The pharmaceutical industry’s irresponsibility has resulted in a wave of litigation against products like Elmiron, Zantac, IUD ParaGard, and opioids in the United States. The Truvada lawsuits are one of these cases that make up the lion’s share. We are aware that many medications have side effects, but we have a right to get information about these risks so we can decide whether to use a medication or not.

Patients’ lives are put at peril when pharmaceutical companies deliberately mask the hazards of their drugs from consumers and physicians. The intention of this blog is to dig up the details of Truvada, what Truvada is used for, how Truvada works, and what makes people pursue Truvada lawsuits. Travel with me to have a deep insight into  how to proceed with a Truvada lawsuit 2022.

Unveiling the story of Truvada

What’s Truvada? Truvada is one of the antiviral medications prescribed to treat HIV infection and hepatitis B virus infection. The medicinal compound in Truvada is emtricitabine and tenofovir disoproxil fumarate. Emtricitabine is a nucleoside reverse transcriptase inhibitor, whereas tenofovir is a nucleotide reverse transcriptase inhibitor. They are known as NRTIs.

Truvada has long been the drug of choice for preventing HIV cell proliferation and the development of AIDS. Therefore, it is also used as pre-exposure prophylaxis or PrEP for HIV-negative patients. Truvada is manufactured by the pharmaceutical company Gilead Sciences, Inc.

Viread® and Truvada® are two of the first brand-name HIV medications developed by Gilead Sciences. Viread® and Truvada (Tenofovir disoproxil fumarate) were approved by the FDA in 2001 and 2004, respectively, for use in adult HIV-infected patients and adolescent HIV in March 2010. It was presented to the PAC in May 2012, April 2014, and September 2014, and the PAC recommended routine pharmacovigilance monitoring. As pre-exposure prophylaxis (PrEP) for HIV-negative people who are at a high risk of contracting HIV, Truvada® was given FDA approval on July 16, 2012.

Truvada comes with a boxed warning for post-treatment acute hepatitis B, or HBV. Patients who stop taking Truvada or other tenofovir disoproxil fumarate-containing medications may experience extreme flare-ups of HBV symptoms and may have to relaunch hepatitis treatment. Truvada also carries a boxed warning stating that it should be used only for PrEP in HIV-negative patients.

When Truvada was approved by the FDA in 2004, Gilead’s R&D team had been working on a new version of TDF. TAF (tenofovir alafenamide fumarate) (named Genvoya) was a newer, safer version of TDF that worked similarly to TDF but was more efficiently absorbed into HIV. It was more effective at slowing the virus’s growth and also was much less toxic. TAF was still toxic to bones and kidneys, but because of its lower dose requirements and other properties, it was less harmful than TDF.

However, on seeing the huge turnover from the two promising drugs, Viread® and Truvada®, Gilead stopped the research on TAF and waited until the 10-year patent period to expire to release Genvoya to hit the shelves very late.

From 2005 to September 30, 2019, 11,381 adverse event reports for Truvada were recorded by the FDA’s Adverse Event Reporting System or FAERS. Around 8,982 of these cases were serious, resulting in 718 fatalities. However, there have been no Truvada recall announcements from the manufacturer until the present.

Gilead in Soup

Apart from the Truvada lawsuits, Gilead is facing a lot of other allegations on the Stribild and the Genvoya lawsuits. A tentative Truvada settlements deal has been announced to partially resolve a class action on HIV medication lawsuit settlement over allegedly expensive HIV drugs as a result of anti-competitive practices by Gilead and several other major antiretroviral pill makers.

Bristol-Myers Squibb has agreed to pay $10 million to settle claims that it conspired with Gilead, Johnson & Johnson, and some of their subsidiaries to artificially inflate the prices of widely used HIV drugs such as Atripla, Biktarvy, Complera, Descovy, Evotaz, Genvoya, Odefsey, Prezcobix, Stribild, Symtiza, Truvada, and Viread.

Side Effects of Truvada

The normal possible side effects of the HIV PrEP drug Truvada mentioned in the product info are

  • Abdominal pain
  • Backache
  • Depression
  • Diarrhea
  • Discoloration and hyperpigmentation of the skin
  • Dizziness
  • Fatigue
  • Headache
  • Infection of the upper respiratory tract
  • Insomnia
  • Itching or a rash on the skin
  • Joint pain
  • Loss of weight
  • Nausea
  • Respiratory issues
  • Stomach ache
  • Strange dreams
  • Sinusitis
  • Vomiting

Do you wonder if the side effects are already noted in the product info, then why are the Truvada lawsuits arising? Truvada is proven to be causing more dangerous side effects than those mentioned above. Let’s see how these dangers occur to the human body.

