healthy4u: US Department of Justice

Health Care Revolving Door Roundup

Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the management of large health care organizations.  One mechanism for this is the "revolving door," the constant interchange of personnel between government agencies and corporate management.  Here is a list of some of this year's interesting cases of people transiting the revolving door between US government agencies that are supposed to regulate health care organizations or enforce the relevant laws and the organizations subject to these regulations and laws.   Note that this list may not be complete.  It is difficult to keep track of these transitions.  Leader of Health Care Fraud Section of Philadelphia US Attorney's Office to Teva Pharmaceuticals <a href="http://www.mainjustice.com/2013/03/03/former-health-care-fraud-chief-in-philly-joins-teva-pharmaceuticals/">Via</a> MainJustice.org in March, 2013, <blockquote class="tr_bq">John Pease, who led the government and health care fraud section in the U.S. Attorney's Office in Philadelphia, has left the Justice Department for a job with a pharmaceutical company. Pease, 45, is a new senior counsel at Teva Pharmaceuticals, where he oversees government investigations of the company for the Americas.  'I was just ready to try something different,' Pease said in an interview.</blockquote>  Leader of US Department of Justice Fraud Section in Charge of Health Care Issues to Law Firm as Defender of Companies and Senior Executives The initial notice again was <a href="http://www.mainjustice.com/2013/03/25/health-care-fraud-unit-chief-sheldon-joins-quinn-emanuel/">via</a> MainJustice.org in March, 2013 <blockquote class="tr_bq">Sam Sheldon, the deputy chief in the Criminal Division's Fraud Section who oversaw health care fraud prosecutions, is leaving the Justice Department to join Quinn Emanuel Urquhart & Sullivan LLP.</blockquote> Mr Sheldon's new job was made clear on the firm's <a href="http://www.quinnemanuel.com/attorneys/sheldon-sam-s.aspx">website</a>, <blockquote class="tr_bq">Sam Sheldon is head of the firm’s Health Care Practice Group.  He is a trial lawyer who represents companies and senior executives in litigation before the United States federal government including Department of Justice and Department of Health and Human Services, and other law enforcement and regulatory agencies.</blockquote> FDA Deputy Commissioner for Global Regulatory Operations and Policy to Mylan This <a href="http://www.reuters.com/article/2013/04/30/us-mylan-fda-idUSBRE93T12D20130430">story,</a> in April, actually made it (briefly) to Reuters, <blockquote class="tr_bq"> n">Generic drugmaker Mylan Inc said on Tuesday it hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.</blockquote> Leader of Health Care Fraud Enforcement of Philadelphia US Attorney's Office to Law Firm as Industry Defender <a href="http://www.bloomberg.com/news/2013-08-07/morrison-foerster-vinson-elkins-cravath-business-of-law.html">From Bloomberg</a>, in August, 2013, <blockquote class="tr_bq">Marilyn May, a False Claims Act litigator at the U.S. Justice Department, joined Arnold & Porter<a href="http://topics.bloomberg.com/arnold-%26-porter/"></a> LLP’s Washington office as litigation counsel with a focus on healthcare, pharmaceutical and medical device industry defense work.  May was the head of healthcare fraud enforcement in the U.S. Attorney’s Office in the Eastern District of Pennsylvania. She coordinated healthcare fraud cases and investigations as well as handled False Claims Act cases involving pharmaceutical and medical device companies, hospitals, nursing homes and other healthcare providers, the firm said. </blockquote> The law firm's <a href="http://www.arnoldporter.com/professionals.cfm?action=view&id=6531">website</a> states, <blockquote class="tr_bq"> Her litigation practice focuses on pharmaceutical, medical device and healthcare defense matters.</blockquote> Summary In each of these cases, a person with responsibility for regulation of and/or law enforcement for health care organizations went through the revolving door to either work for health care corporations subject to such regulation and/or law enforcement, or work for legal firms that specialize in defending such corporations and their leaders in regulatory and law enforcement actions. As far as I know, none of these instances was the least bit illegal.  However, like previous examples of the revolving door, they raise the concern that people in government regulation or law enforcement who think that they may have future lucrative job prospects helping health care organizations attenuate regulation and law enforcement may not be the most enthusiastic, aggressive, or persistent regulators or law enforcers.  Why would one want to upset one's future employer? While these cases of the revolving door are legal, they are clearly conflicts of interest in the sense that the prospect of such future employment likely may increase the risk of compromising a government official's devotion to serving the public and enforcing the law, if not in the legal sense.  In some particular case, the revolving door may actually lead to corruption according to the Transparency International definition, abuse of entrusted power for private gain, if not according to the legal definition.  Thus the continuing occurrence of government officials blithely transiting the revolving door no doubt was a reason that more than 40% of the public consider the US health care sector to be corrupt (see <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">this post</a>.) True health care reform would require curtailing the severe sorts of conflicts of interest created by the revolving door.  This might require both improving pay and working conditions for government regulators and law enforcers, and specific laws to prevent immediate transitions from being a regulator/ law enforcer to handling corporate responses to or defenses of such regulation and enforcement. Of course, I can already hear the protests of those people who decry paying more for government or increasing government regulation.  I can at least hope that the protests are not from those who personally profit from the current seemingly corrupt system.

