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DOJ Claims Interest in Multi-District Opioid Litigation

The Department of Justice announced it will be filing a Statement of Interest in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors.

The plaintiffs include numerous cities, municipalities, and medical institutions that have borne the costs of the prescription opioid crisis. The plaintiffs seek to recover the costs associated with providing treatment and public safety measures relating to the opioid epidemic from those who allegedly used false, deceptive, or unfair marketing practices for prescription opioid drugs.

The Justice Department will primarily argue that the federal government – through various federal health programs and law enforcement efforts – has borne substantial costs from the opioid epidemic and seeks reimbursement.

Named in the litigation are opioid manufacturers Purdue Pharma LP, Johnson & Johnson, Teva Pharmaceutical Industries Ltd, Endo International PLC and Allergan PLC and the three biggest drug distributors in the country – AmerisourceBergen Corp, Cardinal Health Inc and McKesson Corp..

The consolidated litigation pending before U.S. District Judge Dan Polster involves at least 355 lawsuits filed by cities, counties and others.

Polster has been pushing for a quick, global settlement in the litigation and has invited state attorneys general who have cases in state courts or who are conducting a multistate probe of the companies to participate in those talks.

The first settlement hearing was held in January. A second one is expected March on 6.

The Justice Department is not expected to participate in the settlement discussions. Its statement of interest in the litigation will allow it to eventually get a share of the final settlement the companies pay.

Plaintiffs’ lawyers have not quantified the potential costs involved in the cases but have compared them with the litigation by states against the tobacco industry that led to 1998’s $246 billion settlement.

Consideration of Cancer “Latency Period” Required for AOE-COE

Richard Johnson worked as a firefighter for the City of South San Francisco (CSSF) from March 1973 to October 2001. He then worked for the City of Pacifica (Pacifica). He was exposed to known carcinogens during each period of employment. He was diagnosed nasopharyngeal cancer in 2007.

The cancer was found to have initially manifested itself during 2005, when Johnson first noted symptoms of nasal obstruction. The disability was found to have occurred in 2007, during Johnson’s employment with Pacifica.

Johnson filed a workers’ compensation claim against Pacifica. He invoked the presumption of section 3212.1 that cancer manifesting during (or within certain periods following) employment as a firefighter that involves exposure to known carcinogens arose out of and in the course of that employment.

Pacifica denied liability and joined CSSF as a party to the case. CSSF eventually settled with Johnson for all of his cancer-related compensation, and it then sought contribution from Pacifica. An arbitrator denied the petition, ruling that evidence of the latency period for the cancer suffered by Johnson showed the injurious exposure under section 5500.5(a) occurred during Johnson’s earlier employment with CSSF. The Workers’ Compensation Appeals Board (WCAB) upheld and adopted the arbitrator’s order.

CSSF petitioned for review, contending the WCAB, in adopting the arbitrator’s determination, erroneously utilized a more lenient preponderance evidentiary standard in applying section 5500.5(a), rather than the more stringent cancer presumption rebuttal standard provided in section 3212.1. The Court of Appeal affirmed the WCAB in the published case of City of South San Francisco v WCAB, City of Pacifica.

Labor Code section 3212.1 establishes a presumption that cancer manifesting during and for a specified period following employment in certain public safety positions, including firefighters, arose out of and in the course of that employment.

Section 5500.5, subdivision (a) (section 5500.5(a)), however, limits employer liability for a cumulative injury to the employer who employed the applicant during the one year preceding the earliest of (1) the date of injury or (2) the last date of injurious exposure to the hazards that caused the injury. Thus, either CSSF or Pacifica would be potentially responsible for compensation for the entire injury, dependent upon the proper application of section 5500.5(a).

The arbitrator determined the date of injury was in 2007. The dispositive issue was whether the last injurious exposure resulting in the injury occurred during CSSF or Pacifica employment.

The Court of Appeal ruled that an employer is not liable under section 5500.5(a) absent evidence that exposure during that employment was a contributing cause of the disease or injury, i.e., that the exposure was injurious.

Section 3212.1 does not eliminate the requirement that an industrial injury be proximately caused by the hazardous exposure. Instead, it applies presumptions of a causal link between exposure to the industrial hazard (a known carcinogen) and the manifested injury (cancer), unless the employer disproves the existence of such a link.

