’s] injuries.  [M]ost courts will find an absence of causation as a matter of law where the physician testifies that he or she never read the warnings given.

2010 WL 2765358, at *5 (citations and quotation marks omitted).  Bravo!  While that’s certainly the majority rule, it’s not universal, and there was no prior New Hampshire law case on the point.  Bartlett II thus becomes the second case this month to reject warning causation as a matter of law on a “prescriber did not read” rationale.  See also Phillippi v. Stryker Corp., 2010 WL 2650596, at *3 (E.D. Cal. July 1, 2010).

But Judge Laplante, being hyper-thorough, covered a number of interesting sub-arguments that we think defense counsel might find interesting.  For one thing, the prescriber’s testimony about ever reading the brand-name (as opposed to the generic product actually taken by plaintiff) label was a little squishy.  Branded involvement in generic drug cases is a major pet peeve of ours.   Bartlett II toughened up the prescriber’s testimony by pointing out that there was no evidence that anything the generic defendant did could have affected the brand-name label:

[Plaintiff] has presented no evidence that if [defendant] had strengthened its [generic] label, the FDA would have required corresponding changes to the [branded] label.  So far as the record indicates, that sequence of events (i.e., unilateral changes to a generic drug label, followed by FDA-mandated changes to the brand-name drug label) would have been highly unusual, if not unprecedented.

2010 WL 2650596, at *6.  After having been on the receiving end of the same sort of argument in Wyeth v. Levine, 129 S.Ct. 1187, 1197 (2009) (observing that the FDA has never prosecuted the unilateral strengthening of warnings), it’s nice to see plaintiffs get hosed by that same rationale.  This holding – which we’ll call “FDA causation” – is potentially significant since plaintiffs often make wild claims that the FDA might have done something different than what it actually did.

Another straw that the plaintiff tried to grasp was the heeding presumption.  2010 WL 2650596, at *6.  The court observed that the plaintiff probably would have lost that argument anyway, as binding First Circuit precedent has declined to expand liability by recognizing such a presumption in the absence of New Hampshire state precedent.  Id. (citing Wilson v. Bradlees of New England, Inc., 250 F.3d 10, 16 (1st Cir. 2001).  But the court didn’t have to go that far because the same prescriber failure-to-read testimony that defeated warning causation in the first place also rebutted any purported presumption. 2010 WL 2650596, at *6.

Finally, the court refused to let plaintiff shout “credibility” and pray for trial – something we’ve addressed before.  Plaintiff had nothing to impeach the prescriber’s warning causation testimony. “Credibility” isn’t an argument in the absence of any evidence to call a witness’ credibility into question. “A party’s bare assertion that the opposing party’s uncontroverted evidence might be disbelieved is insufficient to resist judgment as a matter of law on an issue as to which the party resisting judgment bears the burden of proof.” 2010 WL 2650596, at *7.

Being thorough, Judge Laplante also entertained – and threw out – plaintiff’s unpleaded, novel “non-label” warning defect theories.  These alleged that the defendant could be liable for not providing better information through some avenue other than the drug’s labeling.  Specifically, plaintiff alleged that the defendant should have; (1) “created a medication guide for Sulindac users”; (2) “sent a ‘Dear Doctor’ letter directly to healthcare providers”; (3) filed a citizen’s petition with the FDA” to change its label; and/or (4) undertaken some sort of “educational campaign.”  2010 WL 2650596, at *7.

Give the plaintiff an “A” for ingenuity, but an “F” for viability.  The medication guide theory failed because it ran headlong into the learned intermediary rule.  Prescription drug warnings only go to doctors; there’s no additional duty to tell anything to patients directly, whether through a “medication guide” or anything else.  Id.

The “Dear Doctor” letter claim was simply the plaintiff blowing smoke.  There was no evidence concerning either the defendant’s policy for sending such letters or the prescriber’s practice of reading them.  Thus, that theory was “purely speculative.”  Id. at *8.

The citizens’ petition theory was not only speculative (for reasons of FDA causation), but failed because of the “same predicament” as the warning claim generally – the most any such petition could have accomplished would have been to change the label.  However, the prescriber didn’t read the label.  Id.

Last, and least, the “educational campaign” theory was pie in the sky.  Even if some such duty could exist, there was no evidence what might have happened had the non-existent campaign been undertaken – it was, in short, “pure speculation.”  Id.

