Recently in Legal Category

In a 3-part criminal and civil agreement with the Department of Justice, Allergan, the maker of Botox, has dropped its free-speech suit against the FDA—which had the potential to be a pivotal case on the rights of commercial free speech. In addition, the company has pleaded guilty to a single misdemeanor "misbranding" charge, stemming from the off-label promotion of Botox during 2000-2005, and will pay $375 million. Last Allergan will fork over another $225 million to resolve civil claims made by the DOJ under the False Claims Act (concerning qui tam or whistleblower complaints). The plea agreement was announced yesterday in a company press release and also by the DOJ.

According to the government, Allergan, during the described time period, "exploited" an approved indication for cervical dystonia (obtained in 2000) to expand the off-label use of Botox for headache. Company reps were also instructed to call on doctors who typically treat off-label conditions (like pediatric spasticity), and Allergan held workshops to inform healthcare providers on how to be reimbused for injecting Botox off label.

The civil settlement resolved 3 qui tam lawsuits, with whistleblowers Dr. Amy Lang (a former Allergan consultant), Charles Rushin (a former Botox sales rep), Cher Beilfuss (a former Regional Healthcare Policy Manager for Allergan), Kathleen O'Conner-Masse (a former Payor Reimbursement Account Manager for Allergan), and Edward Hallivis (a former I-don't-know-what). They will split $37.8 million.

The current, FDA-approved indications for Botox (not Botox Cosmetic) in adults are the following:

• Cervical dystonia
• Primary axillary hyperhidrosis
• Blepharospasm and strabismus
• Upper limb spasticity (approval obtained March 2010)

In an effort to better understand the legal issues surrounding the use of human embryonic stem cells (hESCs) for research, the following timeline is provided. It is is mostly informed by Judge Royce C. Lamberth's August 23rd decision, which blindsided many researchers who work with hESCs; however, it is also supplemented (and confirmed) by other linked sources.

1960s: Researchers discover, isolate, and begin to work with human stem cells, which are derived directly from bone marrow, peripheral blood, or discarded tissues, like the umbilical cord and placenta. These cells are multipotent, meaning that they can differentiate into a limited number of cell types. Their most notable therapeutic use during the next decades is the reconstitution of bone marrow during bone marrow transplantation.

1996: Congress passes and President Bill Clinton signs the Balanced Budget Downpayment Act, which contains the Dickey-Wicker Amendment. The amendment, or really rider, prohibits the use of federal funds to support research "in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero." Since 1996, Congress includes the Dickey-Wicker Amendment in every iteration of its appropriations bill for the DHHS.

November 1998: James Thomson, VMD, PhD, of the University of Wisconsin, and colleagues report their process of creating stem cells from human embryos. The hESCs are pluripotent, meaning that they can differentiate into any of the 200 or so cell types found in the human body. They can also be maintained indefinitely. The potential of hESC-based research surpasses that of work on traditional stem cells, because the latter are only multipotent, not pluripotent. Creation of the hESCs, however, requires destruction of a human embryo (or really its potential to develop into a human being), which produces a moral/ethical dilemma.

July 7, 1999: The Clinton administration circumvents the Dickey-Wicker Amendment by arguing that hESCs are not embryos as defined by the statute and that research on existing hESC lines should not be prohibited, because it does not destroy embryos. Congress subsequently fails to alter the Dickey-Wicker Amendment.

August 9, 2001: President George W. Bush publicly addresses the use of federal funds to conduct research on hESCs. Informed by his conservative beliefs, he reports to the nation,

As a result of private research, more than 60 genetically diverse stem cell lines already exist. They were created from embryos that have already been destroyed, and they have the ability to regenerate themselves indefinitely, creating ongoing opportunities for research. I have concluded that we should allow federal funds to be used for research on these existing stem cell lines, where the life and death decision has already been made.

June 20, 2007: President Bush issues Executive Order 13435, which expands on his statement from August 2001. The order stipulates,

The Secretary of Health and Human Services (Secretary) shall conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus [emphasis added].

And

...[T]he destruction of nascent life for research violates the principle that no life should be used as a mere means for achieving the medical benefit of another...human embryos and fetuses, as living members of the human species, are not raw materials to be exploited or commodities to be bought and sold...

