HIV Drug Lawsuit Against Gilead Sciences Over Kidney Failure
In recent years, medications like Truvada and Viread have been important in treating human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome (AIDS), giving hope and longer lives to many people with HIV. But along with their benefits, these drugs have caused serious side effects like kidney damage and weaker bones, leading to many lawsuits against drug companies like Gilead Sciences Inc. This shows worries about safety and not enough warnings for consumers. At Ethen Ostroff Law, we know how tough it is for people hurt by these drugs. We stand up for those hurt by drug companies’ mistakes, fighting to get them fair money for their injuries. Read on to see how we can help you with your HIV drug lawsuit if you’re one of them.
HIV and Its Management
HIV remains a major health issue in the US, affecting around 1.2 million people by 2021, with most aware of their status. Despite progress, the virus still impacts communities nationwide. Antiretroviral therapy or ART is key in managing HIV, using a combo of meds to suppress the virus and improve patients’ health. Drugs like Truvada and Viread from Gilead are widely used for HIV treatment. They not only enhance the quality of life but also lower transmission risks. These medications offer hope for those living with HIV to lead fulfilling lives while curbing virus spread.
Gilead's TDF Drugs
Gilead’s TDF gained the US Food and Drug Administration approval in 2001 as Viread for HIV treatment. Truvada, another TDF drug, followed in 2004. These breakthrough medications revolutionized HIV treatment. Millions relied on Viread or Truvada, generating substantial revenue for Gilead and other companies.
Gilead’s TDF drugs that offer various options for HIV treatment and prevention include:
- Atripla: This medication is used for treating HIV infection and is not intended for prevention. It’s also known as Efavirenz.
- Complera: Another HIV treatment drug. It is also known as Rilpivirine.
- Stribild: Used for HIV treatment, not prevention. It goes by the names Elvitegravir, Cobicistat, and Emtricitabine.
- Truvada: Medication for both HIV treatment and pre-exposure prophylaxis or PrEP for HIV-negative individuals.
- Viread: This drug is for Hepatitis B treatment as well as HIV. It is also known as Tenofovir DF.
Problems with HIV Drugs with TDF
Regrettably, while HIV drugs containing TDF offer significant benefits, they also come with drawbacks. TDF isn’t easily absorbed by the body, requiring high doses for effectiveness. Research from the National Institute of Health in 2021 revealed that HIV patients may endure a decade of additional kidney and bone toxicity due to TDF.
This toxicity leads to a host of potential side effects, including:
- Acute kidney injury.
- Bone fractures.
- Chronic kidney disease.
- Declining kidney function.
- Fanconi syndrome.
- Osteopenia.
- Osteoporosis.
- Renal failure.
- Tooth loss.
Common side effects of Truvada and other TDF drugs include:
- Abnormal dreams.
- Decreased weight.
- Depression.
- Diarrhea.
- Difficulty sleeping.
- Dizziness.
- Fatigue.
- Headache.
- Increased creatinine and transaminases levels.
- Nausea.
- Rash.
- Stomach pain.
Gilead's Withholding of a Safer HIV Drug
Truvada’s approval in 2004 coincided with Gilead’s development of a safer alternative to TDF called TAF (tenofovir alafenamide fumarate). Unlike TDF, TAF was absorbed more efficiently by HIV cells, making it both more effective and less toxic. Although TAF still posed risks to bones and kidneys, its lower dose requirements and improved properties made it a safer option.
Despite the potential benefits of TAF, Gilead delayed its release. The company was already profiting immensely from Viread and Truvada, which were under patent protection. Releasing TAF earlier would have jeopardized revenue from these drugs, as it would have outshined their predecessors. Gilead chose to withhold TAF until shortly before Viread’s patent expiration. This decision prolonged patients’ exposure to the risks associated with TDF, highlighting the ethical concerns surrounding pharmaceutical companies’ practices.
