Last week with dismay, we described the Eastern District of Pennsylvania’s decision in Gross v. Coloplast Corp., et al., 2020 WL 264691 (E.D. Pa. Jan. 17, 2020).   The Gross court (we are resisting the immature cheap shot) “predicted,” in the face of decades of contrary evidence, that the Pennsylvania Supreme Court would not extend the “unavoidably unsafe product” exemption of comment k to Section 402A to the Restatement (Second) of Torts to prescription medical devices. The court acknowledged that, under long-settled Pennsylvania law, comment k exempts manufacturers of prescription drugs from strict liability claims, and it identified neither law nor logic supporting a distinction between prescription drugs and prescription medical devices. Nevertheless, it denied the device manufacturer’s motion for summary judgment on the plaintiff’s strict liability claims.

We promised to keep you apprised of better-reasoned decisions that reach the (obviously) correct result, and today we deliver. In Kohn v. Ethicon, Inc., 2012 U.S. Dist. LEXIS 24996 (E.D. Pa. Feb. 12, 2020) – another pelvic mesh case – a different judge in the Eastern District of Pennsylvania considered the same question: does comment k bar strict liability claims against manufacturers of prescription medical devices. And this judge issued a decision that makes sense (at least on this issue, but stay tuned).

The plaintiff alleged strict liability design defect and failure-to-warn claims, and the defendants moved for summary judgment. This court, like the Gross court, reviewed comment k’s history under Pennsylvania law, dating back to the Pennsylvania Supreme Court’s 1996 Hahn decision holding that prescription drugs were “unavoidably unsafe products,” exempt from strict liability claims, under comment k and including appellate decisions extending the exemption to prescription medical devices. But this court rejected the plaintiff’s tortured constructions of decisions that, read properly, stand for nothing more than the proposition that the Supreme Court has not yet squarely addressed the medical device question.   The court held that it “[could] not adopt [the plaintiff’s] position” considering that Hahn had never been overruled.  Kohn, 2012 U.S. Dist. LEXIS 24996 at *10.   Nor did the court accept the plaintiff’s argument that either Lance or Tincher limited the application of comment k, holding (correctly) that Lance held only that comment k did not “readily translate into the negligence arena,” id. at *10-11 (internal punctuation and citation to Lance omitted) and that Tincher “dealt with steel tubing, not pharmaceutical products.” Id. at * 11.   The court acknowledged contrary Eastern District decisions, including Schrecengost v. Coloplast Corp., our eighth worst case of 2019, and Gross. But it also acknowledged Pennsylvania federal decisions (we count over forty) reaching the opposite result. The court concluded, “As a result of the current state of Pennsylvania law, the court finds that strict liability claims cannot proceed against medical device manufacturers.” Id. at *12.

We are sure that our grandmother must have had a saying to the effect that nothing is “all good.”  And, sure enough, just as we were about to raise a glass (a lovely Cabernet we found at a bargain price on a closeout site) to the Kohn court, we read the rest of the decision. The defendants also moved for summary judgment on the plaintiff’s negligent failure-to-warn claims, arguing that the device’s warnings were adequate as a matter of law, and that, in any event, the plaintiff could not prove the proximate causation element of her failure-to-warn claim. The court found that there were fact issues defeating summary judgment on the adequacy of the warnings. We won’t spend any time on that.  But this court, like so many, started down the correct path on the proximate causation question then contradicted itself to reach the wrong result.

A bit of background for those (unlike us) who do not spend huge portions of their professional lives litigating this question.   In a case alleging that a drug or device manufacturer failed to supply adequate warnings, a plaintiff must prove two things. First, she must prove that the warnings were inadequate – that the manufacturer did not adequately warn of the adverse events she claims she suffered. But that is only half of the equation. Even if the plaintiff can prove that the warnings were not adequate, she still must prove so-called “warnings causation;” in other words, she must prove that the inadequacy of the manufacturer’s warnings proximately caused her alleged injuries.   To prove this, the plaintiff has the burden of proving that a different or stronger warning would have changed the treating doctor’s decision to prescribe the drug or device, thereby proving that it was the inadequate warning that caused the prescribing decision and, in turn, the plaintiff’s injury.

Read that again: “the plaintiff has the burden of proving” this element of her warnings claim, just as she has the burden of proving the elements of all of her claims. There is no heeding presumption applicable to prescription medical products in Pennsylvania. It is not the defendant’s burden to prove the negative; in other words, the defendant need not prove that nothing would have changed in the face of a different warning.  Federal summary judgment procedure allows motions that point out the non-moving party’s lack of evidence on essential elements on which that party bears the burden of proof.  So, to win summary judgment on a failure-to-warn claim, a defendant need only demonstrate that the plaintiff has adduced no evidence tending to prove that the doctor would have changed his prescribing decision if the warnings were different, right?

Of course it’s right, as a matter of law. And the Kohn court got it right at first, stating, “Plaintiffs must also prove proximate causation by showing that the learned intermediary would have altered his behavior had the defendant issued a proper warning.” Id. at *14-15. That’s the last thing the court got right. The decision goes on to confirm that the plaintiff had adduced no evidence to support warnings causation (and, in fact, that there was evidence to the contrary). But the court managed to conclude that there was “a question of fact as to whether [the doctor] would have gained a different understanding of the risks associated with the devices” if a “proper” warning had been included. Id. at *17.

Not only was this the wrong answer, it was the wrong question. We learned about burden of proof in our first year of law school, all those decades ago, and the decision in Kohn turned on misapplication of this simplest of hornbook principles. We are fighting an identical battle in dozens of pending summary judgment motions. While we are grateful for Kohn’s thumb on the correct side of the comment k scale, the “warnings causation” decision is cause for despair. As always, we will keep you posted on similar decisions, and, hopefully, on dissimilar ones.

When we see a case title with the same name on both sides of the v, we think of Jarndyce v. Jarndyce, the will contest described by Dickens in Bleak House. That fictional case dragged on for years and throughout the course of the book, ending only when legal expenses devoured all the estate funds. When a case is Surname X vs. Surname X, it is usually a family law matter. That is not the usual stuff for our cozy little blog, and maybe that’s why did not pay much attention to Aybar v. Aybar, 2019 WL 288307 (N.Y. App. Jan. 23, 2019), when it came out a little more than a year ago.

Aybar was about a car accident – a bad one, involving three fatalities and three serious injuries. The plaintiffs were the survivors and the estates of the decedents. The defendants included the driver (who must have been a relative of at least one of the plaintiffs, thereby accounting for the same names) and the manufacturers of the vehicle and the tires. The auto manufacturer and tire manufacturer moved to dismiss the case against them for lack of personal jurisdiction. The vehicle was manufactured in Missouri and sold in Ohio. Nothing involving the manufacture of the vehicle in question occurred in New York. The auto manufacturer had no factories in New York and, to the extent it did any business there, operated via independent dealers. The tires were made in Tennessee and tested and inspected outside of New York.

