Friday, July 30, 2010

New Defense Learned Intermediary Wins In Pennsylvania

This week the Superior Court of Pennsylvania (the intermediate appellate court) issued two new opinions on warning causation in the context of the learned intermediary rule.  Cochran v. Wyeth, Inc., ___ A.2d ___, No. 2838 EDA 2008, slip op. (Pa. Super. July 27, 2010), and Owens v. Wyeth, No. 185 EDA 2009, slip op. (Pa. Super. July 26, 2010) (memorandum).

Both of these cases arise from the few remaining fen-phen cases in Philadelphia County, which involve primary pulmonary hypertension as the claimed injury.  Obviously, Cochran is the more important of the two, because it will be published, and is precedential.

Cochran involved a peculiar warning claim.  The plaintiff conceded that the warnings regarding primary pulmonary hypertension were adequate.  Instead she claimed that the warnings about valvular heart disease (VHD) - a condition she admittedly never contracted - were inadequate, and that had the prescribing physician been warned of that risk (as opposed to PPH), he would not have prescribed the drug.  Obviously, opening up the entire warning to inadequacy attacks, regardless of the injury actually suffered, would have been a major increase in the scope of liabilty.  Fortunately the Superior Court didn't buy the theory:
Here, [defendant] allegedly breached its duty in failing to disclose the risk of VHD, and Appellant’s injury was PPH.  The risk of VHD did not develop into the actual injury of VHD. Although [the prescriber] testified in his deposition that he would not have prescribed [the drug] to Appellant had he known of the risk of VHD, this does not alter the fact that [defendant] failed to disclose the risk of VHD and Appellant suffered from PPH.  In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation.  Therefore, as a matter of law, there is no proximate, causal connection between [defendant's] failure to disclose the risk of VHD and Appellant’s specific injury.
Cochran, slip op. at 14-15.
In Owens - which as an unpublished opinion is neither precedential nor even citable in Pa. state court - the prescriber knew all about the risk of PPH.  He testified he would have prescribed notwithstanding a black box (which wasn't on the drug at the time) because the risk of a fatal obesity-related disease (diabetes) was much worse.  Slip op. at 8-9.  Owens also had the VHD/PPH issue, but the physician testimony didn't support but for (as opposed to the proximate causation rationale in Cochran) causation.  Slip op. at 11.
Owens also affirmed dismissal of three novel claims.  The first was "negligent marketing," which the Superior Court limited strictly to overpromotion:
Appellant next argues that her claim for “negligent marketing” is cognizable under Baldino v. Castagna, 478 A.2d 807 (Pa. 1984).  Indeed, our Supreme Court has recognized a cause of action against a drug manufacturer when over-promotion of a drug effectively nullifies adequate warnings.  See Baldino, 478 A.2d at 810.  However, in her complaint, Appellant did not make any averments that [defendant] marketed [the drug] in a manner that negated its warnings concerning [the drug's] risks. Therefore, Appellant’s alleged “negligent marketing” claim does not fit within the rubric of Baldino’s over-promotion cause of action, and fails to state a claim upon which relief could be granted.
Owens, slip op. at 12-13.
The second novel claim to bite the dust was “negligent failure to withdraw [the drug] from the market” - a failure to recall claim. The Superior Court joined unanimous precedent in rejecting that theory:
Appellant’s contention lacks merit. In [a prior case], this Court refused to recognize a duty to retrofit a product.  Following the natural direction . . ., this Court is persuaded by the majority of modern jurisdictions that have decided not to impose a common law duty to recall on a manufacturer.  We conclude, accordingly, that in Pennsylvania, a drug manufacturer does not have a duty to withdraw or recall a prescription drug from the market.
Owens, slip op. at 13 (citations omitted).
The third novel claim was "negligent failure to test":
Pennsylvania law has not recognized an independent tort for negligent failure to test. In fact, this Court has held that the claim for negligent failure to test is not a viable cause of action recognized by our courts.
Owens, slip op. at 14 (citation and quotation marks omitted).

Thursday, July 29, 2010

Preemption and generic drugs: the Department of Justice tells the Sixth Circuit to get in line behind the Supreme Court

We told you last month that the Sixth Circuit had asked the FDA for its views of preemption in the generic drug context. The FDA's brief was due today, and we were all geared up to read it.

Alas, we must gear down. The Department of Justice filed a letter today with the Sixth Circuit that says:

The Supreme Court has invited the Solicitor General to file a brief expressing the views of the United States on whether that Court should grant certiorari to review the Eighth Circuit's resolution of the preemption question in PLIVA v. Mensing (Sup. Ct. 09-993) and Actavis v. Mensing (Sup. Ct. 09-1039). The Acting Solicitor General intends to file an amicus brief with the Supreme Court setting for the Government's view on the preemption issues raised in the Mensing cases, which are the same issues as those in the above-captioned cases pending before this Court.

In view of this, the Government respectfully requests 14 days from the date it files a brief with the Supreme Court to respond to this Court's request.

And so we and the Sixth Circuit have to wait until the Acting Solicitor General responds to the Supreme Court's request, a request we discussed here and here. When that happens, we'll let you know about it.

Cornett - The Sequel

Yesterday we regaled you with the first half of the decision in Cornett v. Johnson & Johnson, ___ A.2d ___, 2010 WL 2867811 (N.J. Super. A.D. July 23, 2010), concerning the court's decision to apply the law of the plaintiff’s residence to the statute of limitations in a prescription drug case. We explained how that was a big deal, given the number of out-of-state plaintiffs who have flocked to New Jersey in recent years to take advantage of the state’s reputation for liberality in tort matters – a reputation that, as we pointed out before, isn’t entirely deserved.

Today we tackle the other half of the Cornett decision – concerning preemption.  Preemption loomed large in Cornett because the product involved, a drug eluting coronary stent, is a Class III premarket approved (“PMA”) medical device.  That means, of course, to anyone who follows this blog with any regularity at all, that the plaintiffs’ personal injury claims ware subject to express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and – depending on the allegation – maybe implied preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as well.

There are two ways of looking at this aspect of Cornett, since the Appellate Division found most, but not all, of the claims preempted – whereas the Law Division of the Middlesex vicinage (that Jerseyspeak for “trial court in Middlesex County”) had found the plaintiffs’ entire cases (the ruling applied to several dozen suits) preempted.

On one hand, there’s the glass-is-half-full approach: that getting an affirmance of a dismissal on the pleadings that knocked out large portions of these cases is a big step forward, given the notable liberality that many prior Appellate Division panels have shown towards expansive tort liability.  See Smith v. Alza Corp., 948 A.2d 686 (N.J. Super. A.D. 2008); Sinclair v. Merck & Co., 913 A.2d 832 (N.J. Super. A.D. 2007), rev’d, 948 A.2d 587 (N.J. 2008); International Union of Operating Engineers Local No. 68 Welfare Fund v. Merck & Co., 894 A.2d 1136 (N.J. Super. A.D. 2006), rev’d, 929 A.2d 1076 (N.J. 2007); Rowe v. Hoffmann-La Roche Inc., 892 A.2d 694, (N.J. Super. A.D. 2006), rev’d, 917 A.2d 767 (N.J. Mar 29, 2007); In re Lead Paint Litigation, 2005 WL 1994172 (N.J. Super. A.D. Aug 17, 2005), rev’d, 924 A.2d 484 (N.J. Jun 15, 2007); James v. Arms Technology, Inc., 820 A.2d 27 (N.J. Super. App. Div. 2003) (overruled by Lead Paint); Staub v. Eastman Kodak Co., 726 A.2d 955 (N.J. Super. App. Div. 1999); Delgozzo v. Kenny, 628 A.2d 1080 (N.J. Super. App. Div. 1993).

On the other hand, the glass-is-half-empty approach laments that any of the plaintiffs’ allegations escaped dismissal and laments especially that New Jersey has not adopted Twombly/Iqbal and still allows vague, anything goes pleadings.

Both approaches probably have merit.

The preemption facts were not exactly easy from a defense perspective.  First, the stent was used in an off-label manner – it was not approved for use in diabetic patients and at least the lead plaintiff of the group was a diabetic.  Plaintiffs made by-now-familiar allegations of illegal off-label promotion.  Second, the FDA issued a warning letter asserting violations of Good Manufacturing Practices ("GMPs”) that resulted in “nonconforming” stents being sold.  Third, plaintiffs alleged that the defendants had not complied with some of the post-marketing surveillance conditions of the PMA, and had thus did not reveal an increased risk of the condition (thrombosis) that the lead plaintiff, at least, claimed to have.  Cornett, 2010 WL 2867811, at *2-4.

Faced with Riegel and Buckman preemption, the plaintiffs made two major arguments.  First, they argued that, since there was an off-label use, there wasn’t any preemption at all – their theory being that the FDA neither considered nor approved the off-label use.  Second, they tried to ram all their claims through the narrow preemption exception for “parallel” violation claims.

In a ruling that is Exhibit A for the glass-is-half-full approach, the court rejected the off-label use = no preemption argument.  Initially the court pointed out, as many other courts have, that off-label use is perfectly legitimate under the Medical Device Amendments:

Two decades after it enacted the MDA, Congress clarified that the off-label use of devices was not illegal per se, by denying the FDA any power “to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”  21 U.S.C.A. §396.  It also provided a safe harbor for manufacturers of Class III devices to “disseminate” to health-care providers peer-reviewed articles or “reference publications” “concerning the safety, effectiveness, or benefit of a use not described in the approved labeling[.]”  21 U.S.C.A. §§360aaa, 360aaa-1.
Cornett, 2010 WL 2867811, at *11.

