Filed under: Compliance, Elder Issues, Litigation and Liability, New Jersey, Public Health, Quality Improvement, Whistleblowers
New Jersey has perhaps the most employee-friendly whistleblower law in the nation, and the NJ Supreme Court is one of the most employee-friendly courts. It was, therefore, more than a little surprising to read the court’s most recent Conscientious Employee Protection Act decision, Hitesman v. Bridgeway, Inc.
A quick summary of the law and the facts make it even more surprising.
Law-wise, CEPA protects employees from retaliation for opposing any activity “the employee reasonably believes . . . is incompatible with a clear mandate of public policy concerning the public health.” Further, and seemingly tailor-made for Mr. Hitesman, CEPA also bars retaliation “in the case of an employee who is a licensed or certified health care professional, [for opposing conduct he] reasonably believes constitutes improper quality of patient care.”
As for the facts, plaintiff, a registered nurse who was shift supervisor for the defendant, believed that there was an upswing in respiratory and gastrointestinal infections at the nursing home. He reported his concerns first to management, then to local and state health agencies, and, not getting much of a reaction, went to a local television station. Perhaps needless to say he was fired.
In this kind of scenario, if the whistleblower loses, it’s usually because (1) he can’t prove that he was reasonable in his belief as to a violation of public policy or (2) he can’t prove that the adverse employment action he suffered was causally linked to his protected conduct. But neither was the problem for plaintiff since a jury had found both that Hitesman’s beliefs about improper patient care were “objectively reasonable” and that Hitesman’s reporting his concerns to the government was a “determinative motivating factor” in his discharge.
So why did he lose before the Supreme Court? Apparently, because his attorney never put in evidence that inadequate infection control was a threat to patient health. Really. And in a nursing home at that, which necessarily serves a more vulnerable population. Although it would seemingly have been easy to prove medical standards of care in dealing with potential infection, for example, citing to Center for Disease Control publications, the only evidence put in of the relevant policies was an American Nursing Association Code of Ethics and two internal policies of the nursing home, none of which focused directly on infections.
The court wrote:
[A] pivotal component of a CEPA claim is the plaintiff’s identification of authority in one or more of the categories enumerated in the statute that bears a substantial nexus to his or her claim. . . . [T]he plaintiff must identify the authority that provides a standard against which the conduct of the defendant may be measured.
While CEPA recognizes “a range of standards that may support a claim,” including professional codes, a claim “cannot proceed unless the plaintiff demonstrates a reasonable belief that the defendant’s patient care is ‘improper,’ measured against an authority recognized by CEPA,” which requires plaintiff to “identify a law, rule, regulation, declaratory ruling adopted pursuant to law or professional code of ethics that applies to and governs the employer in its delivery of patient care.”
That plaintiff hadn’t done, or at least so said the majority. The dissent of Justice Albin disagreed on several counts, but one of which was that the plaintiff had testified about the CDC Guidelines on infection control. The majority dismissed this on the ground that “Neither the trial court’s prior references to CDC standards in its summary judgment decision, nor plaintiff’s vague references to CDC-recommended precautions in his testimony” provide the detail of what CEPA requires.
Especially given the court that handed it down, Hitesman is a head-scratcher. Arguably, it’s a sport opinion, whose major impact will be a cautionary tale to attorneys to introduce exhibits citing chapter and verse rather than relying on plaintiff’s testimony and common-sense conclusions. But it’s possible the case may have more significance, signaling to the lower courts that CEPA has been applied too broadly in the past.
Filed under: Drugs & Devices, Health Insurance, Health Law, Health Reform, Litigation and Liability, Patient Protection and Affordable Care Act, Public Health, Seton Hall Law, Women's Health Issues
We are very pleased to welcome Angela Carmella, a Professor here at Seton Hall Law, to the blog today. Professor Carmella’s intellectual focus is the intersection of law and religion, specifically the First Amendment’s religion clauses, religious land use, and Catholic social thought.
