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T h e n e w e ng l a n d j o u r na l o f m e dic i n e Whistle-Blowers’ Experiences in Fraud Litigation
against Pharmaceutical Companies
Aaron S. Kesselheim, M.D., J.D., M.P.H., David M. Studdert, LL.B., Sc.D., M.P.H., and Michelle M. Mello, J.D., Ph.D., M.Phil.
Prosecution and prevention of health care fraud fraud litigation on the basis of recovery amounts and abuse are essential to reducing U.S. health (average and gross).6,15,16 care spending.1-3 A number of recent high-pro- file cases have uncovered suspect business prac- tices and led to substantial recoveries; in Septem- ber 2009, for example, Pfizer paid $2.3 billion to Officials in the Civil Division of the U.S. Depart- settle allegations that it marketed its drugs ille- ment of Justice helped us identify 17 federal qui gally to physicians, leading to unnecessary pay- tam cases against pharmaceutical manufacturers settled between January 2001 and March 2009 Currently, 90% of health care fraud cases are (Table 1). Using the unsealed complaints and set- “qui tam” actions in which whistle-blowers with tlement agreements, as well as direct approaches direct knowledge of the alleged fraud initiate the to attorneys involved in the litigation, we identi- litigation on behalf of the government.5 Qui tam fied 42 whistle-blowers involved in these cases. derives from the Latin phrase qui tam pro domino We conducted individual, semistructured inter- rege quam pro se ipso in hac parte sequitur, meaning views with 26 (62%) of them. The interviews had “who as well for the king as for himself sues in a median duration of 40 minutes (interquartile this matter.” If a qui tam action leads to a finan- range, 31 to 49) and addressed the whistle- cial recovery, the whistle-blower stands to collect blowers’ motivations and experiences. We ana- a portion of the award. From 1996 through 2005, lyzed the interview transcripts using the constant qui tam actions led to more than $9 billion in comparative method of qualitative analysis.17,18 recoveries.6 Although such actions are touted as A detailed description of the study methods is pro- cost-effective7 and may deter inappropriate behav- vided in the Supplementary Appendix, available ior,8 little is known about how well the qui tam with the full text of this article at NEJM.org.
From their vantage point at the center of the process, whistle-blowers have valuable insights. Popular portrayals of whistle-blowers vary widely: some anecdotes paint them as heroes struggling The federal False Claims Act (FCA) prohibits the against corporate greed, emphasizing the hard- submission of false claims or statements to the ships and retaliation they must endure; other ac- government. Violators face fines of $5,500 to counts question their motives and the “excessive” $11,000 per claim, plus treble damages. Whistle- blowers (referred to as relators) can initiate cases The goal of this study is to shed light on the by filing a sealed complaint in federal court, near- motivations and experiences of whistle-blowers in ly always with the help of a personal attorney. In cases of major health care fraud. We conducted our sample, 22 (85%) were employees of the de- interviews with whistle-blowers who were key in- fendant company (insiders), including 9 at the ex- formants in recent prosecutions brought against ecutive or midmanagerial level and 13 lower-level pharmaceutical manufacturers. Enforcement ac- employees.
tions against pharmaceutical manufacturers have The Justice Department then investigates the become the most lucrative type of health care allegations, often in conjunction with other in- n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. Table 1. Whistle-Blower–Initiated Federal Pharmaceutical Fraud Cases Settled between January 2001 and March 2009.
Settlement
Company and Year
(millions of $)
Summary of Alleged Improper Conduct
Inflated government reimbursement for prescription of its drug by re- porting average wholesale price as significantly higher than the aver- Violated best-price rules by offering rebates to private insurers*; gave kickbacks to private insurers for favoring drug on formularies Inflated government reimbursement for prescription of its drug by re- porting average wholesale price as significantly higher than the aver- Sold relabeled drugs to private payers at discounted prices and then con- cealed this information to avoid obligation to pay such rebates to the Aggressively marketed drug for off-label indications; gave kickbacks to high-prescribing physicians; made false statements about safety Offered underpriced and free goods and services to private sector that it Inflated government reimbursement for prescription of its drug by re- porting average wholesale price as significantly higher than the aver- Paid kickbacks to induce prescribing and falsified bioelectrical imped- ance analysis test results to make patients appear to be candidates Submitted inaccurate price data to the government, resulting in rebate amounts on its drug products that were lower than they should Conducted off-label marketing, including making false statements about drug efficacy to induce prescription writing and creating a “safety registry” to facilitate off-label sales Conducted off-label marketing, including using misleading reprints and other sources, inducing prescription writing by offering rebates and gifts to off-label prescribing physicians, and holding continuing medi- cal education meetings to induce writing of unapproved prescriptions Conducted off-label marketing, including suppression of data about a dangerous side effect (acute promyelocytic leukemia differentiation syndrome) and manipulation of efficacy studies Conducted off-label marketing, including organizing continuing medical education events with speakers describing unapproved uses of the drug and teaching physicians to falsify billing codes Conducted off-label marketing of an antifungal cream, approved for use in adults, for the treatment of diaper rash in children; misrepresented Failed to pay proper rebates to government programs and paid providers to induce prescriptions through payments for training, consultation, Conducted off-label marketing, including active help in securing govern- ment reimbursement for prescriptions for unapproved uses Conducted off-label marketing to children and to elderly patients in long- term care facilities; failed to provide information about drugs’ side * Best-price rules state that Medicaid must be granted the lowest price for drugs offered to any private purchaser.
