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A sharp-eyed reader (who wishes to remain nameless) yesterday put together our Bruesewitz user’s guide with our post last Tuesday about the Superior Court affirming (and confirming) in the Lance case that strict liability design defect claims don’t don’t lie against the manufacturers of prescription medical products in Pennsylvania.
The reader’s comment was:  “Do you wonder–as i do–how they got to preemption in Bruesewitz when there is no design defect claim under the relevant state law??”
We thought it was a good question, so we thought we’d try to find the answer.  Wyeth hires good lawyers (like us, but not in Bruesewitz) so we didn’t figure it was inadvertent.  We were right.  It turns out that Wyeth did indeed make the argument – based upon the Pennsylvania Supreme Court’s decision in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), that Pennsylvania law did not recognize design defect cases at all.
In an ironic turnaround, the plaintiffs argued that Pennsylvania law refusing to recognize such a cause of action was preempted.  The district court – in a footnote – more or less bought the argument:

Wyeth alternatively argues that Pennsylvania state law does not allow for a finding of strict liability for design defect or manufacturing defects in this case.  Plaintiffs counter that the Vaccine Act preempts any bar to their claim. Pennsylvania has adopted Section 402A of the Restatement (Second) of Torts.  Therefore, Pennsylvania also provides immunity to the manufacturers of prescription drugs pursuant to comment k.  See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 891 (1996) (“the manufacturer’s negligence, is the only recognized basis of liability.”)  However, not only does the Vaccine Act preempt state law allowing claims arising out of defectively designed vaccines, it also explicitly prohibits states from “establish[ing] or enforc[ing] a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this subtitle.”  42 U.S.C. §300aa-22(e).  The Vaccine Act clearly permits manufacturing defect claims under §22(b)(1), without reference to the theory of liability.  Therefore, strict liability claims for manufacturing defect are not barred by the Vaccine Act.   As such, the preemption provision in §22(e) applies, and Pennsylvania’s bar to strict liability claims for manufacturing defects, enunciated in Hahn, is preempted.  As the Court will grant summary judgment as to Count III based on Vaccine Act preemption and Count IV on the merits, preemption of the Hahn rule does not impact the outcome of this case.

Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430, 451 n.15 (E.D. Pa. 2007) (emphasis added, irrelevant citations omitted).
The district court in Bruesewitz bought the plaintiffs’ identical preemption arguments as to manufacturing defects, and avoided any decision on design defects by holding them preempted.
What to make of this?  Well, we’d have to say that, if the plaintiffs were somehow to succeed on their presumption against preemption-based arguments in overturning the preemption of design defect claims under §22(b)(2) of the Vaccine Act, then they’d still lose – because application of the very same (we would say incorrectly applied) presumption would conversely prevent operation of §22(e) to preempt Pennsylvania’s general common-law rule, expressed in Hahn that comment k precludes design defect claims.  The wording of this part of the Vaccine Act strongly suggests that Congress was looking to preempt only statutes aimed at protecting vaccines (there are a number of them) and not common-law principles like comment k (which the Act actually sought to follow) that apply globally to all product liability claims.
Heads, Wyeth wins; tails, plaintiffs still lose.

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When the Levine, Riegel, and Kent cases were briefed in the United States Supreme Court, we provided our readers with “users’ guides”/”guided tours” that summarized the defense side arguments and pointed out whatever we thought was interesting.
Today we’re continuing that tradition with the Bruesewitz (sooner or later we’ll memorize how to spell that) v. Wyeth case on Vaccine Act preemption, which the Court will decide this coming term.  Being defense lawyers, we only review our own side’s arguments (in public, at least), but all the Brusewitz briefs are available on a this nifty website provided by the ABA.

Wyeth’s brief
We’ll start, of course, with the brief filed by respondent (that means it won in the court below) Wyeth, the defendant maker of the DTP vaccine at issue in Bruesewitz.  As we’d expect, the brief starts off by reminding the court of the spectacularly beneficial effect that vaccines have on the public health, and takes the Court back to those dark days in the 1980s when product liability plaintiffs came very close to doing to vaccines what they’d done to Bendectin – drive them off the market through litigation costs and potential liability, regardless of the product’s actual risks.  Wyeth br. at 1, 5-9.

We remember those days well, as we (well, Bexis) defended DTP manufacturers against the same sort of bizarre design defect claims at issue in Bruesewitz – that an alternative “safer” design can render a vaccine categorically defective, even though that design was not FDA approved.  See White v. Wyeth Laboratories, Inc., 533 N.E.2d 748 (Ohio 1988) (the Ohio Supreme Court rejecting the theory).  See also Wyeth br. at 19-21 (detailing regulatory history of supposed “alternative” designs of DTP).  Basically no alternative “acellular” DTP vaccine received FDA approval for use in the relevant age group until 1996 – 4 years after the injury claimed in Bruesewitz.
Continue Reading Users’ Guide to Defense Briefs in Bruesewitz v. Wyeth

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We know that some followers of this blog are law professors and law students.  Conversely anybody who follows the blog knows that we like – really like – the more sensible approach that the Supreme Court took towards pleading in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009).  We’ve gone head to head with law professors about this, and we maintain a TwIqbal cheat sheet of useful decisions in our area.
Anyway, we’ve just found out that TwIqbal is the subject of this year’s Washington Legal Foundation legal writing contest for law students, and we wanted to help get the word out.  The precise question presented is:

“How have recent U.S. Supreme Court rulings on civil lawsuit pleading standards impacted litigation, and what are the potential implications of congressional efforts to repeal those judicial decisions?”

