When we last left our story, plaintiffs had lost their fight to have Pennsylvania law apply to residents of Texas ( Atkinson I) and lost a chunk of their claims as barred by the Texas statute prohibiting failure to warn claims where a drug’s label has been approved by FDA and comment k ( Atkinson II).  But the court left the door open for a third installment when it ruled that while plaintiffs had failed to adequately plead their negligent failure to test claims, they would get a chance to amend.  Spoiler alert – we’re skipping to the end.  In Atkinson III, the court found plaintiffs’ negligent failure to test claim as amended survived TwIqbal satisfying the standards for pleading both negligence and gross negligence.  Atkinson v. Luitpold, 2020 WL 4518022 (E.D. Pa. Aug. 6, 2020).  That’s a horrible ending.  We’ve all read books we’ve loved right up until the end (for this blogger it’s Tara French’s In the Woods and Alice’s Adventures in Wonderland (that ending only worked for Bob Newhart).  But the ending of Atkinson III isn’t really what rankles us – it’s the story itself.  The ending is only bad because it’s based on a botched premise from the start – that Texas recognizes an independent claim for failure to test.

It’s this bungled conclusion that led to plaintiffs being given the opportunity to re-plead the claim in the first place.  That’s Atkinson II, 2020 WL 1330705 (E.D. Pa. Mar. 23, 2020)), which had many more positives than negatives so we didn’t really focus on the court’s faux pas on failure to test.  But now that the claim has survived round three, we thought it time to elaborate.

To do so, we have to step back to Atkinson II for just a moment.  The court’s ruling that Texas allows an independent duty to test, when no warning or design claims exist, is inexplicable because the court cites American Tobacco Co. v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997) as supporting such an independent duty when in fact the Texas Supreme Court held, “the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim” and affirmed summary judgment for the same reason as warnings.  See Atkinson II, 2020 WL 1330705, at *9.

In both Atkinson II and Atkinson III, the court also relies on Romero v. Wyeth LLC, 2012 WL 12547105, at *4 (E.D. Tex. May 30, 2012).  Romero does not address a duty to test as an independent claim at all.  In fact, the only mention of testing comes in the court’s analysis of plaintiff’s failure to warn claim which it dismisses.  Atkinson III conveniently leaves out the first part of the quote it relies on.  The full text reads:

Moreover, a manufacturer also has a duty to instruct its users on the safe use of its product, which means that it must “not only keep abreast of scientific knowledge, discoveries, and advances, but, more importantly, test and inspect its product.

Romero, at *4 (emphasis added).  The court was talking about a duty to warn not a duty to test.

The last case relied on by Atkinson III is Bates v. Dow Agrosciences LLC, 544 U.S. 431, 444 (2005).  But once again, a closer look belies the court’s interpretation of this case.  The question before the Supreme Court in Bates was whether certain claims were preempted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Notably, at the start of the Court’s analysis it states that “[t]he briefing and the record leave some confusion as to what precise claims are at issue.”  544 U.S. at 443n.15.  Therefore, the determined that it would decide if the following claims were preempted:  “breach of express warranty, fraud, violation of the Texas DTPA, strict liability (including defective design and defective manufacture), and negligent testing. We will also address negligent failure to warn, since the Court of Appeals read petitioners’ allegations to support such a claim.”  Id.  This was further explained by Justice Thomas, concurring in part and dissenting in part:  “petitioners have not advanced an actual failure-to-warn claim. Instead, the Court of Appeals treated petitioners’ claims for negligent testing and defective design and manufacture as “disguised claim[s] for failure to warn.”  Id. at 457.  Given the less than clear set of claims under review, it is hard to read this as a ringing endorsement of an independent duty to test under Texas law.

Indeed, the Court of Appeals decision in Bates is further support for a duty to test being subsumed under a duty to warn.  “[A] negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.”  Dow Agrosciences LLC v. Bates, 332 F.3d 323, 333 (5th Cir. June 11, 2003), reversed on other grounds, 544 U.S. 431 (2005).  Fifth Circuit precedent on the issue both pre- and post-dates Grinnell.  See Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 n.5 (5th Cir. Feb. 3, 1992) (plaintiff’s “negligence claims, such as the alleged failure to adequately test [the product], are subsumed within” a failure to warn claim);  Morris v. PLIVA, Inc., 713 F.3d 774, 778 (5th Cir. 2013) (noting that any “useful reporting” resulting from adequate testing would “ostensibly consist of some sort of warning”).  Morris sums up negligent failure to test claims as “yet another attempt to circumvent disfavored failure-to-warn claims.”  Id.

 So how did the Atkinson court wind up turning Texas law on its end?  We simply don’t know.  We aren’t going to even hazard a guess.  We’re putting this down as an outlier decision that simply got it wrong.  If this were a book review it would read – predictable bad ending built off an under developed story line brimming with plot flubs that are simply unbelievable.

Every now and then something happens that’s unique.  It’s hardly unique for defense counsel to send us a case, with his/her client’s consent and invite us to blog about it – but only once in twelve years has that happened where the result was a loss.  That decision was Mantgem v. Spinal Kinetics, No. 19CV350146, slip op. (Cal. Super. June, 11 2020), and it certainly involved unusual facts and procedure.  Unusual facts:  The plaintiff, a resident of California, was a medical tourist.  She “traveled to Germany to undergo” surgery with a medical device that had not yet been approved in the United States.  Slip. op. at 1.  According to the complaint she received informed consent in Germany.  Id.

Since it’s a product liability case, there are, of course, allegations that the surgery failed, the product was defective, etc.  Id.  Since the defendant device manufacturer happened also to have its principal place of business in California, suit was filed in that state’s court.

The unusual procedure was the defendant filing a motion to dismiss for forum non conveniens, which would have required plaintiff to refile in Germany, since plaintiff voluntarily went to Germany for the surgery and implant at issue.  Id., slip op. at 2.  Although there were good grounds for so proceeding – Germany was a proper and available forum, much of the relevant evidence was there, and the device was only approved for use in Germany by German regulators – that proved to be too heavy a lift for the court.  After all, how often has forum non conveniens been invoked where both the plaintiff and the defendant are resident in the jurisdiction where suit was filed, regardless of any other facts?  Cf. Kleiner v. Spinal Kinetics, Inc., 2016 WL 1565544, at *7 (N.D. Cal. April 19, 2016) (granting forum non conveniens dismissal in case involving same product – but where the plaintiffs were Germans who had surgery in Germany).  We do not know of any successful forum non conveniens dismissals where both plaintiff and defendant were residents of the forum.  This is not to say that it shouldn’t be done in cases like Mantgem, but courts are not likely to be sympathetic.

In Mantgem the court hinged most of its reasoning on plaintiff’s assertion that 41 (or 38, or 35, take your pick) different California physicians had treated her claimed injuries.  Slip op. at 4-5.  But what caught our eye was the very last reason asserted by the court:

Neither party applies a full three-part government interest test to determine the choice of law that would be applied in this case. . . .  Assuming the first two factors apply, given the above analysis, California still holds a stronger interest in applying its law, and would be more impaired if German law was applied.

Slip op. at 5.  But in the very next paragraph, Mantgem states, “This Court takes no position as to the applicable choice of law for the trial of this matter.”  Id.

Mantgem’s choice of law finding, if that is what is, struck us as bizarre.  Our gut reaction is that where medical treatment is at issue, the governing law is that of the jurisdiction in which that treatment occurred.  But having never addressed that question before in any depth, we decided to take a closer look.

Our reaction was driven by case law in the Third and DC Circuits, where most of our bloggers practice.  Third Circuit law was established in Blakesley v. Wolford, 789 F.2d 236 (3d Cir. 1986), holding that a malpractice lawsuit by a Pennsylvania resident plaintiff, who went to Texas for surgery, would be governed by Texas law.  Blakesley held that, where claims arise from medical treatment, the place of injury is where the treatment took place, not where its eventual “effects” are “felt.  “Clearly, the place where the injury occurred, that is, the place where the operation which injured [plaintiff] took place.”  Id. at 243.  To hold otherwise is to give “double weight” to the plaintiff’s domicile, since “the effects of an injury necessarily follow a plaintiff to his or her state of residence.”  Perhaps even more important, since the plaintiff “voluntarily and intentionally went to” another state for medical treatment, doctors in that state “w[ere] fully entitled to rely on [their] home state’s law” in performing such treatment.  Id. at 243.  “[I]t is only fair that the law of the state to which the patient has voluntarily traveled, and in which the doctor has chosen to conduct the operation, be applied to adjudicate the respective rights, duties, and obligations between the parties.”  Id.