California Voters to Revisit Billion Dollar Stem Cell Funding

California received its first royalty check on $3 billion in bonds sold to support stem cell research. Now, debate is kicking up on whether a $190,346 check is enough of a return on investment to get voters’ OK for billions more to fund the state stem cell agency, the California Institute for Regenerative Medicine (CIRM).

The payment from City of Hope, a Los Angeles County-based research center, comes as supporters of CIRM gear up for a 2020 voter initiative to fund another series of billion-dollar bond sales. The current authority to sell bonds ends in 2019.

Connecticut, Maryland, New Jersey, and New York also are among the states publicly funding stem cell research, though none to the extent of California in issuing billions of dollars in bonds.

In the aggregate, CIRM has awarded $2.48 billion to fund stem cell research, including infrastructure such as lab construction at Stanford University and University of California campuses, since voters approved Proposition 71 creating the agency in 2004.

California Proposition 71 was on the November 2, 2004 general election ballot in California as an initiated constitutional amendment. Voters approved it. The measure has been codified as Article XXXV of the California Constitution and is also known as the California Stem Cell Research and Cures Initiative.

The City of Hope’s Beckman Research Institute paid the state $190,346 according to a CIRM royalty formula when the agency awarded the institute $5.125 million to develop stem cell therapies for glioblastoma, an aggressive form of brain cancer. The payment was announced Feb. 12.

The 2012 City of Hope award led to two clinical trials and a number of offshoot inventions subsequently licensed to a Mustang Bio, a subsidiary of Fortress Biotech Inc., CIRM spokesman Kevin McCormack said in a blog post.

But, as the original funding based upon Proposition 71 is about to run out, the promoters of CIRM are out with a new scheme to get another $5 billion from California taxpayers. The initial $3 billion in bonds were estimated to cost the state $5.5 billion to $6 billion in interest and principal over their 30-year life.

CIRM battled lawsuits over Prop. 71’s validity that hindered California’s ability to sell bonds and defended against complaints about built-in conflicts for the initiative requiring disease advocates and researchers sit on the governing board.

Victorville Physician Arrested for Illegal Opioid Prescriptions

A medical doctor was arrested on federal charges of illegally selling prescriptions without a legitimate medical purpose to undercover operatives who visited the physician’s Victorville medical office.

Wendell Mark Street, 66, of Las Vegas, was arrested without incident at his residence by special agents with the Drug Enforcement Administration.

Street is a 1981 graduate of the Medical College of Wisconsin. He practiced at 14075 Hesperia Road in Victorville, Street surrendered his California medical license in 2016.

The 44 page Accusation filed by the California Medical Board in December 2014 essentially details prescriptions written to a number of patients who are identified only by their first and last name initials. Details are provided on how each of them was prescribed controlled substances in violation of law or professional standards. By February 23, 2016, Street and his attorney, Thomas Chapin Esq., signed a Stipulated Surrender of License.

The arrest is the result of a 10-count indictment returned by a federal grand jury on February 9. The indictment charges Street with five counts of illegally distributing the painkiller oxycodone and five counts of illegally distributing the tranquilizer alprazolam (often sold under the brand name Xanax). Street allegedly issued the prescriptions in 2013 in exchange for cash “while acting and intending to act outside the usual course of professional practice and without a legitimate medical purpose.”

Street allegedly wrote prescriptions without performing any physical examinations in exchange for $200 to $300 in cash from each of two undercover investigators with the California Medical Board and an informant. During the investigation into Street, investigators executed a search warrant at his Victorville office in 2014.

Street is expected to make his initial appearance in the United States District Court in Las Vegas. The five counts related to illegal distribution of oxycodone each carry a statutory maximum penalty of 20 years in federal prison. The five counts related to alprazolam each carry a sentence of up to five years in prison.

This case is being prosecuted by Assistant United States Attorney Victoria A. Degtyareva of the Organized Crime Drug Enforcement Task Force.

Red Bluff City Councilman Gets Jail Time for Comp Fraud

A former Red Bluff City Councilman who pleaded guilty in November to four felonies was sentenced Thursday to a five-year, eight-month suspended prison sentence and placed on probation for five years. The Record Searchlight reported that the 44-year-old Suren Patel, who faced a maximum seven-year, eight-month sentence, pleaded guilty tin November to workers’ compensation fraud, grand theft and two counts of public officer crime.

