Menu Close

Unless Open & Obvious, Injured Worker Must Request Accommodations

Yukio Taira began working for Honeywell International, Inc. in November 2011. On May 14, 2015, Taira was on a flight to a trade show in Georgia when he suffered a “catastrophic stroke.” The flight was diverted and Taira was taken by ambulance to a hospital.

On June 29, 2015, Taira filed two applications for workers’ compensation benefits. One case listed a specific date of injury (May 14, 2015) – the date of his stroke. The other case listed an injury date of November 1, 2011, through May 14, 2015, the entire duration of Taira’s employment with Honeywell.

On September 11, 2018, Taira entered into a partial settlement agreement of $1,125,000 regarding both workers’ compensation cases. In October 2023, he settled the remaining issues in his cases for an additional $6 million, and the Workers’ Compensation Appeal Board approved that settlement.

On September 6, 2018, Taira filed a lawsuit alleging that Honeywell violated the Fair Employment and Housing Act (FEHA) by failing to provide him an accommodation for his disability (Gov. Code, § 12940, subd. (m))1 and failing to engage in the interactive process (§ 12940, subd. (n)). The third amended complaint, which is the operative pleading, alleges FEHA claims against Honeywell for failure to provide a reasonable accommodation (§ 12940, subd. (m)) and failure to engage in the interactive process (§ 12940, subd. (n)).

On June 16, 2022, Honeywell filed its motion for summary judgment which the trial court granted. Because the undisputed evidence establishes that Taira never requested a reasonable accommodation, the Court of Appeal affirmed the judgment in the unpublished case of Taira v. Honeywell International -B328410 (February 2025).

At issue in this appeal is only the question of whether Honeywell failed to reasonably accommodate Taira’s assumed disability.

“‘[I]t is important to distinguish between an employer’s knowledge of an employee’s disability versus an employer’s knowledge of any limitations experienced by the employee as a result of the disability.’” (Scotch, supra, 173 Cal.App.4th at p. 1013.) Thus, FEHA “requires an employer to accommodate only a ‘known physical . . . disability.’” (Avila v. Continental Airlines, Inc. (2008) 165 Cal.App.4th 1237, 1252.) “‘“Vague or conclusory statements revealing an unspecified incapacity are not sufficient to put an employer on notice of its obligations under the [FEHA].”’” (Featherstone v. Southern California Permanente Medical Group (2017) 10 Cal.App.5th 1150, 1167 (Featherstone).)

And, “the employee must request an accommodation.” (Gelfo, supra, 140 Cal.App.4th at p. 54.) “‘“Where the disability, resulting limitations, and necessary reasonable accommodations, are not open, obvious, and apparent to the employer,”’” the employee bears the burden “‘“to specifically identify the disability and resulting limitations, and to suggest the reasonable accommodations.”’” (Doe v. Department of Corrections & Rehabilitation (2019) 43 Cal.App.5th 721,738–739; see also Spitzer v. Good Guys, Inc. (2000) 80 Cal.App.4th 1376, 1378; Raine v. City of Burbank (2006) 135 Cal.App.4th 1215, 1222 (Raine).)

In other words, “[a]n employee cannot demand clairvoyance of his employer. [Citation.] ‘“[T]he employee can’t expect the employer to read his mind and know he secretly wanted a particular accommodation and sue the employer for not providing it. . . .”’ ‘It is an employee’s responsibility to understand his or her own physical or mental condition well enough to present the employer at the earliest opportunity with a concise list of restrictions which must be met to accommodate the employee.’ [Citation.]” (King v. United Parcel Service, Inc. (2007) 152 Cal.App.4th 426, 443 (King).)

There is no evidence that Taira informed Honeywell of specific work restrictions as a result of his disability or that he requested a reasonable accommodation. (See, e.g., Arteaga v. Brink’s, Inc. (2008) 163 Cal.App.4th 327, 349 [affirming summary judgment to the employer because although it learned of the plaintiff’s symptoms, “those symptoms did not interfere with the performance of his job”]; King, supra, 152 Cal.App.4th at p. 444 [given the plaintiff’s apparent ability to get the job done, “it was incumbent upon him to produce clear and unambiguous doctor’s orders restricting the hours he could work”].) Thus, Taira’s claim under section 12940, subdivision (m), fails.

