As Sergeant Joe Friday instructed, just the facts, as Shook was involved.  Those interested in the preemption doctrine will want to read the opinion by Judge Saylor in In Re Zofran, granting summary judgment for defendant and applying the first prong of Wyeth as clarified by Merck v. Albrecht.

In re Zofran (Ondansetron) Prod. Liab. Litig., No. 1:15-MD-2657-FDS, 2021 WL 2209871 (D. Mass. June 1, 2021).

The Eleventh Circuit recently affirmed a jury verdict for defendant in a suit alleging that it sold faulty wood chippers to an equipment rental company.  James v. Terex USA, LLC, No. 20-14553, 2021 WL 2137599 (11th Cir. May 26, 2021).

At trial, the plaintiff  sought to introduce lay testimony from a Shane Dinkins about his experience with a different model of wood chipper that he bought from Terex. Plaintiff argued Dinkins’s testimony about his experience with his own wood chipper was necessary to impeach Terex’s opening statement that it “stood behind all its products.” The district court found to the contrary — that Dinkins’s experience with his own wood chipper would be prejudicial because he purchased a completely different model of chipper and so his experience was not similar enough to that of plaintiff.  And even if Dinkins experienced the same type of problem with his different model of wood chipper, the district court deemed that testimony unnecessarily cumulative under Rule 403.  Plaintiff had many opportunities to introduce evidence that undermined Terex’s theme that it responded to every claim for repair and made the repair.  A number of employees testified about their frustrations with Terex’s chippers and what, in their view, was an insufficient response from TerexPlaintiff offered no reason why the omission of testimony about similar experiences with a dissimilar product substantially prejudiced its ability to impeach Terex’s “theme” presented during its opening statement.

Plaintiff also made the obligatory and hard to show argument that the jury verdict went against the weight of the evidence.  There was no dispute that the chippers had some problems. So the only conflicting testimony was about whether Terex appropriately responded when  informed of these problems. On that point, the jury was presented with evidence sufficient to support its defense verdict.  A number of Terex employees testified that they responded to each of the reported problems with both chippers and, at times, even went above and beyond by providing repairs that were not technically covered by the warranty.  2021 WL 2137599, at *3.

The Tenth Circuit recently affirmed the dismissal of a suit seeking to hold a gunmaker n liable for injuries a woman alleged she suffered when a rifle fired spontaneously.  Harris v. Remington Arms Co., LLC, 997 F.3d 1107 (10th Cir. 2021). The case turned on the admissibility of plaintiff’s expert evidence.

Roughly two years after buying the rifle, Ms. Harris took it to hunt. As she climbed to a tree stand, the rifle got tangled in mesh. Ms. Harris alleged that when she had tried to free the rifle from the mesh, the safety moved to the “off” position and the rifle fired into her hand without anyone pulling the trigger. Ordinarily, a rifle has two separate safeguards preventing an unintentional shot. The first is the safety mechanism. When the safety is on, the rifle can’t fire. The second is the trigger mechanism. Remington puts space between the mechanisms for the safety and trigger so that a user must pull the trigger to fire the rifle.

Plaintiff’s expert first opined that a bond had formed between the two separate mechanisms after the Harrises engaged the safety and stored the rifle in a cold room, causing a liquid bonding agent to solidify. But there was a logic issue here. Remington argued that if a bond had formed from the cold, the rifle would have improperly fired when Mr. Harris turned the safety off at least a year earlier in order to clean the rifle. There was nothing to suggest that the rifle had misfired before Ms. Harris went to hunt. And once the bond broke, the liquid bonding agent wouldn’t solidify again. Confronted with Remington’s argument, the expert changed his explanation, opining for the first time that the bond had formed when a lubricant (called “Molykote”) moved between the safety and trigger mechanisms and caused the liquid bonding agent to solidify.

This raises an important question.  Is expert discovery like a tennis match, with volley responding to volley?  Most courts say it is not. Here, the Harrises did not timely disclose Mr. Powell’s opinion testimony about the movement of Molykote. This opinion did not appear in Mr. Powell’s expert report or deposition testimony, and the Harrises did not disclose this opinion until more than two months after the deadline for expert reports. Id. at 1112.

In deciding whether the delay was harmless, the court considered four factors:

1. the prejudice or surprise to Remington if Mr. Powell could present his new opinion testimony about the movement of the Molykote,
2. the opportunity for Remington to cure the prejudice,
3. the potential for the new opinion testimony to disrupt the trial, and
4. the Harrises’ bad faith or willfulness.
See Jacobsen v. Deseret Book Co., 287 F.3d 936, 953 (10th Cir. 2002).

