Category: Daily News

Platelet-rich plasma injections. Bone marrow aspirate concentrate. Stem cell therapies. If you handle workers’ compensation claims involving musculoskeletal injuries, you have almost certainly seen these treatments — collectively known as orthobiologics — appearing on treatment plans and medical bills with increasing frequency. Patients are now asking for PRP by name. Treating physicians are offering it as an alternative to surgery. And the bills are landing on adjusters’ desks with price tags that can run from several hundred to several thousand dollars per injection.

There is just one problem: the clinical evidence supporting many of these treatments remains thin, inconsistent, and — according to a growing chorus of orthopedic leaders — insufficient to justify the pace at which they are being adopted. A Healio editorial published August 6, 2026, titled “Separate Science from Hope,” put the issue in stark terms: “Few areas of orthopedic practice have grown faster and with thinner evidence than orthobiologics.”

The editorial was prompted by a major institutional response to the evidence gap. In December 2025, the American Academy of Orthopaedic Surgeons (AAOS) announced the creation of the AAOS Orthobiologics Registry, developed in collaboration with the American Orthopaedic Society for Sports Medicine (AOSSM), the Arthroscopy Association of North America, and the Biologic Association. The registry’s stated mission, as its leadership has framed it, is to separate science from hope — to build the kind of rigorous, real-world outcomes data that the existing PRP and orthobiologics literature largely lacks.

Here are some basic terms to understand:

– – Orthobiologics is an umbrella term for biological substances used to promote healing of musculoskeletal tissues — bones, muscles, tendons, and ligaments. The most commonly encountered treatments include:
– – Platelet-rich plasma (PRP), in which a patient’s own blood is drawn, centrifuged to concentrate the platelets and their associated growth factors, and injected into an injured joint or tendon. The theory is that the concentrated growth factors accelerate tissue repair.
– – Bone marrow aspirate concentrate (BMAC), in which marrow is drawn from the patient’s pelvis, concentrated, and injected into the treatment site. BMAC contains mesenchymal stem cells that have the theoretical potential to differentiate into cartilage, bone, or tendon tissue.
– – Stromal vascular fraction (SVF) and adipose-derived stem cells, harvested from the patient’s own fat tissue.

These treatments are appealing in concept. They use the patient’s own biological material, they are minimally invasive compared to surgery, and they promise regeneration rather than mere symptom management. But “appealing in concept” and “supported by clinical evidence” are not the same thing. The clinical evidence for orthobiologics is characterized by three persistent weaknesses that are directly relevant to workers’ comp claims handling.

– – First, there is no standardization. PRP is not a single product — it is a category. The concentration of platelets, the presence or absence of white blood cells (leukocyte-rich versus leukocyte-poor), the activation method, and the volume injected all vary widely between providers and even between injections at the same clinic. Two patients who both receive “PRP for knee osteoarthritis” may be getting fundamentally different treatments. This heterogeneity makes it extremely difficult to draw reliable conclusions from the published literature, because studies using different preparation protocols are being pooled together as though they were studying the same intervention.
– – Second, the high-quality evidence that does exist shows modest and often short-lived benefits. A comprehensive narrative review published in the Journal of Clinical Medicine in June 2025 found that PRP injections — particularly leukocyte-poor formulations — demonstrated some pain relief and functional improvement for mild to moderate knee osteoarthritis compared to hyaluronic acid and corticosteroids. But the improvements were inconsistent across studies, follow-up periods were generally short, and the clinical significance of the measured differences was debatable. As a Healio September 2025 editorial on orthobiologics noted, “when studied through the lens of high-level clinical evidence, the picture is less convincing of the clinical benefit.”
– – Third, and critically for workers’ comp, PRP is not FDA-approved as a drug or biologic therapy. The FDA regulates the centrifuge devices used to prepare PRP, but it does not evaluate or approve the PRP treatment itself for any specific clinical indication. Physicians use PRP off-label, meaning the safety and efficacy for any given condition have not been established through the FDA’s standard approval process. This regulatory gap creates a challenging situation for utilization review teams and bill review departments tasked with determining whether a PRP injection meets medical necessity criteria.

