Category: Daily News

California’s top court on Thursday opened the door for consumers to sue Novartis AG and other makers of brand-name pharmaceutical products over injuries blamed on generic versions of the drugs manufactured by other companies.

The case is T.H. v. Novartis Pharmaceuticals Corporation, California Supreme Court, No. S233898.

The California Supreme Court’s ruling broke with decisions nationally to the contrary and created exposure for brand-name drugmakers who could be sued in the state for failing to warn users about the risks of cheaper, generic versions of their drugs.

Reuters Health reports that Leslie Brueckner, the plaintiffs’ lawyer, said the decision was the only one currently by a state’s top court to favor consumers of generic drugs, who legally cannot sue generic drugmakers for not warning about their products’ risks. “This is just a huge victory for public health and safety, and this victory will be felt nationwide,” she said.

Novartis, whose appeal had the support of industry groups including the U.S. Chamber of Commerce, said it disagrees with the court’s decision to potentially hold it responsible for an injury caused by a different company’s product.

The decision came in a lawsuit centered on two twin children who were diagnosed with developmental delays and autism after their mother while pregnant took a generic version of Brethine to suppress premature labor.

Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.

The father of the children, referred to in court papers as T.H. and C.H., instead sued Novartis, which made Brethine until 2001, and aaiPharma Inc, which bought the rights to it in 2007 while their mother was taking the generic version.

Novartis argued its duty to warn consumers did not cover those taking generics and that a contrary ruling would effectively make it the market’s insurer.

The court disagreed. Justice Mariano-Florentino Cuéllar wrote that brand-name manufacturers are the only entities with the ability to strengthen a warning label.

“So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brandname manufacturer has sufficient incentive to prevent a known or reasonably knowable harm,” Cuéllar wrote.

The court also held 4-3 that Novartis could be sued despite divesting itself of Brethine because its failure to update the warning label before the sale could foreseeably cause the children harm.

Though employers and workers’ compensation insurers have been utilizing telemedicine for quite some time, the Insurance Journal reports that there has been a recent uptick in interest surrounding virtual physical therapy, also known as telerehab.

Telerehab provides virtual access to physical therapy and is intended to be a replacement for an in-person visit to an outpatient facility. According to a recent white paper released by MedRisk, while not all treatment is translatable to telerehab, “online exercise demos, virtual workout supervision, and secure communication tools make it possible to supplement in-clinic physical therapy with valuable remote services including patient follow-ups, home treatment plans, questions and answers, and consultations with specialists.”

Sean Sullivan, chief operating officer and vice president of Business Development for the national rehab and wellness provider Go2Care, said telerehab can include the whole spectrum of what is called “musculoskeletal care management.”

According to Michelle Despres, vice president and national product leader at workers’ compensation firm One Call, telerehab is convenient because it can be done via a cell phone, tablet or a computer. The process can work via live or pre-recorded videos and mobile apps, said Despres. Remote patient monitoring can be achieved by using health and fitness trackers or through patient self-reporting.

“They would have access to one on one live treatment with a physical therapist (PT), the idea being that there’s a convenience factor. If someone would like to be treated, we offer hours between 6:00 AM and 10:00 PM. There’s a lot of flexibility. Most outpatient clinics are not open to those hours,” added Despres. “There may be a possibility that someone could say at lunchtime, ‘I’m going to do my PT. I’m not going to leave my office. I’m going to do it right here.'” She added that injured workers could do it anywhere they have the privacy and the availability to perform their visit.

Highly adaptable, telerehab can begin with online videoconferencing and move toward live, face to face interaction, according to Sullivan of Go2Care.

“We’re also looking at telerehab being defined as a home exercise program support application. This is an apps based concept,” said Despres. “It allows the treating therapist in the brick and mortar facility to offer their individual patients and injured workers the ability to log into an app, much like a fitness app, that many people use on their phones or their tablets and have the opportunity to have their home program delivered electronically.”

While there’s been traction in both the group health and Medicare markets, there has been a slow adoption rate by the workers’ compensation industry, despite the fact the concept has been around for quite a while, said Sullivan.

“In workers’ compensation, to my knowledge no one yet has any deliverable data or outcomes information to be able to say that it’s being adopted at X rate in the work comp space,” said Despres.