terested agencies. If the evidence supports the action. When multiple parties file complaints allegations, the Justice Department may elect to about the same activity, the first to file is assigned intervene and take the lead in the enforcement the role of the “lead relator,” but other relators n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. T h e n e w e ng l a n d j o u r na l o f m e dic i n e who provide useful evidence may be included. matters internally by talking to their superiors, Almost all cases in which the Justice Department filing an internal complaint, or both. One ex- intervenes result in judgments against or settle- plained: “At first it was to the head of my depart- ments with the defendant. For the relators in our ment, the national sales director, and the nation- sample, cases took an average of 4.9 years (range, al marketing director. . . . After being shooed aside, I went to the executive vice president over Under the FCA, relators are eligible to receive all the divisions of sales and marketing. Then 15 to 25% of the recovery. The total relator share eventually I went to the CEO of the company, the is set by the government and then divided among chief medical officer, and the president” (Rela- relators. The recovery may be withheld if the re- tor 7). Insiders who voiced concerns were met with lator was involved in generating the allegedly assertions that the proposed behavior was legal fraudulent activity. After attorney’s fees and taxes, (4 of 22) and dismissals of their complaints, with 5 of the relators in our sample received less than accompanying demands that the relators do what $1 million in financial recoveries from their case, they were told (12 of 22).
13 received between $1 million and $5 million, and 7 received more than $5 million (1 relator did Motivations
Although the relators in this sample all ended If the government decides not to intervene, the up using the qui tam mechanism, only six spe- case may remain sealed and is often dismissed. cifically intended to do so. The others fell into Whistle-blowers may press forward alone (and the qui tam process after seeking lawyers for earn up to 30% of any recovery), but in practice, other reasons (e.g., unfair employment practices) solo actions rarely result in substantial recoveries. or after being encouraged to file suit by family or friends. Every relator we interviewed stated that the financial bounty offered under the fed- eral statute had not motivated their participation in the qui tam lawsuit. Reported motivations Discovery of and Initial Reactions
coalesced around four non–mutually exclusive to the Alleged Fraud
themes: integrity, altruism or public safety, jus- The relators we interviewed became aware of the tice, and self-preservation (Table 2).
troubling corporate behavior in a variety of ways. The most common of the themes, integrity Whereas all 4 of the “outsiders” came across it (11 of 26 relators), was linked by some relators in their normal course of business, the trigger- to their individual personality traits and strong ing event for most (16 of 22) insiders was a ca- ethical standards. One relator reasoned, “When reer change — starting at a new company (10 of I lodged my initial complaint with the company, 16) or being promoted to a new position (6 of 16). I believed what we were doing was unethical Changes in the business environment, such as in- and only technically illegal. This ethical trans- creased competition or new management after a gression drove my decision. My peers could live corporate takeover or merger, also contributed to with the implications of ‘doing 60 in a 55 mph bringing the alleged fraud to relators’ attention. zone’ because it did indeed seem trivial. How- One relator described a time when her employer’s ever, my personal betrayal . . . so filled me with highest-earning product faced generic competi- shame that I could not live with this seemingly tion: “It wasn’t until there were extreme competi- trivial violation” (Relator 25). The relators in this tive pressures and negative effects on earnings group felt that financial circumstances helped that the company’s marketing practices became to subvert such ethical standards in their col- much more aggressive” (Relator 14).
leagues, saying that most colleagues were unwill- Initially, a large proportion (11 of 26) of the ing for personal or family reasons to jeopardize relators refused to participate in the corporate ac- their jobs.
tions that led to the suit. Insiders who took this A slightly less common theme (7 of 26 relators) course reported that their job performances be- involved trying to prevent the fraudulent behav- gan lagging relative to that of their peers, whose ior from posing risks to public health. Most of sales were enhanced by the marketing schemes. the relators who described this type of motiva- Nearly all (18 of 22) insiders first tried to fix tion felt they had unique professional experiences n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. Table 2. Primary Motivations for Initiating Qui Tam Lawsuit.
