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We hope our loyal readers had a wonderful Thanksgiving. As you reflect on what you’re thankful for this year, we would like to suggest one more item for your list: Discounted registration to ACI’s Drug and Medical Device Litigation Conference, coming up on December 5-6. As we mentioned, the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. If you use the code D10-999-DDLB24 when you register, you’ll save 10 percent off your conference registration.

Several of your bloggers will be in attendance – look for Bexis in his usual front row seat – and we are looking forward to interesting presentations from the always-exceptional faculty of in-house counsel, top defense firms, and experienced jurists.

If you want to register, you can do so here. We look forward to seeing you in New York!

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We’ve written about Lone Pine orders many times before.  (Here and here, for example.) In brief, a Lone Pine order (so-called because that is the name of the seminal New Jersey case) requires plaintiffs to furnish medical evidence, usually in the form of an expert affidavit, showing that the plaintiff suffered from the alleged injury and/or that such injury was caused by the product in question.  Drug and device defendants frequently ask for Lone Pine orders in aggregated litigation, with the goal of getting rid of the junky part of the case inventory.  And by “part,” we are usually talking about more than half of the cases.  It’s no surprise that plaintiff lawyers hate Lone Pine orders.  Compliance puts a hurt on plaintiff lawyer pocketbooks and leverage.  Sadly, some benighted judges steer clear of Lone Pine orders, for reasons that are unclear or specious.  Many defense hacks will tell you that the best shot at getting a Lone Pine style order is to call it something else.  It’s as if the name itself is poison.  But things change once a defendant settles a big chunk of cases.  At that point, many judges will enter a Lone Pine-ish order as a form of “docket control.”  The order cuts off the tail, makes the settlement viable, and rewards the defendant for playing ball.  One cannot help but wonder why, if the order makes sense near the end of the litigation, it doesn’t make even more sense much earlier, when it could have done some real good and avoided undue litigation expense. 

In today’s case, Warman v. Livanova Deutschland, GMBH, 2023 WL 7383158 (Ohio Ct. App. Nov. 8, 2023), Lone Pine takes root in Ohio.  Warman is a one-off case, rather than the usual aggregated mass tort extortion festival, but the court’s use of a Lone Pine order is still a breath of fresh (pine aroma) air.  The plaintiff sued a device manufacturer and a hospital, alleging that he had been exposed to harmful bacteria from a heater-cooler device employed during his heart surgery. The plaintiff claimed that he developed a serious infection after exposure to the bacteria. His lawsuit bounced around among various courts and then ended up in the Hamilton County Court of Common Pleas.  Then the plaintiff lobbed a bunch of discovery requests at the defendants.  They balked.  The defendants demanded that, before revving up the discovery sadness machine, the plaintiff should come across with some proof that he had actually developed a post-operative infection and that it had some causal connection to bacteria emitted by the heater-cooler device. The trial court considered this request (the fact that it did not reject it outright was already a small victory), and paid attention to the defendants’ point that the plaintiff side should have whatever medical records needed to establish the existence of a post-operative infection. 

The plaintiff lawyer objected to the Lone Pine order, but assured the court that “I’ve got all kinds of medical records that he’s got an infection.  Do you want me to have a doctor produce a report that my client got an infection as a result of the surgery?  I can do that.”  Good, said the court, go ahead and do that.  The court gave the plaintiff 60 days to show evidence of an infection.  Those 60 days came and went and the plaintiff “had not produced an expert statement or other evidence of any post-operative infection.”  Then the trial court issued an order making further discovery contingent on production of the expert report.  The court set a status conference approximately 90 days in the future and warned the plaintiff that the plaintiff needed to produce an expert report by the status conference “or the cases will be dismissed.” 

Now picture calendar pages flipping by.  Now picture the courtroom on the date of the status conference.  Now picture an empty chair at the plaintiff counsel table.  The plaintiff lawyer did not show up and had not filed an expert report. The plaintiff lawyer had not lived up to his promise.  But the court did.  It dismissed the case.  A couple of hours later, the plaintiff lawyer filed an expert disclosure identifying an expert who would testify that the plaintiff’s exposure to the heater-cooler device during the operation placed him “at risk” for an infection.  The expert did not discuss whether the plaintiff had actually developed an infection or even whether he had suffered any unexplained negative symptoms after his surgery.  Armed with this rather unimpressive expert disclosure (truly too little too late), the plaintiff appealed dismissal of his case, arguing “that the trial court unfairly truncated discovery.”

