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Tag: 2020 News

3M Sues California Company Selling Fake N95 Masks

3M’s legal battle to keep price gougers from profiting on sales of its N95 face masks during the coronavirus pandemic grew on new fronts.

The Star Tribune reports that on Monday, 3M targeted a third-party seller on Amazon.com for using its trademark to sell $350,000 worth of masks at up to 20 times list prices.

KM Brothers Inc., a California company trading under several different business names, “claimed to be reselling authentic N95 respirators, while actually selling damaged and fake goods at highly inflated prices,” 3M said.

After customer complaints, Amazon pulled the KM Brothers ads from its online shopping forum.

3M’s federal court lawsuit against Mao Yu, the owner and operator of KM Brothers, explains a strategy that uses multiple business names to carry on selling if a single business gets taken down.

3M said that on Feb. 20, various business under KM Brothers control began selling “what were purported to be 3M-branded N95 respirators across three connected accounts on Amazon.com.”

The company also “maintained at least 45 different Amazon Standard Identification Numbers.”

The new lawsuits offer a glimpse into the depth and breadth of attempts to profit from a national shortage of N95 masks, said to be among the most effective in blocking airborne COVID-19 molecules.

The new legal actions bring to 14 the number of suits 3M has filed since January to try to control price gouging for its product by what the company calls “pandemic profiteers.”

3M said it “has won five temporary restraining orders and three preliminary injunction orders from courts across the country that put a stop to other defendants’ unlawful and unethical profiteering from the pandemic.”

It has shut down more than 3,000 websites and 4,000 social media posts that try to expropriate the 3M brand for profit, the company explained.

3M asks the court to shut down KM Brothers’ mask-selling operations and to force the company to repay any profits derived from by claiming the resale of 3M masks when it was instead “selling counterfeit, damaged, deficient, or otherwise altered masks.”

The seller charged Amazon customers up to $23.21 for a single mask that normally listed for prices ranging from 60 cents to $3.40 each. Customer complaints tipped off Amazon.

Reopenings Continue Despite COVID-19 Hotspots

Facing budget shortfalls and double-digit unemployment, governors of U.S. states that are COVID-19 hotspots on Thursday pressed ahead with economic reopenings that have raised fears of a second wave of infections.

Governors face pressure to fire up economies facing fiscal year 2021 budget shortfalls of up to 30% below pre-pandemic projections in New Mexico. Nevada, which has seen cases increase by nearly a third in the past two weeks, is suffering 28% unemployment.

Reuters reports that the moves by governors of states such as Florida and Arizona came as Treasury Secretary Steven Mnuchin said the United States could not afford to let the novel coronavirus shut its economy again and global stocks tanked on worries of a pandemic resurgence.

As Florida reported its highest daily tally of new coronavirus cases on Thursday, Governor Ron DeSantis unveiled a plan to restart public schools at “full capacity” in the autumn, arguing the state’s economy depended on it.

North Carolina reported record COVID-19 hospitalizations for a fifth straight day on Thursday, a day after legislators passed a bill to reopen gyms, fitness centers and bars in a state where more than one in ten workers are unemployed.

“This is about saving lives, this is also about livelihoods in the state of Arizona,” Governor Doug Ducey told a news briefing, adding that a second shutdown of the economy was “not under discussion” despite official figures showing a 211% rise in virus cases over the past 14 days.

About half a dozen states including Texas and Arizona are grappling with rising numbers of coronavirus patients filling hospital beds.

Ducey and Texas Governor Greg Abbott say their hospitals have the capacity to avoid the experiences of New York, where the system was stretched to near breaking point as some COVID patients were treated in hallways and exhausted workers stacked bodies in refrigerated trailers.

A note of caution came from Utah, where Governor Gary Herbert said most of the state would pause its reopening after a 126% rise in cases over the past two weeks.

Austin, Texas on Thursday also said it would likely extend stay-at-home and mask orders past June 15 after the state reported its highest new case count the previous day. Austin health officials blamed a record week of infections on easing business restrictions and Memorial Day gatherings.