The plaintiffs did not assert that there was specific jurisdiction against these defendants. The only issue was whether New York could exercise general personal jurisdiction — i.e., whether the companies engaged in such a continuous and systematic course of doing business in New York such that a plaintiff could hail them into New York courts for any case. The lower court said that New York did have such general jurisdiction over the companies. The appellate court said that the lower court was wrong.

Under the SCOTUS decision in Daimler, there is general jurisdiction over companies that are “at home” in the forum in question. Companies are “at home” in states where they are incorporated and states that house the principal place of business. Nothing else really does the trick, apparently, save having a temporary place of business in a state during a war. None of that applied in Aybar, thus it looked like the companies could escape from New York. The plaintiffs resorted to the usual gambit, pointing to the companies’ long histories of doing lots of business in New York. Of course, any big corporation in this country cannot help doing lots of business in New York. If plaintiffs’ argument won the day, Daimler would be a dead letter, at least within the territorial limits of New York (and, undoubtedly, California, as well). So far, Aybar is pretty ordinary.

What makes Aybar interesting is court’s rejection of plaintiffs’ argument that there was general jurisdiction over the companies because they consented to jurisdiction in New York by registering to do business in New York and appointing an agent for service of process. This argument usually does not work, though it has made headway in a few courts. Those few courts were unspeakably dim, so we won’t speak of them — we’ll leave that to Bexis. But we will speak (kindly) about the reasoning in Aybar.

At first, you might think the Aybar court had it easy, because the New York business registration statutes do not expressly require consent to general jurisdiction as a cost of doing business in New York, nor do they expressly notify a foreign corporation that registering to do business in New York has such an effect. Nevertheless, there is a long line of New York cases (both federal and state) holding that registering to do business in New York does, indeed, constitute consent to general jurisdiction. It was, for sure, a long line, but it was also an old line. The New York theory of consent by registration traces back to a 1916 decision by Judge (not yet Justice) Cardozo. Cardozo, like Holmes, Marshall, etc., gets a lot of cred, and we in the legal business are supposed to treat legal legends as if they were infallible. (By the way, they were not). The Aybar court does not label Cardozo as wrong; rather, his personal jurisdiction decision was of its time. The Aybar court takes us on a tour of personal jurisdiction law from Pennoyer through International Shoe etc., culminating in Daimler. (If you can read the Aybar opinion and not have an anxiety nightmare that night about your law school Civ Pro I exam, you are made of stronger stuff than we are.) Let’s cut to the chase. Daimler was a game changer. And the game now is a lot better for defendant corporations. The old New York consent-by-registration cases are confined to the pre-International Shoe era. Post Daimler, companies do not consent to general jurisdiction in New York merely by registering to do business there.

Unlike Jarndyce v. Jarndyce, in which the justice system perpetuated insanity after insanity, eventually grinding the parties to dust, Aybar v. Aybar shows a justice system capable of evolving, learning, and improving.

Well, at least that’s true when we are blogging about defense wins.  And this week, we have another good gadolinium case.  This time from New York.

Just a quick reminder – gadolinium is a contrast agent that is injected into a patient before undergoing an MRI.  The gadolinium is intended to pass through the body, but there are known risks of retention in patients with impaired kidney function.

Plaintiff in Sabol v. Bayer Healthcare Pharm, Inc., 2020 WL 705170, *1 (S.D.N.Y. Feb. 12, 2020) underwent a remarkable 23 MRIs between 2007 and 2015, and each time she was injected with a gadolinium contrast agent. As in our other recent gadolinium posts, plaintiff here had normal kidney function.  Her lawsuit, therefore, hinges on her contention that defendants should have warned of the risks of gadolinium retention in patients with normal kidney function.

Before we get to the substance of those allegations, two defendants sought dismissal based on a lack of personal jurisdiction.  Neither defendant was headquartered or incorporated in New York.  Id. at *4, *5.  The injections of those defendants’ gadolinium agents occurred in Florida, not New York.  Id. at *7.  Plaintiff currently resides in New York and it appears she received her other injections in New York.  But that wasn’t enough to satisfy New York’s long arm statute because specific jurisdiction requires that plaintiff’s suit “arise out of, or relate to, the defendant’s contacts with the forum.”  Id.  While plaintiff argued that both defendants marketed and distributed their products in New York, she failed to allege any connection between those activities and the injuries she allegedly incurred in Florida.  Id.

As to one of the non-New York defendants, plaintiff made two additional failing arguments.  First, defendant owned a facility in New York.  But plaintiff failed to connect that facility to her alleged injury.  Second, defendant is a wholly-owned subsidiary of a New York company.  The court started by noting that it is uncommon to confer personal jurisdiction on a foreign subsidiary based on the actions of its domestic parent.  Id. at *8.  More importantly, what plaintiff is asking is for the court to exercise general jurisdiction over the parent company.  In a post Daimler AG v. Bauman world, imputing general jurisdiction is questionable at best.  Id. (quoting Daimler AG).  But the court didn’t really need to address that issue head on, because plaintiff failed to allege anything other than that the two entities had a relationship.  Without some allegations regarding alter ego, control, or veil piercing – ownership alone is not enough to impute jurisdiction.  Id. at *9.

The next issue before the court was the reverse – did plaintiff state a claim against the parent company where it alleged no facts that the parent is liable for the claims against the subsidiary.  Same problem.  Mere ownership also is not enough to impute liability to the parent.  Id. at *10.

That left one remaining defendant who made three substantive arguments – preemption, lack of foreseeability, no legally cognizable injury.  The court needed only to address the first issue concluding that all plaintiff’s claims were preempted.

This part might sound a little familiar.  Plaintiff’s argument was that defendant should have and could have revised its labeling to include a warning regarding gadolinium retention in patients with normal kidney function pursuant to the “changes being effected” (CBE) regulations.  Those regulations provide that a manufacturer can “add or strengthen” a warning without prior FDA approval if the manufacturer has “newly acquired information” that provides “reasonable evidence of a causal association” of a “clinically significant adverse reaction.”  Id. at *11.  Further, a “clinically significant adverse reaction” is one that is “potentially fatal,” “serious,” or can “be prevented or mitigated through appropriate use of the drug.”  Id.  So, to avoid impossibility preemption, a plaintiff has to allege not just a labeling deficiency, but “a labeling deficiency that [defendant] could have corrected under [the CBE exception.]”  Id.  A defendant seeking preemption must either demonstrate that the proposed label change falls outside the CBE process or show clear evidence that the FDA would not have approved the change.  Id.  This case follows option one.

