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Category: Daily News

Tramadol – The Other Opioid Crisis

The world has been told that the drug Tramadol, is safer than the OxyContins, the Vicodins, the fentanyls that have wreaked so much devastation. But now they are the root of what the United Nations named “the other opioid crisis” – an epidemic featured in fewer headlines than the American one, as it rages through the planet’s most vulnerable countries.

Mass abuse of the opioid tramadol spans continents, from India to Africa to the Middle East, creating international havoc some experts blame on a loophole in narcotics regulation and a miscalculation of the drug’s danger. The man-made opioid was touted as a way to relieve pain with little risk of abuse. Unlike other opioids, tramadol flowed freely around the world, unburdened by international controls that track most dangerous drugs.

But abuse is now so rampant that some countries are asking international authorities to intervene.

Grunenthal, the German company that originally made the drug, is campaigning for the status quo, arguing that it’s largely illicit counterfeit pills causing problems. International regulations make narcotics difficult to get in countries with disorganized health systems, the company says, and adding tramadol to the list would deprive suffering patients access to any opioid at all.

Tramadol has not been as deadly as other opioids, and the crisis isn’t killing with the ferocity of America’s struggle with the drugs. Still, individual governments from the U.S. to Egypt to Ukraine have realized the drug’s dangers are greater than was believed and have worked to rein in the tramadol trade. The north Indian state of Punjab, the center of India’s opioid epidemic, was the latest to crack down. The pills were everywhere, as legitimate medication sold in pharmacies, but also illicit counterfeits hawked by street vendors.

This year, authorities seized hundreds of thousands of tablets, banned most pharmacy sales and shut down pill factories, pushing the price from 35 cents for a 10-pack to $14. The government opened a network of treatment centers, fearing those who had become opioid addicted would resort to heroin out of desperation. Hordes of people rushed in, seeking help in managing excruciating withdrawal.

Jeffery Bawa, an officer with the United Nations Office on Drugs and Crime, realized what was happening in 2016, when he traveled to Mali in western Africa, one of the world’s poorest countries, gripped by civil war and terrorism. They asked people for their most pressing concerns. Most did not say hunger or violence. They said tramadol.

Most of it was coming from India. The country’s sprawling pharmaceutical industry is fueled by cheap generics. Pill factories produce knock-offs and ship them in bulk around the world, in doses far exceeding medical limits.

In 2017, law enforcement reported that $75 million worth of tramadol from India was confiscated en route to the Islamic State terror group. Authorities intercepted 600,000 tablets headed for Boko Haram. Another 3 million were found in a pickup truck in Niger, in boxes disguised with U.N. logos. The agency warned that tramadol was playing “a direct role in the destabilization of the region.”

The United Kingdom and United States both regulated it in 2014. Tramadol was uncontrolled in Denmark until 2017, when journalists asked doctors to review studies submitted to regulators to support the claim that it has a low risk for addiction, said Dr. Karsten Juhl Jorgensen, acting director of the Nordic Cochrane Centre and one of the physicians who analyzed the materials. They all agreed that the documents did not prove it’s safer.

The Broken FDA Drug Recall System

In mid-September the U.S. Food and Drug Administration received a 19-page document with some startling claims about a popular medicine. The online pharmacy Valisure, which tests prescription drugs before dispensing them, said it had found extremely high levels of a probable human carcinogen in the antacid ranitidine, best known under the brand name Zantac.  As for the carcinogen, NDMA, the FDA knew it well: For more than a year the agency had been recalling batches of the blood pressure medication valsartan because they were contaminated with it.

The FDA issued an alert, one that seemed to downplay Valisure’s findings. The agency said it had learned that some ranitidine medicines contained low levels of NDMA, but it wasn’t advising people to stop taking the drug. In fact, Valisure had found high levels of NDMA in every version of ranitidine it tested and concluded the problem was inherent to the molecule itself. In other words, if Valisure is correct, there is no safe version of ranitidine.

The muted quality of the FDA’s statement didn’t stop concern from going global. By mid-October, a month after the FDA’s alert, at least two dozen countries had pulled ranitidine from stores or halted its distribution. Numerous companies had acted on their own to slow or stop the supply of the drug. The FDA continued to conduct tests.

