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Jury Verdict – Pharmacies Held Liable for Opiod Distribution

A big question in opiod litigation pertains to how far down the chain of distribution, from the drug manufacturer, the prescribing doctor, to the pharmacy that fills a prescription, can liability be established by plaintiffs seeking payment of the opiod litigation. A new jury verdict this week may help answer that question.

Bloomberglaw reports that a Cleveland jury concluded Walmart Inc., CVS Health Corp. and Walgreens Boots Alliance Inc. helped create a public-health crisis by failing to properly monitor opioid prescriptions, the drug industry’s latest loss in the expanding litigation over the painkillers.

The federal-court panel backed claims by northeast Ohio’s Trumbull and Lake Counties that the pharmacy chains failed to create legally mandated monitoring systems to detect illegitimate opioid prescriptions. The counties are seeking reimbursement for the costs of dealing with addictions and fatal overdoses. Similar suits are pending against drugmakers and distributors. A judge will hear arguments in May about the counties’ compensation claims.

The two Ohio municipalities want the pharmacy owners to pay a combined $2.4 billion to replenish depleted budgets for drug treatment, social services and police, with $1.3 billion for Trumbull and $1.1 billion for Lake, according to people familiar with their demands.

Walmart and other pharmacy operators argued the municipalities couldn’t prove they created a so-called “public nuisance” through lax prescription oversight when the scripts were written by licensed doctors. They also touted their systems designed to help pharmacists track patients’ visits, making it easier to spot red flags among prescriptions.

It’s the first jury verdict in the sprawling, four-year opioid litigation. Municipalities across the nation have accused opioid makers, distributors and sellers of downplaying the painkillers’ addiction risks and sacrificing patient safety for billions in profits. The jurors in Cleveland deliberated for more than five days before returning the unanimous verdict on Tuesday.

The jury’s decision sounds a bell that should be heard by pharmacy companies around the country,” Mark Lanier, the Ohio counties’ lead lawyer, said after the verdict was announced. “Laws regarding proper monitoring of prescription drugs are be taken seriously and not ignored or downplayed.”

The companies all said they would appeal the verdict. “We look forward to the appeals court review of this case, including the misapplication of public nuisance law,” Mike DeAngelis, a CVS spokesman, said in an emailed statement. “The facts and law do not support the verdict,” Walgreen’s Fraser Engelman added.

“We will appeal this flawed verdict, which is a reflection of a trial that was engineered to favor the plaintiffs’ attorneys and was riddled with remarkable legal and factual mistakes,” Randy Hargrove, a Walmart spokesman, said in an emailed statement.

DWC Updates Low Back Treatment Guideline

The Division of Workers’ Compensation has posted an order adopting regulations to update the evidence-based treatment guidelines of the Medical Treatment Utilization Schedule (MTUS).

The updates, effective for medical treatment services rendered on or after November 23, 2021, incorporate by reference the American College of Occupational and Environmental Medicine’s (ACOEM’s) most recent treatment guidelines to the Clinical Topics section of the MTUS.

The ACOEM guidelines that are incorporated by reference into the MTUS are:

– – Low Back Disorders Guideline  268 pages, (ACOEM February 13, 2020)

The administrative order consists of the order and two addenda:

– – Addendum one shows the regulatory amendments directly related to the evidence-based update to the MTUS.
– – Addendum two contains a hyperlink to the ACOEM guideline adopted and incorporated into the MTUS by reference.

A few of the more notable recommendations of the new guideline which are illustrative of new approaches are:”

– –  “Patients should be encouraged to return to work as soon as possible as evidence suggests this leads to the best outcomes. This process may be facilitated with temporary modified (or alternative) duty particularly if job demands exceed patient capabilities. Full-duty work is a reasonable option for patients with low physical job demands and/or the ability to control such demands (e.g., alternate their posture) as well as for those with less severe presentations”

– –  “Among the modes of exercise, aerobic exercise has the best evidence of efficacy, whether for acute, subacute, or chronic LBP patients.”

– –  “Many invasive and noninvasive therapies are intended to cure or manage LBP, but no quality evidence exists that they accomplish this as successfully as therapies that focus on restoring functional ability without focusing on pain. In those cases, the traditional medical model of “curing” the patient does not work well. Instead, patients should be aware that returning to normal activities most often aids functional recovery.

– – “Patients should be encouraged to accept responsibility for managing their recovery rather than expecting the provider to provide an easy “cure.” This process promotes the use of activity and function rather than pain as a guide, making the treatment goal of return to occupational and non- occupational activities more obvious.”