Health Care Revolving Door Roundup

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07 Aug 2013

The Myth of the Tough Prosecutor as a Distraction from Health Care Corporate Executives' Impunity

The tragic case of the Boston Marathon bombing illustrates how myth making about tough law enforcement obscures the impunity enjoyed by top health care executives. A "Tough to a Fault" Prosecutor A recent Reuters<a href="http://www.reuters.com/article/2013/04/22/us-usa-explosions-prosecutor-idUSBRE93L00X20130422"> article</a> touted the toughness of the prosecutor who will take on the case of the surviving accused Boston terrorist: <blockquote class="tr_bq">As the top federal law enforcer in Massachusetts, U.S. Attorney Carmen Ortiz has taken heat for being tough to a fault and coming down too hard on some defendants. But as she builds a possible death penalty case against suspected Boston Marathon bomber Dzhokhar Tsarnaev, 19, the unflinching approach that earned her opponents in the past could become a legal asset for the biggest case of her career, said attorneys who have faced off against her. 'The criticism lately has been that they've over-charged some people and been overly harsh,' said Peter Elikann, a Boston defense attorney.'I don't think that's relevant for Tsarnaev because no one is going to accuse any prosecutor of making too big a deal out of this case.'</blockquote> Similarly, an<a href="http://www.businessweek.com/news/2013-04-23/marathon-bomb-prosecutor-seen-as-ready-for-marquee-case"> article</a> in Bloomberg included this: <blockquote class="tr_bq">Ortiz’s former bosses insist that she’s ready for her moment on the big stage. 'She’s tough-minded and exceptionally professional,' [former Massachusetts Attorney General Scott] Harshbarger said. </blockquote> One of the cases cited as an example of Ms Ortiz's toughness was her prosecution of electronic information freedom activist Aaron Swart.  As Rueters noted, <blockquote class="tr_bq">One of Ortiz's best-known cases to date was her prosecution of Aaron Swartz on wire fraud and hacking allegations for downloading millions of articles from an academic database. Swartz, a 26-year-old computer prodigy, hanged himself in his Brooklyn, New York, apartment in January, prompting friends and family to partly blame Ortiz's prosecution for his death.</blockquote> At the time, Ms Ortiz was criticized for being unreasonably harsh, but then as now toughness was touted as her style. Not So Tough on Corporate Crime However, as we <a href="http://hcrenewal.blogspot.com/2013/01/the-tragic-case-of-aaron-swartz-unequal.html">pointed out then</a>, while Ms Ortiz was noted for being tough on individuals accused of various offenses, she was notably not so tough on individuals involved in alleged corporate health care wrong doing. In particular, as we wrote before, Ms Ortiz was involved in three settlements of notably bad behavior by large health care corporations, none of which involved prosecution of, or any penalties for the individuals at the corporations who authorized, directed or implemented the bad behavior. Forest Pharmaceuticals In September, 2010, how Ms Ortiz led the pursuit of a settlement with Forest Pharmaceuticals became apparent (look <a href="http://hcrenewal.blogspot.com/2010/09/forest-pharmaceuticals-pleads-guilty-to.html">here</a>).   The company was accused of promoting its anti-depressant Celexa for use in adolescents and children.  Such drugs have since been shown to increase the risk of suicide by such young patients, and this drug was only approved for adults.  At the time, Ms Ortiz said, "Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public."  Although the offense may have lead to use of the drug by many adolescents and children, and hence may have lead to some of them attempting or committing suicide, the case was settled only with fines.  