Author Topic: What You Need to know About Depression Medication  (Read 4837 times)

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Offline Anonymous

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Re: What You Need to know About Depression Medication
« Reply #15 on: December 05, 2009, 03:30:13 PM »
Quote from: "Inculcated"
Previous poster, not everyone shares your opinion. Of course it’s perfectly understandable that you might feel that way considering it probably exceeds your reading comprehension skills to discern much out of the provided information.

Yep, that must be it.
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Offline Ursus

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Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence
« Reply #16 on: December 06, 2009, 12:27:52 PM »
This from the Alliance for Human Research Protection regarding suicide risk associated with Neurontin and Zoloft:

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Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy

Mon, 26 Jul 2004

On July 23, 2004, a citizen's consumer protection lawsuit was filed against Pfizer Pharmaceuticals for concealment of evidence and deceptive marketing of the antidepressant Zoloft. The California law firm of Baum Hedlund has filed a suit against Pfizer on behalf of a doctor of public health / nurse and on behalf of "all California residents who have been misled about Zoloft." [press release below]

On May 14, 2004, Pfizer pleaded guilty in federal court to criminal fraud charges for the unlawful promotion and marketing of Neurontin by its predecessor, Warner-Lambert. Pfizer agreed to pay $430 million in settlement.

The New York, the law firm of Finkelstein & Partners, petitioned the US Attorney and the Judge who presided over the Neurontin case to consider the thousands of individuals who have been harmed - many died because their "doctors were fraudulently enticed to prescribe Neurontin." The letter noted that Pfizer "with full knowledge of the problem [ ] knowingly continued marketing the drug for unapproved, off-label conditions, thereby becoming criminally prosperous."

Andrew Finkelstein noted that the firm knew of 160 "Americans who, having never attempted any form of suicide before taking Neurontin, committed suicide while on the drug." Furthermore, he informed the court, he knew of "over two (2,000) Americans who, having never attempted suicide before taking Neurontin, were hospitalized following a suicide attempt while on the drug."

Finkelstein asked the court to hold Pfizer officials personally responsible:

"A prison sentence must be considered when so many lives have been damaged through a clear corporate program of criminal activity."

See, Finkelstein's letter: http://www.ahrp.org/SuitsDecisions/Neur ... ea0504.pdf (780K pdf)

The United States Attorney states in the government's final Pfizer / Neurontin settlement:

"The Government notes that in a May 18, 2004 letter to the Court, an attorney, who stated that he represents thousands of former Neurontin users, objected to the proposed criminal resolution on, apparently, the ground that it does not go far enough. The United States believes that evaluation of thousands of claims by individual Neurontin users, each of whose experience is unique, would unduly complicate and prolong sentencing. See U.S.S.G. ? 5E1.1(b)(2). Moreover, the proposed global settlement does not foreclose the rights of nongovernmental victims to seek redress." [p. 43]

See: United States of America v. Warner-Lambert [Pfizer], US Dist. Mass, CRIMINAL NO. 04-10150 RGS, June 2, 2004.

"Moreover, the proposed global settlement does not foreclose the rights of nongovernmental victims to seek redress." That statement refutes and invalidates the FDA-Bush administration policy that prevents individual citizens from seeking redress for medical injury from products approved by the FDA. [See today's follow-up AHRP Infomail]

The statement was signed by the Michael J. Sullivan, United States Attorney, District Of Massachusetts; Thomas E. Kanwit and Sara M. Bloom, Assistant U.S. Attorneys, U.S. Attorney's Office, Dist. of Massachusetts; and Jill Furman, Trial Attorney, Department of Justice.

FDA's failure to take action to protect public safety from hazardous drugs borders on criminal negligence.

The FDA has yet to require Pfizer to issue label warnings about the alarming suicide risk for patients prescribed Neurontin. Indeed, Finkelstein filed a Citizen Petition with the FDA (May 17, 2004) requesting the addition of postmarketing suicide report information to the Neurontin label.

The petition notes that FDA's Adverse Event Reporting System (AERS) database shows "a substantial increase in [ ] fatalities during the first six months of 2003. There were reports of "eight completed suicides from 1998 through 2002. Seventeen additional suicides recorded for the period between January - June 2003."

The disparity in numbers between actual drug-related harm--such as, suicides and suicide attempts--and the incidents voluntarily reported to FDA's MedWatch demonstrates that voluntarism doesn't work. There is a pressing need for mandatory reporting and disclosure of all serious adverse drug effects.