Motivation*
Illustrative Remark
“If these guys go down I’m not going to be the one that gets blamed for all of “Then in the end they were pushing me to break some more laws. I had just said, ‘I’m putting my foot down. I’m being excluded from meetings. They’re making decisions that I’m going to do things that are illegal.’ So I felt like they were “I thought, ‘I’m involved in something that’s illegal. This is dangerous to people. . . . Maybe I’m — am I going to get arrested?’” (Relator 11) “[I] was proud to be involved in it because we thought we were on the right side of justice here . . . this was an illegal activity that needed to be reported.” “Shame on them. They should be held accountable for the way they treat people. They should be held accountable for their illegal and unethical behavior.” “I think it’s our responsibility. It’s our duty. It’s not an act of heroism. It’s not an act of bravery. It’s an act of responsibility.” (Relator 24) “This doesn’t just hurt patients and physicians and give industry a bad name. This hurts everybody, whether you’re a shareholder [or] a retiree with a pension from them. Everybody’s taking a whack on this.” (Relator 4) “It was just something that I knew was wrong. I needed to correct it.” (Relator 15) “This is not right. We have laws to protect people from this, to protect the public from this . . . so I needed to stand up for my rights not only for every other person in this company but for my young daughters coming after me starting “I was angry they were trying to get me to do something wrong.” (Relator 23) Altruism or public safety (reported “I’ve got autopsy reports. I’ve got multiple physician confirmations. I’ve got the chief medical officer who sent me an email saying, ‘Yes. [The side effect] is oc- curring.’ . . . Then they demoted me? I knew there was a problem. That’s when I decided to go down that road.” (Relator 7) “I think if it had been a drug that was like a cream for diaper rash or something like that I don’t know that I would’ve been so idealistic and bold and brave. . . . I don’t think I’ve got that great of character to be honest with you. But I think this drug kind of scared me. I didn’t want to be responsible for somebody dy- “This was really asking programs designed for the poorest among us to under- write a company whose profit rates were pushing 20%. The whole deal was be- ing subsidized by programs for the poor.” (Relator 16) * Some relators identified with more than one source of motivation.
or educational backgrounds that gave them a su- the Investigation
perior grasp of the negative public health impli- Whistle-blowers reported sharing several com- cations of the illegal conduct. Some relators (7 of mon experiences during the investigation phase 26) characterized their action in reporting the of the litigation. First, most (15 of 26 relators, 14 fraud as emanating from a sense of duty to bring of 22 insiders) became active players in the in- criminals to justice. Many of these relators were vestigation. Their involvement included wearing new employees who perceived themselves as be- a personal recording device at face-to-face meet- ing outside the fold in their companies.
ings or national conferences, taping phone con- Finally, several relators (5 of 26) reported fears versations with colleagues, and copying requested that the fraudulent behavior would be discovered documents or files. In addition, after the Justice and would result in legal consequences for them; Department officially joined the case and began therefore, blowing the whistle was a way to pro- to obtain internal company documents by subpoe- na, relators were asked to work closely with de- n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. T h e n e w e ng l a n d j o u r na l o f m e dic i n e partment representatives to explain the evidence — I had a rental house that my kids were [using being gathered and help build the case.
to go] to school. I had to sell the house. Then I had Second, the workload and pressure were per- to sell the personal home that I was in. I had my ceived as intense. One relator estimated spending cars repossessed. I just went — financially I went “thousands of hours” on the case over its 5-year under. Then once you’re financially under? Then duration (Relator 17); another spent “probably 30 no help. Then it really gets difficult. I lost my hours a week” during the first few years. Some 401[k]. I lost everything. Absolutely everything” meetings took place at Justice Department of- (Relator 17).
fices, with relators traveling at their own expense; Financial difficulties often were associated others occurred unnervingly close to home. One with personal problems. Six relators (all insiders) reported that “a typical day could be meeting an reported divorces, severe marital strain, or other FBI agent in a parkway rest stop. Sitting in his car family conflicts during this time. Thirteen rela- with the windows rolled up. Neither heat nor air tors reported having stress-related health prob- conditioning. Getting wired. Running to a meet- lems, including shingles, psoriasis, autoimmune ing. . . . That might happen at 7 for a meeting at disorders, panic attacks, asthma, insomnia, tem- 8” (Relator 16). Another said, “I would have FBI poromandibular joint disorder, migraine head- agents show up in the office. I told them, the aches, and generalized anxiety.
