Posted On: October 25, 2011

Allegations of Illegal Pharmaceutical Marketing Rarely Lead to Penalties for Doctors

A recent review by the Washington Post of lawsuits against pharmaceutical companies shows that drug manufacturers pay billions in settlements and criminal penalties for irregular and illegal marketing of prescription medications. Doctors who participate in the marketing schemes, usually by accepting kickbacks for prescribing particular drugs, however, rarely if ever receive any punishment. This presents a concern for nursing home residents and their advocates. While the big drug companies present deeper pockets and higher-profile targets for regulators, doctors work on the front lines, so to speak, and have the greatest ability to assess the need for particular drugs. Ultimately, the decisions of doctors have the capacity to do the most harm to patients in these situations.

Butterfly_on_Zinnia_10252011.jpgThis Maryland Nursing Home Lawyer Blog has reported earlier on a complaint by the U.S. Department of Justice against Johnson & Johnson regarding alleged kickback payments to a large pharmacy for sales of antipsychotic medications like Risperdal. The suit alleged that J&J’s actions violated warnings from the Food and Drug Administration regarding the accuracy of Risperdal’s marketing materials. Drug manufacturer Eli Lilly pleaded guilty in 2009 to illegally marketing the antipsychotic drug Zyprexa to elderly patients. Accusations of marketing fraud regarding prescription medications and outright kickbacks to pharmacies and doctors in exchange for promoting certain drugs have hit at least fifteen pharmaceutical and medical device companies in the past few years.

The liability for illegal marketing and payment of kickbacks can be substantial for these companies. Eli Lilly paid $1.4 billion for penalties in the Justice Department’s case and settlements in four separate lawsuits related to Zyprexa. Alpharma paid $42.5 million in settlements related to allegations of kickbacks for prescribing the painkiller Kadian. Overall, accusations of marketing fraud and kickbacks have cost the industry $6.5 billion since 2008

The review of these cases found no instances of doctors facing serious sanctions or even professional discipline. Since 2008, federal investigations into kickbacks and illegal marketing have identified 75 doctors who allegedly participated. None received any sort of monetary or other criminal penalty. Few state medical boards conducted investigations into the doctors’ conduct. Many of the doctors allegedly involved say they have been unfairly labeled as key players in these schemes, when in fact they also rely on the drug companies for information on potential uses of their products. Still, doctors should approach any off-label use (i.e. any use not explicitly approved by the FDA) with caution.

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Posted On: October 19, 2011

October is Long-term Care Residents’ Rights Month in Maryland and around the Country

October is Long-term Care Residents’ Rights Month, a time to celebrate the rights and dignity of people living in nursing homes. Thanks to strong legislation and regulations, nursing home residents have a legal guarantee of certain protections against abuse and neglect. Residents do not give up their rights as adult citizens solely by virtue of entering a nursing home environment. All nursing homes participating in Medicaid and Medicare must respect the rights covered by this law.

chair2_xenia_10182011.jpgCongress passed the 1987 Nursing Home Reform Act after a study conducted by the Institute of Medicine found alarming rates of inadequate care, abuse, and neglect in nursing homes around the country. The Institute recommended a wide range of reforms that became law as part of a budget bill. The law aims to protect the physical, mental, and psychosocial wellness of nursing home residents by requiring nursing homes to provide certain services and creating a “Resident’s Bill of Rights.” Nursing homes must comply with the law in order to remain eligible to accept Medicare and Medicaid payments. Laws passed in 2010 expand on the rights protected by the 1987 law.

Nursing homes are required by this law to provide each resident with a personalized comprehensive care plan, along with periodic assessments of their care. They must provide nursing and social services, as well as rehabilitation and the ability to dispense prescription medications. Facilities with more than 120 beds should employ a full-time social worker to assist residents.

The Residents’ Bill of Rights lists numerous rights protected by federal law. These include:
- Freedom from abuse, neglect, or restraint;
- Privacy;
- Dignity;
- A clean and safe environment;
- Accommodation of particular medical and other needs;
- Communication and visitation with others;
- Participation in one’s care plan and frequent updates regarding one’s health condition;
- Complaint without fear of retribution;
- Control of one’s own finances, if possible; and
- Refusal of treatment when desired.

The Nursing Home Reform Act created an enforcement procedure that begins with routine inspections by state governments to review a nursing home’s certification. Surveyors may also investigate specific complaints or allegations, reviewing the amount of danger faced by residents and the likelihood that the alleged incident might occur again. One serious consequence of non-compliance with the law involves loss of Medicare and Medicaid eligibility. The law allows penalties ranging from remedial training for staffers to state management of the nursing home or outright termination of the home’s provider agreement with the state.

