Tag: 2015 News

The Second District Court of Appeal reversed the WCAB finding that the medical evidence on the cause of the psychiatric injury and sleep disorder was not substantial evidence because it is based on an inadequate medical history. Here is what happened in the unpublished case of Radiator USA v. WCAB.

Am Kang sustained an admitted injury to his back on December 24, 2010 while working as a driver for Radiator USA. Kang additionally claimed to have sustained injury to his psyche in the form of a sleep disorder. David B. Pechman, M.D. was the AME in orthopedics. He noted that compression fractures in Kang’s vertebrae appeared old and he thought that most of Kang’s pain related to the compression fractures. Dr. Pechman apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease.

Rodney Bluestone, MD, the qualified medical evaluator of rheumatology, confirmed Kang had metabolic bone disease (osteopenia and osteoporosis) but could not determine a cause. Although Dr. Bluestone requested additional testing to determine the cause of the metabolic bone disease, there was no supplemental report that addressed causation.

Ana L. Nogales, Ph.D., evaluated Kang as a secondary treating physician in psychology. Dr. Nogales obtained a history of the injury, history of the treatment, and physical and emotional complaints exclusively from Kang. Dr. Nogales explicitly noted that she did not receive medical or employment records for review.

On the issue of causation, Dr. Nogales found that, as a “consequence of his industrial accident, Mr. Kang developed anxiety that increased with the passage of time and deteriorated at the end of 2011 when he saw that his condition is not improving.” Dr. Nogales opined that the “percentage of total causation of Mr. Kang’s current mental disorder is estimated at a higher level than the legal threshold of industrial causation of 50 [percent].” She specifically noted a nonindustrial causal factor of a dog bite in 2005 requiring stitches. Dr. Nogales made no mention of Dr. Pechman’s orthopedic diagnosis or his apportionment to the preexisting bone disease.

The matter was heard on September 26, 2013. The sole medical evidence of psychiatric industrial causation came from psychologist Dr. Nogales. Based upon this evidence, the WCJ issued findings of fact concluding Kang sustained industrial injury to his back, to his psyche, and in the form of a sleep disorder. Reconsideration was sought based “upon a lack of medical evidence to support this finding.” Reconsideration was denied. The appeals board found the doctors “based their opinions on extensive discussions with [Kang] regarding how he sustained his injury and his condition thereafter.” The appeals board found that, based on these discussions, Dr. Nogales concluded the industrial cause of Kang’s psychiatric injury was higher than the legal threshold. However the Court of Appeal reversed and remanded in the unpublished case.

In reversing the Court of Appeal noted that Dr. Nogales was completely unaware of the fact that Dr. Pechman had apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease. The Court posed the question does “this mean that 50 percent of the psychiatric injury is attributable to nonindustrial causes?”

The Court acknowledge that “these determinations cannot be made with mathematical precision, it is at least a major issue what portion of the psychiatric injury is attributable to nonindustrial causes. Although 50 percent is a reasonable surmise, on this silent record it is equally plausible to suppose that, given that psychiatric evaluations are unavoidably case-specific, 60 percent of the psychiatric injury – or 40 percent thereof – is attributable to nonindustrial causes. In short, what is needed here is an expert opinion that is based on a complete medical history, which necessarily includes Dr. Pechman’s finding that 50 percent of the orthopedic injury is attributable to nonindustrial causes.”

“Given the lack of competent medical evidence on causation, the decision of the appeals board cannot stand. It is now well established that the appeals board has an affirmative duty to develop an adequate record. As an example, where the medical evidence was evenly balanced on the issue of industrial causation, our Supreme Court held that the appeals board was not free to simply rule that the employee had failed to sustain his burden of proof but was required to take additional evidence in order to resolve the doubts raised by the existing medical reports”.

The decision of the appeals board is annulled and the matter is remanded for further proceedings consistent with this opinion.

As authorities conducted a drug raid on Salinas’ Chinatown last Thursday, a second set of federal officers searched a Salinas doctor’s office and home in connection with an alleged fraud case.

