Health Care & Reproductive Rights

SACRAMENTO -- Attorney General Kamala D. Harris today applauded Governor Jerry Brown’s signature of legislation she sponsored to upgrade and expand California’s prescription drug monitoring program.

The Department of Justice’s Controlled Substance Utilization Review and Evaluation System (CURES) program and Prescription Drug Monitoring Program (PDMP) allow authorized prescribers and pharmacists to quickly review controlled substance information and patient prescription history in an effort to identify and deter drug abuse and diversion.

“I applaud Governor Brown for signing this important piece of legislation, which allows us to strengthen a critical tool to fight prescription drug abuse in California," Attorney General Harris said.

Senate Bill 809 by Senator Mark DeSaulnier (D-Concord) will require all prescribers and dispensers to enroll in and use the system.

“SB 809 is an important step in fighting the prescription drug abuse epidemic,” Senator DeSaulnier said. “Governor Brown’s signature ensures sustainable funding for one of the Department of Justice’s most powerful tools in fighting prescription drug abuse. SB 809 prevents California going from first to worst when it comes to monitoring prescription narcotics. The funding for an upgraded CURES program is a small price to pay when so many lives are at stake.”

Attorney General Harris has worked hard to save the CURES program, which had its funding slashed to almost nothing when the Department of Justice took a $71 million budget cut two years ago. She formed a working group with interested parties to push for an improved prescription drug monitoring system.

SB 809 includes a small increase in the provider license fee of 1.16 percent to pay for the annual cost to operate the program and a one-time assessment on health care plans for the upgrade, which will modernize and improve the information gathering and sharing.

Current funding sources are insufficient to operate and maintain CURES.  If another source of funding is not identified, the program will be eliminated on July 1, 2013.

SACRAMENTO -- Attorney General Kamala D. Harris today praised the passage of a bill she is sponsoring to upgrade and expand California’s prescription drug monitoring program as an important step in combating a serious public health and law enforcement issue. The bill passed out of the Senate Business and Professions Committee on a 7 to 2 vote.

The Department of Justice’s Controlled Substance Utilization Review and Evaluation System (CURES) program and Prescription Drug Monitoring Program (PDMP) allow authorized prescribers and pharmacists to quickly review controlled substance information and patient prescription history in an effort to identify and deter drug abuse and diversion.

“This legislation will modernize and strengthen the program and provide doctors and law enforcement with a powerful tool to fight prescription drug abuse,” Attorney General Harris said. “CURES is about making government smarter and more efficient. Senate Bill 809 will help save lives.”

Senate Bill 809 by Senator Mark DeSaulnier (D-Concord) will require all prescribers and dispensers to enroll in and use the system.

“SB 809 allows us to not only save, but strengthen, the CURES program,” said Senator DeSaulnier. “This must be a top priority for California. The technology exists for us to make a real difference in the prescription drug epidemic, and too many lives have been lost for us not to take action. The price to pay is small when there are thousands of lives on the line.”

“Criminal street gangs use the sale of prescription drugs to fund their operations in the United States,” said Chief Dan Drummond of the West Sacramento Police Department. “CURES is a multi-faceted tool that can be used for intervention, prevention, education and ultimately enforcement.”

Attorney General Harris has worked hard to save the CURES program, which had its funding slashed to almost nothing when the Department of Justice took a $71 million budget cut two years ago. She formed a working group with interested parties to push for an improved prescription drug monitoring system.

SB 809 includes a small increase in the provider license fee of 1.16 percent to pay for the annual cost to operate the program and a one-time assessment on health care plans for the upgrade, which will modernize and improve the information gathering and sharing.

In addition, an annual fee on narcotic drug manufacturers who do business in California will pay for two State of California Regional Investigative Prescription Teams. These teams will increase investigation into incidents of prescription drug abuse, pursue organized crime and provide oversight and auditing of prescription pad printers.

Current funding sources are insufficient to operate and maintain CURES.  If another source of funding is not identified, the program will be eliminated on July 1, 2013.