December 2007: Thomson et al report their success in genetically reprogramming some specialized adult human cells to assume a stem cell-like state. Through the use of viral vectors, these induced pluripotent stem cells (iPSCs) are forced to express genes that confer the defining properties of ESCs. The NIH later warns, however, that, although iPSCs meet the defining criteria for pluripotent stem cells, it is not known if iPSCs and ESCs differ in clinically significant ways. Moreover, in animal studies, the virus that is used to introduce stem cell factors sometimes causes cancers. According to the NIH, researchers are investigating nonviral delivery methods. If iPSCs become, for all practical purposes, equivalent to ESCs, their use cannot be objected to on the basis of the destruction of human embryos.

March 9, 2009: President Barak Obama issues Executive Order 13505 (Removing Barriers to Responsible Scientific Research Involving Human Stem Cells), which states that the DHHS Secretary (Kathleen Sebelius), through the NIH Director (Francis Collins, MD, PhD), "may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law." The executive order pertains to extramural NIH-funded stem cell research. The executive order revokes the President Bush's statement of August 9, 2001 and his follow-up Executive Order 13435 of June 20, 2007.

April 23, 2009: In response to Executive Order 13505, the NIH publishes draft guidelines, "National Institutes of Health Guidelines for Human Stem Cell Research," which allow for the funding of research with hESCs "that were derived from human embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose." The NIH receives approximately 49,000 comments on the draft guidelines.

July 7, 2009: The NIH publishes its final guidelines for scientific work on hESCs, with a number of stipulated conditions for their use. The guidelines also acknowledge,

Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted this provision as not applicable to research using hESCs, because hESCs are not embryos as defined by Section 509. This long-standing interpretation has been left unchanged by Congress, which has annually reenacted the Dickey Amendment with full knowledge that HHS has been funding hESC research since 2001. These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo’s destruction, for which federal funding is permitted.

August 19, 2009: Plaintiffs James L. Sherley, MD, PhD, Theresa Deisher, PhD, Nightlight Christian Adoptions (“Nightlight”), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association (“CMA”) file suit in the US District Court for the District of Columbia against Kathleen Sebelius et al. The plaintiffs seek declaratory and injunctive relief to prevent the NIH's Guidelines for Human Stem Cell Research from taking effect. Specifically plaintiffs argue that the NIH guidelines violate the Dickey-Wicker Amendment.

October 27, 2009: Judge Lamberth dismisses the plaintiffs' suit, finding that the plaintiffs lack standing. Lamberth also denies the plaintiffs' motion for a preliminary injunction as moot. The plaintiffs appeal.

June 25, 2010: The Court of Appeals reverses, concluding that Drs. Sherley and Deisher, who work with adult stem cells, had standing under the competitor-standing doctrine. Because the other plaintiffs did not contest the Court’s prior finding, the Court of Appeals treats "their lack of standing as conceded." The Court of Appeals then remands the matter back to the US District Court for the District of Columbia to consider the plaintiffs’ motion for a preliminary injunction.

August 23, 2010: Judge Lamberth rules "that the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of hardships, and public interest considerations each weigh in favor of a preliminary injunction." Lamberth agrees that federal funding of hESC research increases competition for limited NIH funds, thereby causing an "actual, imminent injury" to Drs. Sherley and Deisher. "Accordingly, plaintiffs would suffer irreparable injury in the absence of the injunction," Lamberth writes. Moreover, Lambert concludes that the imminent injury to Drs. Sherley and Deisher outweighs any potential harm to individuals who may otherwise benefit from hESC research. He concludes, "It is not certain whether ESC research will result in new and successful treatments for diseases such as Alzheimer’s and Parkinson’s disease." Lamberth did not agree with the defendants that the Dickey-Wicker Amendment is ambiguous (thus allowing for the distinction between the creation of hESC lines—which necessarily destroy an embryo's potential to develop into a human being—and subsequent research on extant hESC lines). On the contrary, he ruled that adherence to the amendment is in the public interest.

Here, the will of Congress, as expressed in the Dickey-Wicker Amendment, is to prohibit federal funding of research in which human embryos are destroyed. Accordingly, it is in the public interest to enjoin defendants from implementing the Guidelines because the Guidelines allow federal funding of ESC research, which involves the destruction of embryos.

August 31, 2010: The Justice Department files an emergency motion, asking Judge Lamberth to temporarily stay his ruling, while the government appeals.

Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.

At the heart of Cedillo v. US DHHS was the claim that thimerosal-containing vaccines damaged Michelle Cedillo's immune system, which then allowed attenuated measles virus in the MMR vaccine to injure her brain, thereby causing autism. It's a convoluted (and medically illogical) argument, but one that was ostensibly supported, at least in part, by data from a questionable Dublin-based laboratory, Unigenetics.

In the original 2009 decision against the petitioner in the Omnibus Autism Proceeding,* Special Master George Hastings found the detection of vaccine-derived measles virus by Unigenetics in an intestinal sample from Cedillo "not reliable." The decision was based partly on expert testimony from Stephen Bustin, PhD, a UK-based molecular biologist who, as part of UK vaccine litigation, had obtained access to the Unigenetics laboratory and some of its relevant data. On the basis of a number of procedural flaws at Unigenetics, Bustin testified both in the UK and US courts that the company's work was plagued with potentially contaminating errors. Bustin also suggested that results from Unigenetics might even be fraudulent, after reviewing some of the laboratory's altered notebooks.

Access to documents from Unigenetics, on which Bustin based his expert opinion, was the crux of a recent appeal by Cedillo's parents to the US Court of Appeals for the Federal Circuit. This appeal was denied Friday, August 27th. And while the appeal court ruled that Special Master Hastings "erred in permitting the government to introduce the expert reports and testimony of Dr. Bustin because the government did not make available the underlying Unigenetics documents upon which Dr. Bustin relied," the court also noted that Hastings had given the petitioners virtually every opportunity to obtain this information from the UK court themselves, which they apparently did not try to do. (It should be noted that the government argued against the reliability of Unigenetics with other expert testimony. It is presumed on this basis that the Special Master's error was not a reversible one.)

In 2007, the government, in its case preparation, successfully petitioned the UK court to release the Bustin reports, but it did not request the laboratory notebooks or other data on which Bustin relied. The appellate decision further describes the background facts, 

The government explained at oral argument that UK counsel informed them that an application to the UK court requesting "everything" from the UK litigation would be denied as overbroad, and as a result, they needed to narrow their request to the most essential items. The government therefore subsequently "honed down" their request to cover solely the three reports, two of which were filed by Dr. Bustin, that they eventually obtained.

The upshot: Cedillo v. US DHHS has been put to bed.

In a coda to this case, it can be said that life, outside the courtroom, moves relatively quickly and in curious directions. Unigenetics dissolved as a company 5 years ago, although its former director, pathologist John O'Leary, is evidently still working in Dublin at Trinity College. In 2008, O'Leary, in an apparent effort to regain academic credibility, was coauthor of a multi-institutional study ("Lack of association between measles virus vaccine and autism with enteropathy: a case-control study" in PLoS One) that essentially negated the results produced by his own company for Cedillo.

DHHS = Department of Health and Human Services; MMR = measles-mumps-rubella.

* Which was affirmed by Judge Thomas Wheeler in the US Court of Federal Claims.

Gird yer loins, Austin "Jack" DeCoster. You're about to receive uncompromising media and Congressional attention. And the metaphoric (and partially ironic) tarring and feathering may long be overdue, if archived news stories are any indication.

The growing recall of Salmonella-tainted eggs is focusing widespread attention on DeCoster (photos here and here), who is the owner of Wright County Egg in Galt, Iowa, and Quality Egg, a supplier of chicks and feed to Hillendale Farms in New Hampton, Iowa. On August 13, Wright County recalled 380 million eggs that it had shipped since May 19. Hillandale recalled 170 million eggs on Friday, according to USA Today.

The FDA says that the Wright County eggs had been distributed to "food wholesalers, distribution centers and food service companies in California, Illinois, Missouri, Colorado, Nebraska, Minnesota, Wisconsin and Iowa." These companies distribute eggs nationwide. The recalled eggs were packaged under the brand names of Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms  and Kemps. [Writer's note: Because Lucerne consistently provides the least expensive dairy products in Chicago-area Dominick's stores, I've always been skeptical of their origin. BTW, Lucerne's cheese is absolutely tasteless.]

DeCoster, who also has a history in hog farming, is reportedly no stranger to alleged health, safety, or labor violations, which date back to at least the mid-1990s.