The Californian reports that Dr. Steven Mangar, who runs Pacific Pain Care Institute, was arrested on Valentine’s Day last year on suspicion of driving under the influence of methamphetamine. A California Highway Patrol officer stopped 44-year-old Mangar at Highway 101 and Sanborn Road. But, prosecutor Ed Hazel said the U.S. Department of Justice crime lab in Sacramento is so backed up, Mangar’s toxicology report was not available until last month. Mangar was charged Jan. 21. He was ultimately arraigned 364 days after his arrest. Mangar’s arraignment in Monterey County Superior Court followed a day after federal agents swooped down on his West Alisal Street office and his home on Madeira Avenue in Salinas. Authorities with the Monterey County District Attorney’s Office’s Health Care and Workers’ Compensation fraud units served the search warrant with help from the State Medical Board, the Department of Insurance, the Drug Enforcement Agency and the DOJ Office of the Inspector General. At the same time, another alphabet soup of agents searched Salinas’ Chinatown for methamphetamine, heroin, marijuana and cash. Twelve arrests stemmed from that raid.

Between 2005 and 2012, Mangar collected 10 traffic citations for minor incidents, Hazel said. In that time period, he was also sued four times in civil court. This was not the first time Mangar has come under scrutiny from the State Medical Board. On Oct. 5, 2012, Mangar was placed on three years’ probation following an investigation into his treatment between 2003 and 2010 of a 60-year-old man who had chronic neck pain. According to court documents, Mangar kept shoddy records that indicated he examined the patient at times when, in fact, he hadn’t. Mangar prescribed the man Percocet and Oxycontin, both powerful pain killers, according to the records. After the investigation, he was ordered to enroll in prescribing practices and record-keeping courses.

On May 15, 2013, Mangar was cited and fined $350 for failing to submit a quarterly declaration in conjunction with his probation.

On Nov. 6, 2014, Medical Board officials filed a petition to revoke Mangar’s probation. Doing so could result in the loss of Mangar’s physician’s and surgeon’s certificate. The petition revolved around Mangar’s treatment of a 40-year-old man with chronic back pain, according to court records. Although the patient’s quality of life didn’t improve, Mangar continued prescribing him Oxycontin. He later added in Ritalin when the man said he couldn’t stay awake. In doing so, Mangar acted unprofessionally and failed to develop an objective-oriented treatment plan, according to the allegation. A decision is still pending in that petition.

ProPublica analysis shows Mangar was the third-leading hydrocodone prescriber in California in 2012. Hydrocodone, also known as Vicodin, is another powerful pain killer. In 2012, 72 percent and 55 percent of Mangar’s 241 patients filled Schedule II and Schedule III drug prescriptions, respectively, according to ProPublica. Drugs are classified into five categories, per the DEA. Schedule II drugs are potentially highly addictive. Schedule III drugs carry a moderate to low risk of abuse. On average, specialists in Mangar’s area only prescribed Schedule II and Schedule III drugs 4 percent and 13 percent of the time, respectively. Only 23 percent of Mangar’s prescriptions were for brand names, compared with a 29 percent average at other specialists’ offices. But Mangar’s prescriptions also cost $170 on average compared with $99 from other prescribers.

Mangar, who is represented by defense attorney Susan Chapman, is expected to return to court March 5, Hazel said. Mangar and Chapman weren’t immediately available for comment.

The case of Fernando Martinez v Santa Clarita Community College District involves a denied claim of continuous trauma injury to his back, circulatory system, psyche, nervous system, hypertension,diabetes, and upper and lower gastrointestinal system.

The applicant objected to the report from the treating orthopedist Dr. Robert Reisch dated October 3, 2012, based upon “The disability status of the applicant’s medical condition.” The applicant simultaneously filed three separate requests for QME panels in the specialties of orthopedic, psychiatric and internal medicine. All of the requests are dated January 9, 2014. In each of the Form I 06s, the applicant checked off the box indicating that the reason that the QME panel is being requested is “§4062 (nonmedical treatment dispute under 4062).”

