The WCAB has issued a number of panel level decisions since SB 863 eroding the jurisdiction of the UR and IMR process for technical mistakes that were claimed to have “invalidated” the process. These cases favored handing the issue of appropriate medical treatment over to the WCJ to decide. As a result UR/IMR seemed to be subjected to a slow death by a thousand such cuts.

However, the trend of erosion of UR/IMR jurisdiction may have suffered a setback at the hands of a June 2016 Court of Appeal published decision that has now been followed in at least one subsequent panel decision.

In the precedent setting case, Dorothy Margaris appealed the IMR determination to the appeals board. She argued argued that the IMR determination was invalid because Maximus failed to issue it within the 30-day time period . The judge agreed the IMR determination was issued 13 days late, but nevertheless found the determination was valid and binding on the parties, concluding that an untimely IMR determination “does not confer jurisdiction on the [workers’ compensation judge] to decide any medical treatment issues.”

A majority of the three-member panel agreed with applicant and went on to find, contrary to the IMR determination, that the proposed treatment was supported by substantial medical evidence and was consistent with the treatment schedule promulgated by the director. One member of the panel dissented, and would have found that the IMR determination, though untimely, was valid and binding on the parties.

But the Court of Appeal intervened, disagreed with the WCAB and reversed in the published case of California Highway Patrol and SCIF v WCAB (Margaris).

The Court of Appeal ruled that the 30-day time limit in section 4610.6, subdivision (d), is directory and, accordingly, an untimely IMR determination is valid and binding upon the parties as the final determination of the director. The Court of Appeal interpretation of the statute in this manner is consistent with long-standing case law regarding the mandatory-directory dichotomy, and implements the Legislature’s stated policy that decisions regarding the necessity and appropriateness of medical treatment should be made by doctors, not judges.

Shortly after Magaris was decided, the WCAB reviewed the case of Christopher Tyni v City of Montebello. Tyni sustained industrial injury to his right knee while employed by the City as a Police Officer.

He sought reconsideration of the Findings And Order of the WCJ, who found that the Independent Medical Review (IMR) in this case was “untimely,” but that the untimely IMR determination “does not confer jurisdiction on the WCJ to decide any medical treatment issues.”

The panel affirmed that the “WCAB has no authority to determine the treatment dispute because the time periods for completion of IMR contained in Labor Code section 4610.6(d) are directory not mandatory, and the IMR determination in this case is valid and binding upon applicant even though it issued outside the time described in the statute.1 (California Highway Patrol v. Workers’ Comp. Appeals Board (Margaris) (June 22, 2016, No. B269038) _Cal.App.4th_ [2016 Cal. App. LEXIS 491] (Margaris).”

The workers’ compensation industry is always interested in better medical outcomes for injured workers. What is difficult is to set standards for what measures and quantifies a better outcome.

Holding a treating physician accountable for a treatment outcome starts and ends with a competent outcome measure used throughout the treatment process. In scientific terms, this is know as the “pre-test” and “post-test” assessment model. Simply stated, measure the attributes to be treated before anything is done. Then perform the medical or surgical intervention. Then measure the outcome to see if it worked. In this way you can circumvent vague generalized sweeping medical chart entries like “the patient came in today much improved” and replace that with competently measured data.

Orthopaedic surgeons traditionally rely on X-rays, MRI, CT scans, physical measurements, and functional tests for patient outcomes assessments, but this is changing thanks to new technology that communicates ongoing, real-time outcomes feedback from patients, according to research published in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS).

Two studies described the benefits of the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) to objectively and quantifiably assess and track patient symptoms over time. PROMIS also evaluates the impact of surgical and nonsurgical interventions using the same system to compare and contrast treatment options.

“Orthopaedic surgeons are interested in accurately measuring the outcomes of our treatments,” said Alpesh A Patel, professor of orthopaedic surgery at Northwestern University School of Medicine, in a companion editorial. “Of all the advances in our profession in the last 20 years, one of the most important has been the renewed focus on our patients and their own interpretations of their care.”

New PROMIS approaches apply principles of item-response theory, which allows for reliable and efficient estimation of underlying health traits to assess physical function in the upper and lower extremities. The system fosters shared physician-patient decision making and is proving superior to legacy measures. It has been validated in patient populations with orthopaedic disorders of the foot and ankle, upper extremity, and spine.

Until now, patient outcomes scores were evaluated almost exclusively for research purposes, but the data are becoming more valuable in helping doctors and patients assess clinical progress and recovery from surgery. Typically, patients answer surveys in the doctor’s office on iPads and their responses go to a data warehouse for scoring and near-immediate transmission to the physician.