Here, the district court properly found that

The district court explained that:
• the introduction of the new Molykote opinion would have delayed the trial,
• the case had lingered longer than most of the cases on the court’s docket, and
• the Harrises could have learned earlier about the effect of the Molykote.

Lacking an expert opinion on these issues of defect and causation, summary judgment was granted. And the court of appeals affirmed.

The U.S. Supreme Court overturned the Fourth Circuit’s decision to send a local climate change case against various energy companies. BP P.L.C. v. Mayor & City Council of Baltimore, 141 S. Ct. 1532, 1533 (2021).

Baltimore’s Mayor and City Council sued various energy companies in Maryland state court alleging that the companies concealed the environmental impacts of the fossil fuels they promoted (as if this was an issue no one outside the energy industry could look at). The defendant companies removed the case to federal court invoking a number of grounds for federal jurisdiction, including the federal officer removal statute, 28 U.S.C. § 1442. The City argued that none of the defendants’ various grounds for removal justified retaining federal jurisdiction, and the district court agreed, issuing an order remanding the case back to state court.

Readers who are civil procedure aficionados may recall that although an order remanding a case to state court is ordinarily unreviewable on appeal, Congress has determined that appellate review is available for those orders “remanding a case to the State court from which it was removed pursuant to section 1442 or 1443 of [Title 28].” § 1447(d). The Fourth Circuit, however, read this provision to authorize appellate review only for the part of a remand order deciding the § 1442 or § 1443 removal ground. It therefore held that it lacked jurisdiction to review the district court’s rejection of the defendants’ other removal grounds.

The Supreme Court (7-1) held that the Fourth Circuit erred in holding that it lacked jurisdiction to consider all of the defendants’ grounds for removal under § 1447(d).  The “order remanding a case” here rejected all of the defendants’ grounds for removal because (subject to exceptions not applicable here) the district court was not at liberty to remove the City’s case from its docket until it determined that it lacked any authority to entertain the suit. See, e.g., Carnegie-Mellon Univ. v. Cohill, 484 U.S. 343, 356, 108 S.Ct. 614, 98 L.Ed.2d 720; see also Sprint Communications, Inc. v. Jacobs, 571 U.S. 69, 72, 134 S.Ct. 584, 187 L.Ed.2d 505 (“[C]ourts are obliged to decide cases within the scope of federal jurisdiction” assigned to them). And this case was removed “pursuant to” § 1442 because the defendants relied on § 1442 as a ground for removal when satisfying the requirements of § 1446. It makes no difference that the defendants removed the case “pursuant to” multiple federal statutes.

The Court’s most analogous precedent, Yamaha Motor Corp., U. S. A. v. Calhoun, 516 U.S. 199, 116 S.Ct. 619, 133 L.Ed.2d 578, resolves any remaining doubt about the best reading of § 1447(d). That case involved a dispute about the meaning of § 1292(b)—a statute allowing a district court to certify “an order” to the court of appeals if it “involves a controlling question of law.” The Court held that the statute’s grant of appellate review for the “order,” meant the entire order was reviewable, not just the part of the order containing the “controlling question of law.” Id., at 205, 116 S.Ct. 619.

The City’s “policy” arguments do not alter the result because “even the most formidable” policy arguments cannot “overcome” a clear statutory directive, Kloeckner v. Solis, 568 U.S. 41, 56, n. 4, 133 S.Ct. 596, 184 L.Ed.2d 433. While the City argues that allowing exceptions to the bar on appellate review of remand orders will impair judicial efficiency, that is the balance that Congress struck for cases removed pursuant to § 1442 or § 1443. And allowing full appellate review may actually help expedite some cases.

The Court declined to consider the merits of the defendants’ removal grounds and remanded for the Fourth Circuit to consider those matters in the first instance.  So that battle will continue there.

 

The Tenth Circuit affirmed the grant of summary judgement against a plaintiff who argued that a forklift was defective in design because it lacked a door. Petersen v. Raymond Corp., 994 F.3d 1224, 1225 (10th Cir. 2021).

Plaintiff allegedly injured himself while operating the Raymond Model 4200 stand-up counterbalance lift truck. The Raymond forklift has an open compartment meaning it does not fully enclose the operator’s lower extremities. When Plaintiff lost control of the Raymond forklift, his left leg slid out of the open compartment and he crushed it against warehouse racking. Plaintiff proposed to offer expert testimony that adding a door could cure this deficiency. But Plaintiff’s expert did not commit to the specific type of door he believed necessary. Instead, he offered that any number of doors would have worked.  Surely many doors are better than one? or none?

