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Recent JNJ State AG Settlements
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Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
| Department of Justice
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists -
J.&J. to Pay $2.2 Billion in Risperdal Settlement
Nov 4, 2013 | The New York Times
By Katie Thomas
Johnson & Johnson has agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly promoted the antipsychotic drug Risperdal to older adults, children and people with developmental disabilities, the Justice Department said on Monday. -
Attorney General Kamala D. Harris Issues Statement on $2.2 Billion Settlement with Johnson & Johnson
Nov 4, 2013 | State of California Department of Justice
SAN FRANCISCO -- Attorney General Kamala D. Harris today issued the following statement, following the announcement that California joined with 45 states, the District of Columbia and the federal government in a $2.2 billion settlement with Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., over allegations of the companies’ unlawful marketing practices, including off-label promotion and kickbacks, to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega. -
Attorney General Bondi Announces $1.6 Billion Settlement with Johnson & Johnson and Janssen Pharmaceuticals, Inc.
Nov 4, 2013 | Florida Office of Attorney General
TALLAHASSEE, Fla.—Attorney General Pam Bondi announced today that Florida, 39 other states, the District of Columbia, and the federal government reached a global settlement with New Jersey pharmaceutical manufacturer, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., to resolve civil and criminal allegations of unlawful marketing practices to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega. Under the terms of the civil settlement, the companies will pay more than $1.2 billion to the states and the federal government. Florida will receive more than $18.6 million of this settlement. -
A.G. Schneiderman Announces $1.6 Billion Settlement With Johnson & Johnson And Janssen Pharmaceuticals For Illegal Marketing Of Drugs
Nov 4, 2013 | New York State Office of the Attorney General
New York State To Receive $138 Million As Part Of A Settlement With The States And Federal Government Of Civil Claims And Criminal Charges Against The Companies.
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Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
| Department of Justice
WASHINGTON - Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”
In addition to imposing substantial monetary sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). This agreement is designed to increase accountability and transparency and prevent future fraud and abuse.
“As patients and consumers, we have a right to rely upon the claims drug companies make about their products,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “And, as taxpayers, we have a right to ensure that federal health care dollars are spent appropriately. That is why this Administration has continued to pursue aggressively – with all of our available law enforcement tools -- those companies that corrupt our health care system.”
J&J Subsidiary Janssen Pleads Guilty to Misbranding Antipsychotic Drug
In a criminal information filed today in the Eastern District of Pennsylvania, the government charged that, from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded. For most of this time period, Risperdal was approved only to treat schizophrenia. The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The information alleges that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia. The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.
In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients. Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million. Janssen’s guilty plea will not be final until accepted by the U.S. District Court.The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information. Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses. Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.
“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”
J&J and Janssen Settle Civil Allegations of Targeting Vulnerable Patients with the Drugs Risperdal and Invega for Off-Label Uses
In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”
The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks. For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.
The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.” The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.
In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.
The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.
In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.
As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega. This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal. Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments. The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million. The federal government and Texas each received $59 million from the Texas settlement.
Kickbacks to Nursing Home Pharmacies
The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”
J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs. The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million. In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.
“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz. “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”
Off-Label Promotion of the Heart Failure Drug Natrecor
The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.
In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.
The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug. Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor. Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.
As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor. In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.
“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch. “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”
Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement
In addition to the criminal and civil resolutions, J&J has executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business. Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. J&J may recoup monies from executives who are current employees and from those who have left the company. The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.
“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. "Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management. The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing."
Coordinated Investigative Effort Spans Federal and State Law Enforcement
This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud. Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.
The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch. The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.
One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.
The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act. Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.
The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million. Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability.
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J.&J. to Pay $2.2 Billion in Risperdal Settlement
Nov 4, 2013 | The New York Times
By Katie Thomas
Johnson & Johnson has agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly promoted the antipsychotic drug Risperdal to older adults, children and people with developmental disabilities, the Justice Department said on Monday.
The agreement is the third-largest pharmaceutical settlement in United States history and the largest in a string of recent cases involving the marketing of antipsychotic and anti-seizure drugs to older dementia patients. It is part of a decade-long effort by the federal government to hold the health care giant — and other pharmaceutical companies — accountable for illegally marketing the drugs as a way to control patients with dementia in nursing homes and children with certain behavioral disabilities, despite the health risks of the drugs.
