A fraud conviction and seven-year prison sentence haven’t spared Martin Shkreli from a federal antitrust lawsuit tied to his former company’s infamous drug pricing scandal. Now, the pharmaceutical company formerly known as Turing has agreed to settle for $40 million.

The California Attorney General announced that Vyera Pharmaceuticals has agreed to pay up to $40 million as disgorgement of Ill-Gotten Gains, to settle charges that it engaged in anticompetitive practices to ward off generics and maintain “monopoly profits” from its more than 4,000% overnight price hike on the toxoplasmosis med Daraprim..

The agreement also bans the former Vyera CEO Kevin Mulleady from almost any role at a pharmaceutical company for seven years. Meanwhile, the litigation against Shkreli, who was the architect of the illegal scheme, will continue, James’ office said. His antitrust trial is slated to begin Dec. 14.

In January 2020, New York Attorney General James and the Federal Trade Commission (FTC) filed a lawsuit against Vyera, Shkreli, and Mulleady for antitrust violations that stifled competition and permitted the defendants to protect and maintain their monopoly profits from their more than 4,000 percent overnight increase – to $750 per pill – of the drug Daraprim (pyrimethamine).

Daraprim is the only Food and Drug Administration (FDA)-approved drug for the treatment of toxoplasmosis, a parasitic disease which may pose serious and often life-threating consequences for those with compromised immune systems, including babies born to women infected with the disease and individuals with the Human Immunodeficiency Virus (HIV).

Daraprim was cheap and accessible for decades, then, in August 2015, Vyera purchased the drug, increased the price, altered its distribution, and engaged in other conduct to delay and impede generic competition.
The high price and distribution changes limited access to the drug, forcing many to make difficult and risky decisions for the treatment of a life-threatening disease.

The illegal scheme perpetrated by Vyera, Shkreli, and Mulleady involved restrictive distribution and supply agreements, as well as data secrecy, with the intent and effect of delaying entry by lower cost generic competitors.

In April 2020, the states of California, Illinois, North Carolina, Ohio, Pennsylvania, and Virginia joined Attorney General James’ and the FTC’s lawsuit.

All money deposited in the Settlement Fund shall be used for equitable relief, including consumer redress and other equitable relief that the Plaintiff States determine to be related to the Defendants’ alleged violative practices and injury, any attendant expenses for the administration of such fund, and repayment of out-of-pocket expenses, and to satisfy the amount of any settlement reached in the related case,

Any money remaining in the fund after such distributions shall be deposited by the Plaintiff States as disgorgement to be used consistently with their respective state laws.

Retired WCJ Raymond F. Correro recently published an excellent article on Exploring the Limitations on the WCAB’s Authority to Develop, Augment, and Reopen the Record, on the LexisNexis website.

As he explains, there is tension between the Workers’ Compensation Appeals Board’s power and authority to develop the evidentiary record pursuant to Labor Code sections 5701 and 5906, – and prohibitions on admitting evidence not listed on the pretrial conference statement pursuant to Labor Code section 5502(d)(3) and the closure of discovery at that point of the litigation.

Prior to the late 1990s, the tension was less severe, as the power to reopen a case after submission for decision was somewhat limited. If the applicant failed to carry their burden of proof, they simply did not prevail, and a take nothing award was the result.

Judge Carrero discussed a trifecta of cases that seemed to open the door and exacerbate this tension, by allowing seemingly unfettered power of the trial Judge, or WCAB on reconsideration to further develop the record after submission of the case for decision.

The cases are Tyler v, Workers’ Comp. Appeals Bd. ((1997) 56 Cal.App.4th 389, 62 Cal.Comp.Cases 924, 1967 Cal.App LEXIS 562; McClune v. Workers’ Comp. Appeals Bd. (1998) 62 Cal.App.4th 1117, 63 Cal.Comp.Cases 261, 1998 Cal.App. LEXIS 282; and M/A Com-Phi v. Workers’ Comp. Appeals Bd. (Sevadjian) (1998) 65 Cal.App.4th 1020, 63 Cal.Comp.Cases 821, 1998 Cal.App. LEXIS 670.

Judge Carrero points out that “The WCAB continues to rely on these same three cases from the late 1990’s which has been manifested in numerous cases to become a mantra of sorts frequently expressed or formulated in almost the exact same or similar language with little variation.”