Under the sentence handed down Thursday, Patel will have to serve 364 days in jail, minus 120 days of custody credits, do 80 hours of community service and pay more than $12,500 in restitution. If he violates his parole, he faces nearly eight years in prison.

Tehama County Superior Court Judge Matthew C. McGlynn, who labeled Patel a thief who has shown no remorse for his crimes, imposed the suspended sentence as recommended by probation officials.

After court, Tehama County District Attorney Gregg Cohen, who argued that Patel deserved a prison sentence, said he was “disappointed” in the ruling because Patel violated his position of public trust as a Red Bluff City Councilman and should go to prison. “He certainly deserved it,” he said.

Patel entered his guilty pleas on Nov. 17, but did so without being guaranteed a stipulated sentence, said Tehama County Assistant District Attorney Matt Rogers Patel was originally charged with seven criminal counts that included perjury, elder theft, and conspiracy to commit a crime.

Cohen has said Patel had been the subject of an investigation that started in 2015 that culminated in his July 2016 arrest in Florida.

Patel, the former owner of the American Best Valley Inn in Red Bluff, was arrested as he tried to board a plane, Cohen has said.

Among charges Patel faced were theft, not paying taxes to the city and fraud.  Cohen said Patel did not pay taxes he owed to the city as owner of the American Best Valley Inn. He was investigated for embezzlement in connection to a complaint filed by a guest at the hotel who said her credit card was charged $6,000 after she stayed there, Cohen said. Restitution has been made in her case, he said.

Authorities opened the investigation against Patel in March 2015 and that May the District Attorney’s Office took computers, cell phones and business records from the hotel.

During the investigation, the DA’s Office learned Patel had not paid workers’ compensation insurance and was committing welfare fraud by getting two employees benefits, Cohen has said.

DWC Suspends Popular AME – As He Remains in Jail

An Oakland orthopedic surgeon, and popular AME, who surrendered his medical license last year on grounds of sexual and unprofessional conduct, has now also been suspended from participating in California’s workers’ compensation system.

The DWC said John David Warbritton III, M.D. was one of 20 medical providers it recently suspended from participating in the workers’ compensation system, bringing the total number of providers suspended to 197.

Warbritton was a graduate of Harvard Medical School in 1980, and had an office at Frank Ogawa Plaza in Oakland. He surrendered his medical license on April 7, 2017, after the California Medical Board accused him of sexually harassing two of his workers’ compensation patients.

Warbritton is also facing felony criminal charges in federal court for allegedly transporting child pornography.

The criminal indictment, which was filed on Oct. 13, 2016, alleges that Warbritton violated federal law by knowingly transporting child pornography. He was initially released on an unsecured bond.

But, after the United States Pretrial Services officer reported a violation of his conditions of release (possessing child pornography images on a mobile phone), the Honorable Magistrate Judge Elizabeth D. Laporte held a bail review hearing on January 17, 2017, and detained Dr. Warbritton. He was placed in the Santa Rita Jail.

Last May, he filed a Motion to Reopen his Detention Hearing. His lawyers claimed that “At the time of the alleged offense conduct and the subsequent pretrial release violation in this matter, Dr. Warbritton was suffering from both opioid use disorder and sexual impulsivity disorder.” They claim he subsequently began treatment with Carolyn Ann Schuman, M.D. for his opioid addiction, and that “his incarceration ultimately allowed him to “dry out” from the use of opioids and allowed the Suboxone treatment employed by Dr. Schuman to take effect.”

Prosecutors opposed the Motion claiming “defendant has been a hands-on offender because the defendant was arrested after returning to the United States from Thailand, where he admitted to agents he has spent long periods of time for the last several years” And among the child pornography taken from him by authorities, “one photo collage depicted the defendant along with an Asian female aged 8-10 years old. ….This photograph collage also raises concerns about whether the defendant may be a hands-on offender or someone who was preparing to do so.”

Prosecutors concluding by saying there are no conditions of release that could reasonably assure the safety of the community. Warbritton remains in custody awaiting trial.

Crawford & Company/Broadspire Opens in Australia

Crawford & Company announced the expansion of its service portfolio in Australia to include workers’ compensation. This capability will be delivered through Broadspire, the TPA solution of Crawford & Company. The company’s workers’ compensation service offering will support existing customers and other large insurers, corporations and government departments.

