HIV Viread Lawsuits for Kidney Failure & Bone Problems, Act Now.

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January 10, 2024 — Gilead Sciences Inc. Faces Negligence Claims for Delaying Safer HIV Medications

In a recent ruling, Gilead Sciences Inc. has been unable to evade the claims of numerous plaintiffs who allege harm caused by the company’s delay in developing safer HIV medications. Despite not contending that the drugs they used were flawed, the plaintiffs’ negligence theory remains viable. This groundbreaking decision by the California Court of Appeal sheds light on the relationship between “defect” and “negligence” in product liability cases.

The California Court of Appeal’s Opinion

The California Court of Appeal, in its published opinion, expressed that no previous California case had explicitly addressed the connection between “defect” and “negligence” in the context of product liability. Associate Justice Jeremy M. Goldman, writing for California’s First District Court of Appeal, concluded that manufacturers have a legal duty to exercise reasonable care during the development and distribution of their products. This ruling paves the way for the plaintiffs to pursue their negligence claims against Gilead Sciences Inc.

Scope of Negligence Claims

The plaintiffs’ negligence claims are unique in that they do not rely on the existence of a product defect. Instead, they focus on Gilead Sciences Inc.’s alleged negligence in delaying the introduction of safer HIV medications. This approach expands the traditional understanding of product liability, opening up new avenues for individuals harmed by delayed product advancements to seek legal recourse.

Implications for Gilead Sciences Inc.

The court’s ruling has significant implications for Gilead Sciences Inc. and other pharmaceutical companies. It underscores the importance of timely development and release of safer alternatives in the pharmaceutical industry. Manufacturers must now exercise reasonable care not only in ensuring the safety of their products but also in the timely introduction of improved versions that minimize risks to consumers.

Impact on the Pharmaceutical Industry

The ruling has broader implications for the pharmaceutical industry as a whole. It emphasizes the responsibility of manufacturers to prioritize consumer safety and prompt innovation. The decision sets a precedent that may encourage individuals harmed by delayed advancements in medical technology to pursue legal action against companies that fail to prioritize the timely release of safer alternatives.

Future Considerations for Product Liability Cases

The California Court of Appeal’s decision introduces a new framework for product liability cases. It highlights the importance of considering negligence claims even in the absence of a product defect. Manufacturers across industries will need to be more vigilant in their product development processes, ensuring the timely introduction of safer alternatives to minimize potential harm to consumers.

November 15, 2023 — Once again, Gilead’s attempt to disengage its self from the HIV drug lawsuits failed last month in a federal court in California.

The judgment found that Gilead cannot avoid design defect and warning-related claims in the current litigation, which accuses the company of prioritizing profits over the development of safer HIV drugs.

Gilead’s attempt was to receive a decisive ruling that federal law precludes strict liability claims alleging that the TDF drugs were defectively designed.

The first bellwether trial for the Truvada lawsuit is scheduled and set in California on January 24, 2024.

Gilead’s new tenofovir disoproxil fumarate (TDF) medications hit the market in the 1990s and early 2000s to treat HIV patients and making the difference between life and death for many. Nucleoside reverse transcriptase inhibitors (NRTIs) and other HIV medications turned the deathly virus into a manageable, chronic condition. This was a game-changer for so many people.

One new type of drug, Viread, hit the market in 2001 after gaining approval from the U.S. Food and Drug Administration (FDA). Viread is used in combination with other retroviral drugs to treat HIV in adults and children as young as 2 years old, as well as chronic hepatitis B infection.

Viread, as well as Truvada, Truvada PrEP, Atripla, Stribild and Complera, contains TDF, a chemical compound that Gilead allegedly knew causes serious side effects to patients’ kidneys and bones, including kidney failure. In 2002, they allegedly tested a new formula that replaced the TDF with TAF (tenofovir alafenamide fumarate), later named and sold as Genvoya and Odefsey. TAF achieves the same therapeutic effect as TDF, however, it can do so using a safer dosage that does not cause the same harm to patients.

The TDF drugs have helped treat many people with HIV for nearly two decades, but had a high occurrence of side effects, causing some patients to lose teeth, develop osteoporosis and even destroy their kidneys to the point of dialysis. The drug is associated with severe adverse reactions, including chronic kidney disease and kidney failure, liver problems, bone loss, and a rare condition called lactic acidosis, that have sent numerous patients to the hospital and even caused death.

People affected by these dangerous side effects have begun filing kidney failure lawsuits against the maker of Viread, Gilead Sciences Inc. These lawsuits accuse the manufacturer of developing a defective drug and failing to warn about its risks.

What is Viread?