FDA's failure to perform its regulatory function responsibly - as it is mandated to do, to prevent drug-related harm--has resulted in hundreds of thousands of human casualties--far more than the casualties that resulted from the failure of US intelligence agencies to prevent 9/11.

Too many drugs are being prescribed without physicians' knowledge of the lethal risks.

In hospitals alone, 106,000 Americans die each year due to non-error adverse drug reactions.

In 1994, an estimated 2,216,000 (1,721,000 to 2,711,000) hospitalized patients had serious adverse drug reactions (ADRs) and 106,000 (76,000 to 137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.

See: JAMA April 15, 1998; 279(15):1200-5
BioMed Central Nephrology. December 22, 2003

Contact: Vera Hassner Sharav
Tel: 212-595-8974

-----------------------------------------------------------------

July 23, 2004
FOR IMMEDIATE RELEASE

Baum Hedlund, A Professional Corporation
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233
Evening and Weekend (818) 681-5697
Web: http://www.baumhedlundlaw.com

Pfizer Conceals Evidence and Misleads Doctors and Patients About Safety and Effectiveness of Zoloft
- Private Attorney General Steps in Because FDA Has Failed California Consumers


Los Angeles, California, July 23, 2004 -- Antidepressant litigation attorney Karen Barth Menzies and her partner, Ronald Goldman, filed suit today alleging Zoloft-maker, Pfizer, misled physicians and the public regarding Zoloft's safety and efficacy, particularly with regard to suicidality and withdrawal symptoms caused by the drug's use.

Today's consumer protection lawsuit was filed in Superior Court in downtown Los Angeles (case number BC318871). The suit details Pfizer's actions and omissions that downplayed Zoloft's risks and exaggerate Zoloft's alleged benefits. Pfizer did so, the complaint alleges, by suppressing evidence concerning: (1) Zoloft's lack of efficacy compared to placebos in treating conditions for which Zoloft is prescribed; (2) Zoloft's propensity to induce withdrawal and dependency; (3) the risk of increased suicidal and violent impulses in adult, child and adolescent Zoloft users; and (4) Zoloft's causing other side effects such as convulsions and psychosis.

The Plaintiff, Roberta Madison, is a nurse and doctor of Public Health. She has brought the action as a Private Attorney General on behalf of all California residents who have been misled about Zoloft. Last month, New York Attorney General Eliot Spitzer filed a similar lawsuit on behalf of all "aggrieved consumers" in the state of New York related to the drug Paxil. California's Unfair Competition Law provides that a private citizen may act as Attorney General on behalf of consumers.

Baum Hedlund is a national law firm representing thousands of antidepressant victims. Through its investigations on behalf of clients that suffered unwarned adverse side effects while using Zoloft, Baum Hedlund has obtained information supporting the complaint's allegations.

Karen Barth Menzies of Los Angeles based Baum Hedlund, stated:

"We are looking forward to working with Dr. Madison in this case to expose the fraud that has been perpetrated against the public by Pfizer. Pfizer has promoted the benefits as huge and the risks as minimal in an extremely deceptive way.

"We have been trying for years to raise public awareness about these issues. We believe that the truth has been suppressed for too long and as a result there has been an enormous waste of money, thousands of people have been harmed by these drugs and many lives have been shattered. We hope this lawsuit will be a significant step toward exposing the fraud.

"Once all the evidence comes out it will become clear that Pfizer was well aware of Zoloft's safety and efficacy issues for many years. Despite this knowledge, Pfizer has continued to market Zoloft as "highly effective," when only one out of five or Pfizer's own clinical trials for Zoloft's license application indicated superiority over placebos. We believe that the evidence will prove that the risks of Zoloft far outweigh any alleged benefits. Because of Pfizer's marketing practices and concealment of the truth, California healthcare providers have not been able to conduct accurate risk/benefit analyses when prescribing Zoloft. Additionally, we have seen many doctors who were unaware of Zoloft's serious side effects and consequently mis-diagnosed them. Where the public health is at stake, there is no room for secrecy and deception."

