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Tag: 2021 News

Pfizer to Pay $345M to Resolve Price Gouging Claims

NPR-KCUR in Kansas City reports that Pfizer Inc. and two other companies have agreed to pay $345 million to resolve long-running litigation over EpiPen price hikes. In 2007 an EpiPen package cost about $100. Today, it costs more than $650 without pharmacy coupons or manufacturer discounts.

EpiPens are auto-injectable devices that deliver the drug epinephrine, which is used to treat life-threatening allergic reactions known as anaphylaxis. Anaphylaxis is most commonly caused by food allergies but can also be caused by insect bites, medications and other substances.

The litigation dates to 2016, when numerous class action lawsuits were filed against Pfizer, Mylan and other defendants alleging they engaged in anticompetitive conduct in connection with their marketing of the EpiPen.

The lawsuits were transferred to federal court in Kansas City, Kansas, because of its geographical centrality. Trial was scheduled to begin this Sept. 7, but if Crabtree approves the settlement, Pfizer and the two other companies proposing to settle – Meridian Medical Technologies Inc. and King Pharmaceuticals Inc. – will be off the hook.

Multiple law firms have been involved in the complex litigation, which featured the production of over 11 million pages of documents and 158 depositions, according to court documents.

In documents filed in federal court in Kansas City, Kansas, the companies asked the court to grant preliminary approval to the settlement, which would end the litigation against the three companies.

The proposed settlement comes just three weeks after U.S. District Judge Daniel Crabtree granted summary judgment to another defendant, Mylan, on the plaintiffs’ racketeering claims and some antitrust claims. But he allowed other antitrust claims against Mylan to proceed to trial.

A Pfizer spokesperson said in an email that the company “denies any wrongdoing and continues to believe its actions were appropriate.

“This resolution reflects a desire by the Company to avoid the distraction of continued litigation and focus on breakthroughs that change patients’ lives,” the spokesperson said.

Rex Sharp, a Prairie Village lawyer representing the plaintiffs, said in an email that his clients were pleased that Pfizer had agreed to the settlement while noting it still requires court approval.

He said the plaintiffs looked forward to trying the remaining claims against Mylan before a jury. Mylan owns the rights to the EpiPen brand, but the devices are manufactured by Pfizer.

LA County Reinstates Mask Mandate After 700% COVID Increase

The Los Angeles County Department of Pubic Health reports that the community transmission of COVID-19 has rapidly increased from Moderate to Substantial, based on the trend in daily new cases of COVID-19.

On June 15, the day of the full reopening, the County saw 210 new cases and today the Los Angeles County Department of Public Health (Public Health) confirms the highest number of new COVID-19 cases since mid-March with 1,537 new cases. Today’s test positivity rate is 3.7%; on June 15, the test positivity rate was around 0.5%.

As a result, the Los Angeles County Health Officer Order will be modified to require masking for everyone while indoors, regardless of vaccination status, as Los Angeles County sees more than a seven-times increase in new cases since the June 15 reopening. Wearing a mask when indoors reduces the risk of both getting and transmitting the virus. This additional layer of protection can help to slow the spread and does not limit business occupancy and operations.

The L.A. County indoor masking requirements for everyone will be effective Saturday, July 17 at 11:59 p.m. Some exceptions will apply, similar to masking requirements that were in place prior to the June 15 reopening.

Tracking the proliferation of the Delta variant is a priority because the Delta variant is more easily spread between people – more than other variants of concern. And while emerging data affirms that fully vaccinated people are well protected from severe infections with Delta variants, people with only one vaccine are not as well-protected, and there is evidence that a very small number of fully vaccinated individuals can become infected and may be able to infect others.

From June 27 to July 3, the number of sequenced Delta variants was 124, 71% of all sequences collected that week. Given that slightly under 4 million residents in L.A. County are not yet vaccinated, the risk of increased spread of this variant within the County remains high.

To date, Public Health identified 1,262,578 positive cases of COVID-19 across all areas of L.A. County and a total of 24,566 deaths. Of the three new deaths reported today, one person that passed away was over the age of 80, and two people who passed were between the ages of 50 and 64. Testing results are available for more than 7,142,000 individuals with 16% of people testing positive. There are 406 people with COVID-19 currently hospitalized and 22% of these people are in the ICU.

