Rituxan Whistleblower Lawsuit Ends in $20M Settlement
Genentech has agreed to pay $20 million to settle a whistleblower lawsuit filed over claims that the drug maker aggressively marketed Rituxan for off-label uses and trained sales reps how not to get caught by the FDA while breaking the law.
The Rituxan lawsuit was brought by John Underwood, a former sales manager, who claimed Genentech showered doctors with money and expensive trips and paid speaking engagements in return for promoting Rituxan for uses that were not approved by the FDA at the time. The company also allegedly held workshops for sales representatives that included tips on how to promote Rituxan off-label without being noticed by the FDA.
Drug companies are only allowed to market drugs for uses approved by the FDA. Doctors, however, can prescribe the drugs for any reason they see fit. When a company actively markets a drug off-label and the Medicare and Medicaid programs pay reimbursements for that drug’s prescriptions, it is considered a form of Medicare fraud.
Underwood accused Genentech of paying thousands of dollars to doctors if they would promote Rituxan off-label. They were also sometimes flown to lavish locations for medical education seminars.
Rituxan (rituximab) is a chimeric monoclonal antibody drug that helps the immune system fight specific types of cells, like lymphoma cancer cells. The drug, which is manufactured by Genentech, Inc. and Biogen Idec, Inc., was approved by the FDA in 1997 for treatment of non-Hodgkin’s lymphoma and rheumatoid arthritis, generating annual sales of about $2.3 billion.
As part of the whistleblower settlement, Genentech did not admit guilt to the charges.
Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.
The Justice Department ultimately decided not to intervene in the lawsuit, and Underwood will receive approximately $5.7 million of the $20 million Genentech is paying the government to resolve the claim.
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10 Comments
JasonJanuary 17, 2024 at 12:22 am
My father had CLL and had hepatitis B. He went into the hospital to do a chemotherapy session. They gave him Rituxan. After only 30 minutes he got extremely cold and his hands and feet turned white. Then the next day he began losing his memory and couldn't put sentences together or get the words out he was trying to say. He died 5 days later on my 40th birthday. He couldn't breath on his own. He w[Show More]My father had CLL and had hepatitis B. He went into the hospital to do a chemotherapy session. They gave him Rituxan. After only 30 minutes he got extremely cold and his hands and feet turned white. Then the next day he began losing his memory and couldn't put sentences together or get the words out he was trying to say. He died 5 days later on my 40th birthday. He couldn't breath on his own. He was suffering but still in and out of consciousness. He declined so rapidly that even his oncologist was shocked that he had passed away.
FriedaFebruary 20, 2022 at 9:20 pm
I was diagnosed with rheumatoid arthritis. I was treated with rituximab infusions through my rheumatologist to calm the flares. After second infusion treatment I was hospitalized I had gotten really really sick and had to be admitted and stayed for a week. The hospital contacted the rheumatologist and told him they would not be giving me that drug anymore it was too dangerous for me. In what way [Show More]I was diagnosed with rheumatoid arthritis. I was treated with rituximab infusions through my rheumatologist to calm the flares. After second infusion treatment I was hospitalized I had gotten really really sick and had to be admitted and stayed for a week. The hospital contacted the rheumatologist and told him they would not be giving me that drug anymore it was too dangerous for me. In what way I don't know how and I don't know the medical terms that had used for what happened to me all I know is that was really sick and I remember my blood pressure fluctuation was involved. I will sign a release so that you can review my medical records. Do I also have a case for damages?
LillianJune 3, 2021 at 1:50 am
My mom was given Rituxan in March 2020 for her Rheumatoid Arthritis. She shortly began feeling unwell, developed severe stomach issues which were constant and resulted in her losing 65 pounds. She was then diagnosed with stage 4 metastatic breast cancer, which was unrelated. She then developed PML and passed away a little over a year after receiving her first and only Rituxan treatment. She should[Show More]My mom was given Rituxan in March 2020 for her Rheumatoid Arthritis. She shortly began feeling unwell, developed severe stomach issues which were constant and resulted in her losing 65 pounds. She was then diagnosed with stage 4 metastatic breast cancer, which was unrelated. She then developed PML and passed away a little over a year after receiving her first and only Rituxan treatment. She should have never received this treatment as her RA was stable and she was a previous cancer survivor. In her final month, at only 48 years old, she was unable to remember where she was, was essentially paralyzed from the neck down, and was in constant fear because of the severity of the PML on her neurological functions. I had to spend my final semester in college watching my mother die and slow, but also very quick, painful, heartbreaking death. If I could go back and make sure no one ever received this medication I would. I am infuriated that even after all the research known and shared about Rituxan, she still received it. I will never be able to make peace with what happened to her, and I blame the side effects of this poison.