Finally, on Nov. 1, the agency announced that it had found higher-than-acceptable levels of NDMA in some ranitidine- though not nearly as high as Valisure detected. The FDA then deployed the strongest weapon available to it: The agency asked manufacturers to voluntarily recall some of the Zantac on the market.

At a time when a poorly policed global supply chain and demand for ever-cheaper generics have exposed drugs to new safety risks, an effective recall system is crucial. Spotting problems earlier is getting harder: From 2016 to 2018 the number of FDA inspections of drug manufacturers declined 10% overseas and 13% for domestic facilities, according to a recent report from the Government Accountability Office.

But the agency’s authority over this system is limited. It can only request a pullback – manufacturers can and do say no. It can’t contact patients directly; it relies on pharmacies for that. It doesn’t control how the recall is conducted or how its effectiveness is assessed.

Rosa DeLauro, in her role on the House committee that oversees the agency, has tried to give it more authority over recalls. She sponsored a bill that gave the FDA the power to order food recalls; it was signed into law by President Barack Obama in 2011. The agency also has recall power over manufacturers of vaccines, medical devices, infant formula, and tobacco products. As of last year, it can order a recall of opioids deemed dangerous. It can do all of that, but it can’t order a recall of any other prescription drug.

DeLauro tried to push a bill two years ago to change that.  The bill went nowhere. At least one reason was opposition to it from the trade group representing drug manufacturers. Now, after two high-profile recalls of common drugs have exposed flaws in the system, DeLauro plans to try again to give the FDA more clout.

When the federal government couldn’t make progress, states tried. The first was California, which, because of its size, can establish de facto national standards for industries. In 2004, California passed a law requiring electronic tracking of drugs all the way to the patient by 2009. The drug industry pushed back, saying the changes were technologically impossible to make that quickly. The deadline was extended to 2014. Nothing happened.

Then, in 2013, the industry preempted the California statute and its deadline by winning passage of a federal drug tracking law. The law created a uniform national system for electronically tracing pharmaceuticals from the manufacturer to the pharmacy’s back door. The industry was given 10 years – until November 2023 – to fully comply. Other countries trying to create tracking systems aren’t moving any faster, says Eric Marshall, executive director of a new industry governance group for implementation of the law.

The legislation exempts pharmacies completely. Even after the law goes into full effect, pharmacies won’t have to track which lots they sell to which customers. Nor will they be required to put lot numbers on labels. Some pharmacies do that now, and others don’t. One concern is patient privacy. To further complicate matters, high-volume pharmacies, such as mail-­order companies, mix pills from different lots. Pharmacies can also subdivide packages.

ACOEM Concerned About Cannabis Legalization and Safety

The American College of Occupational and Environmental Medicine (ACOEM), an international society of more than 4,000 occupational physicians and associated professionals, provides leadership to promote optimal health and safety of workers, workplaces, and environments. Occupational and environmental medicine is the medicine specialty devoted to prevention and management of occupational and environmental injury, illness and disability, and promotion of health and productivity of workers, their families, and communities.

ACOEM has taken the position that marijuana is an impairing substance and its legalization has huge public and workplace health implications.  Before passing any legislation legalizing this substance, the U.S. Congress should proceed deliberately and consider workplace safety when dealing with this complex issue.

To date, 33 states and the District of Columbia have legalized the medical and/or recreational use of marijuana. With most Americans living and working in states that allow some form of legal marijuana use, it is critical that safety be at the forefront of any policy discussions regarding the use of cannabinoids outside of the standard Food and Drug Administration approval process.

The current patchwork of laws to address marijuana use and workplace safety is detrimental to employees, employers, and the general public, notes ACOEM in its statement on the Legalization of Marijuana – Implications for Workplace Safety which was sent to all members of Congress late last week.

ACOEM urges legislators to carefully consider the impact of any federal marijuana legislation on workplace safety. “While there is much not known about marijuana, what is known is that marijuana can cause impairment which will interfere with safe and acceptable performance in the workplace,” said ACOEM president Stephen Frangos, MD. “Furthermore, this is particularly concerning for those individuals working in safety-sensitive positions where impairment can affect the health and safety of other workers, customers, the general public, or others.”