“The data we receive from patients reporting on their pain, level of disability, daily function, and overall quality of life can be compared with hundreds of other patients with the same disease or injury,” said Darrell Brodke, coauthor of one of the studies and professor and vice chair of the Department of Orthopaedics at University of Utah School of Medicine. “So the conversation with patients would be: ‘This is where you’re at now and here is where we expect you to be.'”

Brodke added that use of patient-reported outcomes data is expanding rapidly in orthopaedic practices for tracking and assessing patient progress following surgery and also for determining whether surgery is the most appropriate option.

“PROMIS is our best path forward for capturing high-quality, meaningful information for our patients,” noted Dr. Patel. “PROMIS will be the new standard of patient-reported outcome measures and should be incorporated into orthopaedic research moving forward. How we define success and value will continue to evolve, but patients’ perspectives on their care should remain at the centre of our discussions.”

The Senate voted overwhelmingly to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines. It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine.

According to Reuters Health, the 21st Century Cures Act was passed last week by the House of Representatives and will now go to President Barack Obama to sign into law. Supporters say it will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.

“For the second consecutive year, the Senate is sending the President another Christmas miracle for his signature,” Senator Lamar Alexander, a Republican from Tennessee said in a statement. “Last year, it was the Every Student Succeeds Act, and this time, it’s the 21st Century Cures Act – a bill that will hbelp virtually every American family.”

Critics of the legislation say it gives massive handouts to the pharmaceutical industry and will lower standards for drug and medical device approvals.

“This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” consumer watchdog Public Citizen said in a statement.

Democratic Senator Elizabeth Warren was among the handful of senators who voted against the bill, as was independent senator and former Democratic presidential candidate Bernie Sanders. Each decried what they described as big handouts to the pharma industry. Even so the bill passed 94-5. The House passed it by a vote of 392-26.

The $6.3 billion act, sponsored by Republican Representative Fred Upton, authorizes $4.8 billion for the National Institutes of Health and $500 million to the Food and Drug Administration.

It also calls for $1 billion over two years to battle the opioid epidemic. On Tuesday the Drug Enforcement Administration issued a report showing that in 2014 about 129 people died every day as a result of drug poisoning. Of those, 61 percent are opioid or heroin related.

“Opioids such as heroin and fentanyl – and diverted prescription pain pills – are killing people in this country at a horrifying rate,” Acting Administrator Chuck Rosenberg said. “We face a public health crisis of historic proportions.”

The bill also calls for $1.8 billion in funding for Vice President Joseph Biden’s Cancer Moonshot initiative designed to bolster cancer research by reducing bureaucracy and promoting research collaboration.

Critics note that the money described in the bill must be appropriated by separate funding bills and that the money may ultimately never materialize. Yet the changes to the clinical trial process, something long sought by the drug industry, will be set in stone regardless of whether money for the research projects is forthcoming.

Among those changes: Greater prominence will be given to “real world” evidence gathered outside the framework of a randomized, controlled clinical trial, the gold standard for determining whether a drug is safe and effective. Such evidence could be much easier for drug companies to collect.

“The passing of 21st Century Cures Act is a show of extraordinary bipartisan unity after a divisive election that should be celebrated,” said Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research.

Under the Act patient input will be formally incorporated into the FDA’s drug review process.

Funding for the Act will be offset by reductions in some Medicaid payments and through the sale of oil from the Strategic Petroleum Reserve. The White House supports the bill but said earlier it was concerned that draining the Petroleum Reserve “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”

Plaintiffs in these actions for personal injury and wrongful death allege that take-home exposure to asbestos was a contributing cause to the deaths of Lynne Haver and Johnny Kesner, and that the employers of Lynne’s former husband and Johnny’s uncle had a duty to prevent this exposure.

In the first case, Johnny Blaine Kesner, Jr., was diagnosed with perotineal mesothelioma in February 2011. He filed suit against a number of defendants he believed were responsible for exposing him to asbestos and causing his mesothelioma.

Johnny’s uncle, George Kesner, worked at the Abex plant in Winchester, Virginia, for much of George’s life, where George was exposed to asbestos fibers released in the manufacture of brake shoes. According to George, Johnny spent an average of three nights per week at his uncle’s home from 1973 to 1979. When Johnny was at his uncle’s home, he would sometimes sleep near George or roughhouse with George while George was wearing his work clothes.

