Settlement of Suit Alleging Neurontin Risks Concealed
Pfizer has kept busy in court defending against charges that a company it acquired promoted Neurontin (gabapentin) for uses not approved by the US Food and Drug Administration (FDA), and not well supported by the evidence. Most recently, it was convicted by a jury in California of being a racketeering influenced and corrupt organization (RICO) because of a long-term "racketeering conspiracy" involving Neurontin marketing (see post here). Now additionally, according to the Wall Street Journal,
Pfizer Inc. said it reached a settlement agreement in a wrongful-death lawsuit brought by a woman who claimed her husband's use of the antiseizure drug Neurontin caused him to commit suicide in 2002.The new wrinkle here is that Pfizer did not defend a suit that alleged the company knew of a potentially fatal side-effect of the drug, but failed to disclose that risk.
The suit was brought by Linda Shearer of Berkshire County, Mass., whose husband, Hartley Shearer, was prescribed Neurontin to control the effects of his paralysis. The suit alleged Pfizer promoted this use of the drug even though it wasn't approved by U.S. regulators. The suit alleged Pfizer knew the drug was associated with a risk of suicide, but failed to properly warn of the risk.
Jury Awarded Damages for Treatment of Whistle-Blower
Meanwhile, the Hartford Courant reported:
A former Pfizer scientist who claims she has been paralyzed by a virus designed at the pharmaceutical company's laboratory in Groton was awarded $1.3 million by a federal jury in Hartford Thursday following a trial that raised questions about safety practices in the dynamic field of genetic engineering.So, after being convicted by a jury of being a "racketeering influenced and corrupt organization," (RICO), and settling civil and criminal fraud charges for an unprecedented $2.3 billion (see post here), and after many other allegations, settlements, and convictions (look here), Pfizer failed to defend one action, and lost another that argued Pfizer tried to hide information which put the company and/or its products in an unfavorable light.
The amount of the settlement awarded to molecular biologist Becky McClain of Deep River will likely increase in coming days. After about day of deliberation, the jury also awarded McClain punitive damages, to be determined by U.S. District Judge Vanessa L. Bryant, and awarded fees to McClain's two Connecticut lawyers, Bruce E. Newman and Stephen J. Fitzgerald.
McClain claimed in her suit that she was inadvertently exposed through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, or AIDS.
She further claimed that Pfizer wrongly fired her in 2005 for complaining about laboratory safety to the U.S. Occupational Safety and Health administration and to co-workers.
Ultimately, the jury was not permitted during the 12-day trial to hear argument supporting McClain's claim of a causal link between her disability and virus research done at her laboratory in Groton.
The jury based its verdict on evidence concerning McClain's two remaining claims: that her dismissal violated Connecticut's whistle blower law and McClain's free speech right. Her lawyers contended her complaint to federal safety regulators amounted to a whistle blower complaint and that her discussion of safety issues with fellow workers was free speech.
In fact, Even Pfizer CEO Jeffrey Kindler could not put much of a spin on the company's recent record. As reported by Duff Wilson in the New York Times,
The world’s largest drug company, Pfizer, has handled mergers badly, invented too few drugs and left its reputation in disrepair after two criminal cases.
And that is the assessment of its own chief executive.
CEO's Multi-Million Dollar Compensation
But while all this was going on, the company did disclose (as mandated by the US Securities and Exchange Commission [SEC]) that CEO Kindler is continuing his acquisition of riches. As reported by the AP (via USAToday).
The chief executive of drug giant Pfizer Inc., Jeffrey Kindler, received a 2009 compensation package valued by The Associated Press at $13.7 million, down 7.6% from 2008, as the board reduced the stock awards he received, citing economic pressures.
The world's biggest drugmaker paid Kindler, 54, a salary of $1.6 million, up just $25,000 from the year before. But his performance bonus was bumped up to $3.5 million from $3 million in 2008, according to a filing this week with the Securities and Exchange Commission.
Most of Kindler's compensation comes from long-term awards of stock options and restricted shares. The total fell 17% to $8.1 million in 2009, from $9.8 million, even though they were granted in late February, a month after Kindler announced plans to buy Wyeth for $68 billion, a sound strategy to counter Pfizer's looming revenue plunge.
Kindler's other compensation — a variety of perks — totaled $449,731. That included $190,725 for Kindler's use of corporate aircraft as required by Pfizer's board, $43,099 for use of a car, $7,690 for financial counseling and $1,217 for home security.
Even admitting that Kindler's compensation last year was slightly decreased from last year's not so small fortune, there still seems to be a huge disconnect between the company's ethical woes, legal settlements, and guilty pleas and its CEO's rewards. Once again, it seems that leaders of large health care organizations never face real accountability for their company's bad behavior. It almost goes without saying that in the two cases summarized above, no one who authorized, directed, or implemented the actions leading to the settlements or damages seems to have had any negative consequences.
So once more with feeling.... In the US, we have put much of our health care system in the hands of very large organizations, for-profit and not-for-profit, without holding these organizations and their leaders accountable for their actions. The results have been increasingly rich leaders who often behave like a new aristocracy, and repeated bad behavior by the organizations they lead.