The appellate court affirmed the dismissal. The appellate court viewed the Lone Pine order as essentially “a discovery order.” Such discovery orders are largely entrusted to the trial court’s discretion, and it was impossible to say here that the Lone Pine features of the discovery order constituted an abuse of discretion.  The court distinguished away a bad Ohio Lone Pine precedent, pointing out that the plaintiff in Warman did not argue that “he was denied access to any specific tests, documents, or other information from defendants that would have enabled his expert to substantiate whether he had an infection.”  Rather, compliance with the order was entirely in the plaintiff’s control and did not depend on any of the discovery plaintiff had requested, nor did the plaintiff ever seek to compel the discovery.  It was telling that the plaintiff lawyer utterly failed to tell how specific information in the possession of the defendants would have supplemented medical records and shown that an infection occurred: “His inability to do so suggests that the problem with filing a motion to compel was not just that it may have been met with skepticism or hostility; it was that the motion would have lacked specificity and substance.”  Further, the tardy plaintiff expert disclosure was vague and inadequate. The expert said that the infections at issue are hard to diagnose and can incubate for five to seven years.  Okay.  But the disclosure was authored more than seven years after the surgery. How can the existence of an infection still be a jump ball?  The plaintiff expert never explained how any additional information “would illuminate a diagnosis that could not be reached from the medical records alone.” 

The appellate court decided that the trial court’s stay of discovery was an appropriate exercise of discretion.  The stay was “justified by a weightier interest than efficiency.”  Rather than “rushing [the plaintiff] out the door, the court’s order guarded against a potentially frivolous claim that, although sufficiently pleaded to survive a motion to dismiss, apparently lacked basic evidentiary support.”  The defendants were not hiding any information.  The plaintiff simply did not have a case.  Because the plaintiff failed to substantiate that he had ever had the claimed infection, dismissal was appropriate. 

We offer congratulations and we offer thanks (we can read a calendar) to defense counsel, Joe Winebrenner at Faegre Drinker, for winning the appeal in this important and excellent case.

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It’s a short week, so we are going to do a short post about a short decision on a product that lasted a long time. 

An inferior vena cava (“IVC”) filter was implanted in plaintiff in 2004.  Some years later she experienced a complication, not identified in the decision, which led her to file a products liability suit against the manufacturer in June 2022 – over 18 years later.  In re Cook Medical, Inc., 2023 U.S. Dist. LEXIS 205990, at *1 (S.D. Ind. Sep. 27, 2023).  Plaintiff is a resident of Texas and had her 2004 surgery in Texas, so the court applied Texas law which has a 15-year statue of repose. 

A statute of repose sets a definitive date beyond which an action cannot be filed.  It does not matter that plaintiff’s cause of action has not yet accrued.  A statute of repose is triggered by an event like the sale of the product and establishes a bright line cutoff that extinguishes liability.  For that reason, statutes of repose are considered defense friendly.  But they typically require a significant period of time to pass.  The standard is around 10-15 years from sale or manufacturer. (Note Montana’s is only 3 years). 

And while they are usually hard and fast rules, some statutes of repose, like Texas’s, have exceptions.  Texas law provides that the 15-year statute of repose does not apply if the product is accompanied by an express warranty “that the product has a useful safe life of longer than 15 years.”  Id. at *2.  In this case, plaintiff tried to rely on language in the IVC filter’s Patient Guide that said the product was safe effective as a temporary or permanent device.  Id. at *3.  However, the Patient Guide also lists possible adverse effects such as migration of the device or perforation of the vena cava.  Read together, the Patient Guide did “not guarantee the [filter] would conform to a particular standard for the duration of [plaintiff’s] life.”  Id. at *4.  Any “warranty” that the product could remain permanently implanted was qualified by the identification of possible adverse events.  Since the manufacturer did not warrant the IVC filter had a “useful safe life” of more than 15 years, this exception did not apply.  While this may seem case-specific, it is hard to imagine any manufacturer of an implantable medical device warranting the life span of its product given all of the variables of the human body, a person’s healing capacity, a person’s compliance with medical advice, etc. 