Robin McCall
Public Relations Baum Hedlund info@baumhedlundlaw.com
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Offline Ursus

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Pfizer Faces First Trial on Neurontin Suicide Claim (Update1
« Reply #17 on: December 09, 2009, 01:08:28 PM »
Bloomberg.com
Pfizer Faces First Trial on Neurontin Suicide Claim (Update1)

By Margaret Cronin Fisk, Jef Feeley and Cary O'Reilly



 July 24 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, goes to trial next week on claims its epilepsy medication Neurontin increases the risk of suicide, in a case the judge called "very tough" for the plaintiffs to win.

The July 27 trial will be the first of what plaintiffs' lawyers say are about 1,200 cases. It will show each side the other's strategy and may help point the way to settlements. The lead attorney for the family of Susan Bulger, 39, who took the drug before hanging herself in 2004, is Mark Lanier, winner of the biggest verdict over Merck & Co.'s painkiller Vioxx.

Pfizer says Bulger's suicide was unrelated to its medicine and points to what it calls a history of mental disorders and abusing drugs including cocaine. Her past might make it hard for the family to win, said Robert Rabin, a law professor at Stanford University in Palo Alto, California.

"If she was taking other drugs, there's a question if this particular drug contributed to the suicide," Rabin said in a phone interview.

U.S. District Judge Patti B. Saris in Boston made a similar point at a July 20 pretrial hearing. It's "a very tough case because of her personal history," she said.

Pfizer hasn't taken a reserve to deal with litigation expenses tied to the suits, said Christopher Loder, a company spokesman. Neurontin's 2008 sales of $387 million represented 0.8 percent of its total revenue, which included $12 billion for the cholesterol pill Lipitor, the world's biggest-selling drug.

Pfizer rose 19 cents, or 1.2 percent, to $16.34 in New York Stock Exchange composite trading at 11:39 a.m. The drugmaker's shares have fallen 7.7 percent this year.

Bulger's Life

The company says Bulger's life was "fraught with psycho-social stressors, including physical and mental abuse, long-term substance abuse and addiction to cocaine, heroin, Methadone and Oxycontin."

"Mrs. Bulger attempted suicide multiple times before ever ingesting Neurontin," Pfizer said in court papers. "Six months before her suicide, Mrs. Bulger was caught buying cocaine on the street," it said.

Saris told lawyers she hadn't decided how much of the information will be admissible in the trial.

Lanier, a Houston lawyer representing the family and about 600 other Neurontin plaintiffs, counters that the drug helped push a "fragile lady" over the edge. He is asking for $250,000 in compensation plus punitive damages.

Lanier was among attorneys who negotiated a $4.85 billion settlement with Merck & Co. in 2007 to resolve the majority of cases over its painkiller Vioxx. He won a $253 million jury award in 2005 in the first Vioxx trial. The verdict was cut to about $26 million, then thrown out on appeal. The case is still on appeal in the Texas courts.

Lanier on Pfizer

The lawyer vowed in an interview to expose Pfizer's "seedy" handling of Neurontin during the three-week trial. Pfizer hid the drug's health risks to pump up profits, he said.

Lanier also will rely on a December decision by the U.S. Food and Drug Administration to order all makers of epilepsy drugs to add a suicide-risk warning to their labels.

The agency's reviewers found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of 11 drugs. Pfizer opposed the warning, saying Neurontin was safe and it was unfair to combine data for medicines that work differently.

The government-required suicide warning may tip the scales against Pfizer in subsequent trials, said Rabin, the law professor. "Plaintiffs would have a better chance in other cases," he said.

"If this person wins, it opens the door for more litigation," said Les Funtleyder, an analyst with Miller Tabak & Co. in New York. "It could become an issue for Wall Street if the verdicts and settlements are large enough."

Testimony on Cause

The judge refused to dismiss the Bulger case and others on alleged failure to warn of Neurontin's side effects. She rejected Pfizer's bid to block expert testimony the drug increases the risk of suicide.

Their "general causation testimony is reliable," and plaintiffs showed that a relationship between the medicine and increased suicide risk is "biologically plausible," she said.

"What you have here is a standard case of individual trials that are going to produce early readings from a host of jurisdictions," said Professor Anthony Sebok of Benjamin N. Cardozo School of Law in New York. "The manufacturers will have to litigate five to 10 cases as they did in Vioxx to get a clear picture of what juries will do."

After several verdicts, "each side begins to see what its expected returns will be," Sebok said. "That'll impact on the price of settlement."