For the same reason, Taira’s claim under section 12940, subdivision (n), fails. It is undisputed that Taira did not identify a specific, available reasonable accommodation while working at Honeywell. Absent this evidence, Honeywell is entitled to judgment.

The fact that Taira may have reported his medical symptoms to both Ocello and a member of the human resources team does not change the conclusion. While he may have made such reports, he did not request a reasonable accommodation for those symptoms. There was nothing “open, obvious, and apparent” to Honeywell about what limitations were required for those symptoms.

And his complaint about understaffing does not constitute a reasonable request to accommodate a disability. (See, e.g., Nadaf-Rahrov, supra, 166 Cal.App.4th at pp. 975–976.)

Cal/OSHA Guidance During Wildfire Cleanup and Recovery

In response to the ongoing wildfire recovery efforts, the Department of Industrial Relations (DIR) has posted guidance for employers and workers on how to proceed rapidly and safely as they navigate the risks associated with fire debris removal and cleanup.

Even after fires are extinguished, hazardous conditions persist. Employers involved in recovery operations within fire-damaged areas must assess these risks, address unsafe conditions, and ensure proper training is provided to all workers.

DIR is committed to protecting workers on the frontlines of disaster recovery, ensuring their safety and health as they help restore what has been lost.

DIR offers extensive information about worker health including a wildfire cleanup training tool in English and Spanish. Additional resources include information on:

Health and safety protections:

– – Physical hazards: Information is available regarding the risks of structural collapse or contact with live utilities.
– – Hazard Communication: Informing and training workers about chemical hazards from burned buildings, such as fire retardants, lead or asbestos, and other hazardous materials.
– – Cleanup, Debris Removal, and Restoration: Cal/OSHA provides guidance to employers and workers regarding proper training and equipment for safely handling debris during the cleanup of contaminated areas. Cleanup of fire damaged sites and debris removal must be done in accordance with title 8 section 5192 Hazardous Waste Operations and Emergency Response.

Wage and retaliation protections:

Workers have special rights during emergency conditions, including safety, evacuation, communication – such as access to cell phones – time off, and pay, including potential disability benefits. The Labor Commissioner’s Office (LCO) educates employers and workers about these rights, supporting compliance with relevant laws and regulations.

The LCO provides information on workers’ rights with respect to:

Protections During Emergency Conditions: Information on workers’ rights in hazardous situations, including safety measures and employer responsibilities.

– – Retaliation Protections: Safeguards for workers engaging in protected activities, such as raising health and safety concerns, refusing unsafe work, or serving as volunteer firefighters.
– – Immigration-Related Retaliation: Protections against employer retaliation based on a worker’s immigration status.
– – Wage and Overtime Regulations: Guidance on wages, overtime laws, and employer obligations.
– – Public Works: Information on labor laws specific to public works projects and prevailing wage requirements.
– – Filing Wage and Retaliation Claims: Instructions on how workers can file claims for unpaid wages or retaliation.
– – Reporting Labor Law Violations: Steps for workers to report labor law violations and seek enforcement action.

Workers in California are protected regardless of immigration status. Workers who have questions about safety and health in the workplace can call 833-579-0927 to speak with a live bilingual Cal/OSHA representative between the hours of 9:00 a.m. and 7:00 p.m. Monday through Friday. Workers who have questions about labor laws enforced by the LCO can call 1-833-LCO-INFO (833-526-4636) between the hours of 8:00 a.m. to 5:00 p.m. Monday through Friday. Complaints about workplace safety and health hazards can be filed confidentially with Cal/OSHA district offices

Motion to Arbitrate Needs Review of Arbitrator’s Discovery Rules

Prior to beginning his employment with Technology Credit Union (TCU) in 2020, Thomas Vo signed an employment arbitration agreement. Pursuant to the agreement, both parties agreed “to submit to mandatory binding arbitration any dispute, claim or controversy arising out of or relating to Employee’s employment with the Company.”