The AAOS Orthobiologics Registry is designed to address these evidence gaps by collecting standardized, real-world data on orthobiologic treatments as they are actually used in clinical practice, tracking preparation protocols, patient characteristics, treatment indications, and outcomes over time. The Healio editorial noted that the registry’s published attributes are more rigorous than most existing PRP literature.

This matters because the registry could, for the first time, produce the kind of large-scale, standardized outcomes data that would allow the medical community — and, by extension, workers’ comp payers, treatment guideline panels, and utilization review organizations — to determine which orthobiologic treatments work, for which conditions, using which preparation methods, and for which patients. That data does not exist today in any reliable form.

The AOSSM reinforced this priority at its 2026 Annual Meeting in Seattle (July 8-11), where the AAOS Biologics Summit returned as a full-day pre-meeting workshop co-chaired by leading researchers in the field. The summit’s explicit focus was on how biologics are transforming sports medicine — and where the evidence needs to catch up.

PRP injections typically range from $500 to $2,000 per treatment, and many protocols call for a series of two to three injections. BMAC procedures can cost significantly more. These are out-of-pocket costs in many contexts because most health insurers do not cover PRP, but in workers’ comp, where the employer or insurer is responsible for reasonable and necessary medical treatment, the question of coverage cannot be avoided.

Unlike most medical treatments, PRP and stem cell therapies are heavily marketed directly to patients. Injured workers may arrive at their treating physician’s office requesting PRP by name, based on advertising or word of mouth. This consumer-driven demand creates pressure on physicians to offer the treatment regardless of the strength of the evidence for the specific condition.

As the AAOS Orthobiologics Registry begins producing data, that data will likely influence treatment guideline updates, utilization review standards, and medical necessity determinations. Claims professionals should monitor registry publications and be prepared for the possibility that the data could cut either way — validating PRP for some conditions while undermining it for others.

Tracy Simerley worked as a seaman on a ferryboat owned by Golden Gate Bridge Highway and Transportation District (District) when he was injured on the job. Tracy and his wife, Lynette Simerley, sued the District in March 2025, alleging Tracy qualified as a “seaman” under the Jones Act (46 U.S.C.A. § 30104). The complaint asserted causes of action for Jones Act negligence, maintenance and found and cure, and unseaworthiness under general maritime law — a strict-liability theory based on the vessel, its gear, crew, or equipment being unsafe or unfit for service. Lynette’s own claim for loss of consortium was pleaded as part of the unseaworthiness cause of action.

The District demurred to Lynette’s loss of consortium claim, arguing it was unavailable under both the Jones Act and general maritime law. Citing Miles v. Apex Marine Corp. (1990) 498 U.S. 19, the District argued the Jones Act does not permit recovery of non-pecuniary damages, and citing The Dutra Group v. Batterton (2019) 588 U.S. 358, it argued loss of consortium claims are unavailable to spouses of injured seamen under general maritime law as well. The Simerleys opposed, arguing general maritime law provided a common law remedy for loss of consortium and that Atlantic Sounding Co. v. Townsend (2009) 557 U.S. 404 made clear the District’s authority did not control. The San Francisco County Superior Court sustained the demurrer without leave to amend, concluding there was no recovery for loss of consortium under the Jones Act and, applying the framework from Batterton, no such remedy for unseaworthiness claims under general maritime law either.

In the published case of Simerley et al. v. Golden Gate Bridge Highway and Transportation District, No. A173588 (Cal. Ct. App., 1st Dist., Div. 1, August 2026) — the Court of Appeal affirmed.