However he concludes his article by pointing out that there are limitations to the application of the trifecta of cases, and cites as authority a case that followed approximately three years later, McDuffie v. Los Angeles County Metropolitan Transit Authority (2002) 67 Cal.Comp.Cases 138; 2002 Cal.Wrk.Comp. LEXIS 1218 (en banc).

McDuffie sets fourth a limit. Development of the record is allowed only if neither side has presented substantial evidence on which a decision could be based. But it is not appropriate where a decision could be rendered on the existing record and the party seeking to introduce new evidence has failed to show that such evidence “was not available or could not have been discovered by the exercise of due diligence prior to the [mandatory] settlement conference.”

In the case where further development of the record is appropriate, a seven step set of procedures to follow are suggested.

Many thanks to Judge Carrero for his thorough and well reasoned analysis of the limits on developing the record in a submitted case.

The owner of multiple Bay Area Acupuncture clinics admitted to committing medical insurance fraud and violating California’s aggravated white-collar statute.

Dr. Hidenori Anto (aka Dr. Yunyong Lu), age 61, of Saratoga, pleaded no contest to two felony counts of insurance fraud. Dr. Anto’s plea agreement requires that he be placed on five years formal probation, serve one year of county jail, and make complete restitution of $400,000.

During the five-year term of his probation, Dr. Anto cannot bill or assist anyone else in billing insurance companies for acupuncture treatments. He will be sentenced on January 3, 2022 at 9:00 AM in Department 34.

Since 2016, Dr. Anto has operated the following clinics:

– – Anto Acupuncture & Herb Clinic (aka Anto Acupuncture & Chinese Medicine Clinic aka California Holistic Health Center aka Cupertino Holistic Healing Clinic aka Bay Acupuncture Wellness Center) located at 20445 Pacifica Dr #A1 in Cupertino.

– – Vitality Acupuncture Clinic (aka Vitality Health Center aka Mind and Body Wellness Center California Holistic Health Center) located at 2464 W El Camino Real #B in Mountain View.

– – Prospect Acupuncture (aka Cupertino Holistic Healing) located at 18568 Prospect Rd in Saratoga.

– – Green Creek Acupuncture, located at 20735 Stevens Creek Blvd #B in Cupertino.

Between 2016 and 2020, Dr. Anto illegally billed numerous insurance carriers hundreds of thousands of dollars by misclassifying patient treatments, billing for work he was not qualified to complete, overbilling for patient treatments that never occurred, and masking his identity from insurance carriers. In some cases, Dr. Anto billed for medical treatment on patients, but those patients were traveling outside of country at the time.

When insurance carriers attempted to stop the excessive billing by placing Dr. Anto’s clinics on “pre-payment review,” Dr. Anto would simply obtain new identifying information and submit new bills, thus avoiding the pre-payment review process.

After a multi-year investigation, his complex scheme was exposed by Santa Clara County District Attorney investigators with the help of investigators from the respective insurance carriers. In interviews, patients shared that they felt “cheated” and referred to Dr. Anto’s conduct as “pure greed.”

Deputy District Attorney Mattia Corsiglia said: “Medical providers hold a unique position of trust with their patients. When they use that status to defraud insurance companies and line their own pockets, they increase our insurance rates and harm the public’s confidence in our healthcare system.”

Access to medical care, including pharmaceuticals is a critical task for workers’ compensation claim administrators. It may soon become a problem if supply chain issues interrupt the delivery of prescriptions written by the physicians treating injured workers.

As impossible as it may seem, pharmacies are reportedly running out of important prescription medications, and the U.S. Food and Drug Administration (FDA) shows there are about 111 drugs on backorder – including heart medications, antibiotics and cancer drugs.

The agency said on its website that it “continues to take steps to monitor the supply chain.”

“The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak,” it wrote.

The FDA highlights that there are a number of reasons why drug shortages can occur, including manufacturing and quality problems, delays and discontinuations.

“Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages,” it said, also reporting that about 80% of active pharmaceutical ingredients manufacturers are located outside the U.S.

A November survey released by the National Community Pharmacists Association (NCPA) found that the majority of independent pharmacy owners and managers are struggling to fill staff positions and deal with supply chain disruptions, in addition to market pressures.

Sixty percent of respondents said they are dealing with supply chain disruptions and nearly 70% reported struggling to fill staff positions.

