We’ve reviewed litigation precedent concerning causation-related genetic testing orders on the Blog twice before, in 2020 and in 2015.  We even proposed a rule of federal procedure to govern the conditions under which such testing could occur, which predictably went nowhere, since there is no crisis – yet.  Here’s another update.

As we discussed before, the ongoing Zostavax MDL has turned largely on plaintiffs’ failure to conduct what would have been conclusive genetic testing – to determine whether their alleged (and highly questionable) injuries were caused by wild zoster (chicken pox) virus, as opposed to the genetically distinct weakened form of that virus used in the defendant’s vaccine.  That failure prompted the first MDL-wide Lone Pine order requiring plaintiffs to produce genetic testing results, if they had them.

There is compelling medical authority that a laboratory test of the shingles rash of a person who has had chickenpox is the only way to tell whether the shingles was caused by the virus strain contained in [the vaccine] or by the wild-virus strain from chickenpox latent in a person’s body.

In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 WL 952179, at *2 (E.D. Pa. March 30, 2022), aff’d, 2024 WL 3423709, at *3 (3d Cir. July 16, 2024) (genetic “testing [wa]s the only way to establish specific causation”).  The strong scientific basis for compelling genetic testing justified requiring plaintiffs to produce such testing, if it existed, and dismissing their cases on causation grounds if they failed to offer supportive test results.

[Plaintiffs have] not cited any medical literature or expert medical opinion explaining how it can be determined that [the vaccine] caused a person to contract shingles other than, as defendants have shown, through a testing of that person’s rash. . . .  [Plaintiffs] have not provided any guidance as to how the more than 1,700 . . . cases can proceed in a reasonable manner without a Lone Pine order. . . .  It is now time for plaintiffs to come forward with the Laboratory Reports or other documentation . . . to enable the court to weed out non-meritorious from meritorious claims and move along these 1,700 or more cases toward a final resolution.

Id. at *3.  As we discussed here, not a single MDL plaintiff subject to the order had obtained the necessary testing, and as a result all of those bogus claims were dismissed.  In light of Zostavax, MDL defendants should consider adding genetic testing to plaintiff fact sheets, as was done in the pending Paraquat MDL (Part VIII(E)).

In California, a judicially created requirement that discovery implicating “privacy” interests must be supported by a “compelling” interest to support genetic-related discovery was rejected in Williams v. Superior Court, 398 P.3d 698 (Cal. 2017).  The “compelling need” standard was “an unduly onerous burden” on parties’ rights to discovery.  Id. at 87-88.  Williams expressly overruled Johnson v. Superior Court, 95 Cal. Rptr.2d 864, 878 (Cal. App. 2000), which (as we discussed in 2015) had required genetic testing demands to meet that “compelling” interest requirement.  The “compelling need” standard was “an unduly onerous burden” on parties’ rights to discovery, and thus could apply “[o]nly [to] obvious invasions of interests fundamental to personal autonomy.”  398 P.3d at 88-89 n.8 (listing overruled cases).  Thus, we think that the standard for genetic testing discussed in Cruz v. Superior Court, 17 Cal. Rptr.3d 368, 369 (Cal. App. 2004), remains valid in California.

Litigation-wide genetic testing is also being litigated (no ruling yet) in asbestos litigation in New Jersey:

A motion has been filed by defendant in the matter of Mizer v. Nissan North America seeking a sample of plaintiff’s DNA to test for mesothelioma markers to address pre-disposition to a mesothelioma diagnosis; thus an alternate causation theory. . . .  Subject to a continuing development of medical science, I would like to resolve this once.

Re Genetic Testing for Mesothelioma, Letter setting briefing schedule (N.J. Super. Law Div. dated May 15, 2024).  Developing scientific literature is providing an increasingly solid basis for requiring genetic testing in purported asbestos/mesothelioma cases, as discussed most recently in this scientific article:

Various hypotheses, including exposure to increasing amounts of environmental carcinogens, have been proposed, yet there are no firm data to support these hypotheses.  Mesothelioma, one of the best examples of a cancer caused by environmental carcinogens, is one of the malignancies that we see with increasing frequency in younger patients.  This is very difficult to explain because asbestos causes cancer about 30 to 60+ y[ears] after initial exposure, thus most asbestos workers developed mesothelioma when they are old.  Because, asbestos use was banned in the 80s, former asbestos workers are now in their 70s to 90s, thus we should see mesothelioma in older not younger patients!

F. Novelli, et al., “Germline BARD1 Variants Predispose to Mesothelioma by Impairing DNA Repair & Calcium Signaling,” forthcoming, at p.1, Proc. Nat’l Acad. Sci. (accepted 6/12/24).