Johnny alleged that his exposure to asbestos dust from the Abex plant, carried home on his uncle’s clothes, contributed to his contracting mesothelioma. Johnny died in December 2014, after the Court of Appeal issued its judgment in this matter. Cecelia Kesner is his successor in interest.

In the companion case, Lynne Haver was diagnosed with mesothelioma in March 2008 and died in April 2009. Her children, Joshua Haver, Christopher Haver, Kyle Haver, and Jennifer Morris (the Havers), filed a wrongful death and survival action alleging negligence, premises owner and contractor liability, and loss of consortium. They allege that Lynne’s exposure to asbestos by way of her former husband, Mike Haver, caused her cancer and death.

Mike was employed by the Atchison, Topeka, and Santa Fe Railway, a predecessor of BNSF Railway Company from July 1972 through 1974. In his position as fireman and hostler for BNSF, Mike was exposed to asbestos from pipe insulation and other products. The Havers allege that Mike carried home these asbestos fibers on his body and clothing, and that Lynne was exposed through contact with him and his clothing, tools, and vehicle after she began living with him in 1973.

Neither the Havers’ nor Kesner’s suit reached a jury as a result of the holding in Campbell v. Ford Motor Co. (2012) 206 Cal.App.4th 15, 34 (Campbell), which held that “a property owner has no duty to protect family members of workers on its premises from secondary exposure to asbestos used during the course of the property owner’s business.” The California Supreme Court granted review in both cases and consolidated them for argument and decision. The dismissal of their cases was reversed in Kesner v Superior Court.

In reversing the California Supreme Court held that the duty of employers and premises owners to exercise ordinary care in their use of asbestos includes preventing exposure to asbestos carried by the bodies and clothing of on-site workers.

Where it is reasonably foreseeable that workers, their clothing, or personal effects will act as vectors carrying asbestos from the premises to household members, employers have a duty to take reasonable care to prevent this means of transmission.

This duty also applies to premises owners who use asbestos on their property, subject to any exceptions and affirmative defenses generally applicable to premises owners, such as the rules of contractor liability.

Importantly, the Supreme Court held that this duty extends only to members of a worker’s household. Because the duty is premised on the foreseeability of both he regularity and intensity of contact that occurs in a worker’s home, it does not extend beyond this circumscribed category of potential plaintiffs.

The obvious question that arises out of this decision is what other types of toxic claims will follow? Or will this case be strictly limited to asbestos exposure?  If not limited only to asbestos, the potential for this case to open a Pandora’s box of secondary claims by immediate family members of workers injured by toxic materials in the workplace will no doubt follow. These secondary claims will not be limited to worker’s compensation by the exclusive remedy rule, and it is unclear what insurance, if any, will be responsible for indemnification.  

A federal jury in Dallas last Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to six California plaintiffs who said they were injured by Pinnacle hip implants.

The jurors found that the metal-on-metal Pinnacle hip implants were defectively designed and that the companies failed to warn consumers about the risks.

J&J, which faces more than 8,000 lawsuits over the hip implants, said in a statement it would immediately appeal the verdict and was committed to defending itself and DePuy from further litigation over the Pinnacle devices.

The six plaintiffs awarded more than $1 billion are California residents who were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

According to plaintiff’s lawyer Mark Lanier, the total verdict of $1.041 billion included $32 million in compensatory damages. The rest were punitive damages.

Verdicts of such size are often scaled back by courts. In July, the judge presiding over this case, U.S. District Judge Edward Kinkeade, reduced a $500 million verdict in an earlier Pinnacle implant case to $151 million, citing a Texas state law that limits punitive damages awards.

J&J and DePuy have been hit with nearly 8,400 lawsuits over the devices, which have been consolidated in Texas federal court. Test cases have been selected for trial, and their outcomes will help gauge the value of the remaining claims.

The verdict on Thursday came in the third test case, with the second producing the earlier $500 million verdict. J&J and DePuy were cleared of liability in the first test case in 2014

The company rejected a $1.8 million settlement offer from the plaintiffs before trial, Lanier said.

The plaintiffs in the second test case have appealed Kinkeade’s decision to cut the award. Johnson & Johnson and DePuy have also appealed the jury verdict in the case.

John Beisner, J&J’s attorney, said the company will ask the appeals court to postpone any additional trials over the implant defects.

DePuy ceased selling the metal-on-metal Pinnacle devices in 2013 after the U.S. Food and Drug Administration strengthened its artificial hip regulations.

J&J and DePuy also paid $2.5 billion that year to settle more than 7,000 lawsuits over its ASR metal-on-metal hip devices. The ASR devices were recalled in 2010 due to high failure rates.