Health Giant Sutter Destroys Evidence In Crucial Antitrust Case Over High Prices

khn
Chad Terhune November 17, 2017
Sutter Health intentionally destroyed 192 boxes of documents that employers and labor unions were seeking in a lawsuit that accuses the giant Northern California health system of abusing its market power and charging inflated prices, according to a state judge.

In a ruling this week, San Francisco County Superior Court Judge Curtis E.A. Karnow said Sutter destroyed documents “knowing that the evidence was relevant to antitrust issues. … There is no good explanation for the specific and unusual destruction here.”

Karnow cited an internal email by a Sutter employee who said she was “running and hiding” after ordering the records destroyed in 2015. “The most generous interpretation to Sutter is that it was grossly reckless,” the judge wrote in his 12-page ruling.

Sutter, which has 24 hospitals and nearly $12 billion in annual revenue, said the destruction was a regrettable mistake.

Employers and policymakers across the country are closely watching this legal fight amid growing concern about the financial implications of industry consolidation. Large health systems are gaining market clout and the ability to raise prices by acquiring more hospitals, outpatient surgery centers and physician offices.

“It’s stunning what Sutter did to cover up incriminating documents in this case,” said Richard Grossman, the lead plaintiffs’ lawyer representing a class of more than 1,500 employer-funded health plans.

In April 2014, a grocery workers’ health plan sued Sutter and alleged it was violating antitrust and unfair competition laws. The plaintiffs began requesting documents related to contracting practices, such as “gag clauses” that prevent patients from seeing negotiated rates and choosing a cheaper provider and “all-or-nothing” terms that require every facility in a health system to be included in insurance networks.

Sutter disputes the broader allegations in the lawsuit over its market conduct and said its charges are in line with its competitors’.

The judge said that in 2015 Melissa Brendt, Sutter’s chief contracting officer in the managed-care department, and an assistant general counsel, Daniela Almeida, authorized Brendt’s executive assistant to destroy 10 years’ worth of managed-care documents going back to 1995. The company earlier had scheduled the documents to be destroyed in 2035 — 20 years later.

The executive assistant, Sina Santagata, testified in a deposition she wasn’t aware of any other time in her 17 years at Sutter when the managed-care department destroyed records held in storage.

In his Nov. 13 ruling against Sutter, the judge singled out an email by Santagata as “particularly noteworthy.”The executive assistant emailed Brendt, the chief contracting officer, on July 30, 2015, after sending the order to destroy the records. She wrote, “I’ve pushed the button … if someone is in need of a box between 3/15/95 & 11/23/05 … I’m running and hiding. … ‘Fingers crossed’ that I haven’t authorized something the FTC will hunt me down for.”

The Federal Trade Commission (FTC) enforces antitrust laws in health care to prevent hospitals, drugmakers and other industry players from engaging in anti-competitive behavior that could harm consumers.

Santagata testified that she was being “sarcastic” in her email, and Sutter told the judge that the FTC reference was just a “joke.”

Karnow saw no humor in it. “There are infinite topics for jokes, and the choice of this one is strong evidence” in the plaintiffs’ favor, he wrote in his order Monday.

As part of his sanctions against Sutter, the judge ordered the health system to examine email backup tapes covering 2002 through 2005 to search for documents on some of the same topics as the destroyed records. Also, Karnow said he will consider a plaintiffs’ motion for issuing jury instructions that are adverse to Sutter in light of the document destruction. The trial is scheduled for June 2019.

“The record shows that Sutter’s conduct was more than just an inadvertent error,” Karnow wrote.

Sutter spokeswoman Karen Garner said the incident was a “mistake made as part of a routine destruction of old paper records” and the Sacramento-based health system disclosed the error as soon as it was discovered.

“We regret that as part of a routine archiving process we failed to preserve some boxes of decades-old hard-copy documents,” Garner said.

The United Food and Commercial Workers and its Employers Benefit Trust initially filed the case against Sutter in 2014. The joint employer-union health plan represents more than 60,000 employees, dependents and retirees. The court certified the case as a class action in August, allowing hundreds of other employers and self-funded health plans to potentially benefit from the litigation.

In addition to its 24 hospitals, Sutter’s nonprofit health system has 35 surgery centers and more than 5,000 physicians in its network. It reported $11.9 billion in revenue last year and income of $554 million.