“We are excited to bring our workers’ compensation solution to the Australia market to complement our other professional claims solutions which are already well established in country,” said Stuart Greaves, head of Broadspire Australia. “The expansion enables us to further Crawford’s mission of restoring and enhancing lives, businesses and communities as we work to provide the best care for those affected by injury.”

As part of its market launch, Broadspire is sponsoring the 19th Annual National Workers’ Compensation Summit in Sydney to introduce the new service line to insurers, brokers, government bodies and self-insured organizations.

“Providing professional claims management on workers’ compensation claims, along with appropriate clinical oversight for injured employees is a critical aspect of the services we provide,” said Danielle Lisenbey, global president, TPA Solutions for Broadspire.

“Each risk management program is designed around individual client needs to help reduce claims costs and workers’ compensation premiums.”

Broadspire’s workers’ compensation claims solution includes injury management services, legal cost containment, subrogation and a full suite of analytics. This is combined with medical management and multi-disciplinary expertise that it says can help ensure a swift and healthy return to work for employees.

Anthem Accuses Sonoma West Med Center of Fraud Scheme

Anthem Blue Cross is accusing Sonoma West Medical Center and Palm Drive Health Care District of participating in a business fraud scheme that has resulted in more than $13.5 million in improper payments to the medical center.

In a Feb. 9 letter to both the district and medical center,  According to the report in Reuters, Anthem threatened legal action and demanded the money be repaid. District and hospital officials say they’ve done nothing wrong and are preparing a response to the insurance giant.

The Anthem letter states that the medical center “appears to have conspired with several third parties to fabricate or misrepresent claims for toxicology testing services that were improperly billed to Anthem.”

Anthem alleges the fraudulent billing began after Sonoma West Medical Center partnered with Florida-based Durall Capital Holdings and its testing laboratory, Reliance Laboratory Testing.

The partnership with Durall was forged last year as a way to help the financially strapped hospital. In exchange for more than $2 million in much-needed funds, the hospital agreed to conduct toxicology testing for Durall, using part of the money to buy equipment.

John Peleuses, the medical center’s CEO, said the arrangement has been extremely helpful for the hospital, which has actually started showing a profit since September.

The insurance company says that according to the medical center’s own public records, health care providers from around the country send their patients’ specimens to Reliance’s Florida facility, which then distributes specimens to various labs for screening, including the one at Sonoma West Medical Center.

“Reliance Labs keeps a portion of the specimen and conducts testing on it, while purportedly passing on a portion of the sample to Sonoma West for additional testing,” Anthem’s letter states.

“Sonoma West bills Anthem for some or all of this testing – representing that it had performed the services when, in fact, it had not,” the letter states.

Peleuses rejected the claim that no testing is being done at the Sebastopol hospital. “We dispute the assertions in the letter and a response to Anthem is being prepared to address their concerns,” Peleuses said.

Anthem said a review of claims submitted by the medical center were for drug testing on urine samples where the patients “had no connection whatsoever with Sonoma West. That is, the patients were not treated at Sonoma West, nor were they treated by a physician connected with Sonoma West who ordered laboratory services to be performed at Sonoma West.”

Anthem’s letter, written by the insurance company’s associate general counsel Steven Cohen, pointed out that the medical center, as a hospital, “receives substantially higher amounts for urine drug testing, often 10 times or more, relative to the lesser amount” Anthem would pay clinical laboratories like Reliance.

“Indeed, it is that reimbursement delta that appears to be the only value that Sonoma West brings to its partners in the scheme,” Cohen wrote.

But Peleuses said there was nothing improper about billing at the higher rate, particularly in the case of rural hospitals which need higher reimbursement rates to stay competitive. Peleuses also said it was common for toxicology testing to be done by laboratories that do not take samples from patients.

Anthem gave the district and hospital until Friday to respond to several demands.

Alanna Brogan, executive director of the Palm Drive Health Care District, said a response would be submitted by Friday. “There are a number of inaccuracies in the letter and we will be responding to Anthem Blue Cross,” she said The district has scheduled a closed session Friday at 10 a.m. to discuss the matter.

Are Anti-Depressant Drugs Effective?

A vast research study that sought to settle a long-standing debate about whether or not anti-depressant drugs really work has found they are indeed effective in relieving acute depression in adults.