Reverse transcriptase is an enzyme that allows the HIV virus to replicate within the body. Reverse transcriptase production in the body is slowed down by Truvada, which prevents the HIV virus from replicating as quickly. However, high dosage is needed to be taken to achieve the desired effect. Such large TDF doses can accumulate in the kidneys and harm the minuscule tubes that return the blood’s filtered minerals, amino acids, and sugars.

This interferes with the body’s ability to filter blood and absorb vital nutrients. The kidneys are therefore put under more and more stress as they must work overtime to eliminate the poisons from the blood. Thus, these toxin removal challenges can result in rare but serious side effects, including

  • Kidney disease and kidney failure
  • Fanconi syndrome – a tubule condition when the levels of glucose, potassium, and bicarbonate in the urine are elevated
  • Liver problems
  • Osteopenia or loss of bone mineral density- 2 to 6 percent decrease in bone density with the two years of use
  • Osteoporosis and Osteomalacia
  • Potentially fatal lactic acidosis
  • Immune reconstitution syndrome

Allegations of Truvada Lawsuits

Along with Truvada, Gilead is facing lawsuits for other HIV medications, including Atripla, Complera, Stribild, and Viread.

Gilead is accused of various allegations in the Truvada lawsuits, as noted below.

  • Failed to warn consumers about the serious and potentially fatal risks of Truvada, despite having a legal obligation to do so.
  • Blocked an HIV medication, tenofovir alafenamide, or TAF (Genvoya), that had been proven to be a safer and effective alternative to the TDF medications they were already marketing because Truvada was more profitable, says a Truvada lawsuit filed by the AIDS Healthcare Foundation.
  • Made a profit of around $18 billion a year (67 percent of its revenue) on its Truvada and other TDF-based drugs by putting the lives of the patients at stake.
  • The drug has design defects as it was made excessively and needlessly toxic.

Gilead is held accountable for

  • Strict product liability (design defects and failed to warn)
  • Products responsibility for negligence (design defects and failing to warn)
  • Implied warranty breach
  • Explicit warranty breach
  • Negligence and Gross Negligence
  • Fraud by Omission
  • Multiple State Consumer Protection Law Violations

The Course of Truvada Lawsuits

On May 8, 2018, the first batch of Truvada lawsuits was filed by the AIDS Healthcare Foundation against Gilead’s Truvada and other TDF-based HIV prep medications and antiretroviral drugs. Some cases were filed individually, and one was a class action claim. As of 2019, Gilead had hundreds of cases filed against in California and a few others in other states, including Delaware and Louisiana. Since it is suspected that thousands of patients have experienced the severe side effects of Truvada or other TDF medications, all the Truvada lawsuits were consolidated.

The majority of the initial TDF lawsuits were filed in the Northern District of California, where Gilead is based. The Truvada lawsuits were consolidated in Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881 under the Northern District of California (federal court) in April 2019 before Judge Jon S. Tigar for pretrial purposes. Following that, new TDF lawsuits filed against Gilead in other federal districts were routinely transferred to the Northern District of California and consolidated before Judge Tigar for efficiency.

Like all MDLs, Truvada lawsuits MDL too will aggregate all comparable cases for the purposes of the pretrial processes before a single federal district court, including:

  • Collecting evidence
  • Dismissal requests
  • Motions requesting exclusion of evidence and expert witness statements
  • Motions for summary judgment
  • Interrogatories
  • Depositions
  • Expert testimony

MDLs shorten the process and enable victims to collaborate on evidence rather than having to do so individually for each claim for damages, similar to class action cases. After completing most of the processes, now the Truvada lawsuits MDLs are in the bellwether trial phase. The first bellwether trial is scheduled for October 2022.

Certain cases will be chosen by the plaintiff’s side as well as the defendant’s side, and they will be considered bellwether trials. The course and result of these trials will have a tremendous impact on the defendant’s decision to go for a global settlement on the other pending MDLs.

Since there is no settlement in the Truvada lawsuits so far, we can’t speculate on the Truvada lawsuit settlement amounts. The deadline for the Truvada lawsuit is not set, and it is open yet.

