Have You Experienced Bone or Kidney Side Effects After Taking TDF HIV Medications Like Truvada?

There is a TDF Lawsuit growing. Did you take a TDF based HIV medication (like Truvada, Viread, Atripla, Complera, or Stribild)? Have you been treated by a doctor for any of the following serious kidney or bone problems after having used any of those medications?

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truvada kidney

Possible Truvada & TDF Drug Kidney Side Effects

TDF is alleged to cause a toxic buildup in kidneys that may lead to one of the following diagnoses:

  • Declining kidney function
  • Chronic kidney disease
  • Acute renal failure
  • Kidney failure
  • Acute kidney injury
  • Fanconi Syndrome
truvada side effects

Possible Truvada & TDF Drug Bone Side Effects

TDF is alleged to cause a toxic buildup in bones that may lead to one of the following diagnoses:

  • Osteoporosis
  • Decreased bone mineral density
  • Osteopenia
  • Bone fractures
  • Tooth decay or loss
  • Hypophosphatemia (low phosphate levels)

TDF Side Effect Patients Forced Into Dialysis

 

TDF-based medications like Viread, Truvada, Complera, Stribild, and Atripla have several significant potential kidney-related side effects including renal failure, acute tubular necrosis, Fanconi syndrome, interstitial nephritis, nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, and polyuria.

 

Some patients who did not have kidney problems or had mild kidney problems prior to taking these medications have had their kidney function severely impaired. Some of these patients have even been forced into an expensive and intrusive dialysis regimen as a result of these developed symptoms.

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There is a TDF Lawsuit being put together. You May Be Entitled To Compensation For Injuries Related To Truvada & TDF Drug Side Effects

People experiencing serious bone and kidney related side effects after taking TDF based medications such as Truvada, Viread, Atripla, Complera, or Stribild might be entitled to compensation for their injuries.

Gilead Sciences, a major U.S. drug manufacturer and the maker of these medications, has been accused of negligence in understating the potential harmful side effects of these medications in their marketing and promotional content.

Gilead is also accused of purposefully delaying the release of a safer and more effective HIV medication. This was in order to generate billions of dollars in profits from toxic medications all at the expense of the vulnerable HIV population. This has all led to the growing TDF Lawsuit.

Gilead Truvada TDF Lawsuits Are Being Filed

Two California men filed a lawsuit against Gilead Sciences in 2018. They alleged they were harmed because the drug manufacturer knowingly delayed the release of safer TAF-based HIV medications. This was done in order to extend the usefulness of the company’s patents on the TDF drugs. The lawsuit asserts that people taking these drugs were unnecessarily subjected to up to 10 years of additional bone and kidney toxicity when a safer alternative could have been available.

A parallel class action TDF lawsuit seeks to incorporate all affected California residents.

New personal injury and product liability TDF lawsuits are being filed. Affected patients seek potential compensation for the needless bone and kidney injuries caused by these toxic drugs.

tdf lawsuit

Can I File A TDF Lawsuit Against Gilead?

If you took one of Gilead Sciences HIV TDF medications (Truvada, Viread, Atripla, Complera, or Stribild) and you were diagnosed with serious bone or kidney problems due to drug toxicity, you may be entitled to compensation for your injuries.

These TDF-based medications are alleged to cause toxic buildup within bones and kidneys resulting in potentially serious health effects unrelated to the normal effects of aging.

Have you been diagnosed with osteoporosis, osteopenia, bone fractures, decreased bone mineral density, tooth loss or decay, low phosphate levels, chronic kidney disease, declining kidney function, acute kidney injury, acute renal failure, kidney failure, or Fanconi Syndrome?

If your kidney or bone injury diagnosis can be linked to your use of one of the listed HIV medications, it is important to get in touch with an experienced product liability lawyer for a free TDF lawsuit case evaluation. You could find out in just minutes whether your case qualifies. Potentially get compensation for your injuries in this ongoing TDF lawsuit.

A successful TDF lawsuit could help you to recover compensation for related medical costs, current & future lost wages, pain & suffering, or for funeral expenses.

What is TDF?