Our latest effort at health care "reform" has continued to rely on large private organizations, while so far not adding to their or their leaders' accountability. In my humble opinion, if we really want to reform health care so as to improve quality, increase access, control costs, and support professionalism, we will have to make our new health care oligarchs accountable.
Postscript - Pay for Health Care Reform Lobbying?
By the way, a commentary in The [New London, CT] Day suggested an explanation for why Kindler was so richly paid last year:
It takes pages and pages of a company securities filing to explain and justify all the bells and whistles of Kindler's 'annual incentive award,' a complicated stew of stock options and deferred payments and plain old salary.
From all of this, Timothy P. Carney of the Washington Examiner found one juicy tidbit, which especially titillated industry bloggers.
It turns out Kindler's salary increase, from $1.57 million to $1.6 million, was based in part, the compensation committee suggested, on his success in making a deal with President Obama that protected the drug industry from some of the more onerous proposals of health care reform.
Praising Kindler as an effective lobbyist in, among other things, heading off legislation that would allow the importing of cheaper prescription drugs, the committee said: 'These efforts included constructive participation in the U.S. legislative process to advance Pfizer's goals of achieving a more rational operating environment.'
Or, he kept a finger in the dike against health care reform.
Indeed, a recent report by the Sunlight Foundation, a private nonprofit dedicated to more transparency in government, indicates Kindler's extensive role in negotiating a deal for the drug companies with the Obama administration and Senate Finance Committee Chairman Max Baucus.
It turns out Kindler's name turns up four times on last year's White House visitor logs.
The final deal Kindler helped craft promised $80 billion in cost cutting by the drug companies but blocked much more onerous reform measures for the industry, like lowering prescription drug prices through Medicare negotiations, re-importation of drugs from other countries with lower prices and quicker release of generics onto the market.
The cost-saving of such measures, if allowed to occur, could have been in the hundreds of billions of dollars, according to government analysis.
Kindler, as the pay committee says, did good.
Several of our fellow bloggers have suggested that an installment of the Public Broadcasting Service (PBS) program "Frontline" will show just how much of the recent US health care reform effort was the product of health care corporate CEOs (e.g., see this post on GoozNews, and this post on Managed Care Matters). We shall see once the program airs, but maybe Mr Kindler's salary was a good value for Pfizer, but a very bad one for the rest of the country.
The drug industries disregard for the FDA and public at large knows no bounds. In the April 8 WSJ we find FDA Says Tysabri Webcast Was “False or Misleading.”
ReplyDeleteTysabri is sold to treat multiple sclerosis and Crohn’s disease. The problem is the webcast were not submitted to the FDA for review. Additionally this drug produces a brain infection known as PML. The company plans “to have further conversations with the agency. “
Separately a webcast for the drug Truvada was also not submitted for FDA review. The FDA feels the webcast overstates the effectiveness of the drug and the ad was “false or misleading.” The company takes the concerns seriously “and we will be working to respond to the FDA promptly.”
In both of these cases the companies are ignoring not only the FDA’s concerns, but also request for removal of advertising material. The drive for profits exceeds that of public safety or government compliance.
Steve Lucas
What is even worse is that with all these unethical stances Pfizer proudly hails, Mr. Kindler, Pfizer's CEO, was recently placed on the board of the Federal Reserve.
ReplyDeleteWhat is going on here?
Dr. Poses raises some very good issues in his post.
One of your previous posts made connections between the leadership of failed financial firms and health care organizations, with unrestrained greed being a root cause issue. As a poster correctly noted above, in 2009 Pfizer CEO Jeff Kindler was appointed to the board of directors of the New York Federal reserve, the largest and most influential of all the Fed Reserve banks, which sets the entire US monetary policy.
ReplyDeletePfizer's legal woes continue to mount under Jeff Kindler's leadership. Besides the recent RICO conviction, which is a law that was created for prosecuting the Mafia and other organized crime groups, Pfizer paid a record $2.3 billion in criminal penalties in 2009 for being a repeat offender for off-label marketing.
In 2004, it paid a $430 million fine. At that time, while Pfizer's lead counsel was promising the US DOJ that it would never engage in off-label marketing again, the organization was simultaneously executing the off-label marketing plan that resulted in the 2009 record penalty. Guess who Pfizer's lead counsel was during the 2004 promise to DOJ...that's right, Jeff Kindler.
Jeff kindler/aka Jesse James,
ReplyDeletehey you sorta got away with robbing all us Victims of your neurontin scam,so why not think you would be so bold as to go right in and rob the Finanicial sector too, after all,
The U.S. Top U.S. Dept of Justice Attorney isnt gonna track you, cause he too is ex Pfizer employee,that why you get all the Plea deals when busted,Shame on you Obama,I really tried not to type cast you, but you are type casting yourself with whom you chose in your cabinet to screw over us citizens.And you're using White People to bust your reputation.
Can somebody say "ENRON " all over again. WELCOME to "PFIZERGATE.
Pfizer Survivor