Choice of Law Nixes Punitive Damages in Remanded Mesh Case

By Michelle Yeary on May 24, 2022

New Jersey ain’t Florida and vice versa. Obviously, it’s warmer in Florida for more of the year and it never gets cold enough to snow. That could be a pro or a con. Florida has the second longest coastline among U.S. States which gives it a greater opportunity to have more highly rated beaches. But a true New Jerseyan will put Cape May and Long Beach Island toe-to-toe with Miami and Destin. If you’re a football fan, Florida boasts three pro teams (and Tom Brady) while New Jersey technically has none. That is unless you count the two teams who play their home games in East Rutherford. But given their recent records (both went 4-13 last year), New York can keep them. Pro-Florida: Disney World, oranges, taxes. Pro-New Jersey: boardwalks, tomatoes, and not having to pump your own gas. New Jersey has to live down “The Jersey Shore;” Florida has to live down “Florida Man …”

In both New Jersey and Florida, there is a strong presumption against punitive damages in drug and device cases where there’s been regulatory compliance. See Fla Stat. §768.1256; N.J. Stat. §2A:58C-4. But Florida goes a step further with a “one-award” punitive damages statute. So, while Springsteen will always give New Jersey the overall advantage in a head-to-head comparison, on punitive damages Florida has the edge.

In Benestad v. Johnson & Johnson, 2022 U.S. Dist. LEXIS 55502 (S.D. Fla. Mar. 28, 2022), Defendants filed two motions for partial summary judgement and a motion to bar plaintiff’s punitive damages claim following remand from the MDL pending in West Virginia. Plaintiff was a resident of Florida at the time she filed her lawsuit. Her first surgery involving defendants’ pelvic mesh also took place in Florida, as well as her follow-up treatment. Plaintiff had a second pelvic surgery in New Jersey involving a different one of defendants’ products. Defendants were also located in New Jersey. Id. at *17. In all three of their motions, Defendants argued Florida law applied. Plaintiff took no position on choice of law in response to either summary judgment motion but argued for New Jersey law in response to the punitive damages motion. Id. at *15. Applying the “most significant relationship” test – utilized by both states – which places particular emphasis on the location of the injury, the court concluded that Florida’s relationship predominated. Id. at *15-17.

Before turning to the punitive damages claim, we must note the significant paring down of plaintiff’s substantive claims. Plaintiff’s MDL complaint alleged 18 causes of action. In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims. Of the remaining claims 7 claims, one was for “discovery rule and tolling” which is not a substantive claim; one was for gross negligence which is a “standard of culpability, not an independent claim; and one was for loss of consortium which survived because it was derivative of plaintiff’s design defect claim which defendants did not move for summary judgement on. Id. at *23, 27-28. That left three claims – negligent failure to warn, strict liability failure to warn, and punitive damages.

On the failure to warn claims, Florida’s learned intermediary doctrine requires plaintiff to prove causation by showing “that her treating physician would not have used the product had adequate warnings been provided.” Id. at *21. Both of plaintiff’s implanting surgeons testified that they did not read the warnings that accompanied the devices, but both were fully aware of the risks of the surgery, including those experienced by plaintiff. Id. at *10-13. So, the evidence demonstrated that their treatment decisions would not have changed. The only evidence plaintiff offered to support her claim was a notice by the FDA that came out three years after plaintiff’s surgeries – making it immaterial. Id. at *22.

Now for the more interesting punitive damages discussion. Having essentially acquiesced to the application of Florida law to her substantive claims, plaintiff does a bit of an about-face to argue New Jersey law should apply on punitive damages. As noted above, New Jersey’s punitive damages law for prescription drugs/devices is not exactly plaintiff-friendly. In fact, New Jersey based companies (like defendants here) often argue for application of New Jersey’s punitive damages law in products cases. The statute provides:

In any product liability action the manufacturer or seller shall not be liable for harm caused by a failure to warn if the product contains an adequate warning or instruction. . . If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration . . . a rebuttable presumption shall arise that the warning or instruction is adequate.
N.J. Stat. §2A:58C-4.

Florida has a similar statute:

In a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the product is not defective or unreasonably dangerous and the manufacturer or seller is not liable if, at the time the specific unit of the product was sold or delivered to the initial purchaser or user, the aspect of the product that allegedly caused the harm:
(a) Complied with federal or state codes, statutes, rules, regulations, or standards relevant to the event causing the death or injury;
(b) The codes, statutes, rules, regulations, or standards are designed to prevent the type of harm that allegedly occurred; and
(c) Compliance with the codes, statutes, rules, regulations, or standards is required as a condition for selling or distributing the product.
Fla Stat. §768.1256.

So, assuming defendants’ warnings complied with the FDA, plaintiff had a difficult road to punitive damages under either state’s law. But this case is part of a mass tort, so Florida has an additional statute that gave defendants an extra layer of protection:

Except as provided in paragraph (b), punitive damages may not be awarded against a defendant in a civil action if that defendant establishes, before trial, that punitive damages have previously been awarded against that defendant in any state or federal court in any action alleging harm from the same act or single course of conduct for which the claimant seeks compensatory damages. For purpose of civil action, the term “the same act or single course of conduct” includes acts resulting in the same manufacturing defects, acts resulting in the same defects in design, or failure to warn of the same hazards, with respect to similar units of a product.
Fla. Stat. § 768.73(2)(a).