First, the court looked at the 2018 gadolinium FDA-approved label which includes a reference that patients with normal kidney function may retain gadolinium.  But, the FDA’s 2018 finding also included that “gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function” and “in patients with normal kidney function, a causal connection . . . could not be established.”  Id. at *12.  If the FDA has not found a link between retention and adverse health effects in persons like plaintiff with no renal dysfunction, the court was not persuaded that it should ignore that finding and hold that defendant should have changed its label to the contrary years earlier.  Id. Because the FDA’s 2018 notice was attached to the complaint and it contradicted plaintiff’s conclusory allegations, the court did not have to accept those allegations as true.  Id.  But even without the FDA notice, the court found plaintiff’s allegations wouldn’t pass TwIqbal because they were too vague and did “not draw the crucial causal link between” the cited adverse events and gadolinium retention in patients with normal renal function.  Id.

Second, plaintiff cited two studies that were published in 2015 or earlier – the time when plaintiff was injected with the drug.  But neither demonstrated “reasonable evidence” of a causal relationship.  One study focused on skin plaques which the court could not determine were a “clinically significant adverse event” to allow for a CBE label change.  More importantly, it was a case study involving two patients who in fact may have had impaired kidney function.  Id. at *13.  The second study focused on hyperintense signals in the brain which again the court could not assume were a significant enough event to trigger a CBE label change.  It too was a case study with a “tentative, at best, suggestion of a causal relationship.”  Id.

Overall, plaintiff failed to plead any facts showing defendant had newly acquired information that would have permitted it to change its label unilaterally.  Therefore, plaintiff’s claims were preempted.  The court also found the complaint lacking in plausible allegations of a causal association between the drug and plaintiff’s alleged injuries, another fatal flaw.  Id. at *14.

It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.

Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.

Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product to the learned intermediary, it fulfills its duty to warn the consumer.”  Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 949 (Ariz. 2016).  “[P]roviding an adequate warning to the prescribing physician relieves the manufacturer of its duty to warn the patient regardless of how or if the physician warns the patient.”  Larkin v. Pfizer, Inc., 153 S.W.3d 758, 765 (Ky. 2004).  Or, as Bexis puts it in his book, “Once a warning is adequate, the manufacturer has . . . no legal requirement [to] tell a physician more.”  Drug & Medical Device Product Liability Deskbook, §2.04[2], at 2.04-67 (LJP updated 2018).

Bexis’ book, of course, collects citations from all over the country.  Here are just some of those greatest hits.  Virginia − Pfizer, Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980) (“[w]e do not think that the duty of the defendant extended to explaining exactly how the danger against which he had been warned might operate”) (citation and quotation marks omitted).  Ohio − Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003) (“there exists no requirement that [defendant] give any warnings for [its drug] to the consumer if the warnings provided to the physician are adequate”).  Louisiana − Brown v. Glaxo, Inc., 790 So.2d 35, 39-40 (La. App. 2000) (“We are not concerned with what [defendant] could have included in the warning.  The test is adequacy.”).  Illinois − Pluto v. Searle Laboratories, 690 N.E.2d 619, 622 (Ill. App. 1997) (“[defendant] had no duty to warn women in the suspect category that use of the [device] may result in an increased risk of infection because it is not [defendant’s] product which causes infection, rather, it is the lifestyle choice of persons in the suspect category”).  Michigan − Nichols v. Clare Community Hospital, 476 N.W.2d 493, 495 (Mich. App. 1991) (“A manufacturer fulfills its duty to the medical community when it warns of the risk inherent in use of the drug.  There is no requirement that the warning apprise the doctor of how to properly diagnose the condition that renders use dangerous.”).  Kansas − Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1233 (10th Cir. 2001) (having adequately warned of all “dangers caused by drug use,” manufacturer “was required to do no more”; no further duty to warn about product “storage-related problems”).  Florida −  Christopher v. Cutter Laboratories, 53 F.3d 1184, 1193 (11th Cir. 1995) (error to “forc[e] [defendant] to prove that [the prescriber] had a level of knowledge greater than that disclosed by the warning” the adequacy of which was unchallenged).  California −  Chao v. Smith & Nephew, Inc., 2013 WL 6157587, at *4 (S.D. Cal. Oct. 22, 2013) (“Plaintiffs have cited no legal authority . . . for the proposition that a [product] manufacturer owes a duty, beyond providing a warning, to dissuade a physician from using [the product] on a particular patient”).  Minnesota −  Kapps v. Biosense Webster, Inc., 813 F. Supp.2d 1128, 1153 (D. Minn. 2011) (“[a] manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products”; unnecessary to warn that device reprocessing may not have been FDA approved).

This obvious proposition that an adequate warning is enough in a warning case is also the law in Pennsylvania.  “[I]n an action against a drug manufacturer based upon inadequate warnings, the issue to be determined is whether the warning, if any, that was given to the prescribing physicians was proper and adequate.”  Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909, 924 (Pa. Super. 2011) (quoting Taurino v. Ellen, 579 A.2d 925, 927 (Pa. Super. 1990)).

In Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996), the defendant “specifically warned of the hazard of hypertensive crises associated with [the drug] and suffered by [plaintiff].”  Id. at 1155.  That was enough.  The law imposed no duty to do more and include other “helpful information” about how to treat the warned-of adverse reaction.

[Plaintiff’s] expert opinion, even if wholly credited, however, does not evidence that [defendant’s] instructions or warnings to the medical community concerning [the drug] and its side effects were inadequate.  [Plaintiff’s expert] merely points out that [defendant] had the opportunity, but not the obligation, to include helpful information about [a drug that treated hypertensive crisis] when warning physicians about [the drug].  Accordingly, the record supports no basis upon which a reasonable jury could impose liability on [defendant] based on the alleged defect in the [drug’s] warning supplied to prescribing doctors.

Id.

Likewise, in Salvio v. Amgen, Inc., 2012 WL 517446, at *5-6 (W.D. Pa. Feb. 15, 2012), the defendant warned in bold print about “serious infections . . . including fatalities.”  There was thus no need to go further and specifically address “fungal” infections.

[T]he manufacturers of [the drug] issued a broad warning of the risk of infection and highlighted some specific risks. . . .  [Examples omitted]  Therefore, the Court finds that the [drug’s] Package Insert in effect when Decedent was prescribed the drug adequately warned doctors of the risk of serious infections, such as the one which allegedly led to Decedent’s death.

Id. at *6.  See Kline v. Zimmer Holdings, Inc., 2015 WL 4077495, at *25 (W.D. Pa. July 6, 2015) (“Plaintiffs point to no support for the contention that a defective warnings case can be based on information provided to a plaintiff’s treating physician other than via the official warning on the package.”); aff’d, 662 F. Appx. 121 (3d Cir. 2016); Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489, at *7 (M.D. Pa. Dec.2, 2013) (“The law does not require that the drug manufacturer provide such detailed information or instructions so as to remove the medical judgment of the physicians, who are in the best position to monitor and treat their patients and make medical judgments with respect to their care.”); Aaron v. Wyeth, 2010 WL 653984, at *8-9 (W.D. Pa. Feb. 19, 2010)  (“two (2) pages of suicide related warnings including an FDA mandated pediatric ‘black box’ warning” adequate as a matter of law; no need to warn separately about “potential suicidal ideation” in adults).

