Pharmaceutical Issues

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

Education Secretary Signals Shift in Title IX Policy for Dealing with Sexual Misconduct Allegations

On September 7, 2017, Secretary of Education, Betsy DeVos announced a marked policy shift in how the Department of Education will approach Title IX enforcement with regard to sexual misconduct. DeVos indicated that the Department plans to withdraw the controversial Dear Colleague Letters issued during the Obama administration. Instead, the Department will issue formal regulations that will establish a new Title IX framework for educational institutions investigating and responding to sexual misconduct allegations. The full text of Secretary DeVos’s speech can be found here.

Title IX has been a dominant topic in higher education since 2011, when the Obama Administration issued the “Dear Colleague Letter” explaining that a failure to adequately address sexual misconduct on campus constituted discrimination on the basis of sex in education programs under Title IX.[1] Among other things, the Dear Colleague Letter set forth how schools should respond to sexual misconduct, dictated specific procedures schools must follow to investigate and adjudicate such misconduct, and established various other requirements such as climate surveys, standards of proof, and survivor sensitivity. The Letter made clear that a failure to meet these expectations, and the expanded guidance issued by the Department in 2014, could result in a loss of federal funding, and thus had a swift and substantial impact on the way educational institutions responded to reports of sexual assault or harassment.

In a speech at the George Mason University School of Law on September 7, 2017, Secretary DeVos said that schools will still be required to address sexual misconduct. However, she announced the Department would be rescinding the Dear Colleague Letters and instead regulate through actual regulations, subject to notice and comment. Secretary DeVos lamented that “for too long, rather than engage the public on controversial issues, the Department’s Office for Civil Rights has issued letters from the desks of un-elected and un-accountable political appointees.” She made it clear that “the era of ‘rule by letter’ is over.” DeVos emphasized the Department’s ongoing commitment to protecting victims of sexual violence. But she also clearly signaled that the Department will pay more attention to the due process rights of the accused, including questioning the “preponderance of the evidence” standard that the Department required all schools to use in adjudicating sexual misconduct cases. DeVos promised to work more closely with educational institutions, rather than operating “through intimidation and coercion.” And she said the Department would be open to exploring alternative methods of enforcing Title IX, including the possibility of voluntary regional centers where outside professionals would be available to handle Title IX investigations and adjudications.

DeVos did not indicate exactly what the new Department rules might entail, or when they will come into effect, nor has there been an official withdrawal of the Dear Colleague Letter yet. DeVos did indicate, however, that the Department will base the new rules on public feedback and will take into account the views of educational institutions, professionals, and individual students. In her closing remarks, DeVos noted that the Department of Education’s “interest is in exploring all alternatives that would help schools meet their Title IX obligations and protect all students. [The Department] welcome[s] input and look[s] forward to hearing more ideas.”[2]

Schools should take advantage of the Secretary’s call for comments, as the Department moves towards the development and implementation of a different and hopefully clearer set of rules governing the enforcement of Title IX. However, schools should also anticipate a period of uncertainty until final rules are issued. Moreover, schools should be aware of the continuing (and possibly conflicting) state law obligations that have been put into place following the Dear Colleague Letter. For example, many states including Connecticut and New York have passed legislation mandating use of the preponderance of the evidence standard in evaluating sexual misconduct on college campuses. We anticipate further, more detailed guidance in the next few weeks as the Department of Education works to implement Secretary DeVos’s policy announcements.


[1] 20 U.S.C. §§ 1681 et seq.; 34 C.F.R. Part 106.

[2] Secretary DeVos Prepared Remarks on Title IX Enforcement, available here.

 This post was written by Benjamin DanielsAaron Bayer, & Dana M. Stepnowsky of Wiggin and Dana LLP., © 1998-2017
attorney legal consumer

The Supreme Court Enters the Digital Age

Electronic filing is coming to the U.S. Supreme Court! Effective November 13, 2017, amendments to the Supreme Court’s rules take effect that require represented parties (and their amici) to submit petitions, briefs, and most other filings through the Court’s electronic filing system. The Rules explain that the new e-filing requirements are “[i]n addition to the filing requirements” already set forth in the Rules. Accordingly, parties and their amici will still be required to submit forty copies of their briefs on paper in booklet form, and they now must additionally submit one paper copy on 8.5 x 11 inch paper (in case the Clerk’s office needs to scan the brief for any reason). The paper submission remains the “official filing” for purposes of determining timeliness, but e-filing is supposed to occur “contemporaneously” with the paper filing. Pro se parties will continue to file submissions exclusively on paper; those submissions will be scanned by the Clerk’s office and posted on the Court’s web site.