Defendants submitted evidence of prior punitive damages awards in cases involving the same products and allegations as in Benestad. Plaintiff did not offer any evidence in rebuttal, but rather tried to rely on a narrow exception to the rule. The basis for the statute is that under Florida law, the purpose of punitive damages is to punish the defendant and deter similar conduct, not to further compensate the plaintiff. Benestad, at *24. So, the ban on multiple awards may not apply

if the court determines by clear and convincing evidence that the amount of prior punitive damages awarded was insufficient to punish that defendant’s behavior… In addition, the court may consider whether the defendant’s act or course of conduct has ceased.
Fla. Stat. § 768.73(2)(b).

Plaintiff presented no clear and convincing evidence that the earlier awards were an insufficient deterrent. Plus, defendants voluntarily took the product off the market ten years ago. Id. at *26-27. Therefore, the court found that punitive damages could not be awarded under Florida law.

You’ll never get this Jersey girl to pick Sunshine over the Garden (except for Key West) – but we can get behind Florida products liability law when it leads to outcomes like this.

PLAC Shameless Plug

By Bexis on May 21, 2022

Not too long ago we blogged about the value that the Product Liability Advisory Council (“PLAC”) brings to the table – particularly to drug and device manufacturers faced with relentless product liability claims. For the third time, we urged our corporate readers to support PLAC’s pro-defense advocacy by joining and becoming members.

Still not convinced? Then check this out. Next week, PLAC members and invited guests (which can be you) have an opportunity to learn more about PLAC’s amicus work in particular. On Thursday, May 26 at 3:00 p.m. (Eastern), the PLAC Amicus Case Selection Committee – including Bexis − will host a Town Hall Forum to discuss PLAC’s 2021 Amicus Program and also our view of current trends and developments on issues important to PLAC members. It’s an opportunity to ask any question you want to the folks who make PLAC’s amicus program work. So come, take a closer look at PLAC’s advocacy and efforts to influence product liability-related jurisprudence in state and federal appellate courts.

Corporate counsel from drug and device companies are invited to register using this link. It’s all free, but for obvious reasons pre-registration is necessary.

Hope to see some of you there.

No Alleged Harm, No Leg To Stand On

By Steven Boranian on May 20, 2022

We were talking the other day with a colleague with whom we have been in the mass tort trenches for most of the last 20 years, and she observed that “it’s not about the tort anymore.” Well, it is, and it isn’t. We still see cases, sometimes in very large numbers, involving drugs and medical devices where the plaintiffs allege traditional product liability theories, such as negligence and strict product liability. For those cases, it is still very much about the tort.

What our colleague meant is that plaintiffs now more than ever are pushing other theories of liability, including public nuisance and consumer protection claims alleging economic injuries. And they often push too far. Take for example Kimca v. Sprout Foods, Inc., No. 21-12977, 2022 WL 1213488 (D.N.J. Apr. 25, 2002), where the plaintiffs filed a class action alleging the presence of heavy metals in baby food. Id. at *1. Based on these allegations, the plaintiffs sought remedies for violations of consumer protection laws of various states, among other claims. Id. at *2.

Allegations of heavy metals in Mixed Berry Oatmeal and Crispy Brown Rice Toddler Fruit Snacks certainly grab your attention, but could plaintiffs back those allegations up? Not really. In fact, the plaintiffs did not even allege that they (or their children) suffered any harm, which meant that they had no standing to sue.

We have seen this before. We blogged a few years ago on a Third Circuit case where the plaintiffs tested the boundaries of Article III standing by filing a complaint that affirmatively disavowed any alleged injury. They lost, with the Third Circuit holding that there are generally three ways to plead an economic injury. A plaintiff can allege an “alternate product theory” by alleging that, but for the defendant’s conduct, he or she would have purchased an alternative, less expensive product. A plaintiff can also allege a “premium price theory,” under which he or she claims that wrongful advertising of a product as “superior” induced the plaintiff to pay an unfair premium. Finally, a plaintiff can allege that he or she was deprived of the “benefit of the bargain” and did not get what he or she paid for. See In re Johnson & Johnson Talcum Powder Prods. Mktg. Sales Prac. & Liab. Litig., 903 F.3d 278 (3d Cir 2018).

The plaintiffs in In re J&J Talc could meet none of these standards, and neither could the baby food-purchasing plaintiffs in Kimca v. Sprout Foods. They surely did not allege that any baby suffered any physical harm. It was all about purported economic injury, but they failed on that score, too. They did not allege that they would have purchased an alternate product, let alone one that was less expensive. Kimca, 2022 WL 1213488, at *8. They also did not adequately allege that misrepresentations caused them to pay an unfair premium for the product. Id. “Threadbare” allegations that they would not have paid as much for the product “if they had known” did not suffice. The plaintiffs did not identify any comparable, cheaper, or purportedly safer product to demonstrate that they, in fact, paid a premium. Id.