The U.S. Supreme Court has addressed the relationship between general maritime law remedies and federal maritime statutes in a trio of decisions — Miles, Atlantic Sounding, and Batterton — and that Batterton, the most recent, supplies the controlling three-part test: (1) whether the requested relief has traditionally been available for the particular type of claim at issue; (2) whether allowing it would be necessary to maintain uniformity with Congress’s statutory scheme; and (3) whether policy grounds independently compel the relief. The panel rejected Lynette’s argument that Batterton did not control because its reasoning rested primarily on policy grounds and was not “on point,” holding that California courts are bound by the “ratio decidendi” of U.S. Supreme Court decisions on questions of federal law, and that all three Batterton factors, not policy alone, were necessary to that decision’s holding.

On the Jones Act, the panel held the statute’s own text forecloses a loss of consortium claim regardless of Batterton, since the Act permits only “[a] seaman injured in the course of employment” (or, if the seaman dies, his personal representative) to bring a civil action — language that does not authorize a claim by the seaman’s spouse. The panel found this consistent with Batterton’s separate conclusion that the Jones Act, by incorporating the remedial provisions of the Federal Employers’ Liability Act, limits recovery to pecuniary loss, and with the uniform view of federal courts that this pecuniary limitation applies to non-fatal injury claims just as it does to wrongful death claims.

Turning to general maritime law, the panel applied Batterton’s first factor and found the historical record insufficient to establish that loss of consortium was traditionally available for unseaworthiness claims specifically. The Simerleys relied on a federal district court decision, Morgan v. Almars Outboards, Inc. (D.Del. 2018) 316 F.Supp.3d 828, and, through it, on American Export Lines, Inc. v. Alvez (1980) 446 U.S. 274 and Sea-Land Services, Inc. v. Gaudet (1974) 414 U.S. 573. The panel found each of the older cases cited either did not involve an unseaworthiness claim at all, involved a longshoreman rather than a Jones Act seaman (a distinction Miles had already limited Gaudet’s holding to), or came too late to qualify as evidence from the “formative years” of the personal injury unseaworthiness claim, the historical period Batterton requires courts to examine. Because the Simerleys failed to identify a clear historical pattern of loss of consortium recovery specifically for unseaworthiness claims, the panel held that gap was, in the words of Batterton, “practically dispositive.”

The panel likewise found the second and third Batterton factors unfavorable: because the Jones Act itself bars loss of consortium recovery, allowing it under general maritime law for the parallel unseaworthiness claim would undermine rather than promote uniformity between the two causes of action, and the Simerleys offered no independent policy argument favoring the remedy. Having found no historical support, no uniformity-based justification, and no policy grounds favoring recovery, the panel held loss of consortium is unavailable under general maritime law for personal injury unseaworthiness claims brought by a Jones Act seaman’s spouse, affirmed the judgment, and did not reach the Simerleys’ separate argument that the trial court’s reliance on a different case was misplaced, since the appellate court may affirm on any ground supported by the record.

Silvia Morales worked for San Diego Gas & Electric Company (SDG&E) for nearly 20 years, hired in September 2005 as a Human Resources Coordinator. When she was hired, Morales signed an offer letter and a formal acceptance, both stating her employment was “at-will” and both containing an arbitration clause covering “[a]ny dispute regarding any aspect of this letter of agreement or any action that allegedly violates any provision of this agreement.” About a week later, as a non-negotiable condition of employment, SDG&E had her sign a separate nine-page Employment, Confidential Information, and Invention Assignment Agreement containing nearly identical language, requiring arbitration of “[a]ny dispute regarding any aspect of this Agreement or any act which allegedly has or would violate any provision of this Agreement.” That later Agreement contained an integration clause stating it was “the entire Agreement and understanding” between the parties “relating to the subject matter herein” and that it “merges all prior discussions.”

In September 2024, SDG&E terminated Morales, citing a loss of confidence in her ability to work productively with leadership. Morales sued in January 2025, alleging disability discrimination, failure to accommodate, failure to engage in the interactive process, and retaliation under California’s Fair Employment and Housing Act (FEHA; Gov. Code, § 12900 et seq.) and the California Family Rights Act (CFRA; Gov. Code, § 12945.2), and asserting those statutory violations as the basis for a common law claim that she was terminated in violation of public policy under Tameny v. Atlantic Richfield Co. (1980) 27 Cal.3d 167.