Warriner v. Stanton, 475 F.3d 497 (3d Cir. 2007), followed Blakesley in applying the law of the state of treatment rather than the law of the plaintiff’s domicile because as in Blakesley, the plaintiffs “intentionally initiated” the treatment in a different state from where they lived.  Id. at 503.  “In the context of a doctor-patient lawsuit . . ., “it is only fair that the law of the state to which the patient has voluntarily traveled.”  Id. at 504 (quoting Blakesley). The court appended additional practical reasons to the Blakesley analysis.

[A]lthough [plaintiff] was a resident of New Jersey at the time of the alleged malpractice, citizens do not carry their home state’s laws with them wherever they go.  Indeed, . . . by entering the state the visitor has exposed himself to the risks of the territory and should not expect to subject persons living there to a financial hazard that their law had not created.

Id. (citations and quotation marks omitted).  Accord Grossbaum v. Genesis Genetics Institute, LLC, 489 F. Appx. 613, 616 (3d Cir. 2012) (proper to apply law of state where “[a]lmost all of the relevant [medical] events occurred”); Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 517, 526-27 (E.D. Pa. 2009) (“Plaintiff intentionally travelled from New Jersey to Delaware to receive treatment” so Delaware law applied; “Delaware also has an interest maintaining the predictability of its regulations so that health care professionals practicing within its borders know what standards govern their conduct.”), aff’d, 393 F. Appx. 884 (3d Cir. 2010); Capone v. Nadig, 963 F. Supp. 409, 414 (D.N.J. 1997) (applying Blakesley and the law of the place where plaintiff “voluntarily sought the medical care”).

The District of Columbia’s small size and differing tort law, has led to a string of decisions involving medical treatments taking place in Virginia (which has various restrictions) or Maryland (which has a malpractice cap).  In Bledsoe v. Crowley, 849 F.2d 639 (D.C. Cir. 1988), a D.C. plaintiff treated in Maryland tried the same “injury occurred” argument that had failed in Blakesley with no greater luck.  “[Plaintiff’s] attempt to separate the place where the injury occurred from the place where the negligence took place makes no sense.”  Id. at 642.

[A] Maryland court would, we believe, apply the general principle that the applicable law is that of the place where the “wrong” occurred.  If [plaintiff] was wronged anywhere, it was certainly in Maryland.

Id. (footnote omitted).  “Where the entire relationship between the parties was centered in Maryland and the allegedly tortious conduct occurred in that state, Maryland’s interest in regulating the activity must be deemed the stronger one.”  Id. at 642-42

Groover, Christie & Merritt, P.C. v. Burke, 917 A.2d 111 (D.C. 2007), applied Bledsoe to malpractice allegedly committed by a Maryland doctor in Maryland, despite the injury (a stroke) happening in DC.  “[T]he parties’ relationship was “centered” in Maryland − that is where [plaintiff] consulted with [defendant] and where each of her MRI scans was conducted.”  Id. at 1117.  That logic was applied in a device implant case in Hartley v. Dombrowski, 744 F. Supp.2d 328 (D.D.C. 2010).  Surgery and an allegedly negligent discharge occurred in one jurisdiction, and an allegedly negligent prescription of drugs occurred in another.  In each instance that law of the location of the challenged medical treatment applied.  Id. at 338-39.  See Bederson v. United States, 756 F. Supp.2d 38, 52-53 (D.D.C. 2010) (same as Hartley; law of place where alleged malpractice occurred applied, requiring application of different laws to different claims); Paxton v. Washington Hospital Center Corp., 991 F. Supp.2d 29, 34 (D.D.C. 2013) (the “the hospital-patient relationship was centered here” and “the conduct that allegedly caused the injury − the surgery − also occurred here,” thus forum law properly applied); Kaiser-Georgetown Community Health Plan, Inc., 689 F. Supp. 9, 13 n.2 (D.D.C. 1988) (malpractice in Maryland location not “fortuitous” because since plaintiff’s insurer “designated” use of that hospital).

However, an arguably contrary result was reached in Raflo v. United States, 157 F. Supp.2d 1 (D.D.C. 2001), a failure-to-diagnose case.  The court held that “the actionable injury is the condition caused by improper treatment rendered because of the misdiagnosis,” which had occurred elsewhere than the original failure.  The court applied the law of the state where the allegedly unnecessary additional medical treatment occurred.  Id. at 11.

Most other decisions reach the same choice of law result as in Blakesley and Bledsoe.  Huss v. Gayden, 571 F.3d 442 (5th Cir. 2009), is particularly interesting, from our drug/device-oriented point of view, since the alleged malpractice was the prescription of certain drugs.  The court followed Bledsoe and held that the “center of gravity” was the state where the alleged misprescription occurred.  Id. at 450-51.  Another appellate decision, Farwell v. Un, 902 F.2d 282, 287 (4th Cir. 1990), used a “‘place-of-wrong’s-standard-of-care’ exception to the classic lex loci rule,” so that the law of the state where the allegedly negligent medical treatment applied.

In Fields v. Legacy Health Systems, 413 F.3d 943 (9th Cir. 2005), the plaintiff moved from one state to another after receiving the allegedly negligent medical treatment.  That did not allow plaintiff to rely on the statute of limitations of his new domicile.  “Here, Oregon has the most significant contacts. The injury in this case was [the decedent’s] misdiagnosis and inability to seek treatment, not her resulting death.”  Id. at 952.  In addition:

Oregon has the ability to regulate the medical industry in the state.  It also has an interest in protecting its medical providers from stale claims and the excessive financial burdens of litigating wrongful death claims.  We hold that Oregon’s statutes . . . apply to [plaintiff’s] claim whether brought in Oregon or Washington.

Id. at 953 (citation omitted).

Our appellate roundup also includes a state supreme court decision, Grover v. Isom, 53 P.3d 821 (Idaho 2002), which relied upon the same interest analysis as the federal courts we have cited:

[I]t is clear that Oregon has an interest in making certain that oral surgeons practicing in Oregon are subject to Oregon laws and the Oregon standard of care.  The defendants would justifiably expect to be governed by Oregon law, since they were licensed in Oregon and in this case conducted their business in Oregon. . . .  As a general rule, a victim should recover under the system in place where the injury occurred.  Predictability and ease in determining and applying law are also better served by applying Oregon law, because it is a simple policy that the place of the injury should generally govern the choice of law.

Id. at 824.

Once again, however, we found a dissenting voice.  In Kuehn v. Childrens Hospital, 119 F.3d 1296 (7th Cir. 1997).  In order to apply the law of the plaintiff’s residence, rather than the law of the place of surgery, Kuehn did three things differently.  First, Kuehn discounted “predictability,” finding it to be lex loci in disguise.  Id. at 1301.  Second, it redefined “injury” so that it occurred when the plaintiff “received” an allegedly botched bone marrow extraction, rather than when the claimed negligence occurred.  Id.  Third, it held (uniquely, we believe) that because the parties had a “written contract” (the case involved “experimental” treatment), if the medical defendants wanted the law of their state to apply, they should have imposed a “contractual choice of law provision.”  Id. at 1302.  It is no surprise that this singular reasoning came from Judge Posner.

We also uncovered a bunch of federal district court opinions from every circuit making choice of law decisions in medical malpractice cases involving non-forum medical treatment.  Because it also involved product liability claims, Bush v. Thoratec Corp., 13 F. Supp.3d 554 (E.D. La. 2014), aff’d, 802 F.3d 680 (5th Cir. 2015), was also particularly interesting to us.  Plaintiff’s decedent, a Louisiana resident, was transferred to a Virginia hospital for treatment, which included implantation of a medical device.  Id. at 561.  He returned home and later died, allegedly from problems with the device, which was the subject of a Dear Doctor letter.  The Virginia treaters’ response to the letter was a major issue in the suit.  Id. at 565.  On choice of law, the Louisiana court applied Virginia law:

Here, it is apparent that the allegedly negligent acts or omissions occurred in Virginia.  [The] device was implanted in Virginia and much of [decedent’s] recovery occurred in Virginia.  [Defendant treater] received the correction letter and signed the acknowledgment in Virginia, and [they] allegedly failed to inform [decedent] of the new information contained in the correction letter during his recovery in Virginia. . . .  [T]he acts or omissions here took place in Virginia, and accordingly, the substantive law of Virginia is applicable.

