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This post is from the Reed Smith side of the blog only.

The Alabama Supreme Court’s horrendous, but so far outlier, opinion in Weeks v. Wyeth (we discussed it here) will be reconsidered by that court sometime in September, according to a minute order issued on June 13.  Innovator liability is a novel theory that turns the traditional justification for product liability – that a manufacturer should be responsible for injuries caused by defects in its product – on its head.  Instead innovator manufacturers would be liable for their competitors’ generic products.  In the drug context it would also portent making the 30% of the market made up of new, innovative products bear the burden of injuries suffered by the 70% of the market represented by generic products.  For that reason, if widely adopted (which thankfully it is not) it would inevitably make the prices of innovator drugs skyrocket.  This theory hardly existed at all until the Mensing generic preemption decision made recovery against actual manufacturers problematic, so it’s emergence(?) has nothing to do with the proper workings of state law and everything to do with a desperate search for a deep pocket, no matter how bizarre the logic, in generic drug cases.

In Weeks the Alabama Supreme Court had acted precipitously, without oral argument discussing the above policy issues.  Fortunately, it seems to have realized that there is more to this theory than liability uber alles.

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This post, being about metoclopramide/Reglan, is from the ReedSmith side of the blog only.

The Eighth Circuit decided branded and generic liability issues today in Bell v. Pfizer, Inc., No 12-1647, slip op. (8th Cir. June 14, 2013).  The innovator drug drug defendants rang the bell, their dismissal as a matter of law affirmed.  The generics did almost as well, but some issues were sent back.

Bell is a metoclopramide/Reglan case where, as usual, the plaintiff only took the generic (that is, metoclopramide).  The district court gave the plaintiff the old one-two – granting summary judgment to the generic defendant on the basis of preemption under Mensing, and to the innovator defendants because the plaintiff never used their product.

The Eighth Circuit affirmed as to the innovator defendants, since the plaintiff admitted never taking their drug.  That court had already decided the identical issue in favor of the same defendants under Minnesota law in the original Mensing opinion, which we discussed here when it came down.  The Bell court reached the same conclusion under Arkansas law:

Arkansas law compels the same result. . . .  [T]o prove her product liability claims under Arkansas law, [plaintiff] must show that a product manufactured or distributed by the brand defendants caused her injuries.  Because [plaintiff] never used [the product] the brand defendants manufactured, [plaintiff] cannot hold them liable under Arkansas law.

Bell, slip op. at 6 (citations and footnote omitted).  The court refused to recognize any causation distinction between product liability claims and other claims such as “negligence, misrepresentation, suppression of evidence and fraud” that would affect the product identification requirement.  Id. at 7.  Furthermore, even if there had been some sort of duty (which the court rejected), the plaintiff’s claims would still fail under the learned intermediary rule, which Arkansas follows.  Id. at 7-8.  That rule does not support “extending such a duty of care to the customer of a competitor using a competing product.”  Id. at 8.

Continue Reading Breaking News – Innovators Ring The Bell In a Generic Case (And The Generics Do OK, Too)

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Back in 2009, we posted that a recently enacted Oklahoma tort reform statute included a provision to eliminate most class action litigation under the notorious outlier case Ysbrand v. DaimlerChrysler Corp., 81 P.3d 618 (Okla. 2003), by forbidding nationwide classes to be brought under Oklahoma law.  It seems to have worked.  We haven’t heard of any Ysbrand shenanigans since then.

Well, the Oklahoma Supreme Court was plainly out of control in Ysbrand, and unfortunately it remains out of control to this day.  Recently, in Douglas v. Cox Retirement Properties, Inc., ___ P.3d ___, 2013 WL 2407169 (Okla. June 4, 2013), the same court invalidated the entire tort reform statute, under the obscure (and rightly so) “single subject” rule for legislation.  Funny how we never seem to see that invoked except when tort reform is at issue….

Douglas thus resurrects (at least potentially) the anything goes class action practice that existed under Ysbrand – as well as the raft of other litigation abuses that the Oklahoma legislature thought it had addressed in 2009.  That’s bad news.

The silver lining is that, since practically the day Douglas was decided, legislators in Oklahoma, who passed the original bill by a substantial margins, have been quoted as saying that they would break up the original legislation into separate bills.  Moreover, with Douglas reviving tort reform as an issue, additional “measures − to limit liability for gun manufacturers, adopt federal guidelines for expert witnesses and protect restaurants [from] obesity-related lawsuits” may also be on the agenda.