SDG&E moved to compel arbitration, arguing the parties had agreed to arbitrate “all employment-related disputes” arising from Morales’s employment. The San Diego County Superior Court granted the motion. Although it acknowledged the Agreement was a contract of adhesion, the court reasoned that because the Agreement characterized Morales’s employment as “at-will,” any claim invoking a recognized exception to at-will employment — including her statutory and Tameny claims — necessarily concerned “an aspect of” the Agreement and so fell within the arbitration clause. Morales petitioned for a writ of mandate, and the Court of Appeal issued an order to show cause.

In the published case of Morales v. The Superior Court of San Diego County, No. D087448 (August, 2026) — the Court of Appeal granted Morales’s petition, directing the trial court to vacate its order compelling arbitration and enter a new order denying SDG&E’s motion.

The unanimous panel first resolved which document controlled. Because the later-signed Agreement contained an integration clause limited to “the subject matter herein,” the court held it was a partial integration that superseded the earlier offer and acceptance letters specifically as to arbitration, even though it left other employment terms like compensation untouched.

Turning to the Agreement’s arbitration language itself, the panel distinguished it from the broad, frequently enforced arbitration clauses covering any dispute “arising from, related to, or having any relationship or connection whatsoever with” a plaintiff’s employment, of the kind at issue in Sandquist v. Lebo Automotive, Inc. (2016) 1 Cal.5th 233 and Little v. Auto Stiegler, Inc. (2003) 29 Cal.4th 1064, as well as the recently decided Fuentes v. Empire Nissan, Inc. (2026) 19 Cal.5th 93. The Agreement here instead used narrower language, requiring arbitration only of disputes “regarding any aspect of” the Agreement or acts that would “violate” it — wording the court found comparable to other agreements California courts have construed narrowly, limited to disputes over the interpretation or performance of the contract itself rather than every dispute connected to the employment relationship generally.

Applying that narrower scope, the panel held Morales’s FEHA, CFRA, and Tameny claims did not concern “any aspect of” the Agreement and did not allege any “violation” of it. Her claims rested entirely on statutory protections and public policy limitations on at-will employment that exist independently of, and are not created by, the parties’ contract, citing Green v. Ralee Engineering Co. (1998) 19 Cal.4th 66 and Gantt v. Sentry Insurance (1992) 1 Cal.4th 1083. Morales did not dispute that the Agreement classified her as an at-will employee; she instead invoked recognized statutory and public-policy exceptions to that at-will status, claims the court found had “nothing to do with” the Agreement’s own terms. The panel noted SDG&E could easily have drafted broader language tying arbitration to Morales’s employment generally, as the employers in Fuentes and comparable cases had done, but did not do so here.

The panel further held that even if the clause’s scope were considered ambiguous, that ambiguity would not favor SDG&E. While California law generally favors arbitration, courts cannot compel arbitration of disputes the parties did not actually agree to arbitrate, citing Engalla v. Permanente Medical Group, Inc. (1997) 15 Cal.4th 951, and any ambiguity in an employer-drafted adhesion contract must be construed against the drafting employer, citing Sandquist. The court found it particularly unreasonable to expect a newly hired, legally unsophisticated employee, handed a stack of required paperwork, to anticipate that language limited to disputes over an “aspect” of the Agreement would reach statutory discrimination and public-policy wrongful-termination claims entirely independent of the contract. Having concluded the arbitration clause did not apply on its own terms, the panel found it unnecessary to reach Morales’s alternative arguments for unenforceability, granted the petition, and directed entry of a new order denying arbitration, with costs to Morales.