Id. at 568-69.

In Alvarado v. Caesar, 2012 WL 6589184 (D. Mass. Dec. 17, 2012), the same practical concerns − about states’ need to regulate the provision of health care within their boundaries, and health care providers knowing what the rules were – were at the fore:

Rhode Island has a more significant relationship to the case.  It is undisputed that defendant’s allegedly negligent conduct (during and immediately after [plaintiff’s] surgery) occurred entirely in Rhode Island.  Both, patients and health care providers, could reasonably expect that a Rhode Island-licensed physician performing surgery in a Rhode Island hospital would be governed by Rhode Island law. . . .  Rhode Island has a strong and significant interest in seeing that medical providers operating within its borders conform their practices to the laws and standards of that state.

Id. at *2.  See also Engle v. Uhaul, 2016 WL 740327, at *3 (S.D. Ohio Feb. 25, 2016) (“Because [plaintiff’s] claim is based upon treatment he received in Indiana, the undersigned . . . finds Indiana law applicable to [plaintiff’s] malpractice claim”); McKinley v. United States, 2015 WL 5842626, at *6 (M.D. Ga. Oct. 6, 2015) (“Plaintiff’s wrongful death claim is governed by the substantive law of Tennessee because that is where Defendant’s negligence first took effect on Plaintiff.”); Moore v. Central Carolina Surgical Eye Associates, P.A., 2013 WL 1123850, at *4 n.5 (W.D. Va. March 15, 2013) (law of place where “[p]laintiff’s surgery − the basis for her claim and the subsequent treatments – occurred” applies); Bramberger v. Toledo Hospital, 897 F. Supp.2d 587, 598 (N.D. Ohio 2012) (“Ohio’s interest is greater than that of Michigan.  Again, [plaintiff] traveled to Ohio to seek medical care . . ., and these Defendants provided that care to [plaintiff] in Ohio.”); Lewis v. Waletzky, 576 F. Supp.2d 732, 736-37 (D. Md. 2008) (law of place of prescription applies in negligent prescription case due to “strong public interest” in regulating malpractice within state’s borders; following Bledsoe), aff’d, 475 F. Appx. 906 (4th Cir. 2012); Silong v. United States, 2006 WL 948048, at *4 (M.D. Fla. Apr. 12, 2006) (“it seems likely that California law will govern this case because the alleged medical malpractice occurred in California”); Lopez v. United States, 2005 WL 2076593, at *13 (E.D.N.Y. Aug. 26, 2005) (applying law of the place where the claimed malpractice occurred in federal prisoner suit); Stephens v. Norwalk Hospital, 162 F. Supp.2d 36, 43-44 (D. Conn. 2001) (law of place of alleged malpractice applies; “Connecticut has a strong interest in regulating medical practice within its state”); Zimbauer v. Milwaukee Orthopaedic Group, Ltd., 920 F. Supp. 959, 963 (E.D. Wis. 1996) (“plaintiff, while an Illinois resident, sought treatment and was treated in Wisconsin.  Thus, the underlying facts giving rise to the litigation occurred in Wisconsin. . . .  Wisconsin law applies.”); Donnelly v. McLellan, 889 F. Supp. 136, 139 (D. Vt. 1995) (“the only treatment that [defendant] provided to [plaintiff] occurred . . . [in] New York.  Because New York is the site of the alleged tort, New York law . . . must be applied”); Castelli v. Steele, 700 F. Supp. 449, 454-55 (S.D. Ind. 1988) (“[E]ach act of negligence complained of occurred in Indiana.  This is probably the most important factor because Indiana doctors are strictly regulated by the state of Indiana and must conform their practices to the laws of this state. . . .  The doctor-patient relationship was initiated in Indiana, and all of the diagnosis and treatment was rendered in Indiana.  The mere fact that plaintiff resided in Illinois and might well have developed her injuries there does not outweigh the more significant Indiana contacts.”); Truck Insurance Exchange v. Tetzlaff, 683 F. Supp. 223, 2256 (D. Nev. 1988) (“The treatment occurred in Nevada. . . .  The place of the wrong in this case is Nevada, and, therefore . . . Nevada substantive law applies.”).

Again, we also found a case going the other way.  In Scadden v. Northwest Iowa Hosp. Corp., 2010 WL 3805638 (N.D. Iowa Sept. 22, 2010), the court distinguished Blakesley and applied the law of the plaintiff’s domicile, rather than where the alleged malpractice occurred.  Id. at *4.  Unlike Blakesley, “the negligence alleged was not from an affirmative act.”  Instead, “the defendants allegedly were negligent in not hospitalizing the plaintiff, but in sending her home to Nebraska.  Even though the alleged malpractice occurred in Iowa, it is not clear that the the injury occurred in Iowa.”  Id. (quotation marks omitted).

In any event, to answer that choice of law issue alluded to, but not decided in Mantgem, where a major issue involves an assessment of the medical care provided to the plaintiff, a large majority of cases opt to apply the law of the jurisdiction in which that medical care occurred – regardless of the manner in which they analyze choice of law (lex loci or some Restatement variant).  Since the plaintiff in Mantgem sought out surgery in Germany and voluntarily traveled there, the majority rule would apply German law.

One final note.  The cases establishing the majority rule that the law of the place of medical treatment controls in cases concerning liability for that treatment have always involved the plaintiff’s physical presence in that jurisdiction to receive that treatment.  That fact pattern can no longer be assumed.  With the rise of telemedicine – particularly in the wake of the COVID-19 pandemic – the previously simple question of where treatment actually occurred becomes murky.  Our research did not run across a telemedicine malpractice case (a quick search turned up none, outside of pro se prisoner cases), but they will inevitably occur.  We make no predictions how telemedicine will affect choice of law in medical malpractice and similar cases.

This post is a little different.  Several of my colleagues – Reed Smith attorneys Robert J. Hill, Joseph W. Metro, Kevin M. Madagan, Andrew Y. Lu, Sung W. Park, Janine R. Tougas – wrote a client alert on the four recent executive orders that concerned pharmaceutical pricing.  We had thought about doing that ourselves, but it was too far from our product liability sweet spot.  When we read this alert, though, we understood (well, about as well as anyone can understand this mess).  So, even though we don’t ordinarily link to branded law firm posts, in this one instance we’re making an exception.  We think our readers will find the content of this alert useful, and it’s better than anything we could have put together ourselves.  So, please take a minute to read their assessment.

As consumers, and connoisseurs, of personal jurisdiction precedent, we were interested in the latest turn in Thalidomide-related litigation in Pennsylvania.  You can see our prior posts about the former – and extremely time barred – personal injury litigation, here and here.  The personal jurisdiction angle was mentioned more recently in a 360 (that is, paywalled) story here entitled “Hagens Berman Wants Thalidomide Client’s Suit Out Of Pa.”  The article discusses a legal malpractice suit filed in the Eastern District of Pennsylvania.  Because the plaintiff is from Minnesota, and the defendant law firm is based in Washington State, the defendant claims there is no personal jurisdiction.  However, the law firm defendant made the decision to file the now-dismissed lawsuit that underlies the current malpractice action in Pennsylvania.

Having read more personal jurisdiction cases over the six years since Daimler AG v. Bauman, 571 U.S. 117 (2014), than we care to count, our gut reaction was that the “arising out of”/”related to” test for specific jurisdiction (for more about that, see here and here, among many others) would be satisfied by the presence of the underlying lawsuit in the jurisdiction where a subsequent legal malpractice action was filed.  Indeed, it’s hard to describe this set of facts without using the phrase “arising out of.”

So we decided to take a look.  A Westlaw search of federal cases for “legal malpractice” /p “personal jurisdiction” pulled up 152 cases.  That seemed a little excessive for this exercise, so we limited it with “specific /s jurisdiction”.

That didn’t take long.  The second case we looked at answered the question quite thoroughly:

Case law throughout the country supports this conclusion.  To support their respective positions, both parties cite to a number of cases (often the same ones) involving out-of-forum attorneys being sued for malpractice who allege lack of personal jurisdiction in the forum.  Though personal jurisdiction is a fact-specific inquiry, and no two cases are identical, a thorough reading of all these cases reveals a common theme: where the legal malpractice claim is filed in the same forum as the original action serving as the predicate for the legal malpractice (or where it would have been filed), jurisdiction is found. . . .

