healthy4u: Mylan

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

Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the manag...

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Mylan Settles, Merck KGaA Pays the Fine

The<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> parade of legal settlements</a> involving large health care organizations accused of wrong-doing just gets more and more crowded.  Here is the latest, <a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/breaking/s_714910.html#">courtesy</a> the Pittsburgh Tribune-Review: <blockquote>Mylan Inc., a generic-drug manufacturer in Cecil, agreed to a $280 million settlement of allegations that its Dey Inc. specialty-drug subsidiary cheated the government out of millions of dollars by reporting falsely inflated payments for several drugs, the Justice Department said. 'The government paid millions of claims for far greater amounts than it would have if Dey had reported truthful prices,' the Justice Department said. Mylan acquired Dey when it purchased Merck KGaA's generic-drug business in October 2007 for $6.8 billion. The government's action began before Mylan acquired Dey. Dey said in a statement that Merck KGaA is responsible for paying the full amount of this settlement as well as all costs and other expenses associated with pending and future related Medicare and Medicaid reimbursement lawsuits involving Dey.</blockquote> It all gets so tiresome, doesn't it. However, before one starts yawning, remember how such settlements are markers of the prevalence of bad behavior by major health care organizations. The continuing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of settlements</a> thus is a big clue that there is something very rotten going on in health care, that the leadership of health care is increasingly amoral, greedy, and lawless. Here again is our generic statement on the phenomenon:  As in many previous cases, note that the monetary cost of the above settlement, while it seems large to normal humans, would be just slightly more than round-up error for a large multi-national company.  As I have said repeatedly,  penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  As long as the bad behavior continues, expect health care costs to continue to rise, while access falls, and quality suffers.  True health care reform requires accountability, integrity, and transparency of health care organizational leadership.

Mylan Settles, Merck KGaA Pays the Fine

The parade of legal settlements involving large health care organizations accused of wrong-doing just gets more and more crowded. Here is...

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