While employed with TCU, Vo contracted COVID-19 and developed long-term health issues, which persisted throughout his employment. Vo was eventually terminated and brought suit against TCU, alleging (1) harassment in violation of FEHA; (2) discrimination in violation of FEHA; (3) failure to accommodate in violation of FEHA; (4) failure to engage in the interactive process in violation of FEHA; (5) retaliation in violation of FEHA; (6) failure to prevent discrimination and retaliation in violation of FEHA; and (7) wrongful termination in violation of public policy.

TCU moved to compel arbitration pursuant to Code of Civil Procedure section 1281.21 and stay all proceedings. Vo opposed the motion to compel and argued the arbitration agreement was both procedurally and substantively unconscionable. The trial court, relying in part on Aixtron, Inc. v. Veeco Instruments Inc. (2020) 52 Cal.App.5th 360 (Aixtron), found the arbitration agreement unconscionable due to the arbitrator’s inability to compel prehearing third party discovery.

The Court of Appeal reversed in the published case of Vo v. Technology Credit Union -H051619 (February 2025).

TCU contends that the discovery clause does not render the agreement substantively unconscionable when evaluated under the discovery factors established in the Supreme Court’s recent decision in Ramirez v. Charter Communications, Inc. (2024) 16 Cal.5th 478 (Ramirez).

The Court of Appeal on its own motion took judicial notice of the JAMS Comprehensive Arbitration Rules and Procedures, effective July 1, 2014 (JAMS Rules). (Evid. Code, § 459.) JAMS Rule 17 controls prehearing exchange of information.

Rule 17(b) allows each party to take one deposition of an opposing party or individual under the control of the opposing party. (Ibid.) Any issues regarding the time, location, and duration of the deposition must be determined by the arbitrator. (Ibid.) It then states: “[t]he necessity of additional depositions shall be determined by the [a]rbitrator based upon the reasonable need for the requested information, the availability of other discovery options and the burdensomeness of the request on the opposing [p]arties and the witness.” (Ibid.)

Rule 17(d) gives the arbitrator the authority to decide all “dispute[s] . . . regarding discovery issues.” (Ibid.) The arbitrator may appoint a special master to help resolve a discovery dispute. (Ibid.)

Vo contends that the discovery provision renders the agreement substantively unconscionable because: (1) the agreement covers witness intensive employment claims, (2) the discovery terms completely bar third party discovery by excluding reference to the CAA and thereby eliminate an arbitrator’s authority to order prehearing third party discovery under Aixtron, (3) third party discovery is available in conventional litigation, (4) the bar on third party discovery advantages employers as plaintiffs cannot obtain information from relevant witnesses who work for the employer and other third party entities, and (5) an arbitrator has no authority to order additional discovery due to Aixtron. He also maintains that the JAMS Rules cannot allow for third party discovery because third parties do not contractually consent to such terms.

The Court of Appeal disagreed with Vo and the trial court and noted that “This language could have been more precise but does not limit expanded discovery to parties to the arbitration agreement or those under their control and does not preclude an arbitrator from making nonparty discovery available to the parties.” And it went on to say “the Supreme Court recently clarified that we should not construe discovery provisions defining the scope of an arbitrator’s authority “in . . . a limited way” and instead should select an interpretation that renders an agreement valid. (Ramirez, supra, 16 Cal.5th at pp. 506-507.) We thus disapprove of Aixtron to the extent it interpreted the scope of an arbitrator’s authority narrowly.

The Court of Appeal concluded that the agreement allows Vo access to third party discovery that may be necessary to adequately arbitrate his FEHA claims. The trial court’s order denying Technology Credit Union’s motion to compel arbitration was reversed. The trial court was directed to enter a new order granting Technology Credit Union’s motion and staying the litigation pursuant to California Code of Civil Procedure, section 1281.4.