Simply because an off-label use is not itself FDA approved does not mean that the PMA process, and other aspects of the FDCA, do not regulate off-label use.

While plaintiffs are correct that the FDA does not literally “approve” off-label uses, because approval would axiomatically make them label uses, they are incorrect to argue that the absence of affirmative approval mandates the finding that no federal requirements exist.  Federal requirements for off-label use manifestly exist, in the form of the safe harbor for their promotion, and the obligation to seek a supplemental PMA to add warnings to the label for off-label uses even when the manufacturer has no desire to promote them.  Furthermore, plaintiffs’ argument presumes off-label use to be inherently suspect or substandard, which Congress rejected by enacting 21 U.S.C.A. §396 to protect off-label use.
Cornett, 2010 WL 2867811, at *17 (Buckman citation omitted).  Indeed, Riegel itself was an off-label use case.  Id. at *20.  Thus, “we reject plaintiffs' argument that . . . §360k(a) should not preempt any of their claims against defendants arising out of . . . off-label use.”  Id.

Cornett joins the still small but growing list of cases rejecting the plaintiff-side argument that off-label use is incompatible with PMA preemption.  See Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270, 1283-84 (M.D. Fla. 2009); Riley v. Cordis Corp., 625 F. Supp.2d 769, 777-79 (D. Minn. 2009); McMullen v. Medtronic, Inc., 2004 WL 2538642, at *4 & n.2 (S.D. Ind. Sept. 16, 2004), aff’d, 421 F.3d 482 (7th Cir. 2005).

The court’s categorical rejection of the plaintiffs’ categorical argument that off-label use precluded PMA preemption thus counts as a big thumbs up.

The Cornett decision also accurately assessed the preemptive impact of the FDCA’s express prohibition against private assertion of violation claims:

As for enforcement, all “proceedings for enforcement” of the FDCA must by brought “by and in the name of the United States.”  21 U.S.C.A. §337(a).  The statute leaves “no doubt” that it prohibits private actions in which the only wrongdoing is violation of a federal law or standard. That prohibition requires a plaintiff to characterize his or her claims about a device as violations of state law, which 21 U.S.C.A.  §360k or 21 U.S.C.A. §396 may then preempt.
Cornett, 2010 WL 2867811, at *11 (citation omitted).  Thus, tort claims that “exist solely by virtue of the FDCA” are preempted because “they [are] in effect no more than per se claims for violation of a federal requirement.”   Id. at *15.  Truly “parallel” state-law claims do not need the alleged FDCA violation to exist:

[A] claim describes a “traditional” state law cause of action not simply because it contains required elements for the manufacturer’s conduct beyond the violation of a federal requirement, but rather because it would provide the required elements of a state cause of action even with no reference to federal requirements as the measure of the reasonableness or wrongfulness of the manufacturer's conduct. . . .  Regardless of how the plaintiff styles a state claim, if it is a claim that could not be articulated but for the existence of a federal requirement that was allegedly violated, it is functionally equivalent to a claim that is grounded solely on the federal violation, and is therefore impliedly preempted.
Id. at *16 (citations omitted, emphasis added). Thus, to avoid preemption a claimed “parallel” violation claim must navigate between Scylla and Charybdis.  The claim must both parallel the federal requirements (and nothing more) while also being a traditional state-law claim not dependent upon the claimed FDCA violation:

[T]o avoid the statutory preemption of state requirements that vary from federal requirements, a state claim concerning PMA devices must be parallel to the federal requirements, meaning that the state requirements it embodies must not impose any duty on the manufacturer beyond satisfying the federal requirements. However, to avoid the implied preemption of claims outside the traditional areas of state regulation, a claim concerning PMA devices must also represent a traditional state cause of action that would impose a duty on the manufacturer even if there were no federal requirements at all to be referenced, much less violated.
Id. (emphasis added).

We couldn’t have said that better ourselves – and we’ve said this till we’re blue in the face. So we put our other thumb up – at least for the time being.

The court also found claims concerning the defendants’ alleged failure to comply with post-approval surveillance and study could be preempted.  PMA imposes post-marketing duties to report and investigate adverse reactions, but affirmative label changes require additional FDA approval:

However, if such information indicates the need for an enhanced warning, the manufacturer must seek FDA approval before adding it to the label.  Manufacturers have a safe harbor for promoting an off-label use, namely, distributing certain clinical study reports to physicians, as long as they also seek FDA approval for it.
2010 WL 2867811, at *16.

So the Cornett court got the big concepts right.  But the devil’s in the details – or as some have said, “what the big print giveth, the fine print taketh away."

Turning to the plaintiffs’ particular claims, Cornett acknowledged that PMA approval, and thus express preemption, “encompasses the device’s design, manufacturing methods, and label, including the information to be given to patients.”  2010 WL 2867811, at *16.  The court held that there was nothing “parallel” about the plaintiffs’ design defect claim:

Because [New Jersey law] provides a different standard for the adequacy of the device’s design than the federal requirements, plaintiffs' design defect claim is not “parallel” to them and is thus squarely within Riegel’s preemption holding.
Id. at *17. That was easy enough.

To avoid their manufacturing defect claim suffering the same fate, “plaintiffs limit their allegations . . . to what the FDA warning letter identifies as potential deviations.”  Id.  That concession prompted the court to hold that a proper “parallel” claim was pleaded, with the “manufacturing defect” being the violations of GMPs stated in the FDA’s letter.  Id.  As our device preemption scorecard indicates, that’s not all that unusual a ruling in and of itself.

But in federal court, that’s not the end of it.  No, we can use Twiqbal to go after this sort of claim, either for vagueness (failure to plead what’s been violated), non-parallelness (to gin up a violation, the plaintiff interprets the regulation differently than the FDA), or irrelevance (the violation did not involve the plaintiff’s device).  But unfortunately, Cornett is in state, not federal court.  So the plaintiffs skate – at least for now – because it’s enough to “incorporate[] the FDA warning letter’s assertion of manufacturing defects,” and there’s no requirement to “directly connect the injury to the violations named in the FDA warning letter”; “could have” causation is enough.  2010 WL 2867811, at *18 & n.6.

The drip, drip, drip as the water empties from the glass reminds us, once again, why we’re such fans of Twiqbal.  Well, at least the plaintiffs’ manufacturing claims are now limited to what’s in the FDA warning letter.

With respect to warning claims, there’s preemption – and maybe failure to state a claim – with respect to any and all pure failures to add more warnings to the label.  Not only does Riegel preempt such claims, but the court indicates that they fail under the presumption of adequacy that New Jersey law affords to all FDA-approved warnings.  “[A]bsent deliberate concealment or nondisclosure . . . compliance with FDA standards should be virtually dispositive.”  2010 WL 2867811, at *19 (quoting Perez v. Wyeth Laboratories, 734 A.2d 1245, 1259 (1999)).

Okay – but not okay. A “nondisclosure” claim, Cornett holds, isn’t preempted.  “[W]hen the claim about the failure to warn for approved uses was combined with allegations of nondisclosure, it became a claim within a traditional area of state regulation that would have existed even in the absence of federal requirements.”  2010 WL 2867811, at *19.  That’s peculiar, because, while citing Buckman, the court seemingly forgets that Buckman postdates the Perez language.  Buckman, as we all know, holds that fraud on the FDA claims are preempted.

Thus, after Buckman, the Perez language is incomplete.  The question “nondisclosure to whom?” becomes key, because non-disclosure to the FDA is just another way of saying fraud on the FDA.  So, to whom?  Unfortunately, here’s where Cornett comes up short, since the allegations sound to us like a warmed over fraud on the FDA claim:

While defendants supposedly withheld [post-marketing studies] from the FDA and the advisory panel, they allegedly distributed altered versions of them to physicians, to promote both approved and off-label uses with misrepresentations. . . According to plaintiffs' complaint, submission of the studies as federal law required would have caused the FDA to improve the label, and any heightened warnings concerning approved uses would also have increased the safety of off-label uses.
2010 WL 2867811, at *19.

If it walks like a duck and quacks like a duck, chances are it’s a duck.  Plaintiffs allege a claim of “deliberate nondisclosure,” id., to the FDA, and the causation element of their claim is expressly based upon the contention that, but for the nondisclosure, the FDA would have done something other than what it in fact has done.  That has all the attributes of a fraud on the FDA claim, and it’s preempted under Buckman, regardless of what Perez might have said a couple of years earlier.  No two ways about it, then, in this respect the Cornett decision blew it.

We’re back to half empty again

There’s also, apparently, a second failure to warn claim based upon promotion of off-label use.  The court’s reasoning on that is essentially:

(1) New Jersey law limits warning claims to a product’s “intended purpose”;

(2) Off-label promotion places the use among a product’s “intended” uses;

(3) Off-label promotion is illegal, so a claim based upon off-label promotion would “parallel” FDA requirements;

(4) The violation did not have to involve fraud on the FDA, since “there were other ways in which promotion” could violate FDA regulations;

(5) Those “other ways” were “affirmatively represent[ation]” about “mortality differences” and “failure to include adequate warnings about the off-label use they were promoting.”

2010 WL 2867811, at *20.

Hmmm…. We’ve suggested before that false promotion of off-label use might survive as a “parallel” claim.  But, while Cornett dances around the edges, there’s apparently no allegation that any “affirmative representation” was actually false.  Otherwise, we think the court would have said so.

Instead of any allegation of actual falsity, we get, “[u]nder the liberal standard of review for a motion to dismiss, we conclude that plaintiffs' allegation of off-label promotion without adequate warnings was a sufficient pleading.”   2010 WL 2867811, at *21. So, for lack of Twiqbal in New Jersey, the Cornett plaintiffs escape (at least for now) with an ill-defined “failure to warn by non-disclosure during off-label promotion” claim.

