Tag: 2023 News

Following a one week trial, a federal jury convicted Donald Siao, a 58 year old licensed physician who practices family medicine in San Jose, of twelve counts of distributing the controlled substances Oxycodone and Hydrocodone outside of the usual course of his professional practice and without a legitimate medical purpose.

The evidence at his trial, showed that after identifying Siao in a separate prescription fraud investigation, investigators reviewed a California state database and discovered Siao had written 8,201 prescriptions for controlled substance medications in just the one-year period from May 2016 to May 2017.

An investigation followed and resulted in Siao prescribing Oxycodone and Hydrocodone in increasing quantities over seventeen visits by four separate undercover law enforcement agents posing as patients. The undercover agents received prescriptions from Siao despite complaining of only vague pain or discomfort, requesting specific opioids by name, and admitting to sharing the pills with friends and coworkers.

Evidence at trial further established that Siao prescribed dangerous opioids to his patients E.J. and A.J., a mother and son, notwithstanding obvious red flags. Siao continued to prescribe opioids to the mother E.J. after she repeatedly claimed that her pills had been lost or stolen, despite Siao receiving an alert from E.J.’s insurer regarding her opioid prescriptions and despite Siao being advised that E.J. was jailed for selling pills, which was documented in Siao’s medical file for E.J.

Similarly, Siao prescribed opioids to the son A.J. after he overdosed twice. Siao continued to prescribe opioids to A.J. after A.J. repeatedly claimed the opioids were lost or stolen and even after he had been flagged by his prior medical provider for drug-seeking behavior, after his mother reported he had stolen her medications, and after A.J.’s mother E.J. fatally overdosed on opioids. These facts were all documented in Siao’s medical file for A.J.

Trial evidence also demonstrated that Siao refused to heed warnings that his prescriptions were dangerous. Evidence showed Siao was aware that DEA closely scrutinized opioid prescriptions and pointed out to one of the undercover officers posing as a patient that a nationwide epidemic was underway in which large numbers of people were addicted to and dying from opioids. Siao nevertheless continued to prescribe opioids to the agents upon their request and with little to no physical examination, sometimes after visits lasting only a few minutes.

Law enforcement agents interviewed Siao in November 2018 about his prescribing practices, and Siao admitted he was aware of the California Medical Board’s Guidelines for Prescribing Controlled Substances for Pain. During trial, Siao also admitted that he had been taught about the dangers of addiction and how to identify drug-seeking patients.

The jury convicted Siao of twelve counts of distributing opioids outside the usual course of professional practice and without a legitimate medical purpose, all in violation of 21 U.S.C. § 841(a)(1). Of the 12 counts, four related to the undercover agents and eight related to E.J. and A.J.

U.S. District Judge Freeman scheduled Siao’s sentencing for November 7, 2023. Each of the twelve counts carries a maximum sentence of 20 years in prison. The United States is also seeking forfeiture of Siao’s medical license. The court may also order additional fines, restitution, and supervision upon release from prison as part of any sentence. However, any sentence will be imposed by a court only after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.

Assistant U.S. Attorneys Amani Floyd and Dan Karmel are prosecuting the case with the assistance of Mimi Lam. The prosecution is the result of an investigation by DEA, HHS-OIG, and the California Department of Justice Division of Medi-Cal Fraud and Elder Abuse.

The case was investigated and prosecuted by member agencies of the Organized Crime Drug Enforcement Task Force (OCDETF), a focused multi-agency, multi-jurisdictional task force investigating and prosecuting the most significant drug trafficking organizations throughout the United States by leveraging the combined expertise of federal, state, and local law enforcement agencies.

Grace Nunes sustained two admitted industrial injuries while employed by the State of California, Department of Motor Vehicles. In Case No. ADJ8210063, she sustained injury to her neck, upper extremities, and left shoulder, on September 13, 2011. In Case No. ADJ8621818, she sustained injury to her bilateral upper extremities from September 13, 2010 to September 13, 2011.

The parties selected Melinda Brown, M.D., to act as the qualified medical evaluator (QME) in orthopedic medicine. Dr. Brown opined that “[functionally, I do not believe [applicant] would be employable in the open-labor market based on evaluation today … I do believe her inability to work is based on a pain basis and function.”

Applicant’s vocational expert Gene Gonzales evaluated her and issued a report addressing her feasibility for vocational retraining. He Mr. concluded that the “transferable skills analysis tool revealed that applicant sustained a 100 percent loss of access to her open labor market.” Gonzales also addressed apportionment by acknowledging Dr. Brown’s determination that applicant’s left shoulder injury was 100 percent industrial, while 40 percent of the cervical spine injury was attributed to nonindustrial factors. Mr. Gonzales said that “From a vocational standpoint, Ms. Nunes’ preexisting/non-industrial degenerative condition had zero impact to her earning capacity given applicant’s work history.”

