Author: WorkCompAcademy

Mallinckrodt Pharmaceuticals, based in Staines-upon-Thames, England, with its U.S. headquarters in St. Louis, Missouri, produces specialty pharmaceutical products, including generic drugs and imaging agents. Key generic specialty products include Hydrocodone API and tablets and Oxycodone API and tablets

As of 1988, Mallinckrodt was the only company in the US that is allowed to receive cocaine, which it has used to make cocaine hydrochloride, a prescription drug used in hospitals as a local anesthetic by eye and ear, nose and throat doctors.

To combat an escalating opioid epidemic, the Drug Enforcement Administration trained its sights in 2011 on Mallinckrodt Pharmaceuticals. It was the first time the DEA had targeted a manufacturer of opioids for alleged violations of laws designed to prevent diversion of legal narcotics to the black market. And it would become the largest prescription-drug case the agency has pursued.

Ultimately, the DEA and federal prosecutors would contend that the company ignored its responsibility to report suspicious orders as 500 million of its pills ended up in Florida between 2008 and 2012 – 66 percent of all oxycodone sold in the state. Government investigators alleged in internal documents that the company’s lack of due diligence could have resulted in nearly 44,000 federal violations and exposed it to $2.3 billion in fines, according to confidential government records and emails obtained by The Washington Post.

But six years later, after four investigations that spanned five states, the Washington Post reports that the government has taken no legal action against Mallinckrodt. Instead, the company has reached a tentative settlement with federal prosecutors, according to sources familiar with the discussions. Under the proposal, which remains confidential, Mallinckrodt would agree to pay a $35 million fine and admit no wrongdoing.

“Mallinckrodt’s response was that ­‘everyone knew what was going on in Florida but they had no duty to report it,” according to an internal summary of the case prepared by federal prosecutors and obtained by The Post.

The case shows how difficult it is for the government to hold a drug manufacturer responsible for the damage done by its product. DEA investigators appalled by rising overdose deaths said they worked for years to build the biggest case of their careers only to watch it falter on uncertain legal territory and in the face of stiff resistance from the company.

The drug company said that the agreement in principle is subject to additional review and approval by the U.S. Justice Department and U.S. Drug Enforcement Administration and will not have a material effect on Mallinckrodt’s financial condition. In a statement, a Mallinckrodt spokesman said the company has worked hard to fight drug diversion.

The U.S. attorney’s office in Detroit, which is handling the case, issued a statement. “Our office works diligently to use all the legal tools available to us to hold corporations responsible for their actions,” acting U.S. attorney Daniel Lemisch said. “This is particularly true in a highly regulated industry such as the manufacture of opioids. As this case is still in settlement negotiations, we cannot comment on the specifics of the matter.”

According to a 2016 Workers’ Compensation Benchmarking Study survey, national claims leaders rank psychosocial issues as the number one barrier to successful claim outcomes.

A new white paper shows how claims advocacy principles at The Hartford, CNA, Nationwide, and Albertsons Companies are taming the effects of psychosocial issues and coaching injured workers to recovery and claim resolution. In order to understand these findings, it is important to take a brief look at what “psychosocial” is and, perhaps more importantly, what it is not.

The Hartford’s medical director, Dr. Marcos Iglesias, says that the “psych” part does not mean psychiatric issues, such as schizophrenia, personality disorders, or major depressive disorders. Instead, he points out, “we are talking about behavioral issues, the way we think, feel, and act.  An example is fear of physical movement as it may worsen one’s impairment or cause pain, or fear of judgment by coworkers.”

The Hartford’s text mining has found the presence of “fear” in claim notes was more predictive of poor outcomes than a lumbar fusion surgery. Similar findings were recently cited by both Lockton and the Workers’ Compensation Research Institute (WCRI) which independently report that workers who express fear are at greater risk of poor outcomes.

There is no shortage of studies demonstrating the dramatic impact of psychosocial roadblocks and just how hard they are to manage. Lockton’s study directly links worker fears with high litigation rates. Another from the Journal of Occupational and Environmental Medicine found that injured workers with emotional distress, such as pain catastrophizing and activity avoidance, were seven times less likely than those in the low-risk group to return to work within three months.