The settlement, which requires the approval of a federal judge, will also resolve accusations that the company inappropriately promoted two other drugs, the heart-failure drug Natrecor and Invega, a newer antipsychotic drug.
Much of the conduct highlighted in the case, which for Risperdal extends from 1999 through 2005, occurred while Alex Gorsky was vice president for sales and marketing and later president of the company’s pharmaceutical unit, Janssen. Mr. Gorsky became chief executive of Johnson & Johnson last year. Risperdal, which has lost its patent protection, was once one of the company’s best-selling drugs.
In a news conference announcing the settlement, Eric H. Holder Jr., the United States attorney general, said the company’s practices “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly and the disabled.”
As part of the settlement, Johnson & Johnson has agreed to plead guilty to a criminal misdemeanor, acknowledging that it improperly marketed Risperdal to older adults for unapproved uses. It did not admit to wrongdoing for the civil portion of the settlement, which involves claims that the company promoted the drug’s use in children and the developmentally disabled, as well as accusations that it paid kickbacks to doctors and pharmacists in exchange for writing more prescriptions. The company will pay criminal fines and forfeiture of $485 million and civil penalties of $1.72 billion. The civil settlement also resolves similar accusations brought by 45 states.
Johnson & Johnson said on Monday that it stood by the safety and efficacy of Risperdal and was trying to put the chapter to rest. “This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the well-being of patients around the world,” Michael Ullman, the company’s vice president and general counsel, said in a statement.
But some called into question the extent to which the company could move on, given that Mr. Gorsky was now chief executive. “Stockholders and patients will pay the price for the fraud,” said Patrick Burns, co-director of Taxpayers Against Fraud, an advocacy group for corporate whistle-blowers. “Mr. Gorsky, however, gets to keep his job at Johnson & Johnson and all his bonuses.” Mr. Burns has called on federal officials to hold executives more directly accountable in such cases.
Ernie Knewitz, a spokesman for Johnson & Johnson, noted that the misdemeanor charge was being entered on behalf of the company and no individuals were charged with wrongdoing. “Mr. Gorsky has been an outstanding Johnson & Johnson leader for more than 20 years,” he said.
Johnson & Johnson officials tried to expand the market for Risperdal to older dementia patients soon after the drug was approved in 1993 to treat symptoms of psychiatric disorders, according to federal court filings. The drug, whose generic name is risperidone, was primarily tested in schizophrenia patients, and the Federal Drug Administration repeatedly rejected efforts by the company to expand the drug’s use to older dementia patients, according to the filings.
But Johnson & Johnson, federal officials said, actively pursued the market for geriatric patients. The company created a dedicated sales force, ElderCare, to promote the drug and others to doctors who primarily treated older patients.
The drug, the company claimed, could address symptoms that made treating these patients a challenge, especially in a nursing home setting, including agitation, confusion, hostility and impulsiveness. The company’s sales brochures highlighted these symptoms and minimized the fact that the drug was approved to treat schizophrenia, according to federal documents.
Federal officials said the company knew that Risperdal posed serious health risks for older adults, like an increased risk of strokes, but it played them down. The drug’s label was later updated to warn against the use of the drug in older patients with dementia.
During this period, Risperdal was among the company’s top-selling drugs. In 2004, for example, Risperdal brought in $3.1 billion in sales, accounting for about 5 percent of Johnson & Johnson’s total revenue that year, according to company filings.
Johnson & Johnson was not the only company marketing drugs to older dementia patients and the long-term care facilities where they were treated. Within the last five years, federal officials have reached similar agreements regarding Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; and Depakote, by Abbott, which is now AbbVie.
Federal prosecutors also say, as part of the civil settlement, that Johnson & Johnson promoted the use of Risperdal in people with mental disabilities and children, even though the company did not receive F.D.A. approval to market to children until 2006. Janssen told its sales representatives to visit child psychologists and mental health facilities that mainly focused on children, promoting the drug as a safe treatment for disorders like attention deficit hyperactivity disorder and obsessive-compulsive disorder, the government said.
Johnson & Johnson knew that children were susceptible to certain health risks from taking Risperdal, including the possibility that boys could develop breasts through elevated production of the hormone prolactin, federal officials said.