Legal Battles Over TDF Drugs
A wave of product liability lawsuits in recent years has targeted Gilead. Users of its HIV medications have suffered from bone fractures, kidney failures, and other serious health issues. These lawsuits raise several critical allegations:
- Deliberate Delay: Plaintiffs argue that Gilead intentionally withheld the release of the safer alternative TAF drugs, prolonging patients’ exposure to harmful toxins for a decade to maximize profits.
- Inadequate Warnings: Gilead is accused of providing insufficient warnings about the true risks associated with TDF drugs, failing to disclose severe adverse effects such as kidney problems and bone loss.
- Legal Duty: Critics contend that Gilead had a legal obligation to promptly introduce the safer TAF drugs once their efficacy was known, but the company prioritized financial gains over patient safety.
These allegations have prompted a number of legal actions against Gilead, including:
- Breach of warranty.
- Negligence.
- Fraud.
- Strict liability.
- Violations of consumer protection laws across multiple states.
What HIV Drugs Are Being Sued?
Several Gilead’s HIV drugs are at the center of these lawsuits:
- Atripla.
- Complera.
- Stribild.
- Truvada.
- Viread.
Users of these medications have filed product liability lawsuits, alleging severe health consequences due to undisclosed risks and delayed introduction of safer alternatives by Gilead.
Chronology of Truvada and Other HIV Medication Lawsuits
- April 2024: Ongoing litigation includes federal trials scheduled for April 2024, with no court-approved settlements or jury verdicts reported yet.
- February 2024: Truvada lawsuits continue to progress, focusing on Gilead’s alleged delay in developing TAF for financial motives.
- January 2024: Federal consolidated Truvada HIV lawsuits in California are still pending, with the judge dismissing some claims but preserving others.
- November 2023: Gilead reaches a preliminary settlement of $246.75 million in a price-fixing class action related to delaying generic versions of HIV drugs.
- September 2023: A California appeals court hears arguments in state-consolidated lawsuits regarding Gilead’s appeal of the denial of a motion for summary judgment.
- May 2023:The first of two summary jury trials begins, while a group of 19 plaintiffs files a lawsuit against Gilead in California, alleging failure to warn about TDF’s toxicity.
- April 2023: Plaintiffs urge Judge Tigar to reject Gilead’s request to dismiss approximately 650 plaintiffs.
- March 2023: U.S. District Judge Jon S. Tigar excludes eight of Gilead’s experts, suspecting their opinions were ghostwritten.
- December 2022: Gilead faces lawsuits from over 26,000 plaintiffs across multiple states.
- December 2018: In Re: Tenofovir Disoproxil Fumarate Products Liability Litigation (MDL 2881) is established in the Northern District of California.
- May 8, 2018: The AIDS Healthcare Foundation files the first Truvada lawsuit against Gilead, alleging the company withheld a safer alternative, TAF, to maximize profits. The lawsuit also claims kidney problems and bone loss caused by Truvada and other TDF-based drugs.
FDA Warnings and Regulatory Response
Over the years, the FDA has issued warnings and regulatory actions regarding the safety of TDF medications, emphasizing risks like kidney damage and bone fractures. These actions support plaintiffs’ claims in lawsuits against Gilead, highlighting inadequate warnings and failure to disclose risks. As plaintiffs seek justice, FDA warnings play a crucial role in holding pharmaceutical companies accountable.
Public Awareness and Advocacy Efforts
The FDA’s warnings about TDF medications, like Gilead’s, help support lawsuits by showing inadequate warnings and risks. Advocacy groups and legal firms work to educate people about these risks and help those affected seek compensation. They use social media, events, and resources to spread information and support individuals harmed by TDF medications.
Patient Rights and Legal Protections
Individuals harmed by TDF medications have legal rights and protections available to them. Here are key considerations:
- Avenues for Seeking Compensation: Victims can pursue compensation through individual lawsuits, class actions, or multidistrict litigation (MDL), depending on their circumstances.
- Class Action Lawsuits: These allow a group of plaintiffs with similar claims to consolidate their cases. However, plaintiffs should weigh the benefits against potential drawbacks like limited control.
- Ensuring Fair Compensation: Attorneys work to negotiate settlements that accurately reflect plaintiffs’ injuries and losses, while legal protections prevent retaliation against those exercising their rights.