company people, that they were computer peo- ple. Luckily they believed it. . . . That’s amusing Settlement and Life Afterward
now after the fact. But at the time they call you All relators in our sample received a share of the in 5 minutes. They say ‘We’re coming onto your financial recovery. The amounts received ranged from $100,000 to $42 million, with a median of Finally, there was widespread criticism of the $3 million (net values, in 2009 dollars). The set- Justice Department’s collaborative posture, or lack tlements helped alleviate some of the financial thereof, during various phases of the investiga- and nonfinancial costs of the litigation. One re- tion. Ten relators reported conflict with the inves- lator likened his large settlement to “hitting the tigators, most frequently at the outset. One re- lottery” (Relator 5). But a majority perceived their marked, “There was always an undertone of ‘How net recovery to be small relative to the time they much were we involved in this?’” (Relator 16). spent on the case and the disruption and dam- Relators also complained that “the government age to their careers. After settlement, none of the doesn’t tell you anything” (Relator 5) about the 4 outsiders changed jobs, but only 2 of the 22 status of the investigation, including when a set- insiders remained employed in the pharmaceuti- tlement was imminent. Others were frustrated cal industry. One ruefully reported that he “should that “the wheels move really slow” and lamented have taken the bribe” (Relator 7), and another the years spent waiting in a state of uncertainty noted that if she “stayed and took stock options” she “would’ve been worth a lot more” (Relator 4). The prevailing sentiment was that the payoff had Personal Toll
The experience of being involved in troubling Despite the negative experiences and dissat- corporate behavior and a qui tam case had sub- isfaction with levels of financial recovery, 22 of stantial and long-lasting effects for nearly all of the 26 relators still felt that what they did was the insiders, although no similar problems were important for ethical and other psychological or reported by any of the four outsiders. Eighteen spiritual reasons. Relators offered a range of ad- insiders (82%) reported being subjected to various vice for others who might find themselves in simi- pressures by the company in response to their lar situations (Table 4). Some offered strategic complaints (Table 3). A common theme was that suggestions, such as hiring an experienced per- the decision to blow the whistle had “put their sonal attorney, and many suggested a need to career on the line” (Relator 3). For at least eight mentally prepare for a process more protracted, insiders, the financial consequences were report- stressful, and conflict-ridden, and less financially edly devastating. One said, “I just wasn’t able to rewarding, than prospective whistle-blowers might get a job. It went longer and longer. Then I lost expect.
n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. Table 3. Forms of Pressure Reported by Insiders.*
Type of Pressure
Illustrative Remark
Negative persuasion (reported by 7 relators) “Then, after I complained, my territory changed. They started giving me more challenging physicians. Then they started giving me different areas farther out to call on. So it made it difficult to do my job.” “[N]obody spoke to me. Not one person. . . . I was persona non gra- Positive persuasion (reported by 4 relators) “First, they attempted to promote me and bribe me to keep me quiet.” “I was contacted by their lawyers on a couple of different occasions. Including one time which was a random call. Somebody who was ba- sically trying to ask me to drop the lawsuit. That I’d be given some Direct intimidation (reported by 5 relators) “The individuals that threatened me pointed out that the company would hang me out to dry and [said,] ‘Even if they find something the company will throw you under the bus and prove that you were a loose cannon and the only person doing it.’” (Relator 25) “[They said] ‘If you’re not playing along with us the way we play, we’ll throw you under the bus when and if anything ever hits the fan.’” Loss of employment (reported by 5 relators) Q: “Did you try to bring your concerns to your superiors?” “Then I took a job. Then somehow [company name] called the job. Then “I had one interview with [company name] as national trainer. I was actu- ally being offered the job. . . . [I was going to go] to the national meeting. Be introduced as the person in charge basically. I walked in to [the] vice president’s office. They asked me to be escorted out of * Insiders are whistle-blowers who were employees of the defendant company.