By Angela Carmella
On Monday, June 30, the U.S. Supreme Court issued its path-breaking decision in Burwell v. Hobby Lobby Stores, Inc. In a 5-4 ruling, the Court held that HHS’s contraception mandate violates the rights under the Religious Freedom Restoration Act (RFRA) of closely-held, for-profit corporations that object to providing this coverage. The mandate requires employers to provide their female employees with insurance coverage for all twenty FDA-approved contraceptives without cost-sharing. Justice Alito, writing for the majority, repeatedly notes the decision’s narrow applicability to the mandate alone; Justice Ginsburg, in dissent, criticizes the decision for its “startling breadth,” fearing that for-profits will now seek exemptions from other requirements of the Affordable Care Act and from other federal laws, to the detriment of employees and customers.
Critical to the Court’s decision is the “accommodation” currently available to religious nonprofits—charities, colleges, hospitals and the like—that object to providing contraceptive coverage to their female employees (and students). In contrast to the targeted exemption given specifically to churches and their close affiliates, which leaves employees without this coverage, the accommodation requires the nonprofit’s insurer (or third party administrator for self-insured plans) to provide coverage directly and separately to employees. Thus, the accommodation attempts to respect the twin goals of religious liberty and women’s health.
Justice Alito and Justice Kennedy (who joined the majority opinion but also wrote a separate concurrence) regarded the accommodation as evidence that the government had already devised a mechanism to address the religious objections of employers while advancing its public health goals. For the Court, extending this accommodation to for-profits was an obvious and straightforward way for the government to satisfy RFRA’s requirement that it use the least restrictive means to advance its objectives.
Hobby Lobby consolidated two challenges to the mandate, one brought by the Green family, evangelical Christian owners of the Hobby Lobby arts and crafts stores and Mardel religious book stores, and the other brought by the Hahn family, Mennonite owners of cabinet manufacturer Conestoga Wood Specialties. They refuse to provide their employees with coverage for four (out of twenty) contraceptives that might interfere with implantation of a fertilized ovum, because to do so would involve them in facilitating abortions. (Some of the other businesses that have brought similar challenges oppose providing coverage for all contraceptives.)
RFRA prohibits government from “substantially burden[ing] a person’s exercise of religion even if the burden results from a rule of general applicability” unless it “demonstrates that application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.” 42 U.S.C. Secs.2000bb-1(a), (b). RFRA applies to “any exercise of religion, whether or not compelled by, or central to, a system of religious belief.” Sec.2000cc-5(7)(A).
The opinion takes a pragmatic approach, but its driving vision is RFRA’s overarching purpose in this context: to prevent government from excluding religious people “from full participation in the economic life of the Nation” (Alito 46) and to protect the right “to establish one’s religious (or nonreligious) self-definition in the political, civic, and economic life of our larger community.” (Kennedy 2). The Court first determines that for-profit corporations are “persons” capable of “exercising religion” under RFRA. “[A]llowing Hobby Lobby, Conestoga and Mardel to assert RFRA claims protects the religious liberty of the Greens and the Hahns,” (Alito 21). Their religious liberty here consists in being able to “run their businesses as for-profit corporations in the manner required by their religious beliefs” (Alito 2, emphasis supplied).
Next, rejecting HHS’s argument that the connection between the mandate and any immoral act is too “attenuated,” the Court finds that the “mandate imposes a substantial burden on the ability of the objecting parties to conduct business in accordance with their religious beliefs.” (Alito 36, emphasis in original) Given the prospect of fines against Hobby Lobby of up to $475 million per year, the answer for the majority is clear. The Court refused to scrutinize the claimants’ arguments regarding complicity in immoral conduct, noting that “it is not for us to say that their religious beliefs are mistaken or insubstantial.” (Alito 37)
The majority opinion assumes that the mandate fulfills a compelling governmental interest, while Justice Kennedy’s concurrence makes clear that the government has demonstrated it. But both opinions focus on the accommodation as the least restrictive alternative to further the government’s compelling interest. Although government provision of contraceptives might be an alternative, the Court concludes that “we need not rely on the option of a new, government-funded program in order to conclude that the HHS regulations fail the least-restrictive means test. HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.” (Alito 43) The Court notes that under such an accommodation, female employees of Hobby Lobby, Mardel and Conestoga would receive the contraceptive coverage to which they are entitled under the regulations.
