In the last several years, pharmaceutical companies have been targeted by the plaintiffs’ bar for their overtime classification of pharmaceutical sales representatives. Dozens of plaintiffs have filed suit under the Fair Labor Standards Act1 (FLSA) and state laws alleging that pharmaceutical sales representatives are misclassified as exempt from overtime pay requirements and are owed overtime compensation for all hours worked over forty in a workweek and, in some states (like California), over eight in a workday. Nearly all major pharmaceutical companies have been targeted in these actions, including industry giants such as Johnson & Johnson, Pfizer, GlaxoSmithKline, and Novartis Pharmaceuticals.
The pharmaceutical industry is not the first to be targeted by plaintiffs’ lawyers on an industry-wide level under the FLSA—mortgage loan companies, retail establishments, and manufacturing companies are among its predecessors in this regard. But the recent proliferation of cases filed against the pharmaceutical industry, and the Department of Labor’s increasingly active involvement in this litigation, presents unique issues and poses interesting questions for the pharmaceutical industry.
A. An Aggressive Plaintiffs’ Bar Targets the Pharmaceutical Industry
Most people are familiar with the jobs of pharmaceutical sales representatives. While specific duties vary somewhat from employee to employee and company to company, generally, sales representatives are the primary point of contact between pharmaceutical companies and the physicians who prescribe their products. Sales representatives typically are in the field five days per week, calling on physicians with the goal of persuading them of the benefits of the products they sell, thereby increasing their employers’ prescription sales volume and market share vis-à-vis competitors. Sales representatives use a variety of techniques to accomplish these goals, including leaving samples of products with physicians; using sales aids, glossies, or “reprints” to describe the efficacy of their products; and taking advantage of their sales skills to gain access to the physician and identify the physician’s concerns and patient needs.
The Food and Drug Administration (FDA) regulates the manner in which sales representatives perform their jobs. Most obviously, because prescriptions are required for most drugs they sell, sales representatives normally cannot actually transfer title to their product directly to customers, relying instead on physicians to write prescriptions and on patients to fill them. In addition, the FDA regulates the marketing of pharmaceutical products; thus, sales representatives must stay “on label” in their discussions with physicians, promoting their drugs only for FDA-approved uses. In order to ensure that they stay “on label,” most companies require sales representatives to use only company-drafted, pre-approved sales aids in their physician calls.
Traditionally, pharmaceutical companies have classified sales representatives as exempt from federal and state overtime requirements. Relying on “white collar” overtime exemptions such as the outside sales and administrative exemptions, companies have determined that they are not required to pay overtime to sales representatives because they meet the indicia of these exemptions—for instance, consistent with the outside sales exemption, they serve as the primary sales agent for their employers with the physicians who write prescriptions for their products,2 and, consistent with the administrative exemption, they exercise “discretion and independent judgment” in managing their sales territory and in their interactions with physicians.3
In the last several years, however, plaintiffs’ lawyers have seized upon FDA-mandated restrictions to challenge these classification decisions. In particular, plaintiffs’ lawyers argue that sales representatives’ inability to transfer title disqualifies them from the outside sales exemption because they do not actually “sell” product. They likewise argue that sales representatives do not qualify for the administrative exemption because requirements that they stay on-label and use only company-approved sales aids significantly limit their discretion and independent judgment in performing their jobs. Since 2006, plaintiffs’ lawyers have filed nearly 100 collective and class action lawsuits under the FLSA and state laws in dozens of courts throughout the country asserting these theories to challenge the overtime classification of pharmaceutical sales representatives.
Many courts have been resistant to these arguments, reasoning that employees’ job duties should be evaluated in the context of the industry in which they work and recognizing that, even within the limitations of FDA regulations, sales representatives have significant ability to develop sales strategy and shape their sales calls to best persuade physicians to prescribe their products. For example, beginning in 2007, the Central District of California granted summary judgment to employers in at least six separate California state law cases on the grounds that pharmaceutical sales representatives qualified for California’s outside sales exemption.4Among the factors relied upon in these decisions were sales representatives’ lack of day-to-day direct supervision from management, prior sales experience, opportunities for incentive compensation based on sales or market share growth, and their employers’ expectation that they seek affirmative commitments from physicians to write prescriptions for their products.