Grossman, the plaintiffs’ counsel, said he welcomed the judge’s ruling. But he said much of the evidence is irreplaceable, particularly handwritten notes from negotiating sessions and meetings involving key Sutter executives.

He said those records covered a critical period in the early 2000s when there was a “sea change in Sutter’s contracting strategy” and it implemented provisions that insulated the health system from price competition.

“This was groundbreaking in the industry,” Grossman said. “Until we address the anti-competitive behavior of entities like Sutter, we will not solve the problem of high costs in health care.”

The plaintiffs are seeking to recover hundreds of millions of dollars from Sutter from what it claims are illegally inflated prices. The lawsuit alleges that an overnight hospital stay at Sutter hospitals in San Francisco or Sacramento costs at least 38 percent more than a comparable stay in the more competitive Los Angeles market.

A study published last year found that hospital prices at Sutter and Dignity Health, the two biggest hospital chains in California, were 25 percent higher than at other hospitals around the state. Researchers at the University of Southern California said the giant health systems used their market power to drive up prices — making the average patient admission at both chains nearly $4,000 more expensive.

“Sutter is a pretty extreme case of market power, but health care consolidation has become a really important issue across the country,” said Kathy Hempstead, a health care researcher at the Robert Wood Johnson Foundation. “It’s been on the back burner somewhat because of the debate over the Affordable Care Act, but there is bipartisan interest in tackling this.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Chad Terhune: cterhune@kff.org, @chadterhune


Thank You Mr Terhune and Kaiser Health News

Aetna's $37 Billion Takeover of Humana Blocked by Judge

bloomberg

by
David McLaughlin ,
Zachary Tracer , and
Andrew M Harris
January 23, 2017, 11:43 AM EST January 23, 2017, 1:42 PM EST

Deal would hurt competition among insurers, judge rules

Aetna, on hook for $1 billion break-up fee, considers appeal 


Here's the Ruling.

Aetna Inc.’s $37 billion deal to buy rival insurer Humana Inc. was blocked by a federal judge, thwarting one of two large mergers that would reshape the U.S. health-care landscape. Aetna said it was considering an appeal.

The transaction would violate antitrust laws by reducing competition among insurers, U.S. District Judge John D. Bates in Washington ruled on Monday. Under the terms of the merger agreement, Aetna owes Humana a $1 billion breakup fee.

The ruling is a victory for antitrust enforcement efforts initiated by the Obama administration. It may bode poorly for the planned $48 billion merger between Anthem Inc. and Cigna Corp., which was challenged by the Justice Department and is awaiting a ruling. Shares of all four companies declined.

“If the judge blocked this deal, there is very little, if any, chance that the Anthem-Cigna deal gets cleared,” Jason McGorman, a Bloomberg Intelligence analyst, said by e-mail.

Aetna lost 2.3 percent to $119.75 at 12:56 p.m. in New York. Humana fell less than 1 percent percent to $200.05. Molina Healthcare Inc., which planned to acquire assets divested by Aetna and Humana, slumped 2.9 percent. Anthem fell 1 percent, while Cigna lost 0.5 percent.
Medicare Advantage

The government case against the Humana takeover focused on the market for private health plans for the elderly, known as Medicare Advantage. The U.S. argued that the combination of Aetna and Humana would eliminate competition between the insurers in 364 counties in 21 states and probably would drive up seniors’ premiums for Medicare Advantage plans.

Aetna countered that the Medicare market is much larger than the Justice Department claims because it includes both Medicare Advantage plans and government-administered Medicare, providing more choice for seniors than the government portrayed. The insurers also offered to sell assets to Molina Healthcare to guard against any risk to competition.

Bates sided with the government, writing that data showed there are seniors who prefer Medicare Advantage and would be unlikely to switch to original Medicare if prices for Medicare Advantage plans rose. The head-to-head competition between Aetna and Humana benefits these seniors with broader networks and lower costs, Bates said. The companies’ proposal to restore competition by selling assets to Molina was insufficient, the judge said.
‘Unpersuasive’ Rebuttal

“The companies’ rebuttal arguments are unpersuasive: Federal regulation would likely be insufficient to prevent the merged firm from raising prices or reducing benefits, and neither entry by new competitors nor the proposed divestiture to Molina would suffice to replace competition eliminated by the merger,” Bates wrote.

