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JAMA Publishes Study of Traditional Chinese Medicine Compound

A traditional Chinese medicine compound used for cardiac benefits might help reduce the incidence of major adverse cardiac and cerebrovascular events and even cardiac death rates, according to a new study published in the Journal of the American Medical Association.

Tongxinluo, a traditional Chinese medicine compound, has shown promise in in vitro, animal, and small human studies for myocardial infarction, but has not been rigorously evaluated in large randomized clinical trials. So a group of researchers set out to investigate whether Tongxinluo could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).

Tongxinluo in Chinese means “to open (tong) the network (luo) of the heart (xin),” The compound, consists of a mixture of powders and extracts derived from plants, centipedes, cicada, and other sources. It has been approved in China for the treatment of angina and stroke since 1996. The product may be purchased online as a dietary supplement.

A randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.

Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months (a loading dose of 2.08 g after randomization, followed by the maintenance dose of 1.04 g, 3 times a day), in addition to STEMI guideline-directed treatments. Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis.

In patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. But the authors caution that further research is needed to determine the mechanism of action of Tongxinluo in STEMI.

This current study is consistent with smaller studies that essentially came to the same conclusion. In a 2006 published study, authors systematically reviewed evidence from 18 randomised controlled trials for the benefit of tongxinluo with or without other treatments, including routine care or placebo, for patients with unstable angina.

All the trials were conducted in China. The total number of participants was 1413, ranging in age from 25 to 88 years. Most studies randomized patients to receive tongxinluo with conventional medication or conventional medications alone.

The evidence suggested possible benefits relating to a range of outcomes among patients with unstable angina but all the studies were of poor quality and neither blinding nor allocation concealment were used. This makes it impossible to reach firm conclusions about the benefit of this treatment. Thus, in 2006 the authors concluded “Large, high quality, randomized controlled trials are needed to confirm the possible benefit of tongxinluo for unstable angina and to suggest appropriate future use of this herbal medicine.

The editorialist, Richard Bach evaluated the work with a note of skepticism. In his Editorial, Bach raises questions that “underscore lingering uncertainties about the trial results and the use of Tongxinluo outside of China.” But he also notes that the malaria drug artemisinin was isolated from a traditional Chinese medicine, and this research was later awarded the Nobel Prize in Physiology or Medicine.

The 2015 Nobel Prize in Physiology or Medicine was awarded to Professor Youyou Tu for her key contributions to the discovery of artemisinin. Artemisinin has saved millions of lives and represents one of the significant contributions of China to global health. Many scientists were involved in the previously unknown 523 Project, and the Nobel Prize given to a single person has not been without controversy.

DIR Raises Threshold for Software Employees Overtime Exemption

California Labor Code 510 requires that “any work in excess of eight hours in one workday and any work in excess of 40 hours in any one workweek and the first eight hours worked on the seventh day of work in any one workweek shall be compensated at the rate of no less than one and one-half times the regular rate of pay for an employee.”

And that “any work in excess of 12 hours in one day shall be compensated at the rate of no less than twice the regular rate of pay for an employee. In addition, any work in excess of eight hours on any seventh day of a workweek shall be compensated at the rate of no less than twice the regular rate of pay of an employee.”

California Labor Code Section 515.5 provides that certain computer software employees are exempt from the overtime requirements stipulated in Labor Code Section 510 if certain criteria are met.

One of the criteria is that the employee’s hourly rate of pay is not less than the statutorily specified rate, which the Department of Industrial Relations is responsible for adjusting on October 1st of each year to be effective on January 1st of the following year by an amount equal to the percentage increase in the California Consumer Price Index for Urban Wage Earners and Clerical Workers.

Assembly Bill 10 (Committee on Budget, Chapter 753, Statutes of 2008) amended Labor Code Section 515.5 effective on September 30, 2008, to extend the exemptions to salaried employees whose annual and monthly salaries are not less than the statutorily specified rates, which the department is responsible for adjusting every October 1st of each year to be effective on January 1st of the following year by an amount equal to the percentage increase in the California Consumer Price Index for Urban Wage Earners and Clerical Workers.

