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We want to start by emphasizing the word restrictions.  The law at issue in West Virginia was not a ban on plaintiff lawyer advertising, nor could it be.  Since Bates v. State Bar of Arizona, 433 U.S. 350 (1977), the First Amendment’s protection of truthful and non-misleading commercial speech extends to lawyers.  Lawyers, like professionals offering other services, can advertise and such advertising can serve the legitimate purpose of helping an individual determine if they have a legal problem and are in need of a lawyer.  That does not change the defense bar’s perspective that plaintiff lawyer advertising is fraught with problematic behavior that drives serial product liability and mass tort litigation.  That’s especially true for drugs and medical devices.  It is hard to ignore a television ad that sounds like a red flag warning about a medication you are currently taking.  It’s harder still sometimes to differentiate between a lawyer ad and public service announcement.  What the West Virginia law seeks to do is set a balance where advertising is permitted but with restrictions to curtail misleading advertising.  A unanimous Fourth Circuit found that was a valid exercise of the state’s police power to safeguard health and safety of its citizens.

In Recht v. Morrissey, — F.4th –, 2022 WL 1233240 (4th Cir. Apr. 27, 2022), two plaintiff attorneys and one client challenged the constitutionality of West Virginia’s Prevention of Deceptive Lawsuit Advertising and Solicitation Practices Regarding the Use of Medications Act.  The Act places certain restrictions and requirements on ads soliciting plaintiffs for litigation involving drugs and medical devices.  Id. at *1.  The first part of the act is aimed prohibiting ads “that give the false impression that they reflect medical or governmental advice.”  Id.  The ads cannot contain include phrases such as “consumer medical alert,” “health alert,” “consumer alert,” or “public service health announcement.”  Id.  Nor can they include the logo of a federal or state government agency, so as not to suggest affiliation with any such agency.  Finally, they cannot use the word “recall” except “when referring to a product that has been recalled by a government agency or through an agreement between a manufacturer and government agency.”  Id.  The second part of the Act is likewise geared toward preventing confusion or misleading the public but by requiring certain disclosures accompany all ads concerning drugs and devices approved by the FDA:

Such advertisements must include the warning: “Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.” They must also “disclose that the subject of the legal advertisement remains approved by the U.S. Food and Drug Administration, unless the product has been recalled or withdrawn.”

Id. at *2 (citations omitted).

The district court granted plaintiffs’ motion for summary judgment concluding that the act violated the First Amendment.  It conducted its analysis using a strict scrutiny standard rather than the intermediate scrutiny standard announced in Central Hudson Gas & Elec. Corp. v. Public Service Comm’n, 447 U.S. 557 (1980), as the “governing framework for analyzing commercial speech restrictions.”  Recht at *3.  The district court’s rationale for using strict scrutiny rested primarily on Sorrell v. IMS Health Inc., 564 U.S. 552 (2011), believing that case stands for the proposition that content-based laws are subject to strict scrutiny.  Recht at *4.  We’ve had numerous occasions to discuss Sorrell over the years (starting here) and the Fourth Circuit is not the first appellate court to find that Central Hudson’s intermediate scrutiny standard withstands Sorrell (see here).  Primarily because in Sorrell, the Court applied the Central Hudson standard just calling it “heightened” scrutiny instead of “intermediate” scrutiny.  Therefore, “[i]t is difficult to imagine that the Supreme Court, in consciously relying on Central Hudson, was actually overruling it.”  Recht at *4. Because the district court incorrectly applied strict scrutiny (“the most demanding test know to constitutional law”), the Fourth Circuit conducted a de novo review to determine if the Act withstood intermediate scrutiny.  It did.

The first Central Hudson factor is whether the law regulates misleading speech because such speech can be banned completely.  Id. at *5.  The court had no problem concluding that the purpose of the Act was to target “inherently or actually misleading” speech:

The dangers in this area are clear. Drug-related lawyer advertisements might give medically unsophisticated viewers the impression that attorneys are disinterestedly dispensing medical or governmental advice instead of actively soliciting clients. And those viewers might in response undertake a rash course of action detrimental to their health and wellbeing by promptly dropping their medications. West Virginia has merely attempted to abate these dangers.

Id. at *6.

As evidence that the practice of “dressing up a legal advertisement as something it isn’t” is both real and actually misleading, the court relied on a press release by the FTC in 2019 which we discussed here.  It appears plaintiffs did not fight aggressively over the provisions that prohibit calling an ad a “health alert” and such or using logos, but plaintiffs did pushback on the ban on the word “recall.”  It is not a total ban, but the Act prohibits calling a voluntary recall a recall because sometimes “objectively truthful speech can still be misleading.”  Id. at *7.

Precisely because the regulatory meaning of “recall” might not fully align with the ordinary meaning that a consumer would assign, West Virginia seeks to prevent the mistaken assumptions arising from this mismatch.

Id.  Nor does the act prevent other ways to describe a drug or device’s status, such as voluntary withdrawal.  Requiring the use of alternatives instead of a “loaded” word to avoid misleading the public is “eminently reasonable.”  Id.

The second Central Hudson question is whether the government’s interest is “substantial.”  Id. at *8.  The court found West Virginia had two substantial interests – protecting public health and preventing deception.  Either was sufficient to satisfy intermediate scrutiny.  Id.

The final two prongs of the Central Hudson test are whether the Act “directly advances” the state’s substantial interest and “in a way that is not more extensive than necessary.”  Id.  In practice, this means that state must have some evidence that the harm to be addressed is real and not just conjectural and there is a “fit” between that harm and the means chosen to address it.  Id. at *8-9.  The regulations need not be the least restrictive but should be reasonable.  Id. at *9.  Here the court concluded the Act passed this test:

As previously noted, each prohibition targets particular misleading words or images in order to protect public health and prevent citizens from taking misguided medical actions based on attorney advice. . . . The Act does not strip attorneys of the ability to advertise. It does not presume to dictate what attorneys can say about their legal services, but instead reaches misleading statements about drugs or devices that might give rise to a lawsuit. It does not affect other industries or activities, but instead focuses on a particular problem. Really, the Act does not ask for much, but instead requires that attorneys present themselves truthfully as attorneys when they advertise.

Id. So far as the reasonableness of the Act[s regulations, the court noted that at least two other states have similar acts (Texas and Tennessee).  Id. at *10.  For all of these reasons the court concluded that the prohibitions on what a lawyer can include in an ad do not violate the First Amendment.

The court then turned to the disclosure requirements which are judged under the standard set out in Zauderer v. Off. of Disciplinary Counsel, 471 U.S. 626 (1985), which provides that requiring advertisers to included “purely factual and uncontroversial information” is allowed as long as the disclosure is “reasonably related to the State’s interest in preventing deception of consumers.”  Recht at *10. The district court found the Act’s disclosure requirements were not sufficiently factual or uncontroversial to apply the reasonable relation test.  The Fourth Circuit disagreed.

Starting with “don’t stop your medications without consulting your doctor” – it was undisputed that it is “well known, after all, that suddenly discontinuing certain medications can cause injury.”  Id. at *11.  The district court found the second half of the disclosure – consult your doctor – was more advice/opinion than fact.  The Fourth Circuit found the lower court was working from a mistaken premise that an instruction cannot also be factual and uncontroversial:

Is there really any difference between a recipe that says, “Bake at 425 degrees for 35 minutes” and one that says, “The pie will be undercooked if you bake it for much less than 35 minutes and overcooked if you bake it for much longer”? Of course, instructions may turn out to be opinionated or non-factual on closer examination. But not always, and it is the communicative content of the message, rather than the format, that is dispositive. A sentence framed as “an instruction rather than a direct factual statement” may be factual and uncontroversial where it “clearly implies a factual statement” that is true.

Id. at *12.  The second disclosure requirement was to state that the drug remains approved by the FDA if that is true.  A statement the court found “entirely anodyne.”  Id.

Finally, both types of disclosures are reasonably related to the state’s interest in preventing consumer deception.  The district court focused on whether the mandatory disclosures were the “most appropriate remedy” in all circumstances.  But that is not the court’s job.  The West Virginia legislature came to the conclusion that these disclosures, on the whole, would best serve the interests of its citizens and as they are directly related to the state’s interest in preventing deception, the pass the reasonable relationship test.  Plaintiffs’ arguments regarding burden were unjustified given the limited scope of the disclosures.  Id. at *13.