Not so fast. Under Utah law, a plaintiff bringing a strict products liability claim must show that at the time of the injury an “alternative, safer design, practicable under the circumstances” existed. Allen v. Minnstar, Inc., 8 F.3d 1470, 1476, 1479 (10th Cir. 1993).  Plaintiff argued the district court improperly had found that Utah law limits a plaintiff to offering only one alternative design. But the district court did not make such a finding. In fact the district court explicitly referenced that sometimes “multiple design options are warranted.” But, the district court found that Plaintiff’s expert failed to commit to any definitive feasible design alternative.  And it rightfully excluded his testimony on that basis.

Without a definitive design, neither Plaintiff’s expert nor the district court could meaningfully compare any proffered design with the existing design. And neither could a jury. For this reason, the district court did not abuse its discretion in excluding Plaintiff’s expert’s testimony for failure to offer any specific safer, alternative design.  Contrary to Plaintiff’s argument, the district court did not exclude Plaintiff’s expert’s testimony because experts could differ on whether adding a door would on whole be a safer alternative design. The district court found Plaintiff’s expert’s opinions unreliable because
Plaintiff’s expert failed to say how he considered the various doors listed in his report; failed to identify any scientific or technical analysis he applied to each, or any of them, and offered no scientific support for his naked conclusion that each or any of them is safer than the Raymond design.
For a jury to find an alternative design “safer” than the Raymond design, a comparative analysis must be possible. See Restatement (Third) of Torts, Prod. Liab. § 2 cmt. d (1997) (“Assessment of a product design in most instances requires a comparison between an alternative design and the product design that caused the injury ….”). And so Plaintiff had to offer at least one definitive competing design. See Allen, 8 F.3d at 1480–81 (“[I]n showing that the product can be made safer through the use of devices, a plaintiff must show that the devices exist and are not merely speculative.” (internal quotation marks and citation omitted)). A jury cannot compare the existing design to, essentially, anything and everything else. Plaintiff’s expert did not commit to any door design. Without commitment to any design, Plaintiff’s expert offered only sweeping opinions about doors in general. Plaintiff’s expert argued that he could put a door on the Raymond forklift, but he had never done so. 994 F.3d at 1228–29. Affirmed.

Just the facts, as Shook is involved in the litigation.  But worth a read is In re Taxotere (Docetaxel) Prod. Liab. Litig., 994 F.3d 704 (5th Cir. 2021).

There the Fifth Circuit upheld the lower court’s decision granting defendant summary judgment in  suit alleging the pharmaceutical company failed to warn that its lifesaving chemotherapy drug Taxotere carried a risk of permanent hair loss, as patient did not demonstrate that the alleged failure caused her injury.

Pursuant to the Louisiana Products Liability Act, a plaintiff asserting a failure-to-warn claim must prove: (1) a manufacturer’s failure to adequately warn the prescribing physician of a risk associated with the product that the physician did not otherwise know about, and (2) that the failure to warn was the cause in fact and the proximate, or legal, cause of the plaintiff’s injury. Kampmann v. Mason, 921 So. 2d 1093, 1094, 1096 (La. App. 5 Cir. 2006) (citing La. Stat. Ann. § 9:2800.57 (West 2013)).  To prove causation in this context, a “plaintiff must show that a proper warning would have changed the decision of the [prescribing] physician, i.e. that but for the inadequate warning, the [prescribing] physician would not have used or prescribed the product.” Willett v. Baxter Int’l, Inc., 929 F.2d 1094, 1099 (5th Cir. 1991); accord Sharkey v. Sterling Drug, Inc., 600 So. 2d 701, 711 (La. App. 1 Cir. 1992), writs denied, 605 So.2d 1099 and 605 So.2d 1100 (La.).
Plaintiff alleged she might have done something different. The causation analysis in a failure-to-warn claim asserted against a drug’s manufacturer thus is focused on the prescribing physician’s decision to prescribe the drug. Willett, 929 F.2d at 1099; accord Sharkey, 600 So. 2d at 711. So, to the extent that patient choice is relevant, that relevance is cabined to helping the court to decide whether plaintiff’s evidence—including that of other available treatments and the importance she places on her appearance—is sufficient to introduce a genuine dispute of material fact as to whether Dr. Sonnier’s prescribing decision would have been different had he known that Taxotere’s associated risk of alopecia was potentially permanent rather than temporary. 994 F.3d 704, 709.
The prescriber testified that a Taxotere label warning of potentially permanent hair loss—as opposed to temporary hair loss—would not have changed his decision to use the Taxotere-based chemotherapy to treat plaintiff’s breast cancer.  There was a potential alternative, specifically Anthracycline-based therapies. But these alternatives to the Taxotere-based TCH carried a risk of cardio-toxicity and are not recommended for use in those over the age of sixty-five. In light of the fact that Phillips was seventy-five and had pre-existing heart conditions, Dr. Sonnier did not prescribe these alternatives.  Affirmed.

