Category: Daily News

The U.S. Food and Drug Administration is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.

These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.

Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome. The FDA evaluation of respiratory depression with the gabapentinoids provides some evidence contrary to the widely held belief that gabapentinoids lack drug interactions and have wide therapeutic indices. Published studies demonstrate these drugs can behave in an additive way to potentiate central nervous system (CNS) and respiratory depression.

The FDA evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse.

Gabapentinoids are often being combined with CNS depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone.

Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system (CNS) depressant such as a benzodiazepine. Patients with underlying respiratory disease and elderly patients are also at increased risk and should be managed similarly.

Shifting treatment from one CNS depressant to another may pose similar risks. Be aware of the potential additive effects of all these CNS depressants and plan accordingly, by starting with low doses, titrating carefully, and informing patients of the potential for CNS and respiratory depression and their symptoms.

Incorporating one or more medications with non-drug therapies is the prevailing approach for optimizing analgesia. However, pairing an opioid with any CNS depressant – a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product – will increase the risk of respiratory depression.

The gabapentinoid prescribing information already includes guidance for health care professionals to caution patients about dizziness, somnolence, and the potential for impaired ability to operate a car or complex machinery.

The FDA will continue to monitor these medicines as part of our routine monitoring of all FDA-approved drugs.

Many of Canada’s drug suppliers cannot, or will not, agree to ship cheaper prescription medicines into the United States, a new challenge to the Trump administration’s push to reduce drug prices, companies and industry officials told Reuters.

The administration on Wednesday proposed new regulations that would allow states to import prescription drugs from Canada. They would require a state such as Florida to partner with a wholesaler licensed by Health Canada, which regulates drugs.

Florida and other states have said they are eager to start importation programs, and the proposal took the federal government one step closer to approving that plan. But there are practical barriers to actually bringing in drugs.

Two drug distributors and two Canadian industry groups that between them represent all of the potential suppliers named in a proposal published by Florida in August said they are not interested in participating.

“We have not been contacted and we are not planning to participate,” said Loblaw Companies Ltd (L.TO), which owns Canada’s largest pharmacy chain Shoppers Drug Mart. “Canadian patients currently face product and drug shortages and we are concerned this initiative may exacerbate what is already a critical issue.”

Daniel Chiasson, president of the Canadian Association for Pharmacy Distribution Management (CAPDM), said none of its members would participate because their first priority was ensuring a safe and stable supply of medication for Canadians.

Mary Mayhew, secretary of the Florida Agency for Health Care Administration, said she was “excited and enthusiastic” about Wednesday’s announcement.  “We are optimistic that Canadian suppliers will be interested, as the rule is understood, as there is more dialogue around this new and historic federal action,” she said.

Chiasson said agreements between manufacturers and distributors prevent the export of products made for the Canadian market, creating a commercial risk and deterrent to exporting.

“These are issues we continue to consider and are committed to exploring how we might overcome any challenges and issues as we advance the proposed rule,” U.S. Food and Drug Administration spokesman Michael Felberbaum said in a statement.

Some of Canada’s major distributors are subsidiaries of U.S. companies, who are unlikely to participate in a program to lower prices, since their revenue reflects a cut of the value of the drugs they provide to pharmacies in the much larger U.S. market.

AmerisourceBergen said that protecting bottom lines was not the issue, because importation implied that distributors could buy low-cost drugs and sell them in high-cost markets.  “The reality is that legal and contractual barriers, as well as significant threat to the integrity of the supply chain, all stand in the way of importation being a viable solution,” it said in a statement.

The American Society of Journalists and Authors (ASJA) is the nation’s largest professional organization of independent nonfiction writers. Its membership consists of freelance writers of magazine articles, trade books, and many other forms of nonfiction writing. The ASJA was founded in 1948 as the Society of Magazine Writers. Its membership consists of more than 1,100 freelance writers.