Thus, due to Judge Laplante’s addressing every single point made by the plaintiff, no matter how far-fetched, we have precedent rejecting (on one ground or another) four novel theories that some other plaintiff might try to use in some other case.

There’s more.

The court allowed plaintiff to skate with an unusual “design defect” claim.  2010 WL 2650596, at *9-10 (denying summary judgment).  We question whether such a claim should even be allowed to exist, since how does one change the “design” of something that’s a unique molecule?  If you alter the molecular structure, you don’t have the same drug anymore.  The problem is that long ago, the First Circuit – in an Ed Beckeresque expansion of state law in the absence of supporting state court authority – allowed “design defect” claims in prescription drug product liability litigation under New Hampshire law in Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 657 (1st Cir. 1981).  That’s binding precedent, we’re stuck with it unless and until the New Hampshire Supreme Court (where prescription drug product liability cases seem as rare as hen’s teeth) holds otherwise, and Judge Laplante followed it.  The upshot is that the plaintiff gets a shot to prove that Sulindac was “unreasonably dangerous” and the defendant gets it shot at establishing that the drug is “unavoidably unsafe” under Restatement §402A, comment k.  2010 WL 2650596, at *10.

It will be interesting to see what Judge Laplante ultimately makes of a purely “design defect” trial involving a prescription drug.  Will he allow the plaintiff to argue that – contrary to the FDA’s decision not to force NSAIDs off the market due to the SJS risk – a civil jury can conclude that the drug’s risks outweigh its benefits and the drug should not be sold for an approved indication?  Most “design defect” claims involving drugs devolve either into:  (1) “FDA was wrong” claims (which should be preempted or else conclusive deference given to the FDA’s decision, see White v. Weiner, 562 A.2d 378, 383 (Pa. Super. 1989), aff’d mem., 583 A.2d 789 (Pa. 1991)); or (2) “failure to recall” claims that, as we’ve discussed before aren’t recognized in any state.  Maybe we’ll have a Bartlett III to look forward to where Judge Laplante delves characteristically deeply into these questions.

Moving right along, there’s more good news for our side.  Fraud gets the back of the judicial hand.  The reason’s pretty obvious.  Reliance is an essential element of fraud.  The prescriber didn’t even read the warning so there’s no evidence – let alone “clear and convincing evidence” – of reliance.  2010 WL 2650596, at *10.

Then some bad news.  Then the court next addressed punitive damages, which in a New Hampshire peculiarity are called “enhanced compensatory damages.”  It found sufficient evidence of “wantonness” to allow the claim survive, based upon what the court characterized as the defendant’s “admitted (though explained) failure to survey the medical literature for information about Sulindac’s safety risks and its continual manufacture and sale of Sulindac in the face of those risks, even though other drugs were withdrawn from the market.”  Id. at *11. We don’t like punitive damages in drug cases, period, but this adverse ruling in Bartlett II is thankfully quite limited to what we’d have to say is a bizarre set of facts – taking the court’s characterization at face value.  First, we’ve been defending drug/device cases a long time, and this is the first we’ve heard of a manufacturer simply not reviewing at all what’s being published about its product in scientific journals.  Second, to the extent the punitive damages claim is based upon a supposed duty to recall, as we just stated, there’s no such state-law duty – in New Hampshire or anywhere else – in the absence of an FDA order, which obviously doesn’t exist.

The next part of the opinion – dealing with the whole “surveillance of medical literature” issue – is our sentimental favorite. It deals with FDCA-based negligence per se, something we’ve ranted about so much that we’ll simply refer readers to our “negligence per se” topic header, here.

Again, we must say we’re struck by the seeming definitiveness of the underlying facts:  “[defendant] concedes that it did not conduct such surveillance.”  Bartlett II, 2010 WL 2765358, at *12.  But putting that aside, what to make of this failure?  The defendant first argued that there was no violation – its position being “that FDA regulations imposed no surveillance requirement on generic manufacturers.”  Id.  The court in Bartlett II didn’t buy it, holding instead that “any” manufacturer, generic or otherwise, owes the same obligation to conduct continuing surveillance of the medical literature concerning its drugs.  Id.