As is usual in such legal settlements, no individual corporate executive who authorized or lead the off-label and potentially dangerous marketing of the drug was arrested, or accused, and none suffered any negative consequences. GlaxoSmithKline In October, 2010, how Ms Ortiz led the pursuit of a settlement with GlaxoSmithKline became apparent (look <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">here</a>.)  The company was accused of selling drugs that were not what they appeared to be, apparently because the wrong drugs were put in labelled containers.  Obviously, taking one drug, like Paxil, GSK's anti-depressant which has a number of known adverse effects, including suicide risk for adolescents and children as noted above, when a patient is supposed to be taking a wholly different drug could lead to patient harm.  At that time, Ms Ortiz said, "We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers."   Again, while the settlement involved a guilty plea by a GSK subsidiary, again no individual corporate executive who had authority over the drug manufacturing was arrested or accused, much less suffered any negative consequences. St Jude Medical In January, 2011, Ms Ortiz led the pursuit of a settlement with St Jude Medical (look <a href="http://hcrenewal.blogspot.com/2011/01/st-jude-medical-settles-again.html">here</a>).  The company was accused of paying kickbacks to doctors to implant its cardiac defibrillators (ICDs) and pacemakers.  Obviously, providing kickbacks to doctors may have lead them to plant devices in patients who did not really need them, yet the devices and the implantation procedures can have adverse effects.  At that time, Ms Ortiz said, "The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product."  Again, as is usual, the settlement did not require any executive who authorized or directed the activities leading to the kickbacks suffered any negative consequences. Despite this, note that Bloomberg in its recent coverage of the Tsarnaev prosecution even tried to make Ms Ortiz failure to hold any individuals accountable for this health care corporate misbehavior seem like tough prosecution. <blockquote class="tr_bq">The office has been a leader in health-care fraud prosecutions, securing $4 billion in civil and health-care recoveries in 2012. Those included a $3 billion payment from GlaxoSmithKline Plc (GSK), which pleaded guilty to charges that it illegally promoted prescription drugs. </blockquote> Again, note that apparently being a "leader" in health care fraud prosecution involved pushing for big fines to be paid by the corporations involved in actions that may have harmed many patients, but no punishment for  the individuals who may have authorized, directed or implemented the bad behavior, but being "tough" on Aaron Swartz involved pushing for a long imprisonment of someone whose alleged crime was not violent, and did not result in anyone being hurt. Summary As we have noted again and again and again, leaders of large health care organizations, particularly the largest health care corporations, seem to enjoy virtual impunity.  No matter how bad the behavior of the corporations which they are supposed to be leading, and no matter whether such behavior might have harmed patients, they almost never have to face any negative consequences, especially not fines they must pay themselves, much less prison time.  We have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">documented many legal settlements</a> of often egregiously bad alleged behavior that did not involve any penalties for top corporate leaders. One way corporate leaders thus escape accountability seems to be the cultivation of myths that distract the public from what is going on.  One such urban legend seems to be the toughness of government prosecutors.  If prosecutors are believed to be uniformly tough and uncompromising, then the public may be lead to believe either that they are tough and uncompromising on corporate crime    As we have said repeatedly, true health care reform would require making the leaders of health care organizations accountable, especially for the effects of their actions on patients' and the public's health.

