April 07, 2020 Articles

Recent Civil Discovery Decisions Addressing Genetic Testing

Genetic testing of plaintiffs will likely become routine—at least in mass tort product liability litigation—within a decade.

By James M. Beck

Based on existing trends of dramatically decreasing cost and equally dramatic efficiency increases, genetic testing of plaintiffs will likely become routine at least in mass tort product liability litigation within a decade. The cost of such testing is constantly plummeting, even more steeply than would be predicted by Moore’s law. As that happens, it is likely that the rules of civil procedure will be modified to govern such testing. Even now, what little precedent exists mostly agrees that recalcitrant litigants may—with appropriate confidentiality safeguards—be required to provide specimens necessary for genetic testing. To date, almost all of those cases involve blood samples, but technology is enabling even less invasive alternatives:

A high number of patients seem to accept salvia samples as a risk assessment tool . . . and are interested in their specific risk situation. At the same time, it could be demonstrated that it is an effective way to provide high-quality DNA for . . . gene analysis.

Poehls et al., “Saliva Samples as a Source of DNA for High Throughput Genotyping: An Acceptable & Sufficient Means in Improvement of Risk Estimation Throughout Mammographic Diagnostics,” 23 Eur. J. Med. Res. (2018), art. 20 at “Conclusion” (2018).

The great majority of genetic testing cases seek to employ such tests to establish someone’s identity.

The great majority of genetic testing cases seek to employ such tests to establish someone’s identity.

Credit: Pexels, Martin Lopez

Over the last several years, most decisions have ordered genetic testing for diagnostic or causation purposes. The first is Cusick v. Cusick, 210 A.3d 1199 (R.I. 2019), which became the first decision by a state high court to affirm a diagnostic genetic testing order. Cusick involved “an acrimonious post-divorce battle” in which estranged parents disagreed (inter alia) about genetically testing the ex-husband, who had been diagnosed with an inheritable genetic condition. Specifically, the court held:

[G]enetic testing of [ex-husband] to determine whether his children are at risk for [the condition] is the preferred diagnostic path because, if the genetic change that [ex-husband] carries can be identified, then the children can be tested for that specific variant. Alternatively, . . . if genetic testing of [ex-husband] is not undertaken, then [an alternative method] can be used to diagnose the children; however, there is a high risk that this could produce a false-negative.

Id. at 1201.

Cusick affirmed the trial court’s order that such testing be conducted over objection of the ex-husband (who was a lawyer representing himself).

[A]fter careful review . . . , we are satisfied that the hearing justice made sufficient findings of fact and did not overlook or misconceive any evidence. We are of the opinion that the hearing justice carefully balanced the interests of the father in protecting his privacy with that of the children. His conclusion that genetic testing was in the best interest of the children is supported by the evidence. Further, the order under review is both balanced and reasonable. We see no reason to disturb the findings of the hearing justice.

Id. at 1204.

In New York, in Kaous v. Lutheran Medical Center, 30 N.Y.S.3d 663 (N.Y. App. Div. 2016), the court affirmed a genetic testing order in a malpractice case:

[T]he [trial] Court properly determined that the defendants were entitled to perform genetic testing and a physical examination. . . . In a medical malpractice action, where the physical condition of a party is in controversy, “any party may serve notice on another party to submit to a physical, mental or blood examination by a designated physician.” Here, the defendants challenge the plaintiffs’ allegation that [the] injuries were caused by the defendants’ purported malpractice and not . . . [a] genetic predisposition. Given that [the plaintiff’s] physical and mental condition is in dispute, the Supreme Court properly granted those . . . motions . . . to permit genetic testing.

Id. at 666 (citation omitted).

The defendant in Kaous was significantly aided by New York having a rule specifically addressing blood samples. See Kriloff v. Providence Health & Servs.–Or., 2016 WL 11121002, at *1 (Or. Cir. Ct. Jan. 12, 2016) (“defendants’ discovery Motion to obtain blood specimens from Benjamin Kriloff in sufficient volume for the purpose of performing genetic testing is allowed”).

In Burt v. Winona Health Services, 2018 WL 3647230 (D. Minn. Aug. 1, 2018), the court overruled a magistrate’s order and ordered whole exome sequencing (WES) testing where the defendants’ “experts . . . identified genetic disorders and specific conditions that could be likely culprits of [the claimed] disability.” Id. at *2.

[B]ecause Plaintiffs must prove the cause of [minor plaintiff’s] injuries, [minor’s] genetic makeup is “really and genuinely in controversy.” The Court further concludes that Defendants have established good cause for WES testing. Specifically, Defendants’ expert . . . stated that there are numerous genetic disorders that may have caused [the] injuries, while also identifying specific conditions that may be a cause. . . . [The expert] identified specific facts justifying WES testing related to [minor’s] parents—namely, that their medical records indicate the possibility of underlying genetic issues within the family.