Health care providers treating, evaluating (QME), or reviewing (UR or IMR) in the California workers’ compensation system may access the MTUS (ACOEM) Guidelines and MTUS Drug List at no cost by registering for an account.

Supreme Court Denies Review of $86.7M Roundup Award

The outcome of several verdicts in litigation against the makers of the Roundup weed killer are of significance to worker’s compensation administrators who might be involved in CT claims filed b.y agricultural workers. There may, or may not be opportunities for subrogation depending on the eventual trend.

The latest development this month involved an $86.7 million damages award for a Livermore couple stricken with cancer after years of spraying Roundup weed killer. This result will now be final, after the California Supreme Court refused to hear Monsanto’s appeal.

The decision effectively upholds a 2019 jury verdict that found Monsanto was aware of the risks associated with its product and negligently failed to warn consumers, and in so doing also acted with malice, oppression or fraud.

Courthouse news reports that both Alva and Alberta Pilliod were diagnosed with non-Hodgkin lymphoma that they attributed to decades of using Roundup: Alva with systemic diffuse large B-Cell lymphoma in his bones in 2011; Alberta with diagnosed with an aggressive subset of that lymphoma in her brain in 2015.

In addition to $55 million in combined compensatory damages, the jury awarded each of the Pilliods $1 billion in punitive damages. During the course of the five-week trial back May 2019, Alberta testified that she never would have bought the popular herbicide if she had known that it was brought to market based on approval studies that were found to be invalid.

Alameda County Superior Court Judge Winifred Smith ultimately slashed the award to a total of $86.7 million, and an appellate court affirmed it in an August order where Justice Marla Miller wrote that “Monsanto’s continuing to sell Roundup after learning that the original approval studies were invalid shows conscious disregard for public health and safety.”

In other Roundup cases, two other Bay Area residents were awarded hefty damages by separate juries. In August 2018, a jury found Monsanto owed Dewayne Lee Johnson $289 million in damages – later reduced by a judge to $78 million – after finding Roundup caused his terminal non-Hodgkin lymphoma, and a federal jury awarded Ed Hardeman $75 million in punitive damages for failing to warn him about the product’s hazards, which a a judge cut down to $20 million.

Bayer AG, which bought Monsanto for $63 billion in 2016, has since appealed the Hardeman case to U.S. Supreme Court.

However, the defendants recently secured a win in Los Angeles state court, where a jury found there wasn’t enough evidence to prove Roundup was a substantial factor in causing the rare cancer that killed a young boy.

A federal judge in Georgia also found in Bayer’s favor on a plaintiff’s failure to warn claim, ruling that the Federal Insecticide, Fungicide, and Rodenticide Act requires the company to follow instructions by the EPA not to sell Roundup with a cancer warning on its label. An appeal is pending before the Eleventh Circuit.

In June 2020, Bayer announced a $10 billion agreement to settle a bevy of claims related to Roundup users who have contracted non-Hodgkin lymphoma. But this year, U.S. District Judge Vincent Chhabria refused to approve a $2 billion deal to resolve claims from Roundup users who have not developed cancer but may be diagnosed in the future.

Bayer has also vowed to remove glyphosate-based products from retail store shelves by 2023 to prevent future litigation, though the company has consistently said that it stands behind Roundup’s safety.

S.F. Disbarred Attorney Faces Insurance Fraud Charges

The San Francisco District Attorney’s Office has charged Russell A. Robinson, a now-disbarred San Francisco-based attorney, with multiple felony counts for defrauding a client, two courts, and two insurance companies – all while illegally practicing law after he was suspended from doing so.

According to public documents, Mr. Robinson had been placed on involuntary inactive status by the California State Bar in June 2019, and was not authorized to practice law after that time. Nonetheless, according to witnesses and records obtained, Mr. Robinson continued to practice as an attorney. He also is alleged to have made false statements to induce a client to retain his services and even filed a lawsuit on the client’s behalf in a California Superior Court. As a part of that lawsuit, Mr. Robinson filed with the Court numerous false documents bearing the forged signatures of a licensed attorney and a legal assistant.

Other records show that Mr. Robinson also impersonated his client, the licensed attorney, and others in his communications with two different insurance companies, and he is alleged to have forged his client’s signature on documents he submitted to those insurance companies. These fraudulent communications and documents resulted in the insurance companies providing approximately $265,000 in settlement proceeds to Mr. Robinson for his client, most of which he allegedly embezzled.

