Wake Forest Law Review
22Sep

Fake Cures and Real Law: Analyzing the Legal Implications of ‘DIY’ COVID Vaccines

Categories: Current Issues Blog
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By Megan M. Neal

As the public tracks the development of a viable SARS-CoV-2 (“COVID-19”) vaccine, there has been rampant proliferation of fake COVID-19 cures. Indeed, the Food and Drug Administration (“FDA”) has identified a host of products fraudulently marketed to diagnose, treat, or cure COVID-19.[1] Many of these products are faulty, but relatively harmless: fake antibody testing kits and ineffective hand sanitizer, for instance.[2] However, some scientists, frustrated with the lengthy process of testing and approving vaccines, have sought to develop and administer their own COVID-19 vaccines.[3]

Three projects in particular have garnered public attention. The Rapid Deployment Vaccine Collaborative (“RaDVaC”) has “designed, produced, and self-administered several progressive generations of nasal vaccines against SARS-CoV-2.”[4] Its collaborators are publicly listed, as are instructions for making the vaccine.[5] RaDVaC aims to publicize how to make this vaccine, but does not intend to sell the vaccine.[6] So far, collaborators have administered the vaccine to themselves, family, and friends.[7]

Another collaboration, CoroNope, seeks funding to develop a vaccine for eventual public availability.[8] CoroNope collaborators are anonymous, citing fears of repercussions from employer and the FDA.[9] The group acknowledges that any treatment it creates will likely not “be adopted by the medical community in any official sense.”[10]

Finally, an individual, Johnny T. Stine, developed, sold, and administered a vaccine purporting to (1) immunize uninfected recipients against COVID-19 and (2) cure recipients infected with COVID-19.[11] Stine has a background in antibodies through his company, North Coast Biologics, LLC, which focuses on antibody research.[12] Stine’s COVID-19 vaccine development process was dubious. He “tested the product only on himself and potential[ly] a family member.”[13] After doing so, he deemed the vaccine effective and advertised it—at a cost of $400 per person—on Facebook and LinkedIn.[14] Despite some negative responses, these social media advertisements did generate customers for Stine: he inoculated about thirty individuals living in Washington, Montana, Arizona, and Texas.[15]

The manufacture and distribution of homemade or unapproved drugs is not entirely without precedent. For instance, in 2017 a Chicago pediatrician voluntarily surrendered his medical license after altering allergy shots with cat saliva and vodka.[16] Additionally, courts have held against drug manufacturers that distributed unapproved new drugs.[17] In United States v. X-Otag Plus Tablets,[18] a federal district court held that a new drug could be seized, and the manufacturer could be enjoined from further producing the drug, which had not been approved by the FDA prior to distribution.[19] Ultimately, the court accepted the government’s expert testimony that the drug was not “safe and effective” over testimony from the manufacturer’s experts.[20]

Accordingly, RaDVaC, CoroNope, and Stine’s vaccine present a host of legal issues. In fact, Stine has already faced legal action. The Attorney General of Washington sent him a cease and desist letter in April,[21] and the FDA and the Federal Trade Commission sent him a warning letter in May.[22] In June, the Washington Attorney General pressed charges against Stine under Washington’s unfair and deceptive trade practices statute.[23] The parties ultimately reached a settlement in which Stine agreed to offer restitution to all vaccine recipients by refunding the $400 charge.[24] Additionally, the Consent Decree enjoined Stine from further producing or distributing the vaccine[25] and required him to make a monetary payment.[26]

RaDVaC and CoroNope, on the other hand, have not yet faced disciplinary or legal action.[27] Nonetheless, RaDVaC has sought some legal protection. The group consulted an attorney,[28] and the group lists disclaimers on the document detailing how to develop and administer its vaccine.[29]

These projects are not necessarily immune from liability, though. In March, the Department of Health and Human Services published a Notice of Declaration shielding COVID-19 drug manufacturers from potential liability in some circumstances.[30] However, manufacturers that engage in “willful misconduct” are not shielded from liability.[31] As used in the Notice of Declaration, “willful misconduct” means “an act or omission that is taken (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.”[32] Notably, neither the Notice of Declaration nor the relevant statutory guidelines define “wrongful purpose,” likely leaving the definition to judicial interpretation. Given the exigent need for a COVID-19 vaccine, however, a court may determine that RaDVaC and CoroNope’s decisions to fast-track a their vaccines does not constitute a “wrongful purpose.”