Tenofovir Disoproxil Fumarate (TDF) helps to treat HIV in infected people and is also used as PrEP – a method of preventing infection and transmission in high risk populations. TDF has also been approved by the FDA for the treatment of Chronic Hepatitis B in adults and children over 12.

The compound belongs to a class of drugs known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs) which block a critical HIV enzyme that prevents the virus from replicating.

300 mg 

Standard common dose of TDF-based HIV drugs that cause excessive toxicity buildup in bones and kidneys

Is TDF Dangerous?

Gilead’s own research into “TAF” and continued concerns about the bone and kidney toxicity of TDF even before the initial FDA approval of the drug shows that the company was aware of the possible dangers to patients.

Yet, these dangers were seriously understated or misrepresented to patients and doctors, according to the TDF lawsuits.

TDF-based HIV drugs come in a 300mg dose, which is alleged to cause excessive toxicity buildup in bones and kidneys. TAF-based drugs can be given in much smaller doses and have been demonstrated to be a safer and more effective alternative.

Gilead is accused of touting TDF as a “miracle drug” when it was first introduced to the market.

The TDF lawsuits against Gilead allege that the company downplayed known risks to kidney and bone health while also suppressing the development of this safer alternative drug in order to maximize the profitability of their TDF patent.

Gilead released five HIV drugs containing the TDF compound including, Truvada, Viread, Atripla, Stribild, and Complera. These drugs were regularly prescribed both to HIV-infected patients and patients using the drug as a prophylactic. Some of these drugs were also used to treat chronic Hepatitis B in adults and children over the age of 12.

Studies have shown that patients exposed to high levels of TDF over a significant period tended to experience sometimes severe bone and kidney complications. They wouldn’t have otherwise experienced these complications without the toxicity induced by the drug.

by 33% 

The risk of chronic kidney diseases increases if patients used TDF drugs

A UCSF study from 2012 had doctors examine the records of 10,000 HIV patients from the Department of Veterans Affairs. The findings showed a 33% increase in the risk for chronic kidney disease each year that a patient used TDF drugs.

While TDF-based compounds remain legal, available, and for sale, Gilead introduced the TAF-based alternative drugs Descovy, Genvoya, and Odefsey since 2015. They quickly began encouraging patients to switch immediately to these safer alternatives.

It is strongly recommended that you consult with your physician before stopping, starting, or changing any drug.

Did Gilead Choose Patents Over Patients?

Gilead Sciences first acquired the rights to tenofovir in the mid-1990s, obtaining an exclusive license to synthesize the compound.

Beginning in 2001, Gilead began manufacturing a prodrug form of tenofovir called TDF (Tenofovir Disoproxil Fumarate), which could be taken orally.

In the meantime, Gilead also developed another tenofovir-based compound called TAF (Tenofovir Alafenamide Fumarate) which proved to be much less toxic to bones and kidneys than the TDF compound.

However, Gilead mysteriously shelved the TAF project in 2004.

Not until 2014 did Gilead Sciences apply for a patent for TAF.

It is alleged that this timing conveniently coincides with the nearing expiration of the TDF patent, and potentially represents the company’s interest in maintaining their monopoly. This was done by waiting to release the new and safer drug until they had already recovered a maximal profit from the TDF formula.

In 2015, Gilead began marketing the TAF formula as a “new” and “novel” and “safer” alternative for patients.

However, case advocates argue that there was nothing at all new or novel about the drug and that this was the same drug Gilead had kept on the shelf since at least 2000.

Advocates argue that if Gilead had introduced the drug earlier instead of shelving it, they would not have recovered the maximum value of their patent on TDF. Which therefore would have had a long overlapping period in which the patents for TDF and TAF existed simultaneously. In that case, only the TAF patent would have been valuable since it was the “safer” and “better” alternative.

It is then alleged that the TAF compound was shelved for over a decade while Gilead reaped enormous multi-billion-dollar profits from the TDF patent with little regard for the welfare of suffering patients.

The TDF patent would have expired in 2018, opening the market to potentially lower-cost generic competition. However, since Gilead released the TAF compound in 2014, it can enjoy another 20-year monopoly on this “new” and “safer” drug.

Thus, the competition on TDF medicines would be greatly reduced with the TAF alternative available and controlled by Gilead.