Reports USA Today,

• In 1997, DeCoster Egg Farms of Turner, Maine, agreed to pay $2 million to settle health and safety citations. Employment conditions at DeCoster's farm were publicly denounced by Labor secretaries Robert Reich (he called them "dangerous and oppressive") and Alexis Herman (who said they were "simply atrocious"). See the NYT's "In Maine, Egg Empire Is Under Fire."
• In 2000, Iowa (as in the state of) called DeCoster a "habitual violator" of environmental regulations. One infraction: allowing hog manure to run off into waterways. DeCoster was prohibited from building new farms. See a 2000 statement from the Iowa Attorney General.
• In 2002, DeCoster paid more than $1.5 million in a settlement with the EEOC regarding sexual harassment claims (including rape) from Mexican women who worked at Wright County.

Other violations, including those of animal mistreatment, are reported by the Washington Post and detailed by Mercy for Animals here and here. DeCoster's heavy use of battery cages to house chickens has been linked to the spread of Salmonella on egg farms.

More than 1000 Americans have been sickened by Salmonella-tainted eggs in the current recall, according to the latest news reports, and the obligatory litigation is in the works. This may be one case in which it is reasonable to root for personal-injury attorneys. 

The improved outlook for Medicare's solvency, which increased from 2017 to 2029, is due to PPACA, say Medicare's trustees* in their newly released summary report (the full report can be found here). The trustees essentially borrowed on the projected savings (or really anticipated cost-cutting measures) from legislated healthcare reform to extend the life of Medicare's Hospital Insurance Trust Fund specifically.

The life of Medicare's Part B service, which covers outpatient and prescriptions costs for seniors, was also extended. But the trustees' current projection on Part B assumes that the SGR-defined cut in Medicare reimbursement to physicians will kick in December 1, reports MedPage Today. The cut now stands at 23%. Congress has repeatedly voted to stall the cut but is yet to repeal the formula; to do so would add substantially to the deficit. (One healthcare expert recently predicted in the NEJM that Congress will never repeal the formula.)

The trustees' report, in some ways, is a veiled warning to those Republicans (and Republican states—lookin' at you, Missouri) who would attempt to mess legislatively with PPACA. You repeal PPACA, they might say to detractors, you doom Medicare (and Social Security) to an earlier death.

PPACA = Patient Protection and Affordable Care Act; SGR = sustainable growth rate.

* Timothy F. Geithner, Secretary of the Treasury; Kathleen Sebelius, Secretary of HHS; Hilda Solis, Secretary of Labor; and Michael J. Astrue, Commissioner of Social Security.

As predicted

, more or less, by Yale's Jack Balkin in January's NEJM, the T word is hauled out to defend the constitutionality of ObamaCare's health-insurance mandate.

In fact, in one of the many legal cases protesting the insurance mandate (and the associated penalty for not having insurance), Balkin and others rebutted with an amicus brief that argues the T point. The NYT has the story.

An expert panel of the American Academy of Neurology (AAN), the flagship organization of US neurologists, confirms the 1995 criteria for establishing brain death and has little to add on the basis of the interim literature. The panel's assessment is available in the latest issue of Neurology.

Among the findings:

1. There have been no published reports of neurologic recovery once brain death has been diagnosed by using the 1995 criteria.
2. There is insufficient evidence to define a minimal observation period for diagnosing brain death, once brain function has ceased.
3. Complex, spontaneous movements, like facial myokymia, and ventilator triggering can be seen in brain death.
4. The various tests for determining apnea have not been compared—so one test has not been shown to be preferable.
5. Data supporting the use of newer ancillary tests, like MR angiography, to confirm brain death are not sufficiently compelling.

The steps to determining brain death include the prerequisites (eg, excluding the use of CNS depressants and neuromuscular blockers, establishing a normal core body temperature and blood pressure), the clinical evaluation (eg, documenting a lack of responsiveness, assessing brainstem reflexes, performing an apnea test), and ancillary tests (eg, performing an EEG or imaging study). A useful appendix checklist is provided in the article.

In addition, the AAN web site provides a Q&A with one of the panel members, Eelco Wijdicks of the Mayo Clinic, regarding the reassessment of brain-death criteria. In addition to discussing clinical and other parameters, Dr. Wijdicks provides all-important guidance for communicating the diagnosis of brain death to the victim's family. (In my experience, a particularly difficult concept for many family members to understand is the idea that brain death equals death, both functionally and legally. Conveying this information firmly and compassionately can be a challenge.)

