Category: Daily News

Eight medical device makers, including a California startup that uses virtual reality to treat chronic pain, topped an innovation contest aimed at addressing the opioid crisis, the U.S. Food and Drug Administration said on Friday.

As part of the FDA’s ongoing commitment to address the opioid crisis, the FDA’s Center for Devices and Radiological Health (CDRH) launched an Innovation Challenge in May 2018. The challenge was intended to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.

The goal was to provide additional incentives for medical device developers to invest in products that can address the addiction crisis and advance the development of innovative, safe and effective technologies. We received more than 250 applications from medical device developers.

Silicon Valley-based startup CognifiSense, which is developing the virtual reality therapy, and iPill Dispenser, which uses a biometrically controlled mobile app that aims to cut overconsumption by dispensing pills based on prescriptions, were among the winners of the FDA’s contest.

The company is developing VR Neuropsychological Therapy or VRNT, a proprietary VR software platform that provides psychological and experiential training to chronic pain patients to normalize their pain perception.

VR distraction therapy utilizes the immersive power of VR to create high cognitive load. It consists of entertaining games or experiences which focus the user on another task and away from the pain. Distraction therapy has been shown to be effective in providing short-term relief in acute pain. Immersive video games that shift the user’s focus from the pain are known as “distraction therapy”.

VRNT differs from distraction therapy in that it specifically targets the brain’s “neuroplasticity”, or ability to change over time.

Overall eight submissions were selected. The following selected proposals include therapeutic and diagnostic medical devices intended to treat opioid use disorder, detect and treat overdose, dispense medication and treat pain:

– Brainsway, Ltd (Brainsway Deep Transcrainal Magnetic Stimulation (DTMS) Device)
– Avanos (Pain therapy Device)
– iPill Dispenser (iPill Dispenser)
– Masimo Corporation (Overdose Detection Device)
– ThermoTek, Inc. (NanoThermTM and VascuTherm TM Systems)
– Milliman (Opioid Prediction Service)
– Algomet Rx, Inc. (Rapid Drug Screen)
– CognifiSense, Inc. (Virtual Reality Neuropsychological Therapy)

The FDA received over 250 applications for the innovation challenge, which seeks to prioritize the approval of novel medical devices including digital health technologies such as mobile medical apps.

Gino Carl von Eckstein was sentenced to 10 years in prison for possessing with intent to distribute methamphetamine. Eckstein, 25, of Brisbane, Calif., pleaded guilty to the charge on September 5, 2018, after federal agents executed search warrants on his car and three residences he was using.

A federal grand jury filed an indictment on June 26, 2018, charging Eckstein with one count of intentionally possessing with intent to distribute 500 grams and more of a mixture and substance containing methamphetamine, in violation of 21 U.S.C. §§ 841(a)(1) and 841(b)(1)(A)(viii). He pleaded guilty to the charge.

Eckstein admitted that he possessed counterfeit “Adderall” pills, or pills that appeared to be Adderall, but in fact contained methamphetamine. Eckstein admitted he stored the pills in his car, at three locations in San Francisco’s Richmond District, in Brisbane, and in San Leandro. Eckstein further admitted he possessed the equipment and ingredients necessary to manufacture counterfeit Adderall pills. In total, agents allegedly found over 1,000 grams of suspected methamphetamine.

“Counterfeit pharmaceuticals are a danger to the community,” said U.S. Attorney Tse. “As this case illustrates, we are responding to the emerging threat of counterfeit pharmaceuticals in our district, particularly when the substances are laced with potentially life endangering drugs. Those individuals who put these dangerous products in our community will be prosecuted to the fullest extent of the law.”

“Producing unregulated concoctions and marketing them as a legitimate substance is criminal and dangerous. These drugs are unsafe and their use can have devastating consequences,” stated DEA Special Agent in Charge Chris Nielsen. “We will continue working with our partners to hold people accountable who threaten public health and safety by distributing counterfeit pharmaceuticals.”

In addition to the prison term, the court also sentenced the defendant to a 5-year period of supervised release. Eckstein has been in continuous custody since June 15, 2018, and will begin serving his sentence immediately.