The timing of these events looks very bad for Gilead Sciences. Some say this represents a classic and indefensible case of corporate greed over the value of people and patients. This forms the basis of TDF lawsuit complaints.

 

19,414

Total cases

Have been reported relating to one of the 5 TDF drugs released by Gilead, with 697 new cases being reported in the first quarter of 2019,
according to the FDA Adverse Event Reporting System (FAERS).

14,669

Serious cases

Including death are reported of March 31, 2019, and cases that have led to death are reported at 1 244.

860

Acute Kidney Cases

Or 4.4% made up of the total reported cases. Keep in mind that these are only the cases that have been reported to the FDA Adverse Event Reporting System. It is likely that there are many other cases which have not yet been reported.

tdf lawsuit

What Medications Contain TDF?

Tenofovir disoproxil fumarate (TDF) is an anti-HIV compound found in several drugs produced and marketed by Gilead Sciences, Inc.

Drugs containing the TDF compound

tdf lawsuit drugs

Patients taking HIV medications made by Gilead Sciences typically used them as part of a “highly active antiretroviral therapy” (HAART) to treat and manage HIV infection. Some of the medications were marketed and used as “pre-exposure prophylaxis” (PrEP).

TDF is the only active ingredient in the drug sold by Gilead and prescribed under the brand name Viread.

TDF is a component of the drug Truvada, which is used as an HIV treatment medication and as a “pre-exposure prophylaxis” or PrEP. The active ingredients in Truvada include 300mg of TDF and 200mg of emtricitabine.

Atripla, Complera, and Stribild are all-in-one combination antiretroviral drug therapies which also contain the TDF compound.

In 2014, Gilead Sciences redesigned Truvada substituting the safer TAF compound in place of TDF. This “new” formulation was marketed under the brand name Odefsey. And in 2016, the Atripla formula was similarly redesigned using the TAF compound and marketed as Descovy.

New TAF medications now include Odefsey, Genvoya, Biktarvy, and Descovy.

What Serious Kidney & Bone Side Effects Have People Experienced?

truvada kidney

Kidney Injuries Including

  • Declining kidney function
    Kidney functions are impaired making patients susceptible to heart and arterial problems
  • Acute kidney injury
    An abrupt reduction in the ability of the kidneys to filter waste products
  • Acute renal failure
    A rapid decline in kidney function with accumulation of waste products in the blood
  • Fanconi Syndrome
    Inadequate reabsorption in the proximal renal tubules of the kidneys
  • Kidney failure
    kidneys lose the ability to filter waste from the bloodstream
tdf side effects

Bone Injuries Including

  • Osteoporosis
    A medical condition in which bones become fragile and brittle from the loss of tissue
  • Decreased bone mineral density
    A decrease in the amount of bone mineral in bone tissue
  • Osteopenia
    A reduction in bone mass less severe than osteoporosis
  • Bone fractures
    Includes both partial and complete bone fractures due to unusual bone fragility
  • Tooth decay or loss
    Loss or decay of teeth
tdf side effects

Gilead’s own animal toxicology studies prior to TDF approval showed the bones and kidneys as the target organs for toxicity and that bone toxicities included osteomalacia and decreases in bone mineral density.

Clinical studies and adverse event reports dating from 2001 and 2002 document cases of severe renal deficiencies and toxicity in patients with no prior history of kidney problems. Another 2003 case of fatal renal insufficiency was reported in a patient who had before experienced only mild renal impairment. Other studies from as early as 2002 linked TDF with acute decreases in bone mineral density and bone loss.

Patient protection advocates have asserted that Gilead had every reason to know about the dangers posed by the side effects of TDF. It is also asserted that Gilead had in its possession and purposefully withheld a safer formula causing many patients to suffer needlessly for up to a decade.

Gilead Sciences

Gilead Sciences, Inc. (referred to as Gilead Sciences or Gilead) is a California based biotechnology and pharmaceutical manufacturing company which researches, develops, and markets several popular drugs.

Established in 1987, Gilead specializes in antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza.

