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Focus on Regulation

D.C. Circuit Rejects “Academic Deference” Argument In Tenure Denial Discrimination Cases

On June 14, 2019, the United States Court of Appeals for the District of Columbia Circuit rejected the argument that a university should be entitled to special academic deference in employment discrimination claims concerning denial of tenure brought under Title VII of the Civil Rights Act of 1964 (“Title VII”). Mawakana v. Bd. Of Trustees of the Univ. of the Dist. Of Columbia, No. 18-7059 (D.C. Cir. June 14, 2019).

In Mawakana, an African American professor brought suit after he was denied tenure by the University of the District of Columbia (“UDC”). He failed to receive a recommendation for tenure at each step of UDC’s process, including from the relevant faculty committees, the dean and the provost, as well as in the final decision by the university president. Mawakana sued UDC for, among other things, race discrimination under Title VII and the District of Columbia Human Rights Act (“DCHRA”). The district court granted UDC’s motion for summary judgment and dismissed Mawakana’s claims, reasoning that it was required to accord “heightened deference” to UDC’s “academic decisions.” Like the district court here, some courts in prior decisions, including in the District of Columbia, have suggested that they are reluctant to find discrimination in faculty tenure or promotion decisions. See, e.g., Okruhlik v. Univ. of Arkansas, 395 F.3d 872, 879 (8th Cir. 2005) (“The academic setting and complex nature of tenure decisions, however, distinguishes them from employment decisions generally.”); Elam v. Bd. of Trustees of Univ. of D.C., 530 F. Supp. 2d 4, 17 (D.D.C. 2007) (citing Okruhlik for the proposition that “a court must be particularly wary of second-guessing a university’s decisions concerning faculty members”); Jiminez v. Mary Washington Coll., 57 F.3d 369, 376 (4th Cir. 1995) (“We commence with the premise that while Title VII is available to aggrieved professors, we review professorial employment decisions with great trepidation.”).

The D.C. Circuit’s analysis of academic deference

The D.C. Circuit reversed the district court’s grant of summary judgment to UDC, holding that United States Supreme Court precedent “and the concept of academic freedom do not entitle a university to special deference in Title VII tenure cases.” Although the Court acknowledged that the Supreme Court in University of Michigan v. Ewing, 474 U.S. 214 (1985) held that courts must defer to universities in reviewing the “substance of a genuinely academic judgment” made in “good faith,” the question in a Title VII case is “whether the employer acted in good faith.” More specifically:

Ewing dictates that a court cannot second-guess a university’s decision to deny tenure if that decision was made in good faith (i.e., for genuinely academic reasons, rather than for an impermissible reason such as the candidate’s race) . . . . A Title VII claim requires a court to evaluate whether a university’s decision to deny tenure was made in good faith (i.e., for academic reasons rather than for an impermissible reason such as the applicant’s race).

In a footnote, the court, surveying a number of cases across the country, highlighted that many (but not all) other courts have applied “the same Title VII standard to faculty members as to other discrimination plaintiffs,” and that upon a “close examination,” even the cases that “express[ed] solicitude” related to faculty employment decisions effectively were not applying a different Title VII standard.

The court also reversed summary judgment on Mawakana’s claims under the DCHRA, noting that the legal analysis of a race discrimination claim under Title VII and the DCHRA is the same.

Having disposed of the argument that UDC is entitled to academic deference; the D.C. Circuit viewed the evidence in the light most favorable to the professor, as required at the summary judgment stage, and held a reasonable jury could find that race was a motivating factor in UDC’s decision to deny Mawakana tenure. In reaching this decision, the court was heavily influenced by evidence concerning the dean, who in the court’s view, while not the ultimate decision-maker, was a proximate cause of the ultimate negative decision.  The court relied on evidence presented by the professor, including that the dean:

  • sometimes applied stricter review criteria to black applicants for tenure, such as disfavoring co-authored works for black applicants but not white applicants;
  • supported every white applicant for tenure during her time as dean but raised concerns about more than half of the black applicants;
  • had dissuaded two black faculty from applying for tenure; and
  • changed her position on issues that were subsequently relevant to the tenure decision, such as originally speaking favorably of an article by the professor and later stating that it did not meet tenure standards.