There was no talk of new shutdowns.

In New Mexico, Health Secretary Kathy Kunkel pointed to outbreaks at the Otero County Prison Facility, as well as in nursing homes and assisted living facilities, as factors behind an uptick in cases.

California PUC Rules Rideshare Drivers are Employees

The California Public Utilities Commission said in an order Tuesday that drivers for Transportation Network Companies (TNCs), which include services like Uber and Lyft, are considered employees under AB-5, the state’s hotly debated new gig work law.

“For now, TNC drivers are presumed to be employees and the Commission must ensure that TNCs comply with those requirements that are applicable to the employees of an entity subject to the Commission’s jurisdiction,” wrote commissioner Genevieve Shiroma.

The ruling from CPUC, the agency in charge of regulating ride-hail companies, marks a significant development in the battle over the employment status of tens of thousands of gig workers in California.

According to the report in Business Insider, both companies criticized the ruling, saying it could hurt drivers’ wages and pointing to a ballot measure they support that would revoke the law.

CPUC’s presumption is flawed; drivers are correctly classified as independent contractors and overwhelmingly want to remain independent contractors,” a Lyft spokesperson told Business Insider. “Forcing them to be employees will have horrible economic consequences for California at the worst possible time.”

“Uber remains committed to expanded benefits and protections to drivers,” a company spokesperson told Business Insider. “If California regulators force rideshare companies to change their business model it could potentially risk our ability to provide reliable and affordable services along with threatening access to this essential work Californians depend on.”

Ride-hailing companies like Uber and Lyft have been at the center of AB-5, which went into effect this year and made it more difficult for companies to classify employees as independent contractors.

While many drivers and labor groups have praised AB-5, it has also received intense pushback from some corners. Beauticians, truckers, freelance writers and workers in industries long dominated by contractors have said the law is too far-reaching, for example.

AB-5’s most ardent opponents, however, have been its intended targets: gig work companies.

Last year, Uber sued California, seeking an exemption from AB-5, and along with Lyft and various food delivery apps, has publicly argued that its drivers should not be classified as employees, called on taxpayers to foot the bill for drivers’ unemployment insurance, and poured millions into a ballot measure aimed at revoking the law.

Uber and Lyft have so far refused to reclassify drivers under AB-5, leading city attorneys general from Los Angeles, San Francisco, and San Diego to sue the companies to force them to comply with the law. More than 4,000 drivers across the state have also taken action by filing $1 billion worth of back wage claims, driver group Rideshare Drivers United said in a statement.

The COVID-19 pandemic has brought new scrutiny to the labor practices of gig work companies like Uber and Lyft, with drivers facing a steep drop in income, struggling without healthcare or paid time off, and unable to claim unemployment insurance.

California Agricultural Industry Braces for COVID-19 Claims

From apple packing houses in Washington state to farm workers in Florida and a California county known as “the world’s salad bowl,” outbreaks of the novel coronavirus are emerging at U.S. fruit and vegetable farms and packing plants.

Reuters reports that a rising number of sick farm and packing house workers comes after thousands of meat plant employees contracted the virus and could lead to more labor shortages and a fresh wave of disruption to U.S. food production.

The Trump administration said last month it may extend an executive order to keep meat plants operating to fruit and vegetable producers as well, a sign it is concerned fresh produce could be the next sector hit.

While social distancing can be more easily implemented for workers harvesting fruits and vegetables in fields and working outside may reduce some risks for virus spread, plants that package foods such as apples and carrots resemble the elbow-to-elbow conditions that contributed to outbreaks at U.S. meat packing plants.

By late May, there were more than 600 cases of COVID-19 among agricultural workers in Yakima County, Washington. Of those, 62% were workers in the apple industry and other packing operations or warehouses, according to a Reuters review of data from county health officials.

With 4,834 known cases as of June 10, the county had the highest per-capita infection rate on the West Coast.