The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) may also pose an issue for homemade vaccine developers. The FD&C Act restricts misbranded and unapproved drugs.[33] It further prohibits introducing such drugs into interstate commerce.[34] Critically for consumers, the FD&C Act does not allow a private right of action.[35]

Additionally, under the Public Health Service Act (“PHS Act”), unlicensed biological products may not be marketed.[36] The PHS Act also bans the use of unlicensed biological products in humans without proper licensing.[37]

Accordingly, the aforementioned collaborations’ actions may result in legal liability. For instance, one RaDVaC collaborator stated that approximately 30 individuals in the United States and other countries have been inoculated with RaDVaC’s vaccine.[38] However, as the collaboration simply publishes instructions for making its vaccine, but does not actually make and distribute it, it remains unclear whether the vaccine has been introduced into interstate commerce. And, as of now, neither RaDVaC nor CoroNope’s products are licensed biological products as required for use in humans by the PHS Act.

Furthermore, should any recipients be injured as a result of these homemade vaccines, these collaborations may face liability for participants’ injuries, depending on whether the collaborations’ actions are deemed “willful misconduct.”

Liability may also depend on the scale of these projects. One RaDVaC project collaborator posits that the group has not yet faced legal or disciplinary proceedings because the project is relatively small. RaDVaC collaborators have not sold or advertised the vaccine beyond friends and family, and the project has received minimal media attention.[39] Accordingly, should these projects expand or change—perhaps by making and selling the vaccines they have designed—their legal situation may change as well.

[1] Fraudulent Coronavirus Disease 2019 (COVID-19) Products, FDA, https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products (last updated Sep. 21, 2020).

[2] See id.

[3] Heather Murphy, These Scientists Are Giving Themselves D.I.Y. Coronavirus Vaccines, N.Y. Times (Sept. 1, 2020), https://www.nytimes.com/2020/09/01/science/covid-19-vaccine-diy.html.

[4] RaDVaC Mission, Rapid Deployment Vaccine Collaborative, https://radvac.org (last visited Sept. 22, 2020).  

[5] Rapid Deployment Vaccine Collaborative, SARS-CoV-2 (2019-nCoV) Vaccine (2020), https://radvac.org/wp-content/uploads/2020/08/White-Paper-SARS-CoV-2-vaccine-ver-3-0-1.pdf.

[6] Murphy, supra note 3.

[7] Antonio Regalado, Some Scientists Are Taking a DIY Coronavirus Vaccine, and Nobody Knows If It’s Legal or If It Works, MIT Tech. Rev. (July 29, 2020), https://www.technologyreview.com/2020/07/29/1005720/george-church-diy-coronavirus-vaccine/.

[8] CoroNope, CoroNope: A Crowdsourced SARS-CoV-2 Vaccine (2020), https://siasky.net/bACLKGmcmX4NCp47WwOOJf0lU666VLeT5HRWpWVtqZPjEA.

[9] Murphy, supra note 3.

[10] CoroNope, supra note 8, at 1.

[11] Complaint, State v. Stine, No. 20-2-09935-0 SEA (Wash. Super. Ct. June 12, 2020), https://agportal-s3bucket.s3.amazonaws.com/2020_06_12Complaint.pdf.

[12] Id. at 2. Additionally, the Complaint notes that it appears North Coast Biologics was administratively dissolved in 2012, but Stine may have continued to operate under the name of the company. Stine marketed his vaccine through North Coast Biologics’ Facebook page. Id. at 7.

[13] Id. at 8.

[14] Id. at 5.

[15] Id. at 9.

[16] Vikki Ortiz, Doctor Could Lose License After Giving Vaccines Made with Cat Saliva, Vodka, Chi. Trib. (Oct. 20, 2016), https://www.chicagotribune.com/news/ct-flossmoor-doctor-cat-saliva-vaccines-met-20161020-story.html; Search for a License, Ill. Dep’t of Fin. & Pro. Regul., https://ilesonline.idfpr.illinois.gov/DFPR/Lookup/LicenseLookup.aspx (select “Medical Board” License Type and search First Name “Ming” and Last Name “Lin,” from the results select the listing for “Ming Te Lin MD”).