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Posted On: October 11, 2011

Investigation Finds New York Caregivers for Mentally Disabled Rarely Lose Their Jobs, Even in Cases of Wrongdoing

A study conducted by the Poughkeepsie Journal has found that the state of New York has only succeeded twice in twenty attempts since 2007 to fire employees at local state-run facilities that care for the developmentally disabled. The Journal reviewed 1,900 pages of documents relating to disciplinary proceedings for 98 group homes and 6 institutions throughout the state. It found that only two percent of disciplinary actions since 2007, eight out of 341, resulted in firing, even in cases involving serious allegations of neglect or abuse.

winter_2004_16_o10112011.jpgExamples from the study of people who kept their jobs included a female staffer who held a patient by the hair and, while jabbing the patient in the face and yelling obscenities, forced the patient to drink an unknown liquid. Another case involved an aide who held a patient down on the ground by kneeling on the patient’s back and grabbing at the patient’s face, and who then tried to coerce a coworker into altering the report. That worker faced an assault charge in criminal court.

Not all workers involved in these cases actually remained at their facilities. The study found that many accepted resignation or unpaid suspensions, which keeps them on the payroll and has far less public impact than outright termination. It also allows for the possibility that individuals with disciplinary history, which might include abuse and neglect, may be able to obtain employment in homes for the developmentally disabled again in the future.

This situation in New York state underscores the importance of remaining educated about nursing homes, assisted living facilities, and other group care facilities to which you might entrust a loved one. These facilities clearly have an obligation to provide diligent and competent care, since they provide nearly all the daily needs of the residents.

In Maryland, facilities caring for people with developmental disabilities, which may include autism or Down syndrome, are regulated by the Developmental Disabilities Administration. It is part of the Office of Health Care Quality in the Maryland Department of Health & Mental Hygiene. Regulatory compliance is handled by the Developmental Disabilities Unit, which has established a system for complaints regarding misconduct in regulated facilities. Facilities providing full-time care to people with developmental disabilities must be licensed by the state, and reports of abuse, neglect, or misconduct certainly factor into licensing decisions.

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Posted On: October 4, 2011

Indictments Issued in Two Separate Maryland Nursing Home Assault Cases

ward10042011.jpgTwo recent incidents involving assaults on Maryland nursing home residents have led to indictments for abuse and assault. The incidents occurred in different facilities in nearby towns, but both involve nursing home employees allegedly assaulting vulnerable residents. The cases demonstrate the importance of vigilantly protecting the rights of nursing home residents who may find themselves helpless against the unscrupulous or criminal behavior of a few employees who might take advantage of that helplessness.

In the first case, a caregiver at a nursing home in Lutherville, Maryland is accused of stealing $80 from a blind 94 year-old resident, as reported by the Lutherville-Timonium Patch. According to court documents, the employee entered the resident’s room by pretending to be a different employee who had come to turn on the air-conditioning unit. She asked the resident, who in addition to being blind needs a hearing aid, to borrow money. The man told her no, at which point she allegedly tried to take his wallet from his pocket. She threw him out of his bed and onto the ground when he resisted her. When the man screamed for help, another employee intervened.

The employee denied allegations of theft and assault to police investigators that day. The next day, however, she turned herself in to the police. She has been charged with robbery, theft, and second-degree assault. She has also lost her job at the nursing home. The nursing director told the newspaper that if she is convicted, the Maryland Board of Nursing could take steps to keep her from ever working in a nursing home again. The robbery charge is a felony, assault in the second degree and theft of less than $1,000 are misdemeanors. She faces up to 15 years imprisonment for the robbery charge alone.

The second case involves a nursing home in Timonium, Maryland. A geriatric nursing assistant has been charged with abuse of a vulnerable adult in the second degree, neglect of a vulnerable adult in the second degree, and assault in the second degree. Each charge is a misdemeanor under Maryland law. An investigation by the Medicaid Fraud Control Unit, part of the Maryland Attorney General’s office, and the Maryland State Police originated from a referral from the Baltimore County Police Department. The alleged assault occurred in October 2010. Fewer details are available on this case, since it has only recently been filed. The employee is alleged to have assaulted an 84 year-old resident of the nursing home. Each of her charges are misdemeanors, and she faces up to 10 years in prison.

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