On February 13, 2019, a California court ruled that HIV/AIDS patients who have been victimized by Gilead Sciences Inc. may now file personal injury cases against the Bay Area drug company. For years, Gilead promoted TDF-based HIV/AIDS medications as life-saving medicine that would help manage the disease and prevent it from advancing. Instead, patients found that the medication caused permanent damage to kidneys and bones.
Judge Carolyn B. Kuhl, of the Superior Court of California, County of Los Angeles, rejected all but one of Gilead’s arguments in its demurrer, which attempted to have all the HIV/AIDS patients’ legal claims against Gilead dismissed. Judge Kuhl authorized patients to move forward with their tort claims, with the exception of strict liability.
California patients first filed this personal injury lawsuit against Gilead in May 2018, in an attempt to hold the company accountable for its actions promoting TDF drugs while knowing a safer alternative called tenofovir alafenamide (TAF) was available. According to the patients’ lawsuits, the company knew as far back as 2001—based on studies and research conducted by the company—that TDF was “highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.”
Additional research from Gilead’s own studies demonstrated that the TAF formulation of tenofovir was significantly less toxic. Their studies also confirmed that the low absorption and high dosage requirements of TDF carried serious risks related specifically to potential bone and renal toxicity. Gilead never published this research.
Harmful Side-Effects of TDF
The lawsuit also alleged that Gilead failed to sufficiently warn patients of the harmful side-effects of TDF, even going so far as to actively misrepresent TDF’s risk and its overall efficacy. The lawsuit further alleges that Gilead’s motive behind suppressing the alternate drug TAF was to extend the patent life and sales of current TDF medications. Essentially, their motive was to protect their net profits, which amounted to over $18 billion in 2015 alone.
The cases included both Personal Injury Claims and Class Action Status, prepared by HIV Litigation Attorneys and Rutherford Law and filed in the Superior Court of the State of California for the County of Los Angeles. Each case demands a jury trial. The AIDS Healthcare Foundation is funding the litigation and will not receive financial recovery that exceeds its actual costs.
HIV Drug Brand Names
Gilead’s TDF (tenofovir disoproxil fumarate) drugs have been marketed under the following different brand names.
- Truvada (most common)
- Atripla
- Complera
- Stribild
- Symfi-Lo
- CimDuo
- Viread
Lawsuits across the country have alleged that TDF drugs like these have serious side effects, including the following:
Kidney Injuries
- acute kidney injuries
- renal failure
- chronic kidney disease
- related nephritic injuries
Bone Injuries
- osteoporosis
- fractures
- osteopenia
- related orthopedic injuries
Despite patient complaints and research confirming the toxicity of TDF, Gilead continued to push this drug on HIV/AIDS patients, while TAF sat on a laboratory shelf. Meanwhile, the FDA issued two warning letters to Gilead regarding its marketing practices for TDF. These letters further stated that Gilead’s sales representatives broke the law by giving doctors and patients false and misleading information about TDF and its side effects. An FDA warning letter from as far back as 2002 alleges that Gilead salespeople falsely stated that TDF had “no toxicities,” was “benign,” and was “extremely safe.”
An FDA warning letter from 2003 took the drastic measure of requiring the company to provide new training to all of its sales representatives to ensure they provide accurate information regarding the severe side effects associated with TDF in order to comply with the law (Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352). What this means is that Gilead knew for over 15 years that its decision to continue promoting and selling TDF was causing patients prescribed the drug to experience permanent and potentially fatal damage to their kidneys and bones.
Gilead’s Response
Shockingly, Gilead’s response to this pushback was to lie to the public. In October 2004, Gilead’s CEO John C. Martin—who made close to $200 billion from Gilead in 2014—claimed that “the company is discontinuing its development program” for TAF. Presumably, this was to draw attention away from the safer alternative drug available, but the company never actually stopped developing the medicine. In reality, Gilead applied for seven patents associated with TAF between October 2004 and May 2005, long after it claimed they would discontinue the drug.
It must be stated that not every patient who took TDF had the kind of severe or fatal physical side effects that many patients involved in the lawsuit experienced. Moreover, individuals currently taking this medication should not stop taking the medication without first consulting with a medical expert. Regardless, Gilead continued to generate enormous profits while many of its HIV/AIDS patients suffered, all while knowing that a safer alternative existed and the company itself had possession of it in its own labs.
Fortunately, there is reason to celebrate now, as the February court ruling indicates a major victory for the HIV/AIDS patients who suffered as a result of Gilead’s negligence and greed. Moreover, the ruling sets a very important precedent for thousands of patients to also receive justice after experiencing the harmful side effects of TDF and potentially future harmful drugs.
Liza Brereton, a member of HIV Litigation Attorneys and one of the attorneys representing the plaintiffs, said, “Gilead’s perverse motive of outsized profits and increased market share is not in line with patient health and safety and we are grateful that patients will now get their days in court.”
References:
https://www.natlawreview.com/article/what-deal-tdf-drug-and-truvada-lawsuits
https://www.apnews.com/4db956edccff42d7b869cf311b3e5b0d
https://www.latimes.com/business/la-fi-gilead-hiv-drug-lawsuit-20180509-story.html