Because the Court does not decide whether the accommodation “complies with RFRA for purposes of all religious claims,” (Alito 44) Justice Ginsburg’s dissent largely ignores the majority’s solution and focuses instead on what she views as a radical interpretation of RFRA that allows businesses to “opt out of any law (saving only tax laws) they judge incompatible” with their beliefs (Ginsburg 1) without regard to the impacts on third parties (like the female employees of objecting businesses). Her dissent emphasizes the significance of contraception to women’s health, the expenses associated with contraception, and the compelling nature of the government’s interest in an employer-based insurance system that provides it. She draws a sharp distinction between religious nonprofits, which are accommodated because they “exist to serve a community of believers,” (Ginsburg 29) and commercial entities with diverse workforces. Justice Ginsburg concludes that not only is the claim of burden on religious exercise too attenuated, but “[i]n view of what Congress sought to accomplish, i.e., comprehensive preventive care for women furnished through employer-based health plans, none of the proffered alternatives would satisfactorily serve the compelling interests to which Congress responded.” (Ginsburg 30-31)
In other pending cases many religious nonprofits are challenging the accommodation itself as insufficiently protective of their religious liberty. The Court’s praise for this mechanism as meeting the twin goals of religious liberty and women’s health in the for-profit context might be read as a sign that the nonprofits currently in litigation may be sorely disappointed. But predicting the impact of Hobby Lobby in the nonprofit context became more complicated on July 3, just four days after Hobby Lobby came down, when the Court issued an interim order in Wheaton College v. Burwell.
Wheaton College is a religious nonprofit that is unquestionably eligible for HHS’s accommodation for religiously affiliated institutions. It has challenged the accommodation itself as a violation of RFRA on the grounds that the school will be morally complicit in providing abortifacient coverage when it files the required “self-certification” form; this form, it argues, triggers the third party administrator’s obligations to provide the objectionable coverage. Without deciding the merits, the Court decided 6-3 that the college need not use the government’s form; since the government is already on notice of its objection, HHS (and its third party administrator) can proceed as though the form had been filed.
One can view this as consistent with Hobby Lobby: as in that case, the Wheaton Court finds a solution that both respects the college’s religious exercise (it does not have to sign) and meets the government’s interest (the third party provides the contraceptive coverage). But in her dissent to Wheaton, Justice Sotomayor voiced her frustration: since the Court already found that the accommodation was the least restrictive means of furthering the mandate’s goals—indeed, it “served as the premise” for the decision—the “grant of injunctive relief [in Wheaton] simply does not square with the Court’s reasoning in Hobby Lobby.” (Sotomayor 16, 13)
Although it may be impossible to predict Hobby Lobby’s specific impacts in both commercial and nonprofit contexts, two thing are certain: first, the notion that religious liberty and government interests can be reconciled to avoid harms to third parties is now on the table for further consideration; and second, the Court’s broad reading of RFRA marks a new chapter in free exercise jurisprudence.
Filed under: Drugs & Devices, Food and Drug Administration (FDA), Information Technology, Public Health, Transparency
On June 2, 2014, the Office of Informatics and Technology Innovation (OITI) within the Food and Drug Administration (FDA) announced the launch of OpenFDA, a searchable, online public health database containing drug adverse event information compiled between October 2004 and June 2013. The FDA press release reports that OpenFDA employs
a search-based Application Program Interface (API) to collect large amounts of existing publicly available data, offering developers the ability to search through text within that data, ranking results much like a search using Google would do. This method then allows them to build their own applications on top of OpenFDA, giving them a large amount of flexibility to determine what types of data they would like to search and how they would like to present that data to end-users.
