Johnson & Johnson has agreed to pay $2.2 billion to settle a Justice Department investigation into allegations that the company illegally promoted the antipsychotic drug Risperdal, along with several other J&J medications. The announcement was allegedly delayed because J&J was trying to avoid wording in the settlement agreement that could leave it vulnerable to private lawsuits filed by Risperdal users who claim they developed male breasts and other similar Risperdal side effects.

Risperdal is an atypical antipsychotic. This means the drug belongs to a newer class of antipsychotics, designed to reduce the symptoms of schizophrenia without the sedating effects of older antipsychotics. The drug has also been approved to treat bipolar disorder and mitigate some of the symptoms of autism. Risperdal lawsuits have alleged that these drugs can cause males to develop breasts, a condition known as gynecomastia.

According to The Wall Street Journal, the DOJ wanted Johnson & Johnson to admit that they downplayed known risks that Risperdal can cause male breast growth (gynecomastia), preventing patients and their physicians from having all of the information they needed to make informed decision regarding their medical care.

“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.  “[This] settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.”

So far dozens of private Risperdal lawsuits have been filed by young men who claim they developed large breasts, nipple pain, nipple discharge and other side effects from Risperdal.

The DOJ has been investigating Johnson & Johnson over these allegations since 2004 . In 2010, the agency filed a False Claims Act complaint against the drug company over alleged kickbacks to prescribing physicians. Allegedly, these kickbacks included millions paid to nursing home physicians to push Risperdal. In some cases, these alleged kickbacks were to push the drug for off-label purposes, using the drug for conditions beyond its U.S. Food & Drug Administration (FDA) approval. Studies have indicated that Risperdal can cause an increased risk of death when used for dementia patients, one of the off-label uses of the drug.