Cornett finishes up by addressing a few miscellaneous claims.  It follows what is the majority view on express warranty – that is, “liability for statements in the FDA-approved label and other documentation is preempted,” but claimed warranties arising from “any statement that the FDA did not approve or mandate, is not preempted.”  2010 WL 2867811, at *21.  We don’t have a problem with that, but what are the alleged express warranties here?  Dunno.  All we get is a “to the extent that” ruling that doesn’t really decide anything.  Id.  Since (as our cheat sheet demonstrates) one of the most frequent uses of Twiqbal is to require that the substance of claimed express warranties be pleaded, we’re once again left lamenting the difference between federal and state pleading requirements.

Implied warranty doesn’t exist under New Jersey law as a separate claim in product liability actions.  2010 WL 2867811, at *21.

Punitive damages are preempted under McDarby v. Merck & Co., 949 A.2d 223 (N.J. Super. A.D. 2008).

That's it.

So it’s hard to say whether, with respect to preemption, we should consider Cornett to be half full or half empty.  The design defect claim is gone, and the warning and manufacturing claims are trimmed back to specific and hard-to-prove violation related claims.  Upon further development, one warning theory will almost surely be exposed as a preempted fraud on the FDA claim.  From experience, we also doubt there’s any “there there” as to express warranty either.  And no punies.

But one thing’s clear.  The litigation’s going to be more than twice as large as it needed to be.  What happens next is the expensive part, discovery – all over claims that, had they been in federal court, were in one way or another inadequately pleaded under Twombly/Iqbal.

Wednesday, July 28, 2010

Cornett v. Johnson & Johnson Part I: Choice of law and statute of limitations

Last Friday, the New Jersey Superior Court Appellate Division issued a decision filled chock-a-block with interesting rulings. Cornett v. Johnson & Johnson, 2010 WL 2867811 (N.J. Super. Ct. App. Div. July 23, 2010). Today we’ll discuss the part of the opinion that resolves the choice of law and statute of limitations issues raised by the appeal of Vonnie Cornett. Tomorrow we (read: Bexis) will analyze the rest of the opinion, which discusses device preemption, parallel claims, and off-label promotion. Those of you who can’t wait until tomorrow have the citation.

In December 2004, Vonnie Cornett’s husband Billie Cornett received a drug-eluting stent made by Cordis, a Johnson & Johnson subsidiary. On May 18, 2005, a cardiac catheterization found a subacute thrombosis in the artery with the stent. Billie died on June 1, 2005, allegedly from subacute stent thrombosis, but Vonnie did not file her complaint until September 2008, more than three years later, and she filed the complaint in New Jersey state court. The trial court granted defendants’ pre-answer motion to dismiss the complaint as untimely.

On appeal, the court had to decide whether to apply the statute of limitations of Kentucky, where the Cornetts lived, or New Jersey, where Johnson & Johnson has its headquarters and the complaint was filed. The court noted that the two states have different statutes of limitations and performed a full choice of law analysis. As you will see when we discuss how the court resolved the statute of limitations point, the decision to do an elaborate choice of law analysis was a bit curious – not necessarily wrong, just curious – because the court found the complaint time barred under either state’s statute of limitations.

On choice of law, the court applied New Jersey’s “most significant relationship” test and decided, after thorough analysis of the relevant factors, to apply Kentucky law because Kentucky was where Billie Cornett lived, received his medical care (including the stent), and allegedly suffered his injury from the stent. Id. at *5-7. Although no surprise, since most courts apply the place of injury’s law in most circumstances, often with only cursory analysis, this ruling is a big deal because it’s New Jersey. Because of the state’s pro-plaintiff reputation (and being the home of a lot of major pharma companies), hordes of out-of-state plaintiffs have descended upon New Jersey courts hoping to take advantage of, among other things, a rather broad discovery rule (it applies to wrongful death actions, for one thing).

But maybe not any more.

The Cornett court could have ended its discussion right there because the complaint clearly was untimely under the law of Kentucky, which gives plaintiffs one year to file personal injury claims (plus an additional year for representatives of decedents who died within one year of the claimed injury) and does not have a discovery rule for product liability claims. But the court went on to say that the complaint also was untimely under New Jersey’s discovery rule, and that discussion should be particularly interesting to those of you who deal with statute of limitations issues – especially in New Jersey.

New Jersey, like many states, applies a discovery rule under which the statute of limitations clock does not start to run “until the injured person discovers, or by an exercise of reasonable diligence and intelligence should have discovered that he may have a basis for an actionable claim.” Id. at *4. The Cornett court said that the diagnosis of the thrombosis in the artery where the stent was implanted five months after implantation should have made the plaintiff reasonably suspect a possible connection between the device and the decedent’s injury. Id. at *8. A reasonable person should have investigated the matter further or contacted counsel, the court said. Id.

The icing on the discovery rule cake, the court reasoned, was that plaintiff alleged it was self-evident from the cause of death that the thrombosis formed within the stent. Id. The opinion doesn’t say, but we presume that plaintiff made this allegation in the portion of the complaint that tried to show the stent caused Billie Cornett’s injuries.

A plaintiff’s own allegations can provide the best response to a discovery rule claim in drug and device cases. The facts plaintiffs plead to support their claims that they were injured by a drug or device almost always were available to the plaintiff at or near the time of the injury. The real question in many discovery rule cases is this: what has changed between the time of the injury and the filing of the complaint, when (pardon the statement of the obvious) the plaintiff clearly knew enough to file a complaint? Usually nothing has changed, which means that the plaintiff knew enough at the time of the injury to pursue a claim.

Plaintiff tried to answer that key question by arguing that the clock did not start until the medical community reached a consensus as to causation, which supposedly happened at some later time. That’s a pretty weak argument – among other things, how is a plaintiff or a court ever to know the exact date on which the medical community reaches consensus, if it ever does? – and the court made short shrift of it: “neither medical nor legal certainty is required if the state of facts would alert a reasonable person to the possibility of an actionable claim, namely, that a third party’s conduct may have contributed to the injury and the conduct might have possibly been unreasonable.” Id. at *8 (citation omitted). The court concluded that the complaint was untimely under either New Jersey or Kentucky law and affirmed its dismissal.

Tune in tomorrow for Bexis’s analysis of the more complicated preemption rulings.

Tuesday, July 27, 2010

California on Governmental Contingent Fees - It Depends Upon Damage to Existing Business

We've been following the torturous path of the dispute over whether governmental entities can hire attorneys on contingent fee for quite some time.  Our first post on the City of Santa Clara lead paint case was in April 2007.  Anyway, the California Supreme Court has finally ruled.  Here's a link to the opinion.

We're interested - of course - because our pharmaceutical and medical device clients sometimes find themselves on the receiving end of governmental actions farmed out to private counsel.

California had a "bright line" rule forbidding such fee contracts arising out of a public nuisance case involving a dirty book store.  See People ex rel. Clancy v. Superior Court, 705 P.2d 347 (Cal. 1985).  Well, no longer.  In Santa Clara the court distinguished Clancy:
Yet, neither are the interests affected in this case similar in character to those invoked by a criminal prosecution or the nuisance action in Clancy.  Although the remedy for the successful prosecution of the present case is unclear, we can confidently deduce what the remedy will not be.  This case will not result in an injunction that prevents the defendants from continuing their current business operations.  The challenged conduct (the production and distribution of lead paint) has been illegal since 1978.
Santa Clara, slip op. at 18 (emphasis added).  Where "neither a liberty interest nor the right of an existing business to continued operation is threatened by the present prosecution, this case is closer on the spectrum to an ordinary civil case."  Id. at 19.

That being the case, the California Supreme Court held that the " heightened standard of ethical conduct applicable to public officials acting in the name of the public" could be satisfied where governmental officials remain in control of their contingent fee lawyers:
Because private counsel who are remunerated on a contingent-fee basis have a direct pecuniary interest in the outcome of the case, they have a conflict of interest that potentially places their personal interests at odds with the interests of the public and of defendants in ensuring that a public prosecution is pursued in a manner that serves the public, rather than serving a private interest.  This conflict, however, does not necessarily mandate disqualification in public-nuisance cases when fundamental constitutional rights and the right to continue operation of an existing business are not implicated.  Instead, retention of private counsel on a contingent-fee basis is permissible in such cases if neutral, conflict-free government attorneys retain the power to control and supervise the litigation.
Id. at 21.

So where does this leave us?  Well, we'd be lying if we didn't say we prefer a bright line Clancy-like rule forbidding such contingent fees.  But unlike the lead paint situation in Santa Clara, our clients are usually still in the business of selling the drug inplicated in the litigation.  Thus, in our cases, the relief sought would destroy or at minimum seriously interfere with the "current business operations" of our clients.

Thus, we would argue, under Santa Clara - as under Clancy - the bright line prohibition against government by contingent fee should continue to apply.

Monday, July 26, 2010

The Triple Crown: Preemption, Twombly, and Causation

Stop us if you've heard this one before. Actually, you certainly have. Just like we keep telling the same stories to our kids and colleagues, we find ourselves on this blog yapping incessantly about preemption, Twombly and causation. That's no huge surprise, because those are three of the best sieves for filtering out weak drug-and-device cases.

We're not going to linger on the magic of the number 3. We're betting most readers of this blog had at least one professor who divided every analysis into three parts. Caesar divided Gaul into three parts. Three points define a plane. Baseball celebrates the Triple Crown -- home runs, runs batted in, and batting average (even though stat-heads these days think those aren't the most important metrics). And then, of course, there's Moe, Larry, and Curly.

