Long ago, when we first started representing the makers of prescription pharmaceuticals, it was said that people did not tend to sue over life-saving medications.  Contraceptives, pain medications, obesity medications, diabetes medications, psychiatric medications, and many others were fair game, even if the risk-benefit calculus for an individual patient might involve major benefits on one side of the scale.  Plaintiff lawyers would not waste their time, it was said, with medications to treat potentially terminal cancer or other conditions that would kill the patient absent effective treatment.  Regardless of whether that old saw was ever true, dockets have been full for a while with cases about medications that are clearly life-saving.  (Some of those plaintiffs also seek to prevent the defendants from properly characterizing their medicines as life-saving, but that is a different matter.)

AIDS used to be one of those conditions that came with a death sentence.  Now, with dozens of medications, often combining different active ingredients, on the market since AZT was approved in 1987, the ability of the medical community to treat HIV, the virus that causes AIDS, is one of the great success stories of medicine.  Dr. Fauci and others from NIAID who have been in the news over the past several months played an important role in this success, but so too have pharmaceutical companies.  Not only can modern treatment regimens keep viral loads below detectable levels and make it so patients with HIV die of old age or unrelated conditions, but the advent of Pre-Exposure Prophylaxis with combinations of medications can prevent transmission in some instances, something unthinkable in the early days of the HIV/AIDS epidemic.

In Epstein v. Gilead Sciences, Inc., No. 19-81474-CIV-SINGHAL, 202 WL 4333011 (S.D. Fla. July 27, 2020) (Singhal, M.J.), these two trends intersected.  The plaintiff claimed to have suffered kidney and bone damages from his use of the prescription drugs Viread and Atripla, a combination of Viread and two other active substances.  In support, he asserted seven different state law claims, including that the drugs were defectively designed because Viread should have had tenofovir alafenamine instead of the tenofovir disproxil as its active ingredient, the drugs never should have been sold, and the drugs should have had different warnings about the risk of kidney and bone damage (of some sort).  This brought us to another trend:  implied preemption of design and warnings claims with branded prescription drugs.  Leading up to and for a while after the terrible Levine decision there was not much hope of getting such design and warnings claims out on preemption, let alone on a motion to dismiss.  But, after Mensing, Bartlett, Albrecht, and a bunch of cases along the way, things have changed for the better.

After noting the plaintiff’s position that “no federal law prevented Gilead from designing its TDF Drugs to be safer before FDA approval and because Gilead could unilaterally change their label to make it stronger to comply with state law” and citing Albrecht, two cases, and the Supremacy Clause, this was the entirety of the Court’s analysis:

Plaintiff’s Complaint is premised on the allegations that:  (1) Gilead should have designed Atripla and Viread with TAF instead of TDF, and thus, never should have sold Atripla and Viread; and/or (2) Gilead failed to adequately warn Plaintiff or his doctors about the bone and kidney risks associated with Atripla and Viread.  Gilead argues these claims are preempted, because Gilead could not have marketed or sold medications containing this design change without first seeking and obtaining FDA approval.  See 21 C.F.R. §314.7-(b)(2)(i) (defining “changes in the qualitative or quantitative formulation of the drug product” as “major changes” that “requir[e] supplement submission and approval prior to distribution of the product”).  This Court agrees, it would have been impossible for Gilead to comply with both its state duties to change the products’ labels and its federal duties not to make such changes without first obtaining FDA approval.  See Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472, 475 (2013).  Additionally, Plaintiff contends that TAF should have been used instead of TDF; however, the FDA approved Gilead’s formula and any changes would have required further approval.

Id. at *2.  As we said above, short and sweet.  (Not like the path described here.)  Also clearly right on the law.  The narrow CBE exception that Levine latched onto and made something so much bigger did not apply here.  (Peruse these posts, perhaps:  this, this, and this.)  Insisting that a drug should have had a different compound as its active ingredient is not really a design claim, but it definitely requires a few layers of FDA decisions that cannot be taken for granted.  So, plaintiff’s standard product liability claims were preempted.