Currently, OpenFDA consists of approximately three million drug adverse events, though the FDA plans to expand the amount of adverse events, along with product recalls and labeling information, as they increase their capacity.
For various reasons, U.S. governmental agencies have developed open data initiatives in a number of contexts. Perhaps the most long-standing database relevant to the FDA approval process is the clinical trials database maintained by the National Institutes of Health (NIH). NIH has maintained the clinical trials reports and results database since 2000 as directed by Congress in legislation. Recent amendments in 2007 imposed additional requirements on NIH and clinical trial sponsors. Several other governmental initiatives to provide open data across such topics as health, agriculture, climate, and education, can be found here.
The move by FDA follows President Obama’s Executive Order in May 2013, entitled Making Open and Machine Readable the New Default for Government Information. That Executive Order directs executive departments and agencies to implement measures to support an open data policy in their operations and missions. The memorandum detailing this policy “requires agencies to collect or create information in a way that supports downstream information processing and dissemination activities. This includes using machine readable and open formats, data standards, and common core and extensible metadata for all new information creation and collection efforts.” In addition, “it involves agencies building or modernizing information systems in a way that maximizes interoperability and information accessibility, maintains internal and external data asset inventories, enhances information safeguards, and clarifies information management responsibilities.” President Obama has touted an Open Government Directive focusing on transparency, participation, and collaboration since taking office in 2009.
Researchers, web developers, and members of the public praise OpenFDA, citing numerous challenges to access and interpretation of adverse event information in the past. These challenges include lengthy Freedom of Information Act request turnaround times, a lack of uniformity in quarterly bulk reports distributed by the FDA making them difficult to decipher, and no ability to search across data in the FDA adverse event reporting system. A GCN article notes that with OpenFDA “users can find what they’re looking for by typing drug names, QR or UPC codes or even reaction symptoms. Misspellings will likely still return an accurate result because each query is given a score that is similar to how search engines operate.” TechRepublic provides a helpful overview of the technical features of OpenFDA here.
Many sources urge that the new database will maximize the return on the adverse event data and enable the private sector to innovate in an area where the FDA has limited resources. In fact, one application resulting from OpenFDA has already sprung up. ResearchAE, developed by Social Health Insights, is a query interface allowing users to search adverse drug effects by multiple classifications, such as date, location, patient age, drug name, manufacturer, and reaction. HealthCare IT highlights this new application here.
While OpenFDA has been met with widespread enthusiasm, a few concerns have arisen about the availability and use of the information. Some have questioned the security of the information on OpenFDA. However, the FDA assures that all identifying information has been removed from the adverse event data available in the online database. The Chief Health Informatics Officer within OITI, Dr. Taha Kass-Hout, stated “we will not release any data that could be used to identify individuals or reveal other private information.” Others, including pharmaceutical manufacturers, have questioned whether the public and other entities will be able to comprehend the data without causing undue turmoil in the market. To that criticism, Kass-Hout responds that the FDA “will be correcting misinterpretations” of the data.
Filed under: Food and Drug Administration (FDA), Public Health
Last month, the Food and Drug Administration (FDA) finally published its long-awaited notice of proposed rulemaking (NPRM) that “deems” particular products, including electronic cigarettes, within the scope of “tobacco products” as set forth in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) of 2009. The NRPM has sparked significant public attention and has divided consumers, industry, and public health experts alike. Many applaud the FDA for taking the initial step to regulate these nontraditional tobacco products, while others decry the 67-page NPRM as not going far enough. The NPRM applies to a variety of products, identified by the FDA website as including “electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not ‘smokeless tobacco,’ gels, and waterpipe tobacco.”
