Category: Daily News

Reuters reports that Endo International Plc and Allergan Plc have agreed to pay $15 million to avoid going to trial in October in a landmark case by two Ohio counties accusing various drug manufacturers and distributors of fueling the U.S. opioid epidemic.

The tentative deals disclosed on Tuesday came ahead of the first trial to result from 2,000 lawsuits pending in federal court in Cleveland largely by local governments seeking to hold drug companies responsible for the deadly epidemic.

Endo announced said it had reached an agreement-in-principle to pay Cuyahoga and Summit counties $10 million to and provide them up to $1 million worth of two of its of its drug products free of charge.

Allergan has tentatively agreed to pay $5 million to resolve claims involving its branded opioids, though the deal does not resolve claims involving generic painkillers, said Frank Gallucci, a lawyer for Cuyahoga County.

The accords are the first to result from the counties’ cases, which were selected for the first bellwether, or test, trial in the litigation to allow parties to gauge the value of the remaining claims and inform potential settlement talks.

Other companies still set to face trial on Oct. 21 include drugmakers Purdue Pharma LP, Teva Pharmaceutical Industries Ltd and Johnson & Johnson and drug distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp.

Endo, which in 2017 withdrew its painkiller Opana ER from the market, said the settlement includes no admission of wrongdoing.

More than 2,300 lawsuits by state and local governments are pending nationally, accusing drug manufacturers of deceptively marketing opioids in ways that downplayed their risks and drug distributors of failing to detect and halt suspicious orders.

Most of the lawsuits are before U.S. District Judge Dan Polster in Cleveland, who has pushed for a settlement and will preside over the bellwether trial.

Purdue and Teva this year settled claims by Oklahoma’s attorney general for $270 million and $85 million, respectively, ahead of a trial before a state-court judge.

The state subsequently took Johnson & Johnson to trial. An Oklahoma judge will rule on Monday on whether the company should be held liable in a lawsuit by the state’s attorney general who argues the drugmaker should be forced to pay $17 billion for fueling the opioid epidemic.

Ehsan Alnimri sustained injury to his low back on June 20, 2010, while employed by Southwest Airlines as a ramp agent Ontario International Airport. He was required frequent lifting and carrying of weights up to 70 pounds and it occasionally involved lifting up to 100 pounds.

He was taken off work by his PTP, Dr. Sobol until September 2010 when he was returned to full duty.  Alminri continued to work full duty without restriction until he was taken off the job on November 26, 2011.

Dr. Sobol the PTP issued findings based on the AMA Guides of approximately 28 % but with no work restrictions appearing in the report. Dr. Wakim found 14% impairment under the AMA Guides and found work restrictions which precluded him from very heavy lifting on a constant basis and 70 pounds on an occasional basis.”

On November 26, 2011, Alnimri was informed that he was being removed from duty due to a doctor’s report, but was not told which one. He eventually obtained a supplemental report from Dr. Wakim which returned him to full duty as of May 2012. He actually returned to work on June 20, 2012. Thus he was removed from work until June 19, 2012, when he returned to work without restrictions.

The parties resolved the case in chief by Stipulations with Request for Award on August 8, 2013. It proceeded to trial on the remaining L.C. 132a claim for the lost pay between November 26, 2011 and June 19, 2012. The WCJ ruled in favor in Alnimri finding discrimination under L.C. 132a, and awarded a $10,000 penalty and back wages. The WCAB affirmed in th panel decision of Alnimri v Southwest Airlines.

The WCAB conceded the determination by the California Supreme Court in Department of Rehabilitation v. Workers’ Comp. Appeals Bd (Lauher) (2003 ) 30 Cal.4th 1281, 1298-1299 [68 Cal.Comp.Cases 831] that an employer “does not necessarily engage in ‘discrimination’ prohibited by section 132a merely because it requires an employee to shoulder some of the disadvantages of his industrial injury. By prohibiting ‘discrimination’ in section 132a, we assume that the Legislature meant to prohibit treating injured employees differently, making them subject to disadvantages not visited on other employees because the employee was injured or had made a claim.”