“The (production) line moves super fast. And you’re working side by side and back to back,” said Edgar Franks, political director with local farmworker union Familias Unidas por la Justicia in Washington state.

Workers at six fruit packing sites in Yakima County went on strike in May due to concerns they were not being provided adequate protection from COVID-19, Franks said.

The health department in Monterey County, California, known as “the world’s salad bowl” for its sprawling vegetable farms, reported 247 agricultural workers had tested positive for coronavirus as of June 5, 39% of county’s total cases. Monterey is one of only a handful of health departments in nearly 30 of the largest U.S. fruit and vegetable producing counties that tracks virus cases among agricultural workers, Reuters found.

On May 19 the U.S. Agriculture Department and Food and Drug Administration said the government could use the Defense Production Act to keep fruit and vegetable lines moving. The act would give companies some liability protection if workers fall sick.

An FDA spokesperson said the act could be used “to protect the food supply and prevent significant food shortages.”

U.S. Senator Debbie Stabenow, a Michigan Democrat, said in an interview with Reuters farm workers face increased risks as fruits like apples and cherries enter harvest season.

Stabenow, ranking member on the Senate Agriculture Committee, introduced legislation on May 27 that would offer companies grants and loans to upgrade machinery and purchase personal protective equipment, fund COVID-19 testing and facility cleaning.

“You can get ahead of this, which is what didn’t happen in the meatpacking situation,” she said. “The best way to protect our supply chain is to keep workers safe.”

Meanwhile, coronavirus cases near tomato-growing Immokalee, Florida, are also on the rise. The spread of the coronavirus among Florida farm workers has significant implications for national food production, as many agricultural workers travel north through the summer following the harvest through Georgia, the Carolinas, and into the Northeast.

The Florida Department of Agriculture is planning for more on-farm outbreaks by partnering with county health departments, hotels for quarantine housing, and educating workers.

Head of Las Gatos Testing Lab Charged with $69M Hoax

The president of a California-based medical technology company was charged for his alleged participation in schemes to mislead investors, to manipulate the company’s stock price and to conspire to commit health care fraud in connection with the submission of over $69 million in false and fraudulent claims for allergy and COVID-19 testing.

The complaint against Mark Schena, 57, of Los Gatos, California, the president of Arrayit Corporation, is the first criminal securities fraud prosecution related to the COVID-19 pandemic that has been brought by the Department of Justice and charges one count of securities fraud and one count of conspiracy to commit health care fraud.

According to the affidavit in support of the complaint, Schena touted that Arrayit is the “only laboratory in the world that offers” revolutionary “microarray technology” that allows Arrayit to test for allergy and COVID-19 based on a drop of blood that is 250,000 times smaller than the technology touted by Theranos.

Beginning in or around 2018 and continuing to in or around February 2020, Schena and others paid kickbacks and bribes to recruiters and doctors to run an allergy screening test for 120 allergens (including things ranging from stinging insects to food allergens) on every patient regardless of medical necessity, and then made numerous misrepresentations to potential investors about Arrayit’s allergy test sales, financial condition, and its future prospects.

Schena and others issued press releases and tweeted about partnerships with Fortune 500 companies, government agencies and public institutions, without disclosing that such partnerships either did not exist or were of de minimis value.

As the COVID-19 crisis began to escalate in March 2020, Schena and others made false claims concerning Arrayit’s ability to provide accurate, fast, reliable and cheap COVID-19 tests in compliance with state and federal regulations, and made numerous misrepresentations to potential investors about the COVID-19 tests and Arrayit’s future prospects for COVID-19 testing.

Schena stated that it was simple to develop a test for COVID-19 because the switch from testing for allergies to testing for COVID-19 was “like a pastry chef” who switches from selling “strawberry pies” to selling “rhubarb and strawberry pies.” Arrayit’s stock price doubled in mid-March, but Schena and others never disclosed that there were questions about the validity of its data and the accuracy of its COVID-19 test.

