After the Food and Drug Administration (FDA) approved Gilead’s HIV/AIDS drug in 2001, the firm gained FDA approval for a second drug in 2015. Though both drugs are effective and still in use, Gilead is facing a lawsuit from plaintiffs who say they should have developed the second drug sooner.
The complaint makes assumptions that would upend basic concepts underpinning not only drug development and innovation but also the freedom to operate any business relying on R&D.
The suit’s threat to the industry inspired the Biotechnology Innovation Organization (BIO) to join others in filing an amicus brief highlighting the dangers, and potential unintended consequences, of plaintiffs’ theory of legal liability.
“It would be highly damaging to scientific and medical innovation, which is affected by the prospect of litigation,” according to the “friend of the court” brief filed by BIO and others. “The practical impact of any reduction in pharmaceutical research would be felt globally in the context of the COVID-19 pandemic, the monkeypox Public Health Emergency of International Concern, and countless other urgent contexts.”
A decision on Gilead’s appeal for summary judgment is expected by mid-January.
The plaintiffs make the unusual argument that, even though drugs using tenofovir disoproxil fumarate (TDF) are effective, the antiviral tenofovir alafenamide fumarate (TAF) has fewer side effects, and therefore Gilead should have developed it sooner.
Lawyers for Gilead note that the plaintiffs’ claim is unprecedented because they are not saying the product was defective. “Plaintiffs conceded the point in oral argument: TDF has ‘been beneficial’ and ‘greatly helped patients with HIV and AIDS,’ ” according to Gilead’s supplemental brief to the appeals court.
The plaintiffs instead claim that Gilead knew TAF would have fewer side effects, so the company had a duty to work on developing that drug sooner.
As the amicus brief explains, the many drug developers who are BIO members “have a unique interest in ensuring that litigation cannot be used to punish a company for developing and marketing a product that FDA has indisputably determined has benefits outweighing its risks, based on an accusation that the company should have pursued approval for an alternate product or done so on a faster timetable.”
The case and its history
More than 20 years ago, Gilead was investigating a drug called tenofovir to create an antiretroviral for people with HIV/AIDS. Initial research included development of two types of treatment involving tenofovir, TDF and TAF. The first medicine was developed with TDF and was approved by the FDA in 2001. TDF-based medications, of which there were several, went on to change the HIV landscape and become the standard of care. These medicines remain approved by the FDA today and there is no dispute they have treated and prevented HIV in millions of people.
In 2004, with one TDF medicine approved and another poised to enter the market, Gilead made the decision to discontinue development of the second treatment, TAF. The company explains that the data at that time did not show TAF was sufficiently different from TDF in terms of effectiveness, safety, and tolerability. Gilead notes that it focused instead on developing TDF in combination with other medicines, creating single-pill treatment options containing TDF. The single-tablet regimens incorporating TDF were praised by the FDA as a “watershed in HIV treatment” because it reduced the pill burden on patients, increasing patient adherence and avoiding viral resistance to the treatments.
In 2010, Gilead restarted TAF research, and the newer drug was approved by 2015.
The plaintiffs say they could have avoided bone and kidney damage, risks that were and are disclosed on the FDA-approved label, if they had the option to take TAF earlier. Despite these potential side effects, plaintiffs acknowledge TDF is deemed safe by the FDA, remains on the market, and is helping many patients.
As for the litigation, Gilead maintains it should be dismissed. Among other arguments, Gilead points out that holding manufacturers liable for when they develop medicines would stifle research because manufacturers would hesitate to explore potential innovations if they could later be held liable for not bringing them to market—or not bringing them to market fast enough. Gilead also points to the plaintiffs’ concessions that the TDF medicines are not defective and contain adequate warnings as a reason why, under settled law, there can be no claim for liability.
Gilead sought summary dismissal of the case in the Superior Court of the City and County of San Francisco, and when that dismissal was denied, Gilead appealed to the California Court of Appeals.
BIO’s amicus brief
BIO supports Gilead’s arguments in an amicus brief, which explains the potential damage that a ruling for the plaintiffs would have on the normal functioning of drug development.
“For good reason, our society does not withhold safe and effective products from patients today on the possibility that an even safer or even more effective product might be developed at some point in the future. Yet Plaintiffs seek to hold innovative biopharmaceutical companies making scientific breakthroughs liable for not making those breakthroughs sooner,” explains the brief filed by BIO, the Pharmaceutical Research and Manufacturers of America, the California Life Sciences Association, and the Advanced Medical Technology Association.
Under plaintiffs’ argument, drug developers could be “held liable for virtually any medicine, regardless of its demonstrated safety and efficacy, whenever a company is thereafter able to develop an arguably better medicine,” according to the brief. “Imposing such sweeping liability based on hindsight judgments about research that resulted in safe and effective medicines in the first instance will impede pharmaceutical research and development.”
As BIO and its co-amici note, decisions about whether and when to develop potential new drugs are an essential part of the biopharma business.
“Because of the slim chances of success for any particular medicine, biomedical companies often develop multiple medicine options in parallel, and depending on early results make decisions about how to devote resources for further development and approval efforts,” the brief continues.
The plaintiff’s theory, if accepted would have a real impact on doing business, according to the brief. “Were Plaintiffs’ new, speculative claim to become widely adopted in California courts, it would be highly damaging to scientific and medical innovation, which is affected by the prospect of litigation,” BIO’s brief argues. “Without sensible protections from unbounded liability, the California pharmaceutical industry might well contract, harming patients in need of innovative treatment.”