However, it looks like some Pennsylvania plaintiffs are giving this discredited liability theory a go.  In Zitney v. Wyeth, LLC, 2020 WL 499137, at *1 (Pa. C.P. Philadelphia Co. Jan. 9, 2020), the plaintiffs have “conceded the content of Defendants warnings was proper and adequate.”  Id. at *5.  Yet they still appeal from the court’s grant of summary judgment on their warning-related claims.  Why?

Plaintiffs argue Defendants . . . should have sent “Dear Healthcare Professional” letters to physicians, including [their prescriber], alerting those physicians of the [drug’s] labeling change.

Id. at *5.  They didn’t cite any case law – only a nine-year-old amicus brief (2011 WL 741927) filed in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), that merely argued that “this practice would not be prohibited by federal law.”  Zitney, 2020 WL 499137, at *4.

However, given that the warnings at issue were themselves concededly adequate, the availability of some other means of communication was beside the point:

Plaintiffs’ argument fails. . . .  Nothing in Pennsylvania law suggests that a drug manufacturer must convey those warnings in a manner other than by including them on the drug’s label.  Over the past 50 years, the Pennsylvania Supreme Court continuously suggested a drug manufacturer meets its obligation to include an appropriate warning with the drug at issue by providing the warnings in the drug’s label.  [String citation omitted]  Plaintiffs do not argue [defendants] distributed their [drug] without the FDA approved label. . . .  Accordingly, since [defendants] distributed their [drug] with labels containing warnings that Plaintiffs concede are sufficient, Defendants have fulfilled their duty to warn under Pennsylvania law.

Id. at *5.  What precedent do plaintiffs cite in support of their argument that drug manufacturers must do more than provide adequate warnings?  Zilch.  “Plaintiffs do not cite any precedent, binding or persuasive, to support their claim Pennsylvania law imposes such a duty.”  Id.

Should be a fun appeal.

Note:  the elephant in the room here is preemption.  Zitney is a generic drug case.  As our generic preemption scorecard demonstrates, just about every court ever to consider the plaintiffs’ “Dear Healthcare Provider Letter” argument has held it to be preempted.  Pennsylvania, however, is an extreme generic preemption outlier.  See In re Reglan/Metoclopramide Litigation, 81 A.3d 80, 94 (Pa. Super. 2013), which we discussed here.  But even if a theory of liability hypothetically escapes preemption, it must, of course, still state a cause of action under state law.  DHCP letter claims simply don’t, and that’s what is at issue in Zitney.

This is a quick-hit post bringing you two first-of-their-kind orders on proving causation in cases alleging inadequate drug or medical device warnings.  In orders applying Georgia’s and Delaware’s versions of the learned intermediary doctrine, two different federal courts have held that a plaintiff alleging inadequate warnings cannot meet his or her burden of proving causation without testimony from the prescribing physician.

The cases are May v. Ethicon, Inc., No. 1:20-CV-322, 2020 U.S. Dist. LEXIS 23143 (N.D. Ga. Feb. 11, 2020), and Evans v. Johnson & Johnson Co., No. 14-1316-RGA, 2020 WL 616575 (D. Del. Feb. 10, 2020).  But first, some context.  Failure-to-warn claims are a staple of drug and medical device litigation, mostly because failure-to-warn claims are the most widely recognized flavor of product liability in the drug and medical device space.  Sure, we also have design defect and manufacturing defect claims, but even in jurisdictions that cabin those claims in some way, the trade off is that manufacturers owe a duty adequately to warn regarding known and reasonably knowable risks.

But to whom do manufacturers owe the duty?  Under the learned intermediary doctrine (some version of which applies in most every state), prescription drug and medical device manufacturers owe a duty to warn only the prescribing physician (or “learned intermediary”), not the patient directly.  A corollary of that rule is that in order to prove causation in a failure-to-warn case, the plaintiff has to prove that a different or additional warning would actually have changed the physician’s decision to prescribe or implant the product.

We can quibble on exactly what that means, and we have written too many posts on warnings causation to count.  But one thing is clear—because the plaintiff bears the burden of proof, a defendant is entitled to judgment as a matter of law on warnings-based claims when there is no admissible evidence from the prescribing physician.  Maybe a different or additional warning would have convinced the physician to prescribe another product (or no product at all), or maybe it would not have.  Without evidence, we don’t know, which means the defendant wins.

That is what happened recently in May v. Ethicon and Evans v. Johnson & Johnson.  In May, the plaintiff alleged injuries arising from treatment with surgical mesh and that the defendant manufacturer had not provided adequate warnings.  Under Georgia’s learned intermediary rule, “where a learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided, courts typically conclude that . . . the causal link is broken and the plaintiff cannot recover.”  May, U.S. Dist. LEXIS 23143, at *9 (internal citations and quotes omitted).

The problem for the plaintiff was that no one took the implanting surgeon’s deposition, leaving everyone to speculate on whether different or additional warnings would have changed the surgeon’s course of action.  This lack of evidence resulted in summary judgment on the plaintiffs’ warnings claims.  As the district court reasoned,

[D]espite the lack of Georgia precedent on this issue, the Court agrees with the Defendants that the Plaintiffs’ failure to warn claim cannot proceed in the absence of any testimony at all from the implanting physician.  The Plaintiffs cannot establish the necessary elements of their failure to warn claim without any evidence indicating how the implanting physician—to whom the duty to warn was owed—responded to the Defendants’ warning or how he might have responded to some different, more comprehensive warning.

Id. at *11 (emphasis added).  A similar failure of proof played out to the same result in Evans, where the court applied Delaware law.  In Evans, the plaintiff alleged side effects from taking a prescription drug approved for treatment of schizophrenia and bipolar disorder.  Evans, 2020 WL 616575, at *1.  Again, the plaintiff alleged that the drug manufacturer failed adequately to warn regarding certain risks, which triggered application of Delaware’s learned intermediary rule.  That included the burden of proving causation:

To maintain an action against a manufacturer when . . . a genuine factual dispute exists [on the adequacy of warnings], a plaintiff must show that an additional warning would have made a difference to the plaintiff’s treating physician.  This is because, if a more complete warning would not have made a difference to the prescriber, a plaintiff is unable to prove but for causation.

Id. at *4 (internal citations omitted).  The prescribing physician was identified by name in medical records, but no one took his deposition.  As in May, that left the parties and the court to guess as to whether different or additional warnings would have affected the decision to prescribe.  Rejecting the plaintiff’s excuses for why he purportedly failed to seek discovery, the court granted summary judgment on the warnings claims under Delaware law:  “Plaintiff has no evidence that, but for the supposedly inadequate warning, he would not have been prescribed [the drug].  Hence, Defendants are shielded from liability by the learned intermediary doctrine.”  Id. at *4

Both cases cover other issues, but we found this one-two punch on warnings causation to be the most noteworthy.  Add Georgia and Delaware to the “no physician testimony, no causation” column.