“The scheme described in the complaint, in which the defendant allegedly leveraged this allure by appending the fear of the Covid 19 pandemic, amounts to a cynical multi-million dollar hoax,” said U.S. Attorney David L. Anderson of the Northern District of California.

“This defendant allegedly defrauded Medicare through illegal kickbacks and bribes, and then turned to exploiting the pandemic by fraudulently promoting an unproven COVID-19 test to the market,” said Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division.

Workers’ Comp Trails Commercial Lines Growth

U.S. commercial insurance prices again grew significantly in the first quarter of 2020, according to Willis Towers Watson’s most recent Commercial Lines Insurance Pricing Survey (CLIPS).

The survey compared prices charged on policies underwritten during the first quarter of 2020 to those charged for the same coverage during the same quarter in 2019.

The aggregate commercial price change reported by carriers was close to 2% for all four quarters of 2018 and the first quarter of 2019, climbing to almost 4% in the second quarter, almost 5% in the third quarter of 2019, and over 6% for the past two quarters.

Data for nearly all lines indicated significant price increases in the first quarter, with the largest coming from excess/umbrella liability and directors and officers liability, as both coverages saw significantly accelerating increases over the past three quarters.

However CLIPS indicates ongoing material price reductions for workers compensation, in contrast to nearly all other surveyed lines, though the decreases have tempered somewhat for each of the last five quarters.

The past outlier in the results, commercial auto, saw reported price increases near or above double digits for the tenth consecutive quarter, while property coverage saw near double digit increases for the fourth consecutive quarter.

Price changes for most lines other lines were fairly consistent with those observed in the prior quarter.

When comparing account sizes, reported price changes were more muted for small commercial accounts, higher for mid-market accounts, and approaching double digits for large accounts, whereas the prices were fairly consistent by account size four quarters ago.

Specialty lines price increases in aggregate were above double digits increases for the second consecutive quarter.

Stipulation to “Upper Extremity” Includes Thoracic Outlet Syndrome

Michael Perani was a computer software engineer from 1988 until 1995, who sustained an injury to his “upper extremities” while employed by Island Graphics.

In 1994, he filed a workers’ compensation claim after he began suffering from pain, inflammation, swelling and impaired range of motion in his hands, wrists and arms. He was not specifically diagnosed as having a condition known as “thoracic outlet syndrome” (TOS), but his medical records describe symptoms consistent with TOS in the year following his claim.

TOS refers to a constellation of symptoms which arise due to compression of blood vessels or brachial plexus nerves in the space between the clavicle and the first rib (i.e., the thoracic outlet). Compression of the brachial plexus nerves causes a variety of symptoms, including pain in the shoulder and scapula area, pain, numbness, swelling and tingling in the arm or hand, reduced grip strength, and weakness when raising the arm. Thoracic outlet syndrome commonly arises in patients whose occupation requires repetitive motion, which causes inflammation, which in turn results in compression of the brachial plexus nerves.” (Borrayo v. Avery (2016) 2 Cal.App.5th 304, 307.)

In 1998, Perani entered into a stipulated award which stated he “. . . sustained injury arising out of and in the course of employment.” In the space labeled “(Parts of body injured),” the award stated, “bilateral upper extremities.”

The WCAB upheld a decision by the WCJ that thoracic outlet syndrome involves a different part of the body than did the award. It consequently denied Perani’s application for expenses incurred to treat that condition. The court of appeal annulled the decision in the unpublished decision of Perani v WCAB, Island Graphics.

The question presented was whether thoracic outlet syndrome is encompassed within the award.

Upper extremity” includes the hand, wrist, elbow and the shoulder – in other words the entirety of the arm. (See Smith v. Empire Pencil Company (Tenn. S.C. 1989) 781 S.W.2d 833, 837.) The term can be defined even more expansively, to include the neck and shoulders; essentially, everything from the base of the skull down. (M.C. Dean, Inc. v. District of Columbia Employment Services (D.C. App. 2016) 146 A.3d 67, 72-73.