The NRPM stems from the definitional framework and regulatory authority granted in the Tobacco Control Act. A “tobacco product” is defined as:
any product made or derived from tobacco that is intended for human consumption, including any component, part, accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). 21 U.S.C. §201(rr).
The Tobacco Control Act explicitly applies to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco; it also includes “any other tobacco products that the Secretary by regulation deems to be subject to this chapter.” 21 U.S.C. §387a(b) [emphasis added]. Hence, the term “deeming” regulations.
The Tobacco Control Act created a new Center for Tobacco Products within the FDA and sets forth numerous requirements for all tobacco product manufacturers including registration of products, adherence to manufacturing requirements, and disclosure of ingredients. It bans both the use of misleading descriptors without proper substantiation and the presence of flavorings in cigarettes (although menthol is subject to further scientific study). The Tobacco Control Act also grants authority to the agency to establish product standards, reduce nicotine and other harmful ingredients, and enlarge cigarette warning labels coupled with graphic images. The FDA has taken steps to implement the Tobacco Control Act, including the issuance of guidance documents for industry and a failed attempt to finalize graphic warnings for cigarette packages in the face of First Amendment challenges.
The deeming NPRM follows an unsuccessful assertion of jurisdiction by the FDA over electronic cigarettes (e-cigarettes) as drug delivery devices subject to the Food, Drug and Cosmetic Act. In 2010, the U.S. Court of Appeals for the District of Columbia held that the FDA’s authority over the NJOY brand e-cigarette was limited to the provisions covering tobacco products unless the manufacturer made therapeutic claims that brought the product into the drug realm. The FDA ultimately decided to forgo appeal and issued a letter to the public setting forth its reasoning. (For an analysis of the case, and the case law leading up to it, see my recent article entitled No Sisyphean Task: How the FDA Can Regulate Electronic Cigarettes in 13(2) Yale Journal of Health Policy, Law & Ethics 326 (2013). An abstract from PubMed is available here.)
The impact of the NRPM is largely to extend basic requirements to manufacturers of nontraditional tobacco products, including e-cigarettes. The requirements and restrictions include the following:
- Prohibits the sale to minors under age 18.
- Prohibits the distribution of free samples.
- Requires manufacturers to register company and product information.
- Prohibits free samples and sales via vending machines (with exemptions for adult-only locations).
- Requires manufacturers to disclose ingredients and report harmful and potentially harmful constituents.
- Requires warning labels informing of the addictive risk of nicotine.
- Requires FDA approval for use of modified risk descriptors such as “light” or “mild.”
- Requires FDA approval for “new” products (products that entered the market without being substantial equivalent to an existing device after February 15, 2007).
Notably, the NPRM does not prohibit flavorings in these products, nor does it prohibit television and radio advertising that has proven increasingly controversial given celebrity cameos and targeted tactics. The FDA also proposes a second option within the NPRM that would exempt premium cigars from the proposed rule entirely, relying heavily on industry statements about the occasional use of such products not raising public health risks.
The first Congressional hearing to discuss e-cigarettes was held last week by the Senate Committee on Health, Education, Labor and Pensions. During that hearing, Senator Tom Harkin (D-Iowa) described e-cigarettes as posing a “regulatory black hole” for the FDA, citing concerns about the targeted advertising to children and the potential gateway effect for use of cigarettes and other traditional tobacco products. Many urge that the failure to prohibit flavorings in the deemed products will not address the pressing problem of youth use. Analysts reveal that products not covered under the cigarette flavor ban provisions in the statute, such as little cigars and e-cigarettes, are developing new product lines or altering existing products to include candy flavors in order to tap into the youth market. Others are concerned with use of e-cigarettes as a smoking cessation product, without rigorous clinical trials to assess safety and efficacy for such a use. The FDA specifically requests comments on the public health risks of e-cigarettes and evidence of effectiveness as smoking cessation devices.