Umm … guys….

Continue Reading Umm . . . While You’re At It

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One of the few states where there is any doubt about the applicability of the learned intermediary rule is Wisconsin.  That’s primarily because the rule has never been addressed (one way or the other) by any Wisconsin state appellate court.  The Wisconsin cases applying the rule have been federal district courts applying Wisconsin law.  See Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999) (applying Wisconsin law); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999); and Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963 (D. Wis. 1981), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981).

We’ve recently learned that a Wisconsin state trial court followed the learned intermediary rule in a fairly extensive opinion.  We’d give a shout out to our source, but then we’d have to complain about how the opinion was kept under wraps for a decade.  We, of course, sent that along to Westlaw, so now it has a citation.  Straub v. Berg, 2003 WL 26468454 (Wis. Cir. Jan. 6, 2003).

That being accomplished, we pass it along to our readers, in the event they have any litigation under Wisconsin law.  Straub is another case alleging that a drug caused the plaintiffs’ decedent to commit
suicide.  These are not easy cases for plaintiffs to win, and Straub was no exception.  Plaintiffs did manage to stave off summary judgment under the defendant’s first argument, that suicide was an ipso facto superseding cause, due to facts that did not “foreclose the possibility” that the drug could have “create[d] a mental condition capable of resulting in behavior manifested by uncontrollable impulses.”  2003 WL 26468454, at *6.  Maybe later, once all the facts are in, this could be ruled on as a matter of law, but not yet.  Id.

Yes!  Pagination in WL trial orders!  At least going forward.

That’s when the learned intermediary rule rode to the rescue.  Liability would have to be based on warnings of this alleged inherent drug risk, but such warnings, where the drug is by prescription only, go to prescribing doctors, not patients:

Although Wisconsin courts have not addressed the application of the learned intermediary doctrine, courts of numerous other jurisdictions almost universally hold that in the case of prescription drugs, a manufacturer’s provision of proper warnings to a prescribing physician will satisfy the manufacturer’s duty to warn since the patient cannot obtain the drug except through the physician.

Id. at *6 (citing Lukaszewicz).  So there it is.

And in Straub, the rule was dispositive.  The label, right on its face, warned of “depression” (in its own paragraph) as well as mood changes and malaise.  Discontinuation and seeing one’s doctor were recommended.  Id. at *7.  That was exactly the condition plaintiffs alleged in the complaint.  Id.  Plaintiffs responded with a flurry of hearsay documents, most of which were irrelevant to the prevailing state of the art because they post-dated the suicide in the case, and some of which involved foreign regulatory matters.  Id.  None was admissible evidence:

Plaintiffs’ submissions . . . offer no admissible factual basis to support their argument that [defendant] failed to advise treating physicians of the severity of the risk of depression, that is,
that it could induce a depression so severe that it could lead to suicidal thoughts, attempts and suicide.

Id.

Plaintiffs’ final Hail Mary in Straub also failed.  Plaintiffs advocated the direct-to-consumer exception to the rule (although how that would have changed anything is unclear).  In any rate, the court found no basis for it.  “This exception has been addressed by only a few jurisdictions.”  Id. at *7.  Moreover plaintiffs did “not allege[] that [the drug] was advertised directly to consumers and their submissions fail to provide any evidence that [it] was directly marketed to consumers.”  Id.   Summary judgment granted on the basis of the “learned intermediary doctrine defense.”

Id.

Now, we know and you know that the learned intermediary rule is not a “defense” in the sense that the defense beard the burden of proof, only in colloquial terms is it a defense in that it provides, as in Straub, a basis for our side to prevail, but with that nit, we’re happy with the decision.

There doesn’t seem to have been any appeal.  Anyway, Straub is another piece on the Wisconsin board for the good guys concerning the learned intermediary rule.  May there be more.

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Usually when we analyze a case we skip through the preliminaries and try to cut straight to the chase.  That means reading past the standard of review and the generally applicable rules governing the procedure at hand.  Some people act the same way when they write briefs.  They assume it is all interchangeable and doesn’t much matter.  So they plug in the same-old-same-old for, say, summary judgment or Daubert.  But that is a mistake.  A lot has been said by a lot of courts on those standards, and some things we like better than others.  Shame on any brief writer who does not spend time and ink emphasizing the best bits of the relevant procedural standard.  And shame on us for not espying the hints provided by the court early on that almost make the ultimate substantive result seem inevitable.