Video of the press conference can be seen here: http://www.youtube.com/watch?v=WV33itjsrxE

BAKERSFIELD -- Attorney General Kamala D. Harris today announced the sentencing of the former Director of Nursing of a Kern Valley Healthcare District hospital with a skilled nursing facility, a rare case in which a medical professional has been criminally charged and sentenced under elder abuse laws for the illegal chemical restraint of patients. 

Gwen D. Hughes, 59, the former Director of Nursing, was sentenced to three years in state prison Wednesday in Kern County Superior Court. Hughes pled no contest on October 11, 2012 to one felony count of elder abuse with a special allegation that the abuse contributed to the victim’s death.

Hughes ordered the administration of psychotropic medications to 23 elderly residents of the skilled nursing facility not for therapeutic reasons, but instead to control and quiet them for the convenience of staff. The drugs were given to patients who were noisy, prone to wandering, who complained about conditions or were argumentative. The drugs hastened three patients’ deaths, according to the investigation, and all 23 suffered some form of adverse physical reaction as a result. Many of the patients were under care for Alzheimer’s or dementia.

“Elder abuse in skilled nursing facilities is a particularly heinous crime because vulnerable victims and their families have placed their trust in the facilities to provide quality care, preserve their dignity and enjoy a better quality of life,” Attorney General Harris said. “This defendant maliciously and dangerously drugged patients for her own personal convenience. This is clearly outrageous conduct that justifies a state prison sentence.”

This case was investigated and charged by the Justice Department’s Bureau of Medical Fraud and Elder Abuse (BMFEA). Reflecting Attorney General Harris’ career-long commitment to elder abuse prosecutions, BMFEA has created specialized teams in Sacramento and Los Angeles composed of legal and medical professionals to investigate cases involving systemic elder abuse.

The California Department of Public Health began an initial investigation in 2007, following complaints from an ombudsman that a patient in the skilled nursing facility had been held down and injected with psychotropic medicine by force. They found evidence of patient harm, and issued a Certificate of Immediate Jeopardy against the facility, before turning the case over to the Justice Department.

Evidence indicated that Hughes directed the hospital’s director of pharmacy to write doctor’s orders for the unnecessary psychotropic medications.   

The orders were signed at a later time by the medical director. Pamela Ott, former chief executive officer of the Kern Valley Health District, pled no contest to one felony count of conspiracy to commit an act injurious to the public health based on her failure to adequately supervise the Director of Nursing. Ott was sentenced to three years formal probation, 300 hours of volunteer service, restitution pending conclusion of civil lawsuits. She is required to comply with all orders from the Registered Nursing Board, which is conducting its own investigation into the matter. 

In July 2012, Dr. Hoshang Pormir, the Medical Director, was also sentenced to 300 hours of volunteer service, restitution pending conclusion of civil lawsuits, and a requirement to comply with all orders from the Medical Board. Pormir failed to conduct examinations of patients or monitor their reactions to medications.

BAKERSFIELD -- Attorney General Kamala D. Harris today announced the sentencing of the former hospital administrator of Kern Valley Health District, a rare case in which a hospital administrator is being held criminally responsible for conduct by a lower-ranked employee.

Pamela Ott, former hospital administrator of the Kern Valley Health District, pled no contest to one felony count of conspiracy to commit an act injurious to the public health based on her failure to adequately supervise the Director of Nursing. During Ott’s tenure as administrator, Director of Nursing Gwen Hughes administered psychotropic medications to 23 elderly residents in order to chemically restrain them for staff convenience. Three patients died.

“Ott neglected her responsibility to monitor the practices of her employees and, in doing so, she endangered the health and well-being of vulnerable residents,” Attorney General Harris said. “California has strong laws to prevent elder abuse and we will enforce them so we can protect the most vulnerable among us.”

Ott was sentenced to three years formal probation, 300 hours of volunteer service, restitution pending conclusion of civil lawsuits. She is required to comply with all orders from the Registered Nursing Board, which is conducting its own investigation into the matter.  