Suit in 2007

Bulger's family, of Peabody, Massachusetts, sued New York-based Pfizer and its Warner Lambert unit in August 2007, more than three years after Bulger's husband and 4-year-old daughter found her body in their basement. Ronald Bulger said he gave his wife four Neurontin pills an hour before she killed herself.

She took the drug, approved to treat epilepsy, for mood swings and arthritis pain, her family's lawyers said. Pfizer's marketing of the drug for so-called off-label uses played a role in her decision to take it, the family says in the lawsuit.

Companies are forbidden to market medications for off-label use. Doctors may prescribe a medicine for any condition. Drugs developed and approved as safe and effective for one condition sometimes are found to help with others.

Warner-Lambert paid $430 million in 2004 to resolve off- label marketing allegations involving Neurontin by the U.S. Justice Department. The family's lawyers can introduce evidence about that settlement, Saris said July 20.

'Appropriate' Label

"Pfizer believes that the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," said Loder, the spokesman.

"The Neurontin label prior to Mrs. Bulger's death was adequate and appropriate based on the reliable scientific data concerning the medicine, and all pertinent safety information was provided to the FDA," Loder said.

The trial is to start as Pfizer pushes to complete its $64 billion purchase of rival drugmaker Wyeth. Investors in Madison, New Jersey-based Wyeth voted to approve the cash-and- stock buyout earlier this week.

The acquisition will give Pfizer the pneumonia vaccine Prevnar and the antidepressant Effexor to offset some of the $12 billion in sales it will begin losing in 2011 when Lipitor faces generic competition.

Saris is overseeing all federal-court litigation over Neurontin, which includes product-liability claims like the Bulger family's and suits by insurance companies and consumers seeking to recoup money spent on the drug.

No Whitey Bulger Ties

Pfizer hired William Ohlemeyer, a former associate general counsel for cigarette maker Altria Group Inc., to defend it in the case, Lanier said. Loder, the company spokesman, declined to comment on who will be the company's lead defense lawyer, or to say exactly how many Neurontin claims Pfizer faces.

Ohlemeyer, from the New York office of Boies, Schiller & Flexner LLP, along with Mark Cheffo, a mass-tort defense specialist from New York's Skadden, Arps, Slate, Meagher & Flom LLP, are listed as lawyers for the drugmaker on Pfizer's court filings.

Saris told lawyers for both sides she will instruct jurors there are no family ties between the plaintiffs and James "Whitey" Bulger, a Boston crime boss and FBI informant who has been a fugitive since 1994, Lanier said.

Whitey Bulger, one of the FBI's 10 most-wanted men, has been indicted on 18 counts of murder, conspiracy, extortion and narcotics trafficking over his actions as the head of Boston's Winter Hill Gang. The FBI is offering $2 million for information leading to the fugitive's arrest.

The case is Bulger v. Pfizer Inc., 1:07-cv-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at jfeeley@bloomberg.net; Cary O'Reilly in Washington at caryoreilly@bloomberg.net.

Last Updated: July 24, 2009 11:45 EDT


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Joel

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Edited: Wednesday, October 06, 2010
« Reply #18 on: December 11, 2009, 01:55:33 AM »
Edited: Wednesday, October 06, 2010
« Last Edit: October 07, 2010, 02:01:11 AM by Joel »

Offline Anonymous

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Re: What You Need to know About Depression Medication
« Reply #19 on: December 11, 2009, 04:07:28 AM »
Thanks Ursus,

I am loving all of the info you are posting on this thread. Keep it up, I plan to use this thread as a reference after big pharma makes the media corps take down all of this info from the net.

Really, big pharma and the troubled teen industry... both so corrupt you know they are eventually going to be working together. They probably already are. I have heard of kids being heavily drugged in programs...who pays? Somebody pays.

Big pharma probably gets business from teen programs (parents and insurance companies) and the programs get a nice kick-back donation for their cause from big pharma.   F-R-A-U-D
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Offline Ursus

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Pfizer Faces Class Action in Canada Over Neurontin (Update2)
« Reply #20 on: March 26, 2010, 12:28:04 AM »
Bloomberg.com
Pfizer Faces Class Action in Canada Over Neurontin (Update2)

By Cary O'Reilly

 Feb. 19 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, faces a national class-action lawsuit in most of Canada over claims it failed to warn consumers about the risks of its Neurontin epilepsy drug.