Plaintiff asserted (and did not drop) state claim claims for fraud, express warranty, and implied warranty.  The Defendant also moved to dismiss those on preemption, but the court only evaluated them on the adequacy of pleading, presumably because of the doctrine of constitutional avoidance.  So, while the preempted claims were dismissed with prejudice, these three were dismissed without prejudice and the plaintiff was given a little time to try to amend.  We do not know yet if he took a second swing, but, if he did, we expect to see another preemption order out of this case.  Preferably, another one that is concise and correct like this one.


There is no reasonable basis to remand Cazares v. Ortho El Paso, P.A., 2020 WL 4562231 (W.D. Tex. Aug. 7, 2020) because there is no reasonable basis for plaintiff’s strict liability claims against a hospital.  And that is sufficient.

That, however, is not what the magistrate who first ruled on plaintiff’s motion to remand concluded.  While giving lip service to the reasonable basis standard, he actually required a “settled rule” rejecting plaintiff’s theory of liability.  That was a few steps too far.

Plaintiff brought suit in state court in Texas alleging he was injured after receiving an injection of a drug he alleges was contaminated.  Id. at *1.  In addition to suing the manufacturer of the drug, plaintiff sued the hospital where he received the injection.  Id.  Plaintiff’s causes of action were for strict liability, manufacturing defect, negligence, breach of express warranty, and breach of implied warranty.  Specifically against the hospital, plaintiff asserted his strict liability and breach of warranty claims – products liability claims.  While plaintiff is a resident of Texas, all of the defendants, except the hospital, are not.  So, the manufacturing defendants removed the case to federal court alleging that the hospital had been fraudulently joined.  Id.

The motion was originally presented to the magistrate who acknowledged that the standard for determining if a party has been fraudulently joined is whether there is a “reasonable basis for the district court to predict that [Plaintiffs] might be able to recover against [the hospital defendant] in state court.”  Id. at *3.  The magistrate was also correct in stating that to answer that question, the district court should look to the decisions of the state’s highest court or lacking any it should be guided by the decisions of the state’s intermediate appellate court.  Id.  But where the magistrate erred was in tacking on a requirement that fraudulent joinder existed only if there was a “settled rule under Texas law” that plaintiff could not recover against the hospital.  He reasoned that because there is no “settled rule” in Texas regarding whether a hospital could be liable for breach of express warranty, that allowed for reasonable probability that plaintiff could recover against the hospital in state court.  On this basis he recommended the case be remanded.  Id.

The manufacturer defendants objected and the district court judge rejected the magistrate’s recommendation.  In other words, the court denied remand.  Defendants’ primary objection was that the “settled rule” requirement “improperly narrowed” the “no-reasonable basis” analysis.  Id. at *7.  The court agreed.  The district court judge found the Fifth Circuit to be clear in its adoption of only the no-reasonable basis standard.  See Smallwood v. Illinois Cent. R.R. Co., 385 F.3d 568, 573 (5th Cir. 2004) (“To reduce possible confusion, we adopt [the no reasonable basis] phrasing of the required proof and reject all others….”).  The magistrate impermissibly heightened defendants’ burden.  Defendants had to demonstrate no reasonable basis to predict that plaintiffs may recover against the hospital; “it is not their burden, however, to show that Texas state courts have conclusively eliminated the possibility.”  Cazares, at *7.

Applying the proper standard, the court then examined the Texas case law that the magistrate had found unpersuasive.  Such as a Texas appellate court decision explicitly holding that a plaintiff could not recover against a medical center for breach of express warranty. Cobb v. Dallas Forth Worth Medical Center—Grand Prairie, 48 S.W.3d 820, 826–27 (Tex. App. 2001).  The magistrate thought that opinion was too “brief” on the issue to warrant consideration. Or, all of the other cases cited by defendants which while not specifically addressing breach of express warranty, did hold that claims for strict liability and/or breach of implied warranty were not viable against medical providers.  Cazares, at *7-8.

First and foremost, it was not up to the magistrate to decide whether Cobb controlled or not – it does.

Pursuant to Fifth Circuit precedent, it is not within a federal court’s discretion to decide whether it agrees with a state appellate court on issues of state law: a [federal] court must follow the decisions of intermediate state courts’ unless there is ‘convincing evidence that the highest court of the state would decide differently.