dence of fraud reluctant to come forward.19 So- cial and medical complications related to the This study identified several commonalities in stress of involvement in litigation have been well whistle-blowers’ experiences. Generally, whistle- documented in other legal contexts, such as mal- blowers’ first move was to try to address prob- practice,20 where physicians may resort to ex- lems internally; they became litigators either ac- treme measures to avoid being sued.21 Qui tam cidentally (while pursuing other claims) or as a litigation, in contrast, involves a choice for those last resort. The most prevalent motivations re- who initiate it. Its capacity to curb fraud may ported were personal values and self-preserva- therefore be enhanced if Justice Department in- tion rather than financial incentives. These find- vestigators and others involved in the process were ings provide a number of useful insights into the more cognizant of the tribulations faced by rela- qui tam mechanism as a tool for addressing tors, or if relators received needed resources (for example, temporary financial or medical benefits First, the strain the process places on individ- during unemployment) during the course of liti- uals’ professional and personal lives may make gation. The long duration of the investigation pro- prospective whistle-blowers with legitimate evi- cess contributed to this stress. The reported back- n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. T h e n e w e ng l a n d j o u r na l o f m e dic i n e Table 4. Whistle-Blowers’ Advice for Others Considering the Qui Tam Process.
Topic of Advice
Illustrative Remark
“I would say don’t expect any money. It’s going to be a long time. It’s going to be frustrating. But if you’re doing it for the right reasons? Then go for it. But if you’re doing it because you think you’re going to make millions? Don’t do it.” (Relator 9) “The government isn’t there for you as much as you think. I really believe that. They’re not there for you. They’re ultimately there to get the company. You’re just a tool. Just remember that you’re just a tool for them.” (Relator 8) “It wasn’t overly friendly, it was just very methodical. It was very to the point. Very de- tailed, really. Very comprehensive.” (Relator 13) “The process is a long process.” (Relator 4) “[Can they] afford 5 years of their life in turmoil? . . . If they [can’t] I would tell them to find a new job and have a letter written anonymously with any documentation they can put together and send it off to the [Department of Justice]. Tell them to go investigate it. Or it’s going to ruin their life.” (Relator 7) “Be as accurate as possible, have as much information as possible.” (Relator 13) “Make sure you know really thoroughly, for sure, 200% certainty that what you think you know is accurate and factual.” (Relator 19) “[Bring a qui tam case] as an absolute last resort. Try and resolve it by changing “Build alliances and arguments that demonstrate the value of correcting the wrong. . . . [Take] responsibility for becoming a catalyst for internal change. If you blow the whistle, regardless of your ethical foundation or ultimate success, your ability to live out your dreams is severely compromised.” (Relator 25) “You’ve got to find some people, because this could go on for a while, like a minister or a shrink who’s confidentiality-protected. Part of your ability to do anything about this is keeping yourself together.” (Relator 16) “You have to have strong resolve. Strong family life. To know what you want in life, if “The first thing you need to do is get a good lawyer to represent you and guide you through this process because it’s very complicated.” (Relator 17) “[Find] somebody that has done it, somebody that has relationships, somebody that will be honest [and] prepare[d] to be involved.” (Relator 14) “Don’t do it. Either try to find another job or just shut your mouth and don’t sign any- thing. They’re going to keep doing it. So you’re not going to make a change. It still “Honestly, I would not advise anybody to do it.” (Relator 6) log of nearly a thousand health care qui tam cases not distinguish between relators outside and in- at the Justice Department suggests that this prob- side the defendant company, whereas we found lem may get worse, not better, for relators in the that insiders tended to contribute much more to foreseeable future.22 Shortening the timelines and the Justice Department investigation and suffered attendant stresses of qui tam litigation requires more for their involvement. Such factors should more resources for enforcement, an investment be taken into account in determining compen- that should more than pay for itself.
Second, in many of the personal stories we Third, whereas retaliation is clearly proscribed heard, the financial recovery appeared to be quite by the FCA, our report suggests that the protec- disproportionate (in both positive and negative tions are not fully effective, particularly for insid- directions) to the whistle-blower’s personal in- ers. Often, the retaliation was more subtle than vestment in the case. More sophisticated ap- overt harassment. For example, relators reported proaches to determining relators’ recoveries could changes in employment duties that made meet- be used to promote both equity and more respon- ing sales quotas or other expectations impossi- sible whistle-blowing. For example, the FCA does ble, providing a pretext for job termination. For n engl j med 362;19 nejm.org may 13, 2010 Downloaded from www.nejm.org by JAMES J. MURTAGH MD on May 17, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. some relators, the anonymity gained from “seal- and abuse. Washington, DC: General Accounting Office, May ing” their qui tam cases was undercut by the fact 1992. (Publication no. GAO/HRD-92-69.) (Accessed April 22, 2010, at http://archive.gao.gov/t2pbat6/146547.pdf.) that internal complaints filed beforehand fingered 3. Sparrow MK. License to steal: how fraud bleeds America’s
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