Your humble blogger had the privilege some years ago of serving as  Legal Fellow at the Salzburg Global Seminar in Austria.  This unique organization was founded in the ruins of WWII to serve as a sort of “Marshall Plan of the Mind” and a critical element of recovery from the war.  At our session (Lloyd Cutler was the Chair and Justice O’Connor was on the faculty), the theme was transnational legal institutions, at a time in which the EC was evolving into the EU.  A frequent question to us was to explain and describe the relationship between U.S. states and the federal government. And part of our remarks went to the the application of federal or state law, and painting a picture of the role of the federal courts in predicting state law and applying state law as a state supreme court has interpreted it.

That brings us to today’s case, in which the Seventh Circuit reversed a verdict against various paint makers in a trial of claims that lead-based paint pigment caused brain damage to the plaintiffs. Burton v. E.I. du Pont de Nemours & Co., Inc., 994 F.3d 791 (7th Cir. 2021). The reversal was based on the trial court having improperly expanded Wisconsin tort law, and in particular its version of the so-called risk-contribution theory.  In Wisconsin, the rule had its origins in Collins v. Eli Lilly Co., 116 Wis.2d 166, 342 N.W.2d 37 (1984) a DES case. And indeed the few courts that have recognized some version of this rule excusing plaintiffs from proving product identification (that the defendant made and sold the product that injured them) have done so in the DES context.    The goal of this burden-shifting procedure was to create “a pool of defendants which it can reasonably be assumed could have caused the plaintiff’s injuries.” Id. at 52. The court acknowledged that the risk-contribution theory could result in liability for innocent defendants, but it accepted this possibility as “the price the defendants, and perhaps ultimately society, must pay to provide the plaintiff an adequate remedy under the law.” Id.  You can see why we think it is a dangerous notion.

In Thomas ex rel. Gramling v. Mallett, 2005 WI 129, 285 Wis. 2d 236, 701 N.W.2d 523 (2005), the Wisconsin Supreme Court extended the risk-contribution theory to white lead carbonate pigment. The court rejected the manufacturers’ argument that white lead carbonate—which came in three different chemical formulas—was not fungible. because it was supposedly functionally interchangeable; rejected the argument that Collins should not apply because lead poisoning had multiple potential causes and did not produce a “signature injury.” and rejected the argument that Collins should not apply because the pigment manufacturers were not in exclusive control of the risk that their product created. Yet, a plaintiff’s burden was relaxed “only with respect to establishing the specific type of DES the plaintiff’s mother took, which, in this case, translates into the specific type of white lead carbonate Thomas ingested.” Id. Two Justices dissented, expressing dismay that the pigment manufacturers could be “held liable for a product they may or may not have produced, which may or may not have caused the plaintiff’s injuries, based on conduct that may have occurred over 100 years ago when some of the defendants were not even part of the relevant market.” Id. at 567–68 (Wilcox, J., dissenting); see also id. at 590 (Prosser, J., dissenting) (“[T]his court has now created a remedy for lead paint poisoning so sweeping and draconian that it will be nearly impossible for paint companies to defend themselves or, frankly, for plaintiffs to lose.”).

In Godoy ex rel. Gramling v. E.I. du Pont de Nemours & Co., 319 Wis.2d 91, 768 N.W.2d 674 (2009), the court rejected Godoy’s argument that the product in question was actually “residential paint pigment.” Id. at 682.  Plaintiffs in products liability cases, the court explained, “must—at minimum—identify the product alleged to be defective.” Id. “Doing so puts the defendant on notice and allows the defendant to begin building a defense.” Id. More fundamentally, the product at issue could not be residential paint pigment because the risk-contribution theory applied only to “fungible and identically defective” products. Id. In Thomas, that product was white lead carbonate pigment. The court made clear that it had never applied the risk contribution theory to “residential paint pigment,” or to “paint containing white lead carbonate.” Id. at 683 & n.10. On the merits, the court rejected Godoy’s argument that white lead carbonate was defectively designed.  “A claim for defective design cannot be maintained where the presence of lead is the alleged defect in design, and its very presence is a characteristic of the product itself. Without lead, there can be no white lead carbonate pigment.” Id. at 685.

In 2011, the Wisconsin legislature passed Wis. Stat. § 895.046, which effectively overruled Thomas while preserving Collins. The statute reinstates ordinary causation principles in all products liability cases, while carving out a narrow exception for plaintiffs who have no other remedy and whose injuries stem from a “complete[ly] integrated product” produced in “chemically and physically identical” forms and sold in generic packaging. § 895.046(4).