After the diagnosis of brain death is made, the attending physician should meet with the family, accompanied by nursing staff and, often, hospital clergy. Considerable time for conversation and a quiet place to sit are needed. The family members are told that their loved one has passed on and that the medical staff deeply regrets the loss. The family members will have ample time to say their good-byes. The medical staff will be available for support. The family, however, will have to make a decision about possible organ donation and is invited to speak with an organ donation agency. The medical staff is keeping the rest of the organs working with medication and the mechanical ventilator, and if there is no wish for organ donation, the staff will stop the ventilator and other treatments.

David Walk of the Drug and Device Law Blog performed a major takedown of the hallowed NEJM and its publication of an interview study (or "study," depending on your perspective) of successful anti-pharma whistleblowers, which was also criticized 2 weeks ago at this blog.

Walk correctly assails the authors' methodology, or lack thereof; their inherent bias in only interviewing prevailing whistleblowers; and findings (or "findings") that might be found in any lazy magazine piece—like, "a typical day could be meeting an FBI agent in a parkway rest stop. Sitting in his car with the windows rolled up. Neither heat nor air conditioning."

Neither heat nor air conditioning? Walk's pithy response: "Wow."

Another wry criticism of the authors' findings: Questioning how some whistleblowers "accidentally" "fell into the qui tam process." Walk responds, "As lawyers, we know it’s pretty hard to file a lawsuit accidentally," and "Try that argument at home to excuse some dumb thing you did."

And if it truly, really, verily isn't about the money, as the interviewed whistleblowers would like us to believe, then revamp the whole process. Walk logically concludes,

Then the qui tam system urgently needs revision. We're wasting millions that could be benefiting us as taxpayers. Obviously, these relators didn’t need the millions of dollars they received to motivate them to bring qui tam lawsuits. All that money can go back to the taxpayers or, better yet, our clients, the pharmaceutical companies.

Last Walk snipes at the authors' conclusion that the qui tam system should be revamped on the basis of their interviews.

What a great idea – deciding important public policy questions based only on a few interviews of one of many interested groups. Maybe someone will follow this NEJM-approved "scientific" approach to public policymaking and make serious proposals to reform the nation’s regulation of doctors based solely on 30 to 45 minute interviews of 26 successful medical malpractice plaintiffs.

Image of Saint Sebastian by Guido Reni from Wikipedia.

Monday the Drug and Device Law Blog cited a new lawsuit in the "Judicial Hellhole," Madison County, Illinois (and you know how the DDLB feels about Judicial Hellholes). The suit, covered by the Madison and St. Clair Record* and filed by 19 plaintiffs "from across the country," alleges that Novartis, CIBA, and Sandoz failed to warn African Americans of their genetically increased risk of Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin disorders during carbamazepine therapy (brand name, Tegretol; abbreviated CBZ). The plaintiffs are represented by Christopher Cueto of neighboring St. Clair county, the brother of controversial circuit court judge Lloyd A. Cueto and the disbarred Amiel Cueto.

In clumsy language, the suit stipulates, according to the Record:

"Defendants knew or should have known a significant portion of deaths and severe side effects, described herein, resulted from carbamazepine products have included African American persons and children who were found to have increased risks of carbamazepine SJS and TEN in the medical literature..."

And,

"Different races, such as African Americans, Hispanics, native Indians, Asians and Caucasians, face an increased risk of developing SJS and TEN because of their genetics. African Americans and Asians remain especially prone to developing the life-threatening skin conditions because of a gene they have a tendency to carry."

The paper also outlines the long, "storied" history of Tegretol's approval, which is evidently solely based on what's written in the complaint.

Problem is: While there are compelling data linking CBZ-induced SJS and TEN in southeast Asians and the presence of the HLA-B*1502 genetic allele, to my knowledge, there are no comparable data in African Americans, persons of African descent, or black Africans. Nor are there comparable data for Hispanics or Native Americans. In fact, published data indicate a negligible or extrememly low rate of the HLA-B*1502 allele in these non-Asian ethnic groups.