Finally, the plaintiffs did not allege any loss of a benefit of the bargain because they did not adequately allege that their children were at risk of harm from baby food. In other words, they got what they paid for. Id. at *9. Importantly, allegations of a risk of future harm did not establish an economic injury that conferred standing to sue:

Plaintiffs . . . allege that the Baby Food Products were worthless. But Plaintiffs assert the products were worthless precisely because they allegedly exposed their children to the risk of future harm—they do not otherwise allege that the Baby Food Products did not perform their intended purpose or that the products were worthless for any other reason.
Id.

The upshot is that an economic injury claims requires actual harm, and an alleged risk of future harm does not suffice to establish economic injury. As the court emphasized, the plaintiffs alleged that (1) the products contained heavy metals and (2) elevated levels of heavy metals can be dangerous, but they did not connect the two. Id. at *8. They did not allege that the alleged levels of heavy metals in the products were unsafe. Id. “Without this connection, Plaintiffs’ allegations are simply speculation.” Id.

The district court dismissed the claims for lack of standing, but without prejudice. Plaintiffs might try again, but it very well could be that they did not allege harmful levels of heavy metals because they could not truthfully do so. The district court took judicial notice of the FDA’s letter of March 5, 2021, stating that its testing showed no immediate health risk to children from toxic elements in food.” There may be no “there” there? Stay tuned.

E.D. Virginia Loosens the Reins in Horse Prescription Drug Case

By Michelle Yeary on May 19, 2022

This is a follow-up post on the case of Knapp v. Zoetis, Inc. – an animal drug case. While not our typically fare, it is still a prescription drug case involving adverse event reporting to the FDA and the learned intermediary doctrine. So, while this patient had four legs instead of two, the legal framework is primarily the same.

A year ago we reported on the court’s decision to drastically cut down the case by tossing out the class allegations and dismissing without prejudice plaintiff’s negligence and implied warranty claims. New year, new complaint, new decision. This time the court let plaintiff gallop out of the starting gate.

To refresh your memory – plaintiff owned a horse named Boomer. When Boomer started experiencing leg swelling, a veterinarian administered an injection of an equine antibiotic manufactured by defendant called Excede. Plaintiff alleges Boomer suffered an adverse reaction to the antibiotic causing the horse to experience persistent lameness and permanent damage to the musculature in his neck. Knapp v. Zoetis, Inc. 2022 WL 989015, *2 (E.D. Va. Mar. 31, 2022). Based on the decision it appears plaintiff ponied up two primary arguments. First, defendant reported nearly 600 adverse events to the FDA, “some of which included similar symptoms to Boomer’s.” Id. at *7 (emphasis added). Second, Excede is an extended-release antibiotic that uses a “cottonseed oil suspension” in its delivery system. Id. at *3. Apparently that was enough for the court to say giddy up.

For this lap around the track, plaintiff re-alleged her express warranty claim (the only claim that survived the prior the motion to dismiss) along with amended claims for negligent failure to warn, negligent design and manufacture, and breach of implied warranty. Plaintiff also sought punitive damages. Id. Under Virginia law, both negligence and implied warranty claims require a showing that the product was unreasonably dangerous for its ordinary or reasonably foreseeable use. Id. at *5. Here the drug was administered to Boomer for an off-label purpose. But because plaintiff alleged defendant was aware veterinarians used the drug off-label, the court found such use was reasonably foreseeable. Id. at *7.

On design defect we must first reiterate a view often expressed in our posts – design defect does not make much sense as a theory of liability for a prescription drug. As the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.” Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013). So, even when plaintiff can articulate how a compound could be altered, the change would make the drug a different product. So, on design defect we think the court should have said nay rather than spurring the claim along.

In concluding plaintiff plausibly alleged a design defect, the court relies heavily on the “nearly 600” adverse events reported to the FDA — creating a classic case of damned if you do, damned if you don’t. Plaintiffs attack defendants for failing to report adverse events and now for properly reporting? Whoa! The fact that the drug was FDA approved and that the FDA took no action upon receipt of this significant number, in the court’s view, of reported events should have cut against the plausibility of a design defect, not in favor.

Then there is the issue of a safer alternative design – a requirement under Virginia law. The court’s reasoning on this one came up lame. Plaintiff focuses on Excede’s extended-release mechanism. Plaintiff argues that other equine antibiotics without such a mechanism do not cause the type of reaction Boomer experienced. In fact, the safer alternative design plaintiff relies on is another antibiotic manufactured by the defendant called Naxcel. Naxcel is a “non-extended release injectable” antibiotic. Id. at *8. Naxcel is also a different product. Saying Naxcel is an alternative design is the same as saying defendants must stop selling Excede. Plaintiff’s complaint may not talk in terms of withdrawing Excede from the market, but it is implied when they say Excede should really be Naxcel. Afterall, defendant cannot just change the formulation of or the delivery mechanism of Excede without going through a new FDA application process. The court overlooked all these issues holding instead that the question of whether the delivery mechanism would “fundamentally alter” Excede was a jury question. Id. at *9.

The court allowed plaintiff’s manufacturing defect claim to proceed based on what appears to be an unsupported allegation that the cottonseed oil used in the drug may have been unrefined or improperly refined. Sounds to us like this claim should have failed TwIqbal. We will take this part of the decision in stride since it seems like a fairly case-specific issue.