We’ve discussed before how we expect genetic testing of plaintiffs to become routine in prescription medical product liability litigation.  The cost of such testing is constantly plummeting, even more steeply than would be predicted by Moore’s Law.  We even proposed a rule of federal procedure to govern the conditions under which such testing could occur, which predictably went nowhere, since there is no crisis – yet.  In 2015, we discussed the relatively sparse, but mostly favorable case law on forcing recalcitrant plaintiffs to provide the necessary specimens for genetic testing.  Almost all of those cases involved blood samples, but technology is enabling even less invasive alternatives:

A high number of patients seem to accept salvia samples as a risk assessment tool . . . and are interested in their specific risk situation.  At the same time, it could be demonstrated that it is an effective way to provide high-quality DNA for . . . gene analysis.

Poehls, et al., “Saliva Samples as a Source Of DNA For High Throughput Genotyping:  An Acceptable & Sufficient Means in Improvement of Risk Estimation Throughout Mammographic Diagnostics,” 23:20 Eur. J. Med. Res., at “Conclusion” (2018).

Since our last article we’ve become aware of additional decisions ordering genetic testing for diagnostic/causation purposes, so we thought we’d pass them along.  The first is Cusick v. Cusick, 210 A.3d 1199 (R.I. 2019), which we believe is the first state high court to affirm a diagnostic genetic testing order.  Cusick involved “an acrimonious post-divorce battle” in which estranged parents disagreed (inter alia) about genetically testing the ex-husband, who had been diagnosed with an inheritable genetic condition.  Id. at 1201.  Specifically:

[G]enetic testing of [ex-husband] to determine whether his children are at risk for [the condition] is the preferred diagnostic path because, if the genetic change that [ex-husband] carries can be identified, then the children can be tested for that specific variant.  Alternatively, . . . if genetic testing of [ex-husband] is not undertaken, then [an alternative method] can be used to diagnose the children; however, there is a high risk that this could produce a false-negative.

Id.

Cusick affirmed the trial court’s order that such testing be conducted over the ex-husband’s (who was a lawyer representing himself) objection.

[A]fter careful review . . ., we are satisfied that the hearing justice made sufficient findings of fact and did not overlook or misconceive any evidence.  We are of the opinion that the hearing justice carefully balanced the interests of the father in protecting his privacy with that of the children.  His conclusion that genetic testing was in the best interest of the children is supported by the evidence.  Further, the order under review is both balanced and reasonable.  We see no reason to disturb the findings of the hearing justice.

210 A.3d at 1204.

In New York, in Kaous v. Lutheran Medical Center, 30 N.Y.S.3d 663 (N.Y. App. Div. 2016), the court affirmed a genetic testing order in a malpractice case:

[T]he [trial] Court properly determined that the defendants were entitled to perform genetic testing and a physical examination. . . .  In a medical malpractice action, where the physical condition of a party is in controversy, “any party may serve notice on another party to submit to a physical, mental or blood examination by a designated physician.”  Here, the defendants challenge the plaintiffs’ allegation that [the] injuries were caused by the defendants’ purported malpractice and not Fraser Syndrome or any other genetic predisposition.  Given that Sophia’s physical and mental condition is in dispute, the Supreme Court properly granted those . . . motions . . . to permit genetic testing.

Id. at 666 (citation omitted).  Defendant in Kaous was significantly aided by New York having a rule specifically addressing blood samples.  See Kriloff v. Providence Health & Services − Oregon, 2016 WL 11121002, at *1 (Or.Cir. Jan. 12, 2016) (“defendants’ discovery Motion to obtain blood specimens from [plaintiff] in sufficient volume for the purpose of performing genetic testing is allowed”).

In Burt v. Winona Health, 2018 WL 3647230 (D. Minn. Aug. 1, 2018), the court overruled a magistrate’s order and ordered whole exome sequencing (“WES”) testing where defendant’s “experts . . . identified genetic disorders and specific conditions that could be likely culprits of [the claimed] disability.”  Id. at *2.

[B]ecause Plaintiffs must prove the cause of [minor plaintiff’s] injuries, [minor’s] genetic makeup is “really and genuinely in controversy.”   The Court further concludes that Defendants have established good cause for WES testing.  Specifically, Defendants’ expert . . . stated that there are numerous genetic disorders that may have caused [the] injuries, while also identifying specific conditions that may be a cause. . . .  [The expert] identified specific facts justifying WES testing related to [minor’s] parents – namely, that their medical records indicate the possibility of underlying genetic issues within the family.

Id. at *2 (quoting Schlagenhauf v. Holder, 379 U.S. 104, 109 (1964)) (other citations and quotation marks omitted).  For an interesting article on Burt and WES testing (including adverse precedent), see Gendron & Morgan, “Incomplete Penetrance:  Whole-Exome Sequencing & Federal Courts, 61(1) For the Defense 22 (DRI 2019).

Finally this final diagnostic genetic testing case actually existed in 2015, but it wasn’t published anywhere and Bexis didn’t become aware of it until recently.  In Ortwein v Certainteed Corp., 2014 WL 12911977 (Cal. Super. Dec. 22, 2014), the court ordered genetic testing of a “take home” asbestos plaintiff – that is, an occupationally unexposed person (here, a wife) claiming injury from asbestos allegedly present on a spouse’s work clothing.  “Take home” asbestos cases are inherently weak, given the questionable method and amount of claimed exposure, so alternative causation is an important defense.

The moving defendant in Ortwein “moved to compel [plaintiff’s]physical examination, including blood sample, and for limited genetic testing.”  2014 WL 12911977, at *4.  It moved to compel plaintiff “to appear for a medical examination to withdraw blood to be used to test for the presence or absence of the BAP1 mutation.”  Id.  Plenty of medical literature supports “BAP1 tumor predisposition syndrome.”

[Defendant] contended that the testing was calculated to result of the discovery of admissible evidence because the presence of the BAP1 mutation in the germline, defined as the genetic material inherited from a father or mother, would support an opinion by [its expert] that Plaintiff’s mesothelioma could have developed in the absence of exposure to mesothelioma. . . .  [I]t is possible that Plaintiff is affected by the genetic BAP1 cancer syndrome that is characterized by a high incidence of malignant mesotheliomas and other cancers in affected families at a relatively younger age.

Id. at *4.  Defendant sought extraction of eight millileters of blood for the testing.  Id.  Its entitlement to testing lay in California civil procedure rules concerning medical examinations and Cruz v. Superior Court, 17 Cal. Rptr. 3d 368 (Cal. App. 2004), a case we discussed in our 2015 postOrtwein, 2014 WL 12911977, at *4.  Plaintiff opposed on both privacy and “eggshell plaintiff” (discussed in the 2015 post) grounds.  Id. at *5.

In the interim, plaintiff died, so the request for a blood sample was converted to a request for lung tissue.  Id. at *6.

Ortwein ordered that the requested genetic testing take place, subject to privacy-related restrictions.

