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.
This 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.
Congress 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.
Examples 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.
Two 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.
Jack D. Lebowitz
Vadim A. Mzhen



