CNN Investigates Expanding Use of Nuedexta in Nursing Homes

A recent investigation by CNN brought to light the expanding and allegedly inappropriate use of the prescription drug Nuedexta in nursing homes throughout the country. Nuedexta is FDA-approved to treat a rare condition known as pseudobulbar affect (PBA).

What is Pseudobulbar Affect?

Pseudobulbar affect is characterized by sudden and uncontrollable laughing or crying. It is associated with people who have multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALM), known as Lou Gehrig’s disease. Avanir Pharmaceuticals has been aggressively targeting elderly nursing home residents with the drug, the CNN investigation found, although PBA reportedly impacts less than 1 percent of Americans, based on a calculation using the drug maker’s own figures.

What the Investigation Revealed

Nuedexta prescription use in nursing homes is rising at a rapid rate, even though Avanir Pharmaceuticals acknowledges that the drug has not been extensively studied in elderly patients, according to CNN.

CNN found that Avanir Pharmaceutical’s sales force is focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, coupled with “high-volume prescribing and advocacy efforts by doctors receiving payments from the company.”

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.

In response to requests to be interviewed for the CNN article, Avanir reportedly responded by email with a statement that PBA is often “misunderstood” and that the condition can affect people with dementia and other neurological disorders that are common in nursing home residents.

Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with neurological conditions such as dementia. But geriatric physicians, dementia researchers, and other medical experts reportedly told CNN that PBA is extremely rare in dementia patients.

How Can Nuedexta Impact Nursing Home Residents?

One study of 194 patients with Alzheimer’s disease found that patients taking Nuedexta suffered more than twice as many falls as those patients taking a placebo.

CNN reports that Lon Schneider, director of the University of Southern California’s California Alzheimer’s Disease Center, reviewed information from several hundred reports obtained by CNN through the Freedom of Information Act. Schneider expressed concern about potential interactions between Nuedexta and other medications intended to treat problematic behaviors. These medications may include antipsychotic drugs, antidepressants, and anti-anxiety medication which are often given to nursing home residents to suppress anxiety or aggression that may occur with Alzheimer’s disease and other dementia types.

Why Are Doctors Prescribing Nuedexta to Nursing Home Residents?

According to CNN’s analysis of government data, between 2013 and 2016, Avanir and its parent company, Otsuka, paid almost $14 million to physicians for Nuedexta-related consulting, promotional speaking, and other services. The companies also spent $4.6 million on travel and dining costs. CNN found that in 2015 nearly half the Nuedexta claims filed with Medicare came from doctors who had received money or other perks.

According to the investigation, state regulators have found that doctors may inappropriately diagnose nursing home residents with PBA to justify the use of Nuedexta to treat confusion, agitation, and unruly behavior. Further, doctors may inappropriately diagnose nursing home residents with PBA to justify the use of Nuedexta to treat confusion, agitation, and unruly behavior. A diagnosis of PBA may be used because “off-label” prescriptions written by doctors using Nuedexta to treat patients who have not been diagnosed with PBA would typically not be covered by Medicare.

What Adverse Events Have Been Reported With Nuedexta Use By Nursing Home Patients?

Soon after Nuedexta came on the market, doctors, nurses, and nursing home patients’ family members began filing reports including rashes, dizziness, and falls as well as comas and death. CNN found that Nuedexta was listed as a “suspect” medication in nearly 1,000 adverse event reports received by the FDA. These reports disclosed side effects, drug interactions, and other issues. According to CNN, the FDA declined to comment on adverse events or the approval process for Nuedexta.

This post was written by Denise Mariani  of STARK & STARK, COPYRIGHT © 2017
For more legal analysis, go to The National Law Review

New California Laws Provide Protections to Immigrant Employees

On October 5, 2017, California Governor Jerry Brown signed 11 bills essentially making California a sanctuary state.  The California Values Act (SB 54) aims to protect undocumented immigrants living in California.  Brown stated that “this bill strikes a balance that will protect public safety while bringing a measure of comfort to those families who are now living in fear every day.”  The law, which will become effective on January 1, 2018, stops state and local enforcement agencies from using state resources to enforce federal immigration laws.

While the California Values Act has received a good deal of press, it is the Immigrant Worker Protection Act (AB 450), that is most relevant to employers.

With the signing of the IWPA, California became the first state to explicitly affirm the rights of immigrant workers at the worksite. The bill imposes an affirmative obligation on California employers to provide employees notification that ICE has determined they are lacking work authorization, thereby giving them advance warning that ICE may be considering their apprehension and removal from the U.S. through a workplace raid. Beyond union support, the IWPA is designed to protect an immigrant workforce essential to California’s economy – especially its agriculture. “According to [California] state Controller Betty Yee, undocumented immigrants’ labor is worth more than $180 billion a year.”