- Legal Representation: Experienced attorneys, like those at Ethen Ostroff Law, offer essential guidance and advocacy throughout the legal process.
- Potential Reforms: HIV drug lawsuit outcomes may lead to discussions about reforms to improve patient safety and industry accountability.
Patient rights and legal protections play vital roles in advocating for those harmed by TDF medications, ensuring justice, and contributing to broader patient safety efforts.
Process for Filing an HIV Drug Lawsuit
Filing an HIV drug lawsuit involves several crucial steps to ensure that individuals harmed by pharmaceutical negligence receive the compensation they deserve for their injuries. Here’s a concise overview of the process:
- Consultation with an HIV Drug Lawyer: Meet with an HIV medication lawyer who evaluates your case, medical history, and medication details to assess its strength and provide guidance.
- Investigation and Case Preparation: Your HIV drug lawyer conducts a thorough investigation, gathering medical records and evidence to build a strong case demonstrating pharmaceutical negligence.
- Filing the HIV Drug Lawsuit: Your attorney files the HIV medication lawsuit, outlining allegations of defective design, failure to warn, and negligence against the pharmaceutical company.
- Discovery Phase: Both parties exchange information and evidence relevant to the case, including documents, witness statements, and expert testimony, to prepare for trial.
- Negotiation and Settlement: Many cases settle before trial through negotiation, with HIV drug lawyer attorney advocating for fair compensation for your injuries.
- Trial: If no settlement is reached, your HIV drug lawsuit proceeds to trial, where evidence is presented, and a judge and jury decide the outcome.
- Appeal (If Necessary): Either party may appeal the trial outcome if dissatisfied, seeking a review of any legal errors that may have impacted the case.
Eligibility for HIV Drug Lawsuits
Wondering if you’re eligible to file an HIV medication lawsuit? You may qualify if:
- You’ve taken one of Gilead’s HIV drugs, such as Atripla, Complera, Stribild, Truvada, or Viread.
- You’ve experienced bone problems or kidney damage due to the medication.
Uncertain if you meet the criteria? Reach out to Ethen Ostroff Law today to explore your potential HIV drug lawsuit.
Statute of Limitations for TDF Lawsuits
Every state establishes its statute of limitations for dangerous drug claims, typically ranging from two to three years after the injury. However, exceptions may apply, and an attorney can offer guidance on navigating these time constraints.
Regardless, individuals affected by TDF should seek legal counsel promptly. Building a strong case takes time, and attorneys need sufficient opportunity to develop the best possible HIV drug lawsuit on behalf of their clients.
Legal Grounds for Allegations Against Gilead in Truvada Lawsuits
The legal basis for the allegations against Gilead in the Truvada lawsuits involves:
- Concealment of Safer Alternatives: Allegations suggest Gilead withheld a safer alternative, tenofovir alafenamide (TAF), to prioritize profits from Truvada and other TDF-containing drugs, despite knowing the associated risks.
- Defective Design: Lawsuits claim Gilead knew Truvada and TDF could be highly toxic but failed to conduct further studies, inform the public, or offer a safer alternative, resulting in serious side effects like kidney problems and bone loss.
- Failure to Warn: Plaintiffs argue Gilead didn’t adequately warn consumers about Truvada’s health risks, particularly the increased risk of severe kidney damage and bone density loss.
- Misrepresentation of Risks: Allegations suggest Gilead misrepresented Truvada’s risks despite knowing the potential harm, failing to provide accurate information to consumers and healthcare providers.
- Prioritizing Profits: Claims indicate Gilead prioritized financial gains over patients’ health and safety, knowingly or negligently exposing individuals to TDF’s toxic effects in Truvada and other medications.
- Regulatory Compliance: Assertions include Gilead disregarding warnings or recommendations from regulatory bodies like the FDA regarding Truvada’s risks and safety.