The State of California Department of Industrial Relations (DIR) just issued new annual adjusted minimum thresholds for computer software employees who are considered exempt from the state’s overtime requirements under California Labor Code Section 515.5.

The department has adjusted the computer software employee’s minimum hourly rate of pay exemption from $53.80 to $55.58, the minimum monthly salary exemption from $9,338.78 to $9,646.96, and the minimum annual salary exemption from $112,065.20 to $115,763.35 effective January 1, 2024.

This increase reflects the 3.3% increase in the California Consumer Price Index for Urban Wage Earners and Clerical Workers.

The computer software employee exemption in Section 515.5 generally applies to employees who are “primarily engaged in work that is intellectual or creative and that requires the exercise of discretion and independent judgment,” are “highly skilled,” and have job duties such as computer programming, systems analysis, or software design and testing.

There are several provisions where the exemption does not apply. For example, if the employee is engaged in the operation of computers or in the manufacture, repair, or maintenance of computer hardware and related equipment. Or if the employee is an engineer, drafter, machinist, or other professional whose work is highly dependent upon or facilitated by the use of computers and computer software programs and who is skilled in computer-aided design software, including CAD/CAM, but who is not engaged in computer systems analysis, programming, or any other similarly skilled computer-related occupation.

O.C. Insurance Agent Faces 27 Felonies for Comp Premium Theft

49 year old Erin Lee McCarroll, who lives in Laguna Beach, was arraigned on 27 felony counts including grand theft and forgery after a California Department of Insurance investigation found she allegedly stole more than $62,000 in insurance premiums from at least 10 California business owners.

The Department launched an investigation after receiving multiple consumer complaints that McCarroll, who was doing business as Erin McCarroll Insurance Services, allegedly accepted premium payments and pocketed the funds to use for her own personal expenses.

The investigation found that between June 2017 and November 2019, McCarroll allegedly failed to forward premium payments totaling over $62,000 from at least 10 victims who were unaware that McCarroll had stolen their premium payments and did not place the insurance coverage they believed they had.

McCarroll’s victims were contractors and other small business owners who are required by law to have workers’ compensation coverage for their employees in the event of work-related injuries.

McCarroll’s victims also requested and paid McCarroll for general liability policies, which she did not place. The lack of these policies exposed McCarrolls’ victims to possible uncovered claims and the potential for thousands of dollars in losses.

McCarroll was allegedly able to deceive her victims by creating and issuing fraudulent certificates of insurance, which were used to demonstrate proof of proper insurance coverage while bidding contracts. The bogus certificates led her victims to believe they had successfully acquired the insurance policies they purchased from McCarroll.

This case is being prosecuted by the Orange County District Attorney’s Office.

Investigation of Employee Complaints is Protected by Anti-SLAPP

Natalie Operstein was employed as a professor of linguistics at California State University, Fullerton (CSUF). In the course of her employment, she experienced conflict with her colleagues in the linguistics department for which she made various written complaints. By May 2014, the matter had escalated to human resources.

In November 2014, CSUF engaged Seyfarth Shaw LL, a law firm, to investigate Operstein’s accusations against three of her colleagues. Colleen Regan, at the time a partner at Seyfarth, had primary responsibility for the investigation. Regan interviewed Operstein’s three colleagues she accused of misconduct and another individual, but Operstein agreed only to respond to written questions.Regan provided a summary of her investigation and findings in an eight-page report dated December 18, 2014.

The report concluded that none of Operstein’s allegations was well founded and that much of Dr. Operstein’s conduct and email communication was the opposite of collegial. She regularly accused her coworkers of violations and infractions of policy, and of defaming her and violating her rights, all with no apparent basis. Regan also wrote: “Every witness interviewed stated that Dr. Operstein is well regarded as a scholar and researcher, and appears to be a fine teacher. However, since the beginning of her employment at CSUF, she has been difficult for virtually everyone to work with. At least one administrative support employee has requested never to work with her again, and many others find her behavior odd, and even threatening.”