Dennett v. Archuleta, 915 F. Supp.2d 248, 253-54 (D.R.I. 2013) (citations to nine cases omitted) (emphasis added).  That’s the answer.

Plaintiffs often prefer to be in state court, and when we first started doing a lot of product liability litigation way back when, we were struck by how much time and effort plaintiffs spent trying to evade federal jurisdiction and litigating motions to remand to state court.  We don’t wonder so much anymore.  Jaded, we guess.  We cannot, however, help but monitor the cases and find ourselves drawn to cases involving fraudulent joinder of non-diverse defendants.  You know the drill:  The plaintiff sues an out-of-state drug or medical device company in state court and, in order to avoid complete diversity of citizenship, the plaintiff also sues some local defendant.  A local doctor, local hospital, local distributor, whatever.  Sometimes it works and plaintiffs stay in state court; and sometimes it does not.

One group of local defendants for which this tactic should rarely work is sales representatives, and a recent order in Illinois explains why.  In Elrod v. Bayer Corp., No. 19-cv-06048, 2020 WL 4284416 (N.D. Ill. July 27, 2020), the Illinois plaintiff sued a number of medical device-related entities from other locales, and to avoid removal to federal court, she also sued an Illinois sales representative.  Id. at *1.

Let’s pause here.  What liability could a sales representative possibly bear to a medical device patient?  Claims in connection with the sale of the device would be against the manufacturer, so it should not be an option merely to add the sales representative’s name to the complaint.  There should have to be a separate breach of duty attributable directly to the sales representative.  If not, then no dice.

That is essentially what the district court ruled in Elrod v. Bayer.  The defendants removed the case to federal court, and when the plaintiff moved to remand, the defendants argued that the local sales representative’s Illinois citizenship should be disregarded because she was fraudulently joined.

In the Seventh Circuit, “[t]o establish fraudulent joinder, a removing defendant must show that, after resolving all issues of fact and law in favor of the plaintiff, the plaintiff cannot establish a cause of action against the in-state defendant.”  Id. at *2 (citations omitted).  The standard is whether “the plaintiff has any reasonable possibility of success” under the applicable state law.  Id.

The plaintiff argued there was a “reasonable possibility” that an Illinois court would hold the sales representative liable for negligent misrepresentation.  But the district court rejected that argument because the sales representative owed the plaintiff no duty:

Illinois courts have rejected the notion that agents of a company “have to independently substantiate their employer’s representations absent any facts the representations were untrue.” . . .  [Thus,] no legal duty imposing liability can be placed on the [device manufacturer’s] sales representative(s) without any factual findings suggesting that sales representative(s) were knowingly marketing a product with knowledge that the information on the sales brochures was inaccurate.

Id. at *4 (citations omitted).  This is what we were getting at before.  Representing the manufacturer and acting as its agent is not alone sufficient to establish potential liability.  There has to be something more, something specific to the sales representative giving rise to a legal duty.

It therefore was not “reasonably possible” for the Elrod plaintiff to succeed against the sales representative under Illinois law because the sales representative owed no duty.  The plaintiff had alleged that the sales representative “knew or had reason to know” that informational brochures and other statements about the device were false or misleading.  But those conclusory allegations “failed to allege any facts suggesting that the [sales representative] knew or should have known anything about the truth or falsity of [the manufacturer’s] statements.”  Id.

Moreover, although the failure to allege facts (as opposed to legal conclusions) in the complaint would have been enough to establish that the sales representative was fraudulently joined, the manufacturer took the additional measure of submitting a declaration from the sales representative.  In the declaration, the representative “specifically states that she lacked any knowledge about the truth or falsity of the statements, and even lacked the education level to test the veracity of [the manufacturer’s] statements.”  Id. at *5.

Ruling that “an uncontested affidavit of a nondiverse defendant is a sufficient basis to find fraudulent joinder,” the district court easily found that the defendant had demonstrated that the sales representative was fraudulently joined.  Id. at *5 & n.2.  As we said, sometimes plaintiffs succeed in evading removal jurisdiction, and sometimes they do not.  In this case, the plaintiff’s addition of the sales representative to the complaint was for naught.  The case remains properly in federal court.

Any lawyer practicing for more than five minutes has heard of the lawsuit called Jarndyce and Jarndyce. Charles Dickens constructed his great (in size and merit) novel Bleak House around the fictitious case, which drew together the fates of a large cast of characters. Jarndyce and Jarndyce concerned the interpretation of a will, occupied the dreaded Chancery Court for decades and generations, and culminated in an estate thoroughly depleted by legal fees. Nobody won but the lawyers.

Many critics consider Bleak House to be Dickens’s masterpiece. A reason commonly cited for this high estimation is the book’s masterly critique of England’s legal system. While we prefer Great Expectations – the protagonist in Bleak House is perfectly virtuous and perfectly dull – we are glad to have read the 990 pages of Bleak House in this Covid summer. As with all of Dickens’s oeuvre, the dramatis personae in Bleak House leap off the page with humanity and eccentricity. Dickens creates characters who enter our lives and stay there. We feel we’ve really met Mr. Micawber, Uriah Heep, Artful Dodger, Magwitch, Miss Havisham, poor Jo the Sweeper, and the formidable lawyers Tulkinghorn, Vohles, Stryver,and Jaggers. Our lives have grown bigger.

Dickens was well acquainted with the law. He was a court reporter before making his mark as a novelist. After he attained success, he was forced to file suits to protect his intellectual property in several of his works, including A Christmas Carol. Even when he won, Dickens felt he lost. The legal costs were exorbitant. Thus, it is little surprise that by the time he wrote Bleak House – which falls into a late and dark period of Dickens’s career – his descriptions of the legal process dripped with cynicism. Here is one of the more famous, and acidic, passages: “The one great principle of the English law is to make business for itself. There is no other principle distinctly, certainly, and consistently maintained throughout all its narrow turnings. Viewed by this light, it becomes a coherent scheme, and not the monstrous maze the laity are apt to think it. Let them but once clearly perceive that its grand principle is to make business for itself, at their expense, and surely they will cease to grumble.”

There is much more to Bleak House than the inefficiencies of the court system. As usual with Dickens, we begin with a child of uncertain and/or unfortunate parentage. That young person endures many hardships and indignations. Curious characters abound. Life is unfair and death is never far away. Dickens tells us that “All partings foreshadow the great final one.” One character perished from opium, another from exposure, and one from – believe it or not – spontaneous combustion. Disease floats in the foul London air. Smallpox afflicts a couple of characters. One of the most poignant expirations is from a respiratory disease.

Naturally, that last bit reminded us that we were holed up at home digging through our ambitious reading list because … well, as the young people simply and eloquently put it, because Covid-19. The pandemic has changed everything. It changes what we can do and where we can do it. It certainly has changed the practice of litigation. One respect in which it has wrought that change is the increasing resort to remote depositions.

Let us confess that we have been on many sides of this issue. In some cases, we have resisted remote depositions, beseeching the court to await a return to normality. In others, we have pushed for the right to take remote depositions of plaintiffs now, or soon, and promised to make the remote procedure as effortless as possible. In still others, we opposed lawyers trying to force in-person depositions of our clients, arguing that legitimate health concerns made remoteness essential. Our positions have been blithely inconsistent. But the results have been consistent: courts have made a Covid-19 correction and are in favor of employing remote depositions.

Grupo Petrotemex v. Polymetrix Ag, 2020 U.S. Dist. LEXIS 130391 (D. Minn. July 23, 2020), is the latest example, or at least the latest of which we are aware. There is a veritable pandemic of court decisions favoring remote depositions. Grupo Petrotemex was a patent dispute, a field as obscure to us as Jarndyce v. Jarndyce was to all its hapless litigants. But the issue regarding remote depositions was clear enough in Grupo Petrotemex. The plaintiff sought to depose the defendant’s employees and 30(b)(6) designees. The defendant proposed that those depositions be conducted remotely, with the witnesses physically located in Switzerland. The reason for the remoteness was, of course, Covid-19. Physical proximity and travel seem like very bad moves in an era of Covid-19, a disease that is easily transmittable and that is fatal in a non-trivial percentage of cases.