Cal/OSHA: COVID-19 Non-Emergency Standards Expired

The California Division of Occupational Safety and Health (Cal/OSHA) is advising employers that most of its COVID-19 Prevention Non-Emergency Standards ended in February 2025. Cal/OSHA’s regulations took effect February 3, 2023, and remained in effect for two years, except for the reporting and recordkeeping requirements, which remain in effect until 2026.  

Although there is no longer a specific set of regulatory requirements relating to COVID-19 prevention in the workplace, employers in California must still: 

    Maintain a safe and healthful place of employment as required by Labor Code section 6400.
    Establish, implement, and maintain an effective Injury and Illness Prevention Program (IIPP) as required by Title 8, California Code of Regulations, section 3203. 
    Identify, evaluate, and correct any unsafe or unhealthy conditions, work practices, or work procedures associated with COVID-19 if they identify COVID-19 as a workplace hazard at their place of employment.

 COVID-19 reporting and recordkeeping requirements (Title 8 Subsection 3205(j)) remain in effect until February 3, 2026. The requirements specify that the employer:

    Keep a record of and track all COVID-19 cases with the employee’s name, contact information, occupation, location where the employee worked, the date of the last day at the workplace, and the date of the positive COVID-19 test and/or COVID-19 diagnosis.  
        These records must be retained for two years beyond the period in which the record is necessary to meet the requirements of this section.  
    Provide information on COVID-19 cases to the local health department with jurisdiction over the workplace, CDPH, Cal/OSHA, and NIOSH immediately upon request, and when required by law.

More information is available on Cal/OSHA’s webpage under Archived COVID-19 Guidance and Resources.

Employers with Questions on Requirements May Contact: InfoCons@dir.ca.gov, or call your local Cal/OSHA Consultation Office.  

First-in-Class Non-Opioid Painkiller Approved by FDA

The U.S. Food and Drug Administration just approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  

Journavx is the first drug to be approved in this new class of pain management medicines.

Pain is a common medical problem and relief of pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery. Acute pain is often treated with analgesics that may or may not contain opioids.

The FDA has long supported development of non-opioid pain treatment. As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.  

Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.

The safety profile of Journavx is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA.

There are several other promising non-opioid pain treatments currently in the pipeline seeking FDA approval such as:

– – Esketamine: Originally approved for treatment-resistant depression, esketamine is being explored for its potential in managing chronic pain.
– – Cannabidiol (CBD): Various formulations of CBD are being studied for their analgesic properties, particularly for chronic pain conditions.
– – Tanezumab: A monoclonal antibody that targets nerve growth factor (NGF), tanezumab is being evaluated for chronic pain conditions such as osteoarthritis.
– – Zynrelef (Bupivacaine and Meloxicam): This combination drug is designed to provide extended pain relief for surgical patients without the use of opioids.

These treatments represent a growing trend towards developing safer, non-addictive alternatives to traditional opioid painkillers. It’s an exciting time in pain management research!

State Farm Requests Wildfire Caused 22% Rate Increase

State Farm General Insurance Company (SFG) has formally requested emergency interim approval from California Insurance Commissioner Ricardo Lara for significant rate increases following the devastating Los Angeles wildfires. Citing the unprecedented financial impact, SFG is seeking approval for a 22% rate increase for homeowners, 15% for renters and condo owners, and 38% for rental dwelling owners, effective May 1, 2025.

In the wake of the January wildfires, State Farm has reported receiving more than 8,700 claims and has already paid out over $1 billion. The company foresees additional payouts that will further strain its financial position. The letter emphasizes the urgent need for the rate hike to maintain the company’s financial stability and ability to continue serving its nearly three million policyholders in California.

State Farm’s request is driven by the swift capital depletion exacerbated by the wildfires, and the necessity to avert potential downgrades that could impact policyholders with mortgages. SFG highlights that the rate increase will help rebuild its Policyholder Protection Fund, which has seen a significant decline over the past years, with a reported underwriting loss of over $5 billion since 2016.