Franklin v. Medtronic, Inc., 2010 U.S. Dist. LEXIS 71069 (D. Col. May 12, 2010) applies all three filters. The opinion (written by a Magistrate Judge and later adopted by the District Judge on June 22, 2010) is a microcosm for some of our favorite themes. Franklin sued Medtronic claiming that an implantable defibrillator battery malfunctioned and caused her injury. She alleged that the defibrillators were negligently designed and manufactured, that the company should have furnished warnings sooner than it did and should have recalled the devices, that the company breached implied and express warranties, and that the company made misrepresentations and negligently inflicted emotional distress. As usual, the plaintiff emptied out Prosser in drafting the complaint.

Before getting to the substantive claims, the court observed that Plaintiff was proceeding pro se. That means that the court will review the pleadings liberally (although Franklin's complaint had been prepared by an attorney, so that doesn't get such liberal treatment). But the court emphasized that pro se status does not permit the court to assume or supply facts that weren't alleged, and Plaintiff was not entitled "to application of different rules." Franklin, 2010 U.S. Dist. LEXIS 71069, * 8. Got it? Okay. So now the court can slice and dice this case with a clean conscience.

The defibrillators were approved by the FDA pursuant to the premarket approval ("PMA") supplement process. The PMA process is rigorous and squarely implicates Riegel preemption. That plants us in the middle of the metaphysical debate over whether the claims seek to impose a requirement different from or additional to FDA rules, or whether the claims are under state laws imposing a "parallel" requirement. At this point, we're not going to say stop us if you've heard this before. Even though you have heard it, the Franklin court's approach to the issue is singularly clear and useful. (When other courts save claims on the "parallel" claims theory, it often sounds like mush. Or maybe it's non-Euclidean geometry.)

The court begins by tackling the claim that the company should have warned doctors and patients sooner about the battery malfunction. Plaintiff "has not pointed the court to any FDA regulation that requires a device manufacturer to unilaterally contact doctors and patients regarding a potential device defect without FDA involvement." Id., *17. To proceed with a "parallel" claim, a defendant "'must demonstrate that a particular federal violation lead to her injuries.'" Id. (quoting Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (EDNY 2009)(emphasis in original). In other words, a plaintiff cannot simply mouth the word "parallel." Parallel to what? It's got to be something specific. More often than not, there's no there there. Further, as Riegel made clear, the PMA process includes review of proposed labelling. Accordingly, section 360c(a)(2)(B) preempts any warning claim.

Similarly, the court dismissed Plaintiff's claim that the company should have recalled the defibrillators. Again, where is the parallel requirement? The FDA regulation describes a recall as "a voluntary remedial measure to be undertaken on a firm's 'own volition.'" Id. (quoting 21 CFR 7.3). A finding that the company was negligent for failing to recall the device would necessarily establish a requirement different from or in addition to the federal requirement. Not parallel.

The claim for breach of implied warranty is controlled by Riegel and is clearly preempted. But the Supreme Court didn't address claims for breach of express warranty. Lower courts have split. Compare Heisner v. Genzyme Corp., No. 08-C-593, 2008 U.S. Dist. LEXIS 60569 (N.D. Ill. 2008) (express warranty claims not preempted) with In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009) (express warranty claims preempted). The Franklin court came down on the side of preemption, the correct side, because "the PMA process includes a review of a device's proposed labelling and any representation contained therein." Franklin, 2010 U.S. Dist. LEXIS 71069, *20.

The claims for negligence per se and misrepresentation gave the court "more pause." Id. The former claim incorporated a number of FDCA regulations and the latter alleged that the company "failed to duly report information to the FDA" and downplayed risks in a letter to the FDA. Id., at *21. Thus, at first blush, these claims seem vaguely parallel. Note our use of the word "vaguely." For, as the court sees it, "upon a slightly more probing review, it becomes clear that these claims are likewise preempted." Id. And here come Twombly and causation riding to the rescue. Of course, Franklin was at the summary judgment, not motion to dismiss, stage. But the court had no difficulty importing the requirement that allegations be more than conclusory. (Indeed, if anything, the requirement of factual substance makes far more sense at the summary judgment stage.)

Turns out that "Plaintiff makes only conclusory allegations that Defendant failed to timely and fully investigate, analyze, and report adverse events and product failures; and also failed to report any labeling, manufacturing, device modifications, or design validations that might be necessary." Id., at *26. For example, Plaintiff didn't point to a single adverse event or product failure that should have prompted a warning or recall. Basically, Plaintiff was insisting on the court drawing assumptions or filling in gaps. At most, Plaintiff's case added up "to a mere 'suspicion [of] a legally cognizable right of action,'" and did not "state a 'parallel' claim for relief as required to overcome section 360k(a) preemption." Id., at 27 (quoting Twombly, 550 U.S. at 556 n.3). In short, all of the "parallel" play-acting was "formulaic" and couldn't pass muster. It's not unusual that Plaintiff's cannot assemble sufficient facts. It's refreshing when courts actually notice it and push the trap door button.

The court actually pushes the button twice. Even if there were any meat on the bare-bones allegations of FDCA violations, Plaintiff "failed to allege any facts establishing a causal connection between Defendant's alleged failure to comply with FDA regulations and her alleged injuries." Franklin, 2010 U.S. Dist. LEXIS 71069, at * 27. (There's a lot of failure in that sentence, isn't there?) Plaintiff didn't show that any of the regulatory violations made the device less safe. More fundamentally, Plaintiff simply didn't show that any of the alleged regulatory violations made any difference as far as Plaintiff was concerned.

That's it. There's a lot packed into a mere eight pages. But it's the clarity and rigor of thought that stands out. It's relevant to many of the cases we litigate. You know how sometimes when you file a brief you attach an opinion because it's so helpful? We usually attach three. Anyway, this might be one of those cases.

Friday, July 23, 2010

Kitchen Sink Complaint Dismissed

A purported consumer fraud class action complaint that sought to join together off-label promotion allegations about no less than twelve different drugs was recently dismissed with prejudice for failure to state a claim.   Zafarana v Pfizer, Inc., ___ F. Supp.2d ___, 2010 WL 2854170 (E.D. Pa. July 19, 2010).  Talk about throwing in the kitchen sink.  Two individual plaintiffs brough suit under three different states' consumer fraud statutes - Pennsylvania, New Jersey, and Wisconsin.

The court also threw out unjust enrichment claims.

The plaintiffs made three related types of claims:  (1) that off-label promotion caused them to take drugs (but not all 12) that were ineffective for the conditions they had, thus causing them personal injury from their underlying conditions; (2) that they suffered side effects from the drugs themselves, another personal injury claim; and (3) that the off-label promotion caused them to pay for treatments that were more expensive than would otherwise have been the case.  2010 WL 2854170, at *3.

Here's what the court did:

New Jersey:  Plaintiffs' first problem was that the New Jersey Products Liability Act Subsumes all personal injury claims relating to products - something we've discussed before.  Out go theories (1) and (2).   2010 WL 2854170, at *7.  Only the third could clear even this initial hurdle.  And that's as far as it got.  As a consumer fraud claim, it failed for failure to plead causation or injury.  That's because, for any class action involving a prescription drug even to pass a red face test for certification, it has to be pleaded at such a level of generality that it ignores the individualized prescription decisions of prescribing doctors, which is a no-no under the consumer fraud act.  Thus, the commonality that CFA claims would require for there to be any chance of class certification causes them to fail as CFA claims:
Plaintiffs, however, simply have not stated any facts that make it plausible that a less expensive alternative would have been prescribed.  Plaintiffs seem to ignore the role played by the prescribing physician in this case.  They have not stated, and likely cannot state, that they would have been prescribed other, less costly medications, but only that they could have been prescribed such medications.  It is also true, however, that they could have been prescribed a more expensive medication, or a combination of other medications that, while individually less expensive, were cumulatively more expensive.

2010 WL 2854170, at *7.  Obviously, plaintiffs' counsel know how to plead valid claims - they've evidently made a choice that they'd rather have no claim at all than have a claim that couldn't be brought as a class action.  Clients?  What clients?

Wisconsin:  Wisconsin's CFA isn't extraterritorial, and plaintiffs don't allege any transaction that took place in Wisconsin.  2010 WL 2854170, at *8.  That didn't take long.

Pennsylvania:  Unlike New Jersey, the Pennsylvania CFA requires reliance as an element (thanks, Bexis, for the Weinberg opinion).  Thus, the learned intermediary rule pretty much kills (makes it "difficult, if not impossible") CFA claims under the Pennsylvania statute.  Id.  Plaintiffs sure didn't plead anything to get around the rule in this case:
[W]e find that the learned intermediary doctrine prevents there from being any justifiable reliance, and, therefore, Plaintiffs have not stated a claim under the UTPCPL.  Under the learned intermediary doctrine, the drug manufacturer owes a duty of disclosure to the prescribing physician, but it is then the duty of the prescribing physician to communicate any risks or other information about the drug to the patient.  In other words, a patient in Pennsylvania cannot justifiably rely on the prescription drug manufacturer; instead, it is the prescribing physician who provides the grounds for justifiable reliance.  Further, in the present case, any misrepresentations were made to prescribing physicians and not to Plaintiffs.
2010 WL 2854170, at *9 (citation omitted).

Conspiracy/Aiding and Abetting:  Sorry, if you don't have a viable claim for something (an "independent cause of action"), you sure don't have a viable claim for conspiring or aiding and abetting something that's not actionable in the first place.  2010 WL 2854170, at *10-11.

Unjust Enrichment:  (1) "There is no separate tort cause of action for unjust enrichment in New Jersey."  Id. at *11.  (2)  "[U]njust enrichment is not a substitute for failed tort claims in Pennsylvania."  Id.  So go away.