The plaintiff preferred to take in-person depositions. Its proposal was to conduct the depositions in St. Maarten. Now, in general, meeting up in St. Maarten is a splendid idea. It is part of a beautiful island in the Caribbean split up between Dutch (St. Maarten) and French (St. Martin) sides. Legend has it that the demarcation of the island was decided by having a Frenchman, fortified by wine, and a Dutchman, fortified by Holland gin, walk around the island in opposite directions, with a line being drawn across the island connecting the beginning and meeting points. Apparently wine is better fuel than gin, as the French got the bigger part of the island.

Despite St. Maarten’s obvious charms, the defendant declined the tropical invitation, arguing that witnesses would be required to self-quarantine upon returning from St. Maarten. Moreover, even though St. Maarten has a low incidence of Covid-19, it isn’t zero. To get to St. Maarten, the witnesses and lawyers would likely need to connect through Miami. Have you seen the Covid-19 rates in South Florida? Have you ever pushed your way through the mass of humanity sojourning in Miami International Airport? The travel and in-person contact necessarily would expose the witnesses and everyone else to a substantially greater risk of contracting Covid-19 than if the depositions proceeded remotely.

The lawyers on both sides of this dispute are excellent. We have been cocounsel with the firms. They made the best possible arguments for and against remote depositions. The Magistrate Judge ruled in favor of the defendant, reasoning that remote depositions were good enough, and were certainly safer. The plaintiff objected to this ruling, contending that the other side had done nothing but present general concerns, which should not be enough. The witnesses had not filed declarations identifying any specific health concerns. So why not a brief deposition idyll in lovely St. Maarten?

The district court ruled that the Magistrate Judge got it right. Federal Rule of Civil Procedure 30(b)(4) sets out that depositions may “be taken by telephone or other remote means.” That provision isn’t there for nothing. The Grupo Petrotemex court cited a gaggle of June/July 2020 cases favoring remote depositions as the “new normal” in the wake of the Covid-19 pandemic. The technology for doing remote depositions, including the sharing of documents, exists. It might not be perfect, but it is pretty good. Balancing that pretty good against even a small risk of getting Covid-19 made the court’s decision in favor of remote depositions pretty easy. The Grupo Petrotemex court pointed out that “[s]hould these deponents or counsel become ill while in St. Maarten, they would be thousands of miles away from home, their families, and their own medical providers.” (Imagine getting sick in West Virginia! JK, West Virginia lawyers. Please hold your angry emails.)

The Grupo Petrotemex decision recognizes the Covid-19 “new normal,” and adds to the judicial consensus that remote depositions are part of that “new normal.” Remote depositions might be flawed and, especially to technophobes, a tad vexing. But they are usually good enough, easy enough, and not quite bleak.

This post is from the non-Reed Smith side of the blog.

Today’s case involves several multi-plaintiff complaints filed in California involving out-of-state plaintiffs who allege they suffered an injury from using out-of-state defendants’ prescription drug product that was distributed by a company headquartered in California.  Afraid you’ve fallen through a portal that transported you back in time three years?  Let’s see, if it was really 2017 what would we be talking about?  Moonlight over La La Land; Cross-Fit; the eclipse; the Women’s March; Justin Verlander; Hurricanes Harvey, Irma, Jose, Maria; avocado toast.  And of course, Bristol-Myers Squibb Co. v. Superior Court, 137 S.Ct. 1773 (2017).  While the facts of today’s case sound an awful lot like BMS, it’s in fact a decision from just last week.  What are we talking about in 2020?  Covid-19; social distancing; Kobe Bryant; George Floyd; Ahmaud Arbery;  Breonna Taylor.  Of course, the presidential election.  And, In re Amiodarone, 2020 WL 4355756 (Cal. App. Ct. Jul. 30, 2020).

These amiodarone complaints were in fact filed on behalf of hundreds of plaintiffs many of whom reside outside California against brand and generic manufacturers which are also not California residents and McKesson, a then-California-based distributor of the drug.  Id.  at *1.  As with other amiodarone cases the allegations center on off-label promotion and failure to provide medication guides.  Id. at *2.  As in BMS, the question at issue is one of specific jurisdiction – specifically whether “the controversy relates to or arises from the defendant’s contact with the forum.”  Id.  Again, just like in BMS, plaintiffs don’t allege they were prescribed or purchased the drug in California.  The similarities don’t stop there:

We learn from BMS that the fact that a respondent distributes, sells and promotes a prescription drug (in BMS, Plavix; here, amiodarone) in California does not justify the exercise of specific jurisdiction over that respondent for claims unrelated to its California sales. Nor does the mere fact that a respondent has contracted with a California defendant (in BMS and here, McKesson) for the national distribution of a prescription drug, provide an adequate basis for specific jurisdiction.

Id. at *3 (citations omitted).

Apparently undaunted by the confines of the law as handed down in 2017, plaintiffs attempt a 2020 end-run around BMS.  First they argued derivative liability as a basis for personal jurisdiction.  This argument hinges on the Supreme Court’s observation that plaintiffs in BMS “had not alleged that BMS is derivatively liable for McKesson’s conduct in California.”  Id. (citation omitted).  So the amiodarone plaintiffs alleged just that leading the court to “look closely” at the indemnification provisions of the McKesson supply agreements.   The manufacturer defendants agreed to indemnify McKesson against liability arising from the manufacturer’s nonadherence to certain regulatory or legal requirements and against claims arising from manufacturer’s products unless the claims are “proven to be due to McKesson’s negligent handling of the products.”  Id.  at *5.  In other words, the manufacturers agreed to indemnify McKesson for their own conduct.  Nowhere have the manufacturers agreed to be derivatively liable for McKesson’s conduct.

Plaintiffs next argued joint and several duties as a basis for jurisdiction.  This argument centered on the medication guides.  Plaintiffs contended that the FDA regulations imposed a “joint and several” obligation on the manufacturers and McKesson regarding distribution of the medication guides.  Another “close look” at the regulations was plaintiffs undoing.  The regulations say manufacturers have to provide medication guides (or a means to produce medication guides) to distributors, packers, or authorized dispensers.  Id. at *6.  Separately, the regulations provide that distributors are responsible for providing medication guides (or a means to produce them) to any authorized dispenser it ships to.  Id.  Rather than joint duties, the regulations impose “individual duties on each entity in the chain of distribution.”  Id. at *7.

Having struck out with both factual arguments, plaintiffs’ attempted to argue simply that BMS doesn’t apply “if the plaintiff alleges case-related contact with a forum defendant.”  Id. But that’s exactly what BMS said was not sufficient.  None of the cases plaintiffs cited were remotely applicable and did not change the court’s thinking.  BMS controls.

Finally, plaintiffs argued they should have been allowed to take more jurisdictional discovery – namely McKesson’s delivery of amiodarone to the pharmacies used by plaintiffs.  Their theory is that if a plaintiff went to the pharmacy shortly after the pharmacy got a delivery from McKesson it is “virtually certain” that plaintiff got amiodarone from McKesson.  Id. at *8.  This is again tied to a suggestion by the Supreme Court in BMS that such information could be relevant to a jurisdictional inquiry, but plaintiffs neglected to demonstrate how the information would establish jurisdiction in this particular case.  McKesson provided evidence that when it ships to out-of-state pharmacies it does so from an out-of-state (non-California) distribution center.  So, even if plaintiffs took McKesson shipped product, it wouldn’t have come from California.  But even that was immaterial.  Regardless of where the product shipped from, “that would not show anything more than unilateral action by McKesson, as opposed to action by [manufacturers.]”  Id.  Whatever decisions McKesson made about how it would ship and label amiodarone, whether made in California or elsewhere, would be just that – McKesson’s decisions.  McKesson’s decisions alone are insufficient to establish jurisdiction over out-of-state defendants.

Now hundreds of plaintiffs have to refile their cases in their home states (or the defendants’ home states) which may, or may not, bar the action under their statute of limitations tolling rules.  After all, it’s 2020.  Why should litigation tourism thrive when vacation tourism withers?  What are we talking about in 2020?  Zoom; Tik Tok; Zoey’s Extraordinary Playlist; curbside pickup . . . .

The Pennsylvania Supreme Court recently decided Walsh v. BASF Corp., ___ A.3d ___, 2020 WL 4135151 (Pa. July 21, 2020), reaffirming product identification as an essential element of product liability.

