Mass Joins DOJ Johnson & Johnson Lawsuit over Risperdal Off Label Use

On March 11, The Boston Globe reported that Massachusetts has joined the federal lawsuit against pharmaceutical company Johnson & Johnson regarding their off label promotion and kick-back program with Omnicare, the nation's largest pharmacy serving nursing homes. As discussed in a prior post, the U.S. Department of Justice filed suit in January against J&J after settling with Omnicare.

According to The Globe, Massachusetts Attorney General Martha Coakley will join the suit over the marketing and promotion of the drug Risperdal for off label use. The medication is used to treat severe mental illness, but has been allegedly pushed by the company for the off label use of treating dementia in nursing home patients. It is legal for physicians to prescribe drugs off label to treat people with dementia. However, drug companies are prohibited from marketing drugs for any off label use. "The inappropriate off label marketing of anti-psychotic drugs to nursing homes is a significant health and safety issue for our seniors,’’ Coakley said in a statement released by her office.

The other issue addressed by the suit is the payment by the drug company of millions of dollars to Omnicare to encourage the company to intensively push the use of Risperdal between 1999 and 2004, using rebate programs and other incentives. The push by J&J was allegedly successful, nearly tripling the amount of their products sales to Omnicare.

The federal suit against Omnicare was settled last November.

The Globe reports Johnson & Johnson spokeswoman Carol Goodrich said in a statement yesterday that “airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.’’

“We look forward to the opportunity to present our evidence in court,’’ Goodrich said.

Related Resources:

• State joins antipsychotic drug lawsuit (The Boston Globe)
• DOJ Files Suit Against Johnson & Johnson For Alleged Kickbacks (FindLaw's Common Law)
• U.S. Files Suit Against Johnson & Johnson for Paying Kickbacks to Nation’s Largest Nursing Home Pharmacy (DOJ)
• Nursing Home Checklist (FindLaw)
• Nursing Home Injuries FAQ (provided by Knapp & Roberts)
• Products Liability FAQ (provided by Shamberg, Johnson & Bergman)

DOJ Files Suit Against Johnson & Johnson For Alleged Kickbacks

Last November, the Department of Justice reached a $98 million settlement agreement with Omnicare, Inc., the nation's largest pharmacy specializing in prescribing for nursing home patients, over alleged kickbacks in violation of the False Claims Act. On January 15, the Dept. of Justice announced it is filing suit against the other member in the alleged kickback scheme, Johnson & Johnson and its subsidiaries, Ortho-McNeil-Janssen Pharmaceuticals Inc., and Johnson & Johnson Health Care Systems Inc.

The DOJ announced in a recent press release that it has filed suit, under the False Claims Act (as with Omnicare), against J&J and its subsidiaries, for what it alleges is a system of kickbacks designed to entice Omnicare pharmacists to recommend J&J drugs for patients in the nursing homes that it serves. According to the complaint, Omnicare pharmacists reviewed nursing home patients' charts "at least monthly" and made recommendations to physicians for J&J drugs which were followed more than 80% of the time. In fact, the government alleges that the recommendations by pharmacists were so pervasive and well received that Johnson actually viewed the pharmacists as an "extension of [J&J’s] sales force."

Among the types of inducements J&J was alleged to have offered Omnicare were increasing levels of rebates based on how many programs Omnicare implemented to increase the number of J&J drugs prescribed, payment for data that never materialized, "grants" and educational funding which were merely further payment for recommending the company's products.

Under its settlement with the government, Omnicare has admitted no wrongdoing.

Johnson & Johnson issued a statement denying the allegations and stating in part, "We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate. We look forward to the opportunity to present our evidence in court."

Related Resources:

• U.S. Files Suit Against Johnson & Johnson for Paying Kickbacks to Nation’s Largest Nursing Home Pharmacy (DOJ)
• J&J Nursing Home Kickback Scheme Tripled Sales, DOJ Alleges (BNet)
• Nursing Home Checklist (Findlaw)

Health Care Study: Discussing End-of-Life Choices Lowers Costs

A health care study published Monday finds that patients who discuss their end-of-life care options with their physicians, and then make their wishes known, incur significantly lower health care costs in the final weeks of their lives.

The Archives of Internal Medicine study released Monday, Health Care Costs in the Last Week of Life: Associations with End-of-Life Conversations, compared the health care costs of 603 terminal cancer patients, based on whether or not they had discussed end-of-life care with their doctors. The report concludes that "Patients with advanced cancer who reported having end of life conversations with physicians had significantly lower health care costs in their final week of life. Higher costs were associated with worse quality of death."

Reuters reports that patients who have end-of-life care discussions with their doctors tend to choose cheaper "palliative" care options either at home or in a hospice, "to relieve suffering rather than to halt progression or cure the disease." Palliative care doesn't typically include "costly treatments like emergency resuscitation, ventilators to breathe for them and movement to a hospital's intensive care unit," according to Reuters.

• Health Care Costs in the Last Week of Life: Associations with End-of-Life Conversations (Archives of Internal Medicine)
• Reuters: Discussing End-of-Life Care Lowers Cost - U.S. Study
• L.A. Times: Terminally Ill Patients Feel Abandoned by Doctors
• Living Wills and Powers of Attorney for Health Care: How They Work (FindLaw)
• Advance Directives, Living Wills, Powers of Attorney: What's the Difference? (FindLaw)
• Check Out a Sample Living Will (FindLaw)
• Patient Rights (provided by Casper & de Toledo LLC)

State of Washington 'Death with Dignity' Act Goes Into Effect Thursday

A new "Death with Dignity" law goes into effect in the state of Washington on Thursday, allowing doctors in the state to prescribe lethal levels of medication for certain patients who have received a terminal prognosis and been given six months or less to live.

Physicians and health care facilities in the state may choose not to provide services under the Washington 'Death with Dignity' Act, which was approved by voters last November. And as the Seattle Post-Intelligencer reports, at least two major hospitals in the state have already announced that they will not provide treatment under the new law.

The new Washington 'Death with Dignity' Act closely mirrors Oregon's version of the law, which has been on that state's books since 1994. A 2006 U.S. Supreme Court decision upheld Oregon's assisted-suicide law, and declared that states have the authority to regulate health care, including the legality of controversial practices like physician-assisted suicide. According to the Atlanta Journal-Constitution, 36 states have specifically criminalized assisted suicide, while courts in six more states and the District of Columbia have issued rulings that effectively outlaw the practice.

• Washington 'Death with Dignity' Act [PDF] (Washington Secretary of State)
• Seattle Post-Intelligencer: Prosser Hospital Won't Help in Assisted Suicides
• Boston Herald: Washington 'Death with Dignity' Law Kicks In
• Huffington Post: Assisted Suicide Cases Highlight Public Support for Physician Aid in Dying
• Atlanta Journal-Constituton: Laws on Assisted Suicide Vary by State
• State of Oregon 'Death with Dignity' Act (Oregon.gov)
• Gonzales v. Oregon: U.S. Supreme Court Decision Upholding Oregon's 'Death with Dignity' Law (FindLaw)
• Health Care and the Law: Articles, FAQ, and More (FindLaw)
• Living Wills and Healthcare Power of Attorney (FindLaw)