The production of the tissue samples, the testing to obtain . . . genetic information regarding BAP1, and the potential expert testimony is essential to the fair resolution of the lawsuit.  The information is essential because [defendant] has no alternative means to obtain the information it seeks.  This is not a situation where a party can obtain adequate, even if not comparable, information through less intrusive means.

Id. at *9.  The order involved discovery, not admission of evidence, thus Ortwein did not need to address the ultimate admissibility of any expert opinion offered by the moving defendant.  Id. at *8.

As for privacy, after the plaintiff’s death, that interest abated.  “[T]he right of privacy is purely a personal one and . . . does not survive but dies with the person.”  Id. at *7 (citation and quotation marks omitted).  After death only persons who “share genetic information” can assert a privacy interest.  Id.  Nonetheless, the court added  confidentiality conditions to its order:

[Defendant] must use the tissue sample and any and all information derived from the tissue sample solely for this case.  [Its] experts cannot retain, use, or transfer [the] genetic information for potential use in further research.  [Its] attorneys cannot retain, use, or transfer [the] genetic information for potential use in subsequent litigation. . . .  [Defendant] must return or destroy the tissue sample and any and all information derived from the tissue sample at the conclusion of the case.

Id. at *9.

Plaintiff’s “eggshell” argument failed for multiple reasons.  That the decedent was “particularly susceptible to mesothelioma” gives “greater confidence that . . . defenses based on [her] potential possession of the BAP1 mutation are plausible both as a matter of fact in this case and as a matter of expert scientific opinion.”  Id. at *8.  Whether “the BAP1 mutation [actually] can cause mesothelioma” will be addressed later, in connection with the admissibility of expert testimony.  Id.  “[T]hat the BAP1 mutation arguably can make a person susceptible to mesothelioma” is “directly relevant to this case” and supports two legitimate arguments.”  Id.

First, [defendant] can argue that if [the decedent] was susceptible to mesothelioma such that she could have contracted the disease from levels of asbestos that [defendant] would not reasonably have foreseen would cause the disease, then [defendant] might not have had a duty to her on the grounds that the harm was not foreseeable. . . .

Second, [defendant] can argue that if [decedent] was susceptible to mesothelioma, then she could have contracted the disease as a result of exposures to asbestos from more sources than have been identified to date.  [Defendant] may then legitimately argue . . . that that liability should be apportioned among a larger number of sources. . . .

Id. at *8-9.  See also Thrash v. Boeing Co., 2018 WL 2573097, at *3 (N.D. Cal. March 2, 2018) (almost identical California asbestos decision reaching similar result under federal rules).

Readers should note that the research on which this post is based is fairly limited.  We looked only at cases involving diagnostic genetic testing of plaintiffs claiming some sort of personal injury.  Our interest here is in proving or disproving the causation of medical conditions.  We have not reviewed the great majority of genetic testing cases, which involve using such tests to establish someone’s identity.  Nor have we examined any of the criminal matters that these days comprise the substantial majority of cases that concern genetic testing.

Plaintiffs will go to great lengths to stay out of federal court, including naming local defendants against whom the plaintiffs have no real intention of pursuing the lawsuit with even a smidgen of seriousness. Sometimes that is called “improper joinder,” but we prefer the term “fraudulent joinder” because that more accurately captures what is afoot. Why dress up an ugly reality with euphemisms? It is terribly easy for plaintiffs to lob in a local defendant and terribly hard for defendants to satisfy the test typically employed by courts for fraudulent joinder – whether the defendants meet the burden of showing that there is no reasonable basis for recovery against the local defendant. In short, fraudulent joinder is terrible and plaintiffs often get away with it.

But the plaintiffs did not get away with it in In re Taxotere Prods. Liab. Litig., 2020 WL 598043 (E.D. La. Feb. 7, 2020). Plaintiffs in the Taxotere MDL claim that a cancer drug caused permanent hair loss. A group of 16 California plaintiffs contrived to stay out of the federal MDL by filing a lawsuit in Los Angeles County (a delightful place for plaintiffs, and not just because of the splendid weather and Langer’s Delicatessen) against the out of state manufacturers and an in-state distributor.

The manufacturers removed the case to federal court and sought transfer to the MDL. The plaintiffs, not surprisingly, filed a motion to remand the case to the state court. The issue was whether the distributor had been fraudulently — or, if you are squeamish, improperly – joined. The federal court begins by invoking a “Rule 12(b)(6)-type analysis” to see whether the complaint stated a claim against the in-state defendant. But the court also says it can “pierce the pleadings” and consider summary judgment-type evidence as to “discrete facts that would determine the propriety of joinder.” That last bit gladdens our scurvy, defense-hack heart and prompts us to dream up motions setting forth how the particular plaintiff attorneys have a history of dropping local defendants (doctors, distributors – whoever) on the eve of trial. But maybe the court isn’t contemplating that sort of thing. As we said, we were dreaming.

But what the Taxotere court did was pretty good — maybe even “woke,” in the parlance of the young-uns. (Okay, we don’t really know what that means. We are profoundly unwoke.) The complaint alleged that the distributor was a supplier of the drug, but did not allege that it was the exclusive supplier. The fact is that the plaintiffs did not allege that the in-state distributor supplied the medicine that was actually administered to any of the plaintiffs. The best that the plaintiffs could do was allege that the distributor distributed to an infusion facility where one of the plaintiffs was treated. That allegation falls short of the mark. Even that one plaintiff could not establish product identification. “Without more, none of these sixteen plaintiffs have asserted plausible claims” against the in-state distributor. Absent any plaintiff with a plausible claim against the distributor, that in-state defendant could be ignored and diversity jurisdiction therefore existed.

The plaintiff tried to escape this pleading/factual deficiency by citing a prior Taxotere remand order. But in that prior case relied on by the plaintiff, medical records explicitly established that a plaintiff received medicine supplied by the in-state distributor. That factual scenario satisfied the lenient test for joinder. But at least now we know there are limits.

We’ve brought you some great news from the gadolinium contrast agent litigation last year and the hits just keeping on coming.  This time out of federal court in Arizona.  And while the court is giving plaintiff another stab at re-pleading her case, we are doubtful plaintiff will be able to cure the deficiencies identified in this decision.

The case is Drescher v. Bracco Diagnostics Inc., 2020 WL 699878 (D. Ariz. Jan. 31, 2020).  Plaintiff underwent MRIs in 2013, 2015, and 2016 before each of which she was injected with a linear gadolinium-based contrast agent (GBCA) manufactured by defendants.  Plaintiff had normal kidney function at the time of her GBCA injections.  She alleges that she has retained gadolinium in her organs that is causing fibrosis and related symptomology.  Plaintiff brought causes of action for failure to warn and defective design under both negligence and strict liability.  Id. at *1.