The National Press Photographers Association (NPPA) is an American professional association made up of still photographers, television videographers, editors, and students in the journalism field. It was founded in 1946. As of 2017, NPPA had total membership at just over 6,000.

Both the American Society of Journalists and Authors, Inc., and National Press Photographers Association as plaintiffs have just filed a lawsuit federal court against California, over the state’s controversial Assembly Bill 5 (AB 5), saying the law forces their independent contractors to “become employees of their clients,” whether or not this is preferable or even feasible.

“We have no choice but to go to court to protect the rights of independent writers and freelance journalists as a whole,” said Milton C. Toby, JD, president of ASJA. “The stakes are too high, and we cannot stand by as our members and our colleagues face ill-conceived and potentially career-ending legislation.”

“Under the law, a freelancer like me can write 200-plus press releases in a year for a marketing firm, and it’s no problem. But if a newspaper wants me to write a weekly column about local politics, it must put me on staff – a very unlikely prospect – or violate the law. Otherwise I am silenced,” said San Diego freelance writer Randy Dotinga, a board member and former president of ASJA.

The lawsuit asserts that the law violates the U.S. Constitution because it penalizes some freelancers while allowing other visual artists (including marketing photographers, fine artists, and graphic artists) to continue to perform as independent contractors, unencumbered by limits on the number of assignments they do.

Additionally, AB5 forbids any freelancing by visual journalists who shoot video, a provision that is challenged in the lawsuit as a content-based restriction on speech. For still photojournalists, the bill imposes a limit of 35 “submissions” or assignments per year for any single client, another content-based First Amendment violation. Similar limits are imposed on freelance writers, editors, and newspaper cartoonists.

And and an article in Forbes just announced that Vox Media, a large digital media company with an array of niche sites, abruptly terminated hundreds of freelance writers in the state of California. The company will cancel its agreements with about 200 contractors to comply with a new law that goes into effect on January 1, 2020.

The cuts target writers for the SB Nation blog, which covers sports in California. Vox intends to replace the freelance writers with roughly 20 new part-time and full-time staffers.

ABC contracted with the landowners to use a gas station/food mart and car wash for two days to film an episode of a television show. The contract gave ABC “the right to use both the real and personal property . . . together with access to and egress from the Property with its personnel and equipment.”

The property sits on the corner of Foothill Boulevard and Terra Bella Street in Sylmar, California and is surrounded by an eight-foot high metal fence. ABC planned to close the property to the public during filming and needed access through three gates to the interior food mart and the parking areas.

On the side of the property along Terra Bella Street was a parking lot, a wall, and a metal rolling gate weighing approximately 900 pounds. The gate slid along a track that ran through containment towers to keep it upright. Cal-OSHA standards require that “[a]ll horizontal sliding gates . . . be equipped with positive stops or devices that limit the gate travel to the designed fully open and closed positions.” Without stops, the gates are unsafe. The Terra Bella gate lacked stops.

ABC’s location scout, Gary Watt, visited the premises multiple times but did not inspect the gates. During his visits, Watt looked for clearly observable problems, “what they call bear traps, anything that could be a safety hazard or anything that might present a danger to cast, crew, [or] the public.” Watt did not note that the gate was in any particular state of disrepair.

ABC hired Executive Assurance to provide security for the property during filming. On the day of filming, Reina Castro, a licensed security guard employed by Executive Assurance attempted to stop the Terra Bella gate from striking a truck that was backing out. The gate fell on her causing a broken leg, multiple fractures to her left shoulder, and torn ligaments and degenerative arthritis in her knee.

Castro sued ABC Studios, Inc. to recover for for her personal injuries.The trial court granted ABC’s motion for nonsuit under Privette v. Superior Court (1993) 5 Cal.4th 689 and its progeny, ruling that Castro had presented no evidence that ABC controlled the manner or mode by which its independent contractor’s employees, such as Castro, performed their work.