Assistant United States Attorney Sheila Armbrust in prosecuting this case. This case is the result of an investigation by the DEA, CBP, FBI, and IRS-CI, with assistance from the San Francisco Police Department. This case was investigated and prosecuted by member agencies of the Organized Crime Drug Enforcement Task Force, a focused multi-agency, multi-jurisdictional task force investigating and prosecuting the most significant drug trafficking organizations throughout the United States by leveraging the combined expertise of federal, state, and local law enforcement agencies.

Candace Michelle Craven, a Tennessee-based nurse practitioner pleaded guilty in federal court this week, admitting that she participated in a health care fraud scheme that bilked TRICARE – the health care program that covers United States service members – out of more than $65 million. As part of her guilty plea, Craven admitted to conducting sham “telemedicine” evaluations that resulted in the prescription of exorbitantly expensive compounded medications to patients that she never saw or examined in person.

Craven will be sentenced at a hearing scheduled for February 8, 2019.

Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient requires a particular dosage or application or is allergic to a dye or other ingredient.

According to the guilty plea, a team of individuals worked to recruit and pay Marines, primarily from the San Diego area, and their dependents – all TRICARE beneficiaries – to obtain compounded medications that would be paid for by TRICARE.

This information was sent to Choice MD, the Tennessee medical clinic that employed Craven. Craven then conducted phone calls with the TRICARE beneficiaries, and recommended that they be prescribed compounded medications despite never examining the patients in person.

These prescriptions were then signed by doctors employed by Choice MD, were not given to the beneficiaries, but sent directly to particular pharmacies controlled by co-conspirators, which filled the prescriptions and billed TRICARE at exorbitant prices.

Josh Morgan, a former Marine from San Diego, pleaded guilty in April to Conspiracy to Commit Health Care Fraud for his role in recruiting TRICARE beneficiaries to fraudulently receive these prescriptions.

The doctors who signed the prescriptions, Carl Lindblad and Suzy Vergot, pleaded guilty to the same charges in September.

Between December 2014 and May 9, 2015 – the day that TRICARE stopped reimbursing for compounded medications – doctors working at Choice MD signed 4,442 total prescriptions. Over this time, their co-conspirators billed TRICARE $65,679,512 for these prescriptions.

Craven represents the seventh defendant charged in relation to this fraud scheme. In addition to Morgan, Lindblad, and Vergot, Jimmy and Ashley Collins, the owners of Choice MD, and CFK, Inc., the owner of a co-conspirator pharmacy, were indicted in March 2018 on charges of Conspiracy to Commit Health Care Fraud and Illegal Payments of Remunerations. That case remains pending.

This case is being prosecuted by Assistant United States Attorneys Benjamin J. Katz and Mark W. Pletcher.

CalTrans contracted with Viking Construction Company for a construction project, known as the Chico 99 Project, to widen roadways and bridges on a state highway in Butte County. The Chico 99 Project included work on a bridge 21 feet above the ground in the Bidwell Park area.

In 2012, Deborah Davis, the CalTrans assistant resident engineer, told Viking’s foreman, Robert Burns, that the openings in a temporary traffic screen, known as a gawk screen or a glare screen were to be filled in by the end of the shift, 5:00 a.m. The purpose of the screen is to prevent motorists from being distracted by the construction work and to protect workers from the glare of headlights. The screen had been installed in accordance with the standard plans.

Burns and Bradley Capps, an employee of Viking, finished their scheduled work and began to install additional screens where necessary. On the final installation, while it was still dark, as Burns was adjusting the light and Capps unstrapped the screen from the truck, Burns heard a sound like a boot scuffing on concrete. When he turned, Capps had fallen from the bridge. Burns had fall protection for both men in the truck with him, but had not used it. Capps fell to his death from the bridge.

Capps’s surviving wife and children, brought suit against CalTrans, alleging the accident occurred while Capps was performing work at the specific direction of CalTrans. Plaintiffs had received workers’ compensation benefits for the accident.

CalTrans successfully moved for summary judgment on the basis that it was not liable per Privette v. Superior Court (1993) 5 Cal.4th 689 (Privette), which generally prohibits an independent contractor or his employees from suing the hirer of the contractor for workplace injuries, and the exception for negligent exercise of retained control did not apply. The court of appeal affirmed in the unpublished case of Capps v Dept. of Transportation.

On appeal, plaintiffs contend it was error to grant summary judgment because triable issues of fact remain as to whether CalTrans (the hirer) affirmatively contributed to Capps’s death by interfering with Viking’s (the contractor’s) work.