Nathaniel Partridge, a California Highway Patrol (CHP) officer since 2006 assigned to the East Los Angeles office, regularly worked overtime shifts through the Maintenance Zone Enhanced Enforcement Program (MAZEEP), under which Caltrans reimburses the CHP for traffic-enforcement services on highway maintenance projects. Under a standard operating procedure the office adopted in 2012, an officer released early from a MAZEEP detail could still be paid for the full scheduled shift, but only if the officer remained on standby at the station rather than going home. Partridge knew the policy but believed, based on common office practice and a since-retired lieutenant’s own understanding, that going home after early release was tolerated as long as an officer could return if called back.

On September 17, 2017, Partridge’s MAZEEP assignment ended at 10:20 a.m., roughly four hours before its scheduled 2:30 p.m. end time. Partridge returned his patrol vehicle, changed out of uniform, and drove the 35 miles to his home rather than remaining at the station. He was never called back. He nonetheless submitted time records claiming the full 10 hours of scheduled overtime, receiving $288.98 in pay for roughly three hours and 45 minutes he had not worked or remained available for. A 2019 MAZEEP program audit also found that on eight separate occasions in 2017 and 2018, Partridge had failed to record the time he returned his patrol vehicle on a separate vehicle-checkout form, though the CHP’s own investigation did not tie those omissions to any additional false overtime claims. Partridge admitted the September 2017 conduct during the investigation, telling investigators, “I took the chance to go home and would fall on the consequence if I was called back.”

The CHP dismissed Partridge in February 2020 for inexcusable neglect of duty, dishonesty, misuse of state property, violating the state’s incompatible-activities statute, and other failure of good behavior, all grounds for discipline under Government Code section 19572. Partridge appealed to the State Personnel Board (SPB). An administrative law judge (ALJ) found Partridge’s incomplete vehicle forms constituted inexcusable neglect of duty, but credited Partridge’s testimony that he did not intend to deceive the CHP about his September 2017 overtime claim, dismissed the remaining charges, and reduced the penalty to a one-month suspension. The SPB itself rejected the ALJ’s credibility findings on the dishonesty question, concluding Partridge knowingly claimed pay for hours he had not worked and was not entitled to, and sustained all the charged grounds for discipline. Applying the multi-factor test from Skelly v. State Personnel Board for assessing an appropriate penalty, however, the SPB found dismissal disproportionate given the isolated nature of the incident and Partridge’s 16 years of discipline-free service, and imposed a one-year unpaid suspension instead.

The CHP petitioned the Los Angeles County Superior Court for a writ of mandate under Code of Civil Procedure section 1094.5, seeking to vacate the SPB’s penalty and reinstate the dismissal. The trial court denied the petition, finding the SPB had not abused its discretion in concluding that a single, if serious, act of dishonesty did not necessarily establish a propensity for future dishonesty warranting termination. The CHP appealed.

In the published case of California Highway Patrol v. California State Personnel Board, No. B336135 (Cal. Ct. App., 2d Dist., Div. 8, August 2026) — the Court of Appeal affirmed the trial court’s judgment denying the CHP’s petition for writ of mandate. This opinion was originally filed on July 29, 2026 and was not initially certified for publication; on August 5, 2026, the Second Appellate District, Division Eight, ordered it published in the Official Reports with no change in the judgment. It is now citable authority.

Writing for a unanimous panel, Presiding Justice Stratton explained that a court reviewing an administrative agency’s choice of penalty may not substitute its own judgment for the agency’s, and may disturb the penalty only in the exceptional case where reasonable minds could not differ on the appropriate discipline, citing Skelly v. State Personnel Board (1975) 15 Cal.3d 194 and Cate v. State Personnel Board (2012) 204 Cal.App.4th 270. The panel rejected the CHP’s central argument that Partridge’s dishonesty alone mandated dismissal as a matter of law, explaining that while termination is an available and often appropriate penalty for employee dishonesty, no California authority requires it in every case. The court distinguished Kolender v. San Diego County Civil Service Commission (2005) 132 Cal.App.4th 716, which the CHP relied on for the proposition that dishonesty reflects an ongoing character trait rather than an isolated event, on its facts: the officer in Kolender had lied to cover up a fellow deputy’s physical abuse of a jail inmate and maintained that lie until investigators independently uncovered it, conduct the panel found categorically different from Partridge’s single, ultimately admitted overtime claim.