ACOEM notes that employers have a legal responsibility under the Occupational Safety and Health Administration’s general duty clause to protect employees from workplace illness or injury, and an ethical responsibility to prevent impaired workers from exposing themselves, their co-workers, and/or the general public to risk of harm.

Therefore, regardless of marijuana’s legal status in a jurisdiction, ACOEM strongly supports legislative proposals that allow employers to prohibit those employed in safety-sensitive positions from working while under the influence of marijuana.

Apple, Amazon and Google to Take Over Healthcare by 2030

“Healthcare is the biggest business in the world, and it is phenomenally broken,” says Peter Diamandis, cofounder of the X-Prize, Singularity University, and Health Longevity Inc. “So, do I think Apple and Google and Amazon can do a better job? A thousandfold.”

In his upcoming book, The Future Is Faster Than You Think, which will hit bookshelves in late January 2020, Diamandis makes the case for why he believes big tech companies are going to be running healthcare by 2030.

“We’re going to see Apple and Amazon and Google and all the data-driven companies that are in our homes right now become our healthcare providers,” he says, referring to smart speakers such as Google’s Assistant, Amazon’s Alexa, and Apple’s HomePod. While many of these home voice assistants started with simple tasks like restocking home pantries and surfacing cooking tutorials, they’re already starting to move into the business of managing family well-being.

Amazon has put significant effort into making Alexa a health resource. In the United Kingdom, it has partnered with the National Health Service to answer basic health questions such as “What are the symptoms for shingles?” or “What do you do if you have a cold?” It has also made Alexa compliant with U.S. HIPAA laws and signed partnerships with major healthcare insurers and providers so patients can access or remit health information through the device. To date, there are nearly 2,000 health wellness skills on its platform.

Similarly, the Google Assistant uses search to serve up information about medications, symptoms, and diseases, as well as physicians and medical services. Both the Google Home and the Echo have a Mayo Clinic-developed skill called First Aid that helps people navigate minor injuries. Meanwhile, Apple’s HealthKit takes a slightly different approach to tackling personal health. The kit connects to Apple’s own products such as the HomePod, iPhone, and Apple Watch as well as a bevy of devices from other companies, such as scales and blood pressure cuffs. The HealthKit can also tap into electronic medical records and other apps connected to hospitals and doctors. Essentially, it becomes a single repository for all your precious health data.

Diamandis believes the involvement of home health devices has the potential to lower costs by shifting care away from hospitals, where expenses can be much higher. This is the general idea behind telemedicine, but Diamandis thinks that big consumer tech companies will play a big role in driving that vision. He also thinks that these companies, which have mastered using personal data to anticipate user behavior, can use personal health data to make predictions about a person’s long-term health prospects and advise them accordingly.

Diamandis posits that the more information is available about you – your genetic makeup, your health history, what you ate for breakfast, the bacteria in your bowel movement, how you slept last night, what kind of sound you’re exposed to every day – the better artificial intelligence will be at spotting your potential for illness and suggesting care before the problem becomes intractable. This approach might shift the medical establishment from a structure that treats disease once it’s wreaking havoc in your body to one that prevents the disease from striking in the first place. “It is literally hundreds if not thousands of times cheaper to do that,” he says.

It is this cost savings that he believes will allow for new models of healthcare. Diamandis predicts Apple and Amazon will come up with a service where a person pays a company to keep them healthy, rather than to cover the cost of illness, based on their health history and daily activities.

Sedgwick Institute Book Ponders Future for Work Comp Systems

Sedgwick may have been established as a regional claims administrator in 1969, but it has since grown into a global provider of technology-enabled risk, benefits, and integrated business solutions, with 21,000 employees spread across 65 countries. The company’s solutions span from casualty risk to benefits, and property and loss adjusting to marine claims, alongside offering innovative technology platforms and global expertise in areas such as workers’ compensation, liability, property, disability, and absence management.

The Sedgwick Institute serves as an incubator for some of the best and brightest minds to advance the conversations that affect all the players in our industry, including injured and ill members of the workforce, insurance carriers, employers, property owners, third party claims administrators, brokers, lawmakers and medical providers.

The Sedgwick Institute has released a new book that takes a critical look at the workers’ compensation market and what the future holds for the industry.