The suit was certified yesterday by Justice Paul Perell of Ontario Superior Court in Toronto in every province except Quebec, according to court records. He declined to certify claims the drugmaker promoted Neurontin for unapproved uses or that it might be liable for generic versions of the medicine.

The suit alleges that use of Neurontin, a prescription anticonvulsant, causes an increased risk of suicidal behavior in patients, and that Pfizer didn't warn consumers about it. The company faces about 1,200 similar lawsuits in the U.S. Pfizer disputes any connection between suicide and Neurontin use.

"We are very pleased that Canadians who experienced suicidal behavior from using Neurontin, and their family members, will be allowed to go forward with their claims," Michael J. Peerless, an attorney with Siskinds LLP who is representing the class, said in a statement today.

Chris Loder, a spokesman for Pfizer, said the company is "disappointed" at the judge's ruling, though it welcomed his decision to strike the claims on improper marketing and generic liability.

'Widely Studied'

Perell also refused to allow a claim for punitive damages to remain a common issue, Loder said in an e-mailed statement.

"Neurontin is an important medicine that has been widely studied for more than two decades," Loder said. "There is an extensive body of science on the use of Neurontin and physicians have prescribed it to treat millions of patients safely and effectively."

Pfizer rose 26 cents to $17.99 on the New York Stock Exchange. The shares are little changed this year.

The case is Goodridge v. Pfizer Canada Inc., 06-cv- 307728CP, Ontario Superior Court of Justice (Toronto).

To contact the reporter on this story: Cary O'Reilly in Washington at caryoreilly@bloomberg.net.

Last Updated: February 19, 2010 16:21 EST


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Offline Ursus

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Pfizer Found Liable in Fraud Trial Over Neurontin Drug
« Reply #21 on: March 26, 2010, 11:39:09 AM »
Bloomberg.com
Pfizer Found Liable in Fraud Trial Over Neurontin Drug

By Bob Van Voris

March 25 (Bloomberg) -- Pfizer Inc. was found liable for violating civil racketeering law in a trial over its Neurontin epilepsy drug.

To contact the reporter on this story: Bob Van Voris in New York at rvanvoris@bloomberg.net

Last Updated: March 25, 2010 16:08 EDT


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Offline Ursus

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Drug Busts on the Cheap Lack Power to Deter
« Reply #22 on: March 27, 2010, 07:52:10 PM »
Bloomberg.com
Drug Busts on the Cheap Lack Power to Deter: Michael K. Loucks

Commentary by Michael K. Loucks

March 9 (Bloomberg) -- Since 1990, drug companies have paid more than $11 billion to resolve federal criminal and civil health-care fraud investigations. Most of the money was paid in the past 10 years as a consequence of aggressive enforcement, coupled with the potential for mandatory exclusion from federal health-care programs.

This deterrent will dwindle to nothing if the funding for health-care fraud prosecutors isn't increased substantially. That's a real risk under Congress's current funding plans.

In 1997, Congress decreed that anyone convicted of a health-care fraud felony would be excluded from further participation in federally funded health-care programs. The premise was that a company or person convicted of ripping off these programs shouldn't remain a vendor.

This potential death penalty has acted as a deterrent to companies under investigation for criminal conduct involving the fleecing of Medicare and Medicaid. The possibility of debarment has forced many to come clean, plead guilty, pay significant fines and agree to substantial corporate reforms.

Last October, a federal judge ordered Pfizer Inc. to pay $2.3 billion in criminal and civil penalties and restitution following its admission that it had engaged in unapproved so- called off-label promotion of the pain medication Bextra, among other misdeeds.

This was Pfizer's second bite at the criminal apple. Five years earlier, Pfizer admitted that a company it had acquired cheated in the off-label promotion of Neurontin, an epilepsy drug.

Hard Bargaining

Nonetheless, as a part of the settlement that I helped negotiate, Pfizer wasn't excluded. This decision was the result of hard bargaining. On the government side, we had the certainty of the immediate cash payment. We had to balance that against the risk of seeking an indictment and going to trial, as well as the human cost of exclusion to those working for Pfizer who had no involvement in wrongdoing, or on those who depended on Pfizer's products. Pfizer considered its own litigation risk in reaching a conclusion to settle rather than fight.

Not excluding Pfizer was the right choice. The $1.3 billion criminal portion of the penalty was huge and is an effective deterrent, especially when coupled with a new corporate integrity program.