The West Virginia Act is not “draconian.”  West Virginia enacted a statute narrowly focused on prohibiting false and misleading advertising in an area prone to potential deception of unsophisticated consumers.  In fact, these restrictions on lawyer advertising don’t come close to regulations that govern direct-to-consumer advertising by drug/device manufacturers. And ads that masquerade as “science”, “FDA safety warnings,” and “victim forums,” have the potential to do much more harm that a DTC add that at most could drive a consumer to talk to their doctor about a particular medication or treatment.  Fortunately, upholding a law like West Virginia’s is a positive step in reeling in speech that is inherently and actually misleading.

 

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We have posted twice before about decisions that reject duty-to-train claims under the rubric of “educational malpractice.”  Now Pennsylvania has joined the party.  Grady v. Aero-Tech Services, Inc., 2022 WL 683720 (Pa. Super. March 8, 2022), an unpublished, but citable, decision of Pennsylvania’s major intermediate appellate court, applied Pennsylvania’s prior precedents that reject educational malpractice claims specifically to specialized product-related training.  Grady involved a small plane crash, and the plaintiff sued (among others) the flight school that had provided the pilot with the “aerial practicum required prior to obtaining a private pilot license” and several individual instructors.  Id. at *1.

Plaintiff alleged that the instruction had failed to teach the defendant how to use this particular model aircraft – and particularly its safety features − properly:

The [model] aircraft was equipped . . . with a . . . Parachute System known as [“CAPS,” which] . . . consists of a ballistic rocket-fired parachute that extracts a large, rotund parachute attached to the airframe of the aircraft.  When utilized properly, CAPS has been shown to drastically reduce pilot and passenger fatalities. . . .  The wreckage of the . . . aircraft showed that the safety pin remained in the CAPS parachute handle, exhibiting that [the pilot] did not remove the pin when executing his preflight checklist.  Accordingly, CAPS was not able to be activated by [the pilot] prior to impact.

Id. at *2 (citations and quotation marks omitted).

The claim against the flight school were dismissed because “Pennsylvania courts have not permitted cases of negligence resulting from alleged educational malpractice to persist.”  Id. (quoting trial court).

Affirmed.

Plaintiff “acknowledge[d]” that Pennsylvania “does not permit educational malpractice claims to succeed against traditional educational institutions,” but attempted to distinguish this case as involving “a precise activity, which Appellant contends is ultrahazardous.”  Id. at *3.  Adopting the trial court opinion, Grady held:

First, Pennsylvania tort precedent “leave[s] no doubt that Pennsylvania does not recognize educational malpractice as a valid cause of action.”  Id. at *6 (citing, Swartley v. Hoffner, 734 A.2d 915 (Pa. Super. 1999); Cavaliere v. Duff’s Business Institute, 605 A.2d 397 (Pa. Super. 1992); Agostine v. School Dist. of Philadelphia, 527 A.2d 193 (Pa. Commw. 1987); Aubrey v. School Dist. of Philadelphia, 437 A.2d 1306 (Pa. Commw. 1981); Alley v. Bellwood Antis School Dist., 27 Pa. D. & C.3d 307 (Pa. C.P. 1983)).

Yes, all of these cases had involved defendants that offered more general educational services, but that was a distinction without a difference.  Decisions from outside Pennsylvania have all rejected educational malpractice claims against flight and other types of trade schools.  Grady, 2022 WL 683720, at *7-9 (discussing Moss Rehab v. White, 692 A.2d 902, 905 (Del. 1997); Waugh v. Morgan Stanley & Co., 966 N.E.2d 540, 553-54 (Ill. App. 2012); Glorvigen v. Cirrus Design Corp., 796 N.W.2d 541, 553 (Minn. App. 2011), aff’d, 816 N.W.2d 572 (Minn. 2012), and Dallas Airmotive, Inc. v. FlightSafety International, Inc., 277 S.W.3d 696, 700-01 (Mo. App. 2008); Page v. Klein Tools, Inc., 610 N.W.2d 900, 906 (Mich. 2000)) (all of which we discussed in our prior posts).

Further, allowing educational malpractice claims would be contrary to public policy.  The “most instructive” cases:

have outlined a compelling public policy rationale of why educational malpractice is disfavored, which are:  (1) the lack of a satisfactory standard of care by which to evaluate an educator; (2) the inherent uncertainties about causation and the nature of damages in light of such intervening factors as a student’s, attitude, motivation, temperament, past experience, and home environment; (3) the potential for a flood of litigation against schools; and (4) the possibility that such claims will embroil the courts into overseeing the day-to-day operations of schools.

Grady, 2022 WL 683720, at *11.  Grady goes on to examine each of these rationales in detail.  Id. at *11-15.  “[R]egardless of the subject matter or the dangerousness of the content taught,” these policy concerns “stand.”  Id. at at *15.

Thus, our clients can add Grady and its interpretation of Pennsylvania precedent to the arguments against training claims raised in McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 816-17 (E.D. Pa. 2016).  That court guessed that, maybe, Pennsylvania would allow plaintiffs to pursue negligent training claims under the rubric of negligent undertaking.  Id.  The cases cited in McLaughlin, however, had nothing to do with training of anyone for anything.  Given Grady, and its application of the prohibition against educational malpractice to training involving the use of specialized products, the argument that “there is no [Pennsylvania] state law on which to base a negligent training claim,” 172 F. Supp.3d at 816, should now succeed.

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A California appellate court has ruled that California’s mandatory trial preference statute is not always mandatory, an opinion that gives courts and defendants a slight bit of breathing room in an otherwise unforgiving space. Every practitioner in the product liability space has encountered California’s trial preference statute, Civil Procedure Code Section 36.  That is the law stating that a trial court “shall grant” a trial date within 120 days to a plaintiff who is over 70 years of age and in poor health.  We can see the surface appeal to the statute—plaintiffs who are elderly and in poor health should be given a preference to ensure that they “get their day in court.”

Even a gentle scratch though reveals flaws beneath the surface.  The purpose of our civil litigation system is to transfer wealth, and even if a sick and elderly person is given a trial date within 120 days of an order granting a preference, there is no guarantee or even a likelihood that he or she will prevail at trial, survive appeals, and collect on a judgment during his or her lifetime.  Moreover, California is now one of several states that allows a decedent’s estate to recover a decedent’s pain and suffering after the decedent has passed away, which removes a major justifications that supporters of the trial preference statute often give:  They have to get a trial in before the plaintiff dies so his or her claim for pain and suffering will not “die with them.” That argument has now evaporated.

The practical reality is that California’s preference statute generates substantial unfairness for both sides.  As the population ages and plaintiffs’ attorneys increase their skill at building inventories, plaintiffs’ attorneys use California’s preference statute opportunistically to bludgeon defendants for the benefit of a select few.  Defendants are forced to try cases without sufficient time to prepare, and other plaintiffs are pushed aside by individuals who meet the statute’s criteria and are selected by their lawyers to apply for a preference.  Who is to say that a 71-year-old person in poor health deserves a trial date more than a 45 year old who has comparable claims, but is in the prime of her life?  Maybe an earlier trial date is in order, but maybe one is not.  Judges should have the discretion to make that call.

That mandatory nature of the rule—“the court shall grant”—can also wreak havoc on our courts, who sometimes struggle to accommodate their preference cases within the mandated 120-day timeframe, again while others who do not meet the preference criteria wait in line.

Well, maybe the mandatory preference statute is not so mandatory.  In Isaak v. Superior Court, 73 Cal. App. 5th 792 (2022), the California Court of Appeal held that California’s statute allowing for MDL-style coordination trumps California’s trial preference statute, placing trial setting back within the discretion of the trial court.  In Isaak, the plaintiff was 84 years old and suffered from Parkinson’s disease, clearly meeting the criteria for a mandatory trial preference.  Id. at 794.  His case, however, was pending within a California Judicial Council Coordination Proceeding, or “JCCP.”