As of July 11, more than 10,712,037 doses of COVID-19 vaccine have been administered to people across Los Angeles County. Of these, 5,946,447 were first doses and 4,763,590 were second doses. Among L.A. County residents 16 and over, 69% have received one dose of vaccine and 61% have been fully vaccinated. Among L.A. County seniors 65 and over, 88% have received one dose of vaccine and 78% have been fully vaccinated.

UCSF Brain Implant Allows Paralyzed Man to Speak

A man who is unable to move or speak can now generate words and sentences on a computer using only his thoughts.

The ability comes from an experimental implanted device that decodes signals in the man’s brain that once controlled his vocal tract, as researchers reported Wednesday in The New England Journal of Medicine.

The man is currently limited to a vocabulary of just 50 words and communicates at a rate of about 15 words per minute, which is much slower than natural speech.

“This tells us that it’s possible,” says Edward Chang, a neurosurgeon at the University of California, San Francisco. “I think there’s a huge runway to make this better over time.”

A device that allowed people who can’t speak to communicate using brain circuits previously used for speech would be “more natural, and hopefully effortless compared to current assistive devices,” says Chethan Pandarinath, an assistant professor in the Department of Biomedical Engineering at Emory University and Georgia Tech.

Currently, people with paralysis who have lost the ability to speak usually rely on devices that use eye or head movements to spell out words one letter at a time. Some use a device that allows them to control a computer cursor with thoughts.

Chang’s team wanted to find a better solution for the man, identified only as BRAVO1 to protect his privacy. The name refers to his status as the first patient in a study called BRAVO, or Brain-Computer Interface Restoration of Arm and Voice.

BRAVO1, who is in his late 30s, has been paralyzed and unable to speak since he had a stroke 15 years ago, Chang says.

The stroke left him nearly completely paralyzed in his arms and legs but also in the muscles of his vocal tract,” Chang says. But the areas of the brain that once issued speech commands are intact.

“We didn’t know if the speech commands in the brain would still work after 15 years,” he says. “And even if we could revive those dormant brain signals for speech, could we actually translate those into full words?”

To find out, the team implanted sensors on the surface of the man’s brain. Then it had a computer study the patterns of electrical activity produced when he attempted to speak 50 different words. The process took months.

Once BRAVO1 could reliably generate words on a computer screen, the team began having him form sentences. To help improve accuracy, the team added a program that analyzed the context of each word as it was added.

The system is a bit like the texting software on most smartphones. “So, for example, if one word is just not decoded correctly, this autocorrect function can correct it,” Chang says.

After months of adjustments to the system, the man was able to generate a word reliably every four seconds, or roughly 15 words per minute.

A device able to decode words in the brain could eventually help thousands of people who’ve had a stroke or a traumatic brain injury, says Krishna Shenoy, a professor in the School of Engineering at Stanford University.

The ability to recognize even 50 words in the brain is a huge achievement, Shenoy says. “But I think that’s just the tip of the iceberg. I think that could easily become 500 or 5,000 words.”

Napa Doctor Arrested for Fake COVID Vaccination Cards

A California licensed homeopathic doctor was arrested for her alleged scheme to sell homeoprophylaxis immunization pellets and falsify COVID-19 vaccination cards by making it appear that customers received the FDA authorized Moderna vaccine.

41 year old Juli A. Mazi N.D. , of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent CDC COVID-19 vaccination record cards.

Dr. Mazi received her doctorate in Naturopathic Medicine from the National University of Natural Medicine in Portland, Oregon where she trained in the traditional medical sciences as well as ancient and modern modalities that rely on the restorative power of Nature to heal.

According to court documents, in April 2021, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General (HHS-OIG) hotline. The complainant stated that the family members purchased pellets from Mazi, and were told the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The family members did not receive injections of any of the three FDA-authorized COVID-19 vaccines. However, Mazi sent COVID-19 Vaccination Record cards, with Moderna listed, to the family, and allegedly instructed the family members to mark the cards to falsely state that they received the Moderna vaccine on the date that they ingested the COVID-19 homeoprophylaxis immunization pellets.

Homeoprophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity. Mazi is alleged to have falsely claimed that orally ingesting pellets with small amounts of COVID-19 would result in full lifelong immunity from COVID-19.

Prosecutors also claim Mazi offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

If convicted, Mazi faces a maximum statutory prison sentence of 20 years for the wire fraud charge and 5 years for the false statements charge. In addition, each charge carries a maximum $250,000 fine and 3 years of supervised release.

Dr. Juli Mazi is a member of the California Naturopathic Doctors Association and the American Association of Naturopathic Physicians (AANP).

CDC Reports 45.9% Increase in California Drug Overdose Deaths

The U.S. government does not track death rates for every drug. However, the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention collects information on deaths involving many of the more commonly used drugs available through 2019 at a searchable database, called CDC Wonder. The NCHS also has 12 month-ending provisional data available by state and drug category.

The NCHS recently reported that drug overdose deaths rose by close to 30% in the United States in 2020, hitting the highest number ever recorded.

More than 93,000 people died from drug overdoses in 2020, according to provisional data released by the CDC’s National Center for Health Statistics. That’s a 29.4% increase from the 72,151 deaths projected for 2019.

In California, more than 9,500 people died from drug overdoses in 2020, up from 6,500 projected in 2019, a 45.9% increase.

“Overdose deaths from synthetic opioids (primarily fentanyl) and psychostimulants such as methamphetamine also increased in 2020 compared to 2019. Cocaine deaths also increased in 2020, as did deaths from natural and semi-synthetic opioids (such as prescription pain medication),” the NCHS said in a statement.

This is the highest number of overdose deaths ever recorded in a 12-month period, and the largest increase since at least 1999,” Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, said in a statement.

“These data are chilling. The COVID-19 pandemic created a devastating collision of health crises in America,” added Volkow.

As in recent years, inappropriate use of opioids was behind most of the deaths. The NCHS reported that overdose deaths from opioids rose from 50,963 in 2019 to 69,710 in 2020.

President Joe Biden on Tuesday nominated Dr. Rahul Gupta of West Virginia to serve as the administration’s top drug policy official. The former state health commissioner is slated to become the first physician to ever lead the White House Office of National Drug Control Policy, or ONDCP, if confirmed by the Senate. If confirmed, he will replace Regina LaBelle, acting director of the ONDCP , who is an Obama administration alum.

Gupta, a primary care doctor, went on to serve as the chief medical and health officer at March of Dimes, a maternal-and-child advocacy group, after his time working in the West Virginia state government.

Gupta received criticism from some drug reform advocates, who expressed disapproval of the closure of a needle exchange program in Charleston, West Virginia, under his leadership.

“Dr. Gupta brings firsthand experience as a medical doctor and public health official using evidence-based strategies to address the overdose epidemic in West Virginia,” the White House said in a statement. “We hope he will be confirmed by the Senate soon.”

Some say this nomination is a signal that government is looking to integrate medical solutions to reduce the national drug problem under Dr. Gupta’s leadership.

NCCI Publishes 2nd Edition of Medical Trends Dashboard

The Medical Indicators & Trends dashboard – Q4 2020 Edition is part of NCCI’s ongoing strategy to deliver more medical data insight.

It provides an interactive way to visualize state-specific information presented in the Q2 and Q3 2020 Medical Perspective reports and allows readers to download various summary tables.

More detailed state-specific Medical Data Reports can be found in State Insight, which is available to affiliates and regulators.

NCCI just announced the second edition of the dashboard.

It now includes summarized statistics for hospital outpatient services and ambulatory surgery centers, in addition to the key metrics it has been following, to better understand the direct and indirect impacts of COVID-19.

These include impacts to physician services, time to treatment, telemedicine, prescription drugs, and specific COVID-19 treated claim characteristics.

The data source used in this dashboard is NCCI’s Medical Data Call. The Medical Data Call represents data from most of the workers compensation premium written, which includes experience for large-deductible policies. Lump-sum settlements are not required to be reported. Also, self-insured data is generally not included.

While it is too early to fully assess the impact that the COVID-19 pandemic will have on the workers compensation system, this dashboard allows users to analyze state-specific medical treatment results during the spread of the pandemic.

