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Whistleblower says antipsychotic drug maker subverted science & induced others to betray patients

admin — Fri, 20 Jan 2012 19:15:26 +0000

“Janssen ran amok,” Allen Jones, the Pennsylvania-based whistleblower on J&J’s marketing practices who was a plaintiff along with state of Texas, told reporters in the Austin courthouse.

“They trashed the Johnson & Johnson credo and they misused Texas and, I believe, well-meaning officials, to further their marketing aims,” Jones said. “They subverted science and they induced others to betray the people they were supposed to be taking care of. To me that is reprehensible.”

January 20, 2012/Reuters

J&J to pay $158 million to settle Texas Risperdal case

Johnson & Johnson said on Thursday it will pay $158 million to settle a Texas lawsuit accusing the drugmaker of improperly marketing its Risperdal anti-psychotic drug to state residents on the Medicaid health program for the poor.

The settlement fully resolves all Risperdal-related claims in Texas, the company said. The agreement is specific to the state of Texas and does not involve other ongoing state or federal Risperdal litigation.

The deal settles claims brought by Texas in 2004 and involves alleged Medicaid overpayments during the years 1994 to 2008 “and will circumvent potentially lengthy and costly appellate activities,” according to a statement from J&J’s Janssen Pharmaceuticals unit.

The settlement will be paid to the original plaintiff, his attorneys, the state of Texas and the federal government, which provides Medicaid reimbursements, the company said.

The complaint against J&J and several of its units filed in U.S. district court in Texas had alleged company representatives “targeted every level of the Texas Medicaid Program with misrepresentations about the safety, superiority, efficacy, appropriate uses and cost effectiveness of Risperdal.”

“Janssen ran amok,” Allen Jones, the Pennsylvania-based whistleblower on J&J’s marketing practices who was a plaintiff along with state of Texas, told reporters in the Austin courthouse.

The deal marks the first Risperdal settlement with any U.S. state, Janssen spokeswoman Teresa Mueller said.

J&J’s once sterling reputation has been battered in the past two years over quality control problems at several of its plants and manufacturing errors that led to massive recalls of a wide variety of its products, including hip replacements, contact lenses, insulin cartridges and heart devices.

Its biggest black eye came from its McNeil consumer healthcare unit, which in a series recalls was forced to pull hundreds of millions of bottles and packages of popular medicines, such as Children’s Tylenol, Motrin, Rolaids and Benadryl.

J&J shares were down 28 cents, or 0.4 percent, at $65 in afternoon trading on the New York Stock Exchange.

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Record Breaking $327 Million Verdict Upheld Against Manufacturer of Antipsychotic Risperdal—Request for New Trial Denied

admin — Wed, 21 Dec 2011 18:38:04 +0000

PR Newswire – December 21, 2011

(Click image for international warnings on antipsychotic drugs) The "dear doctor" letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal.

The jury verdict in the case of State of South Carolina versus Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson, Inc. has been upheld and requests for a new trial denied, affirming groundbreaking $327 million in civil penalties against the manufacturers of the drug Risperdal.

Circuit Court Judge Roger Couch announced the rulings on December 20 through two written orders. One order denies the defendant’s motion for judgment notwithstanding the verdict or, in the alternative, for a new trial; the second order denies the defendant’s motion to alter or amend the judgment and/or for a new trial. John B. White, Jr. and Donald C. Coggins, Jr. of Harrison, White, Smith & Coggins, P.C., a Spartanburg-based law firm, along with John Simmons of the Simmons Law Firm, a Columbia-based law firm, and Bailey Perrin Bailey, a Texas based law firm represented South Carolina in the case.

“We are obviously very pleased with Judge Couch’s decision and his careful consideration of this matter,” stated John B. White, Jr. one of the attorneys representing the state in the case. “The verdict handed down by the jury is just and speaks the truth. The damages awarded further substantiated the level of deception Janssen used in business practices in our state. Once again, we have sent a clear message to drug companies that deceptive business practices will not be tolerated in South Carolina.”