Best of all, the court dismissed the claims with prejudice.  They'd been given a prior shot and replied with 140 pages of meaningless detail that didn't even address the glaring deficiencies that the defendants pointed out the first time around.   Id. at *12.

So it's a final, appealable dismissal with prejudice.  We can only hope that, since the complaint is a really bad one, that if plaintiffs do appeal, we get a binding Third Circuit opinion putting a stop once and for all to this kind of funny business throughout Pennsylvania, New Jersey, and Delaware.

Bartlett – Not All Pear-Shaped After All

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 Suldinac.  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 Suldinac 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.


Wednesday, July 21, 2010

What To Make Of the Aredia Choice Of Law Kerfuffle?

Perhaps you caught the recent report from our friends over at law360 about the latest Aredia decision. If not, it’s worth a read. In Deutsch v. Novartis Pharm. Corp., Judge Arthur Spatt of the Eastern District of New York was called upon to decide whether New York or New Jersey law governed the plaintiffs’ claim for punitive damages. And you might be wondering, what was all the fuss about? After all, the parties had agreed that New York law governed the plaintiffs’ substantive claims. See Deutsch v. Novartis Pharm. Corp., __ F. Supp. 2d ___, 2010 WL 2803038, at *1 (E.D.N.Y. July 16, 2010). When it came to the applicable punitive damage law, however, counsel for Novartis dug in and argued, persuasively and successfully, that New Jersey law, rather than New York law, governed the claim for punitive damages.

So why didn’t defense counsel just agree to let New York law govern the whole ballgame? Maybe the choice of law fight had to do with New Jersey’s punitive damage cap – punitive awards in the Garden State are capped at the larger of $350,000 or 5 times the compensatory award. Id. at *2. Seems like a good reason to dig in your heels and argue for New Jersey law. But there’s also something else going on here, because the New Jersey Products Liability Act (PLA) bars punitive damage awards in cases involving products approved by the FDA. Section 2A:58C-5c of the PLA has an exception to the general bar on punitive damage awards – where “the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question” – but that sounds suspiciously like a statutory provision that is preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and for good reason: it is. In fact, as we reported back in 2008, the New Jersey Appellate Division has found that Buckman preempts the PLA’s purported “exception” to the general statutory bar on punitive damages in drug and device cases, because that PLA exception would seek to impose punitive damage liability only upon a showing of…you guessed it: fraud on the FDA. Take another look at the language: “knowingly withheld or misrepresented information required to be submitted to the agency.” That is a pretty cut and dry example of a prohibited “fraud on the FDA” claim, if you ask us.

But here’s the interesting wrinkle. The Second Circuit – you know, the circuit court that would hear any appeal of the Deutsch case – has previously ruled that an analogous Michigan statute was not preempted by Buckman. That case was Desiano v. Warner-Lambert, and we’ve spilled a lot of e-ink (and tears) complaining about how the Second Circuit misfired. In case you don't remember, or tuned us out, the Desiano court blessed a Michigan statute that essentially bars tort claims involving FDA-approved drugs and devices unless the plaintiff can prove “fraud on the FDA.” Before and after Desiano came down in 2006, courts across the country have grappled with this slippery preemption issue, with mixed results. Some courts find that imposing liability under a statute that requires a showing of “fraud on the FDA” would violate Buckman, and others, like Desiano, have not. Most notoriously, the Supreme Court fought this issue to a 4-4 draw back in 2008 (in Warner-Lambert v. Kent), with Chief Justice Roberts recusing himself.

So now it’s 2010, and there’s a possibility that down the road this “fraud on the FDA” question could be teed up for the Second Circuit again (albeit with respect to an admittedly different statute). Will the issue ever get up to the Second Circuit? And if so, will the Second Circuit follow the New Jersey court’s lead in McDarby and declare the PLA punitive damages provision preempted, or will the Second Circuit hew to the reasoning of its prior decision in Desiano? It will be interesting to see how it all shakes out, but in any event, this seemingly minor tussle over choice of law could turn out to have wider implications for many of us practicing in this area of law.

Tuesday, July 20, 2010

It’s now not unusual to have a Lone Pine order affirmed

You may have read in the legal or mainstream press that the Fifth Circuit rejected challenges to the Vioxx Master Settlement Agreement. In re Vioxx Products Liability Litigation, 2010 WL 2802352 (5th Cir. July 16, 2010). That’s all well and good, but what really interested us was not given significant play in the media, perhaps because it primarily interests mass tort law geeks like us: The court affirmed the dismissal of plaintiffs who failed to comply with a Lone Pine order. In light of our firm’s involvement in the Vioxx litigation we’ll follow the Thelonious Monk approach and serve up the court’s reasoning and holding straight, no chaser.

For the uninitiated, Lone Pine orders (which we blogged about before here and here) require plaintiffs to produce some basic evidence supporting their claims – usually evidence of exposure to defendant’s product, injury, and proof that the exposure caused the injury – or face dismissal. Trial courts commonly use Lone Pine orders in mass tort litigation to eliminate meritless claims, but appellate court rulings on Lone Pine orders are unusual, which is why this opinion made us do the Carlton dance.

According to the Fifth Circuit's opinion, the Lone Pine order in the Vioxx litigation, PTO 28, required non-settling plaintiffs to notify their healthcare providers to preserve evidence pertaining to the plaintiffs’ use of Vioxx; produce pharmacy records, medical authorizations, and interrogatory answers; and produce a medical expert’s report attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. 2010 WL 2802352 at *1. Plaintiffs who failed to comply could have their claims dismissed with prejudice. Id.

A couple of groups of plaintiffs, including a group called the Dier plaintiffs, complained that PTO 28 was premature and burdensome. The court denied the motion but gave plaintiffs additional time to comply. Some plaintiffs still refused to comply. On Merck’s motion, the court dismissed with prejudice the Dier plaintiffs’ complaints for failure to comply with PTO 28. Id. at *3.

On appeal, the Dier plaintiffs claimed that the district court abused its discretion by requiring a case-specific expert report. The Fifth Circuit noted that the district court had relied on Acuna v. Brown & Root Inc., 200 F.3d 335 (5th Cir. 2000), one of those few federal appellate rulings on a Lone Pine order. The Dier plaintiffs said their situation was different because supposedly they alleged precise injuries and Merck was aware of their injuries and the injuries’ link to Vioxx. The Fifth Circuit found those arguments insufficient “to warrant bypassing the clear holding in Acuna that it is within a court’s ‘discretion to manage the complete and potentially very burdensome discovery that the cases would require.’” 2010 WL 2802352 at *6 (quoting Acuna at 340).

The Dier plaintiffs’ last gasp was to challenge PTO 28 because, they claimed, expert testimony is not needed under New York law for negligent infliction of emotional distress claims. The court rejected that argument given that the Dier plaintiffs all alleged physical injuries. Id. The court therefore affirmed the dismissal of their claims. Id.

Regrettably, the Fifth Circuit designated its opinion not for publication and not precedential, presumably because its decision essentially followed its published, precedential decision in Acuna. Id. at *1 n.*. Nonetheless, those of you looking for a federal court of appeals decision affirming a Lone Pine order in a drug case are free to cite this opinion. See Fed. R. App. P. 32.1.

Monday, July 19, 2010

Vive La Difference

We are in Normandy, France today, scene of one of the key events of the 20th Century - D-Day (6 June 1944). Operation Overlord involved enormous planning and sacrifice, and it's hard to visit this land without being overwhelmed by awe and gratitude. This is also the place where Joan of Arc was burnt at the stake, and where the Bayeux tapestry tells the story of William the Conqueror, who brought Norman rule but, sadly, no crème brulee recipes, to England. Our thoughts are far from drug and device law.

Nevertheless, amidst the hedgerows and Calvados, we reflect on some of the features of French product liability law that are, to our American eyes, strange and tantalizing:

- limited discovery
- no trial by jury
- experts, if used at all, are chosen by judges, not the parties
- no discovery rule to evade the statute of limitations
- no class actions
- no market share liability
- no contingency fees
- no punitive damages

Some of the above items are gross simplifications, so consult a French lawyer before doing anything serious. Anyway, since we are not so far from Giverny, it doesn't seem wrong to be somewhat impressionistic about the nuances of French law. French civil law has many similarities to the German legal system, which our Trusts & Estates professor (John Langbein) called the Mind of God Revealed to Man. We wouldn't go quite that far, but there are obviously a lot of features that would make our lives easier and more rational.

Nevertheless, we get used to certain things. Familiarity breeds comfort more often than contempt. It's embarrassing to admit, but every time we go to Europe we visit McDonald's at least once. (Where else can you get decent ice cubes in a drink?) Is it possible we'd actually miss predatory, class action contingent fee lawyers, strumpety, know-everything plaintiff experts, outrageous emotional appeals to juries, and E-discovery?

It's a thought we Camembert.

Friday, July 16, 2010

Second Circuit Affirms First Zyprexa Learned Intermediary Decision

Sorry for the long title, but we didn't want anybody thinking for even an instant that the Second Circuit affirmed that Zyprexa decision.  Rather, in an unpublished memorandum, the court has affirmed the first of the numerous Zyprexa summary judgments based on the learned intermediary rule that Judge Weinstein has issued over the last year-and-a-half or so.  The case is called Dean, and here's the slip opinion.  Basically the prescribing doctor testified that he knew about the risk at the time he prescribed and that he hadn't learned anything since that would change his mind - thus there's no causation under Florida law.