Plaintiff next argued she qualified for the “latent disease” exception.  This exception provides that if a plaintiff is exposed to a product before the end of 15 years, that exposure caused plaintiff’s disease, but the symptoms of the disease did not manifest in a reasonably noticeable way until after 15 years had passed, the statute of repose does not apply.  Notice the word “disease.”  Plaintiff tried to argue that “disease” should be broadly interpreted to include “medical device failures.”  Id. at *5.  Not only did plaintiff have no case law to support her interpretation, but the statute also establishing the exception does not mention medical devices or the types of injuries that arise from them.  The plain language of the statue applies to “diseases resulting from exposure to a product.”  Id.  Think asbestos, lead, Agent Orange.  Not a medical device that works as intended for more than 15 years. 

Defendants’ motion for judgment on the pleadings was granted in its entirety.

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In stark contrast to the “MDL treatment” that the Valsartan plaintiffs received earlier this year, the decision in Post v. Amerisourcebergen Corp., 2023 WL 5602084 (N.D.W. Va. Aug. 29, 2023), was more mainstream.  Class certification was denied for a variety of good reasons.

Unlike the result, the Post class action allegations, were relatively unusual.  The members of the class were all patients of the same physician.  Plaintiffs alleged that “defendants” “unlawfully made payments to [the physician] to induce him to misdiagnose” them so that they were eligible for the product at issue.  Id. at *1 We’re not 100% sure, but only one of these “defendants” apparently was the product’s manufacturer.  Plaintiffs sought “the return of every payment made from every source” for this treatment – essentially, they wanted after-the-fact (Post-hoc?) free medical care.  Id.  In addition, they demanded various damages for “invasion of privacy” and “negligence,” as well as punitive damages.  Id.

And they wanted this all as a class action.

The Post reaction?  No way.

Continue Reading Post-Out Sticky Notes
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Several of your Reed Smith bloggers are making plans to be in New York on December 5 – 6 to attend ACI’s annual Drug and Medical Device Litigation conference. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.

The good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DDLB24 when you register. You’ll save 10 percent off your conference registration.

If you want to register, you can do so here. We look forward to seeing you in New York!

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As we emerge from our fourth month-long trial in a little over two years, we are sure that we have missed some recent legal developments.  As good as this Blog is as a source for what is going on in drug and device product liability litigation, you do actually need to read it to absorb information.  With all due concern for Bexis’s feelings on the matter, reading the Blog every day can end up being a lower trial priority than witness prep sessions, sleep, and daily hygiene.  Whatever developments we missed, though, we do not think that Bartlett or Mensing are no longer good law or that the Yates decision has been consigned to the scrap heap of preemption history.  We also expect that Twombly and Iqbal, entwined as TwIqbal on these virtual pages, still apply to 12(b)(6) motions in federal court.  The decision in In re Tepezza Mkt’g, Sales Pracs., & Prod. Liab. Litig., MDL No. 3079, 2023 WL 7281665 (N.D. Ill. Nov. 3, 2023), gave us a moment of pause about these assumptions.  Then we realized it was just a bad decision about a common issue in an MDL.

We have been discussing the issues of what a design defect claim with a prescription drug looks like and whether it can survive preemption for a very long time.  When the Sixth Circuit issued the Yates decision that affirmed the dismissal of design defect claims as to the prescription contraceptive Ortho Evra, we took a fairly deep dive into the subject.  It was obvious to us that the teachings of Bartlett and Mensing, along with the interplay of state design defect law and the regulatory requirements for prescription drugs, dictate that a non-preempted design defect claim for a prescription drug is a nearly mythical beast.  In general, a design defect claim for a prescription drug requires proof that the design of the drug—essentially, its chemical composition—presented an unacceptable risk of injury, that plaintiff suffered that injury due to the design of the drug, and that plaintiff would not have been injured if she had used the properly designed version of the same drug instead.  Changing the chemical composition of a drug makes it a different chemical entity, which in turn changes its properties, risks, and benefits.  FDA approval of a different chemical entity to treat the same condition as the original drug cannot be assumed.  Adding on TwIqbal, the plaintiff has to plead sufficient facts to support a design issue with the drug—not merely the existence of some risk—that could have been fixed without sacrificing efficacy or approval (among other things).  Good luck with that.