Something like that happened in Brown v. Roche Laboratories, Inc., 2013 U.S. Dist. LEXIS (N.D. Ga. June 6, 2013), where the court came out with a very good Daubert and summary judgment decision, and where the court supplied the foundation for that decision up front.  In Brown, the plaintiff had taken Bactrim for a sinus infection.  No, this case is not about Bactrim, not really.  But the Bactrim usage ended up dooming the plaintiff’s expert’s causation opinion.  After the Bactrim usage, the Brown plaintiff experienced a fever, headache, and other symptoms.  Her doctor feared that she had developed bacterial meningitis.  Accordingly, the doctor administered doses of Rocephin.  The doctor was aware of the plaintiff’s penicillin allergy, and knew of the  potential cross-reactivity between Rocephin and penicillin.  Nevertheless, the doctor believed that the potential risk was outweighed by the benefit of treating suspected meningitis.  That is the sort of thing that doctors do.  As far as we can tell, the plaintiff in Brown had no complaint about any alleged medical malpractice.  Subsequently, the plaintiff came down with SJS/TEN, a terrible disease about which there has been much high-stakes litigation and about which we have written before.  There are many terrible consequences of SJS/TEN.  At least in Brown, bad law was not one of them.

Continue Reading N.D. Ga. Rule 702 Analysis Excludes Plaintiff’s Expert and Ends SJS/TEN Case

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This post comes only from the Dechert side of the blog since Reed Smith was involved in the appeal that is the subject of the post.

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Usually plaintiffs’ lawyers have the simpler story to tell.  They’ll tell you that they drive on the highway while defense lawyers wander about on side roads.  If this is true, however, it’s usually because the defense is responding to accusations tossed out by plaintiffs, and responding is rarely simple.  But the roles were reversed in the diversity jurisdiction dispute addressed by the Third Circuit in Johnson v. SmithKline Beecham Corporation, Slip Op.(3d Cir. June 7, 2013).  The defense had the much simpler argument, an argument that won at the district court level (before two judges, losing before one other) and, as we discuss below, just won before the Third Circuit.

The plaintiffs originally filed suit in the Philadelphia Court of Common Pleas, naming a number of defendants, including GlaxoSmithKline’s operating company, GlaxoSmithKline LLC (“GSK LLC”) and GSK LLC’s sole member, GlaxoSmithKline Holdings (“GSK Holdings”).  The defendants believed that there was complete diversity and removed the lawsuit to federal court.  Plaintiffs believed otherwise, and moved to remand.  The key issue was the citizenship of the operating company, GSK LLC.  Plaintiffs argued, among other things, that GSK LLC was a citizen of Pennsylvania, the forum state, and was not diverse from one of the plaintiffs, a Pennsylvania citizen.  The defense argued that GSK LLC was a Delaware citizen, making the case removable.

The defense’s argument was simple.  GSK LLC is a limited liability company, and such non-corporate business organizations are citizens of the state or states in which each of their members are citizens.  Slip. Op. at 21 (citing Carden v. Arkoma Assocs., 494 U.S. 185, 195-96 (1990)).  GSK LLC had only one member: GSK Holding, a corporation.  So what was its citizenship?  By statute (21 USC 1332 (c)), a corporation is a citizen of both the state in which it’s incorporated and the state in which it has its principal place of business.  In both instances, that’s Delaware for GSK Holdings.  Accordingly, GSK Holdings is a Delaware citizen and so is GSK LLC.  Done.  Fairly simple.  There’s diversity.

Continue Reading Third Circuit on Diversity Jurisdiction: Keep It Simple

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Remember that weird case where the plaintiff was suing because the defendant removed a drug he liked from the market?  Well, it was affirmed the other day, by the Eleventh Circuit.  See Lacognata v. Hospira, Inc., No. 12-14078, slip op. (11th Cir. June 7, 2013) (unpublished).  The affirmance isn’t much – all of one paragraph – but it expressly affirms “for the reasons stated in the district court’s order.”   As we discussed in our previous post, there were some interesting propositions, mostly about Florida law, in that district court opinion, which have now received the blessing of the relevant court of appeals.  Could be useful.