Id. at *8 (citations omitted).  The court found no convincing evidence that the Texas Supreme Court would decide the viability of products liability claims against medical providers any differently.  Even if Cobb were not enough, the other cases cited by defendants held that medical providers are not “sellers” of goods and without a sale there could be no breach of implied warranty.  Id. at *9.  Since Texas law applies the same definition of “sale” and “seller” to express warranty claims, there is no reason to believe that Texas courts would rule differently in an express warranty case.  While the magistrate did not address the issue, the rulings in these cases likewise preclude plaintiff’s strict liability claim against the hospital.

Because plaintiff cannot prevail on any of its claims against the hospital, the hospital is not properly joined.  Since all properly joined defendants are diverse, the case stays in federal court.

As we round the clubhouse turn and head into the home stretch of this annus horribilis, our nominee for the word of 2020 is “doom-scrolling.“ We’ve sacrificed entire nights of sleep to our iPads, pursuing the latest news (real, fake, or hybrid) of infectious diseases of both the body and the body politic. Three a.m. lucubrations are seldom tranquil or reassuring. Even when our frenzied internet research steered clear of current controversies, we frittered away hours in an oneiric word association game. And then a gray glow appeared around the fringes of the windows. Trucks rumbled by with dawn deliveries. What would the morning bring us? Weariness sank in, along with resignation. Another damned Covid day.

Last week we alluded to Bertrand Russell’s essays about various luminaries he had met, including Joseph Conrad. It was inevitable that we would take Russell’s essay as a cue to tour Wikipedia and other sites to learn more about Conrad. Most of it we already knew – how Conrad spoke several languages (certainly Polish and French, and possibly German and Russian) before he learned English; how Conrad had a successful career as a seaman; and how Lord Jim, Nostromo, and Heart of Darkness occupy secure places in the Western Canon. Some of it arrived as news – how Conrad’s father was a well-regarded translator of Shakespeare; how Nabokov rated Conrad poorly; and how the great Nigerian novelist Chinua Achebe blasted Heart of Darkness as a racist work that employed African natives as “props for the breakup of one petty European mind.”

It was after midnight when we clicked onto the Project Gutenberg site and reread Heart of Darkness for the first time in 40 years. Most of you have some familiarity with the story, even if only from Apocalypse Now. The narrator, Marlow (think backwards to the British playwright or forwards to Raymond Chandler’s detective) takes a boat upriver into the interior of Africa to meet a manager, Kurtz, legendary for his productivity. His district brought in more ivory than all the others combined. There was a cost to this efficiency. Kurtz’s prolonged stay upriver saw him descend into madness. He had yielded to unspeakable rites and unsound methods, and cast away rationality and anything approximating good intentions. “Exterminate the brutes” became his rule. His final, gasping assessment of his life was “the horror, the horror.”

Achebe was right that the natives in the story are barely accorded any humanity. They are “acute angles” of suffering and are described with epithets unprintable here. We’d be surprised if Heart of Darkness is permitted in current high school curricula. But Conrad wasn’t blind to the cruelty of colonialism. Though the African country is not named in the story, we know it was the perversely named Congo Free State, a private, sadistic playground for Belgium’s King Leopold. Maybe Marlow, the narrator, was indifferent to the injustice (maybe not) but Conrad wasn’t. In most of the tale, Marlow plies up the Congo River into the heart of darkness, but the story begins and ends on the Thames, and Conrad tells us that it, too, flowed into the heart of darkness. The horror visited upon colonial outposts was devised in enlightened Western capitals.

Achebe grudgingly allowed that there is something seductive, almost hypnotic, in Conrad’s prose. We are a long way from Russell’s bracing lucidity. One critic described Conrad’s “adjectival insistence on inexpressible and incomprehensible mystery.” That is an insight, perfectly on point and perfectly expressed, that must leave us breathless. It wonderfully mimics Conrad’s style. Want proof? At one bend of the river, Marlow stares at the banks and sees “the stillness of an implacable force brooding over an inscrutable intention.” Achebe might call that a dehumanizing otherness, but Conrad’s inquiry is more psychological than cultural. Behind the calm coastline, or beneath the veneer of civilization, there is an atavistic mess of fear and desire. There are no rules there, save for the rule of tooth and claw. Call it the heart of darkness.