Below, the Superior Court had turned a trial court’s routine Fryebert-like exclusion ruling in a chemical exposure case into scary new precedent in Walsh v. BASF Corp., 191 A.3d 838 (Pa. Super. 2018).  The Superior Court in Walsh reversed the exclusion of the plaintiff’s experts, holding that aggregate expert opinions that “pesticides” in general could cause “cancer” in general was both:  (1) admissible under Pennsylvania’s Frye (as opposed to Daubert)-based framework for evaluating expert testimony, and (2) sufficient to preclude summary judgment as to the chemically disparate pesticide products of fourteen different manufacturers.  Indeed, the Walsh Superior Court decision went so far as to deny that, in Pennsylvania, a trial judge had any “gatekeeping” function at all with respect to expert testimony.  Id. at 844 (“That is not the proper role of the trial court in a Frye inquiry.”).

The Superior Court in Walsh thus not only pushed back on the “bert” part of expert admissibility in Pennsylvania, but went further than ever under Frye towards letting any pro-plaintiff opinion in, regardless of its basis.

With Bexis representing a number of amici curiae, defendants in Walsh successfully obtained Pennsylvania Supreme Court review of three questions:

(1) Did the Superior Court majority commit reversible error in concluding that, when evaluating scientific evidence under the Frye standard, trial courts are not permitted to act as “gatekeepers” to ensure the relevance and reliability of scientific studies offered by experts to support their opinions by scrutinizing whether those studies actually support their opinions?

(2) Did the Superior Court majority commit reversible error in concluding that trial courts may not review experts’ opinions extrapolating from a broad class of products and injuries to a specific product and injury, thereby eliminating plaintiff’s burden to show product-specific causation of plaintiff’s specific injury?

(3) Did the Superior Court majority commit reversible error in concluding that the trial court erred without explaining how it abused its discretion because of manifest unreasonableness, partiality, prejudice, bias, ill-will or such lack of support from the evidence or the record so as to be clearly erroneous?

Walsh, 2020 WL 4135151 at *6.  Still, with the addition of four (out of seven) generally pro-plaintiff justices since 2016, the Pennsylvania Supreme Court is a difficult court for defendants these days, and the worry was that the court could inaugurate a new era of industry-wide toxic tort litigation based on the sort of product-identification-ignoring expert opinions OKed by the Superior Court in Walsh.

The Supreme Court recently decided Walsh, and by a 4-3 (or 5-2 depending on the issue) margin it affirmed the Superior Court’s result, but the basis of the affirmance was quite narrow.  Indeed, the court specifically ordered that the defendants “should be given the opportunity to renew their Frye motions for the reasons addressed in this Opinion.”  2020 WL 4135151, at *1.  All told, Walsh produced four opinions:  the majority opinion, for four justices, just cited; a concurrence by Justice Wecht, who also joined the majority, 2020 WL 4099627; a concurring and dissenting opinion by Justice Baer, who joined the majority as to issues one and three, 2020 WL 4139381; and a dissent by Chief Justice Saylor, joined by Justice Todd, 2020 WL 4139034.  We expect Westlaw to consolidate these opinions, so the numbers will probably change.  The opinions tracked the division in the court we mentioned above.  The three pre-2016 justices proved more hospitable to the defendants’ arguments, while the four post-2016 justices all lined up for affirmance – of the outcome – reached by the Superior Court, but not the reasoning.

Issue One − Gatekeeping

As to issue one, the court affirmed the Superior Court’s result while avoiding any clear ruling on trial courts as “gatekeepers.”  Walsh held that “whether a methodology is generally accepted in the relevant scientific community is a determination that has to be made based on the testimony of the scientists in that community, not upon any scientific expertise of judges.”  2020 WL 4135151, at *7.  In Walsh that “testimony” consisted of the plaintiffs’ experts, on one hand, and the defendants’ experts on the other.

[T]he trial court must be guided by scientists in the relevant field, including the experts retained by the parties in the case and any other evidence of general acceptance presented by the parties.

Id. at *8.

Conversely, trial courts may not question the merits of the expert’s scientific theories, techniques or conclusions, and it is no part of the trial court’s function to assess whether it considers those theories, techniques and/or conclusions to be accurate or reliable based upon the available facts and data.

Id.  That sounds pretty awful – like an expert can get away with anything.  But it’s not as bad as it sounds, as long as the party opposing admission (usually, but not always, our side) does its job.

What produced the nominal affirmance in Walsh was that the trial court appeared to come to its own conclusions, the majority stated, without basing those conclusions on the record before it.  “In so ruling . . . the trial court did so unilaterally, without citation to any authority or to the voluminous expert deposition testimony in the certified record.”  Id. at *9.  Frye determinations involve “scientific judgment[s] that must be guided by the experts, not a trial court.”  Id.

Given that context, it was an abuse of discretion under the Frye test for a trial court to reach a “conclusion . . . based solely upon its own analysis of the scientific studies proffered by [the expert] and not on any review of the methodology that [the expert] was utilizing.”  Id. at *10.  Thus, the Pennsylvania Supreme Court’s ruling on issue one amounts to, in practice, is an admonition to trial courts that, to exercise discretion properly, they must take care to include the necessary record citations for their rulings, and not to go beyond the grounds raised by the relevant Frye motion(s):

The trial court issued no rulings on any of [defendant’s] Frye challenges.  To the contrary . . ., the trial court did not even mention the Bradford Hill criteria. . . .  By questioning the judgment of the [plaintiff’s] experts and the reliability of their scientific conclusions, rather than focusing on whether [plaintiff] satisfied his burden of proof that [his experts] formed their opinions by application of methodologies that are generally accepted in the relevant fields of study, the trial court abused its discretion.  Accordingly, we agree with the Superior Court’s decision to vacate the trial court’s orders. . . .  On remand, the [defendants] should be afforded the opportunity to renew their Frye motions so that the relevant issues can be addressed.

Id. at *11.  Thus, no horrible substantive rulings on Frye standards were forthcoming – only the reminder not to act like federal courts do in Daubert analysis.  Cf. Id. at *7 n.6 (contrasting Frye and Daubert).  Trial courts that are careful to color within the lines (that’s the discretion point) provided by the parties’ motion practice and competing expert testimony are likely to be affirmed.  It’s OK to cite and follow a defense expert’s critique of what the plaintiff’s expert did, as long as it doesn’t appear to the trial court’s own analysis.

As for the “gatekeeper” question, the majority dodged it.  “Whether we refer to the role of the trial court in a Frye contest as that of a ‘gatekeeper’ is not consequential.  What is of consequence is the role that the trial court plays during Frye proceedings.”  Walsh, 2020 WL 4135151, at *8.  Thus, the Superior Court’s ruling disapproving of the “gatekeeper” concept was neither affirmed nor reversed, but rather shrugged off.  That’s all the majority had to say on the point.

The two concurrences (necessary to make the majority), however, are more friendly to the “gatekeeper” role.  Justice Baer concurred specifically”

to distance myself respectfully from the majority opinion to the extent it declines to recognize the trial court as “gatekeeper” in Frye challenges. . . .  [T]he gatekeeping role of the court, far from detracting from the jury’s function, is in fact essential to it as it ensures that what might appear to the jury to be science is not in fact speculation in disguise.

2020 WL 4139381, at *?, penultimate paragraph (at this point, WL has no pinpoint citations for the three non-majority opinions).

In his opinion, Justice Wecht, noted:

[T]he gatekeeper terminology is a commonplace in both Frye and Daubert case law.  Moreover, it is not inapt to say that the trial court acts as a gatekeeper in determining the admissibility of evidence generally.

2020 WL 4099627, at *? n.7 (citations and quotation marks omitted).  However, he “avoids” that “terminology, because at least colloquially it suggests a more jealously guarded portal than the Frye test calls for.”  Id.

The two-justice dissent was four-square in favor of “gatekeeping”:

The majority deems it inconsequential whether or not this Court should denominate trial judges as gatekeepers relative to the admission of novel scientific evidence in Pennsylvania courtrooms.  Personally, however, I find this to be the clear purport of most of this Court’s decisions on the subject. . . .  This Court, like most others, has implemented this particular gatekeeping responsibility in light of the influential nature of expert testimony on complex subjects and the potential that distortions have to mislead laypersons.

2020 WL 4139034, at *? (first two paragraphs) (citations omitted).

Add up the votes, and there are four (of seven members of the court) in favor of the “gatekeeper” rationale in Pennsylvania Frye determinations, at least to some extent.