And that is where the error started to creep in. Each of the defendants was both a white lead carbonate manufacturer and a manufacturer of finished paint products at various points in the twentieth century. The risk-contribution theory, as it evolved in Wisconsin, applies to them only in their capacity as manufacturers of white lead carbonate. In Thomas, the court invariably referred to the defendants as “pigment manufacturers.” The court used this term when setting forth the elements of Thomas’s cause of action.  701 N.W.2d at 564. At one point, the court even drew a critical distinction between “pigment manufacturers” and “paint manufacturers.” The pigment manufacturers in Thomas had argued  that they should not be liable because they “were not in exclusive control of the risk their product created …” Id. at 563. In other words, the pigment manufacturers attempted to shift the blame to paint manufacturers—the companies that sold lead-based paints directly to consumers. The court rejected this argument. In doing so it analogized paint manufacturers to DES drug prescribers: while paint manufacturers mixed white lead carbonate into paint, they “did not alter the toxicity of the white lead carbonate anymore than the pharmacist did by filling a prescription.” Id. If anything, “the paint manufacturers actually diluted the white lead carbonate’s toxicity.” Id. (emphasis added). “[T]he inherent dangerousness of the white lead carbonate pigment existed the moment the Pigment Manufacturers created it.” Id. (emphasis added).  994 F.3d 791, 812–13 (7th Cir. 2021).  And the plaintiffs could not dispute that the key feature of DES and white lead carbonate—fungibility—does not carry over to paint, so the core rationale of Collins and Thomas is inapplicable to paint and paint manufacturers. [Fungibility was a legal question. If fungibility were a fact question, then Thomas would not have held that white lead carbonate was fungible; it would have held instead that there was a fact issue as to fungibility that precluded summary judgment for the pigment manufacturers.]

For years, thus, the defendants had litigated under the (valid) assumption that they were liable only in their capacity as pigment manufacturers. Less than six weeks before trial, however, the defendants learned for the first time that they were also subject to liability as manufacturers of paint products containing white lead carbonate. The court’s last-minute, legally incorrect ruling left them scrambling to adapt their defenses to the plaintiffs’ newly enlarged theory of liability.  994 F.3d 791, 814–15. One defendant’s potential liability went from narrow seven-year period (1917 to 1924)  to a nearly fifty-year period.  Another’s window of liability expanded from a 37-year period in the first half of the twentieth century (1910 to 1947) to a 90-year period (1880 to 1969). Id. at 815.

These errors shaped the trial and impermissibly expanded the defendants’ potential liability. Along with a separate error in the admission of certain expert testimony (which we don’t get into today), these warranted a reversal of the judgments and a remand for further proceedings.

A California judge overseeing the JCCP for diabetes drugs recently made a significant ruling, dismissing more than 500 claims in the coordinated proceeding that alleged the drugs were linked to pancreatic cancer.  In Re Byetta Cases, No. JCCP4574, 2021 WL 2462800 (Cal.Super. Apr. 06, 2021). The Court made both evidentiary rulings regarding plaintiffs’ experts and a decision on preemption in this long-running litigation.

Regarding experts, the court found the unwillingness or inability of the experts (particularly Drs. Madigan, Wells, and Gale) to grapple with all the available epidemiological evidence to be “troubling.”  2021 WL 2462800, at *1.  The court emphasized that the issue was not, as plaintiffs argued, whether an expert can offer an opinion that a substance can cause a disease in the absence of epidemiology, but whether the expert can offer an opinion without taking into account all the existing epidemiology.  “The plaintiffs here would have a much more procedurally respectable expert opinion on the essential issues of general causation if the opinions had considered all the available epidemiological evidence and not just the state of research as it existed in 2015 with limited consideration of studies done thereafter,” the judge reasoned.  Even worse, plaintiffs’ counsel provided a two-hour overview of the scientific evidence and documents they believe support causation including references to numerous studies, documents and analyses that, in large part, never were considered by their experts and, in some cases, were created by plaintiffs’ counsel. Id. at *2. The judge also noted that one expert’s  conclusions in this case were undermined by a peer-reviewed article he published in 2016, which does not repeat his conclusions about the alleged link between the medications and pancreatic cancer, but instead that a potential link requires “further study.”