Applying the Mawakana decision

While the D.C. Circuit’s decision rejects the concept of special deference in cases involving academic judgment, it is important to underscore the limits of the Mawakana holding. While the D.C. Circuit has held that courts should not place a “thumb on the scale” of a university in an employment discrimination simply because of “academic deference,” the case does not mean that an employment discrimination plaintiff can prevail on a discrimination claim by convincing a court that a university’s academic judgment was simply incorrect or unwise. If it can be shown that the university made a genuine academic decision—just like if a non-university employer has made a genuine business decision—a plaintiff cannot prevail (or survive summary judgment) simply by second guessing academic (or business) judgment. Courts have often stated that they do not “serve as a super-personnel department that reexamines an entity’s business decisions.” Barbour v. Browner, 181 F.3d 1342, 1346 (D.C. Cir. 1999). This principle applies equally in and out of the higher education context. Additionally, the D.C. Circuit was careful to point out that, even absent academic deference, it may be “especially difficult” as a practical matter for an employment discrimination plaintiff to succeed in challenging a tenure decision, given, among other things, the complexity of the decision and the numerous decision makers involved.

Furthermore, the D.C. Circuit did not address whether its holding extends beyond employment discrimination cases. Therefore, the court’s decision does not necessarily preclude an academic deference argument in another context, such as in a breach of contract case. See Brown v. The George Washington Univ., 802 A.2d 382, 385 (D.C. 2002) (granting summary judgment on breach of contract claim to university that did not promote professor or renew her contract; explaining that the court must “proceed with particular caution” and “only rarely assume academic oversight, except with the greatest caution and restraint, in sensitive areas as faculty appointment, promotion, and tenure” (quotation marks omitted)); Alden v. Georgetown Univ., 734 A.2d 1103, 1109 (D.C. 1999) (granting summary judgment on breach of contract claim to university that dismissed student from school, emphasizing the heavy burden a plaintiff faces in an academic dismissal case due to the need to defer to a university’s academic judgment).

Nonetheless, the Mawakana decision makes clear that universities should strive in the tenure decision process to:

  • have clear policies and criteria;
  • apply the policies and criteria consistently and evenhandedly;
  • treat similarly situated people similarly; and
  • assure that those involved in the different stages of the process understand their responsibilities and the university’s anti-discrimination policies.

For more information on the Mawakana case or any other employment or higher education law issues, please contact one of the authors or the Hogan Lovells lawyer with whom you work.

Dutch Child Labour Due Diligence Law

The Dutch Child Labour Due Diligence bill (the “Law“) was passed in both houses of parliament and is due to be implemented by royal ratification after 1 January 2020. The aim of the Law is to put more responsibility on companies to prevent goods and services which have come into existence through child labour to hit the Dutch market. As a result of the law entering into force, companies are advised to start establishing an action plan to mitigate risks in cases where child labour has been identified in their supply chain or activities. Continue Reading

The Court of Justice clarifies the EU customs rules applicable to customs valuation

The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment agreements (“Judgment”).

By way of background, in 2005, Oribalt Riga SIA (“Oribalt”) concluded a consignment agreement with Ranbaxy Laboratories Ltd. (“Ranbaxy”). Pursuant to this agreement, Oribalt imported generic medicines, stored and distributed them to Ranbaxy’s clients without acquiring their ownership. Oribalt determined the customs value pursuant to the “transaction value” method (i.e., the price actually paid or payable for the goods when sold for export to the EU). In 2011, Latvian authorities rejected the determination of the customs value based on that method and instead relied on the “deductive value” method (i.e., the unit price at which the imported goods or identical/similar goods are sold to unrelated buyers in the greatest aggregate quantity in the EU). Oribalt appealed Latvian Customs’ approach on the following grounds: (1) the customs value should be determined on the basis of the first applicable valuation method (i.e., the “transaction value” method); (2) if the customs value is established under the “deductive value” method, the reference values should be those of the goods imported on a date as close as possible to the date of importation of the goods considered for valuation; and (3) discounts should be taken into account for the determination of the customs value under the “deductive value” method.

On that basis, the Latvian court referred the following three questions to the Court: Continue Reading

Foreign Investment Control on the Rise – New List of EU Member States’ FDI Screening Mechanisms

Foreign direct investment (“FDI”) screenings have become a relevant factor for global transactions in recent years. More and more jurisdictions are introducing or ramping up their powers for scrutinising FDI, which parties to M&A transactions and their advisors need to consider when structuring such deals and planning for completion of the projects. In Europe, the European Commission (“Commission”) boosted this trend with its recently adopted Regulation (EU) 2019/452 of 19 March 2019 establishing a framework for the screening of FDI into the EU (“the Framework Regulation”).

