Gilead Sued over Toxicity of HIV Treatments

On Friday, a civil suit was brought against pharmaceutical company Gilead for it’s failure to properly report potential health effects of the numerous HIV drugs they had released to the public between 2001 and 2015. The plaintiffs accused the defendants of doing this knowingly in an attempt to maintain their share of the HIV drug market and keep profits high.

The suit was brought by patients suffering from HIV who used either one or a combination of multiple Gilead-produced medications. Start of consumption for these patients spanned anywhere from 2001 and 2014 and the drugs at issue include Viread, Truvada, Atripla, Complera, and Stribild.

The plaintiffs cited kidney and bone deficiencies as a side effect and seek compensation for past and future damages caused by the products, which also include mental anguish, physical pain, loss of enjoyment of life, and loss of income both past and future. The full range of side effects listed in the suit include bone density loss, bone demineralization, kidney disease, low kidney function, high creatine levels, renal disease, bone fractures, and osteoporosis.

According to the suit, all five of these drugs contained an ingredient called tenofovir disoproxil fumarate (TDF), a drug with nearly identical makeup to adefovir. Adefovir was previously used in two HIV drugs produced by Gilead. Only three years after the drug’s FDA approval in 1996, they were pulled from shelves after a Phase III clinical study showed that 59% of patients experienced “severe kidney toxicity” after 72 weeks of use.

 The suit alleged that these dangers were well known by the company but were ignored in order to maintain profits, citing their lack of Phase III clinical studies on medications containing TDF as an indicator of their lack of commitment to rigorous testing and patient safety. Part of this includes improperly labeling dangerous side effects on the bottle, which plaintiffs say was done so intentionally by Gilead.

The plaintiffs also claimed that a drug Gilead was developing called tenofovir alafenamide fumarate (TAF) was known by the company to be of equal effectiveness and could be administered in a lower, therefore less toxic, dose. Gilead allegedly shelved it’s TAF design in 2004 because the patent they possessed for TDF lasted until 2018. The defendants argued that because the TAF patent lasts until 2032, Gilead can “extend the longevity of its HIV drugs franchise and make billions.”. Gilead, which relied on Viread for 68% of all product sales in 2003, purpoertedly did not want to admit health risks out of fear that they would suffer too great of a financial loss. It was only in 2015, near the very end of their TDF patent, that they began to push their TAF products.

Gilead allegedly cited TAF’s superior safety profile when trying to convince health care professionals to switch from a TDF to a TAF regimen, which is contrary to previous claims made by the company in the early years of its patent.

Specific counts raised by the plaintiffs include strict liability, negligence, fraud by omission, breach of implied warranty, and violation of state consumer protection laws.

According to Docket Alarm, Gilead has faced 55 lawsuits in recent years under the Pharmaceutical Personal Injury Product Liability case type.

The plaintiffs are represented by Hagens Berman Sobol Shapiro.