Truvada Lawsuit (TDF) – Bone Loss & Kidney Damage | HIV Medication
Despite recent Truvada lawsuits, Gilead Biosciences’ HIV drugs in the Truvada family have been a giant moneymaker for the company since they were introduced in 1997. This particular class of drugs also known as PrEP, which consisted of five separate medications, made billions of dollars in profits for the company before their patent protection ran out and the company replaced these drugs with a new product that also has earned the company outsized profits. Now, the company is facing a multitude of lawsuits claiming that the first generation of drugs caused bone and kidney damage. The company is now accused of suppressing the knowledge that it had that these drugs could be dangerous. The allegations is that Gilead suppressed this knowledge in order to maximize their profits and to keep selling this class of drugs for as long as possible. “The core allegation is that Gilead, for-profit reasons, decided in 2004 to shelve the safe drug. They knew it was safer and they decided to wait until the patent life had expired on the less safe drug and launch it as new and improved,” 10 News There is currently no Truvada MDL consolidated lawsuit. In 2018, Numerous Plaintiffs were previously attempting to create an MDL which would be known as: In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881. However, the litigants withdrew the motion for an MDL in 2019. However, there is now a state court coordinated proceeding for Truvada lawsuits pending before a single Justice in San Francisco Superior Court. This California state Court lawsuit is known as: Gilead Tenofovir Cases and Coordinated Actions. There is no Truvada class action. There have been no Truvada global settlements. There are thousands of lawsuits in this California state Court coordinated proceeding
What is a coordinated proceeding in California?
The Truvada lawsuits are now part of a Sate Court coordinated proceeding in San Francisco Superior Court. In California state Courts, complicated causes of actions that could be coordinated are lawsuits where multiple lawsuits are filed in different counties which involve fact or law common issues. The court can legally order that the lawsuits be coordinated together in one court using particular procedures and by consent of the litigants. This is type of cause of action is called a Judicial Council Coordinated Proceeding (“JCCP”) This is not considered a class action. The purpose of this type of proceeding is for efficiency and a faster resolution of the lawsuits. Judge Cheng is the Judge in charge of the Gilead Tenofovir Cases and Coordinated Actions
What are the central allegations in The Truvada lawsuits in San Francisco:
“According to the main lawsuit, “Beginning in 2001, Gilead manufactured and sold a prodrug form of tenofovir called tenofovir disoproxil fumarate or TDF. Unbeknownst to plaintiffs and the general public, Gilead had also developed another prodrug form of tenofovir called tenofovir alafenamide fumarate or TAF, which it knew to be more efficacious and less toxic to kidneys and bones than TDF.” 10 News
“The attorneys who are helping to sue Gilead Sciences say that the company already got exclusivity rights on TDF and wanted to profit off that. “The core [allegation] is that Gilead, for-profit reasons, decided…in 2004 to shelve the safe drug. They knew it was safer and [they decided to] wait until the patent life had expired on the less safe drug and launch it as new and improved,” Id.
Side effects, complications and injuries Caused by Truvada:
- Kidney injury: Acute kidney injury, kidney failure, chronic kidney disease (CKD), renal failure, severe liver problems, end-stage renal disease (ESRD), renal insufficiency/impairment
- Bone issues : Osteoporosis, bone density loss, bone breaks/fractures, tooth loss, Broken bones, Osteopenia.
- Headache, abdominal pain, insomnia, Respiratory infections, Renal impairment, weight loss, lactic acidosis, weird dreams, Depression, Dizziness and more
What is the potential timeline for Gilead settlements?
Premised on other defective drug lawsuit settlements in the past, it could possibly be 2 to 3 more years before a Truvada settlement in the Gilead lawsuits. No one knows what the Truvada lawsuit settlement amounts will be.
Gilead Has Faced Allegations Relating to Truvada for Years
The allegations that are at the core of these lawsuits have been levied against Gilead for many years. The basic claims in the lawsuit accuse Gilead of purposefully delaying the release of a safer drug so that they could continue to maximize their profits from a drug that they knew to be dangerous. According to the plaintiffs, Gilead continued to sell this possibly harmful drug for over ten years with the knowledge of the harm that it could cause.
For years, Gilead’s flagship HIV drugs were a series of medicines known as tenofovir disoproxil fumarate (TDF). These are sold under the brand name of Truvada. Eventually, when the patent protections on TDF ran out, Gilead switched to selling tenofovir alafenamide fumarate (TAF). There are differences between these two classes of drugs. Both of these drugs are antiretroviral medications. TDF has a much shorter half life than TAF. As a result, TDF must be given in much higher doses than TAF in order to be effective. The TAF dose is only a fraction of the drug content of TDF since much less is required in order to achieve the same result.