Aetna and Humana will probably turn to other deals to expand, said John Gorman the founder of the Gorman Health Group consultancy. They may look to acquire smaller rivals that specialize in Medicaid, such as Molina, Centene Corp. or WellCare Health Plans Inc.

“Both these companies have a ton of capital to deploy,” he said. “Medicaid is really where all the action is going to be.”

That’s because states are increasingly turning to private companies to help manage costs in the government health program for the poor, a trend that some of President Donald Trump’s health-care proposals could accelerate.
Merger Critic

The American Medical Association, which opposed the merger, applauded the judge’s decision. “Elderly patients were the big winners today,” said Andrew Gurman, the group’s president. “Aetna’s strategy to eliminate head-to-head competition with rival Humana posed a clear and present threat to the quality, accessibility and affordability of health care for millions of seniors.”

The other part of the government’s case focused on lost competition on the insurance exchanges set up under Obamacare in 17 counties in three states: Florida, Georgia and Missouri. After being sued, Aetna withdrew from those exchanges, and the U.S. asserted that the pullout was meant to avoid scrutiny by the court. Aetna’s lawyers said the withdrawal was prompted by financial losses.

Bates ultimately accepted the government’s claim, saying the pullout was designed to improve the company’s litigation position. The judge said Aetna is likely to return to the Florida market and that the merger would reduce competition there.

Aetna signaled that it may appeal. “We’re reviewing the opinion now and giving serious to consideration to an appeal after putting forward a compelling case,” T.J. Crawford, an Aetna spokesman, said. A Humana spokesman didn’t respond to a request for comment.

The Obama Justice Department thwarted several mega-mergers, including Comcast Corp.’s attempted takeover of Time Warner Cable Inc., Halliburton Co.’s deal for Baker Hughes Inc. and AT&T Inc.’s bid for T-Mobile US Inc. The Trump administration is taking over investigations into AT&T’s deal for Time Warner Inc. and Bayer AG’s proposed combination with Monsanto Co.

The case is U.S. v. Aetna Inc., 16-cv-01494, U.S. District Court, District of Columbia (Washington).

Thank You Mr McLaughlin, Mr Tracer, Mr Harris, and Bloomberg.

20 States Sue Six Drugmakers For Alleged Price Fixing

RT News

Published time: 15 Dec, 2016 20:15

Edited time: 16 Dec, 2016 13:42

Six generic drug companies, including Heritage Pharmaceuticals and EpiPen-maker Mylan NV, conspired to manipulate prices of two common drugs, 20 US states allege in a new lawsuit.

TagsHealth, Law, Medicine

 

The lawsuit, filed Thursday in US District Court for the District of Connecticut, says that the six companies — which also include Mayne Pharma, Aurobindo Pharma, Teva Pharmaceuticals, and Citron Pharma LLC — participated in price manipulation of doxycycline hyclate, an antibiotic, and glyburide, a treatment drug for diabetics, Reuters reported.

Heritage Pharmaceuticals Inc. is named as the "ring leader" of the alleged scheme. A company spokesman said any price-fixing it conducted was the responsibility of executives that no longer work for Heritage.

CT Leads 20 State Coalition Filing Federal Antitrust Lawsuit against Generic Drug Companies https://t.co/sixGI6R2iE

— AG George Jepsen (@AGJepsen) December 15, 2016

The lawsuit is connected to a larger antitrust investigation by various states and federal law enforcement of more than two dozen generic drugmakers. Most of the companies are cooperating with authorities, and charges could come by the end of 2016, Bloomberg News reported last month.

The suit alleges that drug company executives and others "entered into numerous illegal conspiracies in order to unreasonably restrain trade, artificially inflate and manipulate prices and reduce competition" for the two drugs, the New York Attorney General's Office said in a statement.

"The defendants routinely coordinated their schemes through direct interaction with their competitors at industry trade shows, customer conferences and other events, as well as through direct email, phone and text message communications," the suit alleges, according to the New York Attorney General's Office, causing "significant, harmful and continuing effects in the country’s healthcare system."

In the suit, the 20 states allege that the companies understood their actions to be illegal and took steps to cover their conduct once they became aware of investigations into their activities.