[17] See, e.g., United States v. Pro-Ag, Inc., 968 F.2d 681, 682 (8th Cir. 1992) (holding that products intended for animal use qualified as drugs because they were “intended to alter the structure or function of the body of animals,” and that “the products have never been approved as animal drugs and, therefore, they may not be sold interstate without such approval under section 331(a) of the Federal Food, Drug, and Cosmetic Act”); United States v. Undetermined Qualities of Articles of Drug, 145 F. Supp. 2d 692, 704 (D. Md. 2001) (holding that injunctive relief was proper to bar defendants from manufacturing and distributing misbranded, unapproved new drugs because the government “establish[ed] that the Defendants violated the FDCA and that there exists ‘some cognizable danger of recurrent violation . . . .’” (quoting United States v. W. T. Grant Co., 345 U.S. 629, 633 (1953))); United States v. Richlyn Labs., Inc., 822 F. Supp. 268, 274 (E.D. Pa. 1993) (holding that “[t]he issuance of a permanent injunction enjoining the Defendants from manufacturing, processing, packaging and distributing their drug products until such time as they are in full compliance with Current Good Manufacturing Practices and the Federal Food, Drug, and Cosmetic Act is the only appropriate remedy available to safeguard and protect the public health, safety and welfare”).

[18] 441 F. Supp. 105 (D. Colo. 1977).

[19] Id. at 107.

[20] Id. at 114.

[21] Cease and Desist Letter from Bob Ferguson, Att’y Gen. of Wash., to Johnny T. Stine, North Coast Biologics (Apr. 23, 2020), https://agportal-s3bucket.s3.amazonaws.com/uploadedfiles/Another/News/Press_Releases/Stine-North%20Coast%20Biologics%20Cease%20and%20Desist%20Letter.pdf.

[22] Warning Letter from Center for Biologics Evaluation and Research, FDA, to Johnny T. Stine, North Coast Biologics (May 21, 2020), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-coast-biologics-607532-05212020.

[23] Complaint, State v. Stine, supra note 11, at 9–10.

The Complaint alleges that Stine’s “unfair and deceptive conduct in trade or commerce” included: “misrepresenting the health benefits of the purported “vaccine” [Stine and North Coast Biologics] developed and marketed”; “representing that the product [Stine and North Coast Biologics] developed could vaccinate consumers against COVID-19 without adequate scientific substantiation for these representations”; “offering a product they represented to be a vaccine without adequately testing the product’s effectiveness or safety for use in humans”; “representing that Stine was immune from COVID-19 without adequate scientific administration”; and “offering to cure a human disease, ailment, or condition without a medical license.” Id. Washington’s unfair and deceptive trade practice statute reads in full: “Unfair methods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce are hereby declared unlawful.” Wash. Rev. Code § 19.86.020.

[24] Consent Decree, State of Washington v. Stine, NO. 20-2-09935-0 SEA, at 4–5 (Wash. King Cty. Super. Ct. 2020), https://agportal-s3bucket.s3.amazonaws.com/2020_06_22ConsentDecree.pdf.

[25] Id. at 3–4.

[26] Id. at 5–6.

[27] Regalado, supra note 7.

[28] Id.

[29] Rapid Deployment Vaccine Collaborative, supra note 5, at 2–5.

[30] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15,198, 15,198 (Mar. 17, 2020). The Public Readiness and Emergency Preparedness Act authorized this action. See 42 U.S.C. §§ 247d-6d, 6e.

[31] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. at 15,198.

[32] 42 U.S.C. § 247d-6d.

[33] 21 U.S.C. §§ 321–399i.

[34] Id. § 331. The FDA noted these prohibitions in its Warning Letter to Stine.

[35] Id. § 327.

[36] 42 U.S.C. § 262.

[37] Id.; see also 21 U.S.C. § 355(i); 31 C.F.R. § 312 (governing “procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications”). The FDA noted these prohibitions in its Warning Letter to Stine.

[38] Murphy, supra note 3.

[39] Regalado, supra note 7.

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10Sep

Will Loss of Chance Doctrine Lose its Chance in North Carolina?

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by Paul Fangrow

Loss of chance is a hot topic in recent American medical malpractice law. In states where it is accepted, loss of chance is a cause of action in medical malpractice cases that asserts a physician’s negligence reduced a patient’s chance for a better outcome or increased their risk of future harm, when the patient’s existing chance is below 50%.[1] Oregon recently changed sides and accepted loss of chance in 2017.[2] Hawaii, one of the last states remaining where loss of chance had not been addressed, just heard oral argument in the Hawaii Supreme Court on Estate of Frey v. Mastroianni[3] involving loss of chance doctrine.[4] Today, nearly every state has either accepted or rejected the doctrine.[5] North Carolina is now one of only three states that have yet to finally rule on the admissibility of loss of chance claims,[6] but that may change very soon.