On March 22, 2011 a jury in the Spartanburg Court of Common Pleas found that New Jersey-based Janssen willfully violated the South Carolina Unfair Trade Practices Act by engaging in unfair or deceptive acts or practices in the conduct of any trade or commerce in the “dear doctor” letter of November 10, 2003 and the drug label (package insert). This decision represents the first jury verdict that finds the defendant violated unfair trade practices since the inception of its pharmaceutical product. The “dear doctor” letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal. Risperdal was introduced by Janssen in 1994 and by 2005, generated annual revenues in excess of $3.5 billion.

On June 3, 2011 civil penalties amounting to $327,073,700 were ordered by Circuit Court Judge Roger Couch based upon violations found with the drug labels and “dear doctor” letters. Regarding the drug label violations, the judge ruled that 509,499 package inserts were distributed with sample boxes, and levied $300 per violation for a total drug label awarded damages of $152,849,700. Regarding the “dear doctor” letter violations, the judge ruled that 7,184 letters were mailed and 36,372 were provided during sales calls, and levied $4000 per violation for a total “dear doctor” letter awarded damages of $174,224,000.

The combination of the drug label and letter damages of $327,073,700 amounts to the highest verdict brought against Janssen for the drug Risperdal.

http://www.marketwatch.com/story/record-breaking-327-million-verdict-upheld-in-janssen-case-and-request-for-new-trial-denied-2011-12-21

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In shift, feds target top execs for health fraud

cchrint — Tue, 31 May 2011 20:46:45 +0000

Associated Press
May 31, 2011

Lewis Morris, general counsel for the Department of Health and Human Services inspector general, poses for a portrait in his office in Washington, Thursday, May 26, 2011. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.

The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.

Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.

Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.

The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.

“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes & Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”

Others say high-powered corporate targets won’t go meekly.

“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”

Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.

Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.

A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.

The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”

Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.

The company said it had considered the case closed. But then came the inspector general’s letter.

“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”

Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”

Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.

The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.

It’s making an entire industry nervous.

Read article here: http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

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WSJ: Feds want $1B settlement in J&J Risperdal probe

cchrint — Fri, 13 May 2011 16:19:06 +0000

FiercePharma
By Tracy Staton
May 13, 2011

Johnson & Johnson could be on the hook for about $1 billion to settle the government probe into its Risperdal marketing. Prosecutors are looking for a settlement about that size, the Wall Street Journal reports, citing sources. That would be the third-largest marketing settlement between a Big Pharma company and the U.S. government; only Pfizer and Eli Lilly have made larger deals with the feds.

Earlier this week, J&J disclosed to the SEC that it had set aside an unspecified amount to cover a potential Risperdal settlement. The company had already taken a $1.4 billion charge against first-quarter earnings to cover legal costs.

The WSJ says J&J officials were surprised that prosecutors were pressing for such a large settlement. Prosecutors are trying to put a settlement of Risperdal marketing claims into context, using as a benchmark Lilly’s $1.4 billion deal to resolve a Zyprexa marketing probe. The difference between the two was that Lilly’s alleged violations extended over a longer period of time, the WSJ source said. The particular allegations against J&J haven’t been disclosed.

The Justice Department has settled a number of marketing cases against Big Pharma over the last several years, and the pace of those deals increased last year. Drugmakers together have paid more than $10 billion to settle government probes; in 2010, the industry’s whistleblower settlements topped the Justice Department charts.

Read article here: http://www.fiercepharma.com/story/wsj-feds-want-1b-settlement-jj-risperdal-probe/2011-05-13

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Drug maker to settle 200 lawsuits for failing to warn patients of diabetes risks caused by its antipsychotic drug

cchrint — Fri, 23 Jul 2010 22:30:08 +0000

AboutLawsuits.com
July 23, 2010

AstraZeneca has agreed to settle Seroquel lawsuits filed by about 200 people who claim that the drug maker failed to adequately warn about the risk of diabetes and other side effects of their antipsychotic drug. The Seroquel settlements are reportedly the first payments AstraZeneca has made out of an estimated 26,000 claims that have been presented against the company.

Bloomberg News reports that AstraZeneca has agreed to pay $2 million as a settlement for the Seroquel lawsuits, which comes out to an average of about $10,000 per claim. It is not clear what injuries were involved in these claims, or what the circumstances are for the cases. All of the settled lawsuits involved plaintiffs represented by one attorney, and Bloomberg News reports that the agreement came as a result of court-ordered mediation.