Specifically, they contend CalTrans interfered with Viking’s work by going outside the established chain of command to order unscheduled work. They further contend the trial court erred in requiring them to prove that CalTrans retained control while the law requires only that they raise a triable issue as to that fact. Finally, they contend all of their evidentiary objections are preserved for appeal because the trial court did not rule on them.

CalTrans provided evidence that under the contract, responsibility for worker safety was delegated to Viking. CalTrans did not give Viking any instructions as to how to fill the gaps in the screen, did not provide any equipment, and did not give any advice as to safety measures.

CalTrans provided excerpts of the deposition of Burns in which he testified he had fall protection with him but did not use it; he had removed or installed these screens at night “many, many times” and knew how to do it safely. Viking’s project manager Quiggle drove by and saw Burns and Capps doing the work and did not give them any safety instructions.

Privette held peculiar risk liability did not extend to employees of an independent contractor when “the injuries resulting from an independent contractor’s performance of inherently dangerous work are to an employee of the contractor, and thus subject to workers’ compensation coverage, the doctrine of peculiar risk affords no basis for the employee to seek recovery of tort damages from the person who hired the contractor but did not cause the injuries.”

The court of appeal found no triable issue as to whether CalTrans retained and negligently exercised control over Capps’s work at the time of his fall.

The manner in which CalTrans directed work to be done did not cause it to retain control over the manner in which Viking performed the work.

The California Consumer Privacy Act (CCPA) is a major new state law poised to affect the privacy landscape not just in California, but in the U.S. as a whole. It was signed into law by California Governor Jerry Brown on June 28, 2018, after being hastily introduced in the California Legislature just a few days prior.

z The Act gives “consumers” (defined as natural persons who are California residents) four basic rights in relation to their personal information:

1) The right to know, through a general privacy policy and with more specifics available upon request, what personal information a business has collected about them, where it was sourced from, what it is being used for, whether it is being disclosed or sold, and to whom it is being disclosed or sold;
2) The right to “opt out” of allowing a business to sell their personal information to third parties (or, for consumers who are under 16 years old, the right not to have their personal information sold absent their, or their parent’s, opt-in);
3) The right to have a business delete their personal information, with some exceptions; and
4) The right to receive equal service and pricing from a business, even if they exercise their privacy rights under the Act.

The Act will apply to for-profit businesses that collect and control California residents’ personal information, do business in the State of California, and: (a) have annual gross revenues in excess of $25 million; or (b) receive or disclose the personal information of 50,000 or more California residents, households or devices on an annual basis; or (c) derive 50 percent or more of their annual revenues from selling California residents’ personal information.

The law does not apply to information already regulated under the Health Insurance Portability and Accountability Act, the Graham-Leach Bliley Act, the Fair Credit Reporting Act, or the Drivers’ Privacy Protection Act; it still applies to entities covered by these laws to the extent they collect and process other personal information about California consumers.

Matthew Smith, director of Government Affairs and general counsel for the Coalition Against Insurance Fraud.commented on new laws governing cyber, data privacy in an article that appeared in the Claims Journal. Two of the most significant laws, he said, came out of South Carolina and California.

“The California Privacy Law applies to insurers and all other businesses in the state and has very severe restrictions on the use of private data,” Smith explained.

“We’re looking at it from the standpoint of what impact it might or might not have on an insurer’s ability to even report fraud. We think we’re all right there, but we’re partnering with others to look to make certain that it does not infringe on the ability to report insurance fraud under the Privacy Act.”

Businesses will incur significant compliance costs in order to update procedures, policies and Web sites in accordance with the new law. Additionally, the Act’s grant of a private right of action means that companies will have to anticipate a possible flood of consumer-driven litigation.

It is expected that the state legislature will continue to refine and amend the Act’s privacy-related requirements before the final version of the law goes into effect on January 1, 2020.

Legal experts in the field of data privacy claim in an article published in a legal newsletter that “data privacy remains one of the most significant concerns facing the insurance industry. A flurry of new and evolving data security and privacy laws and regulations are re-shaping the regulatory landscape, making it more difficult for companies to avoid exposing themselves to regulatory and other legal risk:.

Companies should start formulating compliance strategies well before the law goes into effect January 1, 2020.