Parkes v. Hermann[7] is a North Carolina Court of Appeals case involving loss of chance doctrine with a petition for discretionary review pending before the North Carolina Supreme Court.[8] A patient under the care of Defendant doctor died from a stroke that was misdiagnosed.[9] Proper protocol for a stroke is to administer a type of drug within three hours, which Defendant doctor did not do.[10] Issuing the drug within three hours of a stroke results in a 40% chance of a better outcome.[11] Under current North Carolina law, a patient must have a greater than 50% chance of a better outcome to prove that Defendant doctor more likely than not caused the patient’s injury.[12] The North Carolina Court of Appeals rejected loss of chance as a recognized claim,[13] marking Parkes v. Hermann as the first time a North Carolina court explicitly ruled on the admissibility of a loss of chance claim.[14]

In states that have accepted loss of chance doctrine, an injury resulting in a less than a 50% chance of recovery is still a valid cause of action.[15] Two distinct theories have arisen in the state courts: a causation approach first adopted in Pennsylvania,[16] and an injury approach popularized by professor Joseph King, Jr.[17] This is the approach adopted by Oregon[18] and is under consideration in both Hawaii[19] and North Carolina.[20] The causation approach takes cues from Section 323(a) of the Second Restatement of Torts,[21] and lowers the threshold of proof required to submit the question of proximate cause to the jury.[22] The jury is then called on to decide whether the defendant’s negligence was a substantial factor in bringing about the eventual harm.[23] By contrast, the injury approach recharacterizes the harm that recovery is sought for as the loss of chance itself, not the eventual harm.[24] Under this approach, a plaintiff seeks to prove by a preponderance of evidence that the defendant’s negligence resulted in the plaintiff’s loss of chance for a better outcome, or increased their risk of future harm.[25] In almost all states that have adopted loss of chance in some form, a proportional damages formula is used where if the claim is successful, the plaintiff recovers the percentage of chance lost multiplied by the value of what a full recovery would be.[26] That way, the plaintiff only recovers for the harm that the defendant’s negligence actually caused.[27]

The central reasoning for adopting loss of chance doctrine is to alleviate the harshness of the traditional approach.[28] Under the traditional approach currently followed by North Carolina, a plaintiff cannot recover anything unless they prove a doctor’s negligence more likely than not caused the eventual harm suffered.[29] Put into loss of chance terms, a plaintiff does not recover unless the loss of chance suffered is greater than 50%.[30] Thus, even though the patient in Parkes v. Hermann would have had a 40% chance of a better outcome had Defendant doctor correctly diagnosed the patient’s stroke and followed protocol, the patient is categorically barred from any recovery. If this arrangement seems unfair, many states agree that it is.[31] At present, twenty-five states have accepted loss of chance in either theory.[32] Hawaii may very well make it twenty-six.[33]

North Carolina has the opportunity to become the twenty-seventh[34] state to adopt loss of chance as a compensable claim in medical malpractice cases, but there are troublesome rumblings that suggest an uphill battle for loss of chance advocates. The sheer brevity of the Parkes v. Hermann opinion is one indicator. While the court in Estate of Frey v. Mastroianni took care to analyze both loss of chance theories, debate their merits, and cite case law from dozens of other jurisdictions,[35] the court in Parkes v. Hermann issued a very short and curt opinion comprised of only six paragraphs of analysis.[36] The court only cited a single case with reference to the various approaches adopted in each state.[37] The reasoning given for rejecting loss of chance was that no North Carolina case was cited that recognized such a claim, but this is to be expected when North Carolina courts have never taken any position regarding loss of chance until Parkes v. Hermann, rendering this reasoning entirely circular. While the court points to Gower v. Davidian[38]—a North Carolina Supreme Court case from 1937—to support a broad claim that “[t]he rights of the parties cannot be determined upon chance,”[39] this seems a thin reed upon which to hang the resolution of the loss of chance issue in light of the Gower court’s explicit statement that there was no evidence that loss of chance even occurred.[40] Besides, advances in medical technology made in the last eighty years have enabled expert witnesses to testify to reasonable medical certainty about the chances of recovery are in a wide variety of scenarios, and courts already rely wholly on chance to determine whether a patient had a 51% or more chance of making a recovery to establish proximate cause.