Courts have sometimes divided the design defect preemption analysis into pre- and post-approval design claims.  The latter are clearly preempted—even the plaintiff in Tepezza conceded that.  Some pre-approval claims have been found to sidestep preemption, although we find the logic lacking.  In Tepezza, the plaintiff brought design defect and negligent design claims under the law of an unspecified state (Virginia or Illinois) for alleged “hearing loss and/or tinnitus”—yes, boilerplate on the case-specific injury—from the use (over one of two inconsistent alleged time periods) of an FDA-approved prescription biologic for an eye disease.  The alleged design defect was that the medication posed a risk of “hearing loss and/or tinnitus.”  And, no, we do not think that the allegation of a risk is the same thing as alleging facts that, if true, would establish the existence of a design defect, but that is the only allegation discussed in the Tepezza decision.  When the manufacturer moved to dismiss for failure to state a claim, the court proceeded without mentioning TwIqbal, any state law, or any FDA requirement.  The fuzziness of a preemption analysis untethered to actual factual allegations or state or federal requirements tends to favor the plaintiff.  And so it did in Tepezza.

Rather than looking at plaintiff’s factual allegations to see if they were sufficient to establish a design defect claim under the applicable state law and then comparing that to the federal requirements to see if it would be impossible for the defendant to comply with both independent of action from FDA, the Tepezza MDL court engaged in a more abstract analysis.  Although it started with a recitation of the Mensing principle that requires preemption unless the defendant manufacturer “could independently do under federal law what state law requires of it,” the decision quickly detoured to the much derided reasoning of the Holley case that a manufacturer was not “required to use the allegedly defective design in the first place.”  2023 WL 7281665, *2 (citations omitted).  By “derided,” we mean Holley netted seventh worst in 2019 and Gaetano, which followed it, nabbed fifth worst in 2021.  Based principally on Holley and Gaetano, the court held “to the extent that Horizon had a duty under state law to create a safer alternative design, Horizon could have satisfied that duty without coming into conflict with any federal requirement.”  Id.

Again without considering actual allegations about how the drug’s design could have been changed to make it non-defective, the Tepezza court buttressed its conclusion with three things.  First, without much of a survey, it concluded “[n]umerous district courts presented with this precise question have reached the same conclusion,” noting only two contrary decisions, Yates and another case within the sixth circuit, Fleming.  As can be seen from our prior posts, such as here, here, here, here, here, and here, the majority position actually favors preemption.  Second, the court looked to the Seventh Circuit’s decision in Kaiser, which we bashed here and hereKaiser concerned a class II medical device.  Since Lohr in 1996, design claims about such devices have not been preempted.  The facile conclusion that, “[e]ven though Kaiser involved a federal regulatory scheme for a medical device, its reasoning applies with equal force in this context” and that this reasoning supported the non-preemption of an ill-defined pre-approval design defect claim leaves us stunned.  We cannot recall seeing Lohr applied to a drug approved under an NDA or a biologic approved under a BLA.  We have seen pre-approval design claims against a biologic held to be preempted, though. 

Third, the court distinguished the treatment of the “stop selling rationale” in Bartlett with its application in Yates to pre-approval design defect claims.  In the Tepezza court’s view, there was a gap in the holding that “an actor seeking to satisfy both federal- and state-law obligations is not required to cease acting altogether in order to avoid liability” that allowed liability to be imposed on a failure to “have acted differently” rather than a failure to “have stopped acting.”  Id. at *3 (citations omitted; emphasis in original).  As we explained here, there is no duty to a user/consumer until the product is marketed or otherwise made available for use.  Indeed, whether a product is defective is typically measured at the time it leaves the defendant’s hands, not at some point during its development.  To sell the drug at issue in this case or its hypothetical non-defective variant, the manufacturer needed to obtain a BLA from FDA.  It cannot do that “independently” (see Mensing), so it would have to “cease acting altogether” in terms of trying to manufacture and sell the drug to avoid liability under state law (see Bartlett).  The only other option would be to sell the variant without a BLA, which would subject the manufacturer to all sorts of federal liability.  So, concluding plaintiff’s “claim is that Horizon should have submitted to the FDA a formulation that did not cause permanent hearing loss and tinnitus” and that claim was not preempted skips a few necessary steps.  Id.