But, the panel went on to say “Based on its specific application to the facts of Lauher, we view the Court’s phrase “singled out for disadvantageous treatment ” to be an application of the broader standard adopted by Lauher-that, in addition to showing that he or she suffered an industrial injury and that he or she suffered some adverse consequences as a result of some action or inaction by the employer that was triggered by the industrial injury, an applicant “must also show that he or she had a legal right to receive or retain the deprived benefit or status, and the employer had a corresponding legal duty to provide or refrain from taking away that benefit or status.” (Lauher, supra at p. 1300.) Stated another way, an employee must show they were subject to “disadvantages not visited on other employees because they were injured. .. .” (Id.) Because the employee in Lauher was not deprived of a legal right to TDI, and therefore could not show he was treated differently than other employees with respect to his alleged detriment, he could not establish a prima facie case of discrimination.”

“Thus, on the record before us, including the absence of evidence that defendant acted upon its decision to refer applicant to a company physician or otherwise complete its usual process for resolving conflicts between work status reports before dismissing applicant, we conclude that defendant subjected applicant to disadvantages not visited upon other employees because they were injured.”

Created in 1984, the U.S. Preventive Services Task Force is an independent, volunteer panel of national experts in prevention and evidence-based medicine. The Task Force works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications. All recommendations are published on the Task Force’s Web site and/or in a peer-reviewed journal.

The influential group of health experts recommended that doctors screen all adults for use of illegal drugs, another step toward curbing the epidemic that claims tens of thousands of lives each year.

The U.S. Preventive Services Task Force said that health providers should attempt to determine whether their patients 18 or older are using illicit drugs, including nonmedical use of prescription drugs. But the panel said it did not have enough information to decide whether all adolescents should be screened.

The recommendation is the first time the panel has concluded there is enough evidence to support screening all adults. In 2008, it declined to do so.

The guidance is important because the Affordable Care Act requires that services recommended by the task force be covered free or with very small co-payments. The proposed recommendations are open for public comment until Sept. 9, after which the task force will consider them for final approval.

The panel concluded screening is effective when “services for accurate diagnosis of unhealthy drug use or drug use disorders, effective treatment, and appropriate care can be offered or referred.”

It cited the findings of a 2017 national survey that 11.5 percent of Americans 18 or older were using illegal drugs at the time and data that showed that 8.5 percent of pregnant women aged 18 to 44 had used drugs in the past month.

Among drug users aged 12 and over, 85.3 percent said they used cannabis and 19.5 percent used “psychotherapeutic drugs,” including opioids and other pain relievers.

In 2017, 70,237 people died of drug overdoses in the United States, according to the Centers for Disease Control and Prevention.

The panel suggested several questionnaires, administered by health care providers or taken by patients on their own, that it said were effective in picking up illicit drug use. It warned primary care providers that “screening tools are not meant to diagnose drug dependence, abuse, addiction, or use disorders. Patients with positive screening results may therefore need to be offered or referred for diagnostic assessment.”

It said providers also would have to be aware of state requirements for reporting results to legal authorities.

A new study published in the British Journal of Sports Medicine suggests that surgeons are no better at determining which patients might benefit from operations to treat torn knee cartilage than if they just flipped a coin.

Researchers surveyed 194 surgeons to see whether they would recommend surgery or exercise therapy in 20 test cases with middle-aged patients who had tears in the meniscus, the cartilage that works as a cushion between the shin and thigh bones.

Overall, surgeons correctly predicted which patients would benefit from operations only half of the time. And experienced knee surgeons were no better at guessing correctly than other orthopedic surgeons.

These findings offer one reason these knee operations remain common despite a growing body of evidence suggesting many patients don’t benefit, said Dr. Victor van de Graaf, lead author of the study and a researcher at University Medical Centre, Utrecht, in the Netherlands.

“Orthopedic surgeons believe they are capable of identifying which patients may still benefit more from surgery,” van de Graff said by email. “Therefore, our findings may help to further decrease the number of unnecessary performed surgeries.”

During the operation, a surgeon makes a small incision in the knee and inserts a tiny camera called an arthroscope to view the inside of the joint, locate and diagnose the problem, and guide repairs. Sometimes surgeons remove all of the meniscus, and other times they only remove part of it.

While the procedure is minimally invasive, it’s not risk-free. Patients receive anesthesia, which in any surgery may lead to complications such as allergic reactions or breathing difficulties. In addition, this specific procedure might potentially damage the knee or trigger blood clots in the leg.

Among patients who didn’t respond to surgery, only 39% of the surgeons correctly foresaw this outcome. And among patients who didn’t respond to exercise therapy, only 29% of surgeons correctly predicted this outcome.