In addition, other records show that Mr. Robinson also forged the signature of a legal assistant on twelve documents he filed with the Review Department of the State Bar Court, which recommended that he be disbarred. The California Supreme Court accepted that recommendation and disbarred Robinson in June 2021.

For his acts, Mr. Robinson has been charged with multiple felony counts, including Unauthorized Practice of Law in violation of Business and Professions Code section 6126(b); False Personation in violation of Penal Code section 529(a)(2); Identity Theft in violation of Penal Code section 530.5; Embezzlement in violation of Penal Code section 503; and Forgery in violation of Penal Code sections 470(a) and 470(c); and Filing a False Instrument in violation of Penal Code section 115(a).

“Our legal system depends on lawyers to be truthful and act with integrity,” said the San Francisco District Attorney. “Breaching that trust hurts not only the individuals who have been defrauded, but damages the confidence the public places in the legal system. Those who practice law are not above it.”

This case was investigated by SFDA Inspector Jonathan Collum, who was assisted by the State Bar of California, Office of Chief Trial Counsel. The SFDA’s investigation into Mr. Robinson’s conduct remains ongoing.

November 15, 2021 – News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Federal Court of Appeals Stays OSHA Vaccination Mandate. Court of Appeal Clarifies Math of Subrogation Recoveries. Opioid Drugmakers Prevail in Second Case This Month. Feds Sue Uber for Overcharging the Disabled in California. LAPD Chief Takes Tough Stance on Officer Vaccination. Angelenos Fight Back Over Strict COVID Rules. Feds Say “Most Truckers” Can Avoid OSHA Vaccination Mandate. California COVID-19 Cases on the Rise Again! New Study of Vaccination Outcomes of 780 Thousand Veterans. Elimination of Pre-authorization For PT Improves WC Outcomes.

O.C. Sheriff’s Captain Charged with $17M Premium Fraud

Mercury News reports that a former volunteer reserve captain for the Orange County Sheriff’s Department has been charged with defrauding the state workers’ compensation program of $17 million.

54 year old Simon Semaan, who lives in Los Angeles County,  faces a maximum 16 years in state prison if convicted of seven felony counts of fraud and seven enhancements of committing a white collar crime of more than $500,000.  He has pleaded not guilty and is free on $4 million bail. He was let go by the Sheriff’s Department this September

According to authorities, Semaan ran Pacwest Security Services, but did not have workers’ compensation insurance for his employees as required by law. He did have insurance with two different companies for a firm called PSSM Inc. The Costa Mesa company that provides licensed, unarmed security guards,

Semaan had been a sheriff’s reserve officer since 1993 and was a noted supporter of former Sheriff Michael S. Carona. Carona ultimately was found guilty of a federal charge of witness tampering and served 52 months in prison. Semaan, a Los Angeles resident, was let go by the Sheriff’s Department in September.

In 2008, he was appointed by then Gov. Arnold Schwarzegger to a state private security disciplinary review committee.

The alleged $17 million theft represents the largest insurance premium fraud case ever filed in Orange County and the second largest in California, authorities said.

“The Orange County District Attorney’s Office is committed to prosecuting these dishonest business owners as a way of protecting legitimate business owners who follow the law and play by the rules,” said Kimberly Edds, a spokeswoman for District Attorney Todd Spitzer. “Everyone deserves a level playing field, and Orange County is continuing to ensure that no one is gaining an unfair advantage to undercut the competition.”

An attorney for Semaan did not return Mercury News phone calls seeking comment.

The Sheriff’s Department declined to comment, other than to say he was no longer with the agency.

East Bay Doctor Found Guilty of Illegally Prescribing Opioids

Physician Edmund Kemprud, 78, of Dublin, was found guilty of 14 counts of illegally prescribing opioids and other controlled substances patients. Medical Board records show that he was a 1973 graduate of the University of California at San Francisco School of Medicine. He has been licensed in California since 1974. He stipulated to the surrender of his license effective October 25, 2021, and is no longer licensed in California.

According to evidence presented at trial, Kemprud worked in several locations around the East Bay and Central Valley, including one location in a back room of a nail salon and medi-spa in Tracy.

Evidence at trial showed that Kemprud prescribed highly addictive, commonly abused prescription drugs, including Hydrocodone, Alprazolam, and Oxycodone – outside the usual course of professional practice and not for legitimate medical purpose.