Attorneys practicing before the Supreme Court will be required to register for an account on the Court’s electronic filing system. The Court warns that it could take two days for a new account to be approved, so attorneys should register well in advance of a filing deadline. Attorneys of record will also now be required to file notices of appearance using the Court’s e-filing system. Under the previous regime, the submission of a brief with an attorney’s information constituted a notice of appearance. Now, an attorney need not file a notice of appearance to submit a case-initiating document, such as a cert petition, but must make an appearance before filing any other document.

While the advent of e-filing creates a few new procedural hurdles, it also presents some obvious benefits to litigators. Primarily, all documents e-filed with the Court will be made available to the public free of charge, which will make it easier to access briefs and petitions filed in other cases. Moreover, counsel who enter an appearance will receive immediate notifications of any activity in the case. Under the old system, a party would not learn of an adversary’s filing until it arrived on paper by courier sometimes three days later, unless opposing counsel was courteous and emailed a courtesy copy.

E-filed documents will be posted immediately to the Supreme Court’s web site. (The lone exception is a document that commences a new case, which will first be reviewed by the Clerk’s office and the case assigned a number before the document becomes available to the public). Accordingly, the Court has promulgated new rules and guidelines to ensure that confidential information does not accidentally become public. Specifically, new Rule 34.6 incorporates the privacy protections found in Fed. R. Civ. P. 5.2 in most cases. Moreover, documents containing material under seal must not be submitted electronically but only in paper form.  (This also holds true also for redacted forms of briefs submitted for the public record).

Given the Supreme Court’s arcane procedural rules, Proskauer’s Appellate Department recommends that any party or amicus practicing before the Court use an appellate printer to assist with filings. Printers are typically well-versed in the Court’s procedural minutiae and will be able to help you navigate the Court’s new e-filing process.

This post was written by John E Roberts of Proskauer Rose LLP., © 2017
For more legal analysis, go to The National Law Review

Trump Administration Limits Affordable Care Act’s Contraceptive Coverage Mandate

On Friday October 6, 2017, the Trump administration released two interim final rules expanding the exemptions allowed under the Patient Protection and Affordable Care Act’s (the “ACA’s”) contraceptive coverage mandate. Under the ACA, employer group health plans generally are required to cover contraceptives, sterilization, and related patient education and counseling, with exemptions provided for religious houses of worship. The exemption was expanded by the Department of Health and Human Services (HHS) as a result of the Supreme Court’s decision in Burwell v. Hobby Lobby 34 S. Ct. 2751 (2014), which held health plans of closely held for-profit corporations are not required to cover contraceptives if doing so would contradict the owner’s religious beliefs under the Religious Freedom Restoration Act.

The interim final rules, released by the Treasury Department, Department of Labor (DOL), and HHS, are effective immediately and provide exemptions from the contraceptive coverage mandate to many employers with “sincerely held religious beliefs” or “sincerely held moral convictions”. The interim final rules limit the exemption for “sincerely held moral convictions” to houses of worship, tax-exempt entities, and closely held for-profit corporations, but permit publicly traded for-profit entities to use the exemption for “sincerely held religious beliefs.” According to the Trump administration, the United States has had a long history of providing protections in the regulation of health care for individuals and entities with objections based on religious beliefs or moral convictions. To take advantage of the new exemption, eligible employers must notify employees that they will no longer provide contraceptive coverage but need not inform the federal government. The Employee Retirement Income Security Act of 1974, as amended (ERISA) requires that a Summary of Material Modification (SMM) is provided within 60 days of a “material reduction” in covered services or benefits provided under a group health plan. A material reduction includes the elimination of benefits payable under a group health plan. According to an Obama administration report released last year, 55 million women have gained access to no-cost birth control as a result of the contraceptive coverage mandate. It is not clear how many entities may claim the exemptions, but HHS has predicted about 200 entities (affecting 120,000 women) may do so based on the number of entities that filed lawsuits.  Written comments on the interim final rules are due December 5, 2017.