Viread is a prescription medication used in combination with other drugs to treat patients with HIV. Viread is a type of HIV medication called a nucleotide analog reverse transcriptase inhibitor (RTI) and HBV reverse transcriptase inhibitor. It is approved to treat adults and children as young as 2. It is also used to treat chronic hepatitis B in adults and children 12 years of age or older.

Viread works by incorporating itself into a patient’s DNA and inhibiting the activity of the HIV virus. HIV, or Human Immunodeficiency Virus, is a powerful virus that attacks the body’s immune system and makes the infected person susceptible to other infections. It does this by attacking T-helper cells, a type of white blood cell, by making copies of itself inside those cells and gradually taking over the immune system. If the virus isn’t treated, it will eventually destroy the immune system entirely. Because the immune system is the body’s only natural defense against infections and disease, untreated HIV usually leads to death.

Untreated HIV can also develop into AIDS, or Acquired ImmunoDeficiency Syndrome, which refers to a set a symptoms caused by HIV. A person is said to have AIDS when their immune system is too weak to fight off infection and they develop certain symptoms and illnesses. This is the last stage of HIV and if left untreated will lead to death.

There is no cure for HIV or AIDS but HIV medications can be a life-saving measure to those living with HIV, allowing those individuals to live longer, fuller lives. While Viread and other similar HIV medications have saved the lives of thousands of people living with the virus, the drugs’ active ingredient, tenofovir disoproxil fumarate, has also been linked to potentially serious adverse effects in some patients.

Taking Viread

Viread is available in tablet or powder form. The recommended dose for patients 12 years of age or older is 300 mg per day, taken orally once a day with or without food. The recommended dose for patients younger than 12 years of age varies. These recommendations are not suitable for patients who have impaired kidney function; those individuals should take lower doses of the drug since it is excreted through the kidneys and could cause further damage or complications.

Viread tablets come in different strengths, including 150, 200, 250 and 300 mg. Viread powder comes in one strength, 40 mg per 1 g of oral powder, and is typically given to younger patients who cannot take oral tablets.

The Viread label indicates there are no contraindications that would prevent the drug from being used in certain circumstances or in certain patient populations; however, patients with impaired kidney function should be cautious before starting Viread. It is important to always speak with your doctor before starting a new medication so you can go over the risks and benefits.

Viread Side Effects Linked to Potentially Harmful Complications

Viread and similar medications have been associated with potentially serious side effects that can lead to life-threatening complications, even death.

Some of these serious side effects include:

Chronic Kidney Disease
Severe renal deficiency
Kidney Failure
Fatal renal insufficiency
End stage renal disease
Loss of bone density
Low bone mineral density
Bone loss
Bone breaks of fractures
Tooth loss
Fanconi Syndrome―a rare disorder of kidney tubule function that results in excess amounts of glucose, bicarbonate, phosphates, uric acid, potassium, and certain amino acids being excreted in the urine
Osteomalacia (softening of the bones)
Osteoporosis with pathological fracture

Call your doctor right away if you experience any of the symptoms associated with these side effects.

Severe Kidney Problems and Viread

Viread has been associated with new or worsening kidney problems in some patients. This may be due to the fact that Viread leaves the body mostly through the kidneys. Patients should be tested for creatinine levels before taking Viread, especially if they are at an increased risk for kidney problems prior to starting treatment with Viread or other tenofovir-disoproxil-fumarate- containing drugs. This means having your blood tested before starting treatment.

Kidney problems that some Viread patients have experienced include chronic kidney disease (CKD), severe renal deficiency, fatal renal insufficiency, and end stage renal disease.

Kidney problems that go untreated may progress into kidney failure―a life-threatening condition that could lead to death.

Symptoms of kidney problems include:

Headache
Anemia
Bleeding and bruising easily
Weakness
Nausea, vomiting, or less desire to eat generally
Feeling fatigued and drowsy
Mental symptoms such as lowered mental alertness, trouble concentrating, confusion, or seizures
Muscle cramps or twitching
Thirst
Increased urination at night
High blood pressure
Numbness in the extremities
Diarrhea
Itchy skin or eyes
Skin color changes
Swelling and puffiness
Difficulty breathing due to fluid in the lungs or anemia
Decreased urine output
Poor digestion

Bone Loss and Kidney Failure while using Viread

Some patients have developed bone problems while taking Viread, which may be sign of impaired kidney function. Viread may affect bone mineral density, which can lead to other problems like bone loss, low bone mineral density, bone breaks and fractures, and tooth loss. Osteomalacia, which is the softening of the bones, or osteoporosis with pathological fractures may also be a potential side effect of taking Viread.

The long-term effects of Viread on bone health and fracture risk is unknown. It is recommended that patients—adults and children—with a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss should have their bone mineral density tested before being treated with Viread.