Without admissible expert opinions, the judge granted summary judgment, but continued to analyze whether the claims were preempted under federal law. The court perceived the key issue to be whether the product label could have been amended by the unilateral action  through a Changes Being Effected (“CBE”) label change to add disclosure of a risk of pancreatic cancer without running afoul of the FDA and its supervisory authority over prescription drug labels. 2021 WL 2462800, at *12.  The court noted that plaintiffs—as the parties urging that the FDA should have been presented with additional information by the manufacturers—have the burden of persuasion as to what that information was. The court lists and assess 17 categories of information that the FDA allegedly did not have, concluding that the information did not constitute newly acquired evidence, because the FDA had it, or it was not scientifically significant, or was out of date and superseded by newer, better data.  For example, plaintiffs referred to a Health Canada view of causation, but defendants have persuasively shown that Health Canada, the Canadian counterpart to the FDA, has swung around to express the view that no association of these drugs with pancreatic cancer is shown.  Regarding allegedly unreported data, for example, there have been a number of new studies of the possible connection between pancreatic cancer and incretin-based therapies—to name just a few, the TECOS, LEADER, and EXSCEL studies contained thousands of patients who received defendants’ drugs. The presence of a mountain of new data at the present indicates that the prior pooled data analysis—standing alone—is now out of date and unreliable, and thus its supposed effect on the FDA would be irrelevant in light of the new data.

So, while the Court has seriously considered each piece of plaintiffs’ proposed “new safety evidence,” the Court made the predicate finding of one of the “brute facts” needed to resolve this legal question: plaintiffs have failed to show that defendants failed to provide the FDA in a timely fashion with one or more piece of additional safety evidence which might have a tendency to change the FDA’s behavior.

Turning to the second prong of preemption analysis, the court stated that FDA’s consistent evaluation and reevaluation of a product, coupled with its obligation to raise new safety information with the manufacturer when such information independently comes to the agency’s attention, constitute “official action” for the purpose of preemption. The FDA has treated with the subject of suitable labels for incretin-based mimetic products repeatedly over the last five-plus years. Its consistent declination of addition of a pancreatic cancer warning when it is otherwise officially approving such label changes does show “agency action” under its delegated authority sufficient to support application of the Supremacy Clause.  2021 WL 2462800, at *21.

 

In a much anticipated decision, the Supreme Court unanimously (8-0 with 2 concurrences) decided that certain resident plaintiffs injured by products originally manufactured and sold elsewhere could sue in their home states a defendant which was a nationwide company if it “purposefully avail[ed] itself of the privilege of conducting activities within the forum State.”  Ford Motor Co. Montana Eighth Judicial District Court, ___ S. Ct. ___, 2021 WL 1132515, at *4 (U.S. March 25, 2021).

The Court rejected the argument that the needed link to support personal jurisdiction must be causal in nature: the argument jurisdiction attaches “only if the defendant’s forum conduct gave rise to the plaintiff ’s claims.” This would, in a case like this, lead to locating specific jurisdiction in the State where Ford sold the car in question, or else the States where Ford designed and manufactured the vehicle. 141 S. Ct. 1017, 1026.

What is of particular interest to our readers is the Court’s re-emphasis of the meaning of Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017)(BMS), a decision recognizing that there can be no personal jurisdiction in suits brought by forum-shopping non-residents whose use of the product and alleged injuries occurred elsewhere.

Throughout Ford the Court emphasized this distinction- that the plaintiffs here were not litigation tourists.

-The suits were brought by state residents in Montana’s and Minnesota’s courts.

-Each plaintiff ’s suit arose from a car accident in one of those States.

-Ford had advertised, sold, and serviced those two car models in both States

141 S. Ct. 1017, 1028.

The Court went so far as to say “each of the plaintiffs brought suit in the most natural State.” Id. at 1031.  And, again, that was because the plaintiffs “are residents of the forum States. They used the allegedly defective products in the forum States. And they suffered injuries when those products malfunctioned in the forum States.” Id.

BMS was described as a case involving “non-resident plaintiffs” who “had not bought” the product in the forum; “neither had they used or suffered any harm from the drug there.”   The Court  found jurisdiction improper in BMS because the forum State, and the defendant’s activities there, lacked any connection to the plaintiffs’ claims. 137 S.Ct., at 1781 (“What is needed—and what is missing here—is a connection between the forum and the specific claims at issue”). The plaintiffs, the Court reiterated, were not residents of California. They had not been prescribed Plavix in California. They had not ingested Plavix in California. And they had not sustained their injuries in California. “In short, the plaintiffs were engaged in forum-shopping—suing in California because it was thought plaintiff-friendly, even though their cases had no tie to the State.”  141 S. Ct. 1017, 1030–31.

This reiteration and re-emphasis should be very useful for defendant’s sued in judicial hellholes or subject to attempts at litigation tourism.

A federal court in Alabama recently issued an interesting decision on defendant’s motion to exclude plaintiff’s expert evidence in a medical device case.  See Lowery v. Sanofi-Aventis LLC, 2021 WL 872620 (N.D. Ala. Mar. 9, 2021).

