White Collar Criminal Defense Group

Sexual Harassment Claims At Educational Institutions, Including Medical Residence Programs, Covered By Both Title VII And Title IX

On March 7, 2017 the Third Circuit issued its opinion in Doe v. Mercy Catholic Med. Ctr., 16-1247, — F.3d —-, 2017 WL 894455 (3d Cir. Mar. 7, 2017) addressing two matters of first impression in the Third Circuit: (a) whether a hospital’s residency program was an education program under Title IX of the Education Amendments of 1972; and (b) whether an employee of an educational program covered by Title IX could seek relief for sex discrimination despite the availability of relief under Title VII. 

In Doe, plaintiff, a former medical resident of the defendant medical center, a private teaching hospital with a medical program, brought a claim of sex discrimination against Defendant.  The District Court dismissed plaintiff’s complaint, finding that Mercy was not an “education program or activity” under Title IX. 

The Third Circuit found that Title IX applied to Mercy’s medical residency program.  The Court recognized that “education program or activity” was left undefined by statute but that Mercy’s position that the statute only applies to entities (unlike Mercy), principally engaged in providing educational offerings was untenable given the wide breadth of Title IX.  The Third Circuit found that a “program or activity” is covered by Title XI “if it has features such that one could reasonably consider its mission to be, at least in part, educational.” Id. at *6 (internal quotation marks and citations omitted).  The holding is in accord with case law from the First, Second, Eight, and Ninth Circuits as well as the interpretations of twenty-one federal agencies.  Id. at *6.  

In analyzing the framework for the “educational program or activity” inquiry, the Court considered whether:

(A) a program is incrementally structured through a particular course of study or training, whether full- or part-time; (B) a program allows participants to earn a degree or diploma, qualify for a certification or certification examination, or pursue a specific occupation or trade beyond mere on-the-job training; (C) a program provides instructors, examinations, an evaluation process or grades, or accepts tuition; or (D) the entities offering, accrediting, or otherwise regulating a program hold it out as educational in nature.

Id. 

The Court noted that Mercy’s program had various trappings of an educational program (e.g. lectures, exams, and a general focus on regimented training and studying) which showed that its mission was, at least in part, educational.  The Court also found that that Mercy’s association with Drexel University’s medical school (where plaintiff, in fact, took certain classes) supported a finding that Mercy was covered by Title IX.  Id. at *7.   

The Third Circuit then addressed whether plaintiff’s discrimination claims were cognizable as private causes of action under Title IX.  Id. at *8.  The Court noted, pertinently, that Title IX, unlike Title VII, does not require administrative exhaustion as prerequisite of suit, potentially putting the statute in tension with Title VII’s exhaustion requirements.  While plaintiff may have been a student as well as an employee, plaintiff still fit the bill of employee: she provided various services to Mercy as a medical resident; she received a work schedule; and, the Court presumed, she received taxable payments from Mercy for her services.  The Court concluded that Plaintiff could pursue a Title IX claim despite her ability to also pursue relief under Title VII.  The court therefore found that Title IX protects both students and employees and that Plaintiff’s Title IX claims were legally cognizable. 

The Third Circuit noted that its decision was in line with decisions from the First and Fourth Circuits but at odds with decisions from the Fifth and Seventh Circuits, the latter Circuits holding that Title VII is the exclusive federal remedy for sex discrimination claims by employees against their employers. Given the widening circuit split on this crucial issue, it is likely only a matter of time before the issue comes before the U.S. Supreme Court.  In the interim, employers whose mission, at least in part, may be deemed educational may incur exposure under Title IX from sex discriminations claims without the protections of administrative exhaustion requirements.    

Mobile Health App Makers Investigated For Fraud Enter Into Settlement With The Office Of The Attorney General For The State Of New York

New York State Attorney General, A.G. Schneiderman, has put mobile health application developers on notice – “We won’t tolerate non-evidence-based apps that threaten the wellbeing of New Yorkers”.

On March 23, 2017, AG Schneiderman announced settlements with three mobile health application developers after a year-long investigation into the marketing of mobile health applications distributed through Apple’s App Store and Google Play.  Three of the companies targeted in the investigation Cardiio, Runtastic, and Matis each entered into settlement agreements that require the companies to: (1) provide additional information about the testing of their apps; (2) change their ads to make them non-misleading; (3) post clear and prominent disclaimers informing consumers that the apps are not medical devices and are not approved by the FDA; and, (4) to pay $30,000 in combined penalties to the Office of the Attorney General.

The settlements also require the developers to make certain fundamental changes to their apps to protect consumers’ privacy. The developers are now required to (1) secure affirmative consent to their privacy policies for these apps; and (2) disclose what information they collect and share that may be personally identifying, including a users’ GPS location, unique device identifier, and “deidentified” data that third parties may be able to use to re-identify specific users.

Cardiio is an app “downloaded hundreds of thousands of times that claims to measure heart rates” during rigorous exercise, yet the accuracy of the app had not been tested for that purpose.  The Runtastic app “purports to measure heart rate and cardiovascular performance under stress” and again, as noted by the N.Y. AG’s office, the developer had failed to test the apps accuracy with users who had engaged in vigorous exercise.  Matis, an app downloaded hundreds of thousands of times, had previously claimed that its app could turn any smartphone into a fetal heart monitor, despite the fact that: (1) it had never been approved by the FDA; and, (2) it never conducted a comparison to an FDA approved fetal heart monitor or any other device that had been scientifically proven to amplify the sound of a fetal heartbeat.

In announcing the settlement with these three companies, AG Schneiderman noted that “Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims, and protect sensitive user information”.

Although the Cardiio, Runtastic and Matis settlements primarily involved issues of fraudulent advertising and privacy — developers of health care apps and software should take notice of the U.S. Food and Drug Administration regulations and guidance’s pertaining to certifications of “”. Generally speaking, the U.S. Food, Drug and Cosmetic Act prohibits manufacturers from distributing in interstate commerce any new medical device for any intended use that the FDA has not approved as safe and effective or cleared through a substantial equivalence determination. The FDA has determined that mobile medical applications, including those used on mobile phones (“MMA”), are in fact medical devices if they are intended to either: (1) be used as an accessory to a regulated medical device; or (2) to transform a mobile platform into a regulated device. Further, if a MMA is intended for use in performing a medical device function (i.e. for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease) it is a medical device regardless of the type of platform on which it is run.

The Cardiio, Runtastic and Matis settlements are an important reminder that as technology, including the use of telemedicine, continues to integrate steadily into the provision of all manner of patient care, depending upon a health care application’s intended use, the developer of an app could quickly find itself involved in claims that go well beyond false advertising and privacy concerns. Rather, it could get caught up in more serious claims of civil and criminal health care fraud based upon the use of the MMA in treating a patient if there is a submission of a claim for reimbursement under a government health care program.