Alafi v. Cohen

CourtCalifornia Court of Appeal
DecidedOctober 25, 2024
DocketH050485
StatusPublished

This text of Alafi v. Cohen (Alafi v. Cohen) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Alafi v. Cohen, (Cal. Ct. App. 2024).

Opinion

Filed 10/25/24 CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SIXTH APPELLATE DISTRICT

CHRISTOPHER D. ALAFI et al., H050485 (Santa Clara County Plaintiffs and Respondents, Super. Ct. No. 18CV333075)

v.

STANLEY N. COHEN,

Defendant and Appellant.

This dispute stems from a failed business venture between longtime friends, ultimately resulting in a $20 million judgment against defendant Stanley N. Cohen for negligent misrepresentation. Cohen has been a professor at Stanford University School of Medicine since the 1960s. He is widely known for discovering recombinant DNA in the 1970s, which helped give rise to the field of biotechnology. In 2010, Cohen and a colleague discovered a genetic mutation they believed causes Huntington’s disease. They soon sought a suitable drug to target the mutation, first identifying a compound called “HD106” that had been used in the 1970s for psoriasis, for which they hoped to obtain FDA approval to treat Huntington’s disease. For that purpose, they formed a company called Nuredis in 2016, together with Cohen’s friend Moshe Alafi and his son, Chris, both wealthy biotechnology investors. The Alafis eventually invested $20 million in Nuredis in exchange for a 20 percent stake in the company. In 2017, though, the FDA rejected Nuredis’s initial request for approval to conduct human clinical trials for HD106, citing the drug’s risk of blood clotting and death, and noting its prior removal from the market in the 1970s based on unacceptable toxicity levels. Although the FDA solicited additional information, Nuredis eventually abandoned its pursuit of HD106. In August 2018, Chris Alafi—along with his investment company and family trust—sued Cohen and his colleague Dr. Tzu-Hoa Cheng for negligent misrepresentation and six related causes of action based on defendants’ alleged failure to disclose to plaintiffs that HD106 had been withdrawn from the market by the FDA in the 1970s due to its unacceptable toxicity levels. After a bench trial, the trial court found in plaintiffs’ favor on the negligent misrepresentation cause of action against Cohen only, declined to reach the other causes, and awarded $20 million in damages plus interest. On appeal, Cohen argues that the negligent misrepresentation cause of action fails as a matter of law because (1) it requires an affirmative misrepresentation, rather than a mere omission, (2) plaintiffs did not rely on the alleged omission because they were put on notice of the toxicity risks but failed to make further inquiry, and (3) plaintiffs were not ignorant of the truth because Cohen had informed Moshe Alafi that HD106 was withdrawn from the market in the 1970s, and Moshe was an agent of plaintiffs. Cohen also argues that the trial court committed prejudicial error by failing to issue a statement of decision upon his request. We find that trial court’s failure to issue the requested statement of decision was prejudicial error because it prevents this court from effectively conducting appellate review of the trial court’s factual and legal findings. Accordingly, we do not reach Cohen’s arguments on the merits, and we reverse and remand for the trial court to issue the statement of decision.

2 I. FACTUAL AND PROCEDURAL BACKGROUND A. Cohen’s research and discovery of genetic mutation Cohen has been a professor of medicine and researcher at Stanford University since 1968. In 1973, he and a colleague began collaborating on what eventually resulted in the discovery of recombinant DNA. Cohen has described recombinant DNA as “a way to take genes from one organism and transplant them to another and propagate them in the organism.” The discovery has enabled researchers to study genes and produce products made by genes, which has been described as the genesis of modern biotechnology. That included, for instance, transplanting human genes into bacteria to create RNA and protein, which became the methodology for producing insulin and growth hormones, similar to the cloning used to make messenger RNA vaccines for treatment of COVID infections. Cohen and his colleague’s discovery led to the licensing of roughly 475 patents assigned to Stanford University. Following his discovery of recombinant DNA, Cohen continued his academic research at Stanford over the next several decades. In 2010, Cohen began working with Cheng to research the genetic cause of Huntington’s disease and to seek viable drugs for treatment or cures. Cheng—who is now senior vice president and a professor of biochemistry at the National Yang-Ming Chiao Tung University in Taiwan—had received his postdoctoral training studying under Cohen at Stanford from 2000 to 2003, after which the two remained in touch. In 2003, Cheng started his own lab in Taiwan, where he began conducting research into neurodegenerative diseases such as Huntington’s disease. Huntington’s disease is a fatal neurodegenerative disorder that causes the progressive breakdown of nerve cells in the brain, spinal cord, and central nervous system, affecting the ability to reason, walk, and speak. The disease stems from a genetic defect or mutation in the human gene known as “huntingtin,” or MHTT, in which a

3 person’s DNA has excessive repeats of nucleotides that comprise part of the inner structure of DNA. It typically begins between age 30 and 40 and becomes fatal within 10 to 20 years. There is no known cure or treatment to delay progression. Cheng soon discovered that targeting, or “knocking down,” a particular protein known as “Spt4,” or “Supt4h” in mammals, reduces the mutant huntingtin protein while still enabling healthy cell function. In 2010, Cheng shared this discovery with Cohen while visiting him in the United States, and the two soon began collaborating on further research. After additional study and experimentation, Cheng and Cohen published their results in 2012 in Cell magazine, a peer-reviewed scientific journal. They subsequently published two additional articles in 2015 and 2016, together with other co-authors, summarizing their continuing research on the subject, which included lab experiments using live cell cultures and mice. B. Selection of HD106 In 2013, Cheng and Cohen began searching for acceptable drug compounds to target the protein in humans. They soon identified one particular drug, which they labeled “HD106,” as the most promising option because of its prior human experience. HD106 had previously been approved by the FDA in 1975 to treat psoriasis. At the time, it was used on more than 1,000 psoriasis patients under the drug names “azaribine” and “Triazure.” In 1976, however, the drug was ordered withdrawn from the market by the FDA due to unacceptably high toxicity levels and association with blood clots and death in some patients. Notwithstanding its removal from the market, certain patients were still authorized to use the drug under compassionate circumstances where they did not benefit from any other treatment of severe psoriasis. In Cohen’s view, HD106 offered an advantage because of the preclinical toxicology and safety testing it had undergone in connection with the prior FDA approval in the 1970s. Its history of safety testing, he believed, would accelerate the timeline for

4 obtaining approval to proceed to human clinical trials for use in treating Huntington’s disease.

C. Cohen’s relationship with the Alafis and initial discussions regarding HD106 Cohen had been close friends with Moshe and Chris Alafi since the 1970s, after he and Moshe initially met as directors for a company called Cetus. Moshe was a sophisticated investor who owned early stakes in some of the biggest biotechnology companies, such as Amgen and Biogen. He founded Alafi Capital as a family investment company and served as a managing partner until 2015. Chris Alafi is also an experienced investor in biotechnology with a PhD in biochemistry from Oxford University.

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Alafi v. Cohen, Counsel Stack Legal Research, https://law.counselstack.com/opinion/alafi-v-cohen-calctapp-2024.