Gilead's Defense Against Allegations in TDF Lawsuits
In response to the Truvada lawsuits, Gilead presents various defenses to counter the allegations brought against it. Its stance includes:
- Adequate Warnings: Gilead argues it provided appropriate warnings and instructions regarding Truvada’s potential risks and side effects.
- Exclusive Jurisdiction: Gilead contends that the FDA’s sole authority over drug labeling and safety precludes state claims for failure to warn and design defects.
- FDA Approval: Gilead asserts that the FDA’s approval of Truvada’s labeling supersedes state claims of inadequate labeling.
- Federal Preemption: Gilead argues that federal law overrides state claims related to Truvada, including failure to warn, design defect, and manufacturing defect.
- Good Faith: Gilead maintains it acted in good faith in interactions with patients, healthcare providers, and regulatory agencies.
- No Wrongdoing: Gilead denies withholding a safer alternative or engaging in wrongdoing regarding Truvada’s pricing or marketing.
- Safety and Effectiveness: Gilead asserts Truvada’s safety and efficacy in treating and preventing HIV.
- Seeking Dismissal or Limitation: Gilead has moved to dismiss or limit certain claims, citing lack of evidence or federal law preemption.
Building Evidence in HIV Medication Lawsuits
To substantiate their claims against Gilead, individuals affected by TDF medications and their legal representatives would gather the following evidence:
- Detailed diaries documenting physical pain and mental distress.
- DEXA scans revealing osteoporosis or osteopenia.
- Dialysis records indicating kidney issues.
- Documentation of prescribed TDF medications by the victim’s physician.
- Expert medical witnesses may be enlisted to bolster the case by establishing a clear connection between the TDF medications and the plaintiff’s injuries.
- Financial records demonstrating lost wages due to missed work.
- Medical records, including blood tests, confirming kidney damage.
- Pharmacy records indicating the dates of Truvada or other TDF drug usage.
- Physicians’ notes outlining anticipated future medical treatments and associated costs.
- Receipts for medical expenses, therapy, and necessary equipment.
Compensation Available in HIV Medication Lawsuits
Victims of TDF-related injuries may seek various economic and non-economic damages from Gilead, including:
- Compensation for past and future medical expenses.
- Compensatory damages for TDF-related injuries and associated costs.
- Coverage for disability accommodations.
- Funeral expenses and support loss for wrongful death cases.
- Loss of consortium experienced by the victim’s family.
- Pain, suffering, and diminished quality of life.
- Punitive damages to penalize the manufacturer for dangerous conduct.
- Reimbursement for lost future earnings due to illness.
The settlement amount for each plaintiff varies based on their unique circumstances and the severity of their Truvada-induced injuries. Those unable to work due to severe injuries may receive higher compensation compared to those who have recovered and can still earn a living.
Gilead Truvada Settlements
Currently, no settlements have been finalized in the ongoing Truvada lawsuits. Whether pursuing compensation through the class action in the Northern District of California or an individual Truvada lawsuit or Viread lawsuit, plaintiffs still have steps to take before settlements can be reached. Estimating average settlement amounts for these lawsuits is challenging, but we can evaluate your case’s value by considering factors such as medical expenses, lost income, and other damages caused by the Gilead HIV drug. Settlement amounts often depend on the severity of injuries, with patients facing more severe conditions potentially receiving higher compensation. Rest assured, as your legal advocates, Ethen Ostroff Law is dedicated to ensuring you receive fair compensation tailored to your case.
Ethen Ostroff Law | Advocates for HIV Medication Victims
If you’ve suffered kidney damage or bone fractures due to Truvada, Viread, or other HIV TDF drugs, our team is here to support you through an HIV drug lawsuit. With an experienced HIV medication lawyer from Ethen Ostroff Law by your side, we will:
- Assess your damages accurately.
- Gather evidence to strengthen your case.
- Collaborate with other plaintiffs, if applicable.
- Manage communications with involved parties.
- Negotiate for a favorable settlement on your behalf.
- Provide representation at trial, if needed.
Schedule a free consultation with Ethen Ostroff Law today. Your health and well-being are our primary concerns, and we’re dedicated to securing the compensation you deserve.
