When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm.
But in Gilead’s years-long court battle over its tenofivor-based HIV meds, patients have put a unique twist on that norm with their argument that the company delayed development of a safer drug. By doing so, the company was negligent, according to the plaintiffs, despite the earlier med's effectiveness.
Now, in a decision that could raise uncertainty for manufacturers across several industries, a California appeals court determined that the plaintiff’s negligence claim can stand.
The allegations date back to 2001, when Gilead launched its tenofovir disoproxil fumarate- (TDF) based HIV med. While effective in HIV treatment, users of TDF risked adverse events such as skeletal and kidney damage.
Around the same time, the company discovered a similar but safer candidate called tenofovir alafenamide fumarate (TAF), according to the plaintiffs.
After several separate lawsuits were filed, around 24,000 TDF users joined in on legal action against the company. The bulk of the group’s argument hinges on Gilead’s early testing on TAF, which suggested the med might offer fewer risks while providing the same benefits. According to the patients, the drugmaker purposely chose to hold off on further TAF development to maximize profits from its TDF meds.
Crucially, the plaintiffs acknowledge TDF isn’t faulty on its own and shouldn’t be revoked from the market. Instead, the group categorizes Gilead’s delayed TAF development as an action that falls outside of the company’s duty of reasonable care by knowingly depriving patients of the choice between two options for several years.
Plaintiffs also claim fraudulent concealment, alleging that Gilead skirted its obligation to inform TDF users about the newer, safer potential alternative.
For its part, Gilead argues that a plaintiff cannot seek compensation for harm caused by a product if that product is not proven defective, and that the company had no duty to disclose facts relating to TAF when that med had not yet been approved.
In the California Court of Appeal's latest update to the case, the court tossed two of the plaintiff’s claims and narrowed the scope to one allegation of negligence.
With the move, the court has “upended established California law,” a Gilead spokesperson told Fierce Pharma in an emailed statement. According to Gilead, the decision marks the first time the state’s appellate courts have ever held that a manufacturer can be held liable for a non-defective product.
“If the opinion is not overturned, the court’s decision will have widespread, negative consequences across all fields of innovation and manufacturing, undermining the development of new products and discouraging improvement of existing products,” the company's representative said.
The company further contended that a flood of lawsuits could result from similar scenarios, a claim the court thinks “overstates given the narrowness of the duty at issue.” The duty is reasonable care as opposed to a perfect product, the court said.
Gilead will “continue to defend ourselves” and is evaluating its appellate options, the spokesperson added.

https://www.fiercepharma.com/pharma/negligence-without-defectiveness-appeals-court-allows-unique-argument-gileads-taftdf-drugs