The Myth of the Tough Prosecutor as a Distraction from Health Care Corporate Executives' Impunity

The tragic case of the Boston Marathon bombing illustrates how myth making about tough law enforcement obscures the impunity enjoyed by top health care executives.A "Tough to a Fault" ProsecutorA rece…

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25 Apr 2013

The Tragic Case of Aaron Swartz: Unequal Justice for Web Activists vs Health Care Corporate Executives

The recent tragic case of the suicide of Aaron Swartz raises many issues, and has inspired an outpouring of news coverage and internet discussion.  Yet one issue it should raise that has not received much notice so far is that of how individuals and top executives are treated differently before the law. Summary of the Case Aaron Swartz was a prodigy who <strike>developed</strike>  helped develop the RSS system for disseminating updates on web-site contents, and who helped develop the Reddit web-site.  He was an advocate for information freedom, and more broadly, <a href="http://www.nakedcapitalism.com/2013/01/aaron-swartzs-politics.html">according to</a> Matt Stoller, "a political activist interested in health care, financial corruption, and the drug war."  Furthermore, he "recognized that politics is a corrupt money driven system, but also that it could be cracked if you spent the time to understand the moving parts." Although apparently very well known among internet activists and computer scientists, Mr Swartz did not attract a lot of mainstream media attention, at least until 2011 when he was arrested "on a series of felony counts including wire fraud, computer fraud, unlawfully obtaining information from a protected computer and recklessly damaging a protected computer," <a href="http://www.nytimes.com/2011/07/25/business/media/aaron-swartzs-web-activism-may-cost-him-dearly.html">according to the New York Times</a>.  His alleged crime was that he downloaded thousands of scientific scholarly articles from the site JSTOR, and was accused of intending to make them publicly available for free.  Note that the articles were already publicly available, but only online through expensive subscriptions.  At the time, the US Department of Justice took this to be a very serious crime: <blockquote class="tr_bq">'Stealing is stealing, whether you use a computer command or a crowbar, and whether you take documents, data or dollars,' the United States attorney for Massachusetts, Carmen M. Ortiz, said last week in a statement about the case. 'It is equally harmful to the victim whether you sell what you have stolen or give it away.' </blockquote> The charges Ms Ortiz filed lead to Mr Swartz's arrest <blockquote class="tr_bq">on a series of felony counts including wire fraud, computer fraud, unlawfully obtaining information from a protected computer and recklessly damaging a protected computer. If convicted on all counts, the Justice Department said he could face up to 35 years in prison and $1 million in fines. </blockquote> Yet Mr Swartz certainly was not accused of either violence or of planning to personally profit from his alleged crimes.  At the time of his arrest, the severity of the allegations baffled many: <blockquote class="tr_bq"> 'This makes no sense,' said David Segal, executive director of Demand Progress, an organization Mr. Swartz founded to rally support online for an open Internet. 'It’s like trying to put someone in jail for allegedly checking too many books out of the library.'</blockquote> JSTOR got the hard drives that contained the articles in question back from Mr Swartz, and planned no further action: <blockquote class="tr_bq">Asked if it was pleased that someone misusing the service could be brought to justice, a spokeswoman for Jstor wrote in an e-mail response: 'We wanted the content back, and we were able to secure it and ensure it wasn’t distributed. We were not interested in further legal action around this incident. We have no comment on the prosecution or how they have chosen to characterize it.'</blockquote> Since 2011 the case got little notice until Mr Swartz ended his own life this month.  