That left just failure to warn – where the court seems to want to beat a dead horse. Because defendant reported adverse events with Excede to the FDA and, because Naxcel did not have the same type of adverse events, defendant knew or had reason to know Excede had risks that should have been warned about. Id. at *10. The court also found plaintiff adequately pleaded causation under the learned intermediary doctrine by alleging that defendant failed to warn both her and her veterinarian. Id. at *9.

The last thing the court considered was whether to strike plaintiff’s claim for punitive damages. Punitive damages are not available for breach of contract. So, the court had to decide if plaintiff’s warranty claims sounded in tort or contract. Under Virginia law a claim sounds in contract if based on nonfeasance, whereas a claim based on misfeasance or malfeasance is a tort. Because plaintiff alleges that defendant “affirmatively performed in such a way that injured her horse,” her warranty claims were based in tort and were sufficient to allow plaintiff to seek punitive damages. Id. at *12-13.

All in all, this decision has left us with a bit of a long face.

Illinois Court Imposes Sanctions for Invalid Precomplaint Discovery

By Stephen McConnell on May 18, 2022

Famous (and infamous) Illinois trial lawyer Clarence Darrow once said that he never wished a man dead, but had occasionally read some obituaries with great satisfaction. (That same quote is sometimes incorrectly attributed to Mark Twain.)

We’re no Darrow. We’ve never saved a client from capital punishment, or discredited a former presidential candidate in a courtroom, or made any sort of mark in the culture wars, or bribed a juror. But we get a similar sort of satisfaction when we read a court opinion socking an overreaching plaintiff lawyer with sanctions. We personally avoid seeking such sanctions unless absolutely necessary, but news reports of such sanctions occasionally deliver us a fresh bouquet of schadenfreude.

Consider the case of Ingram v. Intili, 2022 IL App. (1st) 210656 (Ill. Ct. App. May 6, 2022). A plaintiff lawyer seems to have misused some arcane Illinois procedures in an effort to secure an unfair advantage. The respondent (not the defendant, and thereby hangs the tale) did not like what the plaintiff lawyer did. Neither did the lower court. Neither did the appellate court.

Let’s take a brief legal tour of the Land of Lincoln, visit section 2-402 of the Code of Civil Procedure, sit for a spell with a Rule 224 petition, and pose for a selfie next to Illinois S. Ct. R. 137 – but not too close, because Rule 137 sanctions can bite.

Rule 224, titled “Discovery before suit to identify responsible persons and entities,” allows the petitioner to engage in discovery to ascertain the identity of multiple persons and entities who may be responsible in damages. Its only purpose is to ascertain the identity of possible defendants. Once that purpose (the only one, remember) is achieved, the petitioner can then file an actual case and conduct full-blown discovery against a party. Rule 224 is wholly inapplicable when the identity of any potential defendant is known.

Then there is a section 2-402 “summons in discovery,” aimed at “individuals or other entities, other than the named defendants, believed by the plaintiff to have information essential to the determination of who should properly be named as additional defendants in the action. Section 2-402 was originally enacted to provide plaintiffs in medical malpractice actions “with a means of filing suit without naming everyone in sight as a defendant by permitting a plaintiff to obtain discovery against a person or entity against whom he may have a claim.” A person or entity named as a respondent in discovery per section 2-402 may be made a defendant in an action within six months, even if such an action would otherwise have expired during that six month period. Section 2-402 was designed to make litigation more efficient.

What did the plaintiff lawyer do with Rule 224 and section 2-402, and why did that selfsame plaintiff lawyer get hit with sanctions under Rule 137?

The plaintiff represented by the plaintiff lawyer was a woman who claimed personal injuries from the Essure device. Instead of doing what so many other enterprising plaintiff lawyers have done by filing a product liability action against the Essure manufacturer, this plaintiff lawyer decided to be clever by filing both a Rule 224 petition and a section 2-402 summons in discovery against the treating doctor. The plaintiff lawyer was attempting to force the doctor to identify the manufacturer’s sales representative. The apparent advantage in pursuing this Byzantine route was that the manufacturer, not yet being a party, could not be pesky.

The doctor several times pointed out that the plaintiff lawyer was doing things all wrong. Rule 224 was facially inapplicable because it was undisputed that the plaintiff lawyer was aware of at least two proper defendants for the potential action: the device manufacturer and the doctor. What the plaintiff lawyer should have done was file a proper lawsuit against the known defendant, and then named respondents in discovery under section 2-402 instead of filing a Rule 224 petition. The plaintiff lawyer did not do that. So that’s bad.

It gets worse. The section 2-402 “summons for discovery” filed by the plaintiff lawyer falsely stated that a complaint had already been filed. In violation of the rule, which required attaching the complaint, the non-existent complaint was omitted from the summons.

The doctor moved to dismiss this proceeding. The plaintiff opposed unless the information sought by the illegitimate discovery was forthcoming. Some information was provided, but rather than back down, the plaintiff lawyer doubled down and demanded to depose the doctor (before the putative manufacturer defendant would have even known of the litigation). Such a deposition was plainly beyond the permissible scope of a Rule 224 petition, which, again, is limited to identification of potential defendants.