Operstein’s relationship with CSUF further soured shortly after Seyfarth completed its report. She filed a number of lawsuits related to her complaints, including in April 2020, she filed the lawsuit underlying this appeal. In a complaint solely against Seyfarth and Regan, plaintiffs asserted 11 causes of action based on Seyfarth’s work for CSUF in connection with Operstein’s internal complaints of workplace harassment and related mistreatment. In sum, the Seyfarth complaint alleges that, with improper motive, defendants (1) conducted a biased and otherwise flawed investigation of Operstein’s complaints; and (2) prepared and submitted a report that was defamatory of Operstein.

Defendants responded with a motion to strike plaintiffs’ complaint under the anti SLAPP statute (C.C.P § 425.16 strategic lawsuit against public participation), and supported their motion with declarations and extensive documentary evidence, including documents they reviewed in the course of their investigation and the resulting report. Plaintiffs opposed the motion and submitted declarations and evidence of their own totaling nearly 3,000 pages. Defendants filed a reply and plaintiffs filed a 70 page surreply.

On the same day plaintiffs filed their surreply, the trial court issued a tentative ruling. and was inclined to strike three of the 11 causes of action (“negligent misrepresentation and constructive fraud,” “defamation,” and “fraud and deceit”) because those causes of action “arise solely from protected activity under . . . subdivisions (e)(1) and (e)(2),” but was inclined to request further briefing as to whether defendants’ alleged investigative conduct was protected under the anti SLAPP statute.

Later, on the same day the trial court issued its tentative ruling, plaintiffs voluntarily requested dismissal of their entire lawsuit. The court granted their request.

Shortly thereafter, defendants filed their motion for attorney fees and costs pursuant to subdivision (c). Their ultimate total request was $79,889. The trial court granted this only in part, finding defendants would have only partially prevailed on their special motion to strike. It adopted its tentative ruling, and awarded defendants $63,911- 80 percent of the fees they requested.

The trial court awarded the fees without finally ruling on defendants’ anti SLAPP motion to strike – it issued a tentative ruling granting in part and denying in part the motion, and plaintiffs immediately thereafter dismissed their complaint.

Plaintiffs Craig Ross and Natalie Operstein appeal the fee award on three general theories. First, the anti SLAPP statute did not apply to their claims, and, in any event, their claims were meritorious. Second, the fees should not have been awarded because defendants did not meet the fee award requirements of subdivision (c)(1) or because judicially created exceptions to their right to seek a fee award applied. Third, even if fees were awardable, the amount awarded was unreasonable.

Defendants cross appealed and argued that the trial court should have awarded all the fees they requested, not just a portion of those fees, because all of plaintiffs’ claims were based on conduct protected by the anti SLAPP statute, no exceptions applied, and their request was reasonable.

The Court of Appeal agreed with defendants that their motion to strike was wholly meritorious and their fee request therefore should not have been reduced on the grounds that they would have prevailed only partially on their motion. And it disagreed with plaintiffs that the trial court erred in the ways they claim. It therefore affirmed in part and reverse in part and remand for further proceedings consistent with its opinion in the published case of Ross v. Seyfarth Shaw LLP (October 2023).

The anti SLAPP statute provides a procedure for courts to dismiss at an early stage nonmeritorious litigation meant to chill the valid exercise of the constitutional rights of freedom of speech and petition in connection with a public issue. Courts must “broadly” construe the anti-SLAPP statute to further the legislative goals of encouraging participation in matters of public significance and discouraging abuse of the judicial process. (§ 425.16, subd. (a).)

Defendants argued that Seyfarth’s investigation was not an official proceeding authorized by law, and in support cite Vergos v. McNeal (2007) 146 Cal.App.4th 1387 (Vergos), which treated all investigative conduct as communicative.

However, since the Vergos decision issued, our Supreme Court in Bonni v. St. Joseph Health System (2021) 11 Cal.5th 995, 1015, has mandated a more granular evaluation of the allegations underlying a cause of action and its subsidiary claims, and disapproved of the gravamen analysis that appears to have been employed in Vergos, so it said “so we will not rely on Vergos. The Court of Appeal agreed with defendants and concluded “that all conduct by defendants alleged in the complaint is protected under the anti SLAPP statute.”