Allegations against Gilead regarding TDF drugs:
- TDF medication is alleged to be unreasonably dangerous to victims’ kidneys and patient’s bones.
- Gilead is alleged to have known before releasing the drug that the drug is extremely toxic and that there was a better alternative which was less toxic. “Before Gilead began selling its first TDF drug, Viread, in 2001, Gilead knew that TDF could be highly toxic to patients’ kidneys and bones. And once TDF was on the market, Gilead’s knowledge of TDF’s toxic effects grew as patients were injured by each successive TDF product. By the time Gilead designed Stribild, it had ten years’ worth of cumulative evidence that TDF injured patients’ kidneys and bones.” Plaintiff’s brief
- There are allegations that Gilead did not use a safer alternative drug for more than 10 years for financial gain despite victims reports of severe complications. “Gilead also knew, before it started selling its TDF drugs, that it had discovered a safer version of tenofovir—tenofovir alafenamide fumarate (“TAF”). TAF is absorbed into the cells HIV targets much more efficiently than TDF. As a result, TAF can be administered at a dramatically reduced dose compared to TDF without sacrificing efficacy. Because TAF can be administered at a much lower dose than TDF, TAF is much less toxic than TDF. A 25 mg dose of TAF achieves the same therapeutic effect as a 300 mg dose of TDF, with a better safety profile. Despite knowing that TAF could be given at a much lower, safer dose, Gilead intentionally designed Viread, Truvada, Atripla, Complera, and Stribild to contain toxic TDF rather than safer TAF. Falsely claiming that TAF was not different enough from TDF, Gilead abruptly shelved its TAF design in 2004. However, as John Milligan, Gilead’s President and Chief Executive Officer, later admitted to investment analysts, the real reason Gilead abandoned the TAF design was that TAF was too different from TDF. Once Viread was on the market, Gilead did not want to hurt TDF sales by admitting that its TDF-based products are unreasonably and unnecessarily.”
unsafe. ” Plaintiff’s brief
- “In addition, Gilead knew that by withholding the safer TAF design, it could extend the longevity of its HIV drug franchise and make billions two times over: first, with TDF
medications until TDF patent expiration, which would begin by no later than 2018, and second, with TAF medications until TAF patent expiration as late as 2032. Only once Gilead realized billions in sales through most of the TDF patent life did it seek to market safer TAF-based versions of its HIV medications. Finally, in 2015, Gilead began selling the first of its TAF-designed medicines and convinced doctors to switch their patients from TDF-based to TAF-based treatments by demonstrating TAF’s superior safety profile over TDF with respect to kidney and bone toxicity—the very benefits Gilead could have and should have incorporated into its prior product designs but withheld from doctors and patients for over a decade.” id.
- Gilead did not warn medical providers and victims about how to use the TDF drug safely, including the necessity of monitoring for side effects.
“All plaintiffs allege that Gilead intentionally designed its TDF drugs to be unreasonably and unnecessarily toxic to patients’ kidneys and bones, while it purposefully withheld a safer design of the drugs for more than a decade in order to make more money. All plaintiffs also challenge the inadequate warnings Gilead gave to physicians and consumers about the risks and safe use of the TDF drugs.” Plaintiff’s brief
- “TDF is a form of the compound tenofovir, which works by blocking an enzyme HIV needs to replicate.”Id.
- “Gilead manufacturers, markets, and sells five drugs that contain TDF for the treatment of HIV: Viread (300 mg TDF tablets); Truvada (TDF 300 mg/emtricitabine 200 mg
tablets); Atripla (TDF 300 mg/emtricitabine 200 mg/efavirenz 600 mg tablets); Complera (TDF 300 mg/emtricitabine 200 mg/rilpivirine 25 mg tablets); and Stribild (TDF 300 mg/emtricitabine 200 mg/elvitegravir 150 mg/cobicistat 150 mg tablets).” Id.
- “The Related Actions challenge Gilead’s decision to intentionally withhold a safer design of these drugs in order to make more money.” Id.