Mylan has come under fire of late for price hikes of EpiPen, a vital device for people suffering from a life-threatening allergic reaction known as anaphylactic shock, which requires immediate treatment. The company also allegedly defrauded Medicaid over its EpiPen products.

"To date, we know of no evidence that Mylan participated in price fixing," company spokeswoman Nina Devlin told Reuters.

A Teva spokeswoman said the company is currently reviewing the suit, while the other three companies did not offer comment.

In addition to New York, the states suing the companies include Connecticut, Delaware, Florida, Hawaii, Idaho, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, North Dakota, Ohio, Pennsylvania, Virginia, and Washington.

Thank You RT News.

 

Sebelius Acknowledges Tension Between Care Coordination, Antitrust Laws

Fierce Healthcare has;
Sebelius Acknowledges Tension Between Care Coordination, Antitrust Laws
April 10, 2013 | By Julie Bird

The Affordable Care Act's emphasis on coordinating and integrating healthcare can conflict with government antitrust efforts, U.S. Department of Health & Human Services Secretary Kathleen Sebelius said Monday. "There is a tight balance between a coordinated care strategy and a monopoly," Sebelius said in comments at the Harvard School of Public Health, reported Reuters, a co-sponsor of the event.

That pressure is especially acute in smaller communities, where consolidation among limited numbers of providers can "astronomically" increase prices, she said, according to Reuters. Constant federal oversight of antitrust behavior "is really appropriate," she added.

"It's great to know that the secretary of Health and Human Services recognizes that it's a real abiding tension between what the antitrust laws allow and where the Affordable Care Act is really pushing hospitals to go," Melinda Hatton, general counsel for the American Hospital Association, told Reuters.

In fact, the tension between gaining efficiencies through provider collaboration and controlling prices in a less competitive healthcare market was the subject of a General Accounting Office report issued last month at the request of Congress.

GAO found healthcare stakeholders disagreed on the effectiveness of antitrust guidance as it related to provider collaboration in three main areas: clinical integration, exclusive collaborative arrangements, and the size and scope of collaborative arrangements considered exempt from antitrust scrutiny, known as safety zones.

Meanwhile, the Federal Trade Commission continues pursuing antitrust actions against healthcare mergers it deems anticompetitive and likely to increase healthcare prices. Last month, for example, the FTC sued to prevent Idaho's largest hospital group from acquiring the state's largest physician group.

To learn more:
- read the Reuters article
- here's the GAO report (.pdf)

Related Articles:
Healthcare mergers don't improve quality, experts warn
With ACOs, there's a thin line between collaboration and monopoly
Fitch: Supreme Court merger ruling could hurt for-profit hospitals
Healthcare M&A takes post-reform spotlight
FTC Commissioner blasts ACOs


Thank You Fierce Healthcare and Ms Bird

Pharma Pay-To-Delay Foe Leibowitz Leaving FTC

It's a Rare occasion when we Salute a member of our Government swimming in this Ocean of Pharmaceutical Corruption. Sadly, This time, it's because we're Losing one of the good guys.

Fierce Pharma has;
Pharma Pay-To-Delay Foe Leibowitz Leaving FTC
Supreme Court will still take up the matter next month

February 1, 2013 | By Eric Palmer

FTC Chairman Jon Leibowitz, who has been a burr under the saddle of branded drug makers, is stepping down. That won't derail the U.S. Supreme Court from hearing a case next month over one of his favorite subjects, pay-to-delay arrangements. Under those deals, branded drug makers pay their generics-producing competitors a settlement in patent litigation to postpone launching copycats that will cut into profits. Just last month, the FTC put out a report claiming that the practice is costing taxpayers $3.5 billion a year. His fight against pay-to-delay was mentioned by the FTC as one of his biggest accomplishments in his four years as chairman. The lack of love between the FTC and the industry on this issue was evident when Generic Pharmaceutical Association(GPhA) CEO Ralph G. Neas responded to the FTC report with this: "The FTC is wrong on the facts, wrong on the public policy and wrong on the law." Release | More

Here's the FTC release:

FTC Chairman John Leibowitz To Step Down This Month

For Release: 02/01/2013

FTC Chairman Jon Leibowitz to Step Down This Month

After nearly four years as the head of the Federal Trade Commission, Chairman Jon Leibowitz today announced he will step down on February 15, 2013.  He has been a Commissioner since September 3, 2004.