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Here’s a guest post prepared by Dick Dean and Corena Larimer, both of Tucker Ellis, on something we’ve been interested in as well – the transubstantivity of the implied preemption “impossibility” analysis of the Supreme Court’s Mensing opinion, with particular emphasis on generic drugs.  They give a new twist to the argument, tying it to statements made during the Bartlett oral argument (albeit by justices who dissented in Mensing).  Fingers crossed, okay?

As always we’re just the piano player on guest posts.  The authors get all the credit and all the blame.  Here goes:

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As we wait patiently (okay, maybe a little impatiently) for the Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett, we’ve been looking back through the arguments and wondering what the Court has in store for the generic pharmaceutical industry. But what is striking, and very clearly articulated by several justices during the Bartlett oral argument, is what the Court already may have given to all drug and medical device defendants facing design defect claims—two years ago, in Mensing.

Yes, Mensing was a generic drug case. And, yes, it focused on a federal duty that is unique to generic drugs. And it was about failure-to-warn claims, not design defect claims. But hear us out.

Recall that Mensing was an impossibility preemption decision, in which the Court held failure-to-warn claims against generic drug manufacturers preempted because federal law requires a generic drug’s warnings to match those of its brand-name equivalent. That aspect of Mensing is specific to generics.

But the Mensing Court went further, framing the general test for impossibility preemption in broad terms: “The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Mensing, 131 S. Ct. at 2579. And again:

To decide these cases, it is enough to hold that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

Id. at 2580-81.

In essence, the Court held that preemption applies unless a defendant can independently—that is, without FDA permission or assistance—comply with the state-law duty at issue. That’s a pretty broad test, and one that can apply to any type of defendant—brand or generic, drug or device manufacturer.

Now, fast-forward two years. Failure-to-warn claims against generics are should be a thing of the past. Now the Court is considering Bartlett, which asks whether a manufacturer can be held liable for its generic drug’s design—which, like its warning, must match the brand-name equivalent. (And this blog has covered the case extensively.) The Supreme Court may not overtly decide that issue, if it instead finds that the case really presents a warning claim (because the warning has considered by the jury in judging the drug’s design) that is clearly barred by Mensing.

But some of the questions from the Court during oral argument illustrate that a straightforward application of Mensing’s impossibility test would preempt a true design defect claim (i.e. one that doesn’t factor in warnings) against either generic or brand manufacturers. Justice Kagan was first out of the box, asking Mutual’s counsel whether there is any way to distinguish between the two.

Justice Kagan:

It seems to me that in this case we are not really dealing only with generics, we are also dealing with brand-name drugs. . . .  [T]he thought there would be . . . as to design, as compared to warnings, . . . they’re really all in the same boat. In other words . . . they have a design; that it is only that design that’s approved. If they change their design there’s no authority to continue marketing it. They have to go back to square one. And that’s just as true of brand names as it is of generics. So am I right about that? . . . If we’re just looking at a pure design defect claim, putting the warning card aside, where you are in a different position from the brand-name drugs, but as to design, don’t the brand-name and the generics go hand in hand? (Trans. 3:24 – 4:16 (emphases added).)

After continuing to press Mutual’s counsel on the issue (“am I right that generics and brand-name manufacturers are in the same position with respect to [design defect] claims?”), Justice Kagan explained “I just can’t figure out what distinction there would be.” (Trans. 5:3–9, 21–22.)

Justice Sotomayor (who authored the dissent in Mensing) then weighed in, referencing Mensing’s test for impossibility. When Mutual’s counsel suggested that the plaintiff could have brought a design defect claim against the brand-name manufacturer if she had taken the brand-name drug instead of the generic, Justice Sotomayor asked: “How? The FDA approved the design. . . . And they couldn’t change it without FDA approval.” (Trans. 10:5–10.) Later in the argument, responding to a question from Justice Kagan, counsel for Ms. Bartlett agreed that brand and generic defendants stood in the same shoes as to design changes, agreeing that “if there was to be a tweak to the design, they’d need to go to the FDA to get approval for that.” (Trans. 51:10–14.) So both Justice Kagan and Justice Sotomayor seem to believe that a straightforward reading of Mensing leads to preemption of design defect claims.