Gilead is considered a pharmaceutical giant with a market capitalization of over $86 billion and 2018 revenue of over $22 billion. Gilead owns upward of 80% of the antiretroviral drug market. It has been estimated that TDF based drugs bring the company about $11 billion per year in sales.

The company acquired the exclusive right to develop and produce tenofovir based compounds in the mid-1990s. The company was able to bring its first tenofovir based drug – Viread – to market in 2001.

The Story of Gilead’s Alleged Concealment & Fraud leading up to the TDF Lawsuit.

TDF Lawsuit Summary

Though countless patients likely benefited from the development of TDF-based drugs that help to manage and prevent HIV infection, many consumers and advocacy groups are alleging a dark side to the story.

Allegations include a claim that Gilead developed a safer alternative to its TDF drugs which could be taken in a smaller dose and significantly decreased the potential for negative effects to bones and kidneys.

This other compound, TAF, was shelved in 2004 for unspecified reasons. It is claimed that the reason essentially amounted to corporate greed. The company would benefit financially if they were able to fully utilize the life of the patent on the TDF compound before introducing the TAF compound to replace it, at which point they would gain another monopoly on a “new” and “safer” drug foregoing competition for the life of another patent.

Besides the allegation of purposefully and needlessly withholding a better and safer drug in order to gain profits, the company is also accused of misrepresenting the dangers and potential side-effects of TDF. This allegation has some evidence to back it up, as the FDA issued two warning letters early on about Gilead’s marketing practices relating to the safety of its TDF drugs.

TDF Development

Tenofovir Disoproxil Fumarate (TDF) was discovered in the 1980s by European scientists. Gilead acquired the rights to produce and sell the drug in the early 1990s.

In 1997, the company worked with doctors from UC San Francisco to demonstrate how the drug was able to fight HIV by blocking an enzyme necessary for the virus to multiply.

The original formula required intravenous injection, and therefore held little market potential. However, scientists working for Gilead were eventually able to modify the drug to produce an oral caplet.

In 2001, the FDA approved tenofovir under the brand name Viread.

Gilead combined the TDF compound with other HIV medications to develop the world’s fist once-per-day HIV pill called Atripla. Other combinations were also developed resulting in the formulation of Truvada, Stribild, and Complera.

Did Gilead Misrepresent Serious Truvada & Other TDF Drug Side Effects?

Early animal studies conducted by Gilead showed that TDF could cause damage to kidneys and bones.

In 2003, Gilead placed a warning on the Viread label prompted by numerous patient complaints about renal failure and other serious kidney issues. That label cautioned doctors that a study had found more bone loss in patients taking TDF medications than another HIV drug.

In a large study conducted at UC San Francisco in 2012, doctors examined the records of 10,000 HIV patients from the Department of Veterans Affairs. The findings showed a 33% increase in the risk for chronic kidney disease each year that a patient used TDF drugs.

FDA Warns Gilead

Gilead received a warning letter from the FDA in 2002 about incidents in which the company’s sales representatives had violated the law by giving both doctors and patients false and/or misleading information that did not accurately reflect the side effects listed on the drug label.

The 2002 letter referenced incidents occurring at a 2001 medical conference in which sales representatives from Gilead informed the audience that Viread had “no toxicities” and was “extremely safe.” Another Gilead representative was accused of calling Viread a “miracle drug.”

A second warning letter issued by the FDA in 2003 took the rare action of requiring Gilead to retrain its sales representatives “due to the significant public health and safety concerns” over repeated false and/or misleading statements made by those representatives.

Patient advocates are claiming that this represents a long history of false or misleading marketing practices proving that Gilead was aware of the dangerous side effects posed by TDF drugs, and that they were potentially purposeful in their attempts to understate the seriousness of the problems.

Gilead Develops A New & Safer HIV Drug – TAF

Scientists at Gilead had been working to develop a less toxic form of the TDF drug at least as early as 2001, before the FDA had ever approved of Viread. This drug was called tenofovir alafenamide fumarate (TAF).

Initial animal studies in 2001 seemed to show that the TAF formulation could much more effectively penetrate infected cells.

A human trial commissioned by Gilead using 30 HIV patients in Los Angeles, New York, Palo Alto, and Philadelphia seemed to show that TAF had greater antiviral potency at a fraction of the dosage required in TDF drugs.