Authored by Dr. Richard A. Victor of the Sedgwick Institute, “SCENARIOS FOR THE 2030s: Threats and Opportunities for Workers’ Compensation Systems” discusses the workers’ compensation-related challenges faced by US employers, as well as injured workers, lawmakers, and practitioners of occupational medicine. The book highlights the importance of workers’ comp and how such systems have remained despite social and economic changes.

Dr. Victor was appointed to the senior fellow position at Sedgwick Institute in 2016. He is the former founder and CEO of the Worker’s Compensation Research Institute.

One of the key topics discussed in Victor’s book is that workers’ compensation insurance costs could triple from 2016’s levels, while injured workers see no real change to their benefits. Victor observed in his studies that both employers and worker advocates have agreed that the systems could be “out of balance,” despite attempts to file through legislation and regulatory reforms.

This book also explores some of today’s most perplexing questions:

— Is there a plausible scenario where many state workers’ compensation systems remain in a dangerously unbalanced state?
— And where the workers’ compensation reform process is unable to restore a reasonable balance: What might cause that imbalance? What are the threats? Where are the opportunities?
— Why will the workers’ compensation reform process be unlikely to deliver effective solutions?
— What might replace state workers’ compensation systems?

“I am very fortunate that the Sedgwick Institute supported this work. It provides an opportunity to provoke system stakeholders to think outside the box about upcoming challenges to be faced by a critical part of our nation’s social safety net,” commented Victor.

“With more than 30 years of experience in insurance and large global corporate risk management, I am pleased to have the Sedgwick Institute stand behind a book that truly shines a light on the complexity and importance of the industry and the challenges that it faces,” said Sedgwick Institute director and Sedgwick senior vice-president of strategic solutions Christopher E. Mandel.

Amador County Staffing Company Owner Sentenced for Premium Fraud

The owner of a temporary staffing company was sentenced to 180 hours of community service, three years formal probation and ordered to pay $944,718 in restitution after pleading no contest to insurance fraud for underreporting payroll by approximately $4.9 million that resulted in a $944,718 loss to his insurer.

Michael Zendejas, 47, of Turlock, as the owner and president of Trinity Personnel Inc., an employment agency that provides temporary workers, obtained a workers’ compensation policy from State Compensation Insurance Fund (SCIF) in September 2014 through December 2016.

SCIF performed an audit of the policy and found that Zendejas significantly underreported the company’s payroll by $4.9 million and number of employees in order to receive a lower workers’ compensation insurance premium.

The joint investigation with the California Department of Insurance and the Amador County Workers’ Compensation Fraud Unit found Zendejas provided SCIF with fraudulent Employment Development Department and payroll documents resulting in the $944,718 loss in insurance premiums to his insurer.

On November 22, 2019, Zendejas pleaded no contest to insurance fraud. The case was prosecuted by the Amador County District Attorney’s Office.

Insurers Tell Supreme Court Obamacare was “Massive Bait-and-Switch”

The U.S. Supreme Court examined Obamacare for the fifth time on Tuesday. This time the case involves a group of insurers who are claiming the government (and thus taxpayers) owe them $12 billion in promised payments for the costs of providing Obamacare.

The Affordable Care Act promised to partially reimburse insurers if they lost money by covering people with preexisting conditions. The law said that the government “shall” make these payments. But in 2015, Congress attached riders to appropriations bills barring the use of the money for the promised payments.

The consequences were profound. By 2017 three-quarters of the original insurance providers were out of business, and several others stopped participating, leaving just six insurance providers and skyrocketing costs.

The insurers went to court, contending the government had cheated them of $12 billion in promised payments. The effort was to compel the Department of Health and Human Services to make the payments. Insurers involved in the case include Moda Health, Blue Cross and Blue Shield of North Carolina, Maine Community Health Options and Land of Lincoln Mutual Health Insurance Company.

Lower courts split on the merits of the legal claims. Oregon-based Moda Health won a $200 million judgment, but the $70 million claim from the now-defunct Land of Lincoln Health was rejected. A divided appellate court last June ruled against the insurers in a combined case, finding that Congress clearly took action to prevent federal payouts to the program.