He ignored indications that his patients were addicts or that they were diverting the drugs. Instead, he wrote more prescriptions for highly addictive and dangerous controlled substances, charging $79 a visit. He churned out prescriptions so quickly that he often spent less than five minutes with a patient and would see 30 patients in less than a day.

Several pharmacies were so troubled by Kemprud’s prescriptions that they instituted companywide policies to block his prescriptions.

Trial testimony of undercover officers established that on 14 occasions between Sept. 6, 2018, and March 13, 2019, Kemprud prescribed opioids without determining the patients’ medical and prescription histories, without conducting a proper medical examination, without confirming the legitimacy of the patients’ complaints, and without assessing the risk of aberrant drug behavior.

This defendant displayed a blatant disregard for patient safety and the law,” Acting U.S. Attorney Talbert said. “Although he knew his treatment of patients was unlawful, he continued to pump dangerous drugs into the community. It took the effort of agents, investigators, undercover officers, medical professionals who practiced with the defendant and pharmacists to bring an end to Kemprud’s illicit prescription writing. The U.S. Attorney’s Office will continue our vigorous pursuit of those who fuel the opioid epidemic for their own personal benefit.”

This case is the product of an investigation by the California Department of Justice, Bureau of Medi-Cal Fraud and Elder Abuse Drug Diversion Team, the Drug Enforcement Administration, and the Office of Inspector General for the United States Department of Health and Human Services. Assistant U.S. Attorney Veronica M.A. Alegría and Special Assistant U.S. Attorney Robert J. Artuz are prosecuting the case.

Kemprud is scheduled to be sentenced on Feb. 14, 2022, by U.S. District Judge William B. Shubb. Kemprud faces a maximum statutory penalty of 20 years in prison.

SoCal Family Sentenced for $20M COVID Relief Fund Fraud

Three members of a San Fernando Valley family have been sentenced – two of them in absentia after they fled justice following their convictions at trial – to years in federal prison for scheming to fraudulently obtain more than $20 million in Paycheck Protection Program (PPP) and Economic Injury Disaster Loan (EIDL) COVID-19 relief funds.

On Monday, United States District Judge Stephen V. Wilson handed down prison sentences to the Encino residents:

– – Richard Ayvazyan, 43, who was ordered to serve 17 years;
– – Marietta Terabelian, 37, Richard Ayvazyan’s wife, who was sentenced to six years; and
– – Artur Ayvazyan, 41, Richard Ayvazyan’s brother, who was ordered to serve five years in federal prison.

At Monday’s sentencing hearing, Judge Wilson said he could not recall a fraud case conducted in such a “callous, intentional way without any regard for the law.” Judge Wilson further described Richard Ayvazyan as “an endemic, cold-hearted fraudster with no regard for the law” and someone who “views fraud as an achievement.”

The FBI is offering a reward of up to $20,000 for information leading to the arrest of Richard Ayvazyan and Terabelian, who allegedly cut their tracking bracelets on August 29 and went on the run while awaiting sentencing in this case. Judge Wilson sentenced them in absentia, and they remain fugitives from justice.

At the end of an eight-day trial, a federal jury on June 25 found Richard Ayvazyan, Terabelian, and Artur Ayvazyan guilty of one count of conspiracy to commit bank fraud and wire fraud, 11 counts of wire fraud, eight counts of bank fraud and one count of conspiracy to commit money laundering. Richard Ayvazyan and his brother were also convicted of aggravated identity theft.

On June 28, the jury further found that Richard Ayvazyan and Terabelian must forfeit bank accounts, jewelry, watches, gold coins, three residential properties and approximately $450,000 in cash.

Judge Wilson previously sentenced four defendants in this case:

– – Manuk Grigoryan, 28, of Sun Valley, was sentenced on October 25 to six years in prison;
– – Edvard Paronyan, 41, of Granada Hills, was sentenced on September 27 to 30 months in prison;
– – Vahe Dadyan, 42, of Glendale, was sentenced on October 18 to 12 months and one day in prison; and
– – Arman Hayrapetyan, 39, of Glendale, was ordered on October 18 to serve 10 months of probation.

Tamara Dadyan, 42, of Encino, is scheduled to be sentenced on December 6, but Judge Wilson has not yet ruled on a motion to withdraw her guilty plea.

The defendants used dozens of fake, stolen or synthetic identities – including names belonging to elderly or deceased people and foreign exchange students who briefly visited the United States years ago and never returned – to submit fraudulent applications for approximately 150 PPP and EIDL loans. In support of the fraudulent loan applications, the defendants also submitted false and fictitious documents to lenders and the Small Business Administration (SBA), including fake identity documents, tax documents and payroll records.