For you law students out there, all the details about entering the WLF’s contest can be found here.  Moreover, in addition to what the recognition that the winner will receive from the WLF, we’d also be willing to feature the winning essay here as a guest post.

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Last week we reported on two recent decisions by the Pennsylvania Superior Court (an intermediate appellate court) in fen-phen litigation.  Well, there was a third shoe out there, and yesterday it dropped.  In Lance v. Wyeth, No. 2905 EDA 2008, slip op. (Pa. Super Aug. 2, 2010), affirmed – for the first time in a reported appellate decision in Pennsylvania – that the restrictions on strict liability recognized by the Pennsylvania Supreme Court in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), precluded any claim for strict liability design defect in product liability litigation involving prescription drugs (and, we presume, medical devices as well.

Although Appellant labels her claim as “negligent and unreasonable marketing,” her proposed cause of action duplicates a design defect claim, seeking to impose strict liability on [defendant] because [its drug] was unreasonably dangerous.  With our Supreme Court’s adoption of comment k, a design defect claim for strict liability is not cognizable under Pennsylvania law when it is asserted against a manufacturer of prescription drugs.  For purposes of strict liability and §402A, a drug cannot be deemed unreasonably dangerous, even if it is defectively designed, so long as the drug is manufactured properly and contains adequate warnings.

Slip op. at 7-8 ¶15.  We’ve made the argument, of course, that Hahn precluded strict liability of any sort (other that manufacturing defects, which are pretty rare), but now we’ve got an appellate court for the proposition.
But then the court goes and recognizes a negligent design claim for a prescription drug.  That’s better than strict liability, given Pennsylvania’s weird evidentiary restrictions, but not by all that much.   The court bases it on two things:  (1) that Restatement of Torts §395 “contains no exemption or special protection for prescription drugs” and (2) the statement in Restatement of Torts §402A that strict liability “is not exclusive, and does not preclude liability based upon the alternative ground of negligence.”  Slip op. at 10-11 ¶¶18-19.
Continue Reading Pennsylvania Fen-Phen Appeals – The Third Shoe Drops

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The folks over at 360 have a story this morning about the decision, Judy v. Pfizer, Inc., No. 042-1946-02, slip op. (Mo. Cir. St. Louis Co. July 27, 2010), in which the court denied a consumer fraud claim loosely predicated on off-label use/off-label promotion of Neurontin.  We’re, of course, pleased to see that, but as Dechert represents Pfizer in some Neurontin litigation (although not the Judy case), we can’t comment all that much about it.
But we can’t let it go unmentioned that the Missouri consumer fraud statute has a reputation as one of the most liberally construed in the country.  For instance, in our 50-state survey, we couldn’t even find anything good to report on fraud on the market in Missouri.  Nor (before now), did we have anything from Missouri on our state law class action denial cheat sheet.
Thus, the failure of an off-label use economic loss class action under the Missouri statute (on the perfectly reasonable grounds that the effectiveness of off-label uses – like all drugs, when you think about it – varies from person to person) tells us that these no-injury consumer fraud claims should fail in every state of the union.
That’s something we like being able to say.

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A new book, Being Wrong, tries to describe the process of how people get things wrong, how it feels, and what it means. Wrongness can include all sorts of errors, including optical illusions, memory failures, neurological deficits, flights of imagination, or irrational beliefs. A worthy addition to this catalogue of wrongology can be found in a recent learned intermediary case, In re Levaquin Prods. Liab. Litig., 2010 U.S. Dist. LEXIS 75054 (D. Minn. July 26, 2010).
We just returned from a deposition of a prescriber, so this issue is near and dear to our hearts right now. Let’s put aside the issue of whether the plaintiff ever specifies what the warning should have been. (Usually they don’t. It descends into a game of whack-a-mole.) In most pharmaceutical failure-to-warn cases, it turns out that even if the requisite warning had been supplied to the prescriber — indeed, if it had been writ large in neon and hung a few inches from the doctor’s nose — it wouldn’t have made any difference; the same medicine would have been prescribed in the same way at the same time in the same dose. Because it’s called the learned intermediary defense, some might rashly conclude that the burden of proof would be on the defendant to prove that the warning would have made no difference. But what the learned intermediary defense means is that the issue is whether the learned intermediary – usually the doctor — was warned, not the ultimate consumer. And then it becomes an issue of causation: did the lack of a warning make any difference? That burden, friends, is on the plaintiff. (That’s our position, anyway. We’re not saying all jurisdictions agree; only the smart ones.)
The Levaquin opinion seems perfectly muddle-headed as to burden of proof. At one point it says, “If a defendant properly establishes the facts necessary to support the learned intermediary defense, a patient will be unable to show that the defendant’s failure to warn the prescribing physician is a proximate cause of the patient’s injury.” Levaquin, 2010 U.S. Dist LEXIS 75054, *5. That is not clear and definitely not helpful. Later, the court discusses an earlier case that held that “a plaintiff must identify some omitted information that would have convinced the prescribing physician to alter the recommended course of treatment in order to establish causation for failure to warn under Minnesota’s learned intermediary doctrine.” Id. at * 23 (citing Bruzer v. Danek Medical, Inc., 1999 U.S. Dist. LEXIS 4483 (D. Minn. 1999)). That sounds more like putting the burden of proof on the plaintiff, where it should be. But when we look at how the Levaquin court treated the facts in the case, it’s hard to believe that it didn’t get burden of proof wrong, as well as just about everything else.
Continue Reading Wrong on Learned Intermediary

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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 liability.  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.
Continue Reading New Defense Learned Intermediary Wins In Pennsylvania

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.

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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.

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.

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