Frankly, we don’t buy that argument any more than the court.  Even though we’re a defense lawyers, we can’t really see any valid policy reason why any company that manufactures prescription drugs shouldn’t be equally required to keep up with the medical literature concerning that product.  It’s similar to the Conte problem of a branded manufacturer being held responsible for injuries caused by generic products that it didn’t sell.  Where generic drugs are available, by virtue of their cheaper price, they almost always make up a large majority of product sales.  The argument that the generic manufacturer made unsuccessfully in Bartlett II is essentially that only the branded manufacturer has the obligation to review medical literature.  But if generics have, say 95% of a particular market for a drug, why should they get to be free riders?  Why should a branded product manufacturer with 5% of the market have to shoulder 100% of the responsibility to keep track of ongoing research?  Doesn’t make sense to us.

What’s far more significant to us is that, even with the existence of an FDA regulatory violation established in Bartlett II, the court nevertheless rejected a negligence per se claim, and refused to enter summary judgment for the plaintiff on a negligence theory.  It’s another reminder that there are several defenses to negligence per se that aren’t readily apparent from the black-letter, ALI Restatement formulation of such a claim.

We’ve gone over these defenses before, but they bear repeating – they win cases:

  • The FDCA explicitly forbids private enforcement of regulatory violations. Many states do not allow negligence per se claims where to do so would be contrary to legislative intent.
  • Many states do not allow negligence per se unless the allegedly violated enactment provides a specific standard to replace the common law’s “reasonable man” standard.  Many provisions of the FDCA are too vague and broad to meet this specificity requirement.
  • A number of states restrict negligence per se to violations of statutes passed by a legislative body and do not permit such claims for violations of mere administrative regulations.  Most of the specificity in the FDA’s regulatory scheme is found in regulations, rather than the statute.
  • Even in states that allow negligence per se for regulatory violations, there is no claim for violating something that does not have force of law.  Much FDA regulation is informal, through guidance documents and other publications that lack force of law.
  • Some states don’t allow negligence per se where the effect would be to create “novel” forms of liability.  Many FDCA violations, involve obligations that have no parallel in common law and thus impose liability in novel situations that the common law does not reach.
  • Negligence per se is typically unavailable for failure to obtain a license.  FDA approval to market a product for a particular intended use is analogous to a license.  This defense is particularly important in off-label use cases.

The fate of the negligence per se claim in Bartlett II turned on the mere administrative regulation defense, and to a lesser degree on the legislative intent defense.  Critically, New Hampshire courts have not extended negligence per se to regulations:

[T]he FDA’s surveillance requirement is not a statute; it is a safety regulation.  The New Hampshire Supreme Court has suggested that safety codes generally “are not to be accepted as absolute standards” of care “unless they have been incorporated into statutes or ordinances by either State or local legislative bodies.”  That cautionary language casts serious doubt on whether New Hampshire would treat the violation of a safety regulation as negligence per se, particularly a federal regulation which, so far as the record indicates, has not been incorporated into any such statutes or ordinances.

2010 WL 2765358, at *13 (citation omitted).

New Hampshire also predicates availability of negligence per se on the claim being consistent with legislative intent:

Another factor that New Hampshire courts consider in determining whether to recognize a negligence per se theory is whether doing so would be consistent with the legislative intent as expressed in the relevant law.  Here, the FDCA expressly provides that “all such proceedings for [its] enforcement … shall be by and in the name of the United States.”  21 U.S.C. § 337(a).  The Supreme Court has said that this provision “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.” Because the FDCA does not provide for a private cause of action, many courts have held plaintiffs cannot seek to enforce it through negligence per se tort actions.

Id. (various citations and quotation marks omitted).

The court found “no clear answer” under New Hampshire law.  2010 WL 2765358, at *14.  But “[b]ased on the sources and considerations discussed above, this court’s view is that the New Hampshire Supreme Court would not treat [defendant’s] violation of [the medical literature surveillance requirement] as establishing a per se breach of its duty of care.”  Id.  The violation thus did not result in liability – it was simply “evidence” for the jury to consider.  Id.

There are a few left over odds and sods in Bartlett II.  A defense that the defendant called “set off” was really an issue of “apportionment,” and so set off was not properly in the case.  2010 WL 2765358, at *14.  The court denied the defendant’s spoliation claim once the plaintiff gave in and let the defendant inspect the bottle of pills.  Id. at *15.  Finally, the court refused to reconsider its preemption ruling, but did not address any new arguments.  Id. at *15-16.

So that’s Bartlett II.  It’s something of a mixed bag, but we’d have to say that, on balance, the court’s good rulings on warning causation and negligence per se outweigh its adverse decisions on adequacy of the warnings and design defect.  And after two major opinions, we’ll keep looking to see what ultimately happens to what’s left of this litigation.