For patients who did benefit from surgery, surgeons correctly predicted this outcome 60% of the time. And for patients who benefited from physical therapy, surgeons correctly chose this outcome in 72% of cases.

In the same journal, a study published in June went further, concluding that it’s impossible to predict who might benefit from arthroscopic meniscus repair surgery.

Kenneth Pihl of the University of Southern Denmark in Odense and his colleagues built a model based on the real-world outcomes after one year for 641 patients who had undergone the surgery. Out of 18 preoperative factors that surgeons and the medical literature consider predictive of who will benefit, none predicted the actual results for these patients, Pihl’s team found.

The hospital costs of the American medical system are so high that it made financial sense for both a highly trained orthopedist from Milwaukee and Donna Ferguson, a patient from Mississippi, to leave the country and meet at an upscale private Mexican hospital for the surgery. Ferguson gets her health coverage through her husband’s employer, Ashley Furniture Industries.

According to the report in Kaiser Health News, Ferguson is one of hundreds of thousands of Americans who seek lower-cost care outside the United States each year, with many going to Caribbean and Central American countries. A key consideration for them is whether the facility offers quality care.

In a new twist on medical tourism, North American Specialty Hospital, known as NASH and based in Denver, has organized treatment for a couple of dozen American patients since 2017.

Its website proclaims: “The North American Specialty Hospital is committed to providing an exceptional level of quality in healthcare, with pricing that is bundled, transparent, and competitive. NASH accomplishes its mission by tapping into the finest in cross-border resources – from renowned physicians on either side of the border to state-of-the-art facilities. Headquartered in Denver, Colorado, NASH is designed to provide pre-operative and post-operative services throughout the United States, while providing clinical care in Cancun – a city connected by daily, non-stop, and year-round air service from airports located throughout the United States and the entire Western Hemisphere.

Donna Ferguson awoke in the resort city of Cancun before sunrise on a sweltering Saturday in July. She wasn’t headed to the beach. Instead, she walked down a short hallway from her Sheraton hotel and into Galenia Hospital.

A little later that morning, a surgeon, Dr. Thomas Parisi, who had flown in from Wisconsin the day before, stood by Ferguson’s hospital bed and used a black marker to note which knee needed repair. “I’m ready,” Ferguson, 56, told him just before being taken to the operating room for her total knee replacement. For this surgery, she would not only receive free care but would receive a check when she got home.

The cost to her employer, Ashley Furniture Industries, was less than half of what a knee replacement in the United States would have been. That’s why its employees and dependents who use this option have no out-of-pocket copayments or deductibles for the procedure; in fact, they receive a $5,000 payment from the company, and all their travel costs are covered.

Parisi, who spent less than 24 hours in Cancun, was paid $2,700, or three times what he would get from Medicare, the largest single payer of hospital costs in the United States. Private health plans and hospitals often negotiate payment schedules using the Medicare reimbursement rate as a floor.

Parisi, a graduate of the Mayo Clinic, is one of about 40 orthopedic surgeons in the United States who have signed up with NASH to travel to Cancun on their days off to treat American patients. NASH is betting that having an American surgeon will alleviate concerns some people have about going outside the country, and persuade self-insured American employers to offer this option to their workers to save money and still provide high-quality care.

NASH, a for-profit company that charges a fixed amount for each case, is paid by the employer or an intermediary that arranged the treatment.

The American surgeons work closely with a Mexican counterpart and local nurses. NASH buys additional malpractice coverage for the American physicians, who could be sued in the United States by patients unhappy with their results.

Medical tourism has been around for decades but has become more common in the past 20 years as more countries and hospitals around the world market themselves to foreigners.

The high prices charged at American hospitals make it relatively easy to offer surgical bargains in Mexico: In the United States, knee replacement surgery costs an average of about $30,000 – sometimes double or triple that – but at Galenia, it is only $12,000, said Dr. Gabriela Flores Teón, medical director of the facility.

The standard charge for a night in the hospital is $300 at Galenia, Flores said, compared with $2,000 on average at hospitals in the United States.

The other big savings is the cost of the medical device – made by a subsidiary of the New Jersey-based Johnson & Johnson – used in Ferguson’s knee replacement surgery. The very same implant she would have received at home costs $3,500 at Galenia, compared with nearly $8,000 in the United States.

Galenia is accredited by the international affiliation of the Joint Commission, which sets hospital standards in the U.S. But to help doctors and patients feel comfortable with surgery here, NASH and Galenia worked to go beyond those standards.