A JCCP is California’s version of multidistrict litigation, i.e., cases throughout California’s 58 counties can be transferred to a single venue for coordinated proceedings, possibly including trial.  Critically, the coordination statute calls for coordinated proceedings “notwithstanding any other provision of law”:

Notwithstanding any other provision of law, the Judicial Council shall provide by rule the practice and procedure for coordination of civil actions in convenient courts, including provision for giving notice and presenting evidence.

Cal. Civ. Proc. Code § 404.7 (emphasis added).  Under this authority, the Judicial Council promulgated a rule stating that JCCPs generally had to follow the rules applicable to civil actions, except that “if the prescribed manner of proceeding cannot, with reasonable diligence, be followed in a particular coordination proceeding, the assigned judge may prescribe any suitable manner of proceeding that appears most consistent with those statutes and rules.  Isaak, at 797-98 (quoting Cal. Rule of Court 3.504).

You might call this the wiggle room clause, and it applies in JCCPs “notwithstanding any other provision of law.”  That would include California’s trial preference statute.  The practical impact is that if a judge finds that the trial preference statute cannot be followed in a JCCP, he or she can follow a more suitable course.

That is what happened in Isaak.  Sure, the plaintiff met the criteria for a trial preference, but his case was in a JCCP.  That freed the judge to apply discretion and set trial dates under a coordinated protocol that took into account the plaintiffs’ age and health, but not as the only determining factors.  That is the way it ought to be, and it resulted in an order denying the plaintiff’s motion for mandatory trial preference and an opinion from the Court of Appeal approving that result.

California’s coordination statute (“notwithstanding any other provision of law”) trumps California’s trial preference statute.  We see this as a positive development, but with some limitations.  First, there is still a chance that JCCP judges will, in their discretion, jam defendants with early trial dates.  It’s not mandatory, but the potential for unfairness is still there.  Second, the ruling is, for now, limited to JCCPs, where many product liability cases reside, but not all.  The real winner in all this is judicial discretion.

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A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.

The plaintiff received a vena cava filter manufactured by the defendant. Surgically implanted in the vena cava vein, the filter is designed to reduce the risk of pulmonary embolism, a potentially dangerous condition caused by blood clots. According to the plaintiff, he suffered bodily injury when filter shifted after implantation. He sued, alleging that the manufacture had not adequately warned of that danger.

The district court dismissed the failure-to-warn claim under New Jersey law and the Third Circuit affirmed on that basis in a brief per curiam decision.

The court explained that under New Jersey law, “‘[i]f the warning’” at issue was “‘given in connection with a [device] has been approved or prescribed by the [FDA],’” then there is “‘a rebuttable presumption … that the warning or instruction is adequate.’” 2022 WL 1261318, at *1 (quoting N.J. Stat. Ann. § 2A:58C-4). The court further explained that, “[t]o overcome this presumption,” which has been called the “compliance presumption, “a plaintiff must plead specific facts alleging ‘deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process[.]’” Id. (quoting Cornett v. Johnson & Johnson, 48 A.3d 1041, 1056 (N.J. 2012), abrogated on other grounds by McCarrell v. Hoffmann-La Roche, Inc., 153 A.3d 207 (N.J. 2017)).

Employing a two-step analysis, the court “agree[d] with the District Court that [the plaintiff failed to state a claim because the warnings provided by [the manufacturer] in connection with the [device] were adequate as a matter of law.” 2022 WL 1261318, at *2. First, finding it “undisputed that the [device at issue] is subject to FDA oversight,” the court held that the manufacturer’s warnings were “subject to the ‘super-presumption’ in [N.J. Stat. Ann.] § 2A:58C-4.” Id. Second, the court “concluded that [the plaintiff] failed to plead facts sufficient to rebut the presumption” because he did “not allege that [the manufacturer] deliberately concealed or withheld known harmful effects associated with the [device], or that [the manufacturer] manipulated the post-market regulatory process.” Id. Because the plaintiff failed to overcome the presumption, the court held that he had failed to state a failure-to-warn claim under New Jersey law.

That is clearly the correct outcome under New Jersey law. We have no complaints as to the result.

We do, however, have reservations about N.J. Stat. Ann. § 2A:58C-4, the statute that yielded the result.

Do not misunderstand, the presumption established by the statute is not only appropriate but also helpful. As we observed before, the presumption makes it much harder for medical-device and prescription-drug plaintiffs to plead and ultimately prove a failure-to-warn claims in New Jersey. No complaints on that score. Anything to reduce the burden of typically meritless claims is welcome.

But consider how the presumption is rebutted—by pleading, and ultimately presenting evidence of, “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process.” N.J. Stat. Ann. § 2A:58C-4. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability. But state-law claims that rest on alleged fraud on the FDA are contrary to Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), which concluded that fraud-on-the-FDA claims are impliedly preempted because they “inevitably conflict” with the FDA’s regulatory discretion under. 21 U.S.C. § 337(a).

The Fifth and Sixth Circuits have some understanding of this, having respectively held in Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012), and Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), that provisions allowing the rebuttal of a compliance presumption based on alleged fraud on the FDA are preempted unless the FDA itself finds fraud. We don’t think that goes far enough, but at least those courts recognize that Buckman preempts rebuttal provisions in at least some circumstances. The same cannot be said of the Second Circuit, which reached the contrary—and erroneous—conclusion in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by an equally divided court sub nom. Warner-Lambert Co., LLC v. Kent, 552 U.S. 440 (2008)).

We’ll take what we can get, but we are entitled to more when it comes to the preemption of rebuttal provisions.

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Happy Star Wars Day. May the Fourth be with you.

If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.

The plaintiff in Flores claimed that the Gardasil vaccine, which fends off Human Papillomavirus, caused her to suffer from postural orthostatic tachycardia syndrome (POTS) and other injuries. She filed a petition with the U.S. Court of Federal Claims under the National Vaccine Injury Compensation Program. After judgement was rendered in that forum, the plaintiff filed a lawsuit with claims for negligence, strict liability failure to warn, strict liability manufacturing defect, breach of express warranty, and common law fraud. The defendant moved to dismiss the complaint and won across the board.

The negligence claim was a “poorly disguised” design defect claim, which is barred by the Vaccine Act. The negligence cause of action griped about the defendant’s lack of reasonable care in designing the product. It also suggested that ingredients in the vaccine were unsafe. The Flores court was correct in identifying this as a design defect claim. If the negligence claim was aimed at anything else, it was impossible to figure out what that was. The claim was “lengthy, difficult to follow, and replete with run-on sentences.” The court threw up its hands and told the plaintiff to try again.

The failure to warn claim was also a goner. To the extent the claim addressed a failure to warn the plaintiff and her parents, it was barred by both the Vaccine Act and Nevada’s adoption of the learned intermediary doctrine. To the extent the claim addressed a failure to warn the plaintiff’s doctors, it was marked by vagueness and lack of substance. The complaint alleged that the manufacturer did not disclose the vaccine’s “dangerous propensities” and its “carcinogenic characteristics and autoimmune-inducing characteristics,” but never specified what “propensities” and “characteristics” were not conveyed to the plaintiff’s doctors. Again, the plaintiff needed to try again.

The breach of warranty claim was a “veiled failure to warn claim.” Therefore, the Vaccine Act, Nevada’s learned intermediary doctrine, and the vagueness as to what was hidden from the doctors doomed this cause of action. In addition, the complaint failed to substantiate how the manufacturer’s “representations became part of the basis of the bargain.” Moreover, Nevada statutes require that, prior to bringing a breach of warranty claim, a “plaintiff must first provide the defendant with some type of pre-suit notice.” That didn’t happen here. The Flores court dismissed the warranty claim without prejudice and with leave to amend.

The manufacturing defect claim was as defective as such claims usually are. To the extent this claim took issue with “toxins” present in the FDA approved vaccine formula, the claim was preempted by the Vaccine Act. To the extent this claim alleged that the vaccine deviated from the approved design, it was implausible. The plaintiff asserted that the vaccine violated manufacturing specifications, but then “puzzlingly states that her Gardasil products she received did not ‘have a substantial change in their condition as designed, manufactured, sold, distributed, labeled, and marketed’” by the defendant. That blatant contradiction required dismissal, with the plaintiff afforded an opportunity to do a rewrite.