After his death, his family and partner issued a statement, as <a href="http://www.guardian.co.uk/technology/2013/jan/13/aaron-swartz-family-mit-government">reported by the Guardian</a>: <blockquote class="tr_bq">In a statement released late Saturday, Swartz's parents, Robert and Susan, siblings Noah and Ben and partner Taren Stinebrickner-Kauffman said the Reddit<a href="http://www.guardian.co.uk/technology/reddit" title="More from guardian.co.uk on Reddit">t</a> builder's demise was not just a 'personal tragedy' but 'the product of a criminal justice system rife with intimidation and prosecutorial overreach'. They also attacked the Massachusetts Institute of Technology (MIT) for not supporting the internet activist in his legal battles and refusing to stand up for 'its own community's most cherished principles'.</blockquote> And according to the New York Times <a href="http://www.cnbc.com/id/100376112">(via CNBC</a>), Harvard Professor Larry Lessig, Director of the Safra Center for Ethics, where Swartz had been a fellow protested <blockquote class="tr_bq">the idea that he could have seen serious prison time was infuriating. Lawrence Lessig, the Harvard Law professor who founded Creative Commons to advocate greater sharing of creative material online, called the prosecution's case absurd and said that boxing in Mr. Swartz with an aggressive case and little ability to mount a defense ''made it make sense to this brilliant but troubled boy to end it.'</blockquote>  Hounding Swartz but Failing to Pursue Health Care Corporate Executives The Daily Beast just ran <a href="http://www.thedailybeast.com/articles/2013/01/15/aaron-swartz-s-unbending-prosecutors-insisted-on-prison-time.html">a story</a> that suggests that Swartz should have known better to have done something that would have attracted the wrath of one of the toughest federal prosecutors, but one who is also a "liberal's dream."  It opened its piece on US Attorney Carmen Ortiz thus: <blockquote class="tr_bq"> Until she was accused of driving the 26-year-old cyber wunderkind and public-access activist Aaron Swartz<a href="http://www.thedailybeast.com/articles/2013/01/13/mourning-aaron-swartz-internet-activist-and-free-information-advocate.html"></a> to suicide<a href="http://www.thedailybeast.com/articles/2013/01/14/aaron-swartz-s-thought-crime-was-tragically-treated-like-real-crime.html"></a>, the top federal prosecutor in Massachusetts was a liberal’s dream.  Not for nothing was United States Attorney Carmen Ortiz championed by the late Sen. Edward Kennedy and appointed by President Obama nearly four years ago.</blockquote> Then, it suggested how tough Ms Ortiz really is: <blockquote class="tr_bq">She is Hispanic and was raised in a New York housing project, and after her husband died of cancer she raised two daughters on her own. She has taken on political corruption, and she has been so aggressive against white-collar crime that her office collected more in forfeitures and fines than any other jurisdiction in the country. <div class="text parbase section"></div><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="body_text3" style="visibility: hidden;"></a>Her avowed motive in becoming a prosecutor was because 'there’s a greater chance for justice.'</blockquote> that is a pretty amazing summary.  However, it seems decidedly at odds with Ms Ortiz's record dealing with misdeeds by health care corporations, as discussed on<a href="http://hcrenewal.blogspot.com/"> Health Care Renewal</a>.  Ms Ortiz, whose harsh views of Swartz appear above, has been quoted at least three times about three different cases on this blog.  In all instances, her quotes were in the context of legal settlements she made with large health care corporations. Forest Pharmaceuticals In September, 2010, how Ms Ortiz led the pursuit of a settlement with Forest Pharmaceuticals became apparent (look <a href="http://hcrenewal.blogspot.com/2010/09/forest-pharmaceuticals-pleads-guilty-to.html">here</a>).   The company was accused of promoting its anti-depressant Celexa for use in adolescents and children.  Such drugs have since been shown to increase the risk of suicide by such young patients, and this drug was only approved for adults.  At the time, Ms Ortiz said, "Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public."  Although the offense may have lead to use of the drug by many adolescents and children, and hence may have lead to some of them attempting or committing suicide, the case was settled only with fines.  As is usual in such legal settlements, no individual corporate executive who authorized or lead the off-label and potentially dangerous marketing of the drug was arrested, or accused, and none suffered any negative consequences. GlaxoSmithKline In October, 2010, how Ms Ortiz led the pursuit of a settlement with GlaxoSmithKline became apparent (look <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">here</a>.)  