The company has paused new policy issuance and non-renewals in wildfire-affected areas, stressing the need for immediate regulatory intervention to support its solvency and protect Californians’ interests. SFG warns that without the interim rate increase, it may face further downgrades and additional regulatory actions that could disrupt the insurance market in the state.

Commissioner Lara’s decision on this urgent request will have significant implications for the stability of California’s insurance landscape and the continued availability of coverage for homeowners facing increasing wildfire risks.

State Farm has had a history of requesting rate hikes in California, often citing increased risks and financial strain due to natural disasters like wildfires. In June 2023 State Farm requested a 30% rate hike for homeowners, citing financial instability and increased catastrophe claims. This request is still pending.

In March 2023 the company announced it wouldn’t renew 30,000 homeowners policies in California, but paused this process in Los Angeles County following the January 2025 wildfires.

In addition to State Farm, several other homeowner insurance carriers have also previously requested rate increases in California due to the increased risk of wildfires and other environmental factors. Some of these carriers include:

– – Allstate: Like State Farm, Allstate has paused issuing new policies in high-risk areas and has raised premiums for existing policyholders.
– – Farmers Insurance: Farmers has also scaled back offering new coverage in wildfire-prone regions and has increased rates for homeowners.
– – Liberty Mutual: Liberty Mutual has raised premiums and adjusted coverage options in response to the growing wildfire risks.
– – Travelers: Travelers has implemented rate hikes and made changes to policy terms to account for increased risks.

These companies, along with State Farm, have cited the need to align premiums with the heightened risk of wildfires and other natural disasters in California.

Several experts and officials have claimed that the recent wildfires and insurance rate hikes have triggered an insurance crisis in California. Notably, Gary Yohe, a professor at Wesleyan University, has expressed concerns about the broader financial instability that could result from the insurance challenges exacerbated by the wildfires. He mentioned that the state’s insurance market is facing unprecedented conditions, with many homeowners unable to secure coverage.

Additionally, the California Department of Insurance has acknowledged the growing issues of rising premiums, policy cancellations, and limited coverage options, which have led to a significant number of homeowners relying on the California FAIR Plan for basic fire insurance coverage

Pfizer Company Resolves Kickback Case for $60M

The California Attorney General Bonta reported a nationwide settlement agreement against Pfizer-owned Biohaven Pharmaceutical Holding Company for submitting false claims to the Medicaid program and other government healthcare programs. The settlement addresses claims that Biohaven participated in a kickback scheme from 2020 to 2022, where they provided cash and extravagant gifts to healthcare providers in return for prescribing their medication, Nurtec.

The allegations against Biohaven claimed that the company engaged in several practices to provide kickbacks to healthcare providers as follows:

– – Speaker Programs: Biohaven allegedly organized company-sponsored speaker programs where healthcare providers would give presentations about their migraine medication, Nurtec ODT. These programs were intended to promote the drug to other healthcare providers. In numerous instances, speaker events were allegedly attended by the providers’ spouses, family members, and friends, who had no educational need to attend. Also, certain providers allegedly attended multiple programs on the same topic, and received expensive meals and drinks paid for by Biohaven, without obtaining any meaningful educational benefit.
– – Remuneration: Healthcare providers who participated as speakers received honoraria payments and expensive meals at high-end restaurants. Some providers were allegedly paid tens of thousands of dollars, sometimes exceeding $100,000, for participating in these programs1.
– – Repeat Attendance: Certain providers attended multiple speaker programs on the same topic, which the government alleged provided no meaningful educational benefit.
Non-Educational Attendees: Biohaven allegedly invited individuals with no educational need to attend, such as the speakers’ spouses, family members, or friends.
– – Whistleblower Allegations: The allegations were initiated by a whistleblower, Patricia Frattasio, a former Biohaven sales representative, who reported these practices. On August 5, 2021, Frattasio filed a qui tam action in the United States District Court for the Western District of New York captioned United States of America et al., ex. rel Patricia Frattasio v. Biohaven Pharmaceuticals Holding Company Ltd., Case No. 6:2 l -CV-06539.