The 1998 stipulated award did not specify that future medical treatment was authorized only for a particular medical condition such as repetitive strain injury or carpal tunnel syndrome, which can be distinguished from TOS even when the symptoms overlap. Instead, the award broadly stated that the body parts injured were the “bilateral upper extremities,” without specifying a particular medical condition, and that there was a need for further medical treatment of that injury.

Had the parties wished to limit future medical treatment to treatment for particular conditions, they could have done so.

Workers Sue Amazon Over COVID-19 Working Conditions

Amazon has found itself involved in a lawsuit, which was filed by a group of warehouse workers that claim the e-commerce giant put them at risk because of the working conditions at its fulfillment centers during the coronavirus pandemic.

This is not the first lawsuit that Amazon has been involved with over working conditions at its fulfillment centers during the coronavirus pandemic. The company has come under fire for its safety measures as it ramped up its workforce by 175,000 employees to meet the onslaught of demand caused by consumers stocking up on essential items from its website.

Employees at Amazon have staged walkout protests asking for hazard pay, better working conditions, and more COVID-19 testing. Amazon paid its workers $2 per hour extra during the height of the coronavirus pandemic, which expired at the end of May. The company said it has spent $800 million in the first two quarters of the year on safety measures.

Amazon said it was reviewing the complaint. “We are saddened by the tragic impact COVID-19 has had on communities across the globe, including on some Amazon team members and their family and friends,” spokeswoman Lisa Levandowski said in an emailed statement. “From early March to May 1, we offered our employees unlimited time away from work, and since May 1 we have offered leave for those most vulnerable or who need to care for children or family members.”

Amazon emerged as an indispensable service for many customers shopping online during “shelter-in-place” orders. The company scrambled to meet surging demand by hiring 175,000 workers while simultaneously announcing new procedures to protect its workforce.

According to Amazon, over 150 processes have been updated to protect employees, and the company is spending over $800 million in the first half of 2020 on coronavirus safety measures. Workers diagnosed with the virus are also being offered additional paid time off, the company has said.

But the new lawsuit claims Amazon has only “sought to create a facade of compliance” and continued with unsafe practices. Workers “continue to work at dizzying speeds, even if doing so prevents them from socially distancing, washing their hands, and sanitizing their work spaces,” according to the lawsuit.

The plaintiffs also say Amazon punishes employees who complain about workplace safety and tells workers to avoid informing others if they become infected. Amazon has told employees its contact tracing consists only of reviewing its surveillance footage, rather than interviewing infected workers about their interactions, the lawsuit says.

Amazon’s failures have already caused injury and death to workers and family members of workers,” the lawsuit says, noting that a worker at the Staten Island warehouse has been confirmed to have died from Covid-19.  One month later, the worker’s family member reportedly displayed COVID-19 symptoms and died. The plaintiffs in the case are not seeking damages for illness or death but instead asking for an injunction to force Amazon to follow public health guidelines, the news outlet said.

The Staten Island warehouse has been a focus of health and safety complaints since March, when employees mounted the first of a series of walkouts.

Amazon terminated the leader of that protest, claiming he violated a company quarantine order. The company’s action spurred denunciations and calls for investigation by officials including Senator Bernie Sanders and New York Attorney General Letitia James.

Fake Hydroxychloroquine Study Retracted by Lancet and NEJM

Medical treatment in California Workers’ Compensation is based upon treatment guidelines built upon high quality scientific research. At the core is the assumption that published medical studies in leading peer reviewed journals are high quality science. But that might not always be the case.

Nearly a decade ago, headlines highlighted a disturbing trend in science: The number of articles retracted by journals had increased 10-fold during the previous 10 years. Fraud accounted for some 60% of those retractions.

Since then, two longtime health journalists founded the blog Retraction Watch, to get more insight into just how many scientific papers were being withdrawn, and why. They began to assemble a list of retractions.

That list, formally released to the public in 2018 as a searchable database, is now the largest and most comprehensive of its kind. In its tenth year, 2019, nearly 1500 retractions were added to its database in just one year.