Did Gilead Withhold A Safer Drug For Monetary Gain?

Despite the seemingly positive results from TAF testing, Gilead’s CEO in 2004 – John Martin – announced that the TAF project would be indefinitely shelved based on “an internal business review” which determined the drug would be unlikely to be highly differentiated from its predecessor TDF.

TDF Lawsuit 1

TAF Patented

In 2014

It wasn’t until around 2010-2011 when Gilead spokespeople started mentioning TAF again.

At a medical conference in 2011, the company revealed the results of a 2003 trial which showed that TAF was more effective than TDF at 1/6th the dose. Another TAF study from 2002 was eventually published in 2014.

Many medical and legal professionals are against the delayed publication of such findings due to the potential for manipulations and the effects on verifiability. Not to mention that this kind of delay raises a host of suspicions as to why the information is relevant now but not when the study was conducted.

In 2014, Gilead began applying for patents on its “new” TAF drugs.

TAF Brought To Market

In 2015

The patent was approved and in 2015 Gilead began bringing the TAF drugs to market. These drugs were marketed to doctors as a “new” and “novel” and “safer” alternative to the TDF medications.

Patient advocates argue that there was nothing “new” about this medicine.

Gilead had known about it all along, they say. They did the studies. They had the results.

It has been alleged that Gilead had an ulterior motive in not further developing TAF medications after the early trials showed positive results.

 

Did Thousands Of HIV Patients Suffer Toxic TDF Side Effects Needlessly?

A new drug formulation can be patented by the manufacturer for a 20-year term. This gives the manufacturer the exclusive right to produce and sell the compound, creating a virtual monopoly which is supposed to incentivize companies to do research and development by guaranteeing profits on successful formulations through the prevention of generic competition.

It is alleged that when Gilead recognized that the TAF compound was a better and more effective alternative that they also recognized this as a threat to the profitability of the TDF patent. Effectively, if the TAF drugs were immediately introduced, the remainder of the TDF patent would be rendered practically worthless.

Instead, it is alleged, Gilead shelved the TAF project for over a decade to maximize its profits from the TDF patents.

Then, as that patent neared expiration and the company would have been faced with generic competition, Gilead applies for the TAF patent, partially based on the research and studies conducted in the early 2000s.

After approval, Gilead has now effectively extended their monopoly, as any generic TDF medications introduced would be inferior and riskier compared to their exclusive TAF medications.

Gilead Faces Serious Allegations

A huge pharmaceutical company shows a history of deceptively marketing a drug and understating the potential for serious side effects, while simultaneously holding the keys to a similar, safer, and more effective drug.

But instead of choosing the health, safety, and wellbeing of patients, the multi-billion-dollar drug company allegedly choose massive corporate profits instead.

It’s no coincidence, advocates argue, that Gilead suddenly regained interest in the TAF compound and introduced the new drug just when the old patent was nearing expiration and they would be forced to face generic competition for their exclusive (and expensive) TDF drugs.

TDF Lawsuit History & Significant Cases

Early 2000s FDA Warning Letters

In 2002 and 2003 the FDA issued two separate warning letters to Gilead condemning the unlawful misrepresentation of TDF drug effectiveness and possible side effects.

It was noted that Gilead sales representatives were understating the risks of TDF side effects. Company spokespeople were regularly and publicly describing TDF as “extremely safe” and having “no toxicities” while also reportedly calling Viread “a miracle drug.”

2018 TDF Lawsuit & Truvada Class Action Lawsuit

Plaintiffs first filed a personal injury lawsuit in Southern California in May of 2018 alleging they were harmed because Gilead intentionally delayed the release of the safer TAF medications in order to maintain and profit from its monopoly on the less safe TDF drugs. Several other personal injury lawsuits have followed since then.

According to these lawsuits, though Gilead appears to have been aware of the significant risk or serious bone and kidney complications as early as 1997, the companies sales representatives and CEO touted the TDF drugs as being “benign” and “completely safe” as well as a “miracle drug” with “no toxicities.”

