03/11/15

Lair, Liar Pants on Fire

© Wisconsinart | Dreamstime.com

© Wisconsinart | Dreamstime.com

Okay, well perhaps TECHNICALLY Janssen Pharmaceuticals, a division of Johnson and Johnson (J&J) didn’t lie about Risperdal to the public. But thousands of recent lawsuits have charged that there is a troubling side effect in young men who take the medication: gynecomastia. That means it can trigger abnormal breast growth in the males who use the drug.

Mad in America reported that the law firm of Pintas and Mullins (linked above) reported that there were 1,250 pending cases against  J&J (most of which are related to abnormal breast growth) out of which six were selected as “bellwether” trials in 2012. However, Janssen agreed to settle those cases before they went to trial. Janssen also agreed to settle another 80 cases in early 2013. Historically, this has been a regular legal tactic of pharmaceutical companies when they are sued. Peter Breggin has noted how this method and others were used by pharmaceutical companies to neutralize potentially damaging lawsuits against them; and keep the information they contained from becoming public knowledge.

But that doesn’t always work. Pintas and Mullins, Mad in America, Peter Breggin and FiercePharma have reported on past settlements made by Janssen for misleading statements about Risperdal.  In November of 2013 Janssen agreed to pay a $2.2 billion settlement with the federal government for false claims over Risperdal. The company pled guilty to illegally promoting the off-label use of Risperdal with the elderly suffering with dementia or Alzheimer’s in nursing homes. Janssen also settled off-label marketing claims with 36 states and the District of Columbia over Risperdal for $180 million; then with Texas for another $158 million. So I suppose we could say that Janssen was found guilty of lying about Risperdal in these off-label marketing cases.

Recent cases include a lawsuit argued in Philadelphia regarding a 20-year-old man with autism, who took Risperdal to help with irritability caused by his autism. He began taking the drug as an eight-year-old, despite the fact it was only approved for use with adults at that time. FiercePharma reported that the man’s then pediatric neurologist, Jan Mathisen, said sales reps from Janssen had distributed Risperdal samples twenty times between 2002 and 2004, 5 years before the drug was approved for use in autistic children. After a day in court, the autistic man’s mother tearfully said that she was having a difficult time after “Hearing what the pharmaceutical company was doing.”

Janssen claimed that the company’s warnings were complete and proper, and that it did not miss-market the drug. In a statement provided to Blooomberg Business, a Janssen spokesperson claimed that Risperdal “has improved the lives of countless children and adults throughout the world who suffer from debilitating mental illnesses, and it continues to improve patients’ quality of life today.”

Janssen claims that Risperdal’s labels always included warnings of the risk of gynecomastia in adults, and notified doctors that it was not proven safe for use in children. The Pintas and Mullins article said the company claims that the doctor who prescribed Risperdal to the autistic man should be held at fault. In addition,

Janssen is accused not only of illegally marketing Risperdal, but also of paying doctors to speak favorably of the drug. The company paid for gold outings and other flashy incentives to get doctors to prescribe the drug to patients just like the eight-year-old in Alabama. Many of those boys taking Risperdal grew breasts and had to undergo mastectomies.

A former FDA commissioner, David Kessler, testified in Philadelphia that Johnson and Johnson knew as early as 2001 that Risperdal could cause boys to grow breasts—a full five years before the company added the warning about the potential side effect to the drug’s official label. In support of his claim, Kessler pointed to a 2001 study, FUNDED BY J&J that indicated 3.8% of boys using Risperdal in a clinical trial developed breasts. He commented that the study should have been a red flag to the company. According to Bloomberg, the neurologist Mathisen said in his testimony that he would have liked to have known about the study.

A J&J lawyer said that Kessler was a biased witness or “hired gun” because he commonly testified in drug-safety trials since leaving the FDA in 1997 (see articles here and here). She suggested that he was “cutting and pasting” findings from other cases into his conclusions that: 1) officials at Janssen knew Risperdal caused some boys to develop breasts and 2) failed to alert patients, doctors and regulators about it. Kessler disputed her claims saying, “Each case is complex and there is an enormous amount of details associated with them . . . . To say I’ve testified each and every time the same way would be incorrect.” He also indicated where he has testified on behalf of pharmaceutical companies in the past.

As I first wrote this, the trial in Philadelphia was scheduled to take another few weeks. I was rooting for a ruling in favor of the autistic man and his family, which did happen! The Wall Street Journal reported that a Philadelphia jury decided Johnson & Johnson had to pay $2.5 million in damages for failing to warn that Risperdal could cause gynecomastia. The attorney representing the autistic man said: J&J “hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted.”

The settlement is relatively modest, considering what J&J has made from Risperdal. In the seven years between 2003 and 2010, Risperdal grossed more than $24 billion worldwide; 4.5 billion in 2007, the year it went off patent. While there should be enough capital to settle the case without J&J going bankrupt, with the additional 1,200 plus lawsuits, it may be a good time to divest yourself of J&J stock.