Monday’s announcement is the latest in a series of large settlements involving pharmaceutical companies and allegations of improper marketing. Last year, the British drug maker GlaxoSmithKline reached a settlement of $3 billion over the marketing of several drugs, and in 2009, Pfizer settled with the government for $2.3 billion in a deal involving the painkiller Bextra, which is no longer on the market.
“As a group these have kind of sent a message to the pharmaceutical industry that this kind of widespread fraud and disregard for F.D.A. regulations isn’t going to be tolerated,” said David Stone, a lawyer on a team representing the four whistle-blowers who sued to bring the Johnson & Johnson accusations to light. They will share a reward of $112 million from the federal portion of the settlement. Still, Mr. Stone said, the incentives to commit wrongdoing remain. “The more they can expand market share, the more money they make.”
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Attorney General Kamala D. Harris Issues Statement on $2.2 Billion Settlement with Johnson & Johnson
Nov 4, 2013 | State of California Department of Justice
SAN FRANCISCO -- Attorney General Kamala D. Harris today issued the following statement, following the announcement that California joined with 45 states, the District of Columbia and the federal government in a $2.2 billion settlement with Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., over allegations of the companies’ unlawful marketing practices, including off-label promotion and kickbacks, to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega.
California’s share of the national settlement is $89 million, which is the largest recovery ever for California from a national civil settlement regarding atypical antipsychotic drugs.
“Motivated by profit, these companies made false claims that jeopardized the health of California’s most vulnerable patients, including children and senior citizens—and left California taxpayers with the bill,” said Attorney General Harris. “Today’s record settlement reinforces the California Department of Justice’s commitment to rooting out this kind of greed wherever we find it.”
As part of this global resolution, the companies have agreed to resolve civil liabilities for their alleged unlawful conduct, which caused false and/or fraudulent claims to be submitted to Medi-Cal and improper Medi-Cal purchases. The complaint highlights practices by Johnson & Johnson and Janssen, including marketing to patient populations (children, adolescents and the elderly) for whom the drugs were not FDA approved and making false and misleading statements about the efficacy of these drugs.
To compensate the Medicaid programs, the companies will pay $1.114 billion as the combined federal and states’ share of the civil settlement for both drugs. After a statutory relator’s share is paid to the whistleblowers who brought the fraud to the attention of the government, the Department of Health Care Services will be reimbursed $44.5 million for losses incurred from the fraud; the remainder will go to support Medi-Cal fraud and enforcement efforts.
In addition, Janssen Pharmaceuticals, Inc. plead guilty to a criminal misdemeanor charge of misbranding Risperdal in violation of the Food, Drug, and Cosmetic Act. As part of the criminal plea, Janssen has agreed to pay an additional $400 million in criminal fines and forfeitures.
The Attorney General’s Bureau of Medi-Cal Fraud and Elder Abuse investigates and prosecutes claims of Medi-Cal civil and criminal fraud, as well as allegations of elder abuse, such as physical assaults or financial theft.
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Nov 4, 2013 | Florida Office of Attorney General
TALLAHASSEE, Fla.—Attorney General Pam Bondi announced today that Florida, 39 other states, the District of Columbia, and the federal government reached a global settlement with New Jersey pharmaceutical manufacturer, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., to resolve civil and criminal allegations of unlawful marketing practices to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega. Under the terms of the civil settlement, the companies will pay more than $1.2 billion to the states and the federal government. Florida will receive more than $18.6 million of this settlement.
"This $18 million recovery reflects our hard work to protect Florida's taxpayers and to ensure that Medicaid funds are preserved for the neediest among us," stated Attorney General Pam Bondi.
The settlement resolves four qui tam, or whistleblower, lawsuits filed in the United States District Court for the Eastern District of Pennsylvania, under the provisions of the federal False Claims Act and similar state False Claims statutes. In addition, Janssen Pharmaceuticals, Inc. will plead guilty in federal court to a criminal misdemeanor charge of misbranding Risperdal in violation of the Food, Drug, and Cosmetic Act. As part of the criminal plea, Janssen has agreed to pay $400 million in criminal fines and forfeitures.