The doctor also sought sanctions for the plaintiff lawyer’s time-wasting, rule-violating harassment. The trial court dismissed the plaintiff’s petition and imposed sanctions of more than $12K. The plaintiff lawyer appealed, but found no joy in the Illinois appellate court. Reviewing the sanctions order for abuse of discretion, the appellate court held that sanctions were appropriate because the proceedings instituted by the plaintiff lawyer were “inapplicable and invalid from the outset.” The initial filing used the wrong procedure, and then by demanding a deposition, the plaintiff lawyer went well beyond the scope of even legitimate pre-complaint discovery – and then tried to continue after the petition expired by operation of law.

Again, the plaintiff should have filed a complaint (which never happened) and then should have used everyday, unloved-but-well-recognized post-filing discovery procedures. The invalid summons was a “pleading” under the sanctions rule, and the attorney’s conduct demonstrated that the affair was not a mere “mistake made by a paralegal,” as counsel claimed. Even if a paralegal was involved, the attorney was responsible for the paralegal’s actions. (Maybe blaming the paralegal was even worse than skirting all those Illinois rules. Every paralegal we’ve ever worked with has been smart and hard-working. For a lawyer to blame a paralegal for the lawyer’s own screwup would be really, really bad form.) Meanwhile, action against the manufacturer/client was never filed.

That last bit is at least as gratifying as the sanctions award.

Valuable Piece on Class Action Fairness Act (“CAFA”) Advanced Removal Strategies – Distributed with Permission

By Bexis on May 17, 2022

We’re not the font of all legal knowledge; we don’t claim to be. Every now and then we come across material published by our colleagues at other firms defending prescription medical product liability litigation that we think would be valuable to our readers, so we ask if we can republish. That’s how our 50-state survey on state tolling statutes came about. It was a piece by another firm that we thought would be useful to our readers dealing with unsuccessful would-be forum shoppers, so we inquired, and they were gracious enough to allow us to distribute their research to our readers.

Recently, we were duly impressed by a Greenberg Traurig class action-related “advisory” entitled “Class Action Fairness Act Advanced Removal Strategies.” It was written by Greenberg partners, Ryan C. Bykerk, and Christopher S. Dodrill. This advisory is richly enough researched that it looks and reads like a law review article – which we at the Blog appreciate. Here’s a thumbnail list of the CAFA topics covered:

Timing of CAFA removal, including defense ability to remove on their “own information” at any time.
How courts respond to plaintiffs gaming CAFA’s 100-member “mass tort” threshold.
Sufficiency of removal allegations concerning CAFA minimal diversity.
Citizenship of various types of entities involved in CAFA litigation.
Determining and pleading CAFA’s $5 million amount-in-controversy requirement.
Post-removal attempts by plaintiffs to destroy CAFA jurisdiction.
Defense-side jurisdictional discovery in CAFA cases.
Viability of successive CAFA removals.

We’ve uploaded a copy of this piece here, or if you’re so inclined, you can read it on Greenberg Traurig’s website, here.

On multiple occasions the Blog has addressed CAFA-related topics, occasionally with research posts but more frequently discussing new significant decisions. We’re pleased to add this piece to the resources available to our readers.

Ninth Circuit – First Amendment Prevails Over Prop 65

By Bexis on May 16, 2022

California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer” warnings on such everyday products as cola drinks, coffee, beer, and soy sauce, see Riva v. Pepsico, Inc., 82 F. Supp.3d 1045, 1062 (N.D. Cal. 2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment.

We can’t say it was unexpected – indeed, Prop 65 was one of the targets of the First Amendment’s prohibition on governmentally compelled speech that we identified in our 2019 post on American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (“ABA”). And lo it has come to pass.

Design Defect Claim Dismissed in W.D.N.Y. Fosamax Case

By Rachel B. Weil on May 13, 2022

We write today from a room in a rehabilitation facility, where we just shared the Drug and Device Law Dowager Countess’s lunch. The Countess, nearly 88, plunged down a flight of eight concrete stairs 12 days ago and managed to emerge with three broken ribs (one in two places) and no other injuries. A painful injury with a long recovery time, but miraculous all in all. And we are out of the hospital (first the step-down ICU then a regular room) and six days into rehab. We offer this comment: those who choose to enter the nursing professions – RNs, LPNs, aides – deserve a special place in any afterlife your beliefs include. These are thankless, grueling jobs requiring unflagging alertness, judgment, compassion, and kindness, along with the tricky balance between empathy and objectivity. In the past two weeks, notwithstanding burdens imposed by pervasive staffing shortages, we are grateful to have met many spectacular examples (mostly, but not all, women) of people perfectly suited for their professions.

We think the judge in today’s case is similarly well suited for her seat on the federal bench, if today’s decision is an accurate barometer. In MacSwain v. Merck & Co. Inc., 2022 WL 1415031 (W.D.N.Y. May 4, 2022), the plaintiff alleged that the defendant’s osteoporosis drug, Fosamax, caused her to suffer serious injuries, including osteonecrosis of the jaw and atrial fibrillation. She asserted the usual litany of product liability claims, including failure to warn, design defect, breaches of express and implied warranties, fraudulent misrepresentation, and fraudulent concealment. The defendant moved to dismiss all but the warnings claim.

