Gilead Must Face Whistleblower Lawsuit Over Alleged Sovaldi and Harvoni Kickback Scheme

Solvald and Harvoni lawsuit alleges drug maker engaged in a kickback scheme, which included giving high-prescribing doctors vacations and meals under the guise of poorly-attended speaker engagements

A federal judge has ruled that Gilead must face a whistleblower lawsuit over Solvadi and Harvoni, which alleges the company engaged in an illegal kickback scheme to sell its hepatitis C drugs.

The allegations were presented in a complaint filed by Toby Travis, a former Gilead sales specialist-turned whistleblower, who says the company created fake speaker programs in order to secretly give meals and vacations to doctors to speak at poorly attended conferences if they prescribed high volumes of the two drugs. Travis also claims Gilead gave money to the PAN Foundation, a patient assistance program, to get patients to submit claims to get Medicare and Medicaid reimbursements.

Gilead sought to have the charges dismissed, but in an April 1 memorandum opinion (PDF) issued by U.S. District Judge Cynthia Rufe, of the Eastern District of Pennsylvania, the judge stated that Travis’s allegations were sufficient for the case to move forward.

“At this stage, no party disputes that Gilead paid medical practitioners to conduct the Sovaldi and Harvoni speaker programs,” Judge Rufe wrote. However, the Court did dismiss claims involving illegal off-label marketing, indicating that the complaint filed by Travis contained no evidence that patients were prescribed the drugs for medically unnecessary purposes due to Gilead’s marketing.

The whistleblower lawsuit comes as Gilead is continuing to face thousands of lawsuits over Truvada, Viread and other HIV drugs, which allege that the company engaged in a scheme to withhold safer versions of the critical treatments for years in order to increase profits and avoid generic competition.

However, users now allege that they suffered severe bone fractures, kidney damage and other injuries that resulted from the HIV drug side effects, indicating that the problems could have been avoided if a safer formulation had not been withheld by Gilead.

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HIV Drugs Lawsuits

Kidney and bone injuries linked to the HIV drugs Truvada, Viread, Atripla, Complera and Stribild may have been avoided.

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The Sovaldi and Harvoni lawsuit filed by Travis involves illegal marketing for a class of hepatitis C drugs, which also includes Olysio and Viekira Pak, which have long been linked to an increased risk of liver problems and other side effects.

The first major safety signal linked to the drugs occurred in October 2016, when the FDA issued a hepatitis C drug warning, indicating that it had received reports of hepatitis B reactivation. The FDA required the drugs to add a black box warning, the strongest warning the agency can require a drug to carry.

In most case of acute hepatitis B infection, patients have mild symptoms of abdominal pain, yellowing of the eyes, and darkened urine. However, a small portion of individuals develop severe life-threatening forms of chronic hepatitis B that lasts longer than six months, putting them at increased risks of death from cirrhosis and liver cancer, often resulting in the need for a liver transplant.

According to the World Health Organization (WHO), an estimated 240 million individuals across the world have hepatitis B, and on average 686,000 die annually from the result of chronic liver damage and liver cancer.

25 Comments

  • EverettDecember 21, 2023 at 9:25 pm

    My brother died after taking harvoni. He developed liver cancer and died. Said he could live up to 6 months and he was dead in 2 weeks.

  • BillOctober 19, 2023 at 4:06 pm

    Family member died of liver cancer 3 months after finishing their HARVONI treatment.

  • HarryOctober 19, 2023 at 4:03 pm

    3 months after a family member's GILEAD HARVONI treatment, aggressive liver cancer was found. After spending nearly $100K on GILEAD's HARVONI, which directly lead to my family member's liver cancer, we had to bring them to various cancer hospitals across the country. Of course they were of no help and stole hundred of thousands of dollars from us. So, not only did GILEAD's "miracle drug" H[Show More]3 months after a family member's GILEAD HARVONI treatment, aggressive liver cancer was found. After spending nearly $100K on GILEAD's HARVONI, which directly lead to my family member's liver cancer, we had to bring them to various cancer hospitals across the country. Of course they were of no help and stole hundred of thousands of dollars from us. So, not only did GILEAD's "miracle drug" HARVONI, kill my family member, but cost my family hundred of thousands of dollars. Pure evil. Watching, aiding my family member suffer with terminal liver cancer was absolutely horrifying and traumatizing. Everyday was a complete nightmare. Ultimately, we were trying to rid the HEP-C (given to them by a blood transfusion after a car accident) from our loved one and in return, our family member was diagnosed with terminal liver cancer. Please do not let anyone take this poison. Please do not give your money to these devils. Absolutely heinous. Justice needs to be served ASAP.

