Pharmaceutical companies face increasing criticism about their apparent emphasis on profits rather than fulfilling their mission to produce safe and effective medication. The conflict between these competing interests has taken a tragic turn in the treatment of patients who take medication for the treatment and prevention of HIV. Recently released information suggests in the early 2000’s, drug manufacturer Gilead Sciences delayed the development of a safer form of the popular HIV drug, tenofovir disoproxyl fumurate (“TDF”), in order to extend sales and maximize its profits before the expiration of its patent.
Early Developments in TDF Lawsuits
The non-profit organization, AIDS Healthcare Foundation (“AHF”), first cast a spotlight on this matter in 2015. At that time, AHF initiated a federal lawsuit that sought to accelerate the introduction of a lower-cost and safer antiviral agent, tenofovir alafenamide fumarate (“TAF”), into the HIV treatment and prevention marketplace. More recently, and with the AHF’s financial backing, Courtney N. Conner, Liza Brereton, and Arti Bhimani—all principals at HIV Litigation Attorneys™—stepped up the challenge to Gilead’s profiteering with the filing of two lawsuits in California state courts.
One of those lawsuits was a personal injury action on behalf of two HIV-positive individuals who suffered bone and kidney damage after they were prescribed TDF. The second was a class action lawsuit against Gilead on behalf of all HIV-positive individuals who purchased TDF drugs and suffered similar health problems as a result of long-term exposure to TDF drugs.
Since those initial filings, HIV Litigation Attorneys™ have continued the fight against Gilead with other lawsuits filed in the federal courts.
HIV Litigation Attorneys™ File TDF HIV Lawsuit for Personal Injuries
HIV Litigation Attorneys™ kicked off our personal injury campaign against Gilead with the filing of case BC702302 in the Superior Court of Los Angeles County, California. The case demands compensation for two patients who are suffering from kidney damage and bone density loss they allege are related to their long-term TDF drug usage. The case was filed on grounds of strict product liability—design defect and failure to warn; negligent product liability—design defect and failure to warn; breach of implied warranty; and breach of express warranty.
This HIV personal injury lawsuit raises several allegations including:
- Since at least 2001, Gilead knew that TDF was toxic in its recommended prescribed dosages and that patients who used TDF were risking possible serious damage to their kidneys and bones;
- Gilead knew that TAF was a safer alternative, but it suppressed the further development of TAF in order to continue to gain profits from TDF;
- The FDA has twice warned Gilead over its TDF marketing practices, including the misleading statements made by Gilead salespeople that TDF had no toxicities, and was benign and extremely safe;
- Gilead failed to warn prescribing physicians about TDF’s toxicity risks.
The HIV Class Action Lawsuit
The HIV Litigation Attorneys™ also initiated a separate class action lawsuit in the Superior Court of Los Angeles County, California (Case Number BC705063). Unlike the personal injury case, the TDF class action lawsuit seeks consumer remedies and unfair business practices damages and other remedies allowed under California law for the entire class of individuals comprising residents of the State of California who purchased TDF drugs and suffered bone density loss, kidney damage, and related TDF side effects as a result of treatment with the drugs.
With both the TDF class action and personal injury lawsuits underway, HIV Litigation Attorneys™ are leading the charge against Gilead. Though the request for class certification is currently specific to California residents, we hope that it will be expanded to include patients throughout the United States.
Federal Lawsuit Laid Groundwork for Current HIV Litigation
The TDF HIV personal injury and class action lawsuits are the progeny of the AHF’s 2015 federal lawsuit that sought to accelerate the introduction of TAF into the AIDS treatment marketplace. AHF’s complaint against Gilead and other defendants in that case sought a declaration to invalidate certain patents that covered TAF and other products.
A Federal District Court in California dismissed that action. AHF appealed that ruling but the appellate court affirmed the dismissal. AHF’s complaint, however, offered a glimpse into the marketing practices that Gilead employed to delay the widespread distribution of TAF in order to maximize profits from the older, less-safe TDF drug.
Although TDF is an effective treatment against HIV, with extended use, the drug may cause serious and permanent side effects including bone demineralization, bone density loss, renal impairment, tubular toxicity, and chronic kidney disease. Both HIV-positive and PrEP patients who have been taking TDF for years are now coming forward with complaints of side effects.
Gilead’s own public filings suggest that the company was aware of TDF toxicity problems as early as 2000 and that its pharmaceutical development team was then poised to advance the development of the safer TAF drug. Despite early success in clinical trials, the drug giant stopped its TAF research program in 2004, relying instead on its billions of dollars in TDF revenue.
Protecting Your Rights in the HIV Personal Injury and Class Action Lawsuits Against Gilead
All manufacturers of prescription pharmaceuticals have an obligation to warn patients of known drug product risks, and to minimize those risks particularly where safer alternatives may be available. To the extent that Gilead breached this obligation, HIV and PrEP patients can now take steps to protect their rights and to recover financial compensation for their damages.
You may be eligible for compensation if:
- your physician prescribed a TDF drug for long-term HIV treatment or prevention;
- you have been taking a TDF drug for an extended period of time under a physician’s regular care;
- you had inadequate warnings regarding side effects of long-term TDF treatment;
- you are experiencing side effects from long-term TDF usage, including bone density loss or kidney damage.
As the HIV Litigation Attorneys,™we are dedicated to the rights of patients throughout the United States who have used Gilead’s TDF-based HIV drugs and are now experiencing serious side effects. We are currently reviewing potential claims. Call to schedule a complimentary consultation with a member of our team. We will put patient health over profits, and you pay no legal fees unless we recover compensation on your behalf.
- www.latimes.com: Patients Sue Gilead, Saying Drug Company Intentionally Deferred Safer HIV Medicine. https://www.latimes.com/business/la-fi-gilead-hiv-drug-lawsuit-20180509-story.html
- www.pbwt.com: AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc. et al. https://www.pbwt.com/content/uploads/2018/05/AHF-v.-Gilead-Fed-Cir-Decision.pdf
- www.biospace.com: Gilead Lawsuits: California HIV Patients File Class Action and Personal Injury Cases Over Key HIV Drug. https://www.biospace.com/article/releases/gilead-lawsuits-california-hiv-patients-file-class-action-and-personal-injury-cases-over-key-hiv-drug/
- www.aidshealth.org: Lujano et al. v. Gilead Science, Inc. https://www.aidshealth.org/wp-content/uploads/2018/05/gilead-personal-injury-final.pdf
- www.aidshealth.org: Martinez et al. v. Gilead Sciences, Inc. https://www.aidshealth.org/wp-content/uploads/2018/05/class-action-complaint-final.pdf