To protect immigrant employees, the IWPA:

  • Requires employers to ask for a warrant before allowing federal immigration officials into a workplace to interview employees
  • Bars employers from sharing employees’ confidential information (i.e. Social Security numbers) without a subpoena except for I-9s or other documents when a Notice of Inspection has been provided
  • Establishes penalties ranging from $2,000 to $10,000 for employers that:
    • Fail to give employees public notice within 72 hours of an upcoming federal immigration inspection of employee records including written notice to any Collective Bargaining Representative
    • Fail to provide affected employees with a copy of any Notice of Inspection and a copy of any inspection results within 72 hours

In late September, just prior to the signing of these bills, ICE implemented “Operation Safe City.” During the four-day operation about 500 people were arrested in California, Colorado, Illinois, Maryland, Massachusetts, New York, Oregon, and Pennsylvania, in cities and counties specifically targeted for their sanctuary policies.  Thomas Homan, ICE’s Acting Director stated:  “Sanctuary jurisdictions that do not honor detainers or allow us access to jails and prisons are shielding criminal aliens from immigration enforcement and creating a magnet for illegal immigration . . . As a result, ICE is forced to dedicate more resources to conduct at-large arrests in these communities.” Now, in response to the California Values Act and the IWPA, ICE announced it would have to target California neighborhoods and worksites.

This post was written by Brian E. Schield of Jackson Lewis P.C. © 2017
For more Immigration legal analysis go to The National Law Review

Cannabis Prop 65 Liability: Lessons Learned from the Dietary Supplement Industry

The cannabis industry appears to be next on the liability “hit list” under California’s notorious Proposition 65 statute. In June 2017, more than 700 Prop 65 notices were served on California cannabis businesses. Companies in this emerging market should start mitigating risk under Prop 65 now. Fortunately, lessons can be learned from the dietary supplement industry’s expensive Prop 65 battles over the past decade.

California’s Prop 65, also known as the Safe Drinking Water and Toxic Enforcement Act, requires a warning on all products that contain chemicals known to cause cancer or reproductive harm, even in amounts a fraction of what is deemed safe by federal standards. Prop 65 has caused havoc within the dietary supplement and herbal product markets over the past decade, led by a cottage industry of “bounty hunter” attorneys who have weaponized the statute, ostensibly in the public interest but in reality as a lucrative for-profit business. These bounty hunters are now turning their attention to cannabis. Though amendments to the statute were adopted in 2016 for the purpose of reducing this abuse, Prop 65 litigation will continue and cannabis companies must stay vigilant.

Many businesses faced with the necessity of using a Prop 65 warning have no concern with the impact that a warning may have on sales or with consumer confidence in the product. After all, who would look twice at a Prop 65 warning on motor oil or insect repellent? Like the dietary supplement industry before them, however, many cannabis businesses will resist including a warning that the product contains a chemical known to cause cancer or reproductive harm. Many cannabis products rely on the consumers’ belief that the product is harmless and even therapeutic. For many, this will be an important business decision that may give rise to expensive mistakes − a decision should be made with an understanding of the basis for Prop 65 liability and exposure.

What Is Prop 65 and What Does It Require?

Prop 65 was passed by California voters in 1986 after an aggressive lobbying campaign by environmental and public health activists. The stated purpose of Prop 65 was to improve public health. The general consensus, however, is that Prop 65 has placed an undue burden on California businesses while achieving no significant impact on public health over the past 30 years.

As noted above, Prop 65 requires a warning on all products that contain chemicals known to cause cancer or reproductive harm. There are more than 900 such chemicals listed, and marijuana smoke has been included on the list since 2009.

For a warning to be acceptable under Prop 65, it must (1) clearly make known that the chemical involved is known to cause cancer and/or birth defects and/or other reproductive harm and (2) be given in such a way that it will effectively reach the person before he or she is exposed. The warnings must be “clear and reasonable,” meaning that the warning may not be diluted by other language. Various means of communicating the warning are allowed, including product-specific warnings on a posted sign or shelf, warnings on the product label or electronic warnings for internet purchases.

Important Exemptions

There are several important exemptions to Prop 65 that make a warning unnecessary. Businesses with nine or fewer employees are exempt from the statute. There also is an exemption involving chemicals that occur naturally in food. Lead, for example, will be considered naturally occurring only if it “is a natural constituent of a food” and is not added as a result of human activity such as pollution or poor manufacturing processes. The burden is on the company to prove the exemption, however, which is typically time-consuming and expensive.