These actions were claimed to violate the Anti-Kickback Statute, which prohibits offering or paying anything of value to induce the referral of items or services covered by federal healthcare programs.Approximately $50.2 million of the settlement constitutes the federal portion of the recovery and approximately $9.5 million constitutes a recovery for State Medicaid programs. Ms. Frattasio will receive approximately $8.4 million as her share of the federal recovery in this case.

Pfizer has agreed to pay $59,746,277, plus interest, on behalf of Biohaven to resolve allegations that Biohaven engaged in unlawful kickback practices to encourage providers to prescribe Nurtec. That payment will be shared by the federal government and several states, including California. The State of California will receive $413,776 for its share of losses to California’s Medicaid program, Medi-Cal.

Pfizer-owned Biohaven Pharmaceutical Holding Company is headquartered in New Haven, Connecticut. Biohaven was established by a group of biopharmaceutical executives in 2013 with a vision to develop innovative treatments for neurological diseases. The company focused on research and development, targeting conditions such as Alzheimer’s disease, migraine, and anxiety disorders. Pfizer announced its intention to acquire Biohaven in 2022 for approximately $11.6 billion. The acquisition included Biohaven’s breakthrough calcitonin gene-related peptide (CGRP) portfolio, including Nurtec ODT, a migraine therapy.

In a statement, Pfizer emphasized that the settlement relates to conduct that occurred before Pfizer’s acquisition of Biohaven in October 2022. They also mentioned that they are pleased to resolve this legacy matter so they can continue focusing on patient needs. Pfizer promptly terminated the speaker programs once the acquisition was completed, which may have contributed to the favorable terms of the settlement.

The claims resolved by the settlement are allegations only and there has been no determination of liability.

QOL Medical Resolves Specialty Drug Kickback Case for $47M

The California Attorney General also announced a settlement against pharmaceutical manufacturer QOL Medical (“QOL”) and Frederick E. Cooper, the company’s Chief Executive Officer for submitting false claims to the Medicaid program and other government healthcare programs.

QOL Medical is headquartered in Vero Beach, Florida and is a privately held Delaware limited liability company. Cooper, an individual residing in Nashville, Tennessee, has served as QOL’s Chief Executive Officer since 2010; he holds a substantial indirect ownership stake in QOL.

QOL is is a specialty biopharmaceutical company. They focus on the acquisition and commercialization of orphan products in underserved markets. QOL Medical markets two FDA-approved products: Sucraid® (sacrosidase) Oral Solution: Used for the treatment of congenital sucrase-isomaltase deficiency (CSID). And Ethamolin® (Ethanolamine Oleate) Injection, 5%: Used for the treatment of esophageal varices.

The settlement resolves allegations that QOL engaged in a kickback scheme between 2018 and 2022, by providing free Carbon-13 (“C13”) test kits to providers then using the test results to sell their drug, Sucraid. This resulted in some patients taking Sucraid even though it wasn’t medically necessary.

As a part of the settlement, QOL and Cooper, will pay a total of $47 million to resolve federal and state violations of various fraud and kickback statutes, with the State of California receiving $384,406.

The settlement resolves allegations that QOL paid remuneration to induce the purchase of Sucraid, a drug that treats the symptoms associated with sucrose ingestion in patients with a rare gastrointestinal genetic disease called congenital sucrase-isomaltase deficiency (CSID). This is an alleged violation of the Anti-Kickback Statute, the federal False Claims Act and state law False Claims Act corollary statutes.

QOL admitted that beginning in 2018, it distributed free C13 test kits to health care providers and asked them to give these kits to their patients with common gastrointestinal symptoms. They claimed that the C13 test could “rule in or rule out” CSID, for which Sucraid is the only FDA-approved therapy.

QOL paid a clinical laboratory to analyze patients’ C13 tests and received aggregate weekly results, which its commercial team used to find potential Sucraid patients.

Between 2018 and 2022, QOL paid the laboratory for over 75,000 C13 tests and disseminated the results to the QOL sales force, so that the sales force would make Sucraid sales calls to health care providers whose patients had positive C13 test results. This conduct allegedly caused the submission of false claims to both Medicare and Medicaid, including California’s Medicaid program, Medi-Cal.