Signs and symptoms of bone problems include:

Persistent or worsening bone pain
Fractures
Muscular pain or weakness
Pain in the extremities

Lactic Acidosis, Liver Problems, and Other Side Effects of Viread

Lactic Acidosis

Viread and other medications containing the same active ingredient have been associated with other potentially serious adverse effects. Viread and similar medications now carry a black box warning―the FDA’s strongest warning short of taking the drug off the market―for their potential to cause lactic acidosis in some patients.

Lactic acidosis is a rare but serious condition that occurs when too much lactic acid builds up in the blood. Lactic acid is usually made in the body during intense exercise when there is not enough oxygen available to use. The body creates lactate, or lactic acid, to convert into energy, but it can build up in the blood stream faster than the body burns it off, causing sore muscles and other side effects.

Patients taking Viread or similar medications who develop symptoms of lactic acidosis should see their doctor right away to get treatment. Lactic acidosis can lead to death if left untreated.

Some patients may be at increased risk for developing lactic acidosis compared to others. One risk factor for lactic acidosis is taking Viread or other HIV medications that contain the active ingredient tenofovir disoproxil fumarate.

Other risk factors include:

Being female
Obesity
Poor liver function
Pregnancy
Lower CD4 cell count

Signs and symptoms of lactic acidosis include:

Weakness or unusual tiredness
Shortness of breath or fast breathing
Unusual muscle pain
Stomach pain with nausea and vomiting
Fast or abnormal heartbeat
Feeling dizzy or lightheaded
Cold or blue hands and feet

Liver Problems

Some patients have reported severe liver problems after taking Viread to treat their HIV. These problems have been reported by patients who had risk factors for liver disease, while others were reported by patients with no known risk factors. Some of these cases have been fatal and the majority of cases were reported by women, according to the Viread label.

Patients have reported liver problems including chronic kidney disease, severe renal deficiency, fatal renal insufficiency, and end stage renal disease.

Symptoms of liver problems include:

Yellow skin and eyes
Dark, “tea-colored” urine
Nausea
Light-colored stools
Loss of appetite for several days or longer
Stomach-area pain

Common Side Effects of Viread

The most serious potential side effects of Viread are relatively rare, there are more common side effects of the drug.

These common side effects include:

Abdominal pain
Nausea
Diarrhea
Weight loss
Tiredness
Headache
Dizziness
Depression
Rash
Problems sleeping
Abnormal dreams

Speak with your Doctor Right Away if you Experience any of these Side Effects

Patients who experience any of the above-mentioned side effects should speak with their doctor to make sure it is safe for them to continue taking Viread. If not addressed by a healthcare provider, some of these adverse effects can lead to more serious, life-threatening conditions and even death. If these symptoms develop, you may need to stop taking Viread and find a different treatment option that works better with your body. It is important to stay informed and speak to your doctor about all the potential risks of HIV medications when determining which drug is right for you.

Other HIV Medications Associated with Serious Side Effects

There are numerous medications currently on the market that are used to treat HIV-positive patients and that also contain the active ingredient in Viread associated with serious side effects.

These medications include:

Truvada (Gilead Sciences Inc.)
Truvada for PrEP (Gilead Sciences Inc.)
Atripla (Gilead Sciences Inc.)
Complera (Gilead Sciences Inc.)
Stribild (Gilead Sciences Inc.)

All of these drugs contain some form of the active ingredient, tenofovir, which may cause the same serious side effects linked to Viread. Patients taking any of the above-mentioned drugs and experience adverse side effects like liver and kidney problems or bone loss should speak with their doctor right away.

Viread Kidney Failure Lawsuits

People who took Viread and experienced serious, negative side effects are now filing kidney failure lawsuits against the drug’s manufacturer, Gilead Sciences Inc. These lawsuits accuse Gilead Sciences of manufacturing a defective product and failing to adequately warn about the drug’s risks.

Filing a lawsuit may be one of the only ways for those affected to seek compensation for the damages they incurred, such as lost wages and mounting medical expenses. Talking with an experienced lawyer or attorney is the first step towards getting the justice you deserve and holding the pharmaceutical companies accountable for the harm they caused when putting profits over the safety of their consumers.

If you or a loved one were prescribed Viread, or similar drugs like Truvada, Truvada for PReP, Atripla, Complera, or Stribild, and experienced negative side effects, you may be entitled to financial compensation. There may be significant cash payouts or settlements as a result of these lawsuits.

If you experienced side effects like kidney, liver, or bone problems, you may qualify for a Viread claim. Call the experienced attorneys at Schmidt National Law Firm today at 1-800-631-5656 to see if you qualify for a Viread Lawsuit, or visit nationalinjuryadvocates.com to file a claim now.

Viread Kidney Failure Lawsuits are in the early stages of discovery, and no case has gone to trial. There is still time to file a claim, but the statute of limitations vary state to state so don’t wait to contact an attorney.