J&J and Janssen allegedly promoted, marketed, and introduced Risperdal and Invega into interstate commerce for uses that were not approved by the Food and Drug Administration and for uses that were not medically indicated. Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote a drug for an “off-label” use, i.e., any use not specified in the FDA-approved product label. The states contend that during the period January 1, 1999 through December 31, 2005, the companies promoted Risperdal for off-label uses, made false and misleading statements about the safety and efficacy of Risperdal, and paid illegal kickbacks to health care professionals and long-term care pharmacy providers to induce them to promote or prescribe Risperdal to children, adolescents and the elderly when there was no FDA approval for Risperdal use in these patient populations. The states further contend that from January 1, 2007 through December 31, 2009, the companies promoted Invega for off-label uses and made false and misleading statements about the safety and efficacy of Invega. The manufacturers’ alleged unlawful conduct caused false and/or fraudulent claims to be submitted to or caused purchases by government funded health care programs, including the state Medicaid programs.
As part of the global resolution, the companies will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing practices. -
Nov 4, 2013 | New York State Office of the Attorney General
NEW YORK – Attorney General Eric T. Schneiderman today announces that New York has joined with other states and the federal government in a $1.6 billion settlement resolving civil and criminal allegations that Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., promoted the sale and use of Risperdal and Invega for uses not approved by the U.S. Food and Drug Administration and introduced Risperdal and Invega into interstate commerce. Risperdal and Invega are anti-psychotic medications approved by the FDA to treat schizophrenia and Bipolar I Disorder during the periods outlines below.
“Parents of children with hyperactivity disorders and other vulnerable patients should be able to trust their doctor’s advice without fear that drug companies are manipulating their physician’s judgment. This settlement should serve as a warning to pharmaceutical corporations: the illegal promotion of drugs for off-label uses must stop,” Attorney General Schneiderman said. “This landmark agreement holds companies accountable for practices that put patients in danger, and reaffirms one set of rules for the pharmaceutical giants—and it goes even further by ensuring that corporations stop rewarding doctors for prescribing certain drugs.”
Johnson & Johnson and Janssen, pharmaceutical manufacturers based in New Jersey, agreed to pay the states and the federal government more than $1.2 billion in civil damages and penalties to compensate Medicaid, Medicare, and various other government programs. Additionally, Janssen will plead guilty in federal court in Philadelphia, Pennsylvania, to violations of the U.S. Food, Drug, and Cosmetics Act and has agreed to pay $400 million in criminal fines and forfeitures. More than $523 million of the civil settlement will go to state Medicaid programs, which are funded jointly by the states and the federal government. New York State’s Medicaid program will receive more than $138 million. The remaining $749,240,137 is designated for federal health care programs, including the federal Medicaid share, affected by the companies’ conduct.
The investigation resulted from four whistleblower lawsuits filed in the United States District Court for the Eastern District of Pennsylvania, under the federal False Claims Act and various state false claims acts, including the New York False Claims Act. The U.S. and the states contend that from January 1, 1999, through December 31, 2005, the companies marketed Risperdal for off-label uses, made false and misleading statement about the safety and efficacy of Risperdal, and paid illegal kickbacks to health care professionals and long-term care pharmacies to induce them to promote or prescribe Risperdal to patient populations, such as children, adolescents and the elderly, for which there was no FDA approval. They further contend that from January 1, 2007, through December 31, 2009, the companies promoted Invega for off-label uses and made false or misleading statements about the safety and efficacy of Invega.
As part of the global resolution, the companies have also entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
A team from the National Association of Medicaid Fraud Control Units, led by New York and Massachusetts, worked closely with the federal government on the investigation, and conducted the settlement negotiations with the pharmaceutical manufacturers on behalf of the states. For New York State, the case was handled by Special Assistant Attorney General Marie Spencer of the Attorney General’s Medicaid Fraud Control Unit; Computer Program Analyst Nicholas Furnari; Supervising Special Auditor/Investigator Theresa White; Associate Special Auditor/Investigator Deowattie Persaud; and Senior Special Auditor/Investigator Matthew Tandle, under the supervision of Assistant Chief Auditor Michael LaCasse, MFCU Deputy Attorney General Monica Hickey-Martin, and Executive Deputy Attorney General for Criminal Justice Kelly Donovan.
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