The court punted on the issue of whether the drug, “as a biologic, is scientifically incapable of being redesigned,” noting it as a state law issue to be tested after discovery.  Of course, this is why we said above that the proper preemption analysis would have “look[ed] at plaintiff’s factual allegations to see if they were sufficient to establish a design defect claim under the applicable state law and then compar[ed] that to the federal requirements to see if it would be impossible for the defendant to comply with both independent of action from FDA.”  You do not need to wait for costly discovery to do that analysis.

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The legal doctrine we discuss today, the reporter’s privilege, lies outside our traditional bailiwick but is worth a quick visit. Recognized in most states, the reporter’s privilege—also known as the journalist’s or newsman’s privilege—is an absolute or conditional “protection, under constitutional or statutory law, from being compelled to testify about confidential information or sources.” Black’s Law Dictionary (11th ed. 2019). Although rarely relevant in product-liability litigation, the doctrine was recently applied in the Zantac litigation to protect JAMA peer review documents from discovery by a plaintiff.

The plaintiffs allege that ranitidine, which had been sold under the brand name Zantac before it was removed from the market, caused them or their decedents to develop cancer. In 2020, the Journal of the American Medical Association (JAMA) announced that it was going to publish a peer-reviewed article linking Zantac to cancer and sent embargoed copies of the article to various entities. But JAMA pulled the article at the last moment after receiving criticism of the article’s underlying methodology. A revised version of the article was ultimately published after the authors reran their analysis using a different methodology.

Insinuating that JAMA’s decision to pull the original article reflected nefarious efforts “to suppress science critical of Zantac,” one plaintiff subpoenaed JAMA demanding that it produce all documents relating to its decision to withhold the article. JAMA resisted, arguing that its peer review process, which involves the confidential review and criticism of draft articles, is protected by the reporter’s privilege, which Illinois has codified at 735 ILCS 5/8-901 to -909.

The trial court ordered JAMA to produce a privilege log and copies of the documents for in camera review. After the court concluded that the documents were covered by the privilege, the plaintiff filed a motion to divest JAMA of the privilege, which is conditional under Illinois law. The court granted the motion and JAMA appealed.

The appellate court reversed in Gibbons v. GlaxoSmithKline, 2023 IL App (1st) 221666 (2003).

Before concluding that the statutory privilege protects JAMA peer review communications, the court rejected JAMA’s contention that the communications were protected under common law. While recognizing that the common law peer-review privilege protects communications involving assessments of a practitioner’s professional competence, the court refused “to extend that privilege” to “professional publications.” 2023 IL App (1st) 221666 ¶ 32.

Although it rejected JAMA’s common-law claim, it held that JAMA’s communications were protected from disclosure, finding that the plaintiff had failed to establish the prerequisites that must be satisfied before the statutorily enshrined reporter’s privilege may be lifted.

Under Illinois law, the reporter’s privilege “is qualified, not absolute.” To overcome the privilege, the party seeking disclosure must show that the information sought is relevant, that other sources of the information have been exhausted, and that the public interest favors disclosure. The Gibbons court found that the Zantac plaintiff satisfied neither the relevance nor the exhaustion requirement.

Information disclosed in JAMA’s privilege log revealed that JAMA had communicated with an unidentified government official in connection with its decision to drop the original version of the article at issue. The plaintiff seeking JAMA’s communications suspected that the official was someone at FDA given the article’s subject matter and the agency’s known critique of the original version’s underlying methodology.

According to the plaintiff, the possible intervention of an FDA official was relevant to causation because it called the article’s methodology into question and raised the specter of “government misfeasance.” The appellate court found no merit to either assertion. Based on its own in camera review of the documents, the court “fail[ed] to see” how “what JAMA editors or government regulators thought about [the article] is relevant to the causation question” in the plaintiff’s “underlying lawsuit.” 2023 IL App (1st) 221666 ¶ 42. And alleged governmental misfeasance, said the court, was “a ‘collateral matter’ that is not directly relevant to [the plaintiff’s] claims that the pharmaceutical company defendants intentionally or negligently marketed a drug that caused cancer.” Id. ¶ 43.

That finding alone was sufficient to defeat the plaintiff’s subpoena but the court went on to also conclude that the plaintiff had failed to exhaust other means to obtain JAMA’s communications with the presumed-FDA official. In particular, the court faulted the plaintiff for having failed to submit a Freedom of Information Act (FOIA) requesting the communications from the FDA. According to the court, the plaintiff “was required” by Illinois statute “to attempt to obtain the information from that agency before seeking divestiture” of JAMA’s reportorial privilege. 2023 IL App (1st) 221666 ¶ 50.