  • DeannaAugust 26, 2023 at 10:20 pm

    In 2019 I took Harvoni for 3 months.. I now have to walk with a cane. It did something to my knees. It feels like it got in the joints of my knees. All I know, is I am now disabled.

  • DorisAugust 22, 2023 at 12:55 pm

    My husband died 12 hours after taking his first Harvoni pill in 2015

  • RandyApril 26, 2023 at 12:06 am

    I was diagnosed with hep c in 2015. I went to both a natural path and a Gastroenterologist. Useing the NP's methods I drop my viral load way down. The Gastro. trued to get me to do the interferon but I refused. Then Harvoni came out and the Gastro talked me into taking it. $1000 dollars a pill taken dailey for 90 days. Cha-Ching. One month later I was diagnosed with liver cell carsinoma. Do to g[Show More]I was diagnosed with hep c in 2015. I went to both a natural path and a Gastroenterologist. Useing the NP's methods I drop my viral load way down. The Gastro. trued to get me to do the interferon but I refused. Then Harvoni came out and the Gastro talked me into taking it. $1000 dollars a pill taken dailey for 90 days. Cha-Ching. One month later I was diagnosed with liver cell carsinoma. Do to good insurance I was able to get into UW hospital in Seattle Wa. and they cut it out. 3 yrs. later my liver had grown back what was cut out and is fuctioning good. I come to find out that my geno type of Hep. C was one that had a very high risk of cancer if Harvoni was taken. The Gastro. knew and they never said a thing. If I would of known there was any chance of cancer I would of never agreed to taking Harvoni.

  • AnitaApril 14, 2023 at 9:48 am

    My husband's Hep C was treated in 2015 and in December 2016 he developed abdominal pain. He was diagnosed with an aggressive form of heptocellular cancer and was told he was both inoperable and untreatable. He passed 3 months later. He had Hep C for over 20 years and it had no affect on his life. No cancer....constant blood work and ultrasounds all clear. After Harvoni treatment he had this aggres[Show More]My husband's Hep C was treated in 2015 and in December 2016 he developed abdominal pain. He was diagnosed with an aggressive form of heptocellular cancer and was told he was both inoperable and untreatable. He passed 3 months later. He had Hep C for over 20 years and it had no affect on his life. No cancer....constant blood work and ultrasounds all clear. After Harvoni treatment he had this aggressive cancer. I truly believe that Harvoni caused this cancer and death of my husband.

  • stephanieApril 5, 2023 at 9:18 am

    My husband did Harvoni in 2015 years to come he developed three large tumors and liver cancer and still had hep c and he passed away May 2nd 2022. I feel for everyone that is gone through or is going through the same issue. Stay Strong for your loved ones.

  • ElizabethMarch 18, 2023 at 6:05 pm

    My husband had 12 week treatments of harvoni 3 months later he caught liver cancer stage 4 my husband died September 2017. Before he died he tried to get an attorney and he stated that he got sick with harvoni treatment for hepatitis c Harvoni killed thousands of hepatitis c patient and there is no justice I've looked for an attorney no one wants to take my case. I truly believe her harvoni[Show More]My husband had 12 week treatments of harvoni 3 months later he caught liver cancer stage 4 my husband died September 2017. Before he died he tried to get an attorney and he stated that he got sick with harvoni treatment for hepatitis c Harvoni killed thousands of hepatitis c patient and there is no justice I've looked for an attorney no one wants to take my case. I truly believe her harvoni killed my husband.