The HLA-B*1502 link was first made in 2004 in the journal Nature. Taiwanese investigators showed an astronomical association between the allele and CBZ-related SJS and TEN in Han Chinese (see also, Hung et al). The link was also subsequently found in a Thai population and, to a much lesser extent, in East Indians. The HLA-B*1502 allele, however, does not appear to be a risk factor for SJS/TEN in Caucasians.**  

In other words, the allele is neither necessary nor sufficient for the development of CBZ-related skin disorders: meaning that persons who don't carry the allele can develop SJS and TEN, and persons with the allele don't always develop drug-induced skin disorders. Also an association between HLA-B*1502 and severe skin disorders with other anticonvulsants (eg, oxcarbazepine, phenytoin) was recently reported in Han Chinese.

In December 2007, the FDA issued an alert, informing physicians of the link between HLA-B*1502 and CBZ-induced SJS or TEN. The agency reported, "This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians." Genetic testing was advised in "[p]atients with ancestry from areas in which HLA-B*1502 is present," before starting treatment with CBZ. However, "[p]atients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502," the FDA advised. Labeling for CBZ products was accordingly changed with black-box warnings.

Also according to the FDA in 2007, the frequency of the HLA-B*1502 allele in ethnic populations is as follows.

• Chinese, Thai, Malaysians, Indonesians, Filipinos, Taiwanese: 10%-15%
• Other southeast Asians, including Indians: 2%-4%
• Japanese, Koreans: <1%

In 2008, Ferrel and McLeod updated the frequencies of the HLA-B*1502 allele in various Asian and North American populations. Attorney Cueto is evidently hanging his hat on a 0.2% allele rate in African Americans, which hardly constitutes a "tendency." (One at least hopes that the plaintiffs have been tested for the allele.) Curiously enough, Native Americans, who are most likely to have at least a remote Asian ancestry, show a negligible frequency.

Continent	Population/Ethnicity	Allele Frequency (%)	N
Asia	Singapore	11.6	86
	Han Chinese	10.2	572
	Malay	8.4	101
	Thai	6.1	99
	Filipino	5.3	94
	India Khandesh Pawra	6	50
	India North Hindi	2	91
	India Mumbai Marathas	1	72
	Korean	0.5	200
North America	Asian	5.1	396
	African	0.2	251
	European	0	287
	Hispanic	0	240
	Native American	0	235

* Which, by the way, reports that "Pharmaceuticals failed to warn African Americans of drug's dangers" (italics added).

** Nor does the allele increase the risk of maculopapular exanthema in Han Chinese.

Image of bottom-feeding channel catfish from Wikipedia.

Successful whistleblowers in qui tam suits against pharma weren't in it for the money. At least that's what they say in hindsight, according to a newly published interview study of 26 such "relators" in the NEJM. (Did anybody expect them to admit otherwise?) The semi-structured study was conducted by investigators at Harvard and the University of Melbourne, one of whom (Kesselbaum) has served as an expert witness in litigation against Merck.*

The 26 interviewed relators, who received a median of $3 million ($100,000-$42 million), were reportedly motivated by their senses of justice, altruism, or integrity, according to the study. In other cases, whistleblowing was viewed as a way to avert possible future accusations of engaging in illegal activity (eg, off-label promotion). They also cited heavy personal and professional costs during the qui tam investigation and litigation.

However, one sentence in the NEJM article, in particular, suggests that whistleblowers are at least initially motivated by the prospect of a financial windfall and don't accurately anticipate the direct and indirect costs of the qui tam process. In a concluding statement to the section, "Settlement and Life Afterward," the authors report the relators' advice to would-be whistleblowers:

Some offered strategic suggestions, such as hiring an experienced personal attorney, and many suggested a need to mentally prepare for a process more protracted, stressful, and conflict-ridden, and less financially rewarding, than prospective whistle-blowers might expect.

The authors also note that if the Justice Department decides to intervene in whistleblowers' qui tam suits, almost all result in settlements or judgments against the pharma defendant. So once the DoJ picks up a case, it's highly unlikely that the whistleblower would decide to back out, whatever the upfront headaches.

* Related to the alleged improper promotion of Vioxx.

Image of Saint Sebastian by Guido Reni from Wikipedia.

Addendum: In a highly revealing statement, one interviewee "likened his large settlement to 'hitting the lottery,'" which, as we all know, has the sole upfront cost of forking over a buck or two for a ticket.