We lawyers dwell largely on the veneer, and are glad of it. Whatever nobility there is in the profession rests on logic, fairness, proportionality, and incremental gestures in the direction of justice. But sometimes we have to contend with the rawer stuff. Years ago we were at a conference for plaintiff lawyers. A couple of defense hacks had been invited as curiosities. To be fair, we were treated with kindness and respect, and it was exhilarating to hear competing perspectives in a convivial setting. At one point, a plaintiff lawyer whom we rank highly told us about one of his cases. A hospital patient had been exposed to a contrast medical dye that did not exit his body on schedule. That slow exit was due to the patient’s renal insufficiency. The result was that the chemical gradually hardened his internal organs. Death was inescapable and prolonged. In that colorful way that the other side is particularly good at, the plaintiff lawyer characterized the effect as becoming like a statue underneath the skin. That’s a nice turn of phrase, but there was a catastrophic reality underneath the words. The doomed patient spent his last 72 hours on earth screaming on a hospital bed. That, at least, was the story. The horror.

The product was gadolinium. For a while, that story was all we had heard about the dye, and it was alarming. Then we read a Daubert ruling from the gadolinium MDL, and it was one of the most one-sided, anti-defense opinions we ever saw. The gatekeeper seemed strangely selective. Bexis executed a comprehensive take-down of that opinion here. We never got involved with the gadolinium litigation, but we knew it posed enormous challenges.

The Gadolinium litigation evolved, perhaps the plaintiff lawyers overreached, plaintiffs without renal insufficiency filed lawsuits, and defendants turned the corner. This second wave of Gadolinium litigation has been nowhere near as scary as the first. We’ve summarized some good preemption decisions here and here, for example. One was from the Western District of Louisiana. Here is another one: in Smith v. GE Healthcare Inc., et al., 2020 WL 1880787 (W.D. La. March 31, 2020), the magistrate judge recommended dismissal of the plaintiff’s claims for design defect and for failure to warn of the dangers if gadolinium is not completely eliminated from the body.

The design defect claim in Smith ran aground on the Bartlett principle that “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot satisfy those state duties for preemption purposes.” The plaintiff in Smith contended that the gadolinium manufacturer should have made a chemical change, switching from linear bonds to macrocyclic bonds. Whether or not that would be a good idea, it would have been a change to the qualitative formula, thereby constituting a “major change,” as far as the FDA is concerned. Such a major change cannot happen without FDA approval. The manufacturer could not unilaterally have switched to the alternative design for gadolinium. Under the independence and impossibility prongs of post-Bartlett analysis, the design defect claim in Smith was preempted.

The failure to warn claim in Smith also sank on the shoals of preemption. The classic plaintiff maneuver around preemption of failure to warn claims is to assert that the manufacturer was on notice of new risk information and could and should have submitted a warning per the “changes being effected” provision in the FDA regulations. But the risk at issue here was not truly new and did not so much address the health risks of gadolinium retention as it did the predicate fact of retention. More crucially, the SCOTUS Albrecht decision came into play, as there was clear evidence that the FDA would not have approved a warning about the alleged adverse health consequences of gadolinium dye injection. In May 2018, the FDA issued a warning about gadolinium retention, but specifically added that no causal relationship between retained gadolinium and any adverse effect in patients with normal renal function had been established. Thus, the failure to warn claim was preempted and had to be dismissed.

Smith is a sound preemption result in gadolinium litigation, and part of an overall good trend. That trend is not without its hiccups, as we found out last month when we reviewed a bad gadolinium preemption decision out of New Jersey. For some of us, the river that winds its way toward the heart of legal darkness is neither the Congo nor the Thames; it is the Passaic.

Last weekend, the Drug and Device Law Rock Climber passed through to drop off her two dogs – a four-pound Chihuahua and a chubby Pomeranian, now hirsute, who was nearly bald from a skin infection when he was rescued a year ago.  These are very cute dogs who mostly get along with the Drug and Device Law Little Rescue Dogs, and they are frequent houseguests.  This visit will span three weeks, and it did not begin well.  Essentially the moment that the beeps and waves were complete, the Pomeranian made it very clear that he was not feeling well.  One vet visit, one special diet, and one prescription later, we were back home.  Then the Chihuahua got sick.  Same drill, except that tiny dogs are prone to quick and deadly bouts of dehydration, so she also got subcutaneous fluids.  We should mention that the special diet is boiled chicken breast and boiled white rice.  All of the dogs eat together, so we are going on a week of cooking chicken and rice for four, twice each day.  Given the trend, we are waiting for the next shoe to drop.