Leibowitz, who became FTC chair in the wake of the economic downturn in March 2009,continued the agency’s groundbreaking work on consumer protection and competition issues.

“I have been honored to head this extraordinary, bipartisan Commission and to work alongside the best staff in federal government,” said Chairman Leibowitz.  “Our small but mighty agency has safeguarded the privacy of Americans and stopped predatory financial practices by companies taking advantage of cash-strapped consumers.  Our antitrust enforcement has helped contain health care and drug costs, and helped reduce prices and increase innovation for smartphones, computer chips and other high-tech products.”

Setting his priorities as protecting consumer privacy, stopping financial scammers, and promoting competition in health care and high-tech markets, Leibowitz steered the Commission to major enforcement actions and cutting-edge policy work.

In the past four years, enforcement has been a major priority at the FTC.  Most recently, the Commission announced a landmark agreement with Google to ensure consumers would continue to be able to buy a variety of high-tech devices from smartphones to games to tablets.  The settlement gives competitors access to standard-essential patents, and ensures that companies that advertise on Google’s website will have more flexibility to use rival search engines.

Protecting Consumer Privacy

During the last few years, Leibowitz has worked to raise the profile of privacy practices through law enforcement, consumer education and policy initiatives.  FTC settlement orders against Google and Facebook let the companies move on and innovate for consumers while requiring comprehensive privacy programs and affirmative choice for material privacy changes, and prohibiting privacy misrepresentations.

During Leibowitz’s tenure, the FTC issued a landmark report setting forth best privacy practices for businesses and updated the Children’s Online Privacy Protection Rule that strengthens kids’ privacy by requiring that companies get parents’ permission before collecting personal information from their children under 13.  The FTC’s final report on privacy endorsed three principles – privacy by design, greater transparency, and more consumer choice – to help ensure consumer privacy and business innovation.  The report encouraged businesses to improve their privacy practices through self-regulation, including a Do Not Track system, which remained a priority for Leibowitz.

Fighting Last Dollar Fraud

During Leibowitz’s tenure, the FTC has filed more than 50 law enforcement actions to stop “last dollar” scams that prey on consumers in financial distress, such as foreclosure “rescue” and mortgage modification schemes, phony debt-reduction and credit-repair services, and bogus government grant opportunities, job scams, and get-rich quick frauds, with many state Attorneys General as partners.

In 2011, as a result of one of the largest judgments imposed in an FTC settlement, the agency returned almost $108 million to more than 450,000 consumers – about 1 percent of all mortgage holders in the United States – who allegedly were overcharged or had their mortgage loans mishandled by Countrywide while they were in default or bankruptcy.  The company later settled charges that it illegally assessed more than $36 million of servicing fees against struggling homeowners, and agreed to refund or reverse all of those charges.

Promoting Competition in Health Care

Under Leibowitz’s leadership, the Commission continued to take aggressive, bipartisan action to stop sweetheart deals in which branded drug manufacturers allegedly paid potential generic rivals to delay their introduction of lower-cost pharmaceuticals – deals that the agency estimates cost consumers and taxpayers billions of dollars annually.  One of the FTC’s most important “pay-for-delay” cases, against an agreement that postponed generic competition for the testosterone-replacement drug AndroGel, will be argued before the Supreme Court on March 25, 2013.  In another recent case involving generic competition for the wakefulness drug Provigil, the Court of Appeals for the Third Circuit issued a key ruling that supports the FTC’s position on the anticompetitive impact of pay-for-delay deals.   

The FTC also continued its campaign to identify and challenge health care mergers that would harm competition and drive up the cost of health care for both consumers and employers.  The Commission has successfully acted to block hospital mergers in Pennsylvania, Ohio and Illinois, as well as deals to consolidate lab services and physician practices. The hospital merger victories marked a turning point for the government after years of disappointing court rulings in this area.  Another important FTC case in this area, challenging the merger of two hospitals in Albany, Georgia, also will be decided before the Supreme Court during the current term.

Trending in Technology

Another priority under Chairman Leibowitz was making sure that competition continued to thrive in fast-moving technology industries.  In addition to the settlement with Google, the Commission reached another landmark agreement that prevented Intel Corp. from suppressing competition in the market for computer chips and opened the door to renewed competition.  The settlement restored competition that was lost as a result of Intel’s previous anticompetitive tactics, while allowing the company to innovate and offer competitive pricing.