It's more or less cut and dried, and that's why Dean is just a memorandum, but it's significant to us in that, being the first, it portends well for affirmance of the rest of a whole bunch of similar decisions that Lilly's won in the Zyprexa litigation lately.

Thanks to Andy Rogoff at Pepper Hamilton for letting us know.

A Second Significant Decision in Bartlett v. Mutual Pharmaceutical

Anybody interested in generic drug preemption undoubtedly remembers Bartlett v. Mutual Pharmaceutucal Co., 659 F. Supp. 2d 279 (D.N.H. 2009), as one of the earliest detailed examinations of such arguments post-Levine.  Whether one agrees with the conclusions of that decision or not (we mostly don't), it certainly demonstrated that Judge Laplante was almost as thorough and conscientous an opinion writer as the late Ed Becker of the Third Circuit.  We do not make that comparison lightly.

Well, there's now a second Bartlett opinion - Bartlett v. Mutual Pharmaceutical Company, Inc., 2010 U.S. Dist. Lexis 69825 (D.N.H. July 12, 2010), and not only is it just as detailed - but the defendant does considerably better (although not entirely so).  There are a lot of issues, so we'll just highlight them here:

Adequacy of warning - The court refuses to hold as a matter of law that the warning was adequate - that "hypersensitivity" and "severe skin reactions" were the legal equivalent of a specific warning about Stevens-Johnson syndrome, which is frequently fatal.

Warning causation - Summary judgment is granted on warning claims based upon the prescriber's admitted failure to read the defendant's warnings.  There is a lengthy discussion of this recurring issue.

"Non-label" warning theories - summary judgment is granted on non-label warning claims:  (1) should have been a medication guide claim is barred by the learned intermediary rule: (2) should have been a Dear Doctor letter is purely speculative, (3) black box warning is purely speculative, (4) educational campaign is purely speculative.  Further, all the non-label theories lack supporting legal authority

Design defect - claims survives summary judgment, as comment k requires a drug's unavoidably unsafe nature to be estsblished on a case-by-case basis, and because the adequacy of the label cannot be decided as a matter of law to call comment k into play on summary judgment.

Fraud - summary judgment granted for lack of evidence of reliance.

Punitive Damages - the claim survives summary judgment because of what the court characterized as the defendant's "admitted (though explained) failure to survey the medical literature" and the seriousness of the risk involved.

Negligence per se based on failure to survey medical literature - Summary judgment granted.  The court held that there was an FDCA violation due to the generic manufacturer's failure to conduct an ongoing survey of the medical literature.  However, the violation could not be negligence per se mostly because:  (1) New Hampshire does not allow negligence per se based upon violation of a mere regulation (as opposed to a statute); and somewhate because (2) the FDCA does not allow private enforcement of claimed violations.

Preemption - There's no reason to reconsider the prior ruling.

Thursday, July 15, 2010

The Creeping Demise (We Hope) of Market Share Liability

Last week we put up a post commenting on something that we thought was wrong with New Jersey law.  This week we’re compelled to comment on something that the New Jersey courts have gotten right – they don’t like market share liability – maybe not quite as thoroughly as we detest it, but enough that there hasn’t been a successful case in almost forever.

Just this week in Moreno v. American Home Products, Inc., slip op. (N.J. Super. A.D. July 12, 2010), a three-judge appellate panel rejected the latest attempt (which was very late) by an New Jersey plaintiff to invoke market share liability.  The plaintiff claimed – over 30 years after the fact – that a polio vaccine caused his brain tumor.  Because the plaintiff delayed bringing the claim for all this time (until 2002), there were no records left to identify the manufacturer of the vaccine (between 1968 and 1970).  Slip op. at 2.

We’re puzzled why there’s no statute of limitations issue in the case, but apparently there wasn’t – nobody even mentioned it.  We’re presuming that New Jersey has a minority tolling statute, but even that shouldn’t let a plaintiff slide for 30 years.  It also appears that plaintiff wasn’t much quicker after filing suit than before. The case went through five years of discovery before the defendants were granted summary judgment on failure – and plaintiff claimed he should have even more.  Slip op. at 5-8.

No problem, the plaintiff argued on appeal, just let me sue every maker of polio vaccine under a market share theory.  The vaccine was administered in New York, but by the time plaintiff got around to filing suit, he had lived in New Jersey for 35+ years.  So there was a choice of law question – only the court held that there wasn’t.  There wasn’t because the court found that there was no outcome-dispositive conflict.  That is, neither New Jersey (which hasn’t recognized market share liability in any case) nor New York (which allows it for DES) would permit this plaintiff to proceed on that basis.

First, the court ran through the usual litany of non-market share collective liability theories:  (1) Concert of action failed because there wasn’t any common plan to commit a tortious act.  Slip op. at 10-11. (2) Enterprise liability failed (it’s never actually been recognized by anybody anywhere since Judge Weinstein dreamed it up back in 1972) because the product was governmentally regulated (by the FDA) rather than left in the hands of an industry trade association.  Id. at 12.  (3) Alternatively liability failed because all of the defendants weren't negligent.  Rather, the plaintiff claimed a lot-specific manufacturing defect.  Id. at 12-13.

Then the court turned to market share liability – which was the real battleground.  As fate might have it, the question of market share liability in New Jersey was governed by a case, Shackil v. Lederle Laboratories, 561 A.2d 511 (N.J. 1989), that long, long ago (but not in a galaxy that far away) Bexis helped litigate.

Fortunately for the defendants in Moreno, Shackil was also a vaccine (DTP) case, and its rejection of strict liability in such cases was impossible for the plaintiff to avoid:

The New Jersey Supreme Court has held that market-share liability cannot be applied to relieve a plaintiff of the obligation of identifying the manufacturer of a childhood vaccine that causes damage. The Court reasoned that Congress had considered the problem of vaccine-induced injuries and provided a remedy that does not require the injured party to identify a manufacturer. The Court also considered the regressive effect that collective liability would have on the social policy of encouraging vaccine production and research. On those bases, the Court rejected application of market-share liability in cases involving vaccines. . . .
Moreno, slip op. at 13 (a half-dozen or so Shackil cites and quotation marks omitted).  Given Shackil’s “assessment of the public policy favoring the development of vaccines,” slip op. at 14, the court affirmed dismissal under New Jersey law.  Id.

The market share claim was also dismissed under New York law, even though the New York Court of Appeals, in one of its whiftier moments (it’s normally a pretty conservative court on product liability matters) had allowed market share liability in a DES case.  See Hymowitz v. Eli Lilly & Co., 539 N.E.2d 1069 (N.Y. 1989). The DES situation, however, was “singular”:

[T]he DES situation is a singular case, with manufacturers acting in a parallel manner to produce an identical, generically marketed product, which causes injury many years later, and which has evoked a legislative response reviving previously barred actions.
Moreno, slip op. at 14 (quoting Hymowitz).  Except for DES, market share liability had been universally rejected in New York.  Id. at 17-18 (citing cases involving guns, lead paint pigment, and breast implants). Most critically, since the plaintiff’s theory alleged a manufacturer-specific manufacturing defect that contaminated a particular batch of vaccine, there was no industry-wide defect that even plausibly could justify deviating from the usual tort requirement of suing the manufacturer of the purportedly defective product:

[T]he precedents discussed above require a court applying New York law to reject application of market-share liability in cases involving a vaccine that is defective due to failure to comply with protocols and not attributable to a flawed common generic formula. Deviant defective doses are not generic and fungible doses.
Slip op. at 18. So the plaintiff came up short in New York, even though market share liability was a something cognized by that state’s highest court.

Since we don’t like market share liability, we like Moreno.  Practically the only way that it falls short is that for some inexplicable reason it’s designated “not for publication.”

So that’s Moreno – which would be enough except this is when we do our longer posts. Not only that, but writing about Moreno had us looking at market share liability generally, and it just so happens that we haven’t done an analytical post on this subject in our more than three-year existence. So we thought we’d do one of our 50-state updates on what states allow it and which ones don’t.

Federal Law

It’s hard to see how market share liability could arise under federal law, but it has.  In In re Dow Corning Corp., 250 B.R. 298, 362-63 (Bankr. E.D. Mich. 2000), the bankruptcy court rejected market share liability in the context of breast implants where the federal government invoked the theory in an attempt to recover Medicare reimbursement.


Market share liability has been rejected under Alabama law in the asbestos context.  Franklin County School Board v. Lake Asbestos of Quebec, Ltd., 1986 WL 69060 (N.D. Ala. Feb. 13, 1986).


We couldn’t find anything on market share liability in Alaska.


Ah, the wonders of MDL litigation.  In In re Minnesota Breast Implant Litigation, 36 F. Supp. 2d 863 (D. Minn. 1998), the court predicted that Arizona would reject market share liability.  A bit closer to home, the Ninth Circuit declined to predict that Arizona would apply market share liability in an asbestos case.  White v. Celotex Corp., 907 F.2d 104 (9th Cir. 1990).


The Eighth Circuit has predicted that Arkansas would reject market share liability in an asbestos case.  Jackson v. Anchor Packing Co., 994 F.2d 1295 (8th Cir. 1993).  Applying Jackson, a federal district court concluded that “Arkansas has not adopted alternative or market share liability,” in Fields v. Wyeth, Inc., 613 F. Supp.2d 1056, 1060 (W.D. Ark. 2009), a case involving multiple producers of the same drug in branded and generic forms.  See Burns v. Universal Crop Protection Alliance, 2007 WL 2811533 (E.D. Ark. Sept. 25, 2007) (no market share liability in herbicide case).