In that vein, we report today on another shoe dropping on the wrong side of the comment k scale.  In recent months — here and here and here — we have kept you posted as Pennsylvania’s federal courts have wrestled with whether comment k bars strict liability claims against manufacturers of prescription medical devices.  Most of these decisions, including today’s, manage to reach the wrong conclusion, upsetting decades of jurisprudence on what should be a non-issue, (The current flurry started back in December with  Schrecengost v. Coloplast Corp., our eighth –worst case of 2019.  Bexis bemoaned that decision here.)

In today’s case, Patchcoski v W.L. Gore and Assoc., Inc., 2020 WL 4335016 (M.D. Pa. July 28, 2020), the plaintiff underwent hernia repair with the defendant’s mesh in 1999.  He filed suit twenty years later, asserting the usual product liability claims sounding in negligence and strict liability, alleging that he had learned only months before that infected mesh remained in his body after 2001 explant surgery.  Obviously, the defendant moved to dismiss on the ground that the suit was barred by Pennsylvania’s two-year statute of limitations.  That motion was denied and is not the subject of today’s post.

The defendant also moved to dismiss the strict liability claims on the ground that comment k barred them.   As most of you know, comment k to section 402(A) of the Restatement (Second) of Torts exempts manufacturers of “unavoidably unsafe products,” explicitly including prescription drugs, from strict liability for allegedly defective design.  Like similar misguided decisions, the court began by explaining that the Pennsylvania Supreme Court’s 1996 Hahn decision adopted comment k, precluding strict liability across the board in prescription drug cases.  In 2006, in Creazzo v. Medtronic, 903 A.2d 24 (Pa. Super 2006), the Pennsylvania Superior Court held that there was “no reason why the same rationale applicable to prescription drugs” did not apply to prescription medical devices.

In our view, the Creazzo court’s statement is unassailable, for there is no principled (or other) basis on which to distinguish prescription medical devices from prescription drugs or to hold that the latter are “unavoidably unsafe” while the former are not.  For decades, dozens of Pennsylvania federal court decisions acknowledged this reality.  But the Pennsylvania Supreme Court has never addressed this question.

Back to Patchcoski.  The court commented that Hahn was “limited to its facts” and did not “expand comment k to products beyond prescription drugs.”  2020 WL 4335016 at *8.  As we have explained, this is a fallacy.  No “expansion” is necessary to conclude that comment k applies equally to prescription medical devices.  But it provided a “hook” for the court to misconstrue Lance and Tincher to suggest that Pennsylvania would not favor such an “expansion.” The court stated that “Tincher cautions courts against creating such categorical exemptions,” id. at *9-10, but Tincher dealt with steel tubing, not pharmaceutical products   And while the court stated that Lance “more specifically cautions courts against expanding the reach of Hahn and comment k,” id. at *10, Lance held only that comment k did not readily translate into the negligence arena.

But why allow the law to get in the way of a good story.  The court “predicted” that “the Pennsylvania Supreme Court would not categorically extend Hahn and comment k to all prescription medical device manufacturers,” but would “analyze comment k’s applicability on a case-by-case basis determined largely by each case’s developed factual record and the individual characteristics of the medical device at issue.  Id. at *12 (citations omitted).  Motion denied.

We hate this case and the growing body of federal cases reaching the same repugnant holding, and we fear the illusion of authority they create.  We will keep you posted on any new decisions.  In the meantime, it’s time to cook the chicken and rice.  Stay safe out there.



This post comes only from the Cozen O’Connor side of the blog.


If you’re a defendant in a drug or device lawsuit in Arizona court, you have a good chance of avoiding punitive damages.  That’s because Arizona has a statute, a good one.  It exempts manufacturers, including drug and device manufacturers, from liability for punitive damages if their product is designed, made and labeled under an FDA approval or clearance:

A manufacturer, service provider or seller is not liable for exemplary or punitive damages if . . . [t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.

Az. Rev. Stat. Ann. § 12-689(A)(1) (emphasis added).