The court first addressed defendants’ argument that plaintiff’s failure to warn claims were preempted because defendant could not have unilaterally change the drug’s labeling under the “changes being effected” (CBE) regulations.  Under Arizona law, prescription drug manufacturers have a duty to warn of “foreseeable risks of harm from using their products.”  Id. at *3.  However, to warn users of gadolinium of risks of retention in situations of normal kidney function would have required manufacturers to change their labels.  Only if they could do that without FDA approval will plaintiff’s claims survive preemption.  The CBE regulations permit a label change without prior FDA approval where the manufacturer has “newly acquired information,” that supports an additional or strengthened warning where there is “evidence of a causal association between the drug and a risk of harm.” Id. (citations omitted).

The court then looked to see whether plaintiff’s complaint contained sufficient allegations to demonstrate that defendants could have used the CBE process.  It did not.  The complaint contained allegations about studies involving gadolinium and compromised renal function (not plaintiff’s condition), studies performed before the FDA approval of the drug’s original label (not newly acquired information), studies conducted after plaintiff’s last exposure to the drug (not relevant), non-human studies and patient reports (non-causal data).  Id. at *4.  As the plaintiff had no evidence signaling a causal link between gadolinium and harm to patients with normal kidney function, the court was not willing to “accept as true Plaintiff’s conclusory allegations of causation that are contradicted by the supporting facts and studies included in the Amended Complaint and its attachments.”  Id. at *5.

Further evidence of a lack of a causal connection is found in the 2018 FDA approved label change.  Plaintiff attached the 2018 label to her amended complaint which includes the following:  “Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.”  Id. (emphasis added).  Leading the court to find that “[t]he FDA’s conclusion that no known causal association existed in 2017 precludes finding that Defendants could have made a CBE label change years earlier.”  Id. at *6.

It’s also worth pointing out that this failure to adequately plead causation would also have been fatal to plaintiff’s failure to warn claims outside the preemption arena.  Causation is an essential element of a failure to warn claim without which plaintiff would not have made it passed TwIqbalSee id. at n.4.

Moving onto to design defect – defendants again argued preemption based on an inability to alter the FDA-approved design of their drug.  The court began its analysis by determining that Arizona would adopt and apply Restatement (Third) of Torts §6(c), which provides:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Id. at *8.  Therefore, to comply with Arizona law, defendants would be required to redesign their drug which would constitute a major change which is not allowed.  Id.  (“[o]nce a drug . . . is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.”).

Plaintiff tried to argue a safer alternative design but what she was actually asking for was a different product.  Plaintiff argued that macrocyclic GBCAs carried less of a risk than linear GBCAs which is what defendants’ products were.  Id.  But again, changing a linear GBCA to a macrocyclic GCBA would be a major change that is not allowed without FDA approval.

With all plaintiff’s failure to warn and design defect claims dismissed as preempted, the court could have stopped there.  But, since plaintiff was getting a chance to re-plead, the court also opined on the insufficiency of plaintiff’s foreseeability allegations.  Under Arizona law, manufacturers are required to warn of foreseeable risks and design their products to avoid foreseeable risks.  Id. at *9.  Plaintiff cited a dozen places in her complaint where she used the word “foreseeable” but that’s not the same thing as actually pleading facts that support foreseeability.  The court found all of the allegations conclusory or contradicted by the evidence.  Id.  As noted above, the studies cited by plaintiffs weren’t really germane to the issues alleged in the complaint.  Because plaintiff failed to cite a single study “confirming injury to a single patient with normal kidney function due to GBCA exposure,” plaintiff failed to “demonstrate that Defendants should have known their products posed an unreasonable danger or a foreseeable risk of harm.”  Id. at *10.  That combined with the FDA’s 2017 conclusion that GBCAs are not unreasonably dangerous, led the court to discount plaintiff’s unsupported allegations to the contrary.  Id.

Finally, the court tossed out plaintiff’s punitive damages claim as barred by Arizona’s statute that provides that a prescription drug manufacturer is not liable for punitive damages if the drug was manufactured and labeled in accordance with its FDA approval.  Id.  Because plaintiff did not plead that defendants were not in compliance with their FDA approvals, plaintiff could not bring a punitive damages claim.

The court ended its decision with some guidance to plaintiff should she decide to amend her complaint again.  But, even the court thought her chances were “slim” and admonished plaintiff to re-plead only if she had additional factual support for at least one claim.  Id. at *11.  Since we believe a lack of evidence of causation will sink any claim attempted, we think this one is likely over despite the door being left slightly ajar.

We would be remiss (and out of character) if we plunged into a discussion of today’s case without a shout-out to “Siba,” the gorgeous black Standard Poodle who won Best in Show at last week’s Westminster Kennel Club Dog Show. Regular readers of this blog may recall that we attend Westminster every year and that Standard Poodles are the breed of our heart.  A Standard Poodle has not won the gold and purple rosette in three decades, since a glorious Standard known as Champion Whisperwind On A Carousel — “Peter” for short — won the top prize. We were thrilled, of course, but we admit that the final seven included several other dogs who also grabbed our heart. So this was pretty close to a “no lose” scenario for us.

Unlike today’s case, Gross v. Coloplast Corp., et al., 2020 WL 264691 (E.D. Pa. Jan. 17, 2020) which most emphatically is a loss for drug and device jurisprudence and for common sense. Recall that our eighth worst case of 2019 was Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), in which the United States District Court for the Western District of Pennsylvania “predicted” that the Pennsylvania Supreme Court would allow strict liability design defect and warnings claims in cases involving prescription medical devices. In other words, the court predicted that the Pennsylvania Supreme Court would exclude prescription medical devices from the “unavoidably unsafe products” exception established by comment k to Section 402A to the Restatement (Second) of Torts.  Here, you can read Bexis’s excoriation of the Schrecengost decision, explaining that there is nothing to “predict” – that decades of Pennsylvania appellate decisions hold, unanimously, that comment k bars strict liability claims against manufacturers of all prescription medical products, including drugs, devices, and vaccines. By holding otherwise, the court disregarded the limits on federal courts’ power to “predict” novel expansions of state-law liability in diversity cases.

And the bad news keeps coming.  In Gross, the United States District Court for the Eastern District of Pennsylvania falls in line with its western counterpart, denying a medical device manufacturer’s motion to dismiss the plaintiffs’ strict liability claims. The court starts from the correct premise: that, beginning with the Pennsylvania Supreme Court’s adoption of comment k in its 1996 decision in Hahn v. Richter, prescription drugs “indisputably” have been “exempt from strict liability under Pennsylvania law.” Gross, 2020 WL 264691 at *3.   But then the decision goes off the rails. Citing Tincher, the court asserts that the Pennsylvania Supreme Court has “strongly discouraged courts from carving out certain products for special treatment within the common law of product liability” and, specifically, has “cautioned Pennsylvania courts against thoughtlessly extending Hahn and comment k.” Id. at *4. The court goes on to state that the Pennsylvania Supreme Court commented in Lance that Hahn’s analysis “offers a poor foundation for extrapolation.” Id. The court concludes that it should not “mak[e] categorical carveouts from the presumption of strict liability” without a “rich factual record on the [relevant] policy issues,” so the “better result” is to deny the defendant’s motion at the 12(b)(6) stage. Id.