A “prevailing defendant” on a special motion to strike is “entitled to recover that defendant’s attorney’s fees and costs.” (§ 425.16, subd. (c)(1).) The purpose of this provision is to provide the SLAPP defendant financial relief from the plaintiff’s meritless lawsuit. (Liu v. Moore (1999) 69 Cal.App.4th 745, 750 (Liu).) The trial court’s fee award pursuant to this authority is the subject of this appeal.

When a plaintiff dismisses his or her complaint while the defendant’s special motion to strike is pending, courts agree they retain jurisdiction to award fees and costs. (See, e.g., Coltrain v. Shewalter (1998) 66 Cal.App.4th 94, 107 (Coltrain); Liu, supra, 69 Cal.App.4th at p. 752; Tourgeman v. Nelson & Kennard (2014) 222 Cal.App.4th 1447, 1456 (Tourgeman).) This is because permitting an eleventh-hour dismissal to eliminate financial liability would undermine the deterrent purpose of the anti SLAPP statute. (See Liu, at pp. 750-751.)

The Court of Appeal also concluded that “Under either the Coltrain standard or the Liu standard, defendants entirely prevailed in their special motion to strike” and thus was entitled to the entire fee they requested.

Court Refuses to Reduce Employer’s Comp Fraud Felony Convictions

72 year old Carmen Hall Soruco, and her husband 77 year old Antonio Soruco, who both live in Novato, were sentenced last year after pleading guilty to workers’ compensation fraud charges.

Hall was sentenced on multiple felony counts to two years of probation with full search and seizure, 120 days in jail, and ordered to pay over $925,000 in restitution to State Compensation Insurance Fund (SCIF) and Employment Development Department (EDD).

Antonio Soruco was sentenced to one year of probation with full search and seizure, 120 days in jail, and was also ordered to pay over $925,000 in restitution to SCIF and EDD after pleading guilty to multiple misdemeanor charges.

The Department of Insurance investigation revealed Hall and Soruco committed Workers’ Compensation insurance premium fraud by failing to report employees and payroll to SCIF from October 15, 2013 through December 8, 2016, leading to a premium loss of approximately $585,666.

Investigators also discovered Hall and Soruco committed payroll tax evasion by failing to report employees and payroll to California’s EDD from October 15, 2013 through February 6, 2019 which resulted in a payroll tax loss to EDD of approximately $342,405.

As of September 5, 2023, Hall Soruco and her husband, Antonio Soruco, had paid $7,100, Pratt said. Antonio Soruco had been charged and pled guilty to a misdemeanor but is liable with his wife for the restitution.

The law allows a convicted felon to come to court and ask that their charges be reduced to misdemeanors. The court has the discretion to grant or deny the request based upon the underlying facts of the case. Soruco Hall reappeared in court on October 12, 2023, and contended that she had been compliant with the terms of her probation, justifying the reductions.

This October 2023, a Marin County Superior Court judge has denied Halls Soruco’s request to have her 2022 fraud-related convictions reduced from felonies to misdemeanors. The ruling was aligned with recommendations from Marin County District Attorney’s Office prosecutors..

In this instance, Judge Beth S. Jordan agreed with prosecutors and ruled that Hall Soruco’s behavior did not amount to misdemeanor conduct.

Teamsters Condemn Gov. Gavin Newsom’s “Veto Spree”

Founded in 1903, the Teamsters Union represents 1.2 million workers in the U.S., Canada, and Puerto Rico. Following a legislative session where he vetoed a multitude of bills that would have improved worker’s rights, occupational safety, and financial security for the middle class, the Teamsters are condemning California Gov. Gavin Newsom saying he is making life harder for working families in the nation’s most populous state.

The way Gavin Newsom reacted to a vast majority of the pro-labor bills that came before him this year is something that we would expect to see from a governor who got elected with support from the Koch brothers – not someone who received support from organized labor,” said Jason Rabinowitz, President of Teamsters Joint Council 7. “Being a pro-union governor doesn’t mean you stand with us when it’s convenient. It means you stand with organized labor when it counts, which is when it’s time to sign pro-union legislation.”