Results were decidedly more mixed in cases brought under the FLSA, although the weight of authority favored employers. Some courts, such as the Southern District of Texas, the Southern District of New York and the Southern District of Indiana, held that pharmaceutical sales representatives qualified for both the outside sales and administrative exemptions.5 Other courts found that they qualified only for the administrative exemption6 or the outside sales exemption.7 In the District of Connecticut, however, two different courts held that, as a matter of law, Boehringer Ingelheim’s and Schering Plough’s sales representatives did not qualify for the outside sales exemption because they did not consummate sales.8
B. Department of Labor Impact
In October 2009, the Secretary of Labor filed a brief as amicus curiae in the Second Circuit Court of Appeals’ review of In re Novartis Wage and Hour Litigation. In her amicus brief, the Secretary argued for reversal of the trial court’s grant of summary judgment to Novartis, agreeing with plaintiffs that, while Novartis’ sales representatives may bear some indicia of sales people, they did not meet the requirements for the outside sales exemption because they did not actually sell or take orders for drugs, and instead only provided information to physicians. The Secretary also argued that Novartis’ representatives did not qualify for the administrative exemption based on, among other things, her assertion that they were not permitted to deviate from company-approved scripts when calling on doctors. On July 6, 2010, the Second Circuit Court of Appeals vacated the trial court’s decision, finding the Secretary’s amicus brief was entitled to controlling deference under Auer v. Robbins,9 and accordingly finding that Novartis’ sales representatives did not qualify for the FLSA’s outside sales or administrative exemptions.10
As would be expected, plaintiffs have aggressively pushed the amicus brief as the authoritative statement of the Department of Labor (DOL) on the exempt status of pharmaceutical sales representatives, and there has been a great deal of motion practice devoted to the question of whether the DOL brief constitutes a considered interpretation of DOL regulations or a litigation position that runs contrary to past DOL statements. In the Northern District of Illinois, a court held that the amicus brief was entitled to Auer deference as the DOL’s interpretation of its own regulations and granted summary judgment to FLSA collective action plaintiffs on both the outside sales and administrative exemptions.11 Similarly, in the Southern District of Texas, a court granted a motion to reconsider and reversed its grant of summary judgment to the employer based on the Second Circuit’s decision in Novartis.12 In contrast, on a motion for reconsideration of its grant of summary judgment to Eli Lilly, the Southern District of Indiana refused to defer to the DOL.13 Meanwhile, on February 2, 2010, the Third Circuit Court of Appeals affirmed summary judgment for Johnson & Johnson on the administrative exemption, never mentioning the amicus brief despite plaintiffs’ counsel’s insistence that it was entitled to controlling deference.14
The most recent major decision occurred on February 14, 2011 when a unanimous Ninth Circuit panel affirmed summary judgment for GlaxoSmithKline finding that a plaintiff sales representative qualified for the FLSA’s outside sales exemption.15 As in the Second Circuit, the Secretary filed an amicus brief in support of the plaintiff, but, unlike the Second Circuit, the Ninth Circuit refused to grant deference, noting that the DOL had acquiesced in the sales practices of the pharmaceutical industry for over seventy years and finding the DOL’s litigation position both plainly erroneous and inconsistent with its own regulations and practices.
The split between the Second, Third, and Ninth Circuits clearly leaves pharmaceutical companies in limbo as to what exemption, if any, applies to pharmaceutical sales representatives, as well as to what deference should be granted to the DOL’s amicus filings. What’s more, other appellate courts are likely to have their say in the near future. Both Schaefer-LaRose v. Eli Lilly & Co. and Jirak v. Abbott Laboratories are on appeal to the Seventh Circuit, with consolidated argument likely to be held this year. Auxilium Pharmaceuticals has appealed the summary judgment decision in Harris to the Fifth Circuit. Boehringer Ingelheim, which had summary judgment granted against it in a single-plaintiff case in the Southern District of Florida,16 recently had its motion for interlocutory appeal to the Eleventh Circuit denied.17 One might expect in this environment that the Supreme Court would take an interest in these cases, but on February 28, 2011 it denied Novartis’ petition for certiorari in In re Novartis Wage and Hour Litigation. More recently, on August 12, 2011, plaintiffs in Christopher v. SmithKline Beecham Corporation filed their petition with the Supreme Court.
C. Impact on Pharmaceutical Industry
All this leaves an uncertain state of affairs for pharmaceutical companies. It appears that the DOL under President Obama’s administration will continue filing amicus briefs in appeals of wage-and-hour decisions, and, combined with the Supreme Court’s denial of certiorari in In re Novartis, these actions have further emboldened plaintiffs’ counsel, leading to additional lawsuits under both the FLSA and state law.
Indeed, the relative ease with which plaintiffs can obtain conditional collective action certification in FLSA lawsuits allows them access to contact information for potentially thousands of current and former pharmaceutical sales representatives, any number of whom could become class representatives in state law actions. While attorneys for pharmaceutical companies have suggested that the ethics of using the FLSA notice mechanism as a recruiting tool for state law actions is questionable and likely to be the subject of motion practice in the near future, plaintiffs’ counsel have not been reticent in this regard. In many cases, state law class actions are more lucrative than FLSA collective actions because they use Fed. R. Civ. P. 23 “opt-out” mechanisms instead of the FLSA’s affirmative “opt-in” requirement. Notably, the opt-in rate for pharmaceutical collective actions under the FLSA has been low—typically in the range of 4-6%,18 —making opt-out class action procedures more attractive to plaintiffs’ counsel. We can expect to see more state law class actions in the future, especially in states that look to the FLSA for guidance in interpreting their wage and hour laws.