The FTC also took steps to rein in the alleged misuse of standard-essential patents, which can lead to patent hold-up and ultimately higher prices for popular devices such as smart phones, laptop and tablet computers, and gaming consoles.  The Commission made the case publicly – and through law enforcement actions such as the Google consent decree – that companies should be restricted from seeking injunctions on standard-essential patents if they are bound by prior commitments to license their standard-essential patents on fair, reasonable, and non-discriminatory terms.

In addition, the FTC launched an initiative to enhance its longstanding program to make sure the agency’s rules are up-to-date, effective and not overly burdensome.

In joining the Commission, Leibowitz resumed a long career of public service. He was the Democratic Chief Counsel and Staff Director for the U.S. Senate Antitrust Subcommittee from 1997 to 2000, where he focused on competition policy and telecommunications matters. He served as Chief Counsel and Staff Director for the Senate Subcommittee on Terrorism and Technology from 1995 to 1996 and the Senate Subcommittee on Juvenile Justice from 1991 to 1994.  In addition, he served as Chief Counsel to Senator Herb Kohl from 1989 to 2000. Leibowitz worked for Senator Paul Simon from 1986 to 1987.  In the private sector, Leibowitz served most recently as Vice President for Congressional Affairs for the Motion Picture Association of America – from 2000 to 2004 – and worked as an attorney in private practice in Washington from 1984 to 1986.

A Phi Beta Kappa graduate of the University of Wisconsin with a B.A. in American History (1980), Leibowitz graduated from the New York University School of Law in 1984.  He is a member of the District of Columbia Bar.

He lives in Bethesda with his wife, Ruth Marcus, and his two daughters.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC's online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics.  Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

MEDIA CONTACT:

Office of Public Affairs
202-326-2180

Thank You Fierce Pharma, Mr Palmer, and Mr. Leibowitz.

For More, see Pharmalot:

Too Late For Pharma: FTC Chair Leibowitz Is Leaving

Pay-For Delay To Get Supreme Court Consideration

Fierce Pharma has;
Pay-For Delay To Get Supreme Court Consideration

With Justice Alito dropping out, a 4-4 tie is possible

December 10, 2012 | By Eric Palmer 

The U.S. Supreme Court will decide once and for all whether paying generic competitors to hold off on entering the market is legal. Or then again, maybe not. 

The court on Friday said it would take up the so-called pay-for-delay deals, but Justice Samuel A. Alito Jr. recused himself from hearing this case. That leaves open the possibility for a 4-4 tie, The New York Times points out.

The Supreme Court will consider a case in which the Federal Trade Commission went after Abbott Laboratories ($ABT) for paying Watson Pharmaceuticals ($WPI) and other generic drugmakers as much as $42 million a year to keep Solvay Pharmaceuticals' AndroGel treatment for low testosterone off the market for up to 8 years. Solvay is now owned by Abbott.

The FTC claimed the deal was anticompetitive and that these deals cost consumers $3.5 billion a year, Bloomberg reports. But drugmakers claim they are just protecting their investment and the patents that are already in place. Three courts sided with the drugmakers, but a court in Philadelphia found against them, setting up the need for a decision by the Supreme Court. Both sides would like to get the issue resolved. 

The FTC has been trying for years to change the practice, and cases have been brought against Bayer, Merck ($MRK), Bristol-Myers Squibb ($BMY), Watson Pharmaceuticals and Teva Pharmaceutical Industries ($TEVA), Bloomberg points out.

Action has heated up this year with CVS Caremark and Rite Aid filing a lawsuit over a deal between Pfizer's ($PFE) Wyeth unit and Teva Pharmaceutical Industries over Pfizer's blockbuster antidepressant Effexor XR. There has also been an effort afoot to approve legislation that would ban the practice. The American Medical Association recently said it supported that kind of law because it could help reduce healthcare costs. 