The worst veto for good-paying careers in transportation was AB 316 – legislation that would have required a human operator in any vehicle over 10,000 pounds. In addition to being a priority for the Teamsters, the bill was incredibly popular. Over 90 percent of the state legislature voted in favor of it, and public polling shows that nearly three-fourths of Californians across party lines, gender, geography, and all other demographics support AB 316 – unsurprising data given that collisions and accidents with self-driving vehicles continue to occur.

In addition to AB 316, other pro-worker legislation that Newsom vetoed includes:

– – AB 504 – would have banned employers from disciplining or taking any other adverse action against public employees for honoring picket lines or other strike activities;
– – SB 686 – would have required that all household domestic service employers comply with and adhere to all applicable occupational safety and health regulations by January 1, 2025, and remove the exemption of domestic workers from safety and health laws;
– – SB 799 – would have enabled union members who were either on strike or locked out by their employer to collect unemployment insurance benefits (New York and New Jersey both allow this);
– – SB 725 – would have required a successor grocery employer to provide an eligible grocery worker a dislocated allowance equal to one week of pay for each year of employment;
– – SB 627 – would have required an employer, following the shutdown of a chain or franchise location, to provide laid off workers the opportunity to transfer to another site within 25 miles of the closed business;
– – AB 575 – would have expanded eligibility for Paid Family Leave (PFL) benefits to include workers who take time off from work to bond with a child that they are acting as the legally-recognized primary caregiver for. AB 575 would have also removed a restriction that allowed only one family member at a time to access PFL, as well as a provision that allowed employers to make workers use up to two weeks of vacation time prior to accessing PFL;
– – AB 1123 – would have required the California State University (CSU) system to grant workers a leave of absence with pay for one semester of an academic year, or an equivalent duration in a one-year period, following the birth of a child or in connection with the adoption or foster care placement of a child by the CSU worker;
– – SB 751 – would have prohibited franchise agreements for solid waste services from containing provisions that excused a service provider from complying with the agreement in the event of a work stoppage associated with a labor dispute;
– – AB 699 – would have expanded occupational safety protections to lifeguards employed on a full-time basis in the Boating Safety Unit by the City of San Diego Fire–Rescue Department;
– – AB 1145 – would have expanded worker’s compensation benefits for certain nurses, psychiatric technicians, and various medical and social services specialists employed by the Department of Corrections and Rehabilitation, the State Department of Developmental Services, and the State Department of State Hospitals.
– – SB 640 – would have required any food service contract or hotel development project undertaken by the CSU Board of Trustees to be with employers signatory to labor peace agreements; and
– – SB 90 – would have prohibited health plans from imposing a copayment of more than $35 for a 30-day supply of an insulin prescription drug.

Gavin Newsom wants to act like he’s both an ally of labor and an ally of Big Business,” said Chris Griswold, Teamsters International Vice President At-Large and President of Teamsters Joint Council 42. “The last thing America needs right now is more politicians who are friendly with Big Business. What we need is something that’s in short supply: elected officials who are going to stand up for workers.”

Fresno Distributor Arrested for Selling Non FDA Approved Test Kits

Jia Bei Zhu, aka Jesse Zhu, aka Qiang He, aka David He, 62, a citizen of China who formerly resided in Clovis, was arrested on a criminal complaint for manufacturing and distributing misbranded medical devices in violation of the federal Food, Drug, and Cosmetic Act (FDCA) and for making false statements to the Food and Drug Administration (FDA).

According to court documents, between December 2020 and March 2023, Zhu and others manufactured, imported, sold, and distributed hundreds of thousands of COVID-19 test kits, in addition to test kits for HIV, pregnancy, clinical urinalysis, and other conditions in the United States and China. They did so through the companies Universal Meditech Incorporated (UMI) and Prestige Biotech Incorporated (PBI), which were based in Fresno and Reedley. UMI and PBI did not obtain the required authorizations to manufacture and distribute the test kits and mislabeled some of the test kits. When questioned by FDA officials, Zhu made false statements about his identity, his ownership and control of UMI and PBI, and the activities of UMI and PBI.