Gonzalez went on to say that “the limitations that have rendered Ms. Nunes 100 percent permanently and totally disabled are a direct result of the left shoulder and cervical spine injury on September 13, 2011. It should be noted that standing alone, absent the right elbow/shoulder condition, carpal tunnel syndrome, and diabetic condition, Ms. Nunes’ functional limitations and chronic pain clearly render her 100 percent permanently and totally disabled. Without question, vocational apportionment in Ms. Nunes’ case is 100 percent industrial and attributable to the specific injury of September 13, 2011.“

Dr. Koobatian performed a VR assessment on behalf of the employer and concluded that “it is likely that Ms. Nunes is not employable in the competitive labor market resulting in a substantial loss of future earning capacity.” However, the report also detailed nonindustrial factors of apportionment to the cervical spine, right upper limb, and left carpal tunnel, as identified by Dr. Brown. He concluded that “while the majority of Ms. Nunes’ present medical barriers are industrial in origin …. at least 10% vocational apportionment from non-industrial medical factors is attributable to Ms. Nunes’ inability to compete in the open labor market and participate in vocational rehabilitation services.“

The parties proceeded to trial on the issue of permanent disability, apportionment, attorney’s fees, and whether “applicant rebutted the AMA Guides for permanent total disability.” The WCJ found that applicant is entitled to an unapportioned award of 100 percent industrial disability based on the analysis that “applicant has rebutted the AMA Guides. She’s found to be 100% disabled as there is no evidence of previous loss of earnings capacity.”

Reconsideration was granted and the F&A was rescinded in the En Bank decision of Grace Nunes v State of California, Department of Motor Vehicles -ADJ8210063- ADJ8621818 (June 2023).

Section 4663(c) does not provide for collateral sources of expert opinion as to apportionment, and further does not authorize the application of any other standard of apportionment. “Accordingly, ‘vocational apportionment’ offered by a non-physician is not a statutorily authorized form of apportionment. In addition, apportionment determinations that deviate from the mandatory standards described in section 4663(c) are not a valid basis upon which to determine permanent disability.”

“Pursuant to section 4663(c), evaluating physicians play an integral role in the determination of permanent disability. It is therefore appropriate and often necessary that evaluating physicians consider the vocational evidence as part of their determination of permanent disability, including factors such as whether applicant is feasible for vocational rehabilitation, and whether the reasons underlying applicant’s non-feasibility for vocational retraining arise solely out of the present industrial injury or are multifactorial.”

“The same considerations used to evaluate whether a medical expert’s opinion constitutes substantial evidence are equally applicable to vocational reporting. In order to constitute substantial evidence, a vocational expert’s opinion must detail the history and evidence in support of its conclusions, as well as “how and why” any specific condition or factor is causing permanent disability.”

“While vocational evidence may be utilized to assess factors of permanent disability, including whether an injured employee is feasible for vocational retraining, in order to constitute substantial evidence, vocational reporting must consider valid medical apportionment.” … “The apportionment analysis required under 4663(a) and Escobedo, supra, does not permit reliance on facts offered in support of a competing theory of apportionment.”

“Accordingly, a vocational report is not substantial evidence if it relies upon facts that are not germane, marshalled in the service of an incorrect legal theory. Examples of reliance on facts that are not germane often fall under the rubric of “vocational apportionment,” and include assertions that applicant’s disability is solely attributable to the current industrial injury because applicant had no prior work restrictions.”

Thus the WCAB En Banc concluded by saying:

1. Section 4663 requires a reporting physician to make an apportionment determination and prescribes the standard for apportionment. The Labor Code makes no statutory provision for “vocational apportionment.”
2. Vocational evidence may be used to address issues relevant to the determination of permanent disability.
3. Vocational evidence must address apportionment, and may not substitute impermissible “vocational apportionment” in place of otherwise valid medical apportionment.

“Applying these principles to the present matter, we conclude that the current medical and vocational record is analytically incomplete. Accordingly, we will rescind the F&A and return this matter to the trial level for further proceedings consistent with this opinion.”

The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on July 9, 2012. Title X of FDASIA, which addresses drug shortages, took effect on the date of enactment and, among other things, amended the Federal Food, Drug, and Cosmetic Act by adding section 506C-1, which requires the Food and Drug Administration to file an annual report to Congress on drug shortages.

This Tenth Annual Report to Congress published by the FDA on June 7, 2023 summarizes the major actions taken by the U.S. Food and Drug Administration during calendar year 2022 to prevent or mitigate drug shortages in the United States. As a result of presidential, congressional, and Agency actions, manufacturers are notifying FDA earlier than in the past about certain manufacturing interruptions and discontinuances that can lead to shortages.