And the federal government agreed. The Solicitor General’s office, arguing as amicus curiae, confirmed that it is impossible for any drug manufacturer—brand or generic—to change its drug’s design without FDA approval:

[T]he FDCA also has within it the judgment that safety is best effectuated not only by having the FDA set the standard, but by forbidding any manufacturer from deviating from that once it’s been approved by the FDA. When we’re talking about a drug’s formulation, the manufacturer cannot change it. And that’s what brings this within the ambit of PLIVA v. Mensing.

(Trans. 24:1–9 (emphasis added).) (For more on the government’s amicus brief, check out this post.)

The Bartlett oral arguments certainly highlight that the Mensing test for impossibility is not limited to generics or to failure-to-warn claims. Read literally, it requires that design defect claims that would force a manufacturer—any manufacturer—to make a design change that the FDA must approve, clear, or otherwise act on prior to marketing are preempted.

We often do not think of drugs as “designed” when they are composed of a single molecule, but there are many drugs that nonetheless have a design aspect to them (like transdermal patches that deliver a drug through the skin, or combinations of drugs). And the FDA’s regulations describe “major” changes requiring prior FDA approval. See 21 C.F.R. § 314.70(b). “Major” changes include “any change in the drug substance [or] drug product . . . that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.” 21 C.F.R. § 314.70(b)(1) (emphasis added). That covers many changes in the “qualitative or quantitative formulation of the drug product, including inactive ingredients.” 21 C.F.R. § 314.70(b)(2)(i). The “moderate” or “minor” changes that may be made without prior approval (through a Changes Being Effected supplement or in an annual report) are listed in the same regulation, 21 C.F.R. § 314.70(c), (d), and would not have the same impossibility preemption defense.

Medical devices are governed by a different set of statutes and regulations, but the same general principles apply. If the manufacturer could not have independently changed the device’s design to correct an alleged design flaw—but instead would have required the FDA’s permission to make that change—the design defect claim is preempted.

In short, Mensing’s impossibility preemption framework can be a powerful tool for all drug and device defendants facing a design defect claim. We just have to get lower courts to accept what Justice Kagan, Justice Sotomayor, and the Solicitor General all said: as long as a design change requires the FDA’s permission, it doesn’t matter if the defendant is a brand or generic drug manufacturer—or, we think, a drug or device manufacturer.  Those claims are preempted.

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Certain carbon products are supposed to last forever.  Houses should last more than 14 years, but they will need significant upkeep along the way.  Well maintained cars can last more than 14 years, but we think most do not.  We have a hard time thinking of many electrical products that last more than 14 years of regular use without requiring upkeep and parts being replaced.  The batteries we buy certainly do not last long, regardless of the irregularity of their use.  In Mullan v. North Cascade Cardiology, No. 68513-9-1, 2013 Wash. App. LEXIS 1281 (Wash. Ct. App. May 28, 2013), we were struck by the notion that liability might attach to the manufacturer of a battery in a pacemaker if its voltage dropped by about 22% in 14 years of quite regular use.  We do not think the battery in our electric toothbrush keeps 78% of its charge in a day.  In the end, the plaintiff lost in Mullan for the reasons a plaintiff often loses—lack of proof on elements of her prima facie case and lack of diligence in trying to get proof—but it was an interesting case along the way.

The basic facts of Mullan involved a pacemaker implanted in a woman in May 1994 for a congenital heart condition—the opinion is vague on some medical details—and the woman’s death in October 2008 from an apparent arrhythmia, a month after a representative of the defendant manufacturer told a defendant cardiologist that faxed-in readings from the pacemaker indicated that its battery would need to be replaced in five to six months.  [For context, May 1994 was a month after the death of Washington’s own Kurt Cobain.  October 2008 was the month of the epic debate between Sarah Palin and Joe Biden.]  Upon explant the pacemaker’s battery’s voltage tested at below the replacement level—called “end of life” (EOL), perhaps not the best name here.  Defendant manufacturer also evaluated the explanted pacemaker and determined that it had not malfunctioned and had battery life above EOL. The discrepancy in battery voltage readings after explant was explained by the manufacturer by the difference between testing at room temperature and body temperature.  Plaintiff waited more than two years, until the motions for summary judgment were being argued, to ask to test the pacemaker and its battery.  Plaintiff did offer up declarations from an electrical engineer and a cardiologist in opposition to the motions, so there was not exactly a walk over.