According to the criminal complaint, Reedley Code Enforcement officials received a complaint regarding a warehouse in Reedley for using non-permitted plumbing that was visible from outside the warehouse. When code enforcement officials went to the warehouse the next day, they saw various types of in vitro diagnostic test kits, related manufacturing equipment, and shipping supplies.

Further investigation found that UMI first registered as a medical device manufacturer with the FDA in November 2015 in Tulare and moved to Fresno in 2018. FDA records show that its registration lapsed in 2022, and it is no longer permitted to manufacture or import any in vitro diagnostic test kits in the United States. Any test kits that the company manufactured or imported after that date are considered misbranded medical devices.

To manufacture, import, and distribute COVID-19 test kits in the United States during the pandemic, a company must have applied for, and ultimately received, an Emergency Use Authorization (EUA) from the FDA. According to FDA records, UMI applied for an EUA for its COVID-19 test kits, but never received it due to major deficiencies in UMI’s test studies.

In November 2022, Fresno County officials notified UMI that they were going to inspect UMI’s Fresno facility to ensure everything was up to code following a fire that occurred at the facility. FDA officials then received an email from UMI’s attorney saying that the company had gone out of business and sold its assets to PBI, a company that was formed in Las Vegas, Nevada. PBI was never registered with the FDA to manufacture or import any in vitro diagnostic test kits in the United States, and never received an EUA to manufacture and distribute COVID-19 test kits. Therefore, any such test kits would be misbranded medical devices.

According to the criminal complaint, during the investigation, Zhu made several false statements to FDA officials, including that his name was Qiang “David” He; that he was hired by UMI as a COVID-19 consultant in 2021; that he was hired by PBI just a couple of weeks ago to communicate with government agencies and dispose of property at the warehouse as requested by those agencies; that he did not know anything about the manufacturing or distribution histories for UMI or PBI; and that he knew nothing about an Amazon webpage showing PBI‑branded pregnancy test kits for sale or a shipment of 47,500 pregnancy test kits from China to UMI at an address in Las Vegas.

This case is the product of an investigation by the FDA Office of Criminal Investigations, with assistance from the Federal Bureau of Investigation and the California Department of Public Health – Food and Drug Branch. Assistant U.S. Attorneys Joseph D. Barton, Arelis M. Clemente, and Henry Z. Carbajal III are prosecuting this case.

If convicted, Zhu faces a maximum statutory penalty of three years in prison for the misbranding of medical devices charge, and five more years in prison for the false statements charge.

WCIRB Publishes 2024 Experience Modification Data

The Insurance Commissioner issued a May 24, 2023 Decision on the Workers’ Compensation Insurance Rating Bureau of California (WCIRB) September 1, 2023 Regulatory Filing. Since then, the WCIRB has issued over 90 percent of the January 1, 2024 experience modifications (X-Mods) that insurers, agents/brokers and policyholders rely on for January policy renewals.

The following are several tools to access published X-Mods and check the status of a pending X-Mod. The WCIRB provides these tools for member insurers and their authorized third-party administrators (TPAs) and managing general agents (MGAs) as well as licensed agencies and brokerages. See the How to Access X-Mods: A Comparison of WCIRB Products chart for various ways to access X-Mods.

WCIRB Connect®  – Insurer and agent/broker users of WCIRB Connect can view the X-Mod for any policyholder. Authorized users may view and download a PDF of published experience rating worksheets (ratesheets). Insurers are also able to search their own policies for X-Mods that are pending due to missing data.

X-Mod Direct®  – X-Mod Direct allows Connect users to request an email when a new or revised X-Mod is issued for a policyholder. To set an alert, click the “Subscribe to X-Mod Direct” button in the ribbon at the top of the Policyholder Details screen.

Comprehensive Risk Summary (CRS)® Report  – Authorized users can quickly obtain detailed policyholder information in Connect with the CRS Report. The automated process will request authorization directly from the policyholder. The report includes the following information:

– – Up to 10 years of historical data
– – Primary policyholder name, address and Bureau Number
– – All classifications reported on policies that incepted within the last five years
– – WCIRB assigned classifications
– – All policyholder names and FEINs reported on policies that incepted within the last five years
– – All addresses and locations reported on all current policies
– – All exposure and loss details on policies that incepted within the last eight years

Visit the CRS Report page for more information.