Whistleblowers filed a qui tam action in the United States District Court for the District of Massachusetts, captioned United States of America., ex rel. John Doe 1, et al. v. QOL Medical, LLC, et al., Civil Action No. 1:20-cv- 11243-AK (D. Mass.).

FTC Releases New Report – PBMs Markup Generics by 1000%

The FTC commissioners voted unanimously this month to publish a second report which makes similar critical allegations against the controversial drug middlemen known as Pharmacy Benefit Managers or PBMs, as did the agency’s first report released last summer. This second report, titled “Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers,” was released to the public on January 14, 2025.

According to the FTC prescription drugs represent a large and growing amount of healthcare spending – increasing from $393 billion in 2016 to $600 billion in 2023. While traditional drugs dispensed through retail and mail order pharmacies account for much of this spending, a disproportionate share of the growth has come from spending on a class of drugs known as specialty drugs, which more than doubled from $113 billion in 2016 to $237 billion in 2023.2

Historically, specialty drugs were characterized by their need for special handling and administration. This is no longer necessarily the case. There is no standard definition for a specialty drug, and today specialty drugs may be characterized by variety of factors, including their high cost.

The First Interim Staff Report provided an overview of the vertically integrated and highly concentrated markets in which pharmacy benefit managers (“PBMs”) operate and highlighted the increasing importance of specialty drugs to the three largest PBMs, Caremark Rx, LLC (“CVS”), Express Scripts, Inc. (“ESI”), and OptumRx, Inc. (“OptumRx”) (collectively the “Big 3 PBMs”) and their affiliated pharmacies. Among many other findings, the First Interim Staff Report showed:

– – Pharmacies affiliated with the Big 3 PBMs received 68% of the dispensing revenue generated by specialty drugs in 2023, up from 54% in 2016.6
– – The Big 3 PBMs marked up two specialty generic cancer drugs by thousands of percent and then paid their affiliated pharmacies hundreds of millions of dollars of dispensing revenue in excess of estimated acquisition costs for each drug annually.

Two months after this first report, the FTC sued Caremark, Express Scripts and Optum Rx.The lawsuit, filed in September 2024 is ongoing and alleges that these pharmacy benefit managers engaged in anticompetitive and unfair rebating practices that artificially inflated the list price of insulin drugs. The case is currently being overseen by Chief Administrative Law Judge D. Michael Chappell.

Cigna’s Express Scripts filed a countersuit against the FTC calling the report “unfair, biased, erroneous, and defamatory.” We don’t take this step lightly, but … we cannot let the FTC’s unlawful actions and false information stand,” Andrea Nelson, Cigna’s chief legal officer, said in a statement.

Yet “the FTC stands by our study,” said Douglas Farrar, a spokesperson for the agency, in a statement. “This is a complicated and opaque market, and the FTC is committed to using its clear authority to help the public and policymakers understand it.”

Express Scripts, which Cigna acquired for $67 billion six years ago, brought in $26.6 billion in revenue in the second quarter – 44% of Cigna’s entire topline.

This new January 2025 staff report relies on additional data and documents to analyze a broader subset of specialty generic drugs and expands on FTC staff’s initial findings regarding specialty drugs published in the  July 2024 staff report.Key findings in this January 2025 staff report include:

– – The Big 3 PBMs marked up numerous specialty generic drugs dispensed at their affiliated pharmacies by thousands of percent, and many others by hundreds of percent.
– – A larger share of commercial prescriptions for the most profitable specialty generic drugs were dispensed by the Big 3 PBMs’ affiliated pharmacies compared with unaffiliated pharmacies.
– – The Big 3 PBMs’ affiliated pharmacies generated over $7.3 billion of dispensing revenue in excess of NADAC on specialty generic drugs over the study period.
– – In the aggregate, the Big 3 PBMs also generated significant income on the specialty generic drugs assessed in this report from spread pricing – i.e., billing their plan sponsor clients more than they reimburse pharmacies for drugs.
– – The top specialty generic drugs accounted for a significant share of the relevant business segments reported by the Big 3 PBMs’ parent healthcare conglomerates.
– – Plan sponsor expenditures and patient cost sharing on specialty generic drugs increased at double-digit compound annual growth rates during the study period.