Thus, it’s no surprise to see genetic testing orders in asbestos litigation.  Our prior post already discussed Ortwein v Certainteed Corp., 2014 WL 12911977, at *4-6 (Cal. Super. Dec. 22, 2014), and Thrash v. Boeing Co., 2018 WL 2573097, at *3 (N.D. Cal. March 2, 2018).  To those we can now add Sotomayor v. Honeywell International, Inc., 2024 WL 3402783, at *2 slip op. (Cal. Super. March 19, 2024) (genetic testing mandated because “[n]o other feasible alternatives exist to obtain information about whether Plaintiff has the BAP 1 gene mutation”) (“Sotomayor Order”); and McCabe v. 3M Co., No. 1CCV-22-0001318, slip op. (Haw. Cir. Aug. 30, 2023) (ordering genetic testing of mesothelioma patient).

Whole exome genetic testing was ordered in Bruning v. Sanford Clinic North, 2023 WL 9315388 (Minn. Dist. Aug. 17, 2023), a medical malpractice case involving cerebral palsy.  Such testing “has become a standard ‘work-up’ for genetic disorders.”  Id. at *2.

Plaintiffs must prove the cause of [minor plaintiff’s] injuries, and as such, her genetic makeup is really and genuinely in controversy.  The Defendant has established good cause for whole exome sequencing.  Specifically, multiple doctors going back to 2019 have recommended and referred [minor] for genetic testing, based upon her symptomology, her developmental disorder, and her history of seizures. . . .  [R]ecent studies have shown that cerebral palsy is often the result of a genetic condition, not an injury that occurred sometime during labor and delivery. . . .  [T]here are hundreds of possible genetic disorders that may have caused [these] injuries.

Id. at *3 (citations omitted).  See also Simbolon v. North Memorial Health Care, 2010 WL 11889566, at *1 (Minn. Dist. Aug. 18, 2010) (genetic testing ordered in cerebral palsy case where defendants established “good cause to compel a blood sample” through an expert’s opinion and the sampling being “minimally invasive”).

Other recent cases that turn on the results of plaintiff genetic testing include:  Doe v. Netflix, Inc., 2023 WL 2213626, at *2 (S.D. Ind. Feb. 24, 2023) (plaintiffs ordered to sign authorizations for defendant to obtain results of genetic testing they previously underwent at the website 23andMe); First Midwest Bank v. Rush University Medical Center, 2020 WL 4284554, at *3-4 (N.D. Ill. July 27, 2020) (denying plaintiff’s motion to exclude alternative causation testing based on both “the results of genetic testing” and “because the genetic testing is not complete (for instance, mitochondrial gene sequencing was not performed, and [the] was not tested)”); See also Adacsi v. Amin, 2013 Alb. J. No. 988, ¶¶10-12, 14 (Alb. App. 2013) (on the facts, an alternative genetic cause was “not frivolous”; “Since the appellant has chosen to sue for damages, she cannot deprive the respondents from acquiring evidence that may assist in their defence.”) (Canadian decision).

On the other hand, Kallal v. Lyons, 189 N.E.3d 916 (Ill. App 2021), illustrates both a limitation on genetic testing, and as a direct consequence, what we think is a strong merits defense argument against causation.  Over strenuous objection, the trial court in Kallal ordered the parents of the minor plaintiff to undergo genetic testing on the strength of expert testimony that the claimed injuries “likely have a substantial genetic cause.”  Id. at 919.  However, the relevant rule, allowing physical examinations, was limited to “a party,” and the parents, were not themselves parties.  Id. at 920 (a “requirement of the rule was ‘that the physical or mental condition of a party is in controversy’”).  Thus, the genetic testing – no matter how medically justified or crucial to proving causation – was not permitted by the rule.  See also Young v. United States, 311 F.R.D. 117, 121 (D.N.J. 2015) (same result under Fed. R. Civ. P. 35); Meyers v. Intel Corp., 2015 WL 3643470, at *2-3 (Del. Super. June 11, 2015) (same result; genetic testing of minor plaintiff allowed).

Thus, the plaintiffs prevented genetic testing in Kallal and these other cases on something of a technicality − that the relevant rules did apply to non-parties.  Assuming, however, that the defendants were right on the medicine (if not the law), we don’t see how any of these plaintiffs could ultimately establish causation at trial, since their own opposition was what prevented the testing that could have ruled out genetic causes as an alternative reasons for their claimed injuries.  Plaintiffs still have the burden of proving causation, and they cannot advance an admissible differential diagnosis in the presence of a valid but unresolved alternative cause.  E.g. Matuszak v. Cerniak, 805 N.E.2d 681, 686-87 (Ill. App. 2004) (“a differential diagnosis that fails to take serious account of other potential causes . . . cannot provide a reliable basis for an opinion”) (citation and quotation marks omitted).  Without the requisite testing, the genetic cause in Kallal and similar cases cannot be ruled in or out, so these plaintiffs’ very act of preventing genetic testing should eventually preclude them from proving their case at trial. Since the plaintiffs themselves were responsible for the lack of testing in such cases, any contrary argument would seem rather weak.

Thus, in both prescription medical product liability, and other forms of tort litigation, plaintiffs’ resistance to genetic testing discovery leaves them open to adverse causation inferences at trial.  Plaintiffs necessarily have superior access to their own genetic material.  If they manage to avoid medically valid genetic testing on some procedural basis, then in the absence of any testing ruling out a genetic alternative cause supported by the medical literature, they fail to prove their case.