X-Mods and More® – This API web service is for member insurers and their authorized TPAs and MGAs as well as licensed agencies and brokerages. It provides real-time, automated retrieval of the following information to assist in underwriting workers’ compensation policies in California:

– – X-Mods
– – Assigned classification codes
– – Previously reported policyholder names and addresses, FEINs and other information

See the X-Mods and More® Web Service User Guide. Additional ResourceSeptember 1, 2023 Regulatory Filing Documents

Silicon Valley Man to Serve 8 Years for $77M Medical Fraud

The president of a Silicon Valley-based medical technology company was sentenced to eight years in prison and ordered to pay $24 million in restitution for participating in a scheme to defraud investors and a scheme to commit health care fraud and pay illegal kickbacks in connection with the submission of over $77 million in claims for COVID-19 and allergy testing. A federal jury convicted Schena on Sept. 6, 2022

60 year old Mark Schena, who lives in Los Altos, California, served as the president of Arrayit Corporation. Schena engaged in a scheme to defraud Arrayit’s investors by claiming that he had invented a revolutionary technology to test for virtually any disease using a single drop of blood from a finger stick sample.

In meetings with investors, Schena and his publicist claimed that Schena was the “father of microarray technology” and that he was on the shortlist for the Nobel Prize. Schena also falsely represented to investors that Arrayit could be valued at $4.5 billion.

Schena orchestrated an illegal kickback and health care fraud scheme that involved submitting fraudulent claims to Medicare and private insurance for unnecessary allergy testing. Arrayit ran allergy screening tests on every patient for 120 different allergens regardless of medical necessity.

To obtain patient blood specimens, Schena paid kickbacks to marketers in violation of the Eliminating Kickbacks in Recovery Act and orchestrated a deceptive marketing plan that falsely claimed that the Arrayit test was highly accurate in diagnosing allergies, when it was not, in fact, a diagnostic test.

The Health Care Fraud Unit’s Data Analytics Team supported the prosecution and, as the evidence at trial showed, Arrayit billed more per patient to Medicare for blood-based allergy testing than any other laboratory in the United States.

In early 2020, Schena falsely announced that Arrayit “had a test for COVID-19.” Schena told federal agents that it was simple to develop a test for COVID-19 because the switch from testing for allergies to testing for COVID-19 was “like a pastry chef” who switches from selling “strawberry pies” to selling “rhubarb and strawberry pies.” Seeking to capitalize on the nationwide shortage of COVID-19 testing, Schena orchestrated a deceptive marketing scheme that falsely claimed that Dr. Anthony Fauci and other prominent government officials had mandated testing for COVID-19 and allergies at the same time, and required that patients receiving the Arrayit COVID-19 test also be tested for allergies. Schena also concealed from investors and patients that the Food and Drug Administration had informed him that the Arrayit test was not accurate enough to receive an Emergency Use Authorization for use in the United States.

In furtherance of the scheme, Schena failed to release Arrayit’s financial disclosures – as required by the Securities and Exchange Commission (SEC) – and concealed that Arrayit was on the verge of bankruptcy. Schena lulled investors who were concerned that the company was a “scam” by engaging in television appearances and filming videos that fraudulently portrayed the laboratory as busy and high-tech.

Schena also issued false press releases and public statements on social media that Arrayit had entered into lucrative partnerships with companies, government agencies, and public institutions, including a children’s hospital and a major California health care provider. The press releases and statements falsely claimed that such entities had agreed to use the Arrayit technology, when in fact no such agreements existed or were of minimal value.

Arbitration Award Vacated for “Impression of Possible Bias”

Given the exceedingly narrow scope of judicial review of arbitration awards, assuring both the actual and apparent impartiality of a neutral arbitrator is crucial to the legitimacy of arbitration as a dispute resolution mechanism. This month, a Court of Appeal published opinion illustrated on of the rare instances where an arbitration award was vacated for the impression of possible bias.