Finally, it will hardly surprise you that the fraud claim flunked Rule 9(b) specificity. The complaint says that advertisements “duped” the plaintiff’s mother into believing the vaccine was safe and effective, but never specifies when mom saw such ads. The complaint also alludes to fraudulent conduct that misled the general public and doctors, but those allegations “stray even further from Rule 9(b)’s specificity requirements.” Maybe the plaintiff can fix that lack of specificity. Maybe not.

The Flores case demonstrates that it is not impossible to bring a lawsuit against a vaccine, but such a lawsuit must be narrowly and clearly framed. Both the public good and court dockets would benefit if the same restrictions applied to all drug and medical device lawsuits.

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Today’s case is a straight warnings case.  So, there should be little surprise that if it involves a generic drug preemption shuts it down.  But that does not mean that plaintiffs did not try several avenues of attack to try to find a warning claim that would stick.  None did.

The case is Roncal v. Aurobindo Pharma USA, Inc., 2022 WL 1237888 (D.N.J. Apr. 27, 2022).  Multiple plaintiffs and their spouses brought suit against the manufacturer of generic amiodarone, a drug used to treat atrial fibrillation.  Id. at *1.  While the decision does not specify where all plaintiffs are from, we know they are not all from New Jersey and appear to hail from various states around the country.  That’s important because the court had to figure out what law to apply to defendant’s motion to dismiss.  The complaint only mentioned New Jersey and federal law, but plaintiffs apparently argued that the law of their respective states of residence should apply.  Id. at *2-3.  What plaintiffs failed to argue is how the law of their home states conflicted with New Jersey law.  Absent evidence of a conflict, “the law of the forum governs.”  Id. at *3.  Further, plaintiffs only identified their states of residence, not the states where their injuries occurred – which is the presumed applicable law for personal injury claims.  Therefore, on the additional ground of failing to provide the facts necessary to make a proper choice of law analysis, the court chose to apply New Jersey law to all plaintiffs’ claims.  Id. at *9n.4.

Having decided to apply New Jersey law, the court’s next decision was whether all of plaintiffs’ claims were subsumed by the New Jersey Products Liability Act (“NJPLA”).  There was no dispute that the two strict liability claims – failure to warn and manufacturing defect – were subsumed.  But plaintiffs also alleged negligence and fraud claims which if arising “from the independent conduct of a defendant, which is unrelated to the inherent defect in the product itself,” may exist outside the NJPLA.  Id. at *4.  Here they did not.  All of plaintiffs’ claims were premised on three warnings-based sets of allegations:  failure to provide a warning in the form of a Medication Guide; the failure to report adverse events; and the deficiency of the warnings themselves.  Id.  Because the negligence and fraud claims were based on the same products liability allegations, they could not stand separate from plaintiffs’ NJPLA claims and therefore were dismissed.  Id.

That leaves the court’s final analysis on those two NJPLA claims.  First, plaintiffs really did not have a manufacturing defect claim.  The allegations in that count only talked about warnings, labeling and the Medication Guide.  Without any allegation about the product being in a “substandard condition,” plaintiffs simply recast their warnings claims into a count titled manufacturing defect.  The court treated it like another warnings claim.  Id. at n.8.

Now we are back where we started – a straight warnings case.  The court looked at each of plaintiffs’ warnings theories separately.  First was failure to provide Medication Guides.  Medication Guides are the FDA-approved warnings that are directed to the patient.  The FDCA requires manufacturers to provide “distributors, packers, and dispensers” either enough Medication Guides to distribute to all prescribed patients or the means by which to generate sufficient Medication Guides.  And the important part of that is “the FDCA requires.”  Therefore, the violation of the FDCA is a “crucial element” of the claim and

Plaintiffs’ attempt to use a state products liability law to seek relief for a violation of this FDCA requirement is preempted under Buckman. 531 U.S. at 353.

Id. at *6.  Preemption is the end of the story, but the court did address plaintiffs’ argument that under New Jersey law plaintiffs had a duty to provide the Medication Guide directly to patients.  Plaintiffs cite to no case or other authority creating such a duty and none exists.  Id. at *7.  Plaintiffs tried to rely on Perez v. Wyeth Labs, Inc., 734 A.2d 1245 (N.J. 1999).  But what that case said was if a manufacturer undertakes direct-to-consumer marketing, there is a corresponding duty to warn the patient.  Roncal, at *7.  Plaintiffs are not alleging direct-to-consumer advertising and therefore Perez is inapplicable.  Here we have to point out the court dropped a nice footnote on Erie conservatism.  Id. at n.12 (diversity courts should be reluctant to create new rights).  Plaintiffs also failed to plead facts sufficient to support their Medication Guide claim and so even if it not preempted it would not have survived.  Id. at *8.

Next plaintiffs argued that defendant failed to report adverse events to the FDA.  First and foremost:

Plaintiffs have failed to identify any state law that requires [defendant] to report adverse events to the FDA, and courts in this District have concluded no such duty exists.

Id.  So, this claim is likewise preempted by Buckman.  Even if not preempted, plaintiffs only support for the claim is that based on the number of prescriptions there appears to be a “dearth of adverse events.”  Id.  Plaintiffs do not point to any adverse event that was not reported.

Then there is the warning label itself.  Plaintiffs argued that by providing the labeling to doctors, via things like the Physician Desk Reference (“PDR”), defendant “failed to correct certain information on which physicians relied.”  Id. *9.  This is Mensing preemption.    A generic manufacturer cannot change the label; it is required to use the same label as the brand. Presumably plaintiffs were trying to argue that the PDR material was not labeling and was a means by which generic manufacturer could have skirted the duty of sameness.  If you have ever seen a PDR, it is quite simply just a collection of the labels.  So, plaintiffs’ argument falls seriously flat.  Once again, the actual pleadings are sorely deficient because not only did plaintiffs not explain how a generic manufacturer would have control over or authority to change PDR materials, they failed to make any allegation about what was misleading in the labeling.  Id.

Finally, while not addressed in the body of the opinion the court dismissed both plaintiffs’ off-label promotion and negligence per se claims as preempted as well.  Off-label promotion claims are preempted because only the government can enforce FDCA which is the sole source of the duties on which such a claim relies.  The negligence per se claim was based either on the same Medication Guide allegations or failure to provide an adequate warning.  One is preempted by Buckman and the other by Mensing.  Id. at n.6.

Many avenues were pursued but they all ended at preemption.

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As regular readers know, we bloggers have been following the issue of whether software of various sorts – electronic bytes – is a “product” for product liability purposes.  It’s a longstanding issue, since the current Restatements of Torts specifically defines a “product” as something “tangible,” which arrays of electrons are not.  “A product is tangible personal property distributed commercially for use or consumption.”  Restatement (Third) of Torts:  Products Liability §19(a) (1998).  However, this same section also states that “[o]ther items, such as . . . electricity” can be considered “products when the context of their distribution and use is sufficiently analogous to the distribution and use of tangible personal property.”  Id.

As for “computer software,” Restatement §19 found “no cases on point” except “dictum” in Winter v. G.P. Putnam’s Sons, 938 F.2d 1033, 1035 (9th Cir. 1991) (“Computer software that fails to yield the result for which it was designed may be another.”).  Restatement §19, Reporters’ Notes.  Winter’s holding, however, was the opposite – “declin[ing] to expand products liability law to embrace the ideas and expression,” found, in that case, in a book.  939 F.2d at 1036.  These Reporters’ Notes also mention the Uniform Commercial Code, but subsequently, in 2005, the UCC was amended and now defines “goods” only as including “a computer program embedded in goods.”  U.C.C. §9-102(44).  For UCC purposes, “software” is now considered a “general intangible,” not a “good.”  Id. §9-102(42).

The definitions of “goods” and “software” are also mutually exclusive.  Computer programs usually constitute “software,” and, as such, are not “goods” as this Article uses the terms.  However, under the circumstances specified in the definition of “goods,” computer programs embedded in goods are part of the “goods” and are not “software.”

U.C.C. §9-102, Commentary, at 4(a).  See also Uniform Computer & Information Technology Act of 2002 §102(a)(35) (likewise defining “information” − as opposed to “goods” − as including “computer programs”).