Plaintiff advanced claims based on the allegation that he suffered injuries after Defendant’s medical device, Synvisc-One, was injected into his right knee. Plaintiff alleged that a contaminant caused septic arthritis (i.e., a joint infection) in his right knee and other injuries resulting from the onset of septic arthritis, including hearing loss, reduced mobility, and a shortened lifespan. To establish that the bacteria caused septic arthritis and other injuries, Plaintiff was prepared to offer the testimony of Dr. Charles Abney. And, to testify that Defendant’s manufacturing processes and facilities violated federal regulations, Plaintiff offered Dr. Catherine E. Patterson. Defendant challenged the admissibility of both witnesses’ opinion testimony. 2021 WL 872620, at *1.

The Court concluded that Dr. Abney’s opinions were inadmissible for three reasons. First Dr. Abney did not have the knowledge, skill, experience, training, or education to proffer his opinions in this case. Second, he did not employ reliable methods in reaching his conclusions. Third, his opinions failed to assist the trier of fact.  The Court further determined that Dr. Patterson’s expert opinion testimony on the regulatory matters was  inadmissible for two reasons. First, her conclusions that Defendant’s procedures were not in compliance with FDA regulations lacked reliable analysis. Second, even if her opinions were based on reliable scientific methods, they related to preempted issues and thus would not assist the trier of act. Thus, Defendant’s Motions were granted.
Specifically, experts may be qualified to provide opinion testimony in various ways, including training, education, or experience in a given field. Often the issue raised under the qualification prong is not whether the proffered expert is qualified in a general field but whether his training, education, or experience qualify him to render an opinion on a specific “issue before the court.” Jones v. Novartis Pharm. Corp., 235 F. Supp. 3d 1244, 1251 (N.D. Ala. 2017). Particularly where an expert’s qualifications rest on his experience (as opposed to education or training), the expert “must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts.” United States v. Frazier, 387 F.3d 1244, 1261 (11th Cir. 2004) (en banc) (citing Fed. R. Evid. 702). The court cannot simply take the expert’s word for it. Id. Sometimes, an expert’s credentials raise credibility issues, but do not affect admissibility. Maiz v. Virani, 253 F.3d 641, 666 (11th Cir. 2001); Rushing v. Kansas City S. Ry. Co., 185 F.3d 496, 507 (5th Cir. 1999). Nonetheless, a court must always determine whether an expert is qualified to testify to the subject matter at issue.  Kilpatrick v. Breg, Inc., 2009 WL 2058384, at *3 (S.D. Fla. June 25, 2009).

This is one notion of “fit.”  A medical doctor is not qualified to opine on all areas of medicine by virtue of having a medical license or practicing in one area of medicine. See Hendrix v. Evenflo Co., 255 F.R.D. 568, 578 (N.D. Fla. 2009), aff’d sub nom., Hendrix ex rel. G.P. v. Evenflo Co., 609 F.3d 1183 (11th Cir. 2010). Another district court analogized that “just as a lawyer is not by general education and experience qualified to give an expert opinion on every subject of the law, so too a scientist or medical doctor is not presumed to have expert knowledge about every conceivable scientific principle or disease.” Whiting v. Bos. Edison Co., 891 F. Supp. 12, 24 (D. Mass. 1995); see Alexander v. Smith & Nephew, P.L.C., 98 F. Supp. 2d 1276, 1281 (N.D. Okla. 2000) (possession of a medical degree and emergency room experience was insufficient to testify to “the advantages of a spinal fixation device, the medical causation of spine-related ailments, or the mechanical functioning of an orthopedic implantation device”).  In accordance with that line of case law, Dr. Abney was unqualified to testify that Plaintiff in fact had septic arthritis because he lacks specialized training, education, and experience regarding that medical issue.  There was no evidence that Dr. Abney had the expertise needed to reliably assess whether Plaintiff’s reaction was septic versus pseudoseptic.  Except during an approximately two-month long rotation during his residency (which was not in orthopedics and was over twenty years ago), he had never administered Synvisc-One, had never performed any orthopedic procedure on a patient’s knee, had never completed any training in orthopedics, and had never (at any time) researched or written on the subjects of treating osteoarthritis, knee replacements, injections, Synvisc-One, knee infections, or pseudoseptic reactions.  2021 WL 872620, at *8.