CarloAugust 9, 2020 at 1:47 pm
Following my Homeowners insurance company’ refusal to pay for a water damage claim, I developed a condition called Idiopathic Orbital Inflammatory Syndrome on my left eye as a result of a mold infested home. After over a year on Steroids trying to treat my condition, doctors decided to used Rituxan as an alternative to my problem. This drug has ruined my life. I have so much muscle pain that I hav[Show More]Following my Homeowners insurance company’ refusal to pay for a water damage claim, I developed a condition called Idiopathic Orbital Inflammatory Syndrome on my left eye as a result of a mold infested home. After over a year on Steroids trying to treat my condition, doctors decided to used Rituxan as an alternative to my problem. This drug has ruined my life. I have so much muscle pain that I have to take pain killers daily. At 49, my memory has become a disaster.
BettyMay 23, 2017 at 3:38 pm
My husband of 49 years was given rituxan for his lymphoma after going to the hospital for collapsing with extremely low blood counts. His slow growing cancer was growing quickly. He was very weak, had Afib but they gave him Rituxan anyway. He died 6 weeks later never having left the hospital. He was miserable and went through pneumonia and other infections and slammed with antibiotics. He never re[Show More]My husband of 49 years was given rituxan for his lymphoma after going to the hospital for collapsing with extremely low blood counts. His slow growing cancer was growing quickly. He was very weak, had Afib but they gave him Rituxan anyway. He died 6 weeks later never having left the hospital. He was miserable and went through pneumonia and other infections and slammed with antibiotics. He never recovered. We were kept in the dark about the danger if this medicine.
jamesApril 7, 2017 at 9:40 pm
april 28th an may 12th of 2016 my wife was given two four hour injections of rituxan in florida port charlotte fourty days after leaveing our home in florida june 20th i put her into hospital in bay city michigan where she had a hard time breathing,coughting up blood. scat scan showed her lungs being destroyed she died july 30th 41 days of suffering. the drug was on called for by doctors. given t[Show More]april 28th an may 12th of 2016 my wife was given two four hour injections of rituxan in florida port charlotte fourty days after leaveing our home in florida june 20th i put her into hospital in bay city michigan where she had a hard time breathing,coughting up blood. scat scan showed her lungs being destroyed she died july 30th 41 days of suffering. the drug was on called for by doctors. given these two 8,000.00 treatments were uncalled for on a 73 year old women. i lost my beautiful wife
JuneJanuary 30, 2017 at 7:56 pm
I was given Rituxan from 2010 to 2014 for RA. I am left with major bowl problems I've. had six colon surgeries for block bowel. I'm in need of blood transfusion twice a year just cant breath, and I go thru bleeding of the colon often. Looking for a class action law suit in Ca.
DianaMay 18, 2016 at 10:30 pm
My husband was given Rituxan over the course of 4 years for treatment for NHL - MCL and he subsequently died from PML. At no point were counseled on this or was he monitored for the possibility of PML.
TeresaOctober 26, 2015 at 9:35 pm
My mom was diagnosied with CLL and given Rituxan we were told she on multiple times she had a compromised immune system however they (HMO) doctor kept giving her the Rituxan even in his own words " there were other drugs we could have tried. Now I know that we were not told that Ritoxin has a deadly side effect PML it is a rare brain disease. My mother fell several times for no reason just standin[Show More]My mom was diagnosied with CLL and given Rituxan we were told she on multiple times she had a compromised immune system however they (HMO) doctor kept giving her the Rituxan even in his own words " there were other drugs we could have tried. Now I know that we were not told that Ritoxin has a deadly side effect PML it is a rare brain disease. My mother fell several times for no reason just standing there after a ER doctor finally gave her a CAT Scan to see if she had a stroke they discovered she had PML. I confronted her doctor and he basically stated it was a chance we took to make her lukiemia manageable. I guess death was his way of managing death. I know that there was a lawsuit that made sure they did something about this but it did not help with this doctor to give my mother a BAD drug when her immune system could not help only kill her, She could not walk she could not talk she could not see she will never see her grandchildren grow up. Some thing has to be done about this now I see another drug on the market stating calmly it can cause PML and death. I would have never allowed it to be given to my mother Ritoxin if I would have been told. She is in heaven now and I am left with the anger.
PaulaJuly 9, 2015 at 8:33 pm
I was given this drug rituxan for itp the blood diease. I kept telling the hem. Doctor that this medicine is affecting me. I can't walk hardly any more. She kept doing the treatment with rituxan and dexasothone till the next thing I know I can't walk and in a lot of pain. Couldn't take of myself are nothing not even dress myself . My whole life has been alter now I'm wheelchair bound for l[Show More]I was given this drug rituxan for itp the blood diease. I kept telling the hem. Doctor that this medicine is affecting me. I can't walk hardly any more. She kept doing the treatment with rituxan and dexasothone till the next thing I know I can't walk and in a lot of pain. Couldn't take of myself are nothing not even dress myself . My whole life has been alter now I'm wheelchair bound for life. All because I guess in her learning to become a hem doctor she had the big head. I had a idea this what happen but now that my new hem doctor is leaving he own up to it to me and my daughter at a visit 6 months ago.