It seems like the court has no desire to seriously engage with the merits of the debate on loss of chance. Both the majority opinion and the concurrence written by Judge Berger cite dicta from Curl v. American Multimedia, Inc.[41] for the proposition that “recognition of a new cause of action is a policy decision which falls within the province of the legislature.”[42] While this is not a new idea even where loss of chance is concerned, [43] the underlying reason given for requiring legislative action is usually the presence of a conflict between loss of chance and a current medical malpractice statute.[44] The Parkes v. Hermann opinion contains no discussion of any conflict with existing North Carolina medical malpractice law.

In the absence of any statutory conflicts, there is no reason for the judiciary to paralyze itself regarding its own common law. Ever since the founding of the country, courts across the United States have interpreted statutes and maintained their common law without legislative handholding. In the wake of rapid technological progress that puts the legal community in a constant state of catch-up, courts cannot afford to tentatively wait for the legislature on every difficult question of evolving legal doctrine. A substantial majority of states that have both accepted and rejected loss of chance did so without any prior legislative direction.[45] Further, nothing stops the legislature from stepping in after the fact and reverting the law back to the traditional approach should it want to. Lord v. Lovett,[46] Jorgenson v. Vener,[47] and Falcon v. Memorial Hospital[48]are all state supreme court decisions that adopted loss of chance and were subsequently superseded by statutes passed by their respective state legislatures.

Parkes v. Hermann is a case of first impression in the North Carolina courts. Hopefully, the North Carolina Supreme Court considers the issues presented with greater care.

[1] See Joseph H. King, Jr., “Reduction of Likelihood” Reformulation and Other Retrofitting of the Loss-of-a-Chance Doctrine, 28 U. Mem. L. Rev. 491, 508–511 (1998).

[2] Smith v. Providence Health & Servs.-Or., 393 P.3d 1106, 1121 (Ore. 2017).

[3] No. CAAP-14-0001030, 2018 Haw. Ap. LEXIS 327 (Haw. Ct. App. June 29, 2018), cert. granted, No. SCWC-14-0001030, 2018 Haw. LEXIS 255 (Haw. Nov. 29, 2018).

[4] Oral Argument, Estate of Frey v. Mastroianni, No. SCWC-14-0001030 (Haw. argued Feb. 12, 2019), http://oaoa.hawaii.gov/jud/oa/19/SCOA_022119_SCWC_14_1030.mp3.

[5] See Lauren Guest et al., The “Loss of Chance” Rule as a Special Category of Damages in Medical Malpractice: A State-by-State Analysis, 21 J. Legal Econ. 53, 59 (2015).

[6] Id.

[7] 828 S.E.2d 575 (N.C. Ct. App. 2019).

[8] Petition for Discretionary Review, Parkes v. Hermann, No. 241P19 (N.C. filed July 5, 2019), https://www.ncappellatecourts.org/show-file.php?document_id=250145.

[9] Parkes, 828 S.E.2d at 576.

[10] Id.

[11] Id.

[12] Id. at 577.

[13] Id. at 578.

[14] Bennett v. Hospice & Palliative Care Ctr. of Alamance Caswell, 783 S.E.2d 260, 261–62 (N.C. Ct. App. 2016) (pro se plaintiff did not attach Rule 9(j) certification to complaint, among other errors); Curl v. Am. Multimedia, Inc., 654 S.E.2d 76, 80–81 (N.C. Ct. App. 2007) (loss of chance not asserted in the complaint); Franklin v. Britthaven, Inc., No. COA05-1603, 2006 N.C. App. LEXIS 2119, at *12–13 (loss of chance not considered because plaintiff did not raise it at trial).

[15] See Joseph H. King, Jr., Causation, Valuation, and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 Yale L.J. 1353, 1364 (1981).

[16] Hamil v. Bashline, 392 A.2d 1280, 1286–90 (Pa. 1978).

[17] See King, supra note 14, at 1365–76 (for an in-depth explanation of the injury approach to loss of chance).

[18] Smith v. Providence Health & Servs.-Or., 393 P.3d 1106, 1112–17 (Ore. 2017) (discussing and rejecting the causation approach while adopting the injury approach).

[19] Estate of Frey v. Mastroianni, No. CAAP-14-0001030, 2018 Haw. Ap. LEXIS 327, at *13–15 (Haw. Ct. App. June 29, 2018) (agreeing with courts that have adopted the injury approach).

[20] Parkes v. Hermann, 828 S.E.2d 575, 577 (N.C. Ct. App. 2019) (“The question presented is whether her loss of this 40% chance, itself, is a type of injury for which Ms. Parkes can recover.”).

[21] Restatement (Second) of Torts § 323(a) (Am. Law Inst. 1965).