The defendants then used the fraudulently obtained funds as down payments on luxury homes in Tarzana, Glendale and Palm Desert. They also used the funds to buy gold coins, diamonds, jewelry, luxury watches, fine imported furnishings, designer handbags, clothing and a Harley-Davidson motorcycle. The conspirators sought to fraudulently obtain more than $20 million in COVID-19 relief funds.

The FBI, IRS Criminal Investigation, the Small Business Administration’s Office of Inspector General, and the Federal Housing Finance Agency Office of Inspector General investigated this matter.

Drug Overdose Deaths Hit Record High During Pandemic

As the pandemic swept across the country, a record number of Americans died of drug overdoses in the 12-month period ending in April 2021, according to preliminary data released by the Centers for Disease Control and Prevention (CDC).

The more than 100,000 overdose deaths is nearly 30% higher than the 78,000 counted the year before – with much of the blame landing on the availability and potency of synthetic opioids such as Fentanyl – which is up to 50x more potent than heroin, according to Statista, which notes that the CDC has reported more than 60% of overdose deaths last year involved synthetic opioids.

The provisional drug overdose death count for the 12 month-ending period ending in March, 2021 for Los Angeles County, California is: 2132.

These are numbers we have never seen before,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who noted that most of the fatalities were among those aged 25 to 55.

“They leave behind friends, family and children, if they have children, so there are a lot of downstream consequences,” said Volkow. “This is a major challenge to our society.

Responding to the staggering figure, the Biden administration on Wednesday said that it would expand access to medications such as naloxone, which can reverse an opioid overdose, according to the New York Times.

The President failed to mention China in his statement on Wednesday, the nation responsible for the immense amount of fentanyl killing Americans every day. Former President Trump frequently criticized China’s high level of exports of fentanyl or the substances used to make it, which are smuggled into the United States through Mexico.

Back in 2018, under pressure from President Trump, President Xi promised to make trading fentanyl a criminal act, punishable to the highest level: the death penalty. However, Xi failed to follow through on that promise, which President Trump routinely blasted him for. So far in 2021, the Drug Enforcement Administration has seized enough fentanyl to kill every member of the United States population.

OSHA Vaccine Mandate Cases Consolidated in 6th Circuit

6th Circuit Court ‘wins’ lottery to hear lawsuits against Biden’s vaccine rule

Under federal law, when multiple lawsuits involving “one or more common questions of fact” are filed in separate courts, the petitions are consolidated and heard by one court chosen at random. The procedure is often used to handle product liability and antitrust cases, when thousands of lawsuits may be consolidated and heard by a single court.

The 6th Circuit Court of Appeals has won the lottery to hear legal challenges to the Biden administration’s vaccine rule that affects some 84 million workers.

The Biden administration rule was formally issued on Nov. 5 by the Occupational Safety and Health Administration. Lawsuits challenging the rule came in quick succession. Within 10 days, 34 lawsuits were filed, covering all 12 regional circuit courts and giving each of those courts one entry into the lottery.

A report by NPR claims the 6th Circuit Court of Appeals, based in Cincinnati, Ohio, is known to lean conservative, with most of its judges appointed by Republican presidents. Six were appointed by President Donald Trump and five were appointed by President George W. Bush, while a total of five were appointed by Democratic Presidents Bill Clinton and Barack Obama.

It will now be up to the 6th Circuit to decide whether to lift the stay issued by the 5th Circuit. A three-judge panel temporarily blocked the OSHA rule one day after it took effect and reaffirmed that decision last Friday, calling the rule “a one-size-fits-all sledgehammer that makes hardly any attempt to account for differences in workplaces (and workers).”

While a majority of the lawsuits seek to overturn the OSHA rule, several labor unions went the other way. They sued saying the rule does not go far enough to protect workers from COVID-19. The rule does not apply to employers with fewer than 100 workers.

The union lawsuits were mostly filed in courts that either have a majority of judges appointed by Democratic presidents or are evenly split.

But an article in Politico speculates that that the legal challenges are likely to end up in front of the Supreme Court, where a conservative majority seems ripe to limit the federal government’s ability to police workplaces in emergencies more broadly.

Some of the arguments made in the cases could “have serious implications on the constitutionality” of other OSHA rules and regulations, said Benjamin Noren, associate chair of the Labor and Employment group at the law firm Davidoff Hutcher & Citron.