Design Defect

The plaintiff alleged that the defendant’s drug was “defective in its design and/or formulation, as the foreseeable risks exceeded the benefits associated with its design and/or formulation” and because it “posed a greater risk than other similar medications.” MacSwain, 2022 WL 1415031 at *4 (citations to Complaint omitted). Under New York law, to state a claim for design defect sounding in either negligence or strict liability, a plaintiff must allege, inter alia, that “it was feasible to design the product in a safer manner” at the relevant time. Id. (citation omitted). The defendant moved to dismiss the design defect claims on the ground that the plaintiff had not adequately pled the existence of a safer, feasible alternative design. The Court agreed, holding that the plaintiff’s conclusory allegation that there were “several alternative safer products available” did not satisfy her pleading burden. Moreover, the court held, while the plaintiff’s brief could be construed to argue that the drug could have been designed more safely if it did not contain nitrogen, the plaintiff was not permitted to “amend her pleading through her brief to transform this statement into a proposed alternative design.” Id. at *5 (citation omitted.) And while the court conceded that the plaintiff was not required to ‘establish the elements of her claim at the pleading stage,” id. at *6 (citation omitted, emphasis in original), it emphasized that she was still required to “plausibly plead them.” Id. Because she had not “plausibly pled” the existence of a safer, feasible alternative design, her design defect claims failed as a matter of New York law.

In an interesting side discussion, the court explained that the defendant had moved to dismiss the design defect claim on the alternative ground that the design defect claims were preempted by federal law. In Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472 (2013), as readers of this blog are aware, the United States Supreme Court held that a state law design defect claim against a generic drug manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval. After Bartlett, courts split on whether the holding should be extended to preempt design defect claims against branded drug manufacturers, with the Sixth Circuit’s decision in Yates v. Ortho-McNeil-Janssen Pharms, Inc., 808 F.3d 281 (6th Cir. 2015), leading the charge in the “yes” column. Because the MacSwain court had already dismissed the design defect claim on other grounds, it declined to rule on the preemption question.

Breaches of Express and Implied Warranties, Fraud-Based Claims

Plaintiff alleged that the defendant breached an express warranty because it “expressly represented” to the plaintiff, “through its advertising and otherwise” that its drug “had been adequately tested, was to be prescribed in accordance with its intended uses, was of merchantable quality, and was not dangerous.” Id. at *8. The defendant argued that these allegations did not adequately plead a breach of express warranty claim, and the court agreed. Under New York law, as the court explained, “an express warranty is an affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain. To assert a breach of express warranty claim, [a p]laintiff must plausibly allege . . . a specific affirmation of fact or promise that is false and misleading.” Because the plaintiff “fail[ed] to identify any specific affirmation or promise” the defendant made to the plaintiff about the drug’s safety, the court held that the plaintiff’s “generic allegations” did not state a claim for breach of express warranty. Id.

The implied warranty claim did not meet the same fate. As the court explained, a breach of an implied warranty of merchantability “may arise from ‘a manufacturing flaw, improper design, or a failure to provide adequate warnings regarding use of the product.” Id. at *9. Because the defendant did not move to dismiss the failure-to-warn claim, a basis for the breach of implied warranty claim survived the dismissal of the design defect claim.

Finally, the court held that the fraud claims were not pled with the particularity Rule 9(b) requires. The Rule requires that the complaint “detail the statements (or omissions) that the plaintiff contends are fraudulent, (2) identify the speaker, (3) state where and when the statements (or omissions) were made, and (4) explain why the statements (or omission) are fraudulent.” Id.at *10 (citation omitted). “In this case, [the plaintiff included] only vague allegations of misrepresentations and omissions and woefully misse[d] the 9(b) particularity mark: no statements or omissions [were] specified, no speaker [was] identified, and no time or place of the statements or omissions [was] identified.” Id. at *10 (internal punctuation and citation omitted).

A nice, sensible opinion, we think. The court granted the plaintiff leave to amend, and we will keep you posted on further developments,particularly on the Yates preemption issue. In the meantime, stay safe out there.

Pelvic Mesh Remand Cases Continue To Stall

By Eric Alexander on May 12, 2022

We do not care much about car racing. Sure, we have seen some parts of some races on television, had toy racecars in our remote youth, and have craned our necks to see a few fancy “street legal” versions zooming past. However, we have never attended a race in person and do not follow any driver or team. When we heard a presentation last week from a Formula 1 executive, we paid it about as much attention as we pay most presentations in a room full of hundreds of lawyers. We were not surprised by how much it costs to run a team, stage a race, or move a bunch of teams from race to race around the world. We were mildly surprised by how teams manage a race from outside the car and serve as a laboratory for the creation of new technologies. When we saw a video of the fastest pit stop in Formula 1 history, we uttered an expletive of praise. Four tires were changed, adjustments were made, and other pit stop things were accomplished in 1.82 seconds from the car stopping to starting to move again. We are sure that is less time than it takes to open the fuel door and remove the gas cap on our vehicle. We are also sure that quite a bit of planning and practice went into shaving down the time required for that record pit stop.