Perhaps because of the lag from implant to injury, the plaintiff premised liability against the manufacturer only on negligently “providing current, accurate, and timely technical assistance to [the defendant cardiologist] with regard to the useful safe life of the battery.”  Id. at **4-5.  At least that was the allegation being considered on appeal.  We have seen a long lag from release of a product until the plaintiff’s use or injury create legal and practical barriers to recovery.  For instance, statutes of repose can be based on the “useful life” of the product or a set number of years from sale to suit.  The “state of the art” defense, the “alteration” defense, and the absence of a post-sale duty to warn in most places make it hard to sue 17 years after the sale of a drug or implant of a device (as happened here).  There may also be difficulties in getting basic or defect evidence so long after a product has been designed, manufactured, sold, and used.  Whatever the reason, the Mullan plaintiff focused on the “technical assistance” the defendant manufacturer in 2008, its only apparent relevant act or omission within a decade of the plaintiff’s injury.  Such liability, where plaintiff can muster better proof than in Mullan, could pose some real issues for drug and device manufacturers.  Manufacturers tend to be pretty careful about not practicing medicine and not interfering with the doctor-patient relationship that is the center of the learned intermediary doctrine.  At the same time, regulatory requirements and marketing realities can make manufacturers engage in a range of contact with health care providers and even patients (i.e., potential plaintiffs) that might fall under the banner of “technical assistance.”  The longer it is from initial sale until a request for technical assistance, the harder it is for the manufacturer to respond in an accurate and timely fashion, assuming the manufacturer is still around to field the request at all.  We can envision a range of potential pitfalls for the manufacturer.

Mullan, however, suffered from two of the most basic pitfalls for a product plaintiff:  no evidence of breach of duty and no evidence that any breach proximately caused the plaintiff’s injury.  Applying good, basic summary judgment law, the court found that the defendant manufacturer—relying largely on its own testing—had shifted the burden to plaintiff to come forward with real evidence on each element of her cause.  Her expert did not aver that plaintiff’s arrhythmia was caused by a battery failure or by the defendant manufacturer’s technical assistance a month before.  While plaintiff’s expert claimed the defendant manufacturer’s testing of the actual device was unreliable, they never did their own testing and were left with unsupported guesses about product failure and causation.  Id. at *7 (“reasonable hypotheses exist to explain why [plaintiff] died that cannot be tested without access to the pacemaker itself”).  This is where we applaud the Mullan courts, and some very sensible Washington state law, in rejecting the plaintiff’s attempt to delay consideration of summary judgment until she could get the pacemaker and have her experts test it.  We have seen some courts, in the name of fairness, give traction to such late requests, though maybe not as late as the oral argument on summary judgment like here.  The lack of a “good reason for the delay in obtaining the desired evidence’ here was more than enough reason to uphold the trial court’s exercise of discretion in rejecting the late request.  Id. at **11-12.  With that, the case against the manufacturer was gone and the court did not have to reach arguments on “federal pre-emption and the learned intermediary doctrine.”  The claims against the defendant cardiologist, nurse, and their practice fell on a similar lack of proof, although it does look like the plaintiffs’ experts actually did criticize their conduct leading up to plaintiff’s death.

The lack of proof on causation may have been due to plaintiff’s reliance on a logical fallacy:  1) pacemakers are intended to minimize the chance of an arrhythmia (although the approved indication here was surely more technical); 2) plaintiff had an arrhythmia long after the implantation of a pacemaker; therefore, 3) her pacemaker failed and caused an arrhythmia.  This same sort of fallacy plays out in other drug and device cases (e.g., unintended pregnancy suits against a contraceptive product, recurrent hernia after surgery with a hernia patch) with or without rigorous expert proof.  We are pleased to see that the courts in Mullan recognized the fallacy and that the plaintiff’s experts were honest enough to not try to opine that there was causation.  The court did not even have to reach the real causation question:  whether plaintiff could make the added leap—required by the age of the product and resulting focus on recent technical assistance—of proving that inadequate technical assistance caused the plaintiff’s arrhythmia.

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In the dispute about whether GSK is a Pennsylvania or a Delaware citizen, the Third Circuit has just ruled, and GSK has been held to be a citizen of Delaware (and thus diverse for purposes of suits filed in Philadelphia).  That’s all we can say (at least here on the RS side), since RS was involved in this appeal.  For anything more, you’ll have to read the opinion yourself.

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