  • ElizabethFebruary 20, 2023 at 3:05 pm

    Since taking Harvoni, I suffer from severe fibromyalgia, osteoarthritis, bone loss, an increase in my blood pressure and increased fatigue. No studies have been started in an attempt to understand how Harvoni injured some of us. My four cats need me so I stay alive for them.

  • GlennFebruary 17, 2023 at 1:14 pm

    3 months after my Harvoni treatment I slowly developed Vitiligo that has stayed with me along with being lethargic at least half a day every day. I used the VA for this high cost medicine. I am grateful that I was cured. I appreciate that it stopped the HepC, so do not get me wrong here, but now I have other health problems which the VA ignored when I alerted them to the fact. They told me it must[Show More]3 months after my Harvoni treatment I slowly developed Vitiligo that has stayed with me along with being lethargic at least half a day every day. I used the VA for this high cost medicine. I am grateful that I was cured. I appreciate that it stopped the HepC, so do not get me wrong here, but now I have other health problems which the VA ignored when I alerted them to the fact. They told me it must be from something else. I do not even know what to do to get help with this. Time is going by and I move farther away from getting this tended to.

  • DaleJanuary 31, 2023 at 2:46 pm

    How can I file a lawsuit against harvoni

  • JennJanuary 22, 2023 at 3:06 pm

    I had a heart attack within the 1st couple weeks of starting Harvoni (May 2019) at the young age of 44 and have had ongoing cardiac problems since. The ONLY change in my life at the time was taking that drug. I'm currently wearing another holter monitor (my 2 weeks are over tomorrow) & will be having another echo in early Feb. Anyone else out there with cardiac probs since Harvoni?

  • DavidNovember 11, 2022 at 9:38 pm

    Health issues ! Nerves and Liver Pain, legs always in pain from muscle loss !

  • EmmaOctober 29, 2022 at 3:56 pm

    I am severely disabled I had nothing wrong with my liversuggestion from dr was treat so I didn’t get liver cancer I was so sick on treatment and she kept pushing me to continue it take Tylenol drink water Benadryl zofran I broke out in a rash that I still have 7 years later she also treated me 12 weeks when my viral load was low I was treatment niave and wasn’t treated before she didn’t run the pr[Show More]I am severely disabled I had nothing wrong with my liversuggestion from dr was treat so I didn’t get liver cancer I was so sick on treatment and she kept pushing me to continue it take Tylenol drink water Benadryl zofran I broke out in a rash that I still have 7 years later she also treated me 12 weeks when my viral load was low I was treatment niave and wasn’t treated before she didn’t run the proper test or even do an ultrasound I had extensive testing done 1 years prior and was told to leave it alone I had 6 pt blood transfusion in 1983 from a ruptured ectopic. Pregnancy was followed by Yale and was told not to worry I was pushed into treatment I have spent the last 7 years Looking for answers blood tests that have now killed my veins mri Ct scans spinal taps it’s been hell I cannot walk I am in a wheel chair my immune system is dead I have no protection from anything my head hurts I have damage to all my nerves and bones and ligaments I Have sores on my scalp overproducing sores in my mouth and nose been to ent so many times. Constant head pressure it has caused atrophy in my eyes I have Double vision cataracts lose of color vision 70% hearing loss and tinnitus nonstop wiht head pressure 24/7 I have sensory peripheral neuropathy I have radiculopathy myelopathy in pain 24/7 nothing helps I am full of osteoPorosis my bones all of them ache my dr was also On the list of Drs that got. Kickback I still have allergic reactions daily to everything it caused a hypersensity I have been to Immunolgist rheumatologist neurologist ENT I have wasted time 7years I am having kidney issues I can’t hold sodium and my BP is crashing I have a sleep disorder muscle disorder blood disorder this is not a cure I had none of these issues prior to treament my anxiety is unbearable this happened on treatment effected my lungs I can’t get a breath in or out I am a living corpse this is not a cure this is a death sentence I will never recover from this and the daily pain. Is torture no one will help us I will never be the same human being again my days are limited I have been to the ER 15 times and they can’t find out what happened to me I was poisoned