Other conditions, behaviors, and predicaments include obesity, hard feelings about coworkers, troubled home life, the lack of temporary modified work assignments, limited English proficiency, and – most commonly noted – poor coping skills. Additionally, being out of work can lead to problems such as increased smoking, alcohol abuse, illicit drug use, and risky sexual behavior. Suicide rates have been observed to increase by a factor of six.

The national medical director for Albertson Companies uses a modified Linton tool for screening injured workers for psychosocial comorbidities. Approximately nine percent of screened workers receive specialist intervention, which is usually performed by a network of psychologists who provide health coaching consistent with cognitive behavioral therapy principles. This intervention method is short in duration and focuses on active problem-solving with the patient.

Albertson’s medical director cautions that, with the long-tail nature of workers’ compensation claims, it will take three or four years before the strategy’s impact can be effectively measured in claim outcomes, but she is optimistic. Her tentative estimate is duration of disability and medical spending will decline by 20 percent.

When peeling back the psychosocial onion, one can see how adversarial, compliance, and task-driven claim styles are 1) ill-suited for addressing fears, beliefs, perceptions, and poor coping skills and 2) less likely to effectively address these roadblocks due to the disruption they pose to workflows and task timelines.

This short report – “How to Overcome Psychosocial Roadblocks: Claims Advocacy’s Biggest Opportunity” – examines key best practices, skill sets, and training approaches organizations are using to screen for, intervene in, and effectively address psychosocial factors. Rooted in advocacy, these strategies treat the injured worker as a whole person to proactively resolve non-medical barriers to timely recovery.

Pete Romo worked as a firefighter for three different fire departments. He was a volunteer firefighter for Marinwood from 1989 to 1991 and the San Antonio Volunteer Fire District in Sonoma County from 2002 to 2006. From 2006 through trial of his WCAB case, he was employed full time as a paid firefighter for the City of Mill Valley. While working for Mill Valley, Romo was diagnosed with prostate cancer.

Romo filed a claim for workers’ compensation benefits with each of the three fire departments for which he had worked. Mill Valley and San Antonio stipulated that the statutory presumption that cancer suffered while employed as a firefighter arises out of the employment would apply to them if the elements set forth in labor code section 3212.1 were proven.

Marinwood contested the application of the presumption. It was established in the 1950s as an all-volunteer fire department. By the 1980s, it had a paid fire chief and two paid professional firefighters for each shift. At the time Romo was a volunteer firefighter there, Marinwood had a total of seven paid firefighters and 24 volunteer firefighters.

The WCJ concluded that Romo was “an active volunteer firefighting member of [Marinwood] from mid-1989 to early 1991 within the meaning of Labor Code sections 3212.1 and 3361” and that he “is entitled to the extension of the presumption under Labor Code section 3212.1, since he is within 120 months of the ‘last date actually worked in the specified capacity.’ ” The WCAB denied Marinwood’s Petition for Reconsideration.

The Court of Appeal affirmed the WCAB in the published decision of Marinwood Community Services v WCAB (Ramos)

Section 3352 excludes certain categories of persons from the term “[e]mployee” as used in the workers’ compensation statutes. Subdivision (i) of that section generally excludes volunteers. Section 3361 is a nuanced exception to this exclusion for “Each member registered as an active firefighting member of any regularly organized volunteer fire department…” Marinwood contends it is not (and was not when Romo was a volunteer firefighter there) a “regularly organized volunteer fire department” within the meaning of section 3361.

The Court of Appeal concluded that the language “volunteer fire department” in section 3361 is ambiguous in regard to whether it extends to a department comprised predominantly, but not exclusively, of volunteers. “The WCAB’s interpretation of section 3361 is reasonable, and we give it weight. Its interpretation is consistent with the purpose of the statutory scheme.”

Marinwood next contends the WCAB misconstrued section 3212.1 presumption terms that it “shall be extended to a member following termination of service for a period of three calendar months for each full year of the requisite service, but not to exceed 120 months in any circumstance, commencing with the last date actually worked in the specified capacity.” Marinwood argues the above-quoted sentence should be applied separately to each employer for whom a firefighter worked.

The WCJ and WCAB interpreted the language in subdivision (d) “last date actually worked in the specified capacity” to mean the last day worked in the capacity of a firefighter for any employer. The Court of Appeal agreed and concluded that “the WCAB’s interpretation of section 3212.1 in this and other cases furthers the purpose of the cancer presumption.”