In January 2019, plaintiff FCM Investments, LLC (FCM) signed a Purchase Agreement to buy real property in Riverside, California from defendant Grove Pham, LLC (Grove), a company owned by Phuong Pham. Grove operated a nursing home on that property with resident patients. FCM agreed to pay Grove $7.45 million to buy the property, with an upfront deposit of $500,000. Escrow was to close in 30 days.

Disputes arose during the due diligence process, with the parties extending the escrow closing date several times. By April 2019, FCM filed a complaint in Riverside Superior Court against the sellers alleging that their dilatory tactics were preventing completion of the sale. The parties were required to mediate “any dispute or claim” and arbitrate disputes not resolved by arbitration.

Ultimately the parties stipulated to arbitrate their disputes before Honorable Judith C. Chirlin (Ret.) of Judicate West. Arbitration proceeded over two days in June 2021. The arbitrator concluded that the Phams breached the Joint Addendum by failing to provide proof of 66 live-in patients or a notarized agreement regarding the use of Longha’s license. FCM was accordingly justified in terminating escrow. FCM was awarded a return of its deposit with interest, loss-of-bargain damages of $9.1 million plus interest, $127,040 in attorney’s fees, and $20,048 in costs.

FCM filed a petition to confirm the arbitration award, while the Phams moved to vacate it pursuant to the California Arbitration Act (Code of Civ. Proc., § 1280 et seq.). Emphasizing the narrow scope of judicial review, FCM opposed the petition to vacate. Following hearings in December 2021 and January 2022, the court denied the Phams’s motion to vacate and entered judgment for FCM confirming the arbitration award.

The Court of Appeal vacated the arbitration award in the published case of FCM Investments v. Grove Pham, LLC – D080801 (October 2023).

Although the Phams asked to vacate the arbitration award on multiple grounds, the Court of Appeal largely focused on one. In making an adverse credibility finding against Phuong based on her use of an interpreter, the arbitrator’s decision creates a reasonable impression of possible bias requiring that the arbitration.

The arbitrator found the seller in breach based largely on an assessment of witness credibility. She felt the case was unique “both in 12 years of doing arbitration and 24½ years on the Los Angeles County Superior Court, in that the lack of credibility issues are so rampant and obvious.”

In the arbitrator’s view, defendant Phuong Pham lacked credibility because she used an interpreter during the arbitration proceedings. Reasoning that she had been in the country for decades, engaged in sophisticated business transactions, and previously functioned in some undisclosed capacity as an interpreter, the arbitrator felt that her use of an interpreter at the arbitration was a tactical ploy to seem less sophisticated.

While arbitration awards are “nearly immune” from attack, “one of the limited grounds for challenge is bias on the part of the arbitrator.” Courts are empowered to act where that impartiality can reasonably be questioned. “[A]ny tribunal permitted by law to try cases and controversies not only must be unbiased but also must avoid even the appearance of bias.” (Commonwealth Coatings Corp. v. Continental Casualty Co. (1968) 393 U.S. 145, 150.)

Sensitivity toward language difficulties is the hallmark of our multi-lingual state.” (People v. Aguilar (1984) 35 Cal.3d 785, 794; see Gov. Code, § 68560, subd. (e).) Across California, “approximately 40 percent of us speak a non-English language at home; there are more than 200 languages and dialects spoken; roughly 20 percent of us (nearly 7 million) have English language limitations.”

“Arbitration proceedings were unreported, leaving us to guess what evidence, if any, was presented as to Phuong’s English proficiency during arbitration.”

“As a factual matter, FCM’s own pleadings undercut the notion that Phuong’s use of an interpreter was a ploy. In its original complaint, filed long before the relationship between the parties completely unraveled, FCM acknowledged that Phuong used her daughter as a translator during a conference call based on her daughter’s ‘proficiency in English.’ If Phuong relied on her daughter to translate a conference call before the deal unraveled, it seems unsurprising that she would use an interpreter to testify in commercial arbitration proceedings.”

Here, the arbitrator’s credibility finding “rested on unacceptable misconceptions about English proficiency and language acquisition. These misconceptions, in turn, give rise to a reasonable impression of possible bias on the part of the arbitrator requiring reversal of the judgment and vacating the arbitration award.”