So the defense didn’t really lose much on issue one.  As long as defense counsel does the kind of competent job that was done in Walsh, giving the trial court an extensive basis in the record to which it can cite for the proposition that the plaintiff’s expert’s methodology is fatally deficient, nothing much has changed, save how the Frye test should be phrased (hint – stay away from Daubert-like terminology).

Issue Two − Extrapolation

The Walsh decision on the extrapolation issue was 4-3 allowing it, with Justice Baer in full dissent.  But once again the result was explicitly limited.  The most important type of “extrapolation” – that which had the defense community concerned about new, expansive liability − was from a generalized causation opinion to multiple specific products.  As to that type of expert overreach, the Walsh majority was careful to disassociate itself entirely from the Superior Court’s reasoning:

Importantly for present purposes, however, our review of the expert reports of [plaintiff’s experts] does not reflect that either of them used extrapolation in the manner now complained of by [defendants].  Specifically, while both experts employed the Bradford Hill criteria to establish a causal link between cancer (or AML) and long-term exposure to pesticides, neither expert opined that this link wholly constituted product-specific causation between cancer and long-term exposure to the Appellants’ specific pesticide products.

2020 WL 4135151, at *12 (emphasis original).   Bexis read these reports in his amicus role in Walsh, and he’s of a different opinion, but if this is how the Pennsylvania Supreme Court wants to characterize the opinions, all the more power to it.  That, as much as anything, defangs the most worrisome part of the Superior Court’s opinion – which purported to allow a “pesticides cause cancer” opinion to extend to each of the defendants’ individual products.  See Walsh, 191 A.3d at 847 (“Although the epidemiological studies cited by [plaintiff’s] experts did not explore whether exposure to one particular pesticide product caused [the disease], we reject Defendants’ contention that such specific studies were required.”).

Thankfully, even the most pro-plaintiff members of the Pennsylvania Supreme Court were unwilling to go that far.  Instead, Walsh construed the trial court’s opinion as not even ruling on product-specific extrapolation.  2020 WL 4135151, at *12 (“[T]he trial court issued no ruling with respect to whether [plaintiff’s expert’s] failure to opine on whether the [defendants’] specific products may cause [the disease] precludes her use as an expert on general causation.”).  “As a result the Superior Court’s opinion . . . did not eliminate the plaintiff’s burden to show product-specification.”  Id.  Critically, Walsh then reaffirmed product identification as an essential element of product liability:

Pennsylvania law requires that to create a jury question, a plaintiff must adduce evidence that exposure to defendant’s [product] was sufficient . . . to support a jury’s finding that defendant’s product was substantially causative of the disease.

Id. (quoting in part Rost v. Ford Motor Co., 151 A.3d 1032, 1044 (Pa. 2016)).

To the great relief of the defense community, the Walsh majority thus cut the Superior Court’s opinion way back.  That opinion, according to the majority’s reading, “neither blessed the indiscriminate use of extrapolation nor . . . may fairly be read to hold that establishing a causal link between cancer and long-term exposure to pesticides is sufficient to support a causation decision regarding exposure to a defendant’s specific product.”  2020 WL 4135151, at *13.  What the majority did hold wasn’t great – “an expert need not rely on studies mirroring the exact facts under consideration,” id. – but that’s not the disaster that the Superior Court’s opinion seemed to presage.

And of course, the three dissenters were not willing even to go that far, rejecting all of the would-be extrapolations as “ipse dixit” ungrounded in any actual evidence.

[B]oth of [plaintiff’s] experts inappropriately extrapolated from “pesticides” as a product class − including numerous pesticides that [plaintiff] never used − to [defendants] specific products, with no analysis of whether the products were chemically, functionally, or toxicologically similar. There is also abundant record evidence confirming that this form of extrapolation lacks general acceptance in the scientific community. . . .  [T]he proffer − before a jury of laypersons − of expert witnesses whose methodologies are replete with ungrounded extrapolations and other analytical gaps, large-scale abstractions, and patent circularity goes far beyond any reasonable conception of appropriate leeway.

Dissenting op, 2020 WL 4139034, at *? (citations omitted).  See Concurring and dissenting op. at *? (final paragraph) (“I join Part II of the Chief Justice’s dissent”).

To us, this is the most important aspect of Walsh.  The product identification requirement comes through unscathed, perhaps even strengthened, as not a single Justice was willing to hold, (as the split Superior Court panel in Walsh actually did) that an expert can assume, from “pesticides cause cancer,” that any particular defendant’s product does so.

Issue Three – Abuse of Discretion

Given the majority’s rulings on the first two questions, issue three became something of an anticlimax.  It’s now an abuse of discretion, in a Frye context, for a trial judge “to make its own bald judgments about which studies relied upon by [an expert] were scientifically acceptable, relevant and/or supportive of [the expert’s] conclusions.”  2020 WL 4135151, at *13.  That was enough – “[i]t is unnecessary for an appellate court to use any ‘magic language’ when ruling that a lower court abused its discretion.”  Id.

So once again, the takeaway for future Frye determinations is don’t go “bald.”  If you’re making a Frye challenge, make sure to build a record replete with your own experts’ reasons why each aspect of the other side’s expert opinion is unreliable junk science.  And if you’re a judge sustaining a Frye challenge, make damn sure that your decision is replete with citations to the record that the parties have supplied.  Ultimately, that’s all that Walsh actually decided.

We start with a disclaimer:  The following metaphorical exercise is somewhat forced, but we are doing it anyway.  If you are like us, then you are a few months in on a pattern of only buying groceries every week or so, perhaps supplemented by bulk deliveries of meat or seafood that you may need to fit into the rotation of meals prepared at home.  Whether you plan out your meals before you make your main weekly purchase, you wing it, or fit in somewhere in between, you try to minimize waste.  You look at “sell by” dates, “best before” dates, and “eat before this date or you will be violently ill” in making preliminary judgments, but the eyes and nose—the old smell test—play an even bigger role.  You may be able to pick out some rusty lettuce from a bag of salad and use the rest, but gray, funky ground beef is going straight into the garbage no matter what date is on the package.  (Why both of these items seem to stay fresh for less time than they did five months ago is a whole different kettle of fish.)  Depending on your time and tolerance, there may be some other food items you can salvage rather than toss based on how you trim and/or prepare them.

Late-filed lawsuits can get tossed based on either a statute of limitations or a statute of repose, but they operate differently.  Statutes of limitations run from date of accrual, are shorter, and have a bunch of potential exceptions that can be used to a save a case that was filed after the apparent date of accrual plus the limitations period.  Statutes of repose run from the date of the act or omission (e.g., sale), are longer, and have few, if any, recognized exceptions to keep a case from getting tossed.  When a state legislature has declined to include any exceptions with a statute of repose, a conscious decision has been made that the application of the statute may result in some seemingly harsh outcomes, a fact that courts sometimes note in throwing out a case while redirecting any indignation toward the legislature.  (Our old case discussed here comes to mind.)

Statutes of repose, with their later “file by dates” and less wiggle room, can be powerful tools.  We have posted on them more than a few times, including a relatively recent survey of the law across the country.  Today’s case comes from the heart of it all, Ohio, and involves the statute of repose for medical malpractice actions.  While the four-year statute of repose for such cases is much shorter than the ten year statute in Ohio for product liability actions, many of the same principles apply.  That is why we thought Jonas v. Durrani, Nos. C-180457-58, 2020 Ohio App.  LEXIS 21715 (Ohio Ct. App. July 22, 2020), was worth discussing.  We do not often post on decisions from intermediate state appellate courts, but Jonas appears to be one of at least four decisions from the same court relating to cases against the same physician, at least one of which going up to the Ohio Supreme Court.  In addition, we know that lots of smoke does not always mean there is fire, but the physician fled the country and lost his medical license, making us think that cases against him would have been pretty juicy if they survived repose.

Jonas actually had two cases consolidated on appeal with somewhat different facts, which are pared down a bit here.  The Jonas plaintiff had 2008 back surgery and sued the surgeon, his practice, and hospital #1 in 2014.  She then dismissed and refiled in 2015, adding a second hospital and a range of claims.  The Carr plaintiff had surgeries in 2005, 2007, and 2010 performed by the same surgeon, sued him, his practice, and hospital #2 in 2013, dismissed in 2015, and refiled in 2015 against the same defendants.  Both cases were dismissed on statute of repose and had motions for leave denied.  Most of the meat of the decision related to the wide-ranging arguments raised by the Jonas plaintiff.