The Court of Appeal agreed that the Privette doctrine applies to this case and that Castro failed to adduce evidence of an exception in the unpublished case of Castro v. ABC Studios.

Subject to certain exceptions, the Privette doctrine bars employees of independent contractors from recovering damages from the hirer of the contractor for workplace injuries.

The rationale is twofold. First, because workers’ compensation insurance generally provides the exclusive remedy for employees who are injured on the job, allowing the employee to recover from the contractor’s hirer, who did not cause the injury, would unfairly subject the hirer to greater liability than that faced by the contractor who was negligent.

Secondly, by hiring an independent contractor, the hirer implicitly delegates to the contractor any tort law duty it owes to the contractor’s employees to ensure the safety of the specific workplace that is the subject of the contract.

Ten former National Football League (NFL) players have been charged in the Eastern District of Kentucky for their alleged roles in a nationwide fraud on a health care benefit program for retired NFL players.

The alleged fraud targeted the Gene Upshaw NFL Player Health Reimbursement Account Plan (the Plan), which was established pursuant to the 2006 collective bargaining agreement and provided for tax-free reimbursement of out-of-pocket medical care expenses that were not covered by insurance and that were incurred by former players, their wives and their dependents – up to a maximum of $350,000 per player.  According to the charging documents, over $3.9 million in false and fraudulent claims were submitted to the Plan, and the Plan paid out over $3.4 million on those claims between June 2017 and December 2018.

Two separate indictments filed in the Eastern District of Kentucky outline two alleged conspiracies involving different players related to the same scheme to defraud the Plan. Those charged in the indictments are the following:

— Robert McCune, 40, of Riverdale, Georgia, is charged with one count of conspiracy to commit wire fraud and health care fraud, nine counts of wire fraud and nine counts of health care fraud.

— John Eubanks, 36, of Cleveland, Mississippi; Tamarick Vanover, 45, of Tallahassee, Florida; and Carlos Rogers, 38, of Alpharetta, Georgia, are each charged with one count of conspiracy to commit wire fraud and health care fraud, two counts of wire fraud and two counts of health care fraud.

— Clinton Portis, 38, of McLean, Virginia; Ceandris Brown, 36, of Fresno, Texas; James Butler, 37, of Atlanta, Georgia; and Fredrick Bennett, 35, of Port Wentworth, Georgia, are each charged with one count of conspiracy to commit wire fraud and health care fraud, one count of wire fraud and one count of health care fraud.

— Correll Buckhalter, 41, of Colleyville, Texas, and Etric Pruitt, 38, of Theodore, Alabama, are charged with one count of conspiracy to commit wire fraud and health care fraud.

In addition, the government has filed notice that it intends to file criminal informations charging Joseph Horn, 47, of Columbia, South Carolina, and Donald “Reche” Caldwell, 40, of Tampa, Florida, with conspiracy to commit health care fraud in the Eastern District of Kentucky.

The indictments charge that the scheme to defraud involved the submission of false and fraudulent claims to the Plan for expensive medical equipment – typically between $40,000 and $50,000 for each claim – that was never purchased or received.  

The expensive medical equipment described on the false and fraudulent claims included hyperbaric oxygen chambers, cryotherapy machines, ultrasound machines designed for use by a doctor’s office to conduct women’s health examinations and electromagnetic therapy devices designed for use on horses.

According to allegations in the indictments, McCune, Eubanks, Vanover, Buckhalter, Rogers and others recruited other players into the scheme by offering to submit or cause the submission of these false and fraudulent claims in exchange for kickbacks and bribes that ranged from a few thousand dollars to $10,000 or more per claim submitted.  As part of the scheme, the defendants allegedly fabricated supporting documentation for the claims, including invoices, prescriptions and letters of medical necessity.  After the claims were submitted, McCune and Buckhalter allegedly called the telephone number provided by the Plan and impersonated certain other players in order to check on the status of the false and fraudulent claims.