The COVID-19 pandemic aftermath added the alarming retraction of what appeared to be a derogatory study of the effectiveness of Hydroxychloroquine as a treatment modality by two leading medical journals, the Lancet, and the New England Journal of Medicine.

The paper, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” which relied on data from a private company called Surgisphere and had concluded that hydroxychloroquine was linked to a higher risk of death among some COVID-19 patients, has been dogged by questions since its publication in late May.

The publication of the study had prompted the World Health Organization (WHO) to halt a study of hydroxychloroquine, but the WHO resumed that trial once the expression of concern appeared.

Details in the Surgisphere data revealed many obvious inconsistencies to scientific observers – which should have been obvious to the “peers” who supposedly reviewed the article before publication by the Lancet and NEJM.

For example, Matthew Spinelli, MD, of University of California San Francisco, told MedPage Today the “claim to have captured data from over 60,000 hospitalizations at over 550 hospitals in North America by April 13th concerns me, given that there were approximately 60,000 COVID-19 hospitalizations total from approximately 6,000 hospitals across all of the United States through April 13th.”

Walid Gellad, MD, of the University of Pittsburgh, noted on Twitter that 73 deaths were recorded in Australia according to the Lancet authors, which is “more than the number of deaths in Australia on April 20.”

A blog hosted by statisticians at Columbia University in New York City raised several other issues, including the results being confounded by disease severity, lack of hierarchical modeling, and how the data appeared to be aggregated across continents.

Two days after issuing expressions of concern about controversial papers on Covid-19, The Lancet and the New England Journal of Medicine have retracted the articles because a number of the authors were not granted access to the underlying data.

EU Regulators Join FTC Efforts Against Drugmaker Pay-for-Delay Deals

Reverse payment patent settlements, also known as “pay-for-delay” agreements, are a type of agreement that has been used to settle pharmaceutical patent infringement litigation (or threatened litigation), in which the company that has brought the suit agrees to pay the company it sued.

That is, the patent holder pays the alleged infringer to stop its alleged infringing activity (e.g., to stop selling a generic version of a drug) for some period of time and to stop disputing the validity of the patent. These agreements are distinct from most patent settlements, which usually involve the alleged infringer paying the patent holder. Reverse payment patent settlements result from a peculiarity in US regulatory law arising from the Hatch-Waxman Act passed in 1984.

One of the Federal Trade Commission’s top priorities in recent years has been to oppose a costly legal tactic that more and more branded drug manufacturers have been using to stifle competition from lower-cost generic medicines.

According to the FTA, drug makers have been able to sidestep competition by offering patent settlements that pay generic companies not to bring lower-cost alternatives to market. These “pay-for-delay” patent settlements effectively block all other generic drug competition for a growing number of branded drugs.

According to an FTC study, these anticompetitive deals cost consumers and taxpayers $3.5 billion in higher drug costs every year. Since 2001, the FTC has filed a number of lawsuits to stop these deals, and it supports legislation to end such “pay-for-delay” settlements.

Reuters just reported that EU Regulators have now successfully pursued similar initiatives.

EU antitrust enforcers, boosted by recent court victories, reinforced their case against Israeli drugmaker Teva over its deal with rival Cephalon to delay selling a generic version of its sleep disorder drug modafinil.

Three years ago, the European Commission said the company’s cash payments deal with Cephalon as part of a settlement to end a lawsuit over alleged infringement of Cephalon’s patents on the blockbuster drug may have jacked up the price of modafinil.

It sent a statement of objections, or charge sheet, outlining its concerns why the deal may be anti-competitive. Teva later acquired Cephalon in 2011.

On Monday, the EU competition enforcer sent a supplementary charge sheet to Teva, clarifying why it considered that the objective of the pay-for-delay deal was to restrict competition. It also cited recent court judgments backing its stand.

Teva can be fined up to 10% of its global turnover if found guilty of breaching EU antitrust rules. Regulators on both sides of the Atlantic have fought a long-running battle with drugmakers against such deals.