In terms of post-Restatement case law, recently Quinteros v. InnoGames, 2022 WL 898560 (W.D. Wash. March 28, 2022), directly considered this issue where the plaintiff alleged addiction to an “online video game” and economic losses from purchasing “in-game currency.”  Id. at *1.  Among the plaintiff’s multiple liability theories was a products liability claim that the game’s “unfair practices and cheating . . ., and attempting to cause a medical condition” – presumably addiction in its users – implicates “a broader public interest of protecting the public from predatory companies.”  Id. at *7.  Quinteros “agree[d] that [the game] as pled in this case is not a product under the” Washington State product liability statute.  Id.

[O]nline games are not subject to Washington’s products liability law.  [The statute] defines “Product” as “any object possessing intrinsic value, capable of delivery either as an assembled whole or as a component part or parts, and produced for introduction into trade or commerce.”  [The game] is software as a service, not an “object,” hence Plaintiff’s product liability claim must fail as a matter of law.

Id.  Plaintiff sought reconsideration, and lost again.  Quinteros v. InnoGames, 2022 WL 953507, at *2 (W.D. Wash. March 30, 2022) (“The Court will not consider new argument related to Plaintiff’s product liability claim” and “[i]n any event, Plaintiff has failed to demonstrate manifest error”).

For its holding, Quinteros cited the aforementioned Restatement §19, and several cases.  Sanders v. Acclaim Entertainment, Inc., 188 F. Supp.2d 1264, 1278-79 (D. Colo. 2002) (computer games are not products for strict liability purposes); Wilson v. Midway Games, Inc., 198 F. Supp.2d 167, 173 (D. Conn. 2002) (interactive “virtual reality technology” is not a “[product] for the purposes of strict products liability”); James v. Meow Media, Inc., 90 F. Supp.2d 798, 810 (W.D. Ky. 2000) (“[w]hile computer source codes and programs are construed as ‘tangible property’ for tax purposes and as ‘goods’ for UCC purposes, these classifications do not indicate that intangible thoughts, ideas, and messages contained in computer video games, movies, or internet materials should be treated as products for purposes of strict liability”), aff’d, 300 F.3d 683, 700-01 (6th Cir. 2002) (software makers and website operators do not deal in “products”).

We have previously discussed Rodgers v. Christie, 795 F. Appx. 878, 880 (3d Cir. 2020), which held that artificial intelligence software “is neither ‘tangible personal property’ nor remotely ‘analogous to’ it” to qualify as a product for product liability purposes.  Id. at 880 (following Restatement §19):

[The program] is an “algorithm” or “formula” using various factors to estimate [the likelihood of a result]. . . .  [I]nformation, guidance, ideas, and recommendations are not “product[s]” under the Third Restatement, both as a definitional matter and because extending strict liability to the distribution of ideas would raise serious First Amendment concerns.

Id. at 880 (citation and quotation marks omitted).  Strict liability under the New Jersey product liability statute “applies only to defective products, not to anything that causes harm or fails to achieve its purpose.”  Id.

Similarly, in Intellect Art Multimedia, Inc. v. Milewski, 2009 WL 2915273 (N.Y. Sup. Sept. 11, 2009) (in table at, 899 N.Y.S.2d 60), the court refused to find a website to be a “product” for strict liability purposes:

[P]laintiff has failed to demonstrate that, as a matter of law, the . . . website is a product so that [defendant] should be held strictly liable for any “injury” caused thereby.  Although plaintiff argues that the national trend is moving towards a more expansive definition of the term “product” in products liability analysis, this court is not persuaded that this website in the context of plaintiff’s claims is a “product” which would otherwise trigger the imposition of strict liability.

Id. at *7.

A few non-product liability cases are also worth mentioning.  ClearCorrect Operating, LLC v. International Trade Commission, 810 F.3d 1283 (Fed. Cir. 2015), held that 3D printing digital files are not “material” things for purposes of the Tariff Act of 1930 (19 U.S.C. §1337).  ClearCorrect held that digital files were not “articles” because articles must be “material things.”  Id. at 1296. Therefore the statute did not apply, meaning that no administrative authority existed to stop their importation.  Id. at 1293-94.  Reconsideration was denied because “[t]he panel majority was correct in interpreting the word ‘articles’ . . . to mean ‘material things.’”  ClearCorrect Operating, LLC v. International Trade Commission, 819 F.3d 1334, 1336-37 (Fed. Cir. 2016).  The extensive discussion in ClearCorrect suggests that, by analogy, that digital files such as those used in 3D printing may not themselves be “products.”

A similar ruling that computer code was not a “good” occurred in United States v. Aleynikov, 676 F.3d 71 (2d Cir. 2012).  Aleynikov held that proprietary computer source code was not stolen “goods,” “wares,” or “merchandise” as required by the 1948 National Stolen Property Act (18 U.S.C. §2314), “[b]ased on the substantial weight of the case law, as well as the ordinary meaning of the words.”  Id. 676 F.3d at 73-74.  Purely intellectual property was outside the statute, which required “some tangible property must be taken from the owner for there to be deemed a ‘good’ that is ‘stolen’.”  Id. at 77.

Also, in America Online, Inc. v. St. Paul Mercury Insurance Co., 347 F.3d 89 (4th Cir. 2003), computer software was not considered “tangible personal property” for purposes of an insurance claim.  Rather, “[i]nstructions to the computer and the data and information processed by it are abstract ideas in the minds of the programmer and the user.”  Id. at 95.  Such “instructions, data, and information are abstract and intangible, and damage to them is not physical damage to tangible property.”  Id. at 96.  Accord  Cash & Carry America, Inc. v. Roof Solutions, Inc., 117 A.3d 52, 65 (Md. App. 2015) (following AOL).

Recent litigation over social media that allegedly encourages people to drive at recklessly high speeds has so far avoided the question of what is a “product” by pursuing claims solely in negligence, not strict liability.  Lemmon v. Snap, Inc., 995 F.3d 1085, 1092-93 (9th Cir. 2021) (asserting negligent design under Restatement (Second) of Torts §398 (1965); repeatedly referring to a social media application as a “product”); Maynard v. Snapchat, Inc., ___ S.E.2d ___, 2022 WL 779733, at *4 (Ga. March 15, 2022) (plaintiffs “pursued only a negligence theory of design defect”; also repeatedly referring to the same application as a “product”).  Cf. Grossman v. Rockaway Township, 2019 WL 2649153, at *15 (N.J. Super. Law Div. June 10, 2019) (dismissing on other grounds but finding “no facts alleged that would support the theory that [the social media site’s] actions qualify or constitute a product under the Product Liability Act”).  Other social media cases are more or less the same, with the viability of product liability allegations not addressed.  See Doe v. Twitter, Inc., 555 F. Supp.3d 889, 929-30 (N.D. Cal. Aug. 19, 2021) (not reaching question of whether social media is a product; dismissing action for other reasons); Williams v. Apple, Inc., 2020 WL 1296843, at *2-4 (S.D. Tex. March 24, 2020) (product liability claims involving cell phone software update dismissed for multiple other reasons; status of update as a “product” not addressed); Herrick v. Grindr, L.L.C., 306 F. Supp.3d 579, 592 n.9 (S.D.N.Y. 2018) (“not address[ing the website’s] argument that it is not a ‘product’ for purposes of products liability” given dismissal for other reasons), aff’d, 765 F. Appx. 586 (2d Cir. 2019).

On the other side of the ledger, in Hardin v. PDX, Inc., 173 Cal. Rptr.3d 397 (Cal. App. 2014), a case which for other reasons garnered our booby prize as the fifth worst case of that year, a claim against a company that had supplied publishing software to a pharmacy that allegedly generated an incomplete drug “monograph” (purportedly omitting a boxed warning) a survived a motion to dismiss under California’s notoriously lax pleading standards:

[Defendant] also asserts that [plaintiff] cannot prevail on her products liability theory as a matter of law because [it] distributes drug information, and information is not a product for purposes of product liability claims.  But [plaintiff’s] theory is that [defendant’s] software program, not the information it produces, is the defective product.  [Defendant] has not argued, let alone shown, that [plaintiff] cannot prevail under that theory.  Maybe so, but at this early juncture we cannot so conclude.  [To survive a demurrer] causes of action need only be shown to have minimal merit.