An Orthopedic panel issued February 7, 2014. Panels were issued in the specialties of psychiatry and internal medicine on February 10, 2014. The Defendant objected to the internal and psychiatric panels. The parties proceed to trial regarding the limited issue of whether the applicant is entitled to undergo QME panels in orthopedics, psychiatry and internal medicine. The WCJ ordered the defendant to authorize the orthopedic PQME evaluation and found that the applicant was not entitled to undergo PQME evaluations in the specialties of psychiatry and internal medicine, at the time of trial and that issues regarding applicant’s entitlement to psychiatric and internal PQME(s) after completion of the orthopedic PQME evaluation were deferred, with jurisdiction reserved.

The applicant petitioned for removal which was denied in what Lexis is characterizing as a “noteworthy panel decision.” The denial incorporated the reasoning of the WCJ as follows.

The applicant must first complete an initial PQME examination prior to obtaining PQME evaluations in other specialties. The applicant has not met the criteria in rule §31.7 for obtaining different specialties at the time of trial. The applicant also failed to submit the appropriate form to request QME panels regarding other specialties. As per Title 8 California Code of Regulations §31 7 a party “shall” utilize Form 31.7 to request an additional QME panel in a different specialty. It is noted that Fonn 31.7 requires that the prior PQME panel number be identified when requesting other specialties, which could not have been done in this case, as all three QME panels were improperly requested at the same time.

The applicant also failed to comply with the requirements of Labor Code §4062 regarding psychiatric and internal PQMEs. The applicant stated in the three QME requests that the reason for the QME panel is “§4062 (nonmedical treatment dispute under 4062).” However, the letter attached to each PQME request objects solely to the opinions rendered by orthopedist Dr. Reisch in his report dated October 3, 2012. In said report Dr. Reisch stated that the applicant was given refills of Voltaren gel, and was given a Toradol injection. Further, Dr. Reisch stated that the applicant was to continue working modified duties as previously. There is no reference in said report with regard to any alleged internal or psychiatric injuries or complaints. Moreover, the applicant did not object to the findings of a psychiatrist or internal doctor prior to requesting PQME panels in the specialties of psychiatry and internal medicine. Accordingly, the applicant failed to comply with the requirements of Labor Code 4062 with regard to obtaining a PQME panel in specialties other than orthopedics, at the time of trial.

Every year, the FDA inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However according to an investigation published in the JAMA Internal Medicine, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.

Charles Seife, a New York University journalism professor conducted literature research “to identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.” He reviewed 78 published papers on clinical trials with which the Food and Drug Administration (FDA) labeled “official action indicated” (OAI), meaning the agency found objectionable conditions or practices significant enough to warrant regulatory action, yet he found that only three of the papers mentioned the OAI status of the trials. The violations included researchers falsifying data and occurrences where clinical trial participants should have been ruled ineligible. His finding was published in the JAMA Internal Medicine “Research Misconduct Identified by the US Food and Drug Administration Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.”

“This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.” Seife concluded “When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.”

In one of the illustrative cases he reviewed, a case involving a trial of a chemotherapy regimen, the researcher eventually pleaded guilty to fraud and was sentenced to prison after poor results were hidden and a patient died from the treatment (United States of America v. Paul H. Kornak, 03-cr-00436 (Northern District of New York). “Although this episode is described in detail in FDA documents as well as court documents, none of the publications in the peer-reviewed literature associated with the chemotherapy study in which the patient died have any mention of the falsification, fraud, or homicide. The publications associated with two of the three other studies for which the researcher falsified documents also do not report on the violations,” according to the study.

“The FDA has legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect. However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants.”

The article concludes by saying “To better serve the public health, the FDA should make unredacted information about its findings of research misconduct more readily available. The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature. One possible mechanism for this would be to use the national clinical trials database: any OAI inspection affecting a trial site should be promptly noted at http://www.clinicaltrials.gov. The FDA should also create a website or a publicly available database that lists all OAI-rated inspections of clinical sites and provides links to copies of the relevant, unredacted, inspection-related documents.”