[22] Hamil, 392 A.2d at 1286 (“We agree . . . that the effect of § 323(a) is to relax the degree of certitude normally required of plaintiff’s evidence in order to make a case for the jury as to whether a defendant may be held liable . . . .”).

[23] Id. at 1288 (“[S]uch evidence furnishes a basis for the fact-finder to go further and find that such an increased risk was in turn a substantial factor in bringing about the resultant harm . . . .”).

[24] Parkes, 828 S.E.2d at 575 (“[Plaintiff] argues, however, that she has suffered a different type of injury for which she is entitled to recovery; namely, her “loss of chance” of a better neurological outcome.”).

[25] Smith v. Providence Health & Servs.-Or., 393 P.3d 1106, 1114 (Ore. 2017) (“[T]reating loss of chance as a theory of injury does not dispense with causation requirements, but instead shifts the causation inquiry to whether a defendant caused the opportunity of a better outcome to be lost . . . .”).

[26] See, e.g., King, supra note 14, at 1382 (“The value placed on the patient’s life would reflect such factors as his age, health, and earning potential, including the fact that he had suffered the heart attack and the assumption that he had survived it. The 40% computation would be applied to that base figure.”).

[27] See, e.g., Estate of Frey v. Mastroianni, No. CAAP-14-0001030, 2018 Haw. Ap. LEXIS 327, at *14 (Haw. Ct. App. June 29, 2018) (“As such, damages are then limited only to those proximately caused by the medical provider’s breach of duty.”).

[28] See, e.g., King, supra note 14, at 1381 (“In summary, the all-or-nothing approach to the loss of a chance irrationally and unfairly denies the reality of chance as an appropriately cognizable interest in the torts system.”).

[29] Parkes, 828 S.E.2d at 577 (“To establish proximate cause, the plaintiff must show that the injury was more likely than not caused by the defendant’s negligent conduct.”).

[30] Id. at 578 (“Under the “traditional” approach, a plaintiff may not recover for the loss of less than 50% chance of a healthier outcome.”).

[31] See Guest, supra note 4, at 59 (note all the states in the “accepted” category).

[32] Id. (note that since this article was written, Oregon accepted loss of chance doctrine to make 25 states).

[33] See generally Oral Argument, supra note 4.

[34] Assuming Hawaii also adopts the doctrine.

[35] Estate of Frey v. Mastroianni, No. CAAP-14-0001030, 2018 Haw. Ap. LEXIS 327, at *8–18 (Haw. Ct. App. June 29, 2018).

[36] Parkes v. Hermann, 828 S.E.2d 575, 577–78 (N.C. Ct. App. 2019).

[37] Id. at 577 (the cited case is Valadez v. Newstart, No. W2007-01550-COA-R3-CV, 2008 Tenn. App. LEXIS 683 (Tenn. Ct. App. Nov. 7, 2008)).

[38] 193 S.E. 28 (N.C. 1937).

[39] Id. at 30.

[40] Id. at 30–31 (“The evidence discloses that the use of modern equipment and methods by trained and skillful surgeons . . . has availed nothing. . . . Unfortunately, upon this record as it now appears, the plaintiff has suffered an injury that could not then and cannot now be relieved by the medical profession.”)

[41] 654 S.E.2d 76 (N.C. Ct. App. 2007).

[42] Id. at 81. (quoting Ipock v. Gilmore, 354 S.E.2d 315, 317 (N.C. Ct. App. 1987)).

[43] Smith v. Parrott, 833 A.2d 843, 848 (Vt. 2003) (“[W]e are persuaded that the decision to expand the definition of causation and thus the potential liability of the medical profession in Vermont “involves significant and far-reaching policy concerns” more properly left to the Legislature . . . .”).

[44] Id. (“Plaintiff urges us nevertheless to depart from the strict statutory requirements, noting that they were codified in 1976, well before “loss of chance” became a recognized as a viable theory of recovery.”) (emphasis added).

[45] See Guest, supra note 4, at 63–103 (tables showing authority from each state jurisdiction and the reason behind adoption or rejection of loss of chance doctrine).

[46] 770 A.2d 1103 (N.H. 2001) (superseded by a 2003 amendment to N.H. Rev. Stat. Ann. § 507-E:2 (2019)).

[47] 616 N.W.2d 366 (S.D. 2000) (abrogated by S.D. Codified Laws § 20-9-1.1 (2019)).

[48] 462 N.W.2d 44 (Mich. 1990) (superseded by a 1993 amendment to Mich. Comp. Laws. § 600.2912a (2019)).

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