In July 2012, Dr. Hoshang Pormir, the Medical Director, was also sentenced to 300 hours of volunteer service, restitution pending conclusion of civil lawsuits, and a requirement to comply with all orders from the Medical Board. Pormir failed to conduct examinations of patients or monitor their reactions to medications.

In January 2007, the Department of Public Health began an investigation into complaints stemming from the Healthcare District and found that 23 residents suffered adverse reactions as a result of chemical restraints and unnecessary medications. The Department of Justice’s Bureau of Medical Fraud and Elder Abuse took over the case after the Department of Public Health completed its report.

Ott received complaints, some as early as September 2006, concerning Hughes’ conduct towards staff.  Several staff members also had previously informed Ott that residents were forcefully restrained and injected with medications. Ott disregarded the complaints and directed staff to comply with Hughes’ instructions.

Hughes will face a jury trial beginning October 29, 2012 in Kern County Superior Court. She is being charged with multiple felony counts of elder abuse resulting in death, elder abuse resulting in great bodily injury, and assault with force likely to cause great bodily injury. 

SACRAMENTO -- Attorney General Kamala D. Harris today announced a $323.67 million settlement with a Los Angeles-based health maintenance organization over excess Medi-Cal and Medicare payments.

The settlement with SCAN Health Plan, Senior Care Action Network, and Scan Group (collectively known as SCAN), which provides health care and support services in Southern California to the elderly and disabled, constitutes the largest Medi-Cal recovery in the state’s history.

“Californians have lost millions of dollars that should have been going toward the health care of our most vulnerable citizens,” said Attorney General Harris. “This settlement will bring a significant amount of those funds back to the state when it is dearly needed, and I commend all of those involved in this action.”

The matter was initially investigated by the State Controller's Office.  The state Attorney General’s Bureau

of Medi-Cal Fraud and Elder Abuse then commenced its own investigation in cooperation with the United

States Attorney’s Office in Los Angeles. The investigation was conducted with the assistance of the California Department of Health Care Services (DHCS), which administers the Medi-Cal program.

A small component of the settlement resolves certain federal Medicare allegations brought by James M. Swoben in a lawsuit filed in July 2009 in federal court in the Central District of California. Mr. Swoben is a former employee of SCAN.  The lawsuit was filed pursuant to the federal and state False Claims Acts, which provide that any person with information about a false claim can file a sealed lawsuit on behalf of the government to recover the government’s losses.

The federal government will be receiving $3.82 million for the Medicare portion of the settlement. For the Medi-Cal portion of the settlement, $319.85 million will be split between the federal government and California, with the federal government receiving $129.38 million and the state $190.47 million. 

The settlement resolves the state’s allegations that SCAN failed to provide contractually required financial information to DHCS, thereby impairing the department from revising capitation rates for SCAN.

“This settlement is a victory for the Medi-Cal beneficiaries we serve,” said DHCS Director Toby Douglas.

“Using the scarce resources available in the most efficient way possible is a top priority for the state. We will continue our ongoing efforts to strengthen programs that protect the integrity of Medi-Cal.”

A copy of the Third Amended Complaint and copies of the settlement agreement; Joint Notice of Election to Intervene in Part; and the Notice of Dismissal and Order Thereon are attached to the online version of this release at www.oag.ca.gov.

SAN FRANCISCO -- Attorney General Kamala D. Harris announced today that California joined 28 other states in a $151 million settlement with one of the nation’s largest drug wholesalers to resolve allegations the company inflated the price of prescription drugs by as much as 25 percent, causing the states’ Medicaid programs to overpay millions of dollars in pharmacy reimbursements.

California’s recovery of the settlement with San Francisco-based McKesson Corporation is $23,585,849.

“In these difficult budget times, it is crucial that California’s scarce public resources support the urgent needs of our state,” said Attorney General Harris. “We cannot allow dollars meant for patients to be diverted to inflate corporate profits.”

Today’s settlement resolves allegations that McKesson Corporation deliberately inflated the Average Wholesale Prices (AWPs) it reported to First Data Bank, a publisher of drug prices, causing California to overpay on branded prescription drugs from August 1, 2001 through December 31, 2009. Medi-Cal sets the reimbursement rates for pharmacies for many of the drugs dispensed to Medi-Cal patients based on the AWP.