Note our emphasis on “clearance.”  It’s important.  It means that, in device cases, the statute’s exemption extends, without argument, beyond devices approved under the Premarket Approval process to also include devices cleared under Premarket Notification 510(k).

Taylor v. Boston Scientific Corp., 2020 U.S. Dist. LEXIS 140781 (D. Az. Aug. 4, 2020), is an Arizona case that involves a medical device cleared under 510(k).  So the statutory exemption to punitive damages should apply.  The plaintiff, however, claimed that it did not apply because of one of its exceptions.  That exception is triggered if the manufacturer, upon a determination by the FDA, withheld or misrepresented information material to the approval of the product.  Specifically, it states that the exemption from punitive damages does not apply if the manufacturer:

intentionally, and in violation of applicable regulations as determined by final action of the government agency, withheld from or misrepresented to the government agency information material to the approval or maintaining of approval of the product, activity or service, and the information is relevant to the harm that the claimant allegedly suffered.

Az. Rev. Stat. Ann. § 12-689(B)(2).

This is, in essence, a fraud on the FDA exception.  But it has one important additional element.  The FDA itself must have determined that the manufacturer made material misrepresentations or omissions.  It’s not something that the plaintiff can try to independently prove at trial.

This requirement doomed the Taylor plaintiff’s request for punitive damages from the start.  She alleged no facts to suggest that this exception applied, in particular to suggest that the FDA had made such a determination.  Instead, she appears to have simply recited the language of the statute’s exception.  As we all know, “formulaic recitations of the elements,” along with allegations “devoid of factual support,” are insufficient to survive a motion to dismiss.  Taylor, 2020 U.S. Dist. LEXIS 140781, at *14.  And so the court dismissed her request for punitive damages at the pleadings stage.  Id.

This isn’t the first time we’ve seen courts apply Arizona’s statutory exemption to dismiss requests for punitive damages.  We talked about it here and here.  It is about as strong a statutory exemption as you’ll see.  And it’s why drug and device manufacturers in Arizona courts have a good chance of never seeing a punitive damages phase at trial.  And trust us, that’s something that you don’t want to see.

Some of us belong to the Food and Drug Law Institute.  One benefit of FDLI membership is a daily newsletter on FDA-related issues.  The other day that newsletter’s top two links were both COVID-19 related – and we found both of them concerning.

The first item the newsletter featured was this story on “The Hill” entitled “Fauci:  ‘I seriously doubt’ Russia’s coronavirus vaccine is safe and effective.”  It’s concerning because that’s not at all what Dr. Fauci actually said – and that matters.  His actual quote, from a longer interview you can watch here, is “Having a vaccine and proving that a vaccine is safe and effective are two different things.”  So Dr. Fauci didn’t “seriously doubt” whether the Russian “Sputnik V” vaccine (“SVV”) was safe and effective.  Rather, he questioned, quite rightly, if that vaccine had been “proven” safe and effective.

It has’t.  But….

Prescription medical products frequently turn out to be safe and effective without having been “proven” to be that way.  That’s what off-label use is all about.  By definition, off-label use has not been “proven” to be safe and effective, at least not to the FDA’s demanding standards, but nonetheless off-label use is frequently considered by physicians to represent the medical standard of care.  That means, among other things, that it can be malpractice not to use a product off label where doing so is the accepted standard of care.  We’ve discussed this “proven” issue a decade ago, when we criticized plaintiffs (and an occasional court) for trying to flip the burden of proof by arguing that defendants have to “prove” their products’ safety, when the common law (as opposed to the FDCA) imposes that burden on plaintiffs.  So medical products can work just fine without having been “proven.”  It’s not illegal; it’s not a tort; and it happens all the time.

As one of our favorite non-legal bloggers, Skeptical Raptor, has detailed, what the Russians are doing massively violates generally accepted medical ethics.  They have completed only “Phase I” trials, meaning that a small population (here, 38 people) has received the product, it has no immediately disqualifying adverse effects, and it might work.  However, that “phase I trial only included the researchers who developed the vaccine,” which is an immediate red flag.  Id. This kind of self-testing creates huge potential for bias:

[I]t’s the epitome of bias is having the researchers research themselves. They, of course, want the vaccine to work and to be safe, so they’ll overlook anything to make that happen.  And that, my friends, is why it’s no longer ethical to use oneself as an experimental subject.