The FDA reports that at the height of the drug shortage crisis, the number of new drug shortages tracked by Center for Drug Evaluation and Research (CDER) quadrupled, from approximately 61 shortages in 2005 to more than 250 in 2011. “The number of new drug shortages per calendar year has declined from a high of 250 in 2011 to 49 in 2022”.

Although the number of new drug shortages has declined since 2011, the FDA in general terms cautions that “shortages continue to pose a real challenge to public health, particularly when the shortage has involved a critical drug to treat cancer, to provide parenteral nutrition, or to address another serious medical condition, such as a shortage of antibiotics.”

The FDA report is very general and does not specifically point out a supply crisis on the immediate horizon. But a new report just published by Kaiser Health News does not depict a good picture for shortages, especially in the generic drug marketplace.

KHN reports that Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, attention-deficit/hyperactivity disorder pills, blood thinners, and antibiotics.

It claims that “Covid-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.”

“The 10 cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives – though sometimes less effective and often with more side effects – are available. But some doctors are even rationing doses intended to cure.”

The causes of shortages are well established. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.

And some generic manufacturers are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Lannett Co., with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.

The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage.

On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.

So KHN concludes by saying “Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.”

Skye Gray was a caregiver who had been hired by Comfort Keepers Home Care. Employees bid on available shifts and are required to have reliable transportation to get to the shifts. An employee would contact the employer via email when the employee was available for a shift. The employee may accept or reject an assignment.

She was driving to her shift in her personal vehicle when she was involved in a motor vehicle accident shortly before midnight. This was the first time she had been to this particular location. She was in a coma for a period after the accident, and was pregnant at the time of the injury and miscarried after the auto accident.

She did request that she be assigned to this shift, and this specific job did not require her to run errands for the client or take the client anywhere. The distance between Gray’s home and her job assignment was 17-23 miles. She was not traveling between assignments at the time of the MVA. She was not carrying supplies or tools for the employer.

Grey was required to have reliable transportation. The employer testified that a bus pass would be sufficient. But in this case,was traveling late at night to a new location, and it is unknown whether any public transportation was even available at that time of day, to the location she was traveling. She was not travelling to a fixed business at a fixed time.

The only issue submitted for decision was whether the injury was AOE/COE, specifically whether or not the automobile accident occurred during the course and scope of her employment. The parties requested that the going and coming rule be addressed. The WCJ found the injury to be compensable and that it was not barred by the going and coming rule.

The employer’s Petition for Reconsideration was denied in the panel decision of Gray v Comfort Keepers Home Care -ADJ13210964 (June 2023).

“Under the well established going and coming rule, an employee does not pursue the course of his employment when he is on his way to or from work.” (Smith v. Workmen’s Comp.App.Bd. (1968) 69 Cal.2d 814, 815-816 [33 Cal.Comp.Cases 771] Thus, injuries sustained while an employee is “going and coming” to and from the place of employment do not normally arise out of and in the course of employment because the employee is neither providing benefit to the employer nor under the control of the employer during that commute.

However, the California Supreme Court held that the rule applies to a “local commute enroute to a fixed place of business at fixed hours.” (Hinojosa v. Workers’ Comp. Appeals Bd. (1972) 8 Cal.3d 150, 157 [37 Cal.Comp.Cases 734)] (Zhu v. Workers’ Comp. Appeals Bd. (2017) 12 Cal.App.5th 1031, 1038 [82 Cal.Comp.Cases 692].)

The panel went on to conclude that “there is substantial evidence in this case to apply the ‘required vehicle’ exception to the going and coming rule. The ‘required vehicle’ exception may be invoked when ‘the employee is expressly or impliedly required or expected to furnish his own means of transportation to the job (Smith v. Workmen’s Comp. App. Bd. (1968) 69 Cal.2d 814 [73 Cal. Rptr. 253, 447 P.2d 365]).- (Hinojosa v. Workemen’s’ Comp. Appeals Bd. (1972) 8 Cal.3d 150, 160 [37 Cal.Comp.Cases 734] (Hinojosa).)”

“The exception ‘arises from the principle that an employee ‘is performing service growing out of and incidental to his employment’ (Lab. Code, § 3600) when he engages in conduct reasonably directed toward the fulfillment of his employer’s requirements, performed for the benefit and advantage of the employer.’ (Smith, supra, at pp. 819-820.)  (Zhu v. Workers’ Comp. Appeals Bd. (2017) 12 Cal.App.5th 1031, 1039 [82 Cal.Comp.Cases 692].)

The VA Accountability and Whistleblower Protection Act of 2017 is a law that was passed by the United States Congress to improve accountability and whistleblower protection within the Department of Veterans Affairs.