So, only tangentially related to our daily work, but an interesting decision nonetheless.

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In 1972, Neil Young wrote his great song, “Alabama,” the lyrics of which included the following: “Alabama, you’ve got the rest of the union, to help you along; what’s going wrong?”  Those lyrics occurred to us in 2013, when we read the Weeks decision, in which the Alabama Supreme Court endorsed innovator liability. We get how crazy California would embrace such nonsense, but how could Alabama, home of Huntsville rocket scientists and inspiration for To Kill a Mockingbird, arrive at such an error? We called the Weeks decision “execrable” when we wrote about it here.  Two years later, we were humming along to a greater song, Lynyrd Skynyrd’s “Sweet Home Alabama,” when the Alabama legislature abolished the innovator liability doctrine in that great state.  (We discussed that solonic reversal here.)

Today’s case, Watkins v. Pfizer, Inc., 2023 WL 7308325 (S.D. Alabama Nov. 6, 2023), furnishes fresh proof that the product liability element of product identification is alive and well in Alabama, thanks to the legislature’s restoration of sanity. Watkins involves a very popular over the counter (OTC) medicine.  The pro se plaintiff sued a couple of manufacturers, alleging that the OTC pain reliever caused him to suffer from Stevens Johnson Syndrome (SJS).  If you’ve read this blog for any length of time, you know that while SJS is a very rare disease, it is not so rare in the area of OTC litigation.  SJS can be a terrible disease, and SJS plaintiffs can be terribly sympathetic.  Even so, there are legal and medical defenses in SJS cases.  

In Watkins, one of the defendants offered up the defense that it was not a manufacturer, designer, or seller of the product.  It filed a motion to dismiss the case under Fed. R. Civ. P. 12(b)(6).  The injury occurred in Alabama.  Therefore, Alabama substantive law governed the case.  Quoting the same 2015 statutory amendment that the Blog discussed (Ala. Code section 6-5-530(a) says that “Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury”), the Watkins decision threw out the complaint because, no matter how liberally the pro se plaintiff’s complaint was construed —  which, in the Eleventh Circuit can be quite liberal indeed – it did not include the statutorily mandated element of identifying a product made/sold by the defendant. The court took judicial notice of publicly available materials, including the defendant’s annual report, that demonstrated who makes what. The plaintiff did not challenge the information showing that the movant did not make or sell the medicine. Accordingly, the court dismissed all of the plaintiff’s claims against the moving defendant because the plaintiff “failed to state a plausible claim for relief under Alabama law against” the moving defendant. 

As one of our esteemed defense-side colleagues (who played for and won a national championship under Bear Bryant) would say, Roll Tide.   

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We don’t have much patience for litigation attempting to seek damages for drug addicts who injured or killed themselves through their illegal use of drugs.  We’ve discussed several times how such plaintiffs (or their estates) should lose under the in pari delicto doctrine that prevents criminals from recovering damages for the consequences of their own criminal acts.  Lots of cases so hold.  See, e.g., Albert v. Sheeley’s Drug Store, Inc., 265 A.3d 442, 448 (Pa. 2021); Price v. Perdue Pharma Co., 920 So.2d 479, 486 (Miss. 2006); Orzel v. Scott Drug Co., 537 N.W.2d 208, 213 (Mich. 1995); Patten v. Raddatz, 895 P.2d 633, 637-38 (Mont. 1995); Lastrina v. Bettauer, 289 A.3d 1222, 1234 (Conn. App. 2023); Gentile v. Malenick, 112 N.Y.S.3d 364, 365 (N.Y.A.D. 2019); Kaminer v. Eckerd Corp., 966 So.2d 452, 454 (Fla. App. 2007); Pappas v. Clark, 494 N.W.2d 245, 247 (Iowa App. 1992); Inge v. McClelland, 725 F. Appx. 634, 638 (10th Cir. 2018) (applying New Mexico law); Romero v. United States, 658 F. Appx. 376, 380 (10th Cir. 2016) (applying New Mexico law); Messerli v. AW Distributing, Inc., 2023 WL 4295365, at *5 (D. Kan. June 30, 2023), certif. denied, 2023 WL 6961977 (D. Kan. Oct. 20, 2023); Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp.2d 279, 287 (S.D.N.Y. 2009); Sorrentino v. Barr Laboratories, Inc., 397 F. Supp.2d 418, 422-23 (W.D.N.Y. 2005), aff’d, 218 Fed. Appx. 7 (2d Cir. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 705 (E.D. Ky. 2003).