“The FDA should be more transparent about its findings of research misconduct; however, most of the burden for ensuring the integrity of the research in the peer-reviewed literature falls to the authors of the articles submitted to peer-reviewed journals. Currently, there is no formal requirement for authors seeking to publish clinical trial data to disclose any adverse findings noted during FDA inspections. Journals should require that any such findings be disclosed. Voluntary disclosures are never foolproof, but, as with conflict-of-interest statements, requiring authors and journals to be forthcoming about significant departures from good clinical practice will help raise the standard for the reporting of research toward greater transparency.”

The unpublished Court of Appeal decision in Electronic Waveform Lab v. EK Health Services addresses whether UR is an “official proceeding” within the meaning of Code of Civil Procedure section 425.16, subdivision (e)(2) (the anti-SLAPP statute [SLAPP is the abbreviation for strategic lawsuit against public participation]) and whether the trial court correctly resolved the motion to dismiss under that statute filed by defendant State Compensation Insurance Fund.

Waveform manufactures and sells an electrotherapy device, commonly known as an H-Wave device, which physicians may prescribe to assist in treating various muscular injuries. State Fund contracts with EK Health and “independent contractor individual physician reviewers” to provide UR services to workers covered by their employers’ workers’ compensation policies issued by State Fund. Waveform filed suit against EK Health, alleging that EK Health was “situated as a monopolistic ‘gate keeper’ to a significant and substantial market share of patients who are injured on the job.” Waveform further alleged that EK Health and the Reviewers conspired to defame Waveform and consistently denied the H-Wave device for treatment of individual patients, with the result that treating physicians asked Waveform to remove H-Wave equipment from doctors’ offices and physical therapy clinics. Waveform alleged that the conduct of all of the defendants violated the Cartwright Act (Bus. & Prof. Code, §§ 16720 et seq.) and that the acts of EK Health and of a subset of the Reviewers constituted intentional interference with prospective economic advantage and trade libel.

EK Health and the Reviewers filed a special motion to strike the complaint under section 425.16 (anti-SLAPP motion) which was denied. The denial of the EK Health motion was not appealed.

Waveform then filed a first amended complaint adding State Fund as a defendant. Waveform alleged that State Fund had implemented through EK Health a “blanket policy” to deny and reject physicians’ prescriptions for utilization of the H-Wave device in treatment of patients’ injures and that “[w]hile creating the appearance of reviewer independence, EK Health and the reviewers in fact complied with State Fund’s policy that all H-Wave requests be denied.” Waveform alleged, the policy “violates the independent medical decision-making that reviewers are required to engage in. . . .”

State Fund filed its own anti-SLAPP motion seeking to dismiss both causes of action alleged against it. The trial court ruled that State Fund had established that its actions arose from “official proceedings” as its actions constituted “statements made in connection with an issue under consideration in a legally-authorized official proceeding.” The trial court also concluded that plaintiff had not shown a probability of prevailing against State Fund at trial and for these reasons granted the State Funds anti-SLAPP motion and it was dismissed. The Court of Appeal reversed.

The parties contest whether UR is an “official proceeding authorized by law” as that term is used in section 425.16, subdivision (e)(2). State Fund argues that “official proceedings” include administrative agency actions involving review and investigation of grievances, and that the workers’ compensation UR system, which involves resolution of claims for medical treatment, should be similarly viewed. Waveform argues that the UR process is not quasi-judicial or part of a comprehensive statutory licensing scheme which is subject to judicial review by administrative mandate. The Court of Appeal ruled that it was not an official proceeding and distinguished UR from case law on arbitration proceedings by saying “UR review is medical rather than legal and informal rather than formal.” “For this reason alone, the trial court erred in concluding that UR is an “official proceeding” within the meaning of that term in section 425.16, subdivision (e)(2).”

The judgment dismissing State Fund from Waveform’s first amended complaint was reversed.