“There was a push, not from the carriers but from – the employers,” said Sullivan. “I’m having a lot of carriers come to me saying, ‘We want to do it,’ but they don’t know where to start. When the carriers right now are talking to me, they’re saying, ‘Do we do the prevention? Do we do the treatment, or do we do the monitoring?'” He expects carriers will pilot one or all three aspects to determine the best fit.

Not much is needed for telerehab to work, said Sullivan and Despres. “They don’t require anything except the injured worker has to have their own Wi-Fi or their own device a cell phone, a smartphone or a tablet, or a computer,” said Despres. The employer doesn’t have to set up anything, though they might choose to offer a private room that employees could use at lunchtime or at their own discretion.

“It can be done from anywhere. We’re servicing a manufacturing site in rural America. There’s not a whole lot around it, but there are 600 employees,” Sullivan said. “We just set up a kiosk at the location. The employee has the freedom to elect to conduct that visit in the comfort of their home, should they choose. But they’re not choosing that, at least, to date.”

The number of U.S. deaths at work from unintentional drug and alcohol overdoses jumped more than 30% in 2016, according to new government data, showing that the nation’s struggle with a deadly opioid epidemic is migrating to the workplace.

The Bureau of Labor Statistics’ National Census of Fatal Occupational Injuries said that 217 workers died on the job last year as a result of an unintentional overdose from the nonmedical use of drugs or alcohol, up from 165 in 2015. The number of accidental overdose deaths at work has nearly tripled since the BLS began compiling the data in 2011.

And an article in the Wall Street Journal reports that the statistic is part of a bigger problem.

“The surge in deaths, the abuse and the way in which this has turned into a crisis which encompasses so many elements, it’s not at all surprising this crisis has migrated” into the workplace, said John Deskins, an economist at West Virginia University.

The Department of Labor will respond by working “with public and private stakeholders to help eradicate the opioid crisis as a deadly and growing workplace issue,” said Loren Sweatt, the Occupational Safety and Health Administration’s deputy assistant secretary.

Earlier this year, OSHA limited its reporting of fatalities in the U.S., as part of a series of moves by the agency cutting back the amount of information about workplace accidents made available to the public.

Other causes of workplace death still dominated in 2016, a year during which the economy added 2.24 million new jobs.

Total fatal work injuries rose 7% to 5,190 in 2016, according to the report. Deaths due to workplace violence increased 23% last year from the year before, making that the second most common cause of death on the job in 2016 after transportation incidents. The number of workplace suicides rose 27% in 2016 from the year before, to 291, the highest number since the census began recording the number of suicides at work in 1992.

Drug abuse is taking a toll on the U.S. economy. The burden of prescription opioid abuse from crime, lost work productivity through absenteeism or poor job performance and health care costs is an estimated $78.5 billion a year, according to a 2013 study by the CDC.

The Federal Reserve’s Beige Book – a survey based on anecdotes collected from the central bank’s 12 regional banks – reported in July that manufacturers in the St. Louis region cited candidates’ inability to pass drug tests or to consistently report to work as a difficulty in hiring workers.

In a 2015 paper, Princeton University economists Anne Case and Angus Deaton termed the rise in mortality from suicide, drugs and alcohol since the late 1990s among middle-aged white Americans “deaths of despair.”

Physicians who practiced at the Campbell Medical Group, Dr. Vilasini Ganesh a family practitioner and Dr. Gregory Belcher an orthopedic surgeon, were convicted of health care fraud by a federal jury after an eight-week jury trial.

The jury found Ganesh, 47, of Saratoga, guilty of five counts of health care fraud and five counts of making false statements relating to claims fraudulently submitted to health care benefit programs. Belcher, 56, also of Saratoga, was found guilty of one count of making a false statement relating to a health care benefit program. The defendants were acquitted of conspiracy and money laundering counts, and Belcher was also acquitted of four other health care fraud counts and one other count of making a false statement relating to a health care benefit program.

Evidence at trial showed that Ganesh submitted false and fraudulent claims to several health care benefit programs for services that she knew were not properly payable, by including claims for days when the patient had not been seen by the provider, and claims that the patients had been seen by another physician provider who was no longer affiliated with her practice.

Evidence at trial further demonstrated that Belcher had on at least one occasion submitted a false claim in connection with a billing matter related to his physical therapy practice.