Of course, no human governance system will stop all cheating; the best example of this is the corporate integrity program we imposed on Pfizer for the Neurontin cheating. That didn't stop the Bextra cheating.

Personal Obligations

Mindful of that, the new program imposes significant personal obligations on business-unit managers across Pfizer's sales and marketing operations. Midlevel managers must sign periodic statements asserting lawful behavior. That won't stop all deception, but it should deter many and, in the event it doesn't, the certifications should simplify future prosecutions of individuals.

A strong investigation, coupled with the credible threat of mandatory exclusion, produced the correct result.

What does the future hold in terms of enforcement? I see two conflicting forces, one of which should trouble would-be drug-company cheaters, and one that should trouble the public.

As regards the former, political and public patience is wearing thin. Since 1990, there have been 54 civil and criminal settlements with drug companies, with 44 of those after 2000, and 17 in just the past three years. A total of $23 billion has been recovered in all health-care fraud cases since 1990.

$1 Billion

Investigations of kickbacks, off-label promotion and price cheating in the drug industry are now in their 13th year. Several companies, such as Schering-Plough Corp., Pfizer and Eli Lilly & Co., have had two or more criminal or civil bouts in federal court since 1998, with gross recoveries from each company exceeding $1 billion.

After the Pfizer settlement, several U.S. senators proposed legislation to increase jail time for individual health-care fraud offenders. This will increase political pressure to pull the exclusion trigger on one of the next major corporate criminals.

But Congress has failed to put its money where its mouth is. New laws increasing penalties on health-care cheats are useless weapons if there aren't enough soldiers to wield them. U.S. attorneys offices haven't had an increase in funding for health-care fraud since 2003. The Department of Justice's inspector general reported in November 2008 that the number of federal prosecutors spending time on health-care fraud declined nationwide from 2004 to 2007 by 20, a decrease of 12 percent.

Inadequate Support

The stalled health-care reform legislation included $100 million for all federal agencies involved in health-care fraud enforcement. That sounds like a lot, but the increase for the prosecutors would have amounted to just $8.9 million, nowhere near enough to get staffing back to where it was six years ago. Nor do the proposed budgets for the Justice Department and Human Services provide enough money for health-care fraud prosecutors and agents.

We had more than a dozen agents and federal prosecutors working in several different offices for five years on the Pfizer matter; had the case gone to trial, that team would have spent another five years on the case. It will be increasingly hard for the threat of exclusion to remain credible and thus serve as a deterrent to bad corporate behavior unless Congress supports health-care fraud prosecutions with more money.

(Michael Loucks, co-author of "Prosecuting and Defending Health Care Fraud Cases," supervised health-care prosecutions in the Massachusetts U.S. attorney's office for 17 years. The opinions expressed are his own.)

Click on "Send Comment" in the sidebar display to send a letter to the editor.

To contact the writer of this column: loucks_michael@hotmail.com

Last Updated: March 8, 2010 21:00 EST


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Offline Ursus

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Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fr
« Reply #23 on: April 01, 2010, 05:35:54 PM »
Bloomberg.com
Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud

By Bob Van Voris and Janelle Lawrence

 March 26 (Bloomberg) -- Pfizer Inc. violated U.S. racketeering law in the marketing of its epilepsy drug Neurontin and should pay $142.1 million in damages, a jury decided.

Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals claimed in a monthlong trial in federal court in Boston that Pfizer illegally promoted Neurontin for unapproved uses. The insurer said it was misled into believing migraines and bipolar disorder were among the conditions that could be treated effectively with Neurontin, approved in 1993 by the U.S. Food and Drug Administration for epilepsy.

"The jury found Pfizer engaged in a racketeering conspiracy over a 10-year period," Tom Sobol, a lawyer for Kaiser, said after yesterday's verdict. "That bodes well for future cases."

U.S. District Judge Patti Saris, who presided over the trial, is overseeing federal lawsuits from throughout the U.S. targeting Pfizer with injury claims and allegations of fraudulent sales and marketing of the drug. In a ruling last year, Saris said that fraud findings against Pfizer in the case decided yesterday could be binding against it in future trials.

Oakland, California-based Kaiser, the first insurer to try a Neurontin case against the world's biggest drugmaker, claimed it was forced to pay $90 million more than it should have for Neurontin.