Although not addressed in the NPRM, there are also serious questions that have arisen about accidental exposure to e-cigarette nicotine. The New England Journal of Medicine recently published an article highlighting the serious safety issues linked to infant ingestion of nicotine refill liquid for e-cigarettes. In the month of February alone, the Centers for Disease Control and Prevention reported 215 calls to poison control centers for injuries related to ingestion of nicotine liquid; over forty percent of those calls involved children five years old and younger.
While the NPRM is a start, there is a long road ahead. The NPRM is open for comments until July 9, 2014. To date, the regulations.gov website has already logged over 8,000 public comments.
Filed under: Food and Drug Administration (FDA), Public Health
The Food and Drug Administration (FDA) has decisively entered the debate regarding the health risks of artificial trans fatty acids in foods. On November 8, the FDA announced its “tentative” determination that partially hydrogenated oils (PHOs), also known as trans fatty acids, are no longer generally recognized as safe for human consumption. The FDA cited research by the American Heart Association (AHA), the World Health Organization, the American Dietetic Association, the Institute of Medicine, and the FDA Food Advisory Committee Nutrition Subcommittee demonstrating that trans fats increase the risk of coronary heart disease. Trans fats simultaneously raise levels of bad cholesterol and lower good cholesterol, among other adverse negative health effects. In the FDA Press Release, Dr. Margaret Hamburg, Commissioner of the FDA, stated that reduction in trans fat intake “could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”
This is not the first move by the FDA to address the heavily documented health risks of trans fats. Ten years ago, the FDA implemented regulations that required information about the trans fatty acid content in foods and dietary supplements to be declared on the Nutrition Facts label. As a result, the label now identifies the total fat, saturated fat, and trans fat content. While not directly reducing or eliminating trans fats from American diets, the label requirement forced transparency on the part of food manufacturers and provided consumers with information on which to base purchasing decisions. It also incentivized manufacturers to scale down on the use trans fat in food production.
If the FDA determination is finalized, PHOs would no longer be permissible ingredients in food products without prior approval by the FDA as a safe food additive. Food additives, by statutory definition include substances that “result or may reasonably be expected to result, directly, or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use).” The definition excludes several types of substances that are regulated under separate provisions, including pesticide chemicals, pesticide chemical residues, and color additives. All food additives that are not generally recognized by qualified scientific experts to be safe under the conditions of use are thus classified as not safe for market entry. Only after a generally recognized as safe (GRAS) determination by the FDA may a food additive enter the market as an ingredient in any given food product.
The FDA has a well-established regulatory process for determining whether a food additive is GRAS. The FDA maintains GRAS listings in the Code of Federal Regulations that act as a sort of recipe for food manufacturers. These complete listings are available here, here, and here. Generally, if a food additive conforms to that published GRAS listing, including the specific amount, intended use, good manufacturing practices, and any limitations, it may be used as an ingredient without prior FDA assessment. For example, caffeine is a GRAS listed substance for use in cola-type beverages. When added to other food products, however, caffeine is no longer considered GRAS and the FDA can institute an enforcement action against those products where there is a concern about public safety. This scenario played out several years ago with regard to drinks combining alcohol and caffeine.
The announcement is seen by those in the health and nutrition fields as an energizing sign of life in a recently limp FDA. Marion Nestle, a professor at New York University, proclaimed in an interview with the New York Times “[t]he FDA is back!” Likewise, organizations such as the AHA and the Center for Science in the Public Interest (CSPI) that have been advocating for increased regulation over trans fats praise the FDA’s move, though they emphasize that action is long overdue. CSPI originally petitioned the FDA for inclusion of trans fat information on the label in 1994 and subsequently in 2003 to prohibit use of PHO as a food ingredient.
It appears that the FDA anticipates phasing-in of the GRAS requirements, and has solicited the public for feedback on several aspects of scope and implementation. Specifically, the FDA asks for data supporting other approaches, input on the estimated timeframe to reformulate products to bring them into conformance, special considerations for small business, and any other foreseen challenges to such an approach. The comment period is open until January 7, 2014.