On July 13, 2017, a federal grand jury indicted the defendants, charging them with one count of conspiracy to commit health care fraud, in violation of 18 U.S.C. § 1349; one count of conspiracy to commit money laundering, in violation of 18 U.S.C. § 1956(h); and multiple counts health care fraud, in violation of 18 U.S.C. § 1347, and 2 and false statement relating to health care matters, in violation of 18 U.S.C. § 1035.

The indictment alleged that Ganesh would misrepresent, conceal and hide her wrongdoings or direct her subordinates to do as such. When she was approached by representatives from the insurance companies or the patients themselves, for example, to provide documentation or additional information to substantiate the submitted claims, she’d either forbid her office staff from speaking to anyone about the claims or she would just resubmit the false information, according to the DOJ.

She was accused of working with Belcher to submit hundreds of claims for reimbursement from the insurance companies for days that were weekends when their practice was closed, days on which the patients denied they were seen and days when the patients could not have been seen by Ganesh or her staff because either the patient or the doctor was not physically present.

The doctors were suspected of using billing codes that indicated either one of them had spent more than 24 hours in a single day seeing patients. The pair allegedly maintained multiple bank accounts through which they tried to hide their illegally obtained money.

The defendants are currently out of custody, on a $350,000 bond as to Ganesh and a $250,000 bond as to Belcher. Judge Koh scheduled the defendants’ sentencing hearing for April 4, 2018.

Assistant U.S. Attorneys Patrick Delahunty and Jeff Nedrow are prosecuting the case with the assistance of Susan Kreider and Nina Burney Williams. The prosecution is the result of a two-year investigation by the Federal Bureau of Investigation.

Michelle Janet Lias was a food services worker with the Corona/Norco Unified School District.  She claimed she sustained an injury to the lower right side of her back on June 11, 2013, when she picked up a box of frozen burritos.

She received total workers’ compensation benefits of $4,450.43 between June 17 and November 12, 2013. An additional $13,740.60 was also paid out for her medical expenses during that period.

On October 12, 18, and 20, 2013, an insurance investigator recorded three clandestine videos of defendant. In those videos, defendant spent an extended amount of time in a car driving, she went to a pumpkin patch event, she bent down and tied her shoes, she walked without a limp, she carried a package to her car, and she sat in a casino gambling.

On November 12, 2013, the defendant’s treating physician changed his opinion after viewing the videos. The physician said defendant was “milking it.” On the same date, he issued a supplemental orthopedic report in which he wrote that defendant was not disabled and should return to work.

Lias pled guilty to fraudulently making a material statement and representation for the purpose of obtaining compensation. (Ins. Code, § 187.14, subd. (a)(4); count 1.) The People filed a request for restitution in an aggregate amount of $45,747.23, itemized as follows: salary payments of $9,902.69, medical expenses of $15,116.60, clandestine investigation in the amount of $7,651.60, photocopying in the amount of $3,050.80, bill review expenses of $1,312.14, defense fees of $5,859.21, and deposition expenses of $2,854.19.

The court granted defendant three years of summary probation and later imposed victim restitution in the amount of $35,525.08. The court denied restitution for photocopying, bill review, and defense fees. On appeal, defendant contends the court abused its discretion in awarding that amount of restitution. The Court of Appeal affirmed the restitution order in the unpublished case of People v Lias.

Generally speaking, restitution awards are vested in the trial court’s discretion and will be disturbed on appeal only when the appellant has shown an abuse of discretion. Even though the trial court has broad discretion in making a restitution award, that discretion is not unlimited. While it is not required to make an order in keeping with the exact amount of loss, the trial court must use a rational method that could reasonably be said to make the victim whole, and may not make an order which is arbitrary or capricious. When there is a factual and rational basis for the amount of restitution ordered by the trial court, no abuse of discretion will be found by the reviewing court.

“Here, the court acted well within its discretion by implicitly determining that defendant had never suffered an injury; thus, its restitutionary award of all wages and medical expenses incurred as a result of defendant’s faked injury is supported by the record. This is regardless of the date reflected in the complaint and in defendant’s plea. Indeed, the clandestine videos showed that defendant had been capable of performing tasks as early as October 12, 2013, that she was reporting to her physician she could not do.”