The panel likewise rejected the CHP’s argument that the SPB improperly minimized Partridge’s misconduct by comparing it to other officers dismissed for more extensive, repeated MAZEEP overtime fraud. The court explained the SPB used those comparisons only to illustrate why Partridge’s isolated incident did not itself establish a disposition toward dishonesty, not to suggest that repeat offenders set the baseline for termination. The panel found the SPB’s broader weighing of the Skelly factors — harm to public service, the circumstances of the misconduct, and the likelihood of recurrence — was well within its discretion, noting Partridge’s clean 16-year disciplinary record and positive performance history were legitimate considerations, not, as the CHP argued, an improper attempt to offset dishonesty against unrelated good conduct. The court found no fault in the SPB’s related conclusion that Partridge’s separate failures to log his patrol vehicle’s return time on eight occasions reflected carelessness rather than a deliberate scheme to conceal his early departures, since overtime pay was calculated from a different form entirely and none of the omissions was tied to an actual false claim.

The panel also addressed, and rejected, the CHP’s suggestion that upholding the SPB’s decision would perversely reward officers who limit the scope of their misconduct relative to more egregious violators. The court held this policy argument did not establish an abuse of discretion in the specific penalty selected here, citing County of Siskiyou v. State Personnel Board (2010) 188 Cal.App.4th 1606, which likewise held dismissal is not required in every dishonesty case. The panel acknowledged the trial court’s separate observation that Partridge’s dishonesty finding will follow him for the remainder of his career under Brady v. Maryland (1963) 373 U.S. 83, requiring disclosure to defense counsel in any future case where he is a witness, but agreed that consequence did not by itself compel dismissal rather than a severe suspension. Concluding that reasonable minds could differ — and, indeed, had differed, given the ALJ’s initial one-month recommendation, the SPB’s ultimate one-year suspension, and the CHP’s request for outright dismissal — the panel held this was not the exceptional case warranting judicial override of the agency’s chosen penalty, and affirmed the judgment, awarding costs on appeal to the SPB and Partridge.

Gilead Sciences, Inc. developed tenofovir disoproxil fumarate (TDF), an HIV antiretroviral medication marketed as Viread and used in numerous combination HIV therapies, obtaining FDA approval in October 2001. While TDF was still in trials, Gilead began investigating a related compound, tenofovir alafenamide fumarate (TAF), as a possible backup. A brief 2001 phase I/II trial — 30 subjects over two weeks — suggested TAF could match TDF’s antiviral effect at a much lower dose, potentially with less kidney, bone, and tooth toxicity. In 2004, Gilead announced it was discontinuing TAF development, stating TAF’s profile did not appear meaningfully different from TDF’s. Plaintiffs, a large group of TDF users who allege they developed renal, bone, or tooth injuries from the drug, contend Gilead’s stated reason was pretextual and that Gilead actually shelved TAF to protect TDF sales and later timed TAF’s eventual release to extend patent-driven profits across both drugs. Gilead disputes that it knew TAF was safer at the time and says it resumed TAF development in 2010 to address bone and kidney concerns in an aging HIV population, ultimately winning FDA approval for TAF in November 2015. Plaintiffs do not contend TDF itself is defective, and they acknowledge some patients still prefer TDF to TAF; their theory is that Gilead’s delay in developing and commercializing TAF was itself negligent and caused their injuries.

By the time Gilead moved for summary judgment, only negligence and fraudulent concealment claims remained. The San Francisco County Superior Court denied summary judgment on both. Gilead petitioned for a writ of mandate, and the Court of Appeal granted the petition as to the fraudulent concealment claim but left the negligence claim intact, holding in a published 2024 decision that a drug manufacturer’s duty of reasonable care can, in some circumstances, extend beyond the duty to avoid marketing a defective product — specifically, that a manufacturer who has invented a drug it knows to be safer and at least equally effective than one it is currently selling may owe a duty of reasonable care regarding when to commercialize it. (Gilead Tenofovir Cases (2024) 98 Cal.App.5th 911.) The Court of Appeal further held the foreseeability and public-policy factors from Rowland v. Christian did not support an exception to that duty on the record before it.