Among the dilemmas for pharmaceutical companies facing exemption litigation is the fact that the litigation is extremely unpopular among current employees. Indeed; typically fewer than 10% of those who join these cases are actively employed by the company they sue.19 This is to be expected because some of the most attractive qualities of the job are directly related to its exempt status—flexible schedules, the lack of direct supervision, and no requirement to track hours. Any change in these aspects of the job could negatively impact the quality of workforces in the industry. Pharmaceutical companies therefore must engage in a delicate balancing act between the wants and needs of employees essential to driving demand for their products and the current state of the law, and do so in an environment where the law is very much in flux and outcomes seem driven more by differences in legal interpretation than in facts.
* Brent D. Knight is a partner at Jones Day.
** Michelle G. Marks is an associate at Jones Day
In the interest of full disclosure, the authors represent companies in the pharmaceutical industry.
1 29 U.S.C. § 201, et seq.
2 See 29 C.F.R. § 541.500(a),
3 See 29 C.F.R. § 541.200(a).
4 See, e.g., Barnick v. Wyeth, 522 F. Supp. 2d, 1257 (C.D. Cal. 2007); D’Este v. Bayer Corp., No. 07-3206, slip op. (C.D. Cal. Oct. 9, 2007); Menes v. Roche Labs. Inc., No. 07-1444, 2008 U.S. Dist. LEXIS 4230 (C.D. Cal. Jan. 7, 2008); Brody v. Astrazeneca Pharms., LP, No. 06-6862, 2008 U.S. Dist. LEXIS 107301 (C.D. Cal. June 11, 2010); Rivera v. Schering Corp., No. 08-1743, 2008 U.S. Dist. LEXIS 111105 (C.D. Cal. Aug. 14, 2008); Yacoubian v. Ortho-McNeil Pharm. Inc., No. 07-0127, 2009 U.S. Dist. LEXIS 27937 (C.D. Cal. Feb. 6, 2009).
5 See, e.g., Harris v. Auxilium Pharms., Inc., 664 F.Supp.2d 711 (S.D. Tex. 2009), vacated in part on reconsideration by 2010 U.S. Dist. LEXIS 102730 (S.D. Tex. Sept. 28, 2010); In re Novartis Wage and Hour Litigation, 593 F. Supp. 2d 637 (S.D.N.Y. 2009), vacated, 611 F.3d 141 (2d Cir. 2010); Schaefer-LaRose v. Eli Lilly & Co., 663 F. Supp. 2d 674 (S.D. Ind. 2009).
6 See, e.g., Smith v. Johnson & Johnson, No. 06-4787, 2008 U.S. Dist. LEXIS 104952 (D.N.J. Dec. 20, 2008), aff’d, 593 F.3d 280 (3d Cir. 2010); Jackson v. Alpharma, No. 07-3250, 2010 U.S. Dist. LEXIS 72435 (July 19, 2010).
7 See, e.g., Yacoubian v. Ortho-McNeil Pharm. Inc., No. 07-0127, 2009 U.S. Dist. LEXIS 27937 (C.D. Cal. Feb. 6, 2009).
8 Ruggeri v. Boehringer Ingelheim, 585 F. Supp. 2d 254 (D.Conn. 2008); Kuzinski v. Schering Corp., 604 F. Supp. 2d 385 (D.Conn. 2009).
9 519 U.S. 452 (1997).
10 In re Novartis Wage and Hour Litigation, 611 F.3d 141 (2d Cir. 2010).
11 Jirak v. Abbott Labs., No. 07-3626, 2010 U.S. Dist. LEXIS 58804 (N.D. Ill. June 10, 2010).
12 Harris v. Auxilium Pharms., Inc., No. 07-cv-3938, 2010 U.S. Dist. LEXIS 102730 (S.D. Tex. Sept. 28, 2010).
13 Schaefer-LaRose v. Eli Lilly & Co., No. 07-1133, 2010 U.S. Dist. LEXIS 105736 (S.D. Ind. Sept. 29, 2010).
14 Smith v. Johnson & Johnson, 593 F.3d 280 (3d Cir. 2010).
15 Christopher v. SmithKline Beecham Corp., 635 F.3d 383 (9th Cir. 2011).
16 Palacios v. Boehringer Ingelheim Pharm., Inc., No. 10-22398-Civ-UU, 2011 U.S. Dist. LEXIS 77804 (S.D. Fla. July 11, 2011).
17 Palacios v. Boehringer Ingelheim Pharm., Inc., No. 10-22398-CIV-TORRES (11th Cir. Sept. 14, 2011). The case is now scheduled for trial in early 2012, so barring settlement, it may be in the Eleventh Circuit within the next year.
18 See, e.g., Schaefer-LaRose v. Eli Lilly, Case No. 07-CV-1133 (S.D. Ind. 2006) (4.59% opt-in rate); Engel v. EMD Sereno, Case. No. 07-CV-0117 (N.D. Cal. 2007) (4.3% opt-in rate).
19 See, e.g., Schaefer-LaRose, Case No. 07-CV-1133 (S.D. Ind. 2006) (29 of 356 opt-ins are current employees).