In order to increase the visibility of FDI screening regimes, the Commission on 24 June 2019 published a list of FDI screening mechanisms notified by Member States [see the list here]. As part of the Framework Regulation, Member States with an FDI screening mechanism in place are obliged to notify the Commission of such mechanisms. The Commission is, in turn, responsible for maintaining an updated list of notified mechanisms. The recently published list is the first such consolidated list of FDI screening mechanisms in the EU and is likely to spur the debate about introducing such a system in those EU Member States which have not yet done so. Continue Reading

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist human cell, tissue, and cellular and tissue product (HCT/P) manufacturers, as well as stakeholders that market HCT/Ps, to “obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated.”  Under the program, FDA will respond within three business days to each inquiry that contains sufficient detail for evaluation, “resources permitting,” informing the requestor whether an HCT/P appears to be (a) appropriately regulated under section 361 of the Public Health Service Act (PHSA), (b) appropriately regulated under section 351 of the PHS Act and/or Federal Food, Drug, and Cosmetic Act (FDCA), or (c) not an HCT/P. Continue Reading

U.S. Supreme Court Sidesteps Important TCPA Deference Issues

On June 20, 2019, the Supreme Court released its long-awaited decision in PDR v. Carlton & Harris Chiropractic.  The Court was expected to provide greater clarity about the extent to which litigants can challenge the Federal Communications Commission’s (FCC) Telephone Consumer Protection Act (TCPA) interpretations in private litigation.  Instead of deciding that issue, however, the Court vacated the Fourth Circuit’s ruling and remanded the case for further development. How the Fourth Circuit rules on remand may ultimately provide more insight on how much deference is owed to the FCC’s TCPA interpretations. Continue Reading

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing whether a new opioid drug application meets the statutory standard for approval.  FDA also announced it will hold a public meeting on September 17 to discuss this benefit-risk assessment framework as well as potential new preapproval incentives to foster the development of new treatments for pain and opioid addiction.  This public meeting will fulfill the SUPPORT Act requirement that FDA hold at least one public meeting annually to “address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction.”

The draft guidance explains how FDA intends to apply its existing benefit-risk assessment framework to evaluate the benefits of a candidate opioid analgesic drug as well as any risks, including abuse, overdose, addiction, or opioid use disorder.  FDA also indicated it will consider the benefits and risks of the opioid analgesic at issue with those of other approved therapies, including opioid and non-opioid alternatives, in addition to the broader public health risks posed by the candidate drug to both patients and non-patients.

Importantly, while FDA will consider how the new opioid analgesic compares to existing therapies, a sponsor will not be required to show that its drug is superior to the other treatments for approval.  Nonetheless, at the public meeting in September, FDA seeks stakeholders’ input regarding the addition of a comparative advantage requirement for approval of potential opioid analgesic drugs as well as: Continue Reading

The European Commission releases an updated Borderline Manual for medical devices


The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).

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What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

FDA authority to crack down on illegally marketed stem cell treatments confirmed

On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug Administration’s (FDA) motion for summary judgment, and stopping the clinic from offering its stem cell therapy to patients. The court found that the population of stromal and vascular cells in the clinic’s therapy, known as Stromal Vascular Fraction (SVF), constitutes a biological drug product that FDA must review and license before it can be commercially marketed. The court also found that the clinic’s manufacturing procedures and its promotion violated statutory requirements, causing the clinic’s cellular product to be adulterated and misbranded.

Critically, the court rejected the clinic’s argument that because its SVF procedure merely extracts and reinserts cells during the “same surgical procedure,” it is exempt from FDA regulation. Instead, the court adopted FDA’s view that the clinic’s separation of stromal and vascular cells from surgically-removed adipose (fat) tissue disqualified the procedure from this exception. The court held that the exception only applies to a procedure where the human cell, tissue, or cellular or tissue-based product (HCT/P) that is implanted into a patient includes “all” of “the antecedent HCT/P removed from the patient in its original form.” The case is a critical ruling supporting FDA’s increasing enforcement against stem cell clinics. It also clarifies FDA’s authority to regulate SVF therapies in particular, and bolsters FDA’s effort to gain more control over the HCT/P field more broadly.
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The French “PACTE” Law: Growing Space for Social and Environmental Topics in Corporate Management of French Companies

Under the new law on Business Growth and Transformation (the so-called “PACTE Law”), the management of French companies must take into consideration social and environmental issues. Companies are also encouraged to incorporate social objectives into their corporate purpose. This blog looks at the new law and what it means for businesses.

On 11 April 2019, the members of the National Assembly of the French Parliament adopted the PACTE Law. After a decision from the French Constitutional Council on 16 April 2019, the PACTE Law was eventually enacted and then published on 23 May 2019. Continue Reading