Another important exemption is provided by “safe harbor” exposure levels for many chemicals on the Prop 65 list, below which no warning is required. The listed chemicals include additives or ingredients in pesticides, food, drugs and common household products. Most food contains at least some level of one or more of these substances. Prop 65 safe-harbor levels, however, are in many cases around 1,000 times lower than levels set by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and World Health Organization (WHO). The exposure levels established by Prop 65 are often lower than what occurs naturally in fruits, vegetables, grains and even drinking water.

For example, the Prop 65 limit for lead is 0.5 mcg / day, which is below the amount of lead naturally found in many fruits, vegetables and herbs grown in non-contaminated soil. By comparison, the FDA allows 75 mcg / day and the European Union allows 250 mcg / day for lead. The European Food Safety Authority estimates the average adult consumes around 50 micrograms per day, which is 100 times the Prop 65 limit. It is nearly impossible to manufacture herbal products, including cannabis, without trace amounts of lead. Therefore, despite the “naturally occurring” exemption, discussed above, it can be dangerous to simply assume that an herbal product, including cannabis, complies with safe-harbor levels.

Only about 300 of the more than 900 Prop 65 chemicals have specific safe-harbor levels. For those chemicals without a safe-harbor limit, the burden will be on the cannabis business to establish that the subject chemical is within a safe range. This typically requires expensive testing, the results of which may be open to multiple interpretations as to whether a warning is required.

Determining the Exposure Level

Determination of the “exposure level” also is an important consideration. Prop 65 focuses on the level of a chemical to which the consumer is actually exposed. Although a product may have a very low amount of a chemical on the Prop 65 schedule that is below the safe-harbor level, liability under the statute may nevertheless be triggered based on the recommended serving size. It is advisable for companies to work with a laboratory that specializes in Prop 65 testing to determine the cumulative exposure level in order to verify the recommended serving size.

Enforcement of Prop 65

Prop 65 is enforced through litigation brought by the government or by private attorneys that “act in the public interest.” It is the threat of these private lawsuits that causes such consternation among those targeted with Prop 65 liability. After a 60-day notice period, the attorney may file a civil suit against the offending company. Typically, the plaintiff will demand that the defendant provide warnings compliant with Prop 65, pay a penalty, and either recall products already sold or attempt to provide health hazard warnings to those who purchased the products.

Though purportedly brought in the public interest, it is the collection of penalties and attorneys’ fees that in reality drives this litigation. Prop 65 allows individuals who bring suit to recover 25 percent of the penalties awarded, which by statute is calculated at $2,500 per violation per day. Amendments made to Prop 65 in 2016 allow for certain voluntary actions by the defendant – reformulation of the product, for example – in lieu of penalties. The threat of paying the plaintiff’s attorney’s fees makes litigating Prop 65 cases potentially very expensive. The attorney is incentivized to drag out the litigation, and the longer the case goes on, the more difficult it becomes to resolve because of the mounting fees.

This framework has created a cottage industry of Prop 65 “bounty hunter” lawyers who affiliate with “public interest” organizations that bring these cases for profit. According to the California Attorney General, 760 settlements were reported in 2016 with total settlement payments of more than $30 million. Attorneys’ fees accounted for 72 percent of that amount. The 2016 amendments to the statute have attempted to address these abuses to some extent by requiring a showing that the public benefits derived from the settlement are “significant” and by requiring contemporaneous record keeping for fees and costs sought to be recovered. Prop 65 litigation nevertheless continues to burden many industries in California, now including the cannabis industry. For Prop 65 liability, prevention is certainly less costly than a cure.

 

This post was written by Ian A. Stewart of Wilson Elser © 2017

For more legal analysis go to The National Law Review

Is Bullying Harassment?

California is oft thought of as a trailblazer in the arena of sexual harassment law. Because California’s Fair Employment and Housing Act mirrors Title VII, practitioners and employers in other states often look to California cases and laws regarding sexual harassment for guidance.

One area that has created a stir nationwide is California’s latest addition to its statute regarding mandatory sexual harassment training for supervisors. The state now mandates training on the subject of “abusive conduct,” otherwise known as bullying, in addition to training on sexual harassment avoidance. While “abusive conduct” is not illegal in and of itself, this addition to the law’s training requirements has created speculation as to whether legislation may be coming down the pike deeming bullying illegal.