The international study – a meta-analysis pooling results of 522 trials covering 21 commonly-used antidepressants and almost 120,000 patients – uncovered a range of outcomes, with some drugs proving more effective than others and some having fewer side effects.

But all 21 drugs – including both off-patent generic and newer, patented drugs – were more effective than placebos, or dummy pills, the results showed.

“Antidepressants are routinely used worldwide yet there remains considerable debate about their effectiveness and tolerability,” said John Ioannidis of Stanford University in the United States, who worked on a team of researchers led by Andrea Cipriani of Britain’s Oxford University.

Cipriani said these findings now offered “the best available evidence to inform and guide doctors and patients” and should reassure people with depression that drugs can help.

The study, published in The Lancet medical journal, found some differences in the effectiveness of the 21 drugs.

In general, newer antidepressants tended to be better tolerated due to fewer side effects, while the most effective drug in terms of reducing depressive symptoms was amitriptyline – a drug first discovered in the 1950s.

Some well-known medicines – such as the selective serotonin reuptake inhibitor (SSRI) fluoxetine, sold under the Prozac brand – were slightly less effective but better tolerated.

The scientists noted that their study could only look at average effects, so should not be interpreted as showing that antidepressants work in every patient. Only around 60 percent of people prescribed depression medication improve, Cipriani said.

“Unfortunately, we know that about one third of patients with depression will not respond to them,” he said. “It’s clear there is still a need to improve treatments further.”

Several experts not directly involved in the study said its results gave a clear message. “This meta-analysis finally puts to bed the controversy on antidepressants,” said Carmine Pariante, a professor at Britain’s Institute of Psychiatry, Psychology and Neuroscience.

James Warner, a psychiatrist at Imperial College London, added: “Depression causes misery to countless thousands every year and this study adds to the existing evidence that effective treatments are available.”

Philip Sobol Sent to Lompoc Prison for 21 Months

Philip Sobol M.D., an orthopedic surgeon, agreed with Michael Drobot to receive kickbacks in exchange for performing surgeries at Pacific Hospital of Long Beach or referring spinal surgery patients to physicians who would perform the spinal surgeries at Pacific Hospital.

Sobol and Drobot concealed the kickbacks through a series of sham agreements including a management agreement and option agreement. Sobol received approximately $5.2 million dollars in kickbacks.

On November 24, 2015, Sobol entered into an agreement to plead guilty to a two-count information that charged him with Conspiracy in violation of 18 U.S.C. § 371, and Interstate Travel in Aid of a Racketeering Enterprise in violation of 18 U.S.C. § 1952.

Prosecutors filed a Sentencing Report in his criminal case on December 5. On February 24, 2017, the United States Probation Office reported that his sentencing range was 46-57 months’ imprisonment. The report noted that Sobol had agreed to pay restitution but “did not identify any victims from the harm.”

But prosecutors say the Court should apply an additional two level increase because the offense involved more than ten victims.

Prosecutors reported that “it is difficult to determine exactly how many surgeries defendant referred where he received a kickback because the kickbacks were paid through sham management and option agreements that were designed to approximate the number of surgeries referred or performed at Pacific Hospital, Drobot admitted in his plea agreement that he paid between $10,000 and $15,000 per surgery performed.”

His Sentencing Hearing was set for February 16, 2018. On that day, the federal court entered the following order.:

“Pursuant to the Sentencing Reform Act of 1984, it is the judgment of the Court that the defendant, Philip A. Sobol, is hereby committed on Counts 1 and 2 of the Information to the custody of the Bureau of Prisons for a term of 21 months. This term consists of 21 months on each of Counts 1 and 2, to be served concurrently.”

“Upon release from imprisonment, the defendant shall be placed on supervised release for a term of three years. This term consists of three years on each of Counts 1 and 2 of the Information, all such terms to run concurrently..”

“It is further ordered that the defendant surrender himself to the institution designated by the Bureau of Prisons at or before 12 noon, on July 16, 2018. In the absence of such designation, the defendant shall report on or before the same date and time, to the United States Marshal located at the United States Court House, 411 West Fourth Street, Santa Ana, California 92701- 4516.”

“It is recommended that the Bureau of Prisons designate confinement of defendant to the Lompoc, California facility.”