Id. at 407 (citations and quotation marks omitted).  As mentioned in our previous post, however, the primary claim at issue in Hardin involved negligent undertaking, id. at 404-05.

The Louisiana Supreme Court has held computer software to be “corporeal property” for purposes of taxation.  South Central Bell Telephone Co. v. Barthelemy, 643 So.2d 1240, 1244 (La. 1994) (“we hold that computer software at issue in this case constitutes corporeal property under our civilian concept of that term”).  This definition has bled over into product liability, since the Louisiana product liability statute defines product as “a corporeal movable.”  La. Stat. §9:2800.53.  See Schafer v. State Farm Fire & Casualty Co., 507 F. Supp.2d 587, 600-01 (E.D. La. 2007) (based on South Central Bell, a computer “program may be a product for the purposes of the LPLA”) (footnote omitted).

Also in Louisiana, in Corley v. Stryker Corp., a physical product – a medical device – was “designed and manufactured from patient-specific 3D imaging data . . . and the use of proprietary 3D imaging software.”  2014 WL 3375596, at *1 (Mag. W.D. La. May 27, 2014), adopted, 2014 WL 3125990 (W.D. La. July 3, 2014).  On a motion to dismiss, the court concluded that not only the physical implant, but also the defendant’s “software used in creating” it, was “a necessary part” of the “product” as a whole, and therefore was subject to strict liability as a component part even though, physically, the software was entirely separate from the device.  Id. at *4.

That’s what we’ve found so far looking at this fascinating question.  Most cases continue to follow the Restatement and the UCC to hold that computer software is not a “product” for product liability purposes.  So far, anyway, this precedent has led most plaintiffs to pursue software companies under negligence, rather than strict liability, theories of liability.

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We write on a chilly day in Philadelphia – we and the Drug and Device Law Little Rescue Dogs all shivered on our morning walk.  And we are excited to share the news that our scruffy shelter rescues will be joined, a la Lady and the Tramp, by some relative aristocracy later this year:  our dear friend and the breeder of our two treasured and long-departed Standard Poodles has offered to place a retired show dog with us when he finishes his championship.  For the initiated, he won both “majors” last week.  So he could be Philadelphia-bound before too long.  We will keep you posted.

Today’s case also contains good news, particularly for defendants in toxic tort cases.  In Nemeth v. Brenntag North America, et al., 2022 WL 1217464 (Ct. App. NY Apr. 26, 2022), New York’s highest court reversed an asbestos jury’s verdict for the plaintiff, holding that the plaintiff’s experts had not adduced sufficient proof that the defendant’s product caused the plaintiff’s decedent’s fatal mesothelioma.

The decedent was diagnosed with peritoneal mesothelioma in 2012 and died in 2016.  The complaint alleged that the decedent “used lawn care products containing asbestos; worked with construction materials containing asbestos during home renovations; and inhaled asbestos fibers when she laundered the clothing her son wore as an elevator repairman,” and that she used the defendant’s asbestos-containing talcum powder daily from  1960 until 1971. The plaintiff settled with all of the defendants except the manufacturer of the talcum powder and tried the case against only that single defendant.

The plaintiff called a geology expert, who testified about a test he performed to simulate the plaintiff’s use of the defendant’s talcum powder “and to capture the released asbestos fibers.”  Nemeth, 2022 WL 1217464 at *1.   The test involved agitating a vintage sample of the talcum power in a sealed Plexiglas “glove box” chamber containing filters designed to simulate “breathing zones.”  The expert concluded that the asbestos fibers in the powder sample were “significantly releasable” and that, multiplying the numbers of fibers released during the test by “time, duration, and frequency” of the plaintiff’s exposure, the plaintiff “must have been exposed to thousands to millions of fibers, billions and trillions when you add it up through repeated use.”  Id. (internal punctuation omitted).  In turn, the plaintiff’s medical causation expert, an internal medicine specialist, testified that a diagnosis of mesothelioma indicated that the decedent had been exposed to asbestos, and that, based on the geologist’s test results, the talcum powder was a “substantial contributing factor” to the decedent’s peritoneal mesothelioma.

The jury returned a substantial verdict in favor of the plaintiff.  The defendant moved for JNOV, arguing that the verdict “was not supported by legally sufficient evidence as to causation.”  Id. at *2.  The trial court denied the motion.  On appeal, the intermediate appellate court affirmed, holding that “[the geologist’s] testimony about the amount of asbestos released . . . , along with the timing, duration and frequency of the decedent’s use of that product, with his conclusion that the amount of asbestos greatly exceeded, by several orders of magnitude, the amount of asbestos fibers in ambient air, presents a sound basis for the jury’s conclusion.”  Id. (internal punctuation and citation omitted).  One judge dissented, concluding that the geologist’s study was not sufficient to establish the decedent’s exposure because “it did not estimate the quantity of asbestos fibers to which the decedent would have been exposed” and because the doctor’s causation testimony “failed to provide more than vague, conclusory, and subjective terms, characterizing both the level of asbestos exposure sufficient to cause peritoneal mesothelioma and the level of asbestos exposure to which [the] decedent allegedly was subjected.”  Id. (internal punctuation omitted).   The intermediate appellate court granted the defendant leave to appeal, and today’s case is the decision on that appeal.

The Court of Appeals held:

We agree with the dissent below that plaintiff’s proof failed as a matter of law to meet our test for proving causation in toxic tort cases, and we take the opportunity to reaffirm our requirements in such cases. As we noted sixteen years ago, it is well-established that an opinion on causation should set forth a plaintiff’s exposure to a toxin, that the toxin is capable of causing the particular illness (general causation) and that plaintiff was exposed to sufficient levels of the toxin to cause the illness (specific causation).

Id. at *3, (internal punctuation omitted, citing Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 448, 824 N.Y.S.2d 584, 857 N.E.2d 1114 (2006).

The Court continued, “We noted [in Parker] that there might be several ways that an expert might demonstrate causation . . . . but that any method used must be generally accepted as reliable in the scientific community.”  Id. (internal punctuation and citation omitted).  The Court emphasized that, in its toxic tort jurisprudence, it had “repeatedly rejected as insufficient to prove causation expert testimony that exposure to a toxin was ‘excessive’ or ‘far more’ than others, and such testimony that merely links a toxin to a disease or works backwards from reported symptoms to divine an otherwise unknown concentration of a toxin to prove causation.”  Id. (internal punctuation and citations omitted).  In other words, “the fact that asbestos has been linked to mesothelioma is not enough for a determination of liability against a particular defendant; a causation expert must still establish that the plaintiff was exposed to sufficient levels of toxin from the defendant’s products to cause his disease.”   In this case, the majority held, the plaintiff’s causation expert had not established this.  She was vague about the level or duration of asbestos exposure necessary to cause mesothelioma, and she testified that mesothelioma could develop idiopathically – without a known cause.  Moreover, the Court stated, the doctor’s description of mesothelioma as a “sentinel health event” of asbestos exposure was “no different than the conclusory assertions of causation [it had] held . . . insufficient to meet the Parker requirements.”  Id. at *4 (citations omitted).  Nor, the Court emphasized, did the studies or scientific literature support the causation conclusion.  The studies discussed “low level” exposure and “significant” exposure without quantifying what those terms meant; in fact, “not one of the articles [the expert] discussed on the witness stand set[]forth an estimate of the minimum level of exposure to respirable asbestos that would suffice to cause peritoneal mesothelioma.”  Id. (citations omitted).

The Court continued, “Under these circumstances, plaintiff’s proof failed to demonstrate decedent’s level of exposure to asbestos in a manner that established causation.”  The geologist’s “glove box test” was not a “quantification, or at least a scientific expression of decedent’s exposure;” to the contrary, “[w]hile a precise numerical value is not required, [the geologist’s] test simply failed to provide any scientific expression linking decedent’s actual exposure to a level known to cause mesothelioma.”  The Court concluded, “The requirement that plaintiff establish, using expert testimony based on generally accepted methodologies, sufficient exposure to a toxin to cause the claimed illness strikes the appropriate balance” between “the need to exclude unreliable or speculative” causation opinions and the obligation “to ensure that we have not set an insurmountable standard that would effectively deprive toxic tort plaintiffs of their day in court.”  Id. at *5.  Here, the balance tipped in the defendant’s favor, and the Court reversed the Appellate Division’s decision and dismissed the complaint.