The jury, which deliberated for two days, found that New York-based Pfizer violated the federal Racketeer Influenced and Corrupt Organizations Act, or RICO, and California's Unfair Competition Law. Under RICO, the amount of actual damages found by the jury, $47.36 million, will be tripled.

'A Triumph'

"This is a triumph for evidence-based medicine over marketing-based medicine," said Thomas Greene, a Kaiser lawyer.

Pfizer made no offer to settle the case before trial, Greene said.

"We are disappointed in this verdict," said Chris Loder, a Pfizer spokesman. Pfizer will file post-trial motions challenging the verdict and plans to appeal, he said.

Pfizer fell 22 cents to $17.39 yesterday in New York Stock Exchange composite trading.

During the trial, Pfizer argued that Kaiser doctors continued to prescribe the drug even after the health insurer sued Pfizer in 2005. The insurer's Web site also still lists Neurontin as a drug for neuropathic pain, Pfizer lawyers said in closing argument.

"We took that into consideration," said Danielle Hurley, a 22-year-old artist who sat on the jury. "Kaiser was proactive, but could have been more proactive."

Shocked by Evidence

Hurley said she was shocked by evidence that Pfizer knowingly marketed Neurontin for off-label uses without proof that it was effective.

All of the five jurors interviewed after the verdict said they agreed that Pfizer had demonstrated "a pattern of fraud" in marketing the drug.

"It was clearly a snow job," said juror Paul Anderson, a technical writer.

"The message, if there was a message, is that they acted in a fraudulent manner," said Hank Pierotti, foreman of the eight-person jury. "If you're fraudulent, you deserve to be punished."

Kaiser claimed Neurontin was wrongly prescribed for off-label uses, including treatment of neuropathic pain, and in dosages larger than the maximum approved by the FDA.

Jurors yesterday found that Pfizer violated racketeering laws with respect to four of the five off-label uses in question.

Company's Studies

The company's own studies showed that Neurontin was no more effective than a placebo in treating those conditions, though Pfizer never told doctors or patients about the findings, Kaiser said.

Several jurors said they were strongly influenced by the testimony of former FDA Commissioner David Kessler and Kay Dickerson, a Johns Hopkins epidemiologist whose article casting doubt on clinical studies of Neurontin appeared in the New England Journal of Medicine last year. Both testified on behalf of Kaiser.

"Dr. Dickerson was the lynchpin," jury foreman Pierotti said.

Pfizer argued that Kaiser didn't present testimony from any doctors claiming they wouldn't have prescribed the medication if they had known better, Pfizer's lawyer argued.

"No doctor wants to admit they were defrauded," Pierotti said.

Warner-Lambert

Warner-Lambert Co. developed and marketed Neurontin for several years before Pfizer acquired the company in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the U.S. Justice Department.

Saris permitted jurors to hear evidence of the settlement during the trial.

"That helped a lot," said juror Anderson.

The Justice Department claimed in a 2004 sentencing memorandum that Warner-Lambert's marketing increased off-label sales from 15 percent of all Neurontin prescriptions in 1994, its first year on the market, to 94 percent, or $2.12 billion, of Pfizer's Neurontin sales in 2002.

In 2002, responding to press reports of Pfizer's allegedly fraudulent Neurontin marketing, Kaiser began an information campaign that led to a 34 percent drop in Neurontin prescriptions to its members, according to Saris.

Product Liability Suits

Among the cases in Saris's court are product-liability suits claiming the drug is linked to an increased risk of suicide. The first trial in one of those, over the suicide death of a 39-year-old woman, ended when her family dropped the case. A second trial, involving the suicide of a 57-year-old Massachusetts man, is scheduled to begin next week in Boston.

In January, Saris dismissed fraud claims by Aetna Inc. and Guardian Life Insurance Co. against Pfizer. Unlike those companies, Kaiser showed it had considered Pfizer's allegedly false claims and data in deciding to pay for off-label Neurontin prescriptions, Saris ruled before the trial.

The case is In re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629, U.S. District Court, District of Massachusetts (Boston).

To contact the reporters on this story: Bob Van Voris in New York at rvanvoris@bloomberg.net.

Last Updated: March 26, 2010 00:01 EDT


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Offline dsmith

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Re: What You Need to know About Depression Medication
« Reply #24 on: August 21, 2012, 01:47:26 PM »
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« Last Edit: December 31, 1969, 07:00:00 PM by Guest »