The Ohio statute of repose runs from “the occurrence of the act or omission constituting the alleged basis of the medical . . . claim.”  For the Jonas plaintiff, it was clear that the 2008 surgery was the act at issue and her suit was brought more than four years later.  The first attempt was to cast her claims for fraud and negligent credentialing as nonmedical.  Other appeals with this same surgeon as a defendant had already largely addressed this argument.  For instance, “simply placing a ‘fraud’ label on a claim cannot side-step the statute of repose.”  Id. at *7.  Next up was the argument that the court should create an equitable estoppel or fraud exception not included in the actual statute or supported by the legislative record.

Where the General Assembly could have included an equitable estoppel or fraud exception (as some other states have done), but declined to do so, our job is not to supplant that authority, but rather to apply the statute as written.

Id. at *9.  Then plaintiff tried to say that the savings clause—remember, her case was re-filed after voluntary dismissal—saves a case that was originally filed late.  Nah.

Plaintiff also went backwards and argued that the act starting the statute was really something other than the surgery, but “we see no allegations of a later separate act or omission that would enable us to stretch the starting line for the statute of repose period.”  Id. at *11.  The faucet from the proverbial kitchen sink came next with claims that some sort of tolling should apply because of the surgeon’s 2013 flight and 2014 loss of licensure, but her claim was barred in 2012 so the court did not need to decide whether to make new law.

The stopper from that sink came in the way of the old “foreign object” exception, which Ohio has added to both its statute of limitations and statute of repose for medical malpractice actions.  The argument was that the device implanted in connection with the 2008 surgery triggered the exception.  The exception is really intended to cover someone unintentionally left in the body during a surgery—like a sponge—not something intentionally left in—like the device the operative note talked about implanting.  If this analysis sounds familiar, then you might be thinking of this post from March that discussed a Utah decision that Jonas relied on in reaching the same conclusion.

To adopt [plaintiff’s] position would be to expand the ‘foreign objects’ exception and render every medical device case a potential candidate for a longer repose period.  A plaintiff could, by challenging the medical reasoning of the doctor or the effectiveness of the consent, circumvent the repose period.  That would frustrate, rather than further, the intent of the General Assembly.

Id. at *18.  The only thing left for the Jonas plaintiff—the pipe below the stopper in the sink, we guess—was to say she should have been allowed to flesh out her allegations, but this was pointless because all her additional allegations related to the surgery that triggered the repose period.  Id. at *20.

The Carr plaintiff’s arguments were much more direct.  He sued within four years of his third surgery, so his claims based on that third surgery against the defendants involved in it could proceed.  Id. at *22.  The rest were barred (and not resurrected based on a later surgery).  He also did not get to amend his complaint because he wanted to add a claim under the state RICO statute and that required allegations about a criminal enterprise that he did not make.  Id. at **22-24.

While the surgeon, and perhaps other defendants, may have had liability, all the medical malpractice claims from these plaintiffs had they been brought in the timely fashion, we do appreciate the enforcement of the legislature’s intent to bar claims brought outside of the statute of repose.  That does not always happen, but letting older and older claims proceed can end up creating a number of problems that are hard to swallow.

 

Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.”  To wit, we recently noticed a small wet spot on our bedroom ceiling.  The roofing company discovered that the corresponding section of the roof was too shallow to be shingled and replaced the section with the correct material.  That spot dried up and stayed dry, but we walked into our bedroom during the next big storm to find water dripping from a recessed light in a different location under the brand-new section of roof.  Nothing’s perfect.

We could go on (trust us).  But we will move, with a similar sense of resignation, to today’s case.  Vardouniotis v. Pfizer, Inc., 2020 WL 3890928 (N.Y. Sup. July 7, 2020), begins as a rare and lovely example of a court applying the correct standard to dismiss a failure-to-warn claim on federal preemption grounds.  In Vardouniotis, the plaintiff took the defendant’s prescription drug to help her quit smoking.  She alleged that it caused her to suffer injuries that included a number of symptoms related to pain in her back, neck, abdomen, legs, and hips, along with movement disorders, “difficulty lifting items, persistent exhaustion, labored breathing, depression; and anxiety.”  Vardouniotis, 2020 WL 3890928 at *1.  She asserted the usual panoply of product liability claims, including a claim that the defendant had not adequately warned of the risks of “movement disorders, serious injury, or death.”  Id.  In its motion to dismiss, the defendant argued that the warnings claims were preempted by the FDCA.

The court explained that, to “update a label without prior FDA approval, a manufacturer must comply with the ‘changes being effected’ (‘CBE’) regulation, which allows manufacturers to add or strengthen label warnings unilaterally to “reflect newly acquired information.”  Id. at *2, citing 21 CFR § 314.70(c)(6)(iii).  The only time the FDCA and its implementing regulations do not preempt a state law failure-to-warn claim is when the manufacturer could have changed the label pursuant to the CBE regulation.  Under that circumstance, “the burden shifts to the party asserting a preemption defense to demonstrate that there is clear evidence that the FDA would not have approved” the label change.  Id. at *2-3 (citation omitted).  This is the Levine “clear evidence” rule that has confounded courts – and produced singularly bad decisions – since 2009.  Not so here.

The defendant argued that the plaintiff had not alleged that the defendant had “information that . . . revealed risks of a different type or severity or frequency than warned of in the . . . label and [that the defendant] had not previously submitted to the FDA.”  Id. at *3.  In other words, according to the defendant, the plaintiff had not alleged the existence of “newly acquired information” that would have triggered the defendant’s ability to change the label without prior FDA approval.  The plaintiff countered with citations to newspaper articles and journal publications describing risks not listed in the label, and she argued that she didn’t know, before discovery, whether or not those risks were identified to the FDA as part of the defendant’s New Drug Application.

The court commented that, although the plaintiff “cite[d] newspaper articles in her memorandum of law, [the] articles were not annexed to the complaint or her opposition to [the defendant’s] motion to dismiss.” Id.  The court also declined to take judicial notice of “materials derived from a Federal Aviation Administration website or a Wall Street Journal article,” because “[j]udicial notice of facts is reserved for matters of common knowledge, well-established and settled.”  Moreover, “[judicial notice of a fact may not properly be based upon a factual assertion simply because the assertion is contained in a newspaper article.” Id. (internal punctuation and citations omitted).“  Thus,” the court stated, “the plaintiff has not identified any newly acquired information that could have justified [the defendant’s] revising the . . . label unilaterally through the CBE regulation without FDA approval.”  Id.  Nor was the court swayed by the plaintiff’s argument that she needed discovery to defeat preemption, commenting that “the mere hope that discovery may reveal facts essential to justify opposition does not warrant denial [of a motion to dismiss].”  Id. at *4 (internal punctuation and citation omitted).  The court held, “As the plaintiff has failed to make a sufficient showing that such facts could be obtained in discovery, the plaintiff’s failure to warn claims are dismissed.” Id.

We remember the days leading up to the Levine decision and our disappointment when the decision came down.  In the ensuing years, we have been frustrated, far more often than not, by courts’ refusal or inability to approach preemption motion-to-dismiss decisions with open-minded rigor.  It’s pretty simple: if a plaintiff properly alleges that a manufacturer failed to change a label in the face of “newly acquired information” about a new or heightened risk, she may be able to defeat dismissal on preemption grounds.  Otherwise, her failure-to-warn claims should be dismissed as preempted by federal law.  So many courts get it wrong, and we were delighted to read a decision that gets it right.

But nothing’s perfect.  The court granted the defendant’s motion with respect to some of the plaintiff’s remaining claims and denied it with respect to others.  But here is where the decision really went off the rails: the court held that the plaintiff had adequately pled her negligence claim when she alleged that she was injured as a result of the defendant’s “failure to adequately test” its drug.  The court also declined to dismiss the plaintiff’s gross negligence and “wanton and malicious conduct” claims based on the same allegations.  Here’s the thing: our “duty to test” cheat sheet includes four cases, including a Second Circuit case, holding that there is no such duty under New York law.  The Vardouniotis court didn’t even discuss the issue when it allowed these claims to proceed.  We are disturbed by this.  The concept of “failure to test” intrudes on territory that is framed by FDA’s comprehensive regulatory scheme.  Our drug and device clients don’t need common-law “failure to test” claims, especially in jurisdictions that have already rejected them.

Nevertheless, we love the preemption portion of this decision. We will continue to keep you posted on the good, the bad, and the merely imperfect.  In the meantime, stay safe out there.