These results illustrate the increasing financial importance of specialty generic drugs to the Big 3 PBMs, as well as to plan sponsors and patients. The results also reveal that the two case study drugs analyzed in its First Interim Staff Report were not isolated examples. This report confirms that the Big 3 PBMs impose significant markups on a wide array of specialty generic drugs.

The California Attorney General has filed litigation against drug manufacturers Eli Lilly, Novo Nordisk, and Sanofi, along with major PBMs CVS Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx for allegedly leveraging their market power to overcharge patients for insulin.

AI Assisted Electrocardiogram Detects Cognitive Decline

The heart and brain are reciprocally linked in a 2-way connection whereby the heart provides oxygen and nutrients to sustain the brain, and the brain in return provides autonomic nervous system control to the heart. This synergism is vital to the maintenance of brain and bodily health.

Electrocardiogram tests may someday be used with an artificial intelligence (AI) model to detect premature aging and cognitive decline, according to a preliminary study to be presented at the American Stroke Association’s International Stroke Conference 2025.

The meeting is in Los Angeles, Feb. 5-7, 2025, and is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

Stroke can contribute to age-related cognitive decline, affecting quality of life and functioning. An electrocardiogram (ECG) measures the electrical activity of the heartbeat. With each beat, an electrical impulse (or “wave”) travels through the heart. Researchers designed an AI model, termed deep neural network (DNN), to predict people’s biological age (age of body cells and tissues) from their ECG data.

“Unlike chronological age, which is based on years lived, ECG-age reflects the functional status of the heart and potentially the entire organism at the tissue level, providing insights into aging and health status,” said Bernard Ofosuhene, B.A., lead author of the study and clinical research coordinator in the department of medicine at the UMass Chan Medical School in Worcester, Massachusetts.

Previous research has found that ECG-age can help predict heart disease and death. Before this new study, little was known about ECG-age’s relationship to cognitive impairment.

Researchers analyzed data from more than 63,000 participants in the UK Biobank, a large and ongoing study of more than 500,000 volunteers from the United Kingdom who enrolled when they were between 40 and 69 years old. Participants underwent a battery of cognitive tests. Cognitive performance was analyzed during assessment visits to align with the timing of ECG testing and the artificial intelligence model was used to determine their ECG-age. This approach ensured that the cognitive data accurately captured the participants’ cognitive status at the same time their ECG age was estimated.

Based on the ECG-age results in comparison to their actual ages, participants were divided into three groups: normal aging, accelerated ECG-aging (older than their chronological age), and decelerated ECG-aging (younger than their chronological age).

The analysis found that compared with the normal aging group, based on ECG-age, those:

– – younger than their chronological age group performed better on 6 of 8 cognitive tests.
– – older than their chronological age group performed worse on 6 of 8 cognitive tests.

Researchers increasingly recognize the strong connection between heart and brain health. This study shows that when AI analyzes ECG data, a higher biological age is linked to poorer cognitive performance. Using ECG data to assess cognitive ability seems like a futuristic idea. If this study is validated, it could have several important outcomes.

For instance, ECG data collected in a doctor’s office or remotely with wearables could help assess cognition at home or in rural areas lacking neuropsychiatric specialists. Additionally, using ECG data and AI might be quicker and more objective than traditional neuropsychological assessments.

However, one important question remains: can ECG data predict future cognitive decline? Answering this could lead to valuable treatments since some ECG issues can be fixed,” said Fernando D. Testai, M.D., Ph.D., FAHA, chair of the October 2024 American Heart Association scientific statement Cardiac Contributions to Brain Health and professor of neurology and rehabilitation at the University of Illinois College of Medicine in Chicago. Testai was not involved in the study.