Update- 3-15-22- “Lawsuit alleges scheme to delay generic versions of Truvada. BCBS Association has concrete stake in case, judge says. The Blue Cross Blue Shield Association can lead part of a consolidated antitrust case over Gilead Sciences Inc.’s blockbuster HIV prevention drugs, a federal judge in San Francisco ruled, rejecting the idea that the insurance giant is just a middleman with no skin in the game.” Bloomberg law
7-22-21- “Gilead Sciences Inc. must turn over $1.8 million in legal costs and fees to the investors who sued it for records involving its blockbuster HIV drugs, a Delaware judge ruled Thursday, saying Gilead crossed the “fine line between glaringly egregious conduct and an aggressive litigation position. After the pharmaceutical company “declined to produce a single document to any of the five plaintiffs thereby forcing them to commence litigation,” it “took a series of positions during litigation that, when viewed collectively, were glaringly egregious,” Bloomberg law
10-23-2020- “A drug company may have violated the privacy of thousands of people who are taking a medicine to prevent them from coming down with HIV. Gilead Sciences, the biopharmaceutical giant, sent out a mass mailing in mid-April to people on its antiretroviral drugs, Truvada and Descovy. The drugs are used to reduce the risk of HIV infection, a prevention measure called pre-exposure prophylaxis (PrEP). The return address on the envelopes read “HIV Prevention Team.” On Thursday, the AIDS Law Project of Pennsylvania filed a federal class action suit against Gilead. It claims the company illegally compromised the privacy rights of patients by recklessly mailing the inappropriately marked envelopes after promising confidentiality. It’s unclear how many people received the letters. The suit demands that Gilead’s HIV Prevention Team immediately stop sending out letters to patients and seeks unspecified monetary damages. It was filed in the Northern District of California. The AIDS Law Project was joined by law firms Berger Montague and Langer Grogan and Diver.” Inquirer
7/17/2020- “Truvada lawsuits claim that the pre-exposure prophylaxis, or PrEP, drug causes bone loss and kidney problems that the drug’s maker, Gilead Sciences, did not warn the public about. In addition, they claim that Gilead withheld a safer alternative, tenofovir alafenamide, or TAF, in order to maximize profits from Truvada. The majority of individual injury cases are pending in California, and the company faces a related class action in the state. So far, there have been no Truvada lawsuit settlements or trials because the litigation is relatively new. In its 2018 annual report, Gilead said it believes these cases are without merit. However, the company expressed concern that losing these lawsuits could result in “significant monetary damages. Cases against Gilead are pending in state and federal courts and involve hundreds of plaintiffs, according to the company’s quarterly report ending June 30, 2019. In addition to the large group of lawsuits in California, people from other states including Delaware and Louisiana have filed individual injury claims.” Consumer Notice
10-11-2019- The Honorable Andrew Cheng of the Superior Court for the County of San Francisco determined Amy Eski of Schneider Wallace will Co-Lead Counsel in the California Coordinated Truvada lawsuits.
8/8/2019- Judge Kenneth R. Freeman ordered that all Truvada lawsuits be transferred to San Francisco. The new lawsuits will be titled: Gilead Tenofovir Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 5043. “A California judge has ordered that all California lawsuits brought against drugmaker Gilead Sciences, Inc. over HIV medications containing tenofovir disoproxil fumarate (TDF) will be coordinated before a single judge in San Francisco County Superior Court going forward. The ruling will facilitate efficient adjudication in the California court system and coordinate the efforts on behalf of patients claiming injuries in connection with Gilead’s TDF antiviral medications, namely Viread, Truvada, Atripla, Complera and/or Stribild, which are prescribed to treat, and in some cases prevent, HIV-1.” Grant & Eisenhofer press release
2/6/2019- The Plaintiff withdraw their motion for an mdl. The Panel on Multidistrict litigation end the possibility of an MDL. See ORDER DEEMING MOTION WITHDRAWN.
12/19/18- Several Plaintiff’s file a motion attempting to set up a federal Court Truvada MDL. (This motion was subsequently withdrawn in February 2019 and an MDL was never established.
2018- In Gilead’s 2018 annual report, “While we believe these cases are without merit, we cannot predict the ultimate outcome. If plaintiffs are successful in their claims, we could be required to pay significant monetary damages,”
TDF was a class of drugs. There were five different drugs in the class that were sold at one point or another in the last 20 years. Since Gilead is one of the dominant drug manufacturers in the HIV space, hundreds of thousands of people have taken one of these drugs over the years. Regardless of the type of HIV drug, Gilead markets them all under the name of Truvada.
“During a 2016 Conference on Retroviruses and Opportunistic Infections (CROI), researchers from the University of California San Francisco presented a study that showed a decline in kidney function in patients who took TDF-based drugs long term.” Ben Crump
TDF Affects Bone Density and Renal Function
The problem with TDF is that there are negative impacts on both renal function as well as bone density. When TDF was first released, Gilead toured it as a “miracle drug.” Not only that, but the company also stressed the drug’s safety. However, Gilead soon ran afoul of the FDA as a result of the claims that it was making. The regulator took action against Gilead for these claims and directed it to stop making unfounded marketing claims.
However, at the same time that Gilead was making these claims, they allegedly had information in their hands that contradicted the promises of safety. Gilead allegedly had this information in its hands nearly the entire time that it was selling TDF drugs. In fact, one of the lawsuits alleges that Gilead even put this knowledge into a patent application all the way back in 2000, almost 15 years before it applied for the TAF patent.
