The future of litigation over the HIV drug Truvada remains in the hands of the California Supreme Court, whose future actions include a review of lower court decisions on how product liability lawsuits challenging the medication may proceed.
The state high court’s case schedule includes a review of lower court decisions concluding that plaintiffs who used the drug containing tenofovir disoproxil fumarate (TDF) could sue drug manufacturer Gilead Sciences for failing to provide consumers with a safer drug in a timely manner. TDF is used to treat and prevent HIV infections.
“We look forward to the California Supreme Court’s review of the Court of Appeal’s decision,” a Gilead statement emailed to the Southern California Record says. “As we detailed in our briefs, the Court of Appeal overrode a century of common law to impose on manufacturers a duty that no