In everywhere but Russia, Phase I is only the beginning.  The various developers of dozens of would-be COVID-19 vaccines elsewhere are undertaking large (many thousands of participants) Phase III clinical trials, to do precisely what Dr. Fauci advocates – prove (or disprove) their products’ safety and effectiveness.

Russia has decided to skip that step and essentially use the country’s population as guinea pigs for SVV.  It’s entirely possible that Sputnik V will turn out to be Chernobyl II – a disaster that will discredit both Russia’s COVID response and its broader scientific reputation.

But what if it doesn’t?  What if, like many off-label uses of prescription medical products, SVV actually works?  Not every cut corner, no matter how brazen, results in a head-on collision.

That brings us to the second COVID-19 article that FDLI’s update had for us, a Reuters piece entitled “U.S.’s Azar says any U.S. vaccine would be shared once U.S. needs met.”  Apparently Health Secretary Azar made some “America first”-type statements recently in Taiwan:

“Our first priority of course is to develop and produce enough quantity of safe and effective FDA-approved vaccines and therapeutics for use in the United States,” Azar told reporters while on a visit to Taiwan.

Id.  Only “once those needs are satisfied, [would] those products . . . be available in the world community.”  Id.  In other words, the devil take the hindmost.

But Secretary Azar’s comments assume American medical autarky.  An American company may well not produce the first safe and effective COVID-19 vaccine.  It could be the Russians, if their extremely risky decision to release the scientifically unproven CVV in fact bears fruit.  Or it could be one of the other “more than 200,” COVID-19 vaccine candidates from around the world that this article mentions in passing, many of which are being pursued by overseas companies.  If the United States is not willing to share our breakthroughs with anyone else until all our needs are satisfied, we should not expect the Russians or anyone else to do us any favors, if some other country’s efforts grab the brass ring first.  Force majeure is a two-way street, and it could result in the United States not having timely access to a safe and effective COVID-19 vaccine first developed overseas.

We’re taking a timeout from our summer reading parade of baggy 19th Century novels. After gorging ourselves on Dickens, Dostoyevsky, Thackeray, Trollope, and Tolstoy, it was time for a palate cleanser. We kept Anna Karenina on the sideboard and picked up a slim volume of Bertrand Russell’s essays.

Analytic philosophy always left us cold. Perhaps we were simply too stupid and impatient in our college days. Perhaps that “perhaps” was misplaced. Now we opened Russell’s essays with guarded expectations. To our pleasant surprise, Russell was warm and witty. There was a lot more than icy theory in these pages. Russell occupied the public arena as well as the ivory tower. The British government jailed Russell during World War I for his pacifism. Interestingly, Russell looked back on his incarceration as a period of great productivity. He also stuck to his non-guns, arguing that if Great Britain had stayed out of the war and permitted a quick Kaiser victory, the 20th Century might have been spared the scourges of Lenin, Stalin, and Hitler.

Many of Russell’s essays are “portraits from memory” of some of his era’s great figures: G.B. Shaw, H.G. Wells, D.H. Lawrence, Joseph Conrad, George Santayana, Ludwig Wittgenstein, etc. Russell’s era was long, indeed. He was born in 1872 and died in 1970. Russell’s parents perished when he was young, so he was raised by his grandparents. His grandfather had been Prime Minister twice and had met Napoleon. (It is hard to think of an American equivalent. As a lawyer, we naturally think of Oliver Wendell Holmes, who shook hands with both John Quincy Adams and John F. Kennedy.)

We enjoyed our visit with Russell and recommend his company to any of you. Russell was a man of extraordinary talents and virtues. He was intelligent. He was honest. He was self-critical. Most refreshing of all to us, he was concise and clear.

Accordingly, it was our hope today to turn to a concise and clear case. Would you accept one out of two? Kline v. Mentor Worldwide LLC et al., 2019 WL 3245102 (July 19, 2019), is a short case (the very name of the plaintiff would seem to promise that) but hardly clear. Four plaintiffs sued three companies for injuries allegedly caused by breast implants. The lawsuit was filed in state court in Sacramento, though only one of the plaintiffs was a citizen of California. We’d call the other three plaintiffs litigation tourists, but we’ve never considered Sacramento to be a tourist destination. Whether one wants amusing diversions or generous juries, Los Angeles or the Bay Area are more inviting places for plaintiffs. (Plus, after watching “I’ll Be Gone in the Dark,” the HBO series about the Golden State Killer, who did much of his killing in the Sacramento area, does Sacramento really seem very appealing? Then again, San Francisco had Zodiac, and LA had Manson, the Hillside Strangler, and the Night Stalker … and now we are walking down a dark True Crime alley.)