The Medicaid program, which is known as Medi-Cal in California, is funded jointly by the federal government and the State of California.

The settlement is based on a 2005 qui tam case filed under the false claims statutes of the federal government, as well as California and other states.  In April 2012, the federal government settled the federal portion of the lawsuit for more than $187 million.

A team of attorneys and investigative auditors from the California Attorney General’s Office and the New York Attorney’s General Office were appointed by the National Association of Medicaid Fraud Control Units to investigate and conduct the settlement negotiations with McKesson on behalf of the participating states.

Joining California and New York in the settlement are the District of Columbia and the following 27 states: Arkansas, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Maine, Michigan, Minnesota, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wyoming.

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.

A copy of California’s settlement agreement is attached to the online version of this release at http://oag.ca.gov/.   

SAN FRANCISCO -- Attorney General Kamala D. Harris, joined by other attorneys general and the U.S. government, today announced a $3 billion settlement with GlaxoSmithKline (GSK) to resolve allegations the company engaged in various illegal schemes related to the marketing and pricing of drugs it manufactures. 

Today’s action is the largest healthcare fraud settlement in history. California will receive more than $46 million. The $3 billion settlement includes $2 billion in damages and civil penalties to compensate state and federal healthcare programs, including California’s Medi-Cal program, for harm allegedly suffered as a result of the illegal conduct. In addition, GSK has agreed to plead guilty to federal criminal charges related to drug labeling and FDA reporting and pay a $1 billion criminal fine. 

“Californians have the right to expect that their health and well-being – and not profit – drives decisions about their care,” said Attorney General Harris. “This settlement protects consumers and puts an end to unscrupulous marketing practices, kickbacks and illegal labeling of prescription drugs.”

California, along with 44 other states and the federal government, alleged that GSK engaged in a pattern of unlawfully marketing certain drugs for uses for which they were not approved by the Food and Drug Administration (FDA); making false representations regarding the safety and efficacy of certain drugs; offering kickbacks to medical professionals; and underpaying rebates owed to government programs for various drugs paid for by Medicaid and other federally-funded healthcare programs.

Specifically, the government alleged that GSK engaged in the following activities:

• Marketing the depression drug Paxil for off-label uses, such as use by children and adolescents; 
• Marketing the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages;
• Marketing the asthma drug Advair for off-label uses, including first-line use for asthma;
• Marketing the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions;
• Marketing the nausea drug Zofran for off-label uses, including pregnancy-related nausea;
• Making false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
• Offering kickbacks, including entertainment, cash, travel, and meals, to healthcare professionals to induce them to promote and prescribe Paxil, Wellbutrin, Advair, Lamictan, Zofran, the migraine drug Imitrex, the irritable bowel syndrome drug Lotronex, the asthma drug Flovent, and the shingles and herpes drug Valtrex; and,
• Submitting incorrect pricing data for various drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs. 

As part of the settlement, GSK has also agreed to plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (“FDCA”) in connection with certain activities.  The government alleges that GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs were misbranded, meaning containing labels that were not in accordance with their FDA approvals, and that GSK failed to report certain clinical data regarding Avandia to the FDA.

The settlement is based on four qui tam actions brought by private individuals pursuant to state and federal false claims acts and filed in or transferred to the United States District Court for the District of Massachusetts, as well as investigations conducted by the U.S. Attorney’s Office for the District of Massachusetts and the Civil Frauds Division of the U.S. Department of Justice, and a team of attorneys from the Medicaid Fraud Control Units of California (a unit within the Attorney General’s Office), Colorado, Massachusetts, New York and Ohio.

SAN FRANCISCO -- Attorney General Kamala D. Harris today issued the following statement regarding the U.S. Supreme Court’s decision on the Affordable Care Act:

“Today’s decision is a historic victory for Californians, for the President, and for the country. The Affordable Care Act repairs a healthcare system badly in need of reform and ensures that every American has access to affordable health care. We never doubted the constitutionality of this law, and it is already making a difference in the lives of millions of Californians.”