  • CrystalOctober 29, 2022 at 3:15 pm

    I want answers I didn't even feel that bad prior to treatment. Now I live in hell feeling mutated. I used to work and be active. They said tired was normal. No it's not, this is a living nightmare to fight , now disabled from this medication. Please we need help they did this for money it should be punished. I couldn't even afford this medication but they wanted me on it and found a way to get p[Show More]I want answers I didn't even feel that bad prior to treatment. Now I live in hell feeling mutated. I used to work and be active. They said tired was normal. No it's not, this is a living nightmare to fight , now disabled from this medication. Please we need help they did this for money it should be punished. I couldn't even afford this medication but they wanted me on it and found a way to get paid for it!

  • ScottOctober 29, 2022 at 6:31 am

    I took carboni for 8 weeks 2 years out I continue to be sick nausea headache dizziness vomiting diarrhea chest pains problem breathing headaches body aches extremely lethargic none of my doctors have been unable to tell me why my life after harvoni has been a nightmare my doctors cannot tell me why I still feel sick I need answers now

  • BettyOctober 15, 2022 at 10:37 pm

    I took Harvoni and later developed liver cancer.

  • CharitySeptember 13, 2022 at 3:56 pm

    was prescribed 6 months Harvoni and was unaware of my being enrolled into clinical trial. My provider somehow obtained 2 rounds without my knowledge of risks and dangers of the treatment and worse I never qualified for a single dose. I only became aware of this information in 2020 which was 4 years after TX. Pre-authorization was obtained without my signing of any required forms and somehow Medica[Show More]was prescribed 6 months Harvoni and was unaware of my being enrolled into clinical trial. My provider somehow obtained 2 rounds without my knowledge of risks and dangers of the treatment and worse I never qualified for a single dose. I only became aware of this information in 2020 which was 4 years after TX. Pre-authorization was obtained without my signing of any required forms and somehow Medicaid paid out 180k to kill me. I suffered pulmonary embolism by 2nd month and was then induced into coma lasting 18 days. 2020 I was notified by an independent journalist who had uncovered 249 deaths during the same 2016 trial. Following coma and recovery to regain abilities to walk and write, I was dumped by the medical system and deemed disabled. Harvoni took 20 years off my life expectancy, crooked me, exasperated my congenital condition, destroyed my teeth and nearly killed me. My provider was also listed amongst doctors who had received kickbacks amounting to 178 million. My husband and I filed federal case in 2021 and this was for 300 children who are presently being poisoned in Harvoni clinical trial lasting 10 years. Filing only cost my husband and I nearly everything and we have been sabatoged since. I know you cannot file claim if knowingly signing into clinical trial however I was never aware and clearly have a case. Can anyone help in this matter as I presently decline in health and know my time is running short. This medication and negligence has destroyed my bones, skin, liver and future outcome beyond imagination and it's all being covered up for corporate gain. More are dying ad will face severe damages. Presently there is a case in court of Pennsylvania and a Gilead whistleblower has revealed my case with exception of the deaths and current trial. My provider double dosed me and I have only recently come to that finding as this went against the protocol of being treatment naive. Also my insurance was not eligible for the co-payment program offered by Gilead and yet was approved somehow to cover the full cost of 6 months and during the entire treatment I was never seen by prescribing physician. I'm literally dying and my husband and I face constant targeting since filing a Federal case in effort to prevent 300 more fatalities. We are presently in fear for our lives and attempting to flee to find safety as the state of Oklahoma is beyond our of control with Justice. This state is litterally killing innocent victims and we need help please.

  • JamesAugust 30, 2022 at 1:30 pm

    I was prescribed 10 weeks of Harvini back in 2018. Within weeks my health started spiraling out of control. Finally in a coma, released 5 days later with almost Stage 3 liver failure My life has hardly been worth living ever since Harvoni. I keep checking the Internet a couple times a year assuninging it's just a matter of time until the makers of Harvoni are held responsible. I'm not sure ho[Show More]I was prescribed 10 weeks of Harvini back in 2018. Within weeks my health started spiraling out of control. Finally in a coma, released 5 days later with almost Stage 3 liver failure My life has hardly been worth living ever since Harvoni. I keep checking the Internet a couple times a year assuninging it's just a matter of time until the makers of Harvoni are held responsible. I'm not sure how much longer I'll be around to fight this. My family deserves to be compensated for the troubles this has put them through and my lack of earning potential now for over 20 years. I would really appreciate speaking to an attorney regarding this disaster.