A parallel lawsuit seeking class action status for all California residents affected by the drugs was filed simultaneously with the help of the Aids Health Foundation. This suit alleges that Gilead failed to disclose that TDF had significant risk for bone and kidney toxicity; failed to warn about the bone and kidney risk to ALL patients, not just those with pre-existing bone and kidney issues; and misrepresented the risks and benefits of TDF drugs in order to gain greater profits.

2019 TDF Lawsuit Ruling

In February of 2019, Judge Carolyn B. Kuhl of the Superior Court of California, County of Los Angeles rejected Gilead’s request to have all the plaintiff allegations dismissed. Besides the claim of “strict liability,” Judge Kuhl held that the allegations were enough to move forward with the claims of “breach of warranty” and “negligence.”

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How To File A TDF Lawsuit Against Gilead

As of April of 2019, 41 plaintiffs from 12 states have filed personal injury and/or product liability claims against Gilead Sciences for failing to properly warn patients and doctors of the potential side effects of TDF use. The lawsuits also admonish Gilead for failing to deliver a safer and more effective drug that they had allegedly already developed and tested and proved to be a safer and more effective alternative.

People who have taken one of Gilead’s TDF drugs (including Viread, Truvada, Atripla, Stribild, and Complera) and later experienced bone or kidney ailments are encouraged to act now and speak with an attorney today to understand your rights and what compensation might be available to you.

What Serious Kidney & Bone Side Effects Have People Experienced?

Who Can File A TDF Lawsuit?

Any person who used Gilead’s TDF-based HIV medications (Viread, Truvada, Atripla, Stribild, & Complera) and later developed bone or kidney complications related to their use of these drugs is a good candidate.

We are currently accepting TDF induced product liability claims from affected patients in all 50 states. Contact an attorney to receive a free case evaluation today.

How Do I Know If My Side Effects Result From TDF Drugs?

Did you take a TDF medication like Viread, Truvada, Stribild, Atripla, or Complera and later experience bone or kidney problems?

Talk to your doctor.

If those problems can be linked to your use of a TDF medication and not to a pre-existing condition, you may have a solid case. It is important to discuss these issues with your doctor and a qualified personal injury attorney with experience advocating for patients against big pharmaceutical companies.

What Could I Get Out Of A TDF Lawsuit?

If successful, you may be able to recover compensation for:

  • Medical bills
  • Current & Future Lost Wages
  • Pain & Suffering
  • Funeral Expenses
How Do I Choose The Right TDF Law Firm?

It is important to choose a lawyer with experience in product liability claims and who understands what it takes to hold Big Pharma accountable.

What Medications Contain TDF?

Viread, Truvada, Atripla, Stribild, and Complera are the five medications released by Gilead Sciences, Inc. which contain TDF as an active ingredient.

Isn’t TDF Approved By The FDA?

Yes. But FDA approval doesn’t mean “completely safe.” There are many instances in which drug side effects are found to be more pronounced years after FDA approval.

What Is A Product Liability Claim?

A product liability claim rests on the idea that a product manufacturer has a duty to warn about the possible dangers from the regular use of a product. It appears Gilead failed to properly warn of these dangers. This failure resulted in injury and death related to the use of Gilead’s products. By this logic, we assert that Gilead is liable for the damage caused by their products.

What Makes A TDF Product Liability Claim Successful?

You must be able to show that the defective product (Viread, Truvada, Atripla, Stribild, or Complera) is the cause of your injuries or complications, and that you sustained compensatory damages such as medical bills, lost wages, pain and suffering, funeral expenses, or other related costs.

It is important to speak with your healthcare professional in order to better understand how you may have been affected.

It is also important that you contact a qualified lawyer who can help you understand your rights.

Why Are Patients Suing Gilead Over Truvada & TDF Drug Side Effects?

Gilead Sciences has been accused of deceptively marketing the safety of its popular TDF-based HIV medications while simultaneously withholding a safer and more effective drug developed in its own laboratory. They are alleged to have done this as a means of increasing their profits and extending the life of their valuable and exclusive drug patents at the expense of vulnerable patients.

Should I Stop Taking TDF Medications?

You should only start, stop, or change medications after consulting with your physician in order to avoid potentially serious physical harm.

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