But here’s the fallacy: applying comment k to prescription medical devices does not require additional “carveouts,” or “extrapolation”, or “extension of Hahn and comment k,” because there is no principled basis for a distinction between prescription drugs and prescription medical devices. To the contrary, as Pennsylvania’s appellate courts have long acknowledged, all of the policy reasons why prescription drugs are “unavoidably unsafe products” under comment k apply with identical force to prescription medical devices.

The Cross court implies that the strict liability claims may fail at the summary judgment stage, once the factual record has been developed. But these claims should never get that far. As a matter of long-established Pennsylvania law, the claims should not have survived a motion to dismiss. Cross is an early contender to follow its Western District cousin onto our Worst Cases list. We will keep you posted, both on similar dismal decisions and on decisions reaching the correct result that eluded the Cross court.

Don’t stop us if you’ve heard this before, because you have. A plaintiff brings an lawsuit over injuries allegedly from a medical device, sues not only the company that made and marketed the device but also a parent company that did not make or market the device, said parent moves for dismissal for want of personal jurisdiction, and the court grants the motion. That is what happened in Marcovecchio v. Wright Med. Grp., 2019 U.S. Dist. LEXIS 54414 (D. Utah, March 28, 2019). You might wonder whether there is anything to learn from this case, except that some plaintiff lawyers never learn. So at least learn this: when you consider your response to a complaint, don’t assume that the complaint was drafted with any degree of respect for even the most fundamental precedents. Consider a wide variety of motions, including jurisdictional ones. File the ones that look strong, make the other side do some work, and maybe the court will cut back the case to something coherent and manageable.

The plaintiff in Marcovecchio was a Utah resident who brought a lawsuit in Utah alleging personal injuries arising out of a hip replacement system. There were causes of action for strict products liability, negligence, breach of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and punitive damages. The plaintiff sued both the company that manufactured, marketed, and sold the hip system throughout the United States, including in Utah, as well as the parent company, which acted as a parent and holding company for various entities. Neither company was incorporated in or “at home” in Utah.

Utah is a lovely place, but the parent company wanted out. It supplied an affidavit establishing that the parent holding company and the manufacturing company were separate entities with separate accounting and banking records. The parent company had no contacts with Utah and did not manufacture, market, or sell the hip system. Rather, the parent was simply the sole shareholder of the manufacturer. It did not even have any employees. For these reasons, the parent had a strong argument that the court lacked personal jurisdiction over it.

The plaintiff went to the plaintiff playbook and responded with excerpts from the parent’s public SEC filings and press releases in which the parent, according to the plaintiff, publicly identified itself as a company that “specializes in the design, manufacture and marketing of reconstructive joint devices” and claimed the hip replacement products “as its own.” For example, in its 2001 10-K filing, the parent described itself as “a global orthopedic device company specializing in the design, manufacture and marketing of reconstructive joint devices …” that “offers a comprehensive line of products for hip joint reconstruction[.]”

Believe it or not, other plaintiffs have made this exact same argument before against this exact same parent company, citing the exact same documents in support of personal jurisdiction. And it never works. The Marcovecchio court held that these statement are insufficient to establish the parent’s role in the design of the hip system. The filings were outdated and the plaintiff cherry-picked phrases out of them to support his position. Plus, annual reports typically involves this sort of bloviation in characterizing the business of a parent and its subsidiaries. [Note to our transactional colleagues: couldn’t more precise draftsmanship avoid this issue completely?]. Even if the filings are not perfectly clear about separating the roles of parents and subsidiaries, the Marcovecchio court was clear that the filings were not necessarily discussing the activities of the parent as opposed to the subsidiary. Any pufferies in the filings certainly were not enough to contradict the parent’s sworn testimony.

We’re not done. There is a part two to the plaintiff’s jurisdictional playbook, just as ineffective as part one. The plaintiff in Marcovecchio argued that the subsidiary’s contacts with Utah (which were undisputed) could be imputed to the parent. Uh, no. A parent corporation is not subject to personal jurisdiction in a forum solely based on the subsidiary‘s contracts with the forum absent an allegation that either 1) the subsidiary was an agent of the parent, or 2) that the two companies are so intertwined as to be the other’s alter ego. Here, the plaintiff’s conclusory statement that each of the defendants was the “representative, agent … or alter ego of … the other” was not sufficient to establish personal jurisdiction under either an agency theory or an alter ego theory. Farewell, dear parent.

The manufacturing company was stuck in the lawsuit, but it also had a few beefs with the complaint. For example, the manufacturing defect claim contained nothing but conclusory statements. The plaintiff alleged that the hip system had “a tendency to (a) detach, disconnect and/or loosen from a Patient’s acetabulum, (b) generate dangerous and harmful metal debris …; (c) cause pain, (d) inhibit mobility; and (e) require revision surgery.” As the court pointed out, these allegations all identify harms caused by the hip system, not the actual manufacturing flaw that caused the harm. The court put it nicely: “Plaintiff alleges that because he was injured, there had to be a flaw.“ Because the plaintiff never identified the actual flaw in the manufacturing process that caused the hip system to differ from the design, he had failed to state a claim for manufacturing defect.

The plaintiff also failed to state a claim for failure to recall. The Marcovecchio court refused to entertain such a claim unless “(1) a governmental directive issued pursuant to a statute or administrative regulation specifically requires the seller or distributor to recall the product; or (2) the seller or distributor, in the absence of a recall requirement … undertakes to recall the product, and the seller or distributor fails to act as a reasonable person in recalling the product.” The complaint satisfied neither requirement. Instead, the plaintiff alleged only that the defendant failed to recall the product, which is insufficient to state a claim. (Over a decade ago, we wrote about a similar recall issue with a similar analysis here.)

The claim for breach of express warranty was also hobbled by bare-bones pleadings. Reliance is necessary to establish a cause of action for express warranty, and the plaintiff needed to allege that the product descriptions were communicated to him or his doctor and became the basis of the bargain. The plaintiff generally alleged that “express representations” were made “to healthcare providers and patients, including Plaintiff and Plaintiff’s healthcare providers,” but the plaintiff failed to allege how those warranties became a basis of the bargain. The court tossed the claim because “[m]ere recitations that Plaintiff relied are not enough to state a claim for breach of express warranty.”

Finally, there was the suite of deceit claims: fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. The complaint referenced misrepresentations “to the medical community and the general public,” and also referenced misrepresentations in the 510(k) application submitted to the FDA. That last bit implicates Buckman preemption. The Marcovecchio court dodged the preemption issue by bouncing the active misrepresentation claims for failure to plead either the allegedly fraudulent statements or the plaintiff’s reliance with the requisite specificity. The concealment claim was allowed to stand (courts are a little too lenient on such claims), but there was a lot less left to the case than existed before the defendants filed their motions.