The High Dosage Can Cause Bone Loss
The specific danger results from the fact that the dose that must be given to the patient is very high. Since there is an impact on the bones and kidneys as a result of the medication, the high dosage magnifies the side effects of the drugs. Patients also reported suffering damage to their teeth after taking the medication. The side effects impacted both people with HIV as well as people taking the HIV preventative drug Truvada.
Bone loss in the hip area
One particular study performed in 2014-2015 found the bone loss in the hip area to be four times greater in patients taking TDF than those taking TAF. In other words, four times as many patients suffered these side effects. Double the number of patients suffered bone loss in the spinal area.
The problem for Gilead is that it allegedly attempted to have it both ways with regard to the TDF and TAF medication. On one hand, Gilead touted the increased safety of TAF drugs when it began to sell them in the marketplace. The problem with that approach is it invites a natural comparison with the alternative. Here, the other class of drugs was the TDF drugs that Gilead sold for many years.
Is there a difference between Truvada and Tenofovir?
“Truvada is the brand name of the medication you are taking which contains the active drugs tenofovir disoproxil fumarate 300mg (equivalent to 245mg tenofovir) and emtricitabine 200mg.” HIVPA
Gilead Was Making Tons of Money on TDF
However, Gilead had patent protection for TDF drugs and was making billions of dollars on the medications. Gilead is a massive company with sales of over $22 billion in 2018. The lawsuits allege that Gildead avoided replacing TDF drugs with TAF medications so long as it has patent protection on TDF drugs and was profiting handsomely. It was only when the TDF patent expired did Gilead decide that TAF drugs (which carried with them a new patent protection period) were safer and should replace TDF. The lawsuits claim that Gilead knew that TAF was safer all along, and even had the opportunity to replace TDF 15 years ago, but declined to do so out of profit motives.
Sale of TDF drugs
Gilead has faced a number of allegations relating to its sale of TDF drugs. The company was also alleged to have used anticompetitive practices to sell the drugs, but it defeated those lawsuits. Now, the company is facing lawsuits for the fact that it allegedly sold a dangerous product and failed to warn customers of the potential dangers associated with the use of the drug. The company is accused of designing and selling a defective product due to the impact that the drugs had on patients’ bones and kidneys.
Currently, there are hundreds of lawsuits pending against Gilead with new lawsuits being filed. The cases are generally centered in state and federal court in California, where Gilead is based. The cases have survived judicial scrutiny thus far, as a judge has cleared the case to proceed, allowing nearly all of the grounds to survive a motion for dismissal.
July 2020 Lawsuit Filing
In July 2020, a group of 20 additional plaintiffs filed a lawsuit against Gilead in federal court in California. These plaintiffs alleged that Gilead knew all along that TDF was dangerous and learned even more as time passed about the dangers of the drug. The lawsuit further claims that Gilead knew that there was a safer alternative to TDF, but still proceeded to develop the drug for profit considerations.
In fact, the plaintiffs allege that one of the main reasons that Gilead used to obtain FDA approval for the sale of TAF was that it was safer than TDF. Nonetheless, Gilead continued to sell TDF for years after that point, having told the FDA that TDF was potentially dangerous. The plaintiffs even point to even that Gilead was aware of potential dangers to the kidneys when it was developing TDF. However, despite Gilead’s alleged knowledge of the possible side effects, the company did not say anything to doctors or patients while it continues to make large amounts of money from the drug.
The 411 on Gilead:
- Gilead is headquartered and has its principal place of business in the Northern District of California.
- Corporate address: 333 Lakeside Drive Foster City, CA 94404
- “Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.” Gilead website
- Gilead in the news: ” Gilead’s (NASDAQ:GILD) COVID-19 treatment Veklury (remdesivir) can now be used in non-hospitalized adults and adolescents at high risk of progressing to severe disease.” Seeking Alpha
- Product quality complains: Email: QualityComplaints@gilead.com
Reap huge profits in the HIV drug marketplace
In the meantime, the patent to TDF did not expire until 2017, and Gilead continued to sell the drug for as long as it could. Now, it has been replaced on the market by TAF. Still, Gilead continues to reap huge profits in the HIV drug marketplace with market practices that have been challenged in numerous lawsuits.
The Truvada lawsuits were just filed in 2019, so the cases are at a relatively early stage. Since there have been no significant developments, any type of settlement is still far into the future. If you have taken Truvada and have suffered bone loss or kidney damage, you can still file your own lawsuit against Gilead so long as you are still within the statute of limitations. You should contact a Truvada lawsuit lawyer today.