Add to this discussion a new California appellate court decision, Levi v. The Regents of the University of California. In that case, the plaintiff was a neuro-ophthalmologist who claimed that the department chair sexually harassed  her by standing above her and banging his fists on his desk while threatening to fire her and by yelling at her on various occasions.  She also presented evidence of the department chair engaging in similar hostile and intimidating conduct against various co-workers.  The court, however,  refused to accept the plaintiff’s invitation to characterize “bullying” as harassment, and held that because there was no evidence that this conduct was because of the plaintiff’s gender, there was no harassment under the law.

Of course, bullying in the workplace is something that employers should seek to eliminate and prevent for a variety of reasons, such as fostering an inclusive work environment, keeping morale levels high, and ensuring that everyone works to their potential. However, the Levi case makes it clear that the kind of conduct we think of as bullying is not currently illegal harassment in most jurisdictions. Nevertheless, California’s recent sexual harassment regulations make it clear that companies must provide training regarding abusive conduct and avoiding bullying behavior.  The question remains – what does the future hold, and will the California legislature decide to codify its anti-bullying stance?

This post was written by Krista M. Cabrera of Foley & Lardner LLP © 2017
For more Labor & Employment legal analysis go to The National Law Review

Potential for more Trucking Accidents in California if New Federal Law Passes

A provision that is included in pending legislation in the U.S. House of Representatives may result in fewer truck drivers in California taking needed rest breaks while they are working. The bill would apply to truck drivers who drive into California from other states while exempting them from California’s mandatory rest break requirements. If this bill passes, truck drivers may be more fatigued and cause more accidents in both California and in the rest of the U.S.

The proposed law

A provision that is included in a House appropriations bill would exempt interstate truck drivers who drive into California from following the strict rest and meal break regulations in the state. Under California law, all workers, including truck drivers, must take one 30-minute meal break every five hours and one 10-minute rest break every four hours of work. Some other states, including Kentucky and Colorado, have similar rest and meal break laws on the books. Federal law only requires that truck drivers take one 30-minute break during the first eight hours of driving. Officials in California are concerned that reducing the amount of time that drivers spend resting may result in increased injury and accident rates in the state.

According to the Truck Safety Coalition, the legislators are attempting to preempt state labor laws that mandate additional meal and rest breaks beyond those that are required under federal law. While the law would apply to interstate drivers who drive into the state, some experts are also concerned that drivers who only drive within the state but who work for interstate trucking companies may fall into a legal loophole. They believe that their companies would likely pressure the drivers to only take the minimally required breaks under federal law instead of following the state’s requirements. The provision was introduced by two California Republicans, including Rep. David Valadao and Rep. Jeff Denham. Denham has received more than $60,000 in contributions to his campaigns from trucking organizations.

Drowsy driving truck accident statistics

In California, 15,000 large truck crashes happened in 2016. The California Highway Patrol reports that 8,989 of those collisions happened in Los Angeles. Nationally, the Federal Motor Carrier Safety Administration reports that 87,000 injury crashes happened in 2015, and 4,311 trucks and buses were involved in fatal accidents. The FMCSA reports that 55 fatal truck accidents in 2015 were caused by drowsy or fatigued truck drivers and another 71 were caused by driver inattention with unknown causes.

If the proposed law passes in the House and Senate and is signed into law by Trump, many truck drivers may not have to take the rest breaks that they currently have to take. Truck drivers drive for exhaustingly long shifts, and not being able to pull off of the road more frequently may lead them to become exhausted. In Dec. 2016, the AAA Foundation for Traffic Safety found that the crash risk for drivers spikes for every hour of sleep that they lose. Truck drivers who do not get sufficient sleep and who are also not able to take enough rest breaks may have greatly increased risks. For all drivers, AAA found that the risk of accidents doubles for people who get between five and six hours of sleep each night. When they only get four to five hours of sleep, their risks are four times higher of crash involvement than people who are more rested.

Pressures on truck drivers

Truck drivers report that they are under tremendous pressure by their companies to get their loads delivered on time, according to ABC News. When drivers are pressured to make their deliveries under tight deadlines, they may end up driving while they are fatigued. This pressure may compound the potential problems of having fewer rest breaks under the proposed federal law. If that law passes, it is likely that all interstate companies will force their workers to only follow the federal rules rather than pulling off the road more frequently or whenever they feel tired.

Drowsy driving can have serious or even fatal consequences for drivers and those who are traveling on the roads around them. Enacting federal legislation to preempt California’s meal and rest break requirements could lead to many more injuries and deaths in the state each year. Californians may want to lobby their representatives and senators about this provision in order to protect the general safety of everyone in the state.