Bear with us here, but we thought of this when comparing how things went for the defendants in the various pelvic mesh MDLs in the Southern District of West Virginia and how they have been going after remand to various federal district courts around the country. We have commented a number of times about problems with the MDL system in general and in those MDLs in particular. They were generally slow-moving, wasteful, plaintiff-leaning settlement machines. By contrast, while not always fast moving, the remanded cases have received individual attention from judges who know the applicable state law, are not afraid to gut plaintiffs’ cases by tossing experts and claims, and are not trying to send messages across cases. We have offered praise for a number of decisions in remand cases where the defendants won issues they were not winning in the MDL. From our perspective, the individual focus is the big difference. A specific remanded pelvic mesh case is just another case on the judge’s docket that needs a trial date and rulings on motions for summary judgment, to exclude experts, for reconsideration, etc. The plaintiffs often have to deal with the impact of past decisions like which experts to name and which theories to push. Their refusal to accept those impacts without a fight can lead to some surprising postures.

In Enborg v. Ethicon, Inc., No. 2:20-cv-02477-AWI-BAK, 2022 U.S. Dist. LEXIS 78720 (E.D. Cal. Apr. 29, 2022), the judge considered a motion to reconsider in connection with the exclusion of certain opinions from the plaintiff experts in a pelvic mesh remand case. Rulings on motions to reconsider tend not to be blogworthy, but we think this one is. We actually wrote previously about rulings in this case, including the rejection of the plaintiff’s argument that defense experts could not dispute the theory that polypropylene degrades in the human body because of the testimony of a corporate representative. About a week earlier, the court had issued rulings on a few defense motions. The ones we know about from the ruling on the motion to reconsider granted summary judgment on plaintiff’s warning claim for lack of proximate cause, excluded plaintiff’s FDA expert’s opinions that the device was misbranded according to the FDCA, excluded one of plaintiff’s urogynecology expert’s opinions about the absence of references in the device’s label to statements from an MSDS for the polypropylene resin, and excluded another of plaintiff’s urogynecology experts’ opinions on the impact of allegedly inadequate warnings on the implanting surgeon. Id. at *2-3. (We have posted on these issues many times before, like here and here; in the prior Enborg post, we predicted that plaintiff’s own FDA expert would inevitably open the door to the sort of FDA evidence that the MDL court had suggested should be excluded in remand cases.)

Intent on supporting her remaining “negligent design defect” claim—which can be pretty weak in cases like this where plaintiffs’ expert claim every synthetic midurethral sling is defective—plaintiff sought to reconsider the exclusion of the above-described warnings opinions. This is where the arguments got surprising. While there appeared to be several bases for excluding those opinions beyond that plaintiff’s warnings claim was gone, plaintiff argued that each opinion was relevant to a design defect claim under California law. Id. at *3. Typically, when it comes to design defect with a prescription medical product, it is defendant arguing that comment k (which California applies across the board to all prescription medical products) should apply and that adequate warnings should defeat a design defect claim. (See here and here, among many prior posts.) In our experience, plaintiffs prefer presenting on product or procedure risks without context of how those same risks apply to every other product. Similarly, we are used to plaintiffs trying to talk about what is not in a label without ever showing what was actually in the label or answering the question of whether the missing information would ever be included in label. Unexpected things can happen in remand cases, so plaintiff argued that an intermediate appellate case called Hansen v. Sunnyside Prods., Inc., 55 Cal. App. 4th 1497 (Cal. App. 1997), made “package warnings” relevant to determining every design defect claim under the applicable “risk/benefit test.” (We are also used to plaintiffs arguing for the consumer expectation test—focused on the plaintiff’s now-jaded expectations—rather than the risk-utility test.) Rather than argue that warnings never matter to the determination of design defect with a prescription medical product, the defendant argued that Hansen did not change the result.

Hansen was a somewhat unusual case where the plaintiff brought strict liability design defect and failure to warn claims against the manufacturer of a cleaning product for an injury to her finger (because there was a hole in the glove she wore to protect against injury from exposure to the cleaning product). The trial court entered JNOV for plaintiff on liability and a new trial, centered for our purposes on defendant’s closing argument that the extensive warnings on the product were relevant to the jury’s inquiry on design defect. (Having skimmed Hansen to get a little extra detail, we cannot resist saying that the trial court was clearly usurping the jury’s role as trier of fact and reverse engineering to a predetermined result. That is the nice version.) In reversing, the Court of Appeal issued a narrow ruling that California’s risk-utility test for design defect requires considering whether labeling in place at the time of the injury could “reduce the likelihood of [] harm if followed” in assessing whether the product’s design posed “excessive preventable danger.” Enborg, 2022 U.S. Dist. LEXIS 78720, *7 (citing Hansen, 55 Cal. App. 4th at 1512, 1513, 1515 & 1519). Plaintiff’s argument that this holding in Hansen should have allowed her to get in her experts’ criticisms of the device’s labeling seemed like trying to fit the proverbial square exhaust manifold into a round head gasket.