The California Supreme Court invented market share liability in Sindell v. Abbott Laboratories, 607 P.2d 924 (Cal. 1980), a DES case.  California courts are split on whether market share liability could apply in vaccine cases.  A state court said no. Sheffield v. Eli Lilly & Co., 192 Cal. Rptr. 870, 876-77 (Cal. App. 1983), but a federal court said yes – the only decision in the country to do that, as far as we know.  Morris v. Parke, Davis & Co., 667 F. Supp. 1332 (C.D. Cal. 1987).  Attempts to apply market share liability to other prescription medical products have failed.  Kennedy v. Baxter Healthcare Corp., 50 Cal. Rptr. 2d 736 (Cal. App. 1996) (latex gloves).  A bunch of California cases refuse to extend market share liability to a variety of other products.  Ferris v. Gatke Corp., 132 Cal. Rptr. 2d 819 (Cal. App. 2003) (asbestos); Edwards v. A.L. Lease & Co., 54 Cal. Rptr. 2d 259 (Cal. App. 1996) (pipe); Setliff v. E.I. Du Pont de Nemours & Co., 38 Cal. Rptr. 2d 763 (Cal. App. 1995) (paint and varnish); Mullen v. Armstrong World Industries, Inc., 246 Cal. Rptr. 32 (Cal. App. 1988) (asbestos); Sanderson v. International Flavors & Fragrances, Inc., 950 F. Supp. 981 (C.D. Cal. 1996) (perfume); In re Related Asbestos Cases, 543 F. Supp. 1152 (N.D. Cal. 1982) (asbestos).


We didn’t find anything on market share liability in Colorado, which surprised us a bit, since it’s not a small state.


The Connecticut state courts haven’t spoken, but a federal court rejected market share liability in a DES case under Connecticut law.  Gullotta v. Eli Lilly & Co., 1985 WL 502793 (D. Conn. May 9, 1985).


Delaware courts have said no to market share liability, at least in the asbestos context.  Nutt v. A.C. & S. Co., 517 A.2d 690 (Del. Super. 1986); In re Asbestos Litigation, 509 A.2d 1116 (Del. Super. 1986), aff’d, 525 A.2d 146 (Del. 1987).

District of Columbia

The D.C. Circuit, applying D.C. law, has rejected market share liability in a DES case.  Tidler v. Eli Lilly & Co., 851 F.2d 418 (D.C. Cir. 1988).  A “state” trial court likewise rejected market share liability in firearms litigation.  District of Columbia v. Beretta U.S.A. Corp., 2002 WL 31811717 (D.C. Super. Dec. 16, 2002), aff’d in part and rev’d in part on other grounds, 872 A.2d 633 (D.C. 2005).


The Florida Supreme Court recognized market share liability in Conley v. Boyle Drug Co., 570 So. 2d 275 (Fla. 1990), a DES case.  Later, a Florida federal court held that market share liability would lie in a blood products case.  Ray v. Cutter Laboratories, 754 F. Supp. 193, 195 (M.D. Fla. 1991).  However, a Florida trial court refused to apply market share liability where the plaintiff didn’t know which of several companies made the generic drug he took in Sharp v. Leichus, 2006 WL 515532 (Fla. Cir. Feb. 17, 2006), aff’d, 952 So.2d 555 (Fla. App. 2007).  Market share liability has also fared poorly outside of the prescription medical product context.  See Celotex Corp. v. Copeland, 471 So. 2d 533 (Fla. 1985) (no market share liability in asbestos litigation); Pulte Home Corp. v. Ply Gem Industries, Inc., 804 F. Supp. 1471 (M.D. Fla. 1992) (no market share liability against manufacturers of roofing materials).


Georgia state courts have yet to address market share liability, but it has been rejected by federal courts applying Georgia law.  Blackston v. Shook & Fletcher Insulation Co., 764 F.2d 1480 (11th Cir. 1985) (asbestos insulation); Starling v. Seaboard Coast Line Railroad Co., 533 F. Supp. 183, 186 (S.D. Ga. 1982) (asbestos).


There’s certainly no paradise for defendants in Hawai’i when it comes to market share liability.  It’s the only state in the union where the supreme court has imposed market share liability against a prescription medical product other than DES.  See Smith v. Cutter Biological, 823 P.2d 717 (Haw. 1991) (blood products AIDS case).


Nothing in the state court, but in Doe v. Cutter Biological, 852 F. Supp. 909 (D. Idaho 1994), appeal dismissed, 89 F.3d 844 (9th Cir. 1996), a blood products case, the federal court held that market share liability does not comport with Idaho law.


Since the Illinois Supreme Court rejected market share liability in a DES case, Smith v. Eli Lilly & Co., 560 N.E.2d 324 (Ill. 1990), there’s no real chance it would be adopted for any other product.  See Poole v. Alpha Therapeutic Corp., 696 F. Supp. 351 (N.D. Ill. 1988) (no market share liability in blood product case).


In a firearms case, the Indiana Supreme Court refused to recognize market share liability.   City of Gary v. Smith & Wesson Corp., 801 N.E.2d 1222 (Ind. 2003).


Nope, and no way. The Iowa Supreme Court rejected market share liability even in DES cases in Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67 (Iowa 1986).


Not a thing in Kansas on market share liability.


Nothing from Kentucky state courts, but a federal court declined to predict Kentucky’s adoption of market share liability in a case involving the antibiotic tetracycline.  Dawson v. Bristol Laboratories, 658 F. Supp. 1036 (W.D. Ky. 1987).


In In re Factor VIII or IX Concentrate Blood Products Litigation, 2000 WL 282787 (E.D. La. March 14, 2000), a court applying Louisiana law declined to impose market share liability in – you guessed it – a blood products case.  In George v. Housing Authority of New Orleans, 906 So.2d 1282 (La. App. 2005), market share liability was rejected in a case involving smoke detectors.  The theory has also been repeatedly rejected by the Fifth Circuit applying Louisiana law.  Jefferson v. Lead Industries Ass’n, Inc., 106 F.3d 1245 (5th Cir. 1997) (lead paint pigment); Bateman v. Johns-Manville Sales Corp., 781 F.2d 1132 (5th Cir. 1986) (asbestos); Thompson v. Johns-Manville Sales Corp., 714 F.2d 581 (5th Cir. 1983) (asbestos).


No court in Maine has addressed market share liability to date, but a federal district court a couple of states over predicted that Maine would reject the theory, at least in the context of fire resistant tape.  Kinnett v. Mass Gas & Electric Supply Co., 716 F. Supp. 695 (D.N.H. 1989) (applying Maine law).


The D.C. Circuit predicted that Maryland wouldn’t recognize market share liability in a DES case in Tidler v. Eli Lilly & Co., 851 F.2d 418 (D.C. Cir. 1988).  Market share liability also failed when asserted against breast implant manufacturers in Lee v. Baxter Healthcare Corp., 721 F. Supp. 89 (D. Md. 1989), affirmed without op., 898 F.2d 146 (4th Cir. 1990).  The theory has also failed against non-medical products, and Maryland’s high court has a pending case that would allow it to speak on the subject for the first time.  See Reiter v. AC&S, Inc., 947 A.2d 570 (Md. App. 2008) (no market share liability in asbestos litigation), cert. granted, 954 A.2d 467 (Md. 2008); Herlihy v. Ply-Gem Industries, Inc., 752 F. Supp. 1282 (D. Md. 1990) ( no market share liability in fire retardant plywood case).


Massachusetts law can get rather liberal on some things, but not market share liability, as the Supreme Judicial Court rejected non-identification liability in DES litigation in Payton v. Abbott Labs, 437 N.E.2d 171 (Mass. 1982).  Accord Armata v. Abbott Laboratories, 747 N.Y.S.2d 863, 865 (N.Y.A.D. 2002) (applying Massachusetts law and rejecting market share liability in DES case).  Market share liability has also failed under Massachusetts law against various other prescription medical products.  Mills v. Allegiance Healthcare Corp., 178 F Supp 2d 1, 8-9 (D. Mass. 2001) (latex gloves); Spencer v. Baxter International, Inc., 163 F. Supp.2d 74 (D. Mass. 2001) (blood products); Gurski v. Wyeth-Ayerst Division of American Home Products Corp., 953 F. Supp. 412, 418-19 (D. Mass. 1997) (oral contraceptive).


The Michigan Supreme Court recognized something like market share liability in Abel v. Eli Lilly & Co., 343 N.W.2d 164 (Mich. 1984), in a DES case.  No Michigan court that we know of has ever applied the Michigan quasi-market share liability theory outside the DES context.  See Marshall v. Celotex Corp., 651 F. Supp. 389 (E.D. Mich. 1987) (declining to apply market share liability to asbestos litigation).


Oddly, the only context in which market share liability has been raised in Minnesota has been with respect to flammable clothing.  That’s happened twice, and in both cases the theory’s been rejected.  Bixler v. Avondale Mills, 405 N.W.2d 428 (Minn. App. 1987); Mason v. Spiegel, Inc., 610 F. Supp. 401 (D. Minn. 1985).


Nada in Mississippi. That’s another state where we thought we’d find something, but didn’t.


What we said for Massachusetts applies equally to Missouri.  See Zafft v. Eli Lilly & Co., 676 S.W.2d 241 (Mo. 1984) (rejecting market share liability in DES case).  See also City of St. Louis v. Benjamin Moore & Co., 226 S.W.3d 110 (Mo. 2007) (rejecting market share liability in lead paint pigment case).


No court applying Montana law has said anything about market share liability.


Market share liability, per se, has never come up under Nebraska law.  In Menne v. Celotex Corp., 861 F.2d 1453 (10th Cir. 1988) (applying Nebraska law), the court refused to apply something called “market share apportionment,” which seems to be mostly the same thing.


Deafening silence in Nevada on market share liability.