There is an interesting wrinkle in Nemeth:  a long lone dissent (longer than the majority opinion) containing some blatant manipulation involving the decedent’s childhood, relationship with the plaintiff, children/grandchildren, and illness, disguised as “facts” in the relevant chronology.   The dissenting Justice included lengthy exposition of the testimony of both of the plaintiff’s experts, then asserted that the plaintiff had satisfied his burden to prove both general and specific causation.  As to general causation, according to the dissent, the experts testified that epidemiological and case studies supported a finding that exposure to asbestos – sometimes even low levels of exposure – could cause mesothelioma and that the defendant’s product contained asbestos.  The dissenting Justice asserted that “[d]efendant’s cross-examination of both experts failed to undermine their testimony” on general causation, and that the plaintiff also “satisfied his burden as to specific causation.”  Id. at *13.  She stated that the geologist had employed a reliable methodology in his testing and quantified as “millions of fibers” of inhalable size the asbestos released into the Plexiglas chamber.  Then, she continued, the doctor “provided a scientific expression of [the decedent’s] exposure level to asbestos” based on relevant literature, the geologist’s test results, and the evidence of the decedent’s daily routine.  She concluded, “To the extent the majority suggests there was a lack of any evidence of general causation, such a suggestion is unsupportable as there was an abundance of evidence that asbestos-containing talc could cause mesothelioma because the asbestos was releasable during use.  [The plaintiff’s expert physician] also testified that the literature included studies of persons exposed to asbestos who developed peritoneal mesothelioma, a rare cancer.  This was enough under our law.”  Id. at *14 (citations omitted).

The dissenting Justice found similar flaws in the majority opinion about specific causation.  She concluded:

The fault here was not in plaintiff’s proof. . . . Plaintiff met his burden of proof under our law, which the lower courts properly articulated, and the jury found his experts persuasive and rejected defendant’s experts’ views. The fact that the majority would have come to a different conclusion is irrelevant. Concerns about whether the plaintiffs’ experts’ opinions were based on studies and criteria that defendant’s expert disagreed with goes to the weight of the evidence, and not the legal sufficiency of the proof establishing causation. And, this Court has no authority to weigh the evidence.

Id. at *15 (internal punctuation and citations omitted).   So Nemeth features thoughtful, powerfully-expressed opinions on both sides.  But we represent defendants.  And we face, year in and year out, judges who do not demand that plaintiffs prove – really prove – that our clients’ products caused their injuries.  So we are happy with the defense win in this case, and we hope it operates an example to toxic tort judges and a cautionary tale to toxic tort plaintiffs.  We are heading for a firm meeting in Florida – we will reserve the political commentary – and we look forward to talking to you when we get back.  In the meantime, stay safe out there.

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This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog.  To make things even weirder, one athlete is (cisgender) female and one athlete is (cisgender) male, and they come from opposite ends of the country, although their colleges are relatively close to each other.  The authors, by contrast to their children, are far more, ahem, academic than athletic and neither has ever participated in this particular sport.  Why do we mention this, albeit vaguely?  Sometimes there are weird connections that you would not expect.

Cases on First Amendment protection of freedom of speech often create such connections.  People on both ends of the political spectrum might want vigorous judicial protection of free speech, at least for their compatriots.  Companies with very different business interests might advocate strongly for protection of commercial speech.  State and local government entities from very different parts of the country might want leeway in regulating things like the volume or time of demonstrations.  Those jurists who otherwise identify themselves as being strong proponents of federalism and “states’ rights” may favor strict limits against states or municipalities getting such leeway.  Whereas those jurists who otherwise tout the importance of civil rights in our legal system may be inclined to afford local governments more deference in restricting speech.  There seems to be a political angle to just about every contested regulation of speech and, of course, politics makes strange bedfellows.

The rules for what federal, state, or local governments can and cannot regulate when it comes to commercial speech by drug and device companies about their products, the conditions they treat, and competitors’ products are not less complex.  As we have detailed at length previously (like here, here, and here, among many other posts), they are also changing.  First Amendment cases typically turn on the level of scrutiny applied to a challenged government action, with the application of strict scrutiny almost always meaning the governmental restriction was unconstitutional.  Cases on how to determine which level of scrutiny applies can also, of course, change the playing field.  The Supreme Court decision in Reed v. Town of Gilbert, 576 U.S. 155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid.  As we noted soon after Reed  and since , these standards flow directly into whether and how FDA can restrict what drug and device manufacturers say about off-label use, the main recurring issue for these companies.

Without delving too far into hypotheticals, the rules on what is a content-based restriction of statements on off-label use might play out something like this.  FDA could take the position, as it arguably did for decades, that a flat-out prohibition on all statements on off-label use was not content-based because FDA did not care which off-label use was at issue, what the company said about it, or whether the statement was well-supported by scientific evidence.  The manufacturer could respond that even evaluating if the statement concerned an on-label use or an off-label use was enough of an evaluation of content to make any restriction of speech content-based.  (On current law, the company would be right.)

In City of Austin v. Reagan Nat’l Adver. of Austin, __ S. Ct. __, 2022 U.S. LEXIS 2098 (U.S. Apr. 21, 2022) (“Austin”), the Supreme Court again waded into the murky waters of when local restrictions on advertising violate the free speech protections of the First Amendment.  Those more focused on advertising law would surely take a deeper dive into the four separate opinions on Austin.  We will start by recapping where the nine justices came down, reserving the labeling of political and doctrinal camps and the relative strangeness of bedfellowship for others.  Justice Sotomayor delivered a fairly succinct opinion for the majority; she was joined by Chief Justice Roberts and Justices Breyer, Kagan, and Kavanaugh.  Justice Breyer wrote a concurrence to emphasize that he thought Reed was wrongly decided, although controlling.  Justice Alito wrote an opinion concurring in part and dissenting in part, urging that a determination of the facial (un)constitutionality of the local ordinance was all the Court had to address.  Justice Thomas authored a long dissent—much longer than the Court’s opinion—that railed that the Court had established “an incoherent and malleable standard,” among other things; he was joined by Justices Gorsuch and Barrett.

The core issue was relatively straightforward:  the city of Austin (Texas) like many other political subdivisions regulated billboards and other signs based on whether they advertised “a business, person, activity, goods, products, or services not located on the site where the sign is installed.”  In other words, the regulation distinguished between on-site and off-site advertising, something apparently common since the Highway Beautification Act of 1965.  Id. at *7.  Going farther back, “[b]y some accounts, the proliferation of conspicuous patent-medicine advertisements on rocks and barns prompted States to begin regulating outdoor advertising in the late 1860s.”  Id. at *6 (citations omitted).  We told you there were would be some weird connections.  For off-site advertising like that offered by the defendants, which owned billboards, the distinction in the regulation meant the defendants could not digitize their signs, something that would have been permitted for on-site advertising.  After a bench trial, the district court found the local ordinances were content neutral and thus constitutional as written and applied.  Id. at **9-10.  The Fifth Circuit reversed, finding that resolving the on-site versus off-site distinction necessarily involved a content-based inquiry.  Id. at **10-11.

The Court’s first substantive paragraph of its decision fairly encapsulates its analysis, so we will paste it here:

A regulation of speech is facially content based under the First Amendment if it “target[s] speech based on its communicative content”—that is, if it “applies to particular speech because of the topic discussed or the idea or message expressed.” Reed, 576 U.S. at 163.  The Court of Appeals interpreted Reed to mean that if “[a] reader must ask: who is the speaker and what is the speaker saying” to apply a regulation, then the regulation is automatically content based.  972 F.3d at 706.  This rule, which holds that a regulation cannot be content neutral if it requires reading the sign at issue, is too extreme an interpretation of this Court’s precedent. Unlike the regulations at issue in Reed, the City’s off-premises distinction requires an examination of speech only in service of drawing neutral, location-based lines. It is agnostic as to content. Thus, absent a content-based purpose or justification, the City’s distinction is content neutral and does not warrant the application of strict scrutiny.