The company was accused of selling drugs that were not what they appeared to be, apparently because the wrong drugs were put in labelled containers.  Obviously, taking one drug, like Paxil, GSK's anti-depressant which has a number of known adverse effects, including suicide risk for adolescents and children as noted above, when a patient is supposed to be taking a wholly different drug could lead to patient harm.  At that time, Ms Ortiz said, "We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers."   Again, while the settlement involved a guilty plea by a GSK subsidiary, again no individual corporate executive who had authority over the drug manufacturing was arrested or accused, much less suffered any negative consequences. St Jude Medical In January, 2011, Ms Ortiz led the pursuit of a settlement with St Jude Medical (look <a href="http://hcrenewal.blogspot.com/2011/01/st-jude-medical-settles-again.html">here</a>).  The company was accused of paying kickbacks to doctors to implant its cardiac defibrillators (ICDs) and pacemakers.  Obviously, providing kickbacks to doctors may have lead them to plant devices in patients who did not really need them, yet the devices and the implantation procedures can have adverse effects.  At that time, Ms Ortiz said, "The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product."  Again, as is usual, the settlement did not require any executive who authorized or directed the activities leading to the kickbacks suffered any negative consequences. So in summary, in three major cases involving unethical practices by big health care corporations that could have put patients at risk, US Attorney Carmen Ortiz provided strong words, but did not apparently seek any punishment of any form of any of the corporate leaders who authorized or directed the bad, and potentially dangerous behavior.  Yet in the sorry case of Aaron Swartz, Ms Ortiz charged a gifted computer activist whose alleged crimes certainly did not put any individuals at risk of adverse medical effects or any bad physical outcomes with crimes that if proven would have lead to years in jail and millions in fines for him as an individual. Equal Justice Under the Law? So it seems ironic, or worse, that the main narrative of the Swartz case has become: well meaning but reckless hacker versus implacably tough law enforcer.  As noted above, Ms Ortiz's office appeared anything but tough when dealing with misdeeds by big pharmaceutical and device companies.  So the real question is why she went after Mr Swartz so relentlessly, when his alleged crime was non-violent and physically hurt nobody, when she failed to pursue corporate executives who enriched themselves while leading companies whose unethical practices likely harmed a lot of patients. In that light, the dark imaginings of Matt Stoller do not seem so far-fetched.  On Naked Capitalism he <a href="http://www.nakedcapitalism.com/2013/01/aaron-swartzs-politics.html">wrote</a>, <blockquote class="tr_bq"> As we think about what happened to Aaron, we need to recognize that it was not just prosecutorial overreach that killed him. That’s too easy, because that implies it’s one bad apple. We know that’s not true. What killed him was corruption. Corruption isn’t just people profiting from betraying the public interest. It’s also people being punished for upholding the public interest. In our institutions of power, when you do the right thing and challenge abusive power, you end up destroying a job prospect, an economic opportunity, a political or social connection, or an opportunity for media. Or if you are truly dangerous and brilliantly subversive, as Aaron was, you are bankrupted and destroyed.</blockquote> I did not know Aaron Swartz, but am very sorry that we have lost someone so intelligent and imaginative.  I hope one question that his untimely death raises is what has become of the idea of equal justice under the law, and how its apparent demise has enabled the dysfunction of our health care system, and our whole society.

The Tragic Case of Aaron Swartz: Unequal Justice for Web Activists vs Health Care Corporate Executives

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15 Jan 2013

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