Physician Not Protected by Anti-SLAPP in Allstate’s Fraud Action

Dr. Sonny Rubin is a physician who controls two medical companies (Sonny Rubin, M.D., Inc., and Coastal Spine and Orthopedic Specialists, Inc.).

A portion of Rubin’s practice involves “lien patients” involved in automobile accidents who are referred by attorneys. Lien patients have signed a “medical lien” authorizing their attorney “to pay directly to [Rubin] such sums as may be due and owing . . . and to withhold such sums from any settlement, judgment, or verdict as may be necessary to pay for” the patient’s treatment (this case only involves lien patients).

After providing medical treatment, Rubin prepares medical narrative reports, operative reports, and billing statements to be used in support of claims for insurance benefits under policies of insurance issue by Allstate.

In September 2019, Allstate filed a complaint on behalf of itself and the People of the State of California (qui tam). The complaint pleaded two causes of action: insurance fraud and unfair competition.

Allstate generally alleged Rubin violated the law by: “Presenting or causing to be presented false or fraudulent claims for the payment of a loss of injury under a contract of insurance[.]” (Ins. Code, §1871.7; Pen. Code, §§ 549, 550.) Allstate specifically alleged Rubin recommended unnecessary medical treatments, falsely represented it had treated injuries, engaged in deceptive billing practices, and prepared false invoices for insurance claims. According to Allstate, Rubin “engaged in a conspiracy, scheme, or plan to prepare and present false, fraudulent, and/or misleading narrative reports, operative reports, and billing statements . . . in support of, or in connection with” claims against Allstate and other insurers.

In March 2020, Rubin filed an anti-SLAPP motion, and argued in his motion to strike that “preparing and providing to the patient’s attorney the necessary documents supporting the medical services provided on a lien, falls within the definition of prelitigation activities” under the anti-SLAPP statute.

The trial court ruled “Rubin has failed to establish that Allstate’s claims arise from protected activity. Accordingly, the Court need not reach step two of the anti-SLAPP analysis and the special motion to strike is denied.” Ruben appealed and the Court of Appeal affirmed the trial court in the published case of The People ex rel. Allstate Insurance Company v Sonny Rubin,

Strategic Lawsuits Against Public Participation (SLAPP suits) are meritless lawsuits designed to punish parties for constitutionally protected activities (free speech or the right to petition). A defendant can seek to strike a SLAPP suit by filing an anti-SLAPP motion. (Code Civ. Proc., § 425.16.) The analysis is two-fold: usually the defendant must first show the lawsuit arises from its protected activities; if so, the plaintiff can defeat the anti-SLAPP motion by showing its lawsuit has merit.

Litigation is not “under [serious] consideration” – and thereby protected activity under the anti-SLAPP statute – if the ligation is merely a “‘possibility.’” (Mission Beverage Co. v. Pabst Brewing Co., LLC (2017) 15 Cal.App.5th 686, 703.)

Here, Rubin failed to show its medical reports and bills were prepared outside of its usual course of business in anticipation of litigation that was “under [serious] consideration.” (Ibid.)

Attorney Matthew J. Smith, on behalf of the Coalition Against Insurance Fraud, requested that the opinion be certified for publication. The Court granted his request.

Prison Inmate to Serve 5 More Years for EDD Fraud

51 year old Jason Vertz, of Fresno, and 45 year old Alana Powers, an inmate at the Central California Women’s Facility (CCWF) in Chowchilla, were each sentenced to five years and one month in prison for conspiracy to commit mail fraud and aggravated identity theft.

According to court documents, Vertz and Powers submitted several fraudulent unemployment insurance claims in Powers’ and other CCWF inmates’ names to the California Employment Development Department (EDD). Recorded jail calls and emails show that Powers and other inmates provided names, dates of birth, and social security numbers for inmates at CCWF to Vertz to submit the fraudulent claims. Shortly thereafter, the benefits were loaded onto debit cards that were mailed to the addresses the defendants provided.