Id. at *12.  The city ordinance required “reading a billboard to determine whether it directs readers to the property on which it stands or to some other offsite location,” but the “sign’s substantive message itself is irrelevant to the application of the provisions.”  Id. at *15.  “Reed does not require strict scrutiny to this kind of location-based regulation.”  Id. (citations omitted).  The Court thus remanded the case to determine if the ordinance could survive intermediate scrutiny, which would focus on whether there was an impermissible purpose or justification.  Id. at *22.  Again, this seems like a relatively straightforward analysis that did not upset the approach by many jurisdictions in regulating signs and billboards.

First, though, the Court took aim at the Thomas dissent, noting that it also did not “embrace the read-the-sign rule” from the Fifth Circuit.  Id. at **20-21.  The dissent, it said, falsely accused the Court of creating a “novel ‘specificity test’” when it had “merely appl[ied] those precedents [from Reed and other cases] to reach the ‘commonsense’ result that a location-based and content-agnostic on-/off-premises distinction does not, on its face, ‘singl[e] out specific subject matter for differential treatment.’”  Id. at *21 (citations omitted).  Instead, “[i]t is the dissent that would upend settled understandings of the law.”  Id.  For a majority opinion of the Supreme Court, this is pretty wild stuff.

The dissent brought at least as much venom.  The Austin “off-premises restriction . . . discriminates against certain signs based on the message they convey—e.g., whether they promote an on- or off-site event, activity, or service.”  Id. at *36.  The dissent claimed the majority had replaced the standard from Reed with “an incoherent and malleable standard.”  Id.  It then cited an older case not discussed in the Court’s opinion, which we think provides some insight into the intensity of the disagreement:

In so doing, the majority’s reasoning is reminiscent of this Court’s erroneous decision in Hill v. Colorado, 530 U.S. 703 (2000), which upheld a blatantly content-based prohibition on “counseling” near abortion clinics on the ground that it discriminated against “an extremely broad category of communications.”  Id. at 723.  Because I would adhere to Reed rather than echo Hill’s long-discredited approach, I respectfully dissent.

Id. at **36-37.  This caused us to look up Hill, which had a majority opinion authored by Justice Stevens and joined by, among others, Chief Justice Rehnquist.  It also did not concern a “content-based” restriction focused on abortion clinics.  The Colorado statute at issue concerned all healthcare facilities and instituted a bubble around people entering or exiting those facilities to further obvious public safety goals.  So, without re-litigating all the Supreme Court freedom of speech cases over the last twenty-plus years, we can say the decisions setting the standards for evaluating local restrictions on signs or FDA limits on statements on off-label use will remain contentious and driven by shifting concerns and alliances.

As for FDA limits on statements by drug and device companies, did Austin change anything compared to Reed and the rest of the cases examined in Austin?  Not really.  If anything, Austin emphasized that any such restrictions would be subject to strict scrutiny.  At least for now.  As the Breyer concurrence noted, there are many federal, state, and local laws that “turn, often necessarily, on the content of speech.”  Id. at *26.  One of his examples was FDA’s regulation of prescription drug labeling under 21 U.S.C. § 353(b)(4)(A).  He was not arguing, however, that such regulation should be subject to strict scrutiny, but that Reed “too rigidly ties content discrimination to strict scrutiny (and, consequently, to ‘almost certain legal condemnation’).”  Id. at **27-28 (citation omitted).  As for us, our views on the differential treatment of statements about off-label and on-label uses are well known, but we certainly do not argue that the entire regulatory scheme for the labeling of medical products should be toppled.  With the shifting slate on standards and the implications of applying strict scrutiny to certain limits on commercial speech, however, it is not hard to see how the broader and vigorously partisan fights on freedom of speech could have the unintended consequence of creating major changes to that scheme.

 

Photo of Stephen McConnell

Did you know that both LeBron James and Steph Curry were born in Ohio? So were Neil Armstrong, Halle Berry, Simone Biles, Thomas Edison, Dean Martin, Jack Nicklaus, and Steven Spielberg. (We once ran into – we mean literally – Dean Martin as he was launching himself out of a Beverly Hills restaurant. He was old and was wearing super-thick glasses, but we recognized him. We doubt he recognized us.) The two best Union generals, Grant and Sherman, hailed from Ohio. And, of course, William Howard Taft, the man with one of the most sparkling resumes in American history (President, SCOTUS Chief Justice, Secy. Of War, Solicitor General, Governor of Cuba and the Philippines, Yale Law professor, first Commander-in-Chief to throw out first pitch at a baseball game) was a native Buckeye. While sitting as a Sixth Circuit judge, Taft authored the U.S. v. Addyston Pipe & Steel Co. case, which Robert Bork pegged as the font of all antitrust wisdom. Taft can also get some legislative credit, as he helped write the Judiciary Act of 1925, which reduced the SCOTUS caseload and was referred to as the Judges Act. You could easily triple the number of names listed above and still not run out of accomplished Ohioans. (Good grief, we left off Toni Morrison and a Wright brother!) The point is, a lot of greatness has come out of Ohio. Including – ta da! hello, tacky segue – a recent and delicious judicial opinion tossing a shingles vaccine complaint.

In Gentile v. Merck & Co., 2022 U.S. Dist. LEXIS 66206 (S.D. Ohio April 11, 2022), the plaintiff filed a class action alleging that the advertising of the Zostavax shingles vaccine falsely inflated its effectiveness. The complaint included causes of action for violations of the Ohio Consumer Sales Practices Act (OCSPA) and Ohio Deceptive Trade Practices Act (ODTPA), as well as for constructive fraud, negligent misrepresentation, and breach of contract. The defendant moved to dismiss the complaint. Like a story by Ohio writer Ambrose Bierce, the Gentile court’s decision was short and sharp.

First, the OCSPA claim was a goner because it was not brought, as required per statute, by a consumer. A “consumer” is defined as a person who “engages in a consumer transaction with a supplier.” There was no allegation that the plaintiffs in Gentile directly purchased the vaccine from the manufacturer. Nor is there likely any possible basis for such an allegation. As Dino sang, “Ain’t That a Kick in the Head?”

Second, arrivederci to the ODTPA claim because the plaintiffs lacked standing. The Ohio Supreme Court has not yet spoken to this issue, and S.D. Ohio decisions have landed on both sides, but most courts, including the Sixth Circuit in an unreported decision, have ruled that the ODTPA is like the federal Lanham Act insofar as only commercial entities (think of competitors) can sue thereunder. The Gentile court went with the majority rule, the plaintiff was not a business entity, and the ODTPA claim was, therefore, dismissed.

Third, an essential element of a constructive fraud claim is a special or confidential relationship between the plaintiffs and defendant. The plaintiff in Gentile could not plausibly plead such a special/confidential relationship. The plaintiff alleged that the vaccine advertisements were widespread on tv, in pharmacies, and on the internet. But the defendant “cannot be said to to have created a special or fiduciary relationship with with every individual who saw one or more of their advertisements.” Moreover, “[a]verage consumers impose confidence in their physicians when deciding whether to receive a vaccine, not advertisements in newspapers and on television.” It’s as if the court said (translation from “Volare”) “let’s leave the confusion and all disillusion behind” … and get rid of this silly constructive fraud claim.

Fourth, under Ohio law, the tort of negligent misrepresentation applies only in those limited circumstances in which the defendant was in the business of supplying information and the plaintiff sought guidance from the defendant with respect to a business transaction. That is, negligent misrepresentation under Ohio law is related to professional malpractice. Drug and device manufacturers are not at all like accountant statements/opinions that are expressly issued for third-party reliance. The plaintiff in Gentile did not and could not plead that the defendant was in the business of supplying information and that she sought such information for purposes of a business transaction. We are not quite ready to burst into a rendition of “That’s Amore,” but it is easy for a defense hack to feel amorous about Ohio law on negligent misrepresentation.

Finally, the breach of contract action failed for the reason that any first year (heck, first week) law student could recite: the plaintiff had not pleaded the existence of a valid contract. Rather, the plaintiff acknowledged that it was the physicians who bought the vaccines from the suppliers.

Our favorite Dean Martin song is “Everybody Loves Somebody.” Maybe love is too strong a word, but right now we are at least infatuated with the Gentile opinion.

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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