  • LeRoyAugust 17, 2022 at 6:57 pm

    My doctor was payed by Gilead Science to boost there sales and his treatment injured me in the Process cause adverse action that damage my nerves system cause permanent damage to my Branchial plexus root to my vertebrae.

  • LeRoyJune 26, 2022 at 12:39 am

    I was treated with Harvoni and I ended up with adverse reaction that attack my Central Nerves System which I was diagnosed with Branchial plexus and ulcers that could have been caused be Sovadi my doctor was payed by Gilead Science to distribute the medicine to boost sales which I wasn’t told of the dangers of the medI one.

  • CharityJune 2, 2022 at 5:44 am

    I was prescribed 6 months Harvoni and was unaware of my being enrolled into clinical trial. My provider somehow obtained 2 rounds without my knowledge of risks and dangers of the treatment and worse I never qualified for a single dose. I only became aware of this information in 2020 which was 4 years after TX. Pre-authorization was obtained without my signing of any required forms and somehow Medi[Show More]I was prescribed 6 months Harvoni and was unaware of my being enrolled into clinical trial. My provider somehow obtained 2 rounds without my knowledge of risks and dangers of the treatment and worse I never qualified for a single dose. I only became aware of this information in 2020 which was 4 years after TX. Pre-authorization was obtained without my signing of any required forms and somehow Medicaid paid out 180k to kill me. I suffered pulmonary embolism by 2nd month and was then induced into coma lasting 18 days. 2020 I was notified by an independent journalist who had uncovered 249 deaths during the same 2016 trial. Following coma and recovery to regain abilities to walk and write, I was dumped by the medical system and deemed disabled. Harvoni took 20 years off my life expectancy, crooked me, exasperated my congenital condition, destroyed my teeth and nearly killed me. My provider was also listed amongst doctors who had received kickbacks amounting to 178 million. My husband and I filed federal case in 2021 and this was for 300 children who are presently being poisoned in Harvoni clinical trial lasting 10 years. Filing only cost my husband and I nearly everything and we have been sabatoged since. I know you cannot file claim if knowingly signing into clinical trial however I was never aware and clearly have a case. Can anyone help in this matter as I presently decline in health and know my time is running short. This medication and negligence has destroyed my bones, skin, liver and future outcome beyond imagination and it's all being covered up for corporate gain. More are dying ad will face severe damages. Please help

  • CrystalApril 12, 2022 at 4:15 pm

    My husband was prescribed harvoni for the full 3 months without any dr visits or calls. He had good insurance so he was scanned a few months later and they found a spot. It was cancer. We were sent UW hospital in Seattle and thank goodness they got it all. We had a large team of doctors and one asked us if we were made aware that with his genome type, harvoni had a 90% risk of liver cancer! Of co[Show More]My husband was prescribed harvoni for the full 3 months without any dr visits or calls. He had good insurance so he was scanned a few months later and they found a spot. It was cancer. We were sent UW hospital in Seattle and thank goodness they got it all. We had a large team of doctors and one asked us if we were made aware that with his genome type, harvoni had a 90% risk of liver cancer! Of course he would NOT have done the treatment. He was doing super without anything but milk thistle. I am soooo angry that this happened in 2015 and nothing has been done!!! He has had 12 mri's with contrast which gilead is also responsible!! What a horrid example of greed at any cost!!! Who knows what other weird symptoms will pop up!! He is very angry too because everyone knew and they are still getting away with bofily harm and murder!! WE WANT JUSTICE!!!!!

  • KarenApril 7, 2022 at 3:36 pm

    10 weeks on Harvoni I suffered liver failure..was in ICU and had to have the TIPS procedure. Was never given a biopsy prior to being prescribed but had Hep C...diagnosed in 2003. Now have severe Cirrhosis and many other health issues...

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