Earlier this year the U.S. Supreme Court agreed to have the final word on the dispute. Oral argument was heard this week.

Inside the Supreme Court, lawyer Paul Clement, representing the insurers, told the justices that the case involves a “massive government bait-and-switch.”  When the government makes a promise to pay money, he said, it has to “keep its promise.”

Chief Justice John Roberts chimed in: You claim the insurance companies were “basically seduced” into this program, but they have good lawyers. Why didn’t they “insist upon an appropriations provision” in the law before putting themselves “on the hook for $12 billion?”

Clement replied that when the law was written in 2010, anyone who looked at the money-mandating language would have thought that was sufficient. “Now could it have been better … belt and suspenders,” asked Clement. “Sure, but it’s good enough.”

And so went the back and forth arguments. The case is now under submission, and the Supreme Court will decide the case, for or against the insurance companies, shortly.

Tort Claim Removable to Federal Court Until Employer Intervenes

Jose Gutierrez was injured while working for Green Team of San Jose, a waste disposal company. Gutierrez and his spouse initiated a personal injury suit in state court against Defendant McNeilus Truck & Manufacturing, Inc., the designer and manufacturer of the garbage trucks used by Green Team.

Defendant removed the action from California state court to federal court based on diversity of citizenship under 28 U.S.C. §1441(b).

Diversity jurisdiction in civil procedure provides that a United States district court in the federal judiciary has the power to hear a civil case when the amount in controversy exceeds $75,000 and where the persons that are parties are “diverse” in citizenship or state of incorporation, which generally indicates that they differ in state and/or nationality.

Mostly, in order for diversity jurisdiction to apply, complete diversity is required, where none of the plaintiffs can be from the same state as any of the defendants.

Once the case was in federal court, the Plaintiffs’ filed a motion to remand the case back to state court. A remand may be ordered either for lack of subject matter jurisdiction or for any defect in the removal procedure. 28 U.S.C. § 1447(c). Plaintiffs did not dispute that the parties are diverse and the amount in controversy exceeds the jurisdiction $75,000 minimum. Rather, Plaintiffs contend that this is a “nonremovable action” because Plaintiffs’ claims “aris[e] under” California’s worker compensation law.

28 U.S.C. § 1445(c) provides that “[a] civil action in any State court arising under the workmen’s compensation laws of such State may not be removed to any district court of the United States.” If section 1445(c) applies, a case is not removable even if it presents a federal question or there is diversity. Humphrey v. Sequentia, Inc., 58 F.3d 1238, 1244 (8th Cir. 1995).

However, the federal judge denied the motion for remand in the case of Gutierrez v McNeilus Truck & Manufacturing, Inc.

Plaintiffs contend that their claims “arise under” California’s workers’ compensation law not because their three claims for negligence, products liability and loss of consortium “arise under” California’s workers’ compensation law, but because California Labor Code section 3852 provides Gutierrez’s employer, Green Team, a right to subrogation.

A civil action ‘arises under’ a state’s workers’-compensation law when the worker’s-compensation law creates the plaintiff’s cause of action or is a necessary element of the claim. There is no question that an insurer’s suit under section 3852 to recover workers’ compensation benefits “arises under” California’s workers’ compensation law and is therefore nonremovable.

However, neither Green Team nor the workers’ compensation insurance carrier has sought to intervene. Neither is a party to this action. Plaintiffs anticipate that one or the other will assert their subrogation rights.

Only after a party lawfully intervenes in state court, the plaintiff’s otherwise removable claim can no longer be removed.

Court of Appeal Resolves WCAB Concurrent Jurisdiction Issue

Kirk Hollingsworth was involved in a fatal accident while working for defendant Heavy Transport, Inc. in June 2016. His wife, Leanne Hollingsworth, and son, Mark Hollingsworth, filed a wrongful death complaint in superior court on January 22, 2018.

Plaintiffs alleged that Heavy Transport did not have workers’ compensation insurance. They also alleged that defendant Bragg Investment Company purported to have merged with Heavy Transport in 1986, but that the two companies had always maintained separate operations. Plaintiffs asserted that Bragg “sought to extend Worker’s Compensation Benefits” to them. Plaintiffs also alleged that defective Bragg equipment contributed to the incident.