Daniel Ramirez sustained an injury to his lower leg and ankle in the course of his job as an office assistant for the State Department of Health Care Services. The claims were administered by the State Compensation Insurance Fund.

Ramirez settled his case by stipulations providing him with further medical treatment for the injury. The treatment included a gym/swim membership, and, over the course of about one and a half years.

His physician prescribed another 12 sessions of acupuncture. The utilization review recommended that the requested treatment be denied. Ramirez appealed the utilization review denial under the independent medical review process. IMR upheld the UR decision.

Ramirez appealed the decision of the independent medical review to the Board. The grounds for the appeal were that the independent medical reviewer “may have been subject to a material conflict of interest that is in violation of Section 139.5,” and the “determination may have been the result of bias on the basis of race, national origin, ethnic group identification, religion, age, sex, sexual orientation, color, or disability.”

Ramirez wanted discovery to determine whether the doctor performing the independent medical review was biased or had a conflict of interest. He also raised constitutional violations regarding the UR/IMR process which were beyond the jurisdiction of the WCAB. The appeal was taken off calendar pending resolution of the constitutional issues.

Ramirez filed a petition for writ of review with the Court of Appeal. His constitutional challenges were rejected in the published case of Ramirez v WCAB.

The Court concluded that the Board had no jurisdiction to review a utilization review that was alleged to be defective for failure to follow the medical treatment utilization schedule. Whether the utilization review followed the medical treatment utilization schedule is directly related to a determination of medical necessity. By statute, a review of a determination of medical necessity is limited to the medical professionals performing the independent medical review.

On the constitutional challenges, the Court affirmed the prior decision of Stevens v. Workers’ Comp. Appeals Bd. (2015) 241 Cal.App.4th 1074 on these issues.

Safety violations citations issued to staffing firm Barrett Business Services following a September 28, 2011 carbon monoxide warehouse incident in Anaheim that sent eight temporary workers to the hospital were upheld by the Occupational Safety and Health Appeals Board (OSHAB).

For months prior to the incident, the workers contracted by Barrett Business Services to package fruits and nuts in L&L Foods’ warehouse in Anaheim had complained to their supervisor that they were experiencing headaches, nausea and other health issues caused by forklifts operating in an enclosed area with poor ventilation. Neither the Ontario-based staffing company nor host employer L&L Foods took any action.

On the day of the incident, a forklift driver became ill and was hospitalized for carbon monoxide (CO) poisoning, while seven other workers were taken to the hospital for treatment.

Cal/OSHA tested the facility and found the workers were exposed to CO levels of 250-350 parts per million, which exceeded the ceiling limit of 200 parts per million. Following an investigation, Cal/OSHA issued citations in 2012 to both Barrett Business Services and L&L Foods for numerous safety violations, including willful violations for failing to take action on known hazards.

Both employers filed appeals protesting the citations; L&L Foods settled its case on April 22, 2013. Following a lengthy appeal process that started in 2013, an administrative law judge last April denied Barrett’s appeal and imposed total civil penalties of $80,050.

Barrett objected to the appeal decision and on August 29, 2016, filed a petition for reconsideration with the Appeals Board.

The Board rendered its decision last December, citing evidence gained from Cal/OSHA’s investigation that the employer did not properly train its employees, disregarded workers’ reports of health hazards and failed to monitor the worksite.

The evidence revealed that L&L Foods had sealed all of the vents at the facility to prevent vermin from entering the establishment. Barrett did not assess the safety conditions for the enclosed environment, failed to control the increased carbon monoxide levels in the workplace and continually disregarded worker’s reports of headaches and nausea from the fumes.

The citations issued included three violations for one general, one willful general and one willful serious category violation. A willful violation is cited when the employer is aware of the law and violates it nevertheless, or when the employer is aware of the hazardous condition and takes no reasonable steps to address it.

A serious violation is cited when there is a realistic possibility that death or serious harm could result from the actual hazard created by the violation.

A general violation is cited when an accident or occupational illness resulting from violation of a standard would probably not cause death or serious physical harm, but would have a direct or immediate relationship to the safety or health of employees.