According to the group, 76% reported being concerned about possible tax increases on small businesses and 64% were also worried about inflation.

Only 31% of respondents described the overall financial health of their business as very good or somewhat good, 28% described it as average and 41% described it as somewhat poor or very poor.

“Pharmacists have worked heroically throughout the pandemic so to have insurance middlemen push so many of these small business owners to the edge is troubling,” NCPA CEO B. Douglas Hoey said in an accompanying statement. “Policymakers in Congress, the Biden administration and in the states should keep this in mind. There are important policy changes they can make to lower drug prices for seniors and protect small businesses, like eliminating pharmacy DIR fees.”

“Between rollouts of COVID-19 vaccines for children, boosters, and seasonal flu shots – on top of their other existing patient care services – pharmacies are stretched very thin, while patients need them more than ever,” he said. “Independent pharmacies are the safety nets protecting their communities, and owners are working overtime, docking their own pay and doing everything they can to answer the call. Policymakers must repair the broken prescription drug payment model to better support pharmacy teams; successful pharmacies mean healthier, happier lives for patients.”

An American Society of Health-System Pharmacists report warned earlier this year that supply chain disruptions in the midst of the COVID-19 pandemic have the potential to negatively impact patient care.

Tom D’Angelo, chairman of the Pharmacists Society of the State of New York, told Long Island’s Newsday that “a lot of stuff is stuck on barges,” including generic blood pressure pills and cold and flu medication.

Public Health and Medical Professionals for Transparency (PHMPT) is a not-for-profit organization. It’s members include over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, UCSF, UCI and Brown.

These academics and scientists represent a cross section of every discipline relevant to the licensure of the Pfizer vaccine and include many of the best our country has to offer when it comes to reviewing and assessing the appropriateness and validity of the FDA’s decision-making in licensing of the Pfizer COVID Vaccine.

In furtherance of its mission, on August 27, 2021, PHMPT submitted the Freedom of Information Act (FOIA) Request to the FDA seeking all data and information pertaining to the application and approval of the Pfizer Vaccine. Federal law (21 C.F.R. § 601.51(e)) provides that: “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.” PHMPT desires to perform its own independent analysis of the safety and efficacy the the vaccine, especially in light of the vaccine mandates being promulgated at the federal and state levels.

FOIA provides for “expedited processing of request for records” upon a showing of “compelling need.”  PHMPT requested expedited processing of the FOIA Request, which was rejected by the FDA. Thus, PHMPT filed a lawsuit in federal court, seeking to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine by way of expedited processing. The FDA denied the expedited processing request.

In the Second Joint Status Report following filing this case, the FDA assessed that there are more than 329,000 pages potentially responsive to the PHMPT FOIA request. The FDA asks that the Court limit the FOIA response to no more than 500 pages per month. This would be nearly 55 years or until about 2077.

PHMPT requests that the Court enter an order requiring the FDA to produce all documents on a rolling basis such that all of it shall be produced on or before March 3, 2022. The Court will at some point dictate the schedule.

Meanwhile, in the months following the August FOIA request, the FDA has managed to dribble out five documents by November 17, which are now on the PHMPT website. The most alarming of these is the “Cumulative Analysis Of Post-Authorization Adverse Event Reports Of Pf-07302048 (Bnt162b2) Received Through 28-Feb-2021.” This document covers just three months of Adverse Events after commencement of marketing of the Vaccine (December 1, 2020 through February 28, 2021.

In that short time span which was in the first few months of the Vaccine roll out, Table 1 shows that Pfizer became aware of 1,223 deaths reported as a result of the Vaccine administration. Moreover, there were 42,086 Adverse Events as a result of the vaccine in total, with various outcomes between death (1,223), recovered.with sequela (520) and “recovered” (19,582).

In Table 7, there are 69 cases of confirmed (57) or probable (12) cases of acute kidney injury and renal failure. In section 3.1.4 the U.S. topped the charts in medical errors with US (1201), France (171), UK (138), Germany (88), Czech Republic (87), Sweden (49), Israel (45), Italy (42), Canada (35), Romania (33), Finland (21), Portugal (20), Norway (14), Puerto Rico (13), Poland (12), Austria and Spain (10 each) with ten of these “medical errors” reported as fatal.

The next scheduling conference is set for December 14, 2021, and it remains to be seen if the FDA will be compelled to deliver documents in a more expedited manner.