The underlying applications for the claims stated that the inmates had worked within the prescribed period as maids, cleaners, fabrication welders, and other occupations, and that they were available to work, which was not true because they were incarcerated. The claims would have been denied if accurate answers had been given. EDD and the United States have suffered an actual loss of over $74,000 as a result of the fraud.

This case was the product of an investigation by the FBI, the California Department of Corrections and Rehabilitation Investigative Services Unit, and the California EDD. Assistant U.S. Attorneys Alexandre Dempsey and Joseph Barton are prosecuting the case.

On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the Department of Justice in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud. The Task Force bolsters efforts to investigate and prosecute the most culpable domestic and international criminal actors and assists agencies tasked with administering relief programs to prevent fraud by, among other methods, augmenting and incorporating existing coordination mechanisms, identifying resources and techniques to uncover fraudulent actors and their schemes, and sharing and harnessing information and insights gained from prior enforcement efforts.

Anyone with information about allegations of attempted fraud involving COVID-19 can report it by calling the Department of Justice’s National Center for Disaster Fraud (NCDF) Hotline at 866-720-5721 or via the NCDF Web Complaint Form at: https://www.justice.gov/disaster-fraud/ncdf-disaster-complaint-form.

Orange County Man Indicted $3M Fake Protective Gear Scam

An Orange County man is expected to be arraigned in federal court on an indictment charging him with defrauding victims who paid for COVID-related medical protective equipment that was never delivered, causing nearly $3 million in losses.

60 year old Christopher John Badsey, who lives Lake Forest, was arrested by FBI agents on July 8 without incident. He is charged with four counts of wire fraud and two counts of money laundering. He was arraigned in United States District Court in downtown Los Angeles.

According to an indictment returned by a federal grand jury on July 7, Badsey falsely represented that he had access to millions of boxes of medical-grade nitrile gloves through his Irvine-based company, First Defense International Security Services Corp. (FDI)

This type of personal protective equipment was in high demand and short supply during the COVID-19 pandemic.

Badsey allegedly entered into contractual agreements with victims, whom he required to provide a money deposit to inspect the gloves before delivery.

After receiving the deposits, Badsey allegedly instructed victims to travel to the Los Angeles area, where he claimed the gloves were stored in a warehouse. But when victims attempted to visit the warehouse, Badsey and other FDI employees allegedly provided excuses as to why the gloves could neither be inspected, nor delivered, to the victims.

Nitrile gloves were never provided to the victims, and Badsey is alleged to have absconded with the deposit money totaling nearly $3 million. After obtaining the victims’ wire deposits, Badsey and others are believed to have used those funds to make lavish purchases for their personal benefit.

If convicted of all charges in the six-count indictment, Badsey would face a statutory maximum sentence of 100 years in federal prison.

Orange County Man Indicted $3M Fake Protective Gear Scam

An Orange County man is expected to be arraigned in federal court on an indictment charging him with defrauding victims who paid for COVID-related medical protective equipment that was never delivered, causing nearly $3 million in losses.

60 year old Christopher John Badsey, who lives Lake Forest, was arrested by FBI agents on July 8 without incident. He is charged with four counts of wire fraud and two counts of money laundering. He was arraigned in United States District Court in downtown Los Angeles.

According to an indictment returned by a federal grand jury on July 7, Badsey falsely represented that he had access to millions of boxes of medical-grade nitrile gloves through his Irvine-based company, First Defense International Security Services Corp. (FDI)

This type of personal protective equipment was in high demand and short supply during the COVID-19 pandemic.

Badsey allegedly entered into contractual agreements with victims, whom he required to provide a money deposit to inspect the gloves before delivery.

After receiving the deposits, Badsey allegedly instructed victims to travel to the Los Angeles area, where he claimed the gloves were stored in a warehouse. But when victims attempted to visit the warehouse, Badsey and other FDI employees allegedly provided excuses as to why the gloves could neither be inspected, nor delivered, to the victims.

Nitrile gloves were never provided to the victims, and Badsey is alleged to have absconded with the deposit money totaling nearly $3 million. After obtaining the victims’ wire deposits, Badsey and others are believed to have used those funds to make lavish purchases for their personal benefit.

If convicted of all charges in the six-count indictment, Badsey would face a statutory maximum sentence of 100 years in federal prison.