Id. (quoting Schlagenhauf v. Holder, 379 U.S. 104, 109 (1964)) (other citations and quotation marks omitted). For an interesting article on Burt and WES testing (including other precedent), see Andrew Gendron & Thomas M. Morgan, “Incomplete Penetrance: Whole-Exome Sequencing and Federal Courts,” 61 For the Defense 22 (Jan. 2019).

Finally, in Ortwein v. Certainteed Corp., 2014 WL 12911977 (Cal. Super. Ct. Dec. 22, 2014), the court ordered genetic testing of a “take home” asbestos plaintiff—that is, an occupationally unexposed person (here, a wife) claiming injury from asbestos allegedly present on a spouse’s work clothing. “Take home” asbestos cases are inherently weak, given the questionable method and amount of claimed exposure, so alternative causation is an important defense.

The moving defendant in Ortwein “moved to compel [plaintiff’s] physical examination, including blood sample, and for limited genetic testing.” Id. at *4. It moved to compel the plaintiff “to appear for a medical examination to withdraw blood to be used to test for the presence or absence of the BAP1 mutation.” Id. Plenty of medical literature supports “BAP1 tumor predisposition syndrome.”

[Defendant] contended that the testing was calculated to result of the discovery of admissible evidence because the presence of the BAP1 mutation in the germline, defined as the genetic material inherited from a father or mother, would support an opinion by [its expert] that Plaintiff’s mesothelioma could have developed in the absence of exposure to mesothelioma. . . . [I]t is possible that Plaintiff is affected by the genetic BAP1 cancer syndrome that is characterized by a high incidence of malignant mesotheliomas and other cancers in affected families at a relatively younger age.

Id.

The defendant sought extraction of eight millileters of blood for the testing. Id. Its entitlement to testing lay in California civil procedure rules concerning medical examinations and Cruz v. Superior Court, 17 Cal. Rptr. 3d 368 (Cal. Ct. App. 2004). Ortwein, 2014 WL 12911977, at *4. The plaintiff opposed on both privacy and “eggshell plaintiff” grounds. Id. at *5.

In the interim, the plaintiff died, so the request for a blood sample was converted to a request for lung tissue. Id. at *6.

Ortwein ordered that the requested genetic testing take place, subject to privacy-related restrictions.

The production of the tissue samples, the testing to obtain . . . genetic information regarding BAP1, and the potential expert testimony is essential to the fair resolution of the lawsuit. The information is essential because [defendant] has no alternative means to obtain the information it seeks. This is not a situation where a party can obtain adequate, even if not comparable, information through less intrusive means.

Id. at *9.

The order involved discovery, not admission of evidence, thus Ortwein did not need to address the ultimate admissibility of any expert opinion offered by the moving defendant. Id. at *8.

As for privacy, after the plaintiff’s death, that interest abated. “[T]he right of privacy is purely a personal one and . . . does not survive but dies with the person.” Id. at *7 (citation and quotation marks omitted). After death only persons who “share genetic information” can assert a privacy interest. Id. Nonetheless, the court added confidentiality conditions to its order:

[Defendant] must use the tissue sample and any and all information derived from the tissue sample solely for this case. [Its] experts cannot retain, use, or transfer [the] genetic information for potential use in further research. [Its] attorneys cannot retain, use, or transfer [the] genetic information for potential use in subsequent litigation. . . . [Defendant] must return or destroy the tissue sample and any and all information derived from the tissue sample at the conclusion of the case.

Id. at *9.

The plaintiff’s “eggshell” argument failed for multiple reasons. That the decedent was “particularly susceptible to mesothelioma” gives “greater confidence that . . . defenses based on [her] potential possession of the BAP1 mutation are plausible both as a matter of fact in this case and as a matter of expert scientific opinion.” Id. at *8. Whether “the BAP1 mutation [actually] can cause mesothelioma” will be addressed later, in connection with the admissibility of expert testimony. Id. “[T]hat the BAP1 mutation arguably can make a person susceptible to mesothelioma” is “directly relevant to this case” and supports two legitimate arguments.” Id.

First, [defendant] can argue that if [the decedent] was susceptible to mesothelioma such that she could have contracted the disease from levels of asbestos that [defendant] would not reasonably have foreseen would cause the disease, then [defendant] might not have had a duty to her on the grounds that the harm was not foreseeable. . . .

Second, [defendant] can argue that if [decedent] was susceptible to mesothelioma, then she could have contracted the disease as a result of exposures to asbestos from more sources than have been identified to date. [Defendant] may then legitimately argue . . . that that liability should be apportioned among a larger number of sources. . . .

Id. at *8–9. See also Thrash v. Boeing Co., 2018 WL 2573097, at *3 (N.D. Cal. Mar. 2, 2018) (almost identical California asbestos decision reaching similar result under federal rules).

Readers should note that the research on which this article is based was fairly limited. In particular, it is limited to cases involving diagnostic genetic testing of plaintiffs claiming some sort of personal injury. This article discusses only proving or disproving the causation of medical conditions. The great majority of genetic testing cases seek to employ such tests to establish someone’s identity.

James M. Beck is a senior life sciences policy analyst at Reed Smith, LLP, in its Philadelphia, Pennsylvania, office.


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