This post was written by Steven M. Sweat.
For more legal analysis go to the National Law Review.

California Employers Face New Notice Requirement for Domestic Violence, Sexual Assault, and Stalking Time Off

The California Division of Labor Standards Enforcement (DLSE) has published a new form that must be added to the growing list of documents that employers are required to provide to employees at the time of hire.

The new form refers to employees’ rights under California Labor Code Section 230.1 relating to protections of employees who are victims of domestic violence, sexual assault, and/or stalking. Last October, we notified California employers about this new law amending Section 230.1, Assembly Bill (AB) 2337. The amended law requires employers with 25 or more employees to provide an employee with written notice of his or her rights to take time off for the following purposes:

  1. “To seek medical attention for injuries caused by domestic violence, sexual assault, or stalking.
  2. To obtain services from a domestic violence shelter, program, or rape crisis center as a result of domestic violence, sexual assault, or stalking.
  3. To obtain psychological counseling related to an experience of domestic violence, sexual assault, or stalking.
  4. To participate in safety planning and take other actions to increase safety from future domestic violence, sexual assault, or stalking, including temporary or permanent relocation.”

The law requires employers to provide the notice “to new employees upon hire and to other employees upon request.”

As we reported previously, employers were not required to distribute this information until the California Labor Commissioner published a form employers could use to comply with the law. The law gave the Labor Commissioner until “on or before July 1, 2017” to develop and post the form.

As required by AB 2337, the Labor Commissioner’s office recently released the notice. The DLSE has made both an English and Spanish version of the notice available on its website. The notice also contains information on employees’ rights to reasonable accommodation and to be free from retaliation and discrimination.

Finally, the new law clarifies that employers that do not use the Labor Commissioner’s notice may use an alternative that is “substantially similar in content and clarity to the form developed by the Labor Commissioner.”

This post was written by Christopher W. Olmsted and Hera S. Arsen of Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
Read more legal analysis on the National Law Review.

California’s Equal Restroom Access Act: 5 Facts You Need to Know

California’s Equal Restroom Access Act, which requires some establishments with single-occupancy restrooms to display signs indicating that the restroom is gender-neutral, has been in effect since March 1, 2017. Assembly Bill No. 1732 (AB 1732), which Governor Jerry Brown signed on September 29, 2016, requires these restrooms “to be identified as all-gender toilet facilities” and that the signs used to designate these restrooms comply with Title 24 of the California Code of Regulations.

1. Which Restrooms Are Covered?

The new law applies to “[a]ll single-user toilet facilities in any business establishment, place of public accommodation, or state or local government agency.” AB 1732 defines “single-user toilet facility” as “a toilet facility with no more than one water closet and one urinal with a locking mechanism controlled by the user.”

2. What Does the Law Require?

The law simply requires businesses, agencies, and places of public accommodation to use the proper signage—i.e., gender-neutral signage—on any single-user restrooms that they have.

3. What Must the Sign Look Like?

The signs on single-user restrooms must comply with Title 24 of the California Code of Regulations. This means that each covered single-user restroom must, at minimum, have the following signage:

  • A sign with a geometric symbol of a triangle superimposed on a circle
  • A designation tactile (i.e., capable of being read by touch) sign that indicates that the facility is a restroom

4. Does the Law Require That Specific Language Be Used?

The law does not require any specific wording on the signs as long as the wording used is gender neutral. For example, the sign may state “Restroom,” “All-Gender Restroom,” “Gender-Neutral,” “Unisex,” or “All Welcome.” Similarly, language written in raised letters and/or Braille must also be gender-neutral.

Note that the City of San Francisco has more restrictive laws in place regarding the wording and images on restroom signs.

5. How Will the Law Be Enforced?

The law permits inspectors, building officials, and other local officials who are “responsible for code enforcement” to inspect a restroom for compliance with this section during “any inspection of a business or a place of public accommodation.”

Key Takeaways

Affected employers with single-occupancy restrooms on their premises should ensure that the signs on the single-user restrooms are in compliance with Title 24 of the California Code of Regulations. Employers should also take this opportunity to review the Fair Employment and Housing Council’s gender identity regulations that went into effect on July 1, 2017. The regulations’ restroom access provisions require an employer to allow an employee to use the restroom facility that corresponds to the employee’s gender identity or gender expression, regardless of the employee’s sex assigned at birth.

For more analysis check out The National Law Review.

This post was written by Hera S. Arsen  of Ogletree, Deakins, Nash, Smoak & Stewart, P.C.