This post was written by Cassandra Labbees of Epstein Becker & Green, P.C. All rights reserved., ©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

Trump Administration Issues “Principles” in Exchange for Relief for DACA Recipients

Deferred action for DACA recipients will start to expire in March 2018 and there is still no certainty about what will happen to them.  Amidst legal challenges to the rescission of DACA, the introduction of a number of statutory fixes, and a supposed “deal” between President Trump and Democratic leaders to protect the “Dreamers,” there is now a new twist.  The Trump Administration has announced a list of principles to include in any deal for the Dreamers.  Those principles, some of which derive from the President’s various Executive Orders, include:

  • Construction of a wall across the US southern border;
  • Improve infrastructure and security on the northern border;
  • Eliminate loopholes that make it difficult to return Unaccompanied Alien Children (primarily from Central America) and their families to their home countries;
  • Hire 10,000 immigration agents and 300 Federal prosecutors;
  • Hire 370 Immigration Judges and 1,000 ICE attorneys;
  • Increase scrutiny of asylum petitions and impose penalties for baseless or frivolous claims;
  • Terminate “catch and release” policies;
  • Expand grounds of inadmissibility and deportability;
  • Deny federal aid to sanctuary jurisdictions;
  • Discourage visa overstays by classifying overstays as misdeameanors;
  • Require use of E-Verify by all employers and increase penalties for a pattern or practice of violations;
  • Eliminate extended family “chain migration” and establish a new merit-based green card system; and
  • Eliminate the diversity lottery.

It is not clear whether these principles represent a first offer in a negotiation or if these principles are non-negotiable. Some Democrats in Congress have threatened the possibility of a government shutdown in December if DACA recipients receive no relief. Senator Jeff Flake (R-Ariz.) has pieced together parts of other proposed legislation and introduced what he believes would be a compromise bill, the Border Security and Deferred Action Recipient Relief Act. This Act provides:

  • DACA recipients or other children who have been in the U.S. since 2012 can obtain Conditional Resident Status for 10 years by pursuing vocational or higher education, are gainfully employed or by enlisting in the military. Upon meeting certain conditions, after the 10 years, they will be eligible to apply for Green Cards.
  • $1.6 billion for border security measures: 74 miles of border fortifications and funding to plan for further construction.
  • Construction of border access roads to simplify CBP patrols of the border.
  • Targeting of gangs and cartels for deportations.
This post was written by Forrest G. Read IV of Jackson Lewis P.C. © 2017
For more Immigration legal analysis go to The National Law Review

U.S. Suspends Nonimmigrant Visa Services in Turkey; Turkey Responds by Suspending Visas to U.S. Citizens

The U.S. Embassy announced it was suspending all nonimmigrant visa services in all U.S. diplomatic posts in Turkey. Turkey responded within a few hours of the U.S. Embassy’s announcement by saying it would no longer issue visas to U.S. citizens, including the physical “sticker” visas at border posts as well as the online Turkish electronic visa (e-visa).

It’s important to note that while the U.S. has halted its visa services in Turkey, it appears that the U.S. State Department is still issuing visas to Turkish nationals outside of Turkey. The U.S. has not indicated how long the suspension will last. Nevertheless, Turkish nationals who are currently in the US with expiring visas in their passports and who need to travel internationally should consider applying at another post as a third-country national. While applying as a third-country national is not ideal because such applications can be subject to delays, applying at another post may become necessary if the suspension of visa services in Turkey continues.

This post was written by Rebecca B. Schechter  of Greenberg Traurig, LLP. All rights reserved., ©2017
For more Immigration news, go to The National Law Review
fingerprints biometrics

Employees Sue for Fingerprint Use

Employees of Peacock Foods, an Illinois-based food product manufacturer, recently filed a lawsuit against their employer for alleged violations of Illinois’ Biometric Information Privacy Act. Under BIPA, companies that collect biometric information must inter alia have a written retention policy (that they follow). As part of the policy, the law states that they must delete biometric information after they no long need it, or three years after the last transaction with the individual. Companies also need consent to collect the information under the Illinois law, cannot sell information, and if shared must get consent for such sharing.

