Viread, the first Tenofovir Disoproxil Fumarate (TDF) based antiretroviral drug, appeared on the market in 2001. Three years later, combination drug Truvada debuted for the treatment of HIV infection, chronic Hepatitis B, and the prevention of HIV. Later, the FDA approved Atripla (2006), Complera (2011), and Stribild (2012).
Patients took these drugs in the hopes of living longer, healthier lives, and reducing the risk of HIV transmission. What they didn’t know is that tenofovir use is associated with an increased risk of very serious side effects like kidney failure and bone density loss, and that the manufacturer of these drugs suppressed a safer, cheaper medication for more than a decade in order to continue reaping huge profits.
Showard Law Firm represents individuals who have suffered adverse health effects and financial loss after taking TDF drugs. A growing number of people have filed lawsuits against the drugs’ manufacturer, claiming defective design, failure to warn, fraud, and concealment. Free consultations are available now, as the litigation unfolds.
TDF Primary Side Effects
Common TDF side effects include mild nausea, diarrhea, loss of appetite, headache, and a little dizziness. It is other, more serious side effects, however, that form the basis of more than 25,000 adverse event reports logged in the FDA database from patients using tenofovir:
- Tubular Dysfunction: Renal tubular disorders lead to fluid loss, electrolyte imbalance, and acid-base homeostasis. Without immediate treatment, patients can develop kidney stones, muscle weakness, chronic fatigue, and severe pain.
- Fanconi Syndrome: This rare kidney tube disorder releases essential nutrients into the urine, rather than the bloodstream, causing pain, muscle weakness, and bone fracture.
- Acute Kidney Injury or Acute Renal Failure: A buildup of waste products in the blood disrupts the body’s fluid balance, requiring immediate emergency care to prevent permanent kidney injury. Even after patients stop taking TDF drugs, the effects can last a year or more.
- Chronic Kidney Disease: Declining kidney function impairs the body’s ability to purify the blood, filter out excess water, and regulate blood pressure. Diminished kidney function can progress to end-stage kidney failure, where patients must receive an organ transplant or routine dialysis to survive.
- Bone Thinning (Osteopenia): Weaker than normal bones cause pain, loss of height and posture, and increase the risk of bone fracture. Treatment can help, but the condition cannot be cured.
- Bone Density Loss (Osteoporosis): Of the 10 million Americans with porous osteoporosis bones, 1 in 2 women, and 1 in 4 men, will break a bone after a minor fall, cough, or sneeze.
- Bone Fractures: Clinical studies found tenofovir users increased bone loss by an average of 1-2% a year. In some cases, patients on HIV drugs have had up to 6% loss within the first two years of starting treatment.
- Lactic Acidosis: When the liver cannot remove excess acid, a buildup of lactic acid in the blood prompts a life-threatening emergency. Without a sodium bicarbonate IV infusion, 75% of sufferers die. The median survival rate for patients with lactic acidosis related shock is just 28 hours.
FDA History: Has a Tenofovir Recall Been Issued?
To date, the FDA has issued no tenofovir recalls.
Gilead Sciences Inc. is the American biotechnology company responsible for developing, manufacturing, and marketing TDF drugs like Viread, Truvada, Atripla, Complera, and Stribild. According to court documents filed by plaintiffs, the FDA has issued two warning letters pertaining to TDF marketing practices in 2002 and 2003. The first letter reprimanded the manufacturer for violating the law with off-label marketing recommendations to prescribe Viread for use in patients with Hepatitis B co-infection, which was not FDA approved, and as a first-line treatment for HIV (which did not gain FDA approval until late 2003).
The company was also accused of misleading doctors to believe these drugs were “benign” and “extremely safe,” with “no toxicities.” The FDA ordered the drug-maker to “cease and desist” these communications at once.
The second FDA letter required a retraining of sales professionals to provide more accurate safety information. FDA representatives were concerned with comparison statements that were not substantiated by research, the failure to include the most common and serious safety issues in their marketing materials, and the failure to include limitations in their data.
TDF Label Changes and Adverse Events
Over the years, the FDA approved several warning label changes to indicate that Viread “increased the risk for renal impairment” and “severe acute exacerbations of Hepatitis B” in patients with co-infection of HIV and HBV. Patients at risk for renal failure should have their creatinine clearance tested prior to starting the medication, and should receive routine monitoring, according to updated physician guidelines.
As of June 2019, the FDA’s Adverse Event Reporting System listed 3,785 serious injuries, including 629 deaths, associated with tenofovir since 2001. These adverse outcomes included 691 cases of renal dysfunction and 279 musculoskeletal issues. Keep in mind these figures are by no means comprehensive; they’re just the people who took the time to make a formal report.
HIV Medication Lawsuits: Multidistrict Litigation
One class action claim was filed in the Superior Court of Los Angeles County, under the California Consumer Legal Remedies Act and the Unfair Competition Law, on behalf of plaintiffs based in the State of California who suffered bone density loss or kidney damage who could have benefitted from alternatives on the market. Claimants included in the class action would receive a small portion of a larger settlement sum.
The first individual HIV medication lawsuit involving tenofovir was filed against Gilead in May 2018 by a 58-year-old man whose bones resembled that of an 85-year-old woman’s. Most tenofovir lawsuits will be filed similarly, allowing attorneys to pursue more significant compensation, with each case determined based on its own unique merits.
The cases may be consolidated into Multi-District Litigation to streamline early proceedings. A petition was filed on May 20, 2019 for California State Coordination in Santa Clara County or San Francisco County.
There are also three early cases consolidated for pre-trial motions in the Northern District of California before U.S. District Judge Jon Tigar. Gilead’s motion to dismiss has been denied.
TDF Lawsuit Settlement Amounts
There are no tenofovir lawsuit settlements or jury verdicts yet, as litigation is in the early stages.
Litigants may be eligible to file a claim for financial compensation that covers:
- Past, present, and future medical bills
- Past and present loss of wages, and reduced future earning capacity
- Disability-related medical expenses, assistive technology, and home modifications
Family members who have lost a loved one may be able to file a wrongful death lawsuit to recoup losses related to medical bills, lack of financial support, funeral expenses, and burial costs.
The amount a successful TDF lawsuit plaintiff receives will be determined by the amount of medical bills, lost work, and suffering, as well as the irreversibility of the diagnosis.
Contact Showard Law Firm to Learn More About Filing a TDF Lawsuit
Showard Law Firm offers free consultations and legal representation with NO upfront costs. Contact us to explore your full set of legal options and learn more about the evolving HIV drug lawsuits.
Additional Resources for Tenofovir Disoproxil Fumarate:
- POZ – Lawsuit Alleges Safer Version HIV Med Withheld, https://www.poz.com/article/lawsuit-alleges-safer-version-hiv-med-tenofovir-withheld
- US News & World Report – HIV Prevention Pill Will Do More Harm Than Good, https://www.usnews.com/opinion/articles/2012/08/03/hiv-prevention-pill-will-do-more-harm-than-good-hiv-pill-will-give-a-false-sense-of-security
- AIDS Info – TDF, https://aidsinfo.nih.gov/drugs/290/tenofovir-disoproxil-fumarate/0/patient
- LA Sentinel – Judge Rules Profit Over People Lawsuit May Proceed, https://lasentinel.net/judge-rules-profit-over-people-lawsuit-may-proceed-against-pharmaceutical-giant-gilead-sciences-inc.html