On March 14, 2018, Bragg and Heavy Transport filed an application for adjudication of claim with the WCAB. The application listed Bragg as the employer, included insurance information, and noted that a lawsuit had been filed.

Bragg and Heavy Transport demurred to plaintiffs’ complaint. They asserted that Heavy Transport was a fictitious business name for Bragg, and therefore they were the same entity. Bragg had a workers’ compensation policy that covered the accident, so plaintiffs’ action was barred by workers’ compensation exclusivity. The Superior Court overruled the demurrer.

In December 2018 the WCAB determined that the accident had occurred in the course of decedent’s employment. The WCAB then set a hearing for February 19, 2019 to determine if any applicable workers’ compensation insurance covered the incident.

Defendants made an application to the Superior Court that the civil case be stayed until the WCAB determined the insurance issue, which would then determine which tribunal had exclusive jurisdiction. Plaintiffs also had filed a motion with the WCAB to stay those proceedings, but rather than grant the motion, the WCAB set the case for trial before a WCAB arbitrator on June 6, 2019, on the issue of insurance coverage. The Superior Court conceded jurisdiction to the WCAB on the issue of insurance coverage.

Plaintiffs then filed a petition for writ of mandate in the Court of Appeal , and requested an order staying the June 6 arbitration scheduled in the WCAB proceeding. It issued an alternative writ and an order staying the WCAB proceedings, and requested briefing from the parties.

This case presented a relatively simple question: Which tribunal – the superior court or the WCAB – should resolve the questions that will determine whether the superior court or the WCAB has exclusive jurisdiction over plaintiffs’ claims?

The Supreme Court in Scott v. Industrial Acc. Commission (1956) 46 Cal.2d 76, 81, decided this issue in 1956, and held that whichever tribunal exercised jurisdiction first should make the necessary findings to determine which tribunal has exclusive jurisdiction over the remainder of the matter.

The Court of Appeal followed that rule, and found that the trial court erred by deferring to the WCAB to determine jurisdiction in the published case of Hollingsworth et al., v. The Superior Court of Los Angeles County et al., (2019) 84 Cal.Comp.Cases 718.

The WCAB argued the statement in Sea World Corp. v. Superior Court (1973) 34 Cal.App.3d 494, at p. 501 that “[p]recedential jurisdiction” – concurrent jurisdiction to determine exclusive jurisdiction – “may be the subject of waiver by the court having it.”

In Sea World the court cited Scott and several similar cases, and noted that “the court where jurisdiction first attaches may yield it, and that it is the right of the court to insist upon or waive its jurisdiction.” Here, however, the evidence does not support a finding of waiver or estoppel, and neither the WCAB or defendants assert facts to support such a finding.

To the contrary, from the initiation of the action, plaintiffs and defendants consistently asserted their respective positions regarding jurisdiction, unlike the employer in Sea World. Thus, waiver or estoppel does not compel us to depart from the rule in Scott.

Here, the superior court exercised jurisdiction first. Plaintiffs’ complaint was filed on January 22, 2018, and defendants’ demurrer was filed on March 5, 2018. Defendants’ WCAB application was filed on March 14, 2018. Under Scott, the appropriate tribunal to determine the question of exclusive jurisdiction is the superior court, because that tribunal exercised jurisdiction first.

San Joaquin County Doctor Indicted

A federal grand jury brought a 14-count indictment against a physician, Edmund Peter Kemprud M.D. charging him with prescribing opioids to patients outside the usual course of professional practice and not for legitimate medical purpose, U.S. Attorney McGregor W. Scott announced.

According to court documents, Kemprud was a physician licensed to practice medicine in California and maintained a medical practice in Dublin and Tracy.

Kemprud is a 1973 graduate of the University of California San Francisco School of Medicine. Medical Board records do not reflect any prior disciplinary matters against him.

Prosecutors say that on 14 occasions between Sept. 6, 2018 and March 13, 2019, Kemprud allegedly 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.

After Kemprud was arrested he pleaded not guilty at his arraignment. He is due back in court on Jan. 30. If convicted, he faces a maximum statutory penalty of 20 years in prison.

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 Vincenza Rabenn is prosecuting the case.