Although AstraZeneca has previously indicated that they would fight all Seroquel cases at trial, company officials now indicate that they will continue to negotiate with plaintiffs’ attorneys.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism.

In July 2006, all Seroquel lawsuits filed in federal courts throughout the United States were consolidated for pretrial litigation before U.S. District Judge Anne Conway in the Middle District of Florida as part of a multidistrict litigation (MDL). In May of this year, Judge Conway determined that the majority of the work in the Seroquel litigation was complete, and began remanding cases back to the original jurisdiction where they were filed for trial.

Read entire article: http://www.aboutlawsuits.com/settlement-for-seroquel-lawsuits-reached-in-some-cases-11647/

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GlaxoSmithKline settles case with woman who linked her use of antidepressant Paxil to the death of her infant son

cchrint — Mon, 19 Jul 2010 19:57:36 +0000

The Associated Press
By Wayne Ortman
July 19, 2010

SIOUX FALLS, S.D. — A settlement has been reached in a lawsuit filed against a pharmaceutical company by a Watertown woman who linked her prescribed use of Paxil to the death of her infant son, according to court files.

Jennifer Berg of Watertown sued SmithKline Beecham, doing business as GlaxoSmithKline, in October 2007. The complaint said Nathan Berg died in 2004 because of a heart disorder caused by her use of the antidepressant Paxil while she was pregnant.

The federal court lawsuit sought unspecified damages from the company for failing to warn of a link between the two. Letters from her attorneys to the presiding judge indicate there’s a settlement. No settlement documents have been filed in court.

Lawyers at a California firm handling the case for Berg did not immediately return a phone call Monday for comment.

GlaxoSmithKline said last week that it expects to take a $2.36 billion charge against second-quarter earnings for settlements, agreements to settle and other provisions for long-standing legal cases over Paxil, the diabetes drug Avandia and other issues. The company said settlement details would be confidential.

According to the lawsuit, Nathan Berg was born Aug. 20, 2004 at Watertown and was immediately transferred to a Minneapolis hospital where he died 58 days later of Persistent Pulmonary Hypertension of the Newborn (PPHN), a disorder which prevents proper oxygenation of the blood.

“At the time Paxil was prescribed to Ms. Berg, GSK (GlaxoSmithKline) knew or should have known through pre-market studies and post-market studies and reports that Paxil was associated with an increased risk of PPHN in babies whose mothers ingested Paxil during pregnancy,” according to the lawsuit.

Read entire article: http://www.google.com/hostednews/ap/article/ALeqM5j7UU4otrHhelqaJFcC3ttvwj4bYgD9H29RK00

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Heavy Doses—Drug Company J&J Pays Docs Millions for “speaking & consulting gigs”

cchrint — Sat, 10 Jul 2010 02:53:39 +0000

Portfolio.com
By Brett Chases
July 9, 2010

Speaking and consulting gigs for drug companies can be lucrative for doctors.

Birmingham, Alabama, psychiatrist James E. Parker was paid more than $21,000 in speaking fees between January and March by a Johnson & Johnson company that sells mental health drugs.

Patricia Quinn, a retired Washington, D.C., physician and expert on attention deficit hyperactivity disorder, received more than $26,00 in the same period for consulting and speaking fees paid by a J&J company that markets Concerta, a leading drug for the condition.

The payments are part of just-released disclosures by J&J, which is following Pfizer Inc. and GlaxoSmithKline Plc in making public the amounts of money it pays physicians for speaking, consulting and conducting clinical trials.

Unlike other drug companies, J&J didn’t aggregate the total payments but the Wall Street Journal tallied the sum to be around $2.85 million in payments in the first quarter. J&J has a large medical device division and it pledges to divulge doctor payments for that business by next year. In three years, drug and device companies will be required to report such payments to the government as part of the new health reform law.

The financial relationships between doctors and health products companies are being scrutinized more closely by critics, Congress and the Justice Department. Pfizer’s decision to reveal its payments wasn’t voluntary. It agreed to do so as part of a $2.3 billion fraud settlement with the government. The company was accused to pushing docs to prescribe medicines for unapproved uses.