Continue Reading Another Opioid Addict Overdose Case Dismissed, Several Times Over
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California’s Proposition 65 has become a poster child for ineffective and counterproductive over-warning.  You know what we are talking about.  Prop 65 is the voter-enacted law that requires businesses to warn Californians about significant exposures to chemicals that allegedly cause cancer or birth defects.  See Cal. H&S Code § 25249.5 et seq.  A decent idea in concept, but California is now blanketed with boilerplate warnings of chemicals “known” to cause cancer, to which literally no one pays any attention.  No one.  We saw multiple such warnings while running errands just the other day, and the only people they are conceivable helping are attorneys who file lawsuits to recover generous statutory penalties and attorneys’ fees. 

The Ninth Circuit has now identified another problem with Prop 65:  The required warnings are government-compelled speech, which the First Amendment protects against.  In National Association of Wheat Grower v. Bonta, No. 20-16758, 2023 WL 7314307 (9th Cir. Nov. 7, 2023) (to be published in F.4th), a group of agricultural producers sued to enjoin California from requiring Prop 65 warnings in connection with glyphosate, the active ingredient in Roundup.  There were multiple versions of the warning that the state was trying to impose, but all would have compelled the plaintiffs to post statements that glyphosate was known to cause cancer or was “listed” or “classified” as causing cancer. 

The Ninth Circuit held that this violated their First Amendment right to be free from compelled speech.  The core issue is that there is no scientific consensus that glyphosate is a carcinogen.  The state relied on an International Agency for Research on Cancer (“IARC”) monograph classifying glyphosate as “probably carcinogenic to humans.”  Id. at *5.  But in this regard, IARC stands alone.  As the Ninth Circuit observed, “While IARC has concluded that glyphosate poses some carcinogenic hazard, federal regulators, California regulators, and several international regulators have all concluded that glyphosate does not pose a carcinogenic hazard.”  Id. at *4 (emphasis in original).  Thus, not only is there no scientific consensus, the evidence overwhelming shows that glyphosate does not pose a cancer risk in humans.  Even the IARC’s lonesome opinion is that glyphosate poses some “hazard,” which is theoretical and does not indicate a likelihood of cancer at real-world levels of exposure. 

Why does this matter?  It matters because compelled commercial speech is subject to intermediate scrutiny under the First Amendment, which requires the government to “directly advance” a “substantial” governmental interest, and the means chosen must not be “more extensive than necessary.”  Id. at *10 (citing Central Hudson).  There is, however, an exception for compelled commercial speech that is “purely factual and uncontroversial.”  Id. (citing Zauderer). 

Despite trying mightily, the state could not force its required warnings into the exception because none of the multiple proposed warnings was “purely factual and uncontroversial.”  The Prop 65 warning was not “purely factual” because the term “known carcinogen” carries a complex meaning, with considerable ambiguity on what an ordinary consumer would understand it to say.  Moreover, the warning was anything but “uncontroversial.”  It is obviously controversial to inform consumers that something is carcinogenic without a strong scientific consensus that it is.  On another level, it is likewise controversial to force these plaintiffs to convey a message fundamentally at odds with their businesses.  Id. at *12-*13. 

Intermediate scrutiny therefore applied, and the state’s proposed warnings failed.  California clearly has a substantial interest in protecting public health.  However, “compelling sellers to warn consumers of a potential ‘risk’ never confirmed by any regulatory body—or of a hazard not ‘known’ to more than a small subset of the scientific community—does not directly advance that interest.”  Id. at *16.  The means were also not narrowly tailored, since the state had “other means to promote its (minority) view that glyphosate puts humans at risk of cancer ‘without burdening [Plaintiffs] with unwanted speech.’”  Id.  The state could, for example, post information on its own website. 

Given the laundry list of chemicals on California’s Prop 65 list, we would not be surprised to see additional First Amendment challenges to Prop 65 warnings.  We also would not be surprised to see California’s AG continue to resist.