A dozen people who took drugs containing tenofovir disoproxil fumarate (TDF) have filed a lawsuit against Gilead Sciences over alleged kidney and bone damage.
The lawsuit alleges Gilead failed to warn about the risks associated with TDF drugs, including Truvada, Stribild, Complera, Atripla and Viread, which are used for the treatment of HIV infection. The lawsuit claims Gilead failed to warn about these risks despite knowing about them.
The lawsuit also alleges that Gilead intentionally withheld a safer HIV medication, tenofovir alafenamide (TAF) in order to successfully monetize two drugs instead of one.
“Before Gilead’s first TDF product, Viread, received FDA approval in 2001,
Gilead knew that two of its other antiviral drugs that are structurally similar to tenofovir caused
significant kidney damage,” the lawsuit states. “Gilead’s preclinical studies of TDF showed that it could be toxic to kidneys and bones.”
The lawsuit notes that 40% of adverse events related to Viread were related to the renal/urinary system, and that Gilead updated its Viread labeling four times from 2002 to 2006 to describe kidney damage that patients taking TDF were experiencing.
The lawsuit notes that “Gilead’s long-term clinical data also demonstrated that TDF was damaging patients’ bones.”
Gilead scientists published an article in which they acknowledged safety issues with TDF, including serious renal events, according to the lawsuit.
The lawsuit claims Gilead knew TAF was much less toxic to bones and kidneys than TDF before it developed its TDF drugs. The lawsuit alleges Gilead withheld this knowledge so they could maximize sales of TDF before approving TAF.
“Gilead knew that by withholding the safer TAF design, it could extend the longevity of its HIV drug franchise and make billions two times over: first, with TDF medications until TDF patent expiration, which would begin by no later than 2018, and second, with TAF medications until TAF patent expiration as late as 2032,” the lawsuit states.
“Only once Gilead had realized billions in sales through most of the TDF patent life—having built Viread sales up to $1.1 billion and the TDF portfolio up to $11 billion in sales in 2015 did Gilead create TAF-based versions of its prior TDF Drugs and work to convert its TDF Drug sales to TAF drug sales,” the lawsuit continues. “Once TAF entered the market, Gilead successfully convinced a large percentage of doctors to switch from TDF-based to TAF-based regimens by highlighting TAF’s improved safety profile with respect to bone and kidney toxicity—the very benefits that Gilead could have and should have incorporated into its product design from the beginning but withheld from patients with each successive TDF Drug for over a decade.”
The lawsuit seeks damages under numerous counts, including strict products liability – design defect, strict products liability – failure to warn, negligence and gross negligence, fraud by omission and breach of implied warranty of merchantability.
Studies have linked TDF when used to treat existing HIV infections with kidney and bone damage, but TDF has not been linked to kidney or bone damage when used as pre-exposure prophylaxis (PrEP).
For more information on TDF, visit https://www.personalinjurylawcal.com/tenofovir-tdf-lawsuit/