Related to this, the Court explored a very useful distinction between testimony about a patient’s condition, and opinions about the cause of that condition.  In Harvey v. Novartis Pharm. Corp., the court held that a maxillofacial surgeon, who had “no experience in identifying the specific cause” of the diagnosed condition at issue, was incompetent to opine on the issue of causation. 895 F. Supp. 2d 1206, 1211-12 (N.D. Ala. 2012) (citing Thomas v. Novartis Pharm. Corp., 443 F. App’x. 58, 63 (6th Cir. 2011)). The surgeon, while eminently qualified to testify “within the ordinary expertise of maxillofacial surgeons” and generally knowledgeable of the condition, did not have any practical experience in identifying the cause of the condition at issue in that case. Id. That is, mere expertise about treatment of a condition simply does not equate to expertise about what causes that condition. Id.
Indeed, the Harvey result is not an outlier. See Jones, 235 F. Supp. 3d at 1292 (holding that treating physician and board-certified orthopedic surgeon was not competent to opine on cause of femur fracture).

Next, because the ultimate issue in this case was whether a contaminant caused Plaintiff’s injuries, this was akin to a toxic tort case that requires expert testimony to establish two types of causation: general and specific. General causation is established by an expert “laying a scientific groundwork” that the toxin in question “can cause the harm plaintiff alleges.”  Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296, 13o3 (11th Cir. 2014).  Specific causation, secondly, requires a court to evaluate whether the expert’s methodology reliably concludes that the “substance ‘caused the plaintiff’s specific injury.’ ” Id.  But,  the Curt concluded, Dr. Abney’s medical causation opinion testimony was inadmissible because (1) he failed to conduct or rely on reliable scientific groundwork before arriving at his conclusions regarding Plaintiff’s condition; and (2) his specific causation analysis was not the product of reliable methods and analysis.  2021 WL 872620, at *12. Dr. Abney admitted that he did not know the propensity of Methylobacterium thiocyanatum to cause septic arthritis and (before this case) that he had not heard of Methylobacterium thiocyanatum.  He also conceded that exposure does not “automatically” result in an infection.  At the same time, Dr. Abney was aware that a pseudoseptic reaction is a known side effect of Synvisc-One and can cause symptoms like septic arthritis.

While some courts have held that differential diagnosis (that is, differential etiology) is reliable for determining medical causation., there are two steps in a proper “process of elimination” differential diagnosis: (1) the expert rules in “the possible causes of a condition”; and (2) the expert then arrives at a cause by ruling out the possible causes “one-by-one, leaving only one cause remaining.” E.g., Hendrix, 609 F.3d at 1198. An expert must consider the most relevant potential causes, and must provide a “reasonable” explanation for eliminating other causes under the circumstances and cannot “simply” claim that he “performed a differential diagnosis.”  Such a “process,” that wholly fails to provide a reasonable explanation, is not a method at all but rather a substitution of the expert’s own assertion for the scientific method (the “ipse dixit”). Dr. Abney relied on “the temporal sequence” between the injection and the onset of symptoms, but temporal proximity is not a reliable indicator of causation as it “leads to the blunder of the post hoc ergo propter hoc fallacy.” This is particularly true where, as here, Dr. Abney admitted that the “onset of pain and swelling” could be a sign of septic arthritis or a pseudoseptic reaction.  2021 WL 872620, at *14.

Turning to the second expert, despite her statement that her methods analyze the GMPs and other federal requirements, Dr. Patterson failed to explain which GMPs that Defendant has violated, let alone how Defendant’s conduct or processes violate them. Without any analysis connecting the facts to the conclusions in her report, her opinions amount to little more than her personal beliefs.  This same analysis applied to her conclusion that the Lot in question was not “sterile” and “would be considered adulterated by the FDA.”  With respect to guidance documents or other supporting materials, Dr. Patterson made an impermissible logical jump and contended that Defendant’s deficiencies in those documents are themselves violations of the GMPs. Yet, such guidance documents are not binding rules or regulations but recommended procedures. The same lack of analysis existed for Dr. Patterson’s list of problems related to equipment maintenance, procedures, and historical manufacturing deficiencies where she listed her criticisms and cited generally to an FDA guidance document. 2021 WL 872620, at *19–20.

Dr. Patterson’s opinion testimony that Defendant should have conducted additional testing did not assist the trier of fact in this case for two reasons. First, Dr. Patterson’s opinion that Defendant should have implemented different testing methods that are not compelled by a federal law would go, at best, to a theory of liability that is preempted and, for that reason, cannot be an issue put to the jury at trial.  This same analysis applied to Dr. Patterson’s other criticisms of Defendant’s facilities and manufacturing practices. Her lack of support connecting Defendant’s alleged actions to binding federal requirements would leave it to the fact-finder to bridge the gap in her analysis (and, furthermore, would otherwise be directed to issues preempted by federal law).  Second, Dr. Patterson’s conclusion that the deficient tests “could” have led to false negatives shows the equivocal nature of her opinion and would not assist the jury in finding causation by a preponderance of the evidence. 2021 WL 872620, at *21–22.