Enborg cut off the need for a deep dive with the conclusion that the case “does not involve use instructions.” Id. at *7-8. Each expert’s excluded warnings opinions concerned the failures to disclose alleged inherent risks of the device, rather than how to “reduce the ‘likelihood’ (or gravity) from using the [device].” Id. at *8-9. For once, there was a helpful MDL ruling on basically the same issue with the same device, albeit under Texas law. Id. at *9 (citing In re Ethicon, Inc., No. 2:12-CV-4301, 2014 WL 457544, at *5 (S.D.W. Va. Feb. 3, 2014)). That ruling rejected plaintiffs’ attempt to offer expert opinions on warnings in support of a design defect claim because they “serve[d] only to inform physicians of the risk of implanting the device” so they could decide whether to “implant[] the device or choose[] an alternative treatment.” Id. The proposed warnings opinions in Enborg had the same failing and the motion to reconsider was denied.

We think there is a simpler bright line test here, even if a simpler negligence equivalent to comment k does not apply to design defect claims for a prescription medical device (as we think it should): What the label actually said about how to use or not use the product may be relevant to the risk-utility inquiry, but any proposals about what the label might have said about any subject are not. For the cleaning product in Enborg, the label actually said things like “Use only with rubber gloves, avoid contact with skin” and what first aid steps to take in the event of contact with skin or eyes. Those are clearly relevant to the extent of risk of using the product at the time the plaintiff actually used it because they were actually on the bottle in the plaintiff’s hands. None of the nearly infinite combinations of what the label could, should, or might have said instead sheds light on that inquiry. Opinions on what the label should have said—whether the same as or different than what it actually said—do not go to this inquiry. Those opinions are for a failure to warn claim. If the particular plaintiff cannot sustain that claim because of a failure of proximate cause, then she cannot backdoor her criticisms of the label as a way to pump up her design defect claim.

Sex, Drugs, Booze, and Contributory Negligence

By Stephen McConnell on May 11, 2022

Sometimes we write about a case because it is important. Sometimes we write about a case because it is novel. And sometimes we write about a case simply because it is fun. Nixon v. Kysela Pere et Fils, Ltd. et al., 2022 U.S. Dist. LEXIS 48067 (W.D. Va. March 17, 2022), tumbles into that last category.

The defendant Kysela Pere et Fils, LTD. (“the Company”), was an international wine and spirits distributor. The plaintiff sued both the Company and its owner – that would be the Kysela part of Kysela Pere et Fils. The plaintiff alleged that she and Kysela were engaged in a romantic relationship while the plaintiff was employed as a wine salesperson at the Company. According to the plaintiff, she was fired from the Company because she ended the personal relationship. She contended that the Kysela engaged in quid pro quo sexual harassment, in violation of Title VII of the Civil Rights Act of 1964.

The facts are predictably steamy. The plaintiff and Kysela had an on and off relationship. There were salacious, nasty notes. Honestly, you will have a much better time reading the Nixon opinion than our necessarily Bowdlerized version. We’ll leave it at this: the Nixon court held that the plaintiff failed to establish a genuine issue of material fact as to certain elements of her prima facie case of quid pro quo sexual harassment — e.g., whether there were any unwanted sexual advances and whether the plaintiff was discharged on account of sex (her gender) as opposed to lack of sex (the bawdy bits). Accordingly, the court held that the defendants were entitled to summary judgment on the Title VII claim.

What does any of this have to do with drug and device law? So far, nothing. But the plaintiff had also made a claim against the Company owner for gross negligence because he let the plaintiff ingest his Clonazepam, a Schedule IV controlled substance. The owner’s doctor prescribed him Clonazepam as a sleeping aid. During the course of their romantic relationship, the plaintiff requested that Kysela share his Clonazepam with her because she was having difficulty sleeping. The plaintiff took the medication without knowing what it was called or conducting any research on possible effects. At the same time, the plaintiff knew that taking medication that had been prescribed to someone else was illegal. The plaintiff said that she eventually became addicted to the medication. Three years after she began taking the owner’s Clonazepam, she asked her doctor to prescribe the medication to her. Her doctor refused and advised the plaintiff to stop taking the medication. Nonetheless, she continued taking the drug for two more years. After the plaintiff ended the personal relationship, she required therapy to discontinue her use of the Clonazepam. She claimed injuries from her use of the sleeping pills.

Not surprisingly, the Company owner argued that he did not owe a duty to the plaintiff. But because the case was “devoid of any evidence” that the Company owner “took any action whatsoever to avoid or advise [the plaintiff] of the harm involved in taking his prescription medication” the court could not conclude as a matter of law that the owner did not act with gross negligence when he gave his girlfriend his Clonazepam.

But that did not end the inquiry The Nixon case was governed by Virginia law, which still follows the old rule making contributory negligence a complete defense to allegations of negligence. The Nixon court reasoned that any reasonable juror could conclude that the plaintiff “failed to act as a reasonable person would have acted for her own safety by ingesting medicine without knowing what it was, what it did, or consulting a physician.” She “knew at the time that taking drugs that were prescribed to another individual constituted a crime under Virginia law.” Her “continued use of the drug after being denied her own prescription and being instructed by her physician to stop taking the drug” bolstered that conclusion. The plaintiff’s “failure to act prudently as it regards her own safety in taking a controlled substance without a physician’s advice” acted as a complete defense. The court granted summary judgment in favor of the defense.

So there you have it. The Nixon case had sex, drugs, wine, and, perhaps most delicious of all, application of the old contributory negligence rule that most of us have not encountered since we took the bar exam. What more could a law nerd want?

Drug & Device Law