In the case of Gilead Tenofovir Cases, No. S283862 (Cal. Sup. Ct., August 2026) — the California Supreme Court reversed the judgment of the Court of Appeal and remanded with directions to grant summary judgment for Gilead on all remaining causes of action. Chief Justice Guerrero and Justice Kruger (joined by Justices Corrigan and Desautels) each filed separate concurring opinions; Justice Evans filed a dissent

Writing for the majority, Justice Groban expressed “significant doubt” that California law recognizes a manufacturer’s negligence duty independent of a product defect at all, noting decades of precedent tying a manufacturer’s duty under Civil Code section 1714 to the duty to design, manufacture, and market products free from defects, citing Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465. But the majority found it unnecessary to resolve that threshold question. Even assuming a broader duty could exist, the Court held that the foreseeability and public-policy factors from Rowland v. Christian (1968) 69 Cal.2d 108 compel an exception to it here, applied “categorically” rather than to Gilead’s specific case, consistent with Kuciemba v. Victory Woodworks, Inc. (2023) 14 Cal.5th 993.

On foreseeability, the majority held a manufacturer generally cannot reliably know, based only on early-phase clinical data, that an alternative drug is in fact safer than and as effective as an existing one; the Food, Drug, and Cosmetic Act itself generally requires two adequate, well-controlled studies (typically phase III trials) before FDA approval, and only about 25 to 30 percent of drugs that reach phase III succeed. Because that comparative knowledge is essentially unattainable during the early development stages at issue here, the Court held harm to existing-drug users was not reasonably foreseeable from a decision to pause a still-unproven alternative, and separately found the causal chain from that decision to any eventual injury too attenuated, given the intervening, independent, and uncertain decisions of regulators, physicians, and patients that stand between a development decision and any patient’s actual treatment.

On the public-policy factors, the majority found moral blame difficult to assess categorically, since manufacturers may delay developing a backup drug for many morally neutral reasons, including allocating resources toward diseases with no existing treatment; found the policy of preventing future harm cut both ways, since a duty could speed development of safer alternatives but could equally distort research priorities, discourage manufacturers from investigating backup candidates at all, or push manufacturers to delay releasing improved drugs until every conceivable alternative has been fully vetted; and found the burden on manufacturers substantial, since phase III trials alone can cost tens of millions of dollars and take years, with no guarantee of eventual approval. The Court noted Gilead’s own estimate that completing TAF’s remaining development would cost roughly $100 million. Taken together, the majority held drug manufacturers owe no duty of care, when deciding whether and when to develop and commercialize an allegedly safer alternative, to users of a current, concededly nondefective drug — while emphasizing the ruling does not immunize manufacturers from ordinary defect, failure-to-warn, or fraud-based claims.

Chief Justice Guerrero concurred in the result but not the reasoning, arguing the majority should not have assumed a broader duty of care exists at all. In her view, decades of settled products liability law establish that a defect is an essential element of any negligence claim against a manufacturer, citing Jiminez v. Sears, Roebuck & Co. (1971) 4 Cal.3d 379, and because plaintiffs expressly disclaimed any allegation that TDF was defective, their claim should have failed on that threshold ground without needing to reach Rowland’s foreseeability or policy factors at all. Justice Kruger, joined by Justices Corrigan and Desautels, separately concurred to elaborate on aspects of the majority’s Rowland analysis. Justice Evans dissented, arguing the majority’s application of Rowland effectively guaranteed the outcome by treating the manufacturer’s own alleged profit motive and superior knowledge as insufficient to establish moral blame, and characterizing the majority’s holding as granting drug manufacturers sweeping immunity from liability for delay-driven development decisions.