SAN FRANCISCO -- Attorney General Kamala D. Harris today announced two historic settlements with Abbott Laboratories over the illegal off-label marketing of its Depakote drug.

California joined other states and the federal government in a $1.5 billion civil and criminal settlement with Abbott Laboratories. The second largest recovery ever from a pharmaceutical company, this settlement resolves false claims made by Abbott Laboratories to Medicaid and other federal healthcare programs. The second settlement, a $100 million civil consumer protection settlement, is the largest consumer protection settlement ever reached with a pharmaceutical company.

As a result of the settlements, Abbott Laboratories will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration.

“This company put people in harm’s way through the deceptive off-label uses of its drug,” Attorney General Harris said. “Californians should be able to trust the companies that produce pharmaceuticals and the magnitude of this settlement shows the seriousness of the offenses.”

As part of the $1.5 billion settlement, Abbott Laboratories will pay the states and the federal government $800 million in civil damages and penalties to compensate Medicaid, Medicare, and various federal healthcare programs for harm suffered as a result of its conduct. The California gross share recovery is $52 million plus 2.5 percent annual interest, which will be split among various parties, including the U.S. Department of Health Care Services, the whistleblowers the California Department of Health Care Services and the California False Claims Act Trust.

Abbott Laboratories also pled guilty this morning to a violation of the Food, Drug, and Cosmetic Act (FDCA) and agreed to pay $700 million in criminal fines. Further as a condition of the settlement, Abbott Laboratories will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General.

“We are pleased that this settlement retrieves scarce Med-Cal funds that should be used for the care of vulnerable Californians,” said California Department of Health Care Services Director Toby Douglas. “Protecting the fiscal integrity of Medi-Cal remains a top priority for this department.”

The $1.5 billion settlement includes 49 states and the District of Columbia and is based on four qui tam cases filed under federal and California false claims statutes. A team appointed by the National Association of Medicaid Fraud Control Units participated in the investigation and conducted the settlement negotiations with Abbott on behalf of the participating states. Team members from the Attorney General Harris’ Bureau of Medi-Cal Fraud and Elder Abuse include Investigative Auditor Martha Valdez, Special Agent Supervisor Cynthia Bentley and Deputy Attorneys General Matt Kilman and Carlotta Hivoral.

The second settlement announced today included 44 other states and the District of Columbia. The $100 million consumer protection settlement included $6.7 million for California, the largest share of any state.

In the complaint filed today with the settlement agreement, the states alleged that Abbott engaged in unfair and deceptive practices when it marketed Depakote for off-label uses. Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines, but the attorneys general alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.

As a result of the states’ investigation, Abbott has agreed to significantly change how it markets Depakote and to cease promoting off-label uses.

Under the consumer protection settlement, Abbott Laboratories is:
-Prohibited from making false or misleading claims about Depakote
-Prohibited from promoting Depakote for off-label uses
-Required to ensure financial incentives on sales do not promote off-label uses of Depakote

In addition, for a five-year period Abbott must:
-Limit responses to requests by physicians for non-promotional information about off-label uses of Depakote
-Limit dissemination of reprints of clinical studies relating to off-label uses of Depakote
-Limit use of grants and continued medical education
-Disclose payments to physicians
-Register and disclose clinical trials

Joining California in the consumer protection settlement are the Attorneys General of the District of Columbia and the following states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin.

SAN FRANCISCO -- Attorney General Kamala D. Harris today issued the following statement:

“As Attorney General of California, I am committed to protecting our nation’s landmark federal healthcare reform law.

Today marks the second anniversary of the Affordable Care Act. This historic reform to our healthcare system protects everyone, particularly the most vulnerable among us, including our children and seniors. Californians can no longer lose their health coverage for being ill, and soon they will not be denied coverage on the basis of a pre-existing condition.

Joined by other Attorneys General, my office has vigorously defended the constitutionality of health care reform in the U.S. Supreme Court and federal appellate courts. Our legislature should be commended for passing a robust package of laws to ensure the swift implementation of the Affordable Care Act in California.”