- read the New York Times story
- get more from Bloomberg
Related Articles:
Appeals court ruling threatens pay-to-delay deals 
Drugstores accuse Pfizer, Teva of blocking Effexor generics 
Appeals court ruling threatens pay-to-delay deals
Less cash, more promises in pay-to-delay deals
CBO: Pay-to-delay ban could save $4.8B


Thank You Fierce Pharma and Mr Palmer

Ex FDA Chief Says J&J Broke The Law In Promoting Risperdal

Philly.com has;
Ex FDA Chief Says J&J Broke The Law In Promoting Risperdal
By David Sell, Thursday, October 4, 2012

Former U.S. Food and Drug Administration Commissioner David Kessler, a pediatrician by training, said that Johnson & Johnson and its Janssen subsidiary broke the law in marketing its antipsychotic drug Risperdal for use in children and adolescents.

"In my opinion," Kessler wrote in a report submitted for a trial set to begin Oct. 9 in in Philadelphia's Court of Common Pleas, "Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act.

"The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning.

"The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning.

"The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning.

"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."

Kessler served as FDA Commissioner from 2000 through 2007, under Presidents George H.W. Bush and Bill Clinton.

It probably won't shock anyone to know that J&J's attorneys in the lawsuit don't want Kessler saying anything on the witness stand in the suit, in which a Missouri mother sued on behalf of her 16-year old son who grew breasts after being prescribed Risperdal.

But the J&J attorneys in their motion to prevent Kessler from testifying focused on the relatively last-minute nature of the plaintiff's attorneys request to add Kessler to the witness list and the submission of Kessler's 92-page report, without letting them depose Kessler ahead of time.

..... .....

Kessler's report was posted to the Court of Common Pleas electronic docket system late Wednesday in four pieces, as part of the J&J motion to preclude him from testifying. The pieces are all PDFs and links are here, here, here and here.

Continue reading Mr Sell's report at Philly.com here.

Thank you Philly.com and Mr Sell



SFGATE.com has;

UC Fires Dean Of Medical School For Undisclosed Reasons

Sabin Russell, Chronicle Medical Writer

Published 4:00 a.m., Saturday, December 15, 2007

In light of the San Francisco Conspiracy with its non-existent Risperdal pushing Hospitals and Staffs, its Illuminati chaired UCSF Psychiatry Dept, and its SFGH being the Only 24hr/16hr PES in town, and its C&C MHB going deaf dumb and blind at City Hall just 6 months earlier, ..... you have to wonder, ..... 

'Mental Health' in San Francisco: Link Fest

SFGATE.com has coverage of Dr. Kessler leaving UCSF:

Dr. David Kessler, the head of the prestigious UCSF School of Medicine, has been fired for reasons the university refuses to disclose.

UCSF Chancellor Michael Bishop announced the departure this morning in a short e-mail to the campus faculty, saying Kessler has "left office," and thanking him for "his energetic service to the university and his substantial achievements on behalf of UCSF."

Kessler, the onetime commissioner of the Food and Drug Administration who became Dean of the UCSF School of Medicine in 2003, told The Chronicle today his dismissal followed years of discord over finances at the medical school.

Kessler said he was labeled a "whistleblower" by the University of California after he repeatedly sought to uncover what he called "financial irregularities that predated my appointment."

At the heart of the dispute, Kessler said, are tens of millions of dollars in funds that should have been in the Dean's office account prior to his starting the job, but have never been properly accounted for because of what he called "poor financial controls."

He was Dean of the Yale School of Medicine when he was recruited in 2003 to the $540,000 a year post as UCSF vice chancellor and medical school dean.

UCSF spokeswoman Corinna Kaarlela declined to comment on the firing, saying, "This is a personnel issue, and we cannot comment further," she said.

And Despite the Difficulty in bringing an AntiTrust Action against Government itself, 

SFGATE.com has; (dateline September 13, 2008)

SF Fire Dept Loses Dominance Over Ambulances

"If the state requires us to go out to rebid, we will go out to rebid," said Dr. Mitch Katz, director of the San Francisco Public Health Department. But he stressed that the state's ruling turns on "a very narrow legal question that's based on an esoteric statute. ... The (state's) letter itself is a little puzzling, so I'm having the city attorney review it."

1. In a July 31 letter to Dr. John Brown, the city's emergency medical services director, California Emergency Medical Services Authority Director Steve Tharratt rescinded San Francisco's long-standing antitrust immunity in running its 911 ambulance operations and advised city officials to begin a competitive process. He made his ruling after the city submitted 127 pages of documents.