New Hampshire

It’s never come up in a drug case, but market share liability under New Hampshire law was rejected in University System of New Hampshire v. U.S. Gypsum Co., 756 F. Supp. 640, 655-56 (D.N.H. 1991) (asbestos).

New Jersey

As discussed above, the New Jersey Supreme Court rejected market share liability in the vaccine context in Shackil. The court did not slam the door on market share liability in all conceivable contexts, however.  Two intermediate appellate courts (pre-Shackil) rejected market share liability and other non-identification theories in DES cases, Lyons v. Premo Pharmaceutical Labs, Inc., 406 A.2d 185 (N.J. Super. App. Div. 1979); Namm v. Charles E. Frosst & Co., 427 A.2d 1121 (N.J. Super. App. Div. 1981), as has a federal court, Pipon v. Burroughs-Wellcome Co., 532 F. Supp. 637 (D.N.J. 1982), aff’d without op., 696 F. 2d 984 (3d Cir. 1982).  Between them, these decisions which pretty much obliterate an even older trial court case allowing market share liability in DES litigation.  Cf. Ferrigno v. Eli Lilly & Co., 420 A.2d 1305 (N.J. Super. Law Div. 1980).  Market share liability has been rejected as against non-medical products as well.  See Becker v. Baron Brothers, 649 A.2d 613 (N.J. 1994) (asbestos); McLaughlin v. Acme Pallet Co., 658 A.2d 1314 (N.J. Super. App. Div. 1995) (wooden pallets); Sholtis v. American Cyanamid Co., 568 A.2d 1196 (N.J. Super. App. Div. 1989) (asbestos).

New Mexico

No New Mexico court has spoken on market share liability – that we’ve been able to find, anyway.

New York

The New York Court of Appeals adopted market share liability in a DES case, all the while emphasizing the unique nature of the DES litigation.  Hymowitz v. Eli Lilly & Co., 539 N.E.2d 1069 (N.Y. 1989).  That uniqueness has been maintained, as market share liability has been rejected in other prescription medical product cases, In re New York State Silicone Breast Implant Litigation, 631 N.Y.S.2d 491 (N.Y. Sup. 1995), aff’d mem., 650 N.Y.S.2d 558 (N.Y.A.D. 1996) (breast implants – duh!), as well in cases involving non-medical products.  Hamilton v. Beretta U.S.A. Corp., 750 N.E.2d 1055 (N.Y. 2001) (firearms); Healey v. Firestone Tire & Rubber Co., 663 N.E.2d 901 (N.Y. 1996) (multi-piece wheels); Brenner v. American Cyanamid Co., 699 N.Y.S.2d 848 (N.Y.A.D. 1999) (lead paint pigment); Gifaldi v. DuMont Co., 569 N.Y.S.2d 284 (N.Y.A.D. 1991) (chemicals used to make insulation); Catherwood v. American Sterilizer Co., 532 N.Y.S.2d 216 (N.Y. Sup. 1988) (ethylene oxide); 210 E. 86th St. Corp. v. Combustion Engineering, 821 F. Supp. 125 (S.D.N.Y. 1993) (asbestos).

North Carolina

Market share liability hasn’t been asserted very much in North Carolina.  It was rejected in Griffin v. Tenneco Resins, Inc., 648 F. Supp. 964 (W.D.N.C. 1986), a case involving benzidine congener dyes.

North Dakota

Market share liability has never been raised in a North Dakota law prescription medical product case, but was rejected in the context of asbestos brake pads in Black v. Abex Corp., 603 N.W.2d 182 (N.D. 1999).


Market share liability is so not happening in Ohio.  Even when it was otherwise pro-plaintiff, the Ohio Supreme Court rejected market share liability in DES.  Sutowski v. Eli Lilly & Co., 696 N.E.2d 187 (Ohio 1998).  So did the Sixth Circuit applying Ohio law. Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1431-32 (6th Cir. 1997) (applying Ohio law).  To top it off, the legislature has barred market share liability by statute.  Ohio R.C. §2307.73(C).


The Oklahoma Supreme Court considered and rejected market share liability in an asbestos case.  Case v. Fibreboard Corp., 743 P.2d 1062 (Okla. 1987).  Likewise, the Tenth Circuit, applying Oklahoma law, has rejected market share liability in both DES and vaccine cases.  Wood v. Eli Lilly & Co., 38 F.3d 510 (10th Cir. 1994) (DES); Miller v. Wyeth Laboratories, 43 F.3d 1483, 1994 WL 708197 (10th Cir. Dec. 21, 1994) (vaccine) (unpublished).


The Oregon Supreme Court refused to recognize market share liability in a vaccine case.  Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215 (Or. 1988).


Pennsylvania courts have not addressed market share liability in DES, but have rejected other non-identification theories in that context.  Burnside v. Abbott Laboratories, 505 A.2d 973 (Pa. Super. 1985).  Market share liability has been rejected as to other prescription medical products.  Mellon v. Barre-National Drug Co., 636 A.2d 187 (Pa. Super. 1993) (syrup of ipecac).  In addition, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have rejected market share liability in quite a few non-prescription medical product situations.  See Skipworth v. Lead Industries Ass’n, Inc., 690 A.2d 169, 173 (Pa. 1996) (lead paint pigment); Pennfield Corp. v. Meadow Valley Electric, Inc., 604 A.2d 1082 (Pa. Super. 1992) (wire); Cummins v. Firestone Tire & Rubber Co., 495 A.2d 963 (Pa. Super. 1985) (tires); City of Philadelphia v. Lead Industries Ass’n, 994 A.2d 112 (3d Cir. 1993) (lead paint pigment); Robertson v. Allied Signal, Inc., 914 F.2d 360 (3d Cir. 1990) (asbestos); Warnick v. NMC-Wollard, Inc., 512 F. Supp.2d 318 (W.D. Pa. 2007) (airplane belt loader); Mathai v. K-Mart Corp., 2006 WL 166521 (E.D. Pa. Jan. 20, 2006) (electrical plug); Santarelli v. BP America, 913 F. Supp. 324 (M.D. Pa. 1996) (fish); In re School Asbestos Litigation, 1990 WL 168400 (E.D. Pa. Oct. 30, 1990) (asbestos); Vigiolto v. Johns-Manville, 643 F. Supp. 1454, 1463 (W.D. Pa. 1986) (same), aff’d mem., 826 F.2d 1058 (3d Cir. 1987).

Rhode Island

The Rhode Island Supreme Court has rejected market share liability even in DES cases.  Gorman v. Abbott Laboratories, 599 A.2d 1364 (R.I. 1991).

South Carolina

The South Carolina state courts haven’t spoken on the subject, but two federal district court decisions reject market share liability even in the DES context.  Mizell v. Eli Lilly & Co., 526 F. Supp. 589 (D.S.C. 1981); Ryan v. Eli Lilly & Co., 514 F. Supp. 1004 (D.S.C. 1981).

South Dakota

A long time ago, a federal district court – blatantly ignoring federalism – predicted that the South Dakota Supreme Court would adopt market share liability.  McElhaney v. Eli Lilly & Co., 564 F. Supp. 265 (D.S.D. 1983).  A quarter century later and that hasn’t happened yet, only another federal court refusing to apply market share liability in a multi-piece tire rim case.  Bradley v. Firestone Tire and Rubber Co., 590 F. Supp. 1177 (D.S.D. 1984).


The Sixth Circuit refused to predict that Tennessee would adopt market share liability in a dental amalgam case.  Barnes v. Kerr Corp., 418 F.3d 583 (6th Cir. 2005) (applying Tennessee law).  The theory has also been rejected in asbestos litigation.  Bailiff v. Manville Forest Products Corp., 772 F. Supp. 1578 (S.D. Miss. 1991) (applying Tennessee law).


“Texas state courts have not adopted the theories of alternative liability, concert of action, enterprise liability, or market share liability.”  Hicks v. Charles Pfizer & Co., 466 F. Supp.2d 799, 804 (E.D. Tex. 2005) (vaccine case).  “We know of no Texas appellate decision which ... has even approved of in dicta, much less adopted, the theories of ‘alternative liability, concert of action, enterprise liability, or market share liability” Cimino v. Raymark Industries, Inc., 151 F.3d 297, 313-14 (5th Cir. 1998) (asbestos).  What we do know is that the Texas Supreme Court considered and broadly rejected market share liability in an asbestos case. Gaulding v. Celotex Corp., 772 S.W.2d 66 (Tex. 1989).  A federal court also rejected market share liability in a blood products case under Texas law.  Les v. National Hemophilia Foundation, 2001 WL 432628 (N.D. Tex. April 25, 2001).


No Utah court has given market share liability either a thumbs down or a thumbs up.


Zilch in Vermont on market share liability.


Nothing in Virginia on market share liability either – the most populous state in the county about which that may be said.


The Washington Supreme Court recognized market share liability in Martin v. Abbott Laboratories, 689 P.2d 368 (Wash. 1984), in a DES case.  No Washington court has applied market share liability outside the DES context.

West Virginia

West Virginia courts have not spoken to market share liability.


Wisconsin is the pits on this issue.  First, the Wisconsin Supreme Court recognized a variant of market share liability in Collins v. Eli Lilly & Co., 342 N.W.2d 37 (Wis. 1984), a DES case.  Then the court compounded the error by expanding Collins even further so that a fungible product isn’t even required.  See Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005) (lead paint pigment).  This theory hasn’t raised it’s ugly head in Wisconsin prescription medical product cases yet, to our knowledge.  We recently blogged about how one federal court found the Thomas/Collins liability theory so expansive and bizarre as to be unconstitutional.


Wyoming law is silent as to market share liability.