Whatever the reason for the plaintiffs’ decision to file the case in Sacramento, the defendants removed the case to federal court. But there was a problem. Actually, there were two problems. First, one of the defendants shared citizenship with the sole California plaintiff, thereby destroying diversity. Second, another of the defendants shared Pennsylvania citizenship with one of the plaintiffs. Was the Kline case headed for swift remand?

In the end, the answer is Yes.

The defendants argued that the California defendant was fraudulently joined. It was a mere holding company and had nothing to do with the manufacture or sale of the breast implants at issue. Further, the defendants argued that the plaintiffs’ cases – certainly the California and Pennsylvania plaintiffs’ cases – should be severed. In a sense, what we have in Kline is a case with both plaintiffs and defendants who have been improperly joined. The Kline court addressed the fraudulently joined defendant, but decided not to address the severance issue. Before we talk about what that means, let’s talk about how the Kline court got to that result.

It is hard for a defendant to win a fraudulent joinder argument. The Kline court recognized a “general presumption against a finding of fraudulent joinder.” It also held that “a removing party must prove by clear and convincing evidence that joinder was fraudulent” and that the district court must remand if there is a “non-fanciful possibility” of stating a claim against the non-diverse defendant. (Compare that to the Seventh Circuit’s “any reasonable probability of success” standard about which we wrote last week and which seems more forgiving in theory, if not in practice.)

As if that isn’t hard enough, a C.D. Cal. judge in a similar case had held that the selfsame alleged holding company had not been fraudulently joined. That is what we in the biz call a bad precedent. Nevertheless, the defendant prevailed on its fraudulent joinder argument in Kline because it presented a strong evidentiary record, consisting of affidavits and deposition testimony to the effect that the California company had ownership interests but no business activity. The earlier court did not have such an evidentiary feast placed before it. The most awkward fact for the holding company defendant was its filing with the California Secretary of State that it was engaged in the “Manufacture of Silicon Products.” Oops. But the sworn statements submitted by the defendant established that the filing was a mere clerical error. The plaintiffs offered skepticism, but no contrary evidence. The one-sided presentation meant that the defendants had met their heavy burden for fraudulent joinder. The plaintiffs could not muster any “non-fanciful possibility” claim against the non-manufacturing/non-selling defendant, so that defendant had to be dropped from the case. Kudos to the defense side for learning from the earlier case and improving the state of the evidence. Facts might be stubborn things, but factual records need not be.

We still did not have federal diversity jurisdiction in Kline, because Pennsylvania citizens sat on both sides of the v. The defendants, quite rightly in our view, contended that the various plaintiffs should be severed because they were improperly joined under Federal Rule of Civil Procedure 20 and no plaintiff was necessary and indispensable under Rule 19. It is not as if the plaintiffs had anything to do with each other. They weren’t involved in the same transaction, event, or occurrence. It is not as if they were all victims of the same bus crash. This analysis seems perfectly obvious to us. The logic is clear. If Bertrand Russell had extended his lifespan a mere 50 years, we feel sure he’d be with us on this point. But alas, Russell is dead and so is logic in California. Several federal courts in California had decided that California state courts were competent to decide the severance issue on remand. That is what happened in Kline. The court in Kline remanded the case, muttering (at least, that is how we read it) that “[i]t does not appear that doing so will frustrate defendant’s statutory right if removal in the event that the state should subsequently sever [our copy said “severe,” which is almost a Freudian slip] plaintiffs’ claims.” Really? Why is fraudulent joinder of defendants a federal issue, but misjoinder of plaintiffs is a state issue? How can it serve judicial economy to remand a case that must come back to federal court if the state judge is sentient and/or fair?

And just like that, we have been ousted from Russell’s analytic philosophy and hurled back into Dickens, where the law is — well, you know.

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 GrinnellSee 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 BledsoeHuss 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.