According to the plaintiff-employees, Peacock Foods used their fingerprints for a time tracking system without explaining in writing how the saved fingerprints would be used, or if they would be shared with third parties. According to the employees, this violated BIPA’s requirement for explaining -in the consent request- how information would be used and how long it would be kept. The employees also alleged that Peacock Foods did not have a retention schedule and program in place for deleting biometric data. The employees are currently seeking class certification.

Putting it Into Practice: This case is a reminder that plaintiffs’ class action lawyers are looking at BIPA and possible complaints that can be brought under the law. To address the Illinois law – and similar ones in Texas and Washington – companies should look at the notice and consent process they have in place.   

This post was written by Liisa M. Thomas & Mukund H. Sharma of Sheppard Mullin Richter & Hampton LLP., Copyright © 2017

For more Labor & Employment legal analysis, go to The National Law Review

Senate Confirms Lee Francis Cissna to lead USCIS

On Oct. 5, the U.S. Senate approved the nomination of Lee Francis Cissna to lead the U.S. Citizenship and Immigration Services agency (USCIS) on a bipartisan vote of 54-43. All Republican senators supported the nomination and were joined by Democrat Senators Donnelly (IN), Heitkamp (ND), Manchin (WV) and McCaskill (MO). Senators Cochran (R-MS), Cortez Masto (D-NV) and Heller (R-NV) did not vote.

 

This post was written by Robert Y. Maples of Greenberg Traurig, LLP. All rights reserved, ©2017

For more legal analysis go to The National Law Review

US Attorney General Jefferson Sessions Issues New Guidance On Transgender Employees

Yesterday, U.S. Attorney General Jefferson Sessions issued new guidance reversing the federal government’s former position that gender identity is protected under Title VII.

In a memo sent to the heads of all federal agencies and the U.S. attorneys, the attorney general stated that as a matter of law, “Title VII does not prohibit discrimination based on gender identity per se.” The memorandum further stated the DOJ will take the position in all pending and future matters that Title VII does not protect against discrimination on the basis of gender identity or transgender status.

Sessions’ memo explains Title VII expressly prohibits discrimination on the basis of sex but makes no reference to gender, and that courts have interpreted “sex” to mean biologically male or female. Sessions concluded employers may differentiate on the basis of sex in employment practices, so long as the practices do not expose members of one sex to disadvantageous terms or conditions of employment to which the other sex is not exposed. The memo highlighted sex-specific bathrooms as such an example. Sessions explained while Title VII prohibits “sex-stereotypes,” insofar as that sort of sex-based consideration causes disparate treatment between men and women, Title VII is not properly construed to proscribe employment practices that take into account the sex of employees, but do not impose different burdens on similarly situated members of each sex.

This guidance reverses and withdraws previous guidance by Attorney General Eric Holder in a December 15, 2014 memorandum in which Holder stated Title VII prohibits employers from using “sex-based considerations,” such as gender identity, in employment decisions. Sessions’ memo also runs contrary to the current position of the U.S. Equal Employment Opportunity Commission, which treats discrimination against an employee on the basis of gender identity, including transgender status and sexual orientation, as violations of Title VII.

Currently, there is a split of authority in the courts on whether sex discrimination under Title VII includes discrimination on the basis of gender identity and sex stereotyping, and thus prohibits discrimination against transgender individuals. The U.S. Supreme Court will likely have to resolve the issue in the future, but may issue some relevant guidance this term in the Gloucester County School Board v. G.G. case (involving issues of a school district’s obligations to a transgender student).

While it is now the position of the Department of Justice that Title VII protections do not extend to transgender individuals, employers should still be careful to avoid discrimination on the basis of gender identity, as the law is still unsettled. As Attorney General Sessions’ memorandum notes, there are still federal statutes that prohibit discrimination against transgender persons, and states and localities may have additional protections. Moreover, the EEOC could still bring suit against employers who engage in transgender discrimination.

This post was written by Allison L. Goico & Hayley Geiler of Dinsmore & Shohl LLP. All rights reserved., © 2017
For more Labor & Employment legal analysis, go to The National Law Review