Read entire article: http://www.portfolio.com/views/blogs/heavy-doses/2010/07/09/johnson-and-johnson-pays-doctors-millions-in-first-quarter

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Eli Lilly to pay $24 million in Utah Attorney General’s Zyprexa lawsuit/AG says “we want their bad conduct to stop”

cchrint — Thu, 12 Nov 2009 19:50:59 +0000

Geoff Leisik
Deseret News
November 11, 2009

Pharmaceutical giant Eli Lilly and Co. has agreed to pay $24 million to settle a lawsuit filed by the Utah Attorney General’s Office.

Attorney General Mark Shurtleff sued the company after a nearly four-year investigation revealed that Lilly concealed its knowledge of significant weight gain and obesity associated with the anti-psychotic medication Zyprexa. Investigators also showed that Lilly’s sales representatives illegally promoted the drug for uses not approved by the U.S. Food and Drug Administration.

“We’re not just asking them for money. We want their bad conduct to stop,” Shurtleff said Wednesday while announcing the settlement.

“As part of the settlement agreement, there are corporate integrity responsibilities and remedial provisions that will continue to be monitored by the court to stop (Lilly’s) harmful behavior.”

Zyprexa is approved for the treatment of schizophrenia and certain types of bipolar disorder in adults. But authorities say that in 1999, Lilly’s marketing arm that focuses on doctors who treat the elderly began encouraging physicians to prescribe the drug for dementia, Alzheimer’s disease, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. Lilly also trained its sales teams to avoid discussions with health-care professionals about the weight gain side effect, investigators said.

Read entire article: http://www.deseretnews.com/article/705343716/Firm-to-pay-Utah-24M-in-settlement.html

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$112 million settlement: charged with kickbacks from drug company & recommending docs prescribe antipsychotic drug Risperdal

cchrint — Wed, 04 Nov 2009 18:02:03 +0000

Reuters
November 3, 2009

Omnicare Inc, the largest U.S. provider of pharmacy services to nursing homes, will pay $98 million and Teva subsidiary IVAX Pharmaceuticals will pay $14 million to settle allegations of kickbacks, the U.S. Department of Justice said on Tuesday.

The department said Omnicare both solicited and paid kickbacks.

Omnicare allegedly asked IVAX to pay $8 million in exchange for agreeing to purchase $50 million in IVAX drugs, the DOJ said.

It also accused Omnicare of soliciting kickbacks from Johnson & Johnson in exchange for recommending that physicians prescribe the antipsychotic drug Risperdal to nursing home patients.

“J&J’s kickbacks to Omnicare took multiple forms, including rebates that were conditioned on Omnicare engaging in an ‘Active Intervention Program’ for Risperdal and payments disguised as data purchase fees, educational grants, and fees to attend Omnicare meetings,” the Justice Department said.

Read entire article: http://www.reuters.com/article/healthcareSector/idUSN0350746820091103

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Eli Lilly’ s confidential settlement with seven states over its antipsychotic drug Zyprexa

cchrint — Fri, 25 Sep 2009 00:14:06 +0000

Bob Van Voris, Margaret Cronin Fisk and Jef Feeley
Bloomberg.com
September 21, 2009

Eli Lilly & Co. agreed to settle, on confidential terms, lawsuits filed by seven states alleging the company improperly marketed its antipsychotic drug Zyprexa, a court-appointed official said.

“All of the states have essentially settled for the same” non-monetary arrangements, said Michael Rozen, special master appointed by the court to help settlement negotiations. The money terms, which weren’t disclosed, “have fallen roughly in line,” he said at a hearing today in federal court in Brooklyn, New York.

Lawyers told U.S. District Judge Jack B. Weinstein, who is overseeing the cases, that finishing the settlements may be delayed while the parties determine how much money the U.S. government plans to claim in compensation for federal dollars spent on Zyprexa through state Medicaid programs.

If completed and approved in court, the settlements would leave four suits filed by states pending against Lilly.

Read entire article: http://www.bloomberg.com/apps/news?pid=20601103&sid=aUgLzDmvzVK0

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CCHR International » settlement

Whistleblower says antipsychotic drug maker subverted science & induced others to betray patients

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