Prior to passage of this act,it was whistleblowers who helped expose the nationwide scandal over long waits for care. Beginning in 2014, VA medical facilities across the country were found to have covered up delays in providing care, making waits as long as four months appear much shorter.

The law created a new Office of Accountability and Whistleblower Protection (OAWP) within the VA, which is responsible for investigating allegations of misconduct and retaliation against whistleblowers. The law also expanded the definition of protected disclosures to include allegations of gross mismanagement, gross waste of funds, and abuse of authority.

Following passage of the Act, members of Congress asked the Office of the Inspector General to determine the success or failure of the VA in implementing this Act. The OIG reported in October 2019 that implementation was not successful.  For example it said that “A critical purpose of the Act was to facilitate holding Covered Executives accountable for misconduct and poor performance. However, as of May 22, 2019, the Inspector General determined that VA had removed only one Covered Executive from federal service pursuant to the authority provided by the Act.”

And it does not seem that things have gotten much better since the 2019 OIG report. Earlier this year Rep. Jay Obernolte (R-Calif.) issued a press release stating that the VA informed him that “it will no longer use the tools provided by the bipartisan VA Accountability and Whistleblower Protection Act, which was signed into law in 2017″ citing that this was “because the Biden administration paused the use of the law.”

His consternation at the time of this press release was his request for “answers on a situation at the Loma Linda VA Medical Center (VAMC) where a supervisory employee continues to be employed by the medical center despite creating a hostile work environment, ultimately reducing accountability, impacting employee morale, and hindering the good delivery of services to veterans.”

Also last April 2023, U.S. Senators Marco Rubio (R-FL) and Steve Daines (R-MT) sent a letter bashing U.S. Department of Veterans Affairs Secretary Denis McDonough for announcing the VA will ignore important provisions of the VA Accountability and Whistleblower Protection Act that require the agency to hold bad employees accountable.

The Government Executive website confirmed the VA decision to discontinue use of the Act starting April 3. It claims the reason was that the “Federal Labor Relations Authority found VA violated its collective bargaining agreement with the American Federation of Government Employees when it eliminated ‘performance improvement plans’ from the pre-disciplinary process. The decision required VA to reinstate all employees fired without first being provided such a plan, a process McDonough told members of Congress on Thursday is currently under negotiation.”

And the situation at Loma Linda VA is discussed in detail by a news story published on June 18 by Military.com. According to it’s report, several VA Loma Linda Healthcare System whistleblowers have come forward with new allegations of retaliation, harassment and hostile working conditions amid a widening investigation by the House Veterans Affairs Committee.

Last Friday, committee member Jay Obernolte, met behind closed doors with VA Loma Linda’s interim director Bryan Arnette, and other officials to discuss the whistleblower complaints and map out needed changes.

“Sometimes in federal government – we can create a workplace environment that is tolerant of people that don’t follow the rules,” Obernolte said during a press briefing following the meetings without offering specific details about what was discussed. “We want to make sure that doesn’t occur.”

Separately, staff members from the House Veterans Affairs Subcommittee on Oversight and Investigations met with whistleblowers at an undisclosed location to review their complaints that suggest systematic failures by the federal government to address problems at VA Loma Linda. Obernolte declined to disclose the specific nature of the confidential whistleblower allegations

Obernolte’s visit follows a Southern California News Group report in May that revealed a 2021 federal investigation found that a VA Loma Linda manager frequently used racial slurs, required workers to buy him food and drive him to and from work, and then punished those who refused his demands with bad assignments.However, instead of being terminated for creating a hostile work environment, the manager – identified by multiple sources as grounds department supervisor Martin Robles – was inexplicably promoted.

“There were numerous instances where inappropriate language and racial slurs were used which appears to be a common practice,” a Veterans Administration investigative board said in a heavily redacted 61-page report obtained by the Southern California News Group. “Inappropriate and discriminatory hiring practices were found, which have contributed to the lack of trust, poor morale, and fractured culture.”

The Administrative Investigation Board (AIB) recommended Robles be removed from employment because of “overwhelming evidence to support that the supervisor was intimidating, exhibited bullying behavior, threatening behavior, and contributed to a hostile work environment,” said a source familiar with the probe. The AIB investigation, which began on Dec. 9, 2020, and concluded the week of Jan. 11, 2021, included 57 hours of testimony from 36 witnesses and 4,000 pages of exhibits.

Robles also was the focus of two other VA Loma Linda investigations in 2020 and 2022 that substantiated allegations he fostered a hostile work environment. Details of those two investigations were not immediately available.

The controversy involving Robles is the latest in a string of troubling incidents involving VA Loma Linda employees.