Latest Truvada Lawsuit Update 2022

As per the latest update, on 08/19/2022, U.S. District Judge Jeffrey White in Oakland, California, ruled that Gilead Sciences Inc must face a potential class action lawsuit accusing it of paying off Indian generic manufacturer Cipla Ltd not to compete with its HIV preventative medicine Truvada.

Over 25 individual litigants have recently joined forces to bring a new Truvada product liability case against Gilead Sciences. Since every plaintiff resides in Florida, the action was initially brought in that state’s Middle District. But as soon as Gilead filed a motion to shift the court, the plaintiffs consented to have the case relocated to the Northern District of California (Harlan et al. v. Gilead Sciences, Inc., 4:22-cv-03156-JST). It was consolidated for pre-trial discovery.

The first Gilead sciences TDF Truvada bellwether trial date in 2022 is expected to commence toward the end of 2022. Once the bellwether trial verdicts turn in favor of the plaintiffs, it will show the course of settlement. The Gilead lawsuit settlements amounts will depend on the severity of the injuries the victims have.

Do I Qualify for a Truvada Lawsuit?

If you or a loved one has been prescribed Truvada or another TDF medication and are later diagnosed with a kidney or bone injury, you may be eligible to join the Truvada lawsuit.

See a couple of sample cases where the plaintiffs were affected. At the age of 30, one of the Los Angeles plaintiffs received a diagnosis of osteopenia and osteoporosis of the spine, neck, and hip. Another Californian plaintiff used the medication for 12 years before he experienced Fanconi syndrome and osteoporosis at the age of 50. Here, you can see that diseases take some time to manifest. As a result, the records you have are essential to support your claims.

Documents needed to fortify your claim

  • Proof that you have taken Truvada
  • Medical reports of your diseases and injuries
  • Medical treatment records, such as surgery records
  • Medical bills and statements
  • Medications receipts
  • Records of any emotional distress counseling you received
  • Receipts for medical device purchases
  • Pay slips and bank statements are required to demonstrate lost wages
  • Workplace absence records
  • Documents of your mental anguish and pain levels
  • Images of your injury

Damages Claimed for Truvada Lawsuits

As per the Truvada lawsuit attorneys, the victim is entitled to economic as well as non-economic damages, such as

  • Current and future medical expenses
  • Dialysis and organ transplant expenses
  • Physical therapy expenses
  • Travel expenses for doctor’s appointments
  • Lost wages
  • Loss of earning capacity
  • Pain and suffering
  • Emotional distress
  • Loss of social enjoyment
  • Loss of consortium
  • Wrongful death damages, if the victim loses his life
  • Punitive damages

Value of Medical Records and Chart Review in Truvada Lawsuits

Fighting against the Pharma behemoths is not an easy task. They will have professional and expert attorneys lined up at their service to nullify your claim if it is weak. Your medical records are solid evidence of your suffering, and so they should be error-free and intact from any baffling contradictory reports. Ensure that your medical report has the start date of the intake of Truvada and your health condition from the beginning of the initial dosage.

The medical records can stand alone in proving the progression of your deteriorating health condition and the medical expenses. You may have a huge pile of medical records to be reviewed for your Truvada lawsuit. Your Truvada lawsuit lawyers will then review your medical records with the help of a medical record review company.

An experienced medical record review company with a team of professional chart reviewers can filter those mammoth records and compress them with all the vital points that can help your Truvada litigation. LezDo techmed has wide experience in medical record reviews.

To sum up,

Physicians and patients lay their great hope on pharmaceutical drugs and devices to get the betterment of their ailments. Regrettably, most of these pharma tycoons frequently prioritize profits over their customers’ health and safety, and they must be held liable for their negligence.

If you have been taking Truvada, don’t panic and stop the usage, as sudden medication termination will also be dangerous. Consult your physician to find out the safer alternatives to safeguard you. Get a physical examination for possible kidney and liver diseases and do a bone density check.

At present, there are no active class-action lawsuits on Truvada claims. If you are affected by Truvada and injured, you can go for individual claims. Since the bellwether trials in the Gilead Truvada lawsuits are scheduled, it is never late to join the bandwagon to make the wrongdoers pay for their negligence. The statute of limitations to file a Truvada lawsuit is based on the discovery rule set by the different states. Based on this, the time limit is calculated from the time of discovery of the harm or injury. Contacting a Truvada injury attorney on time will give you more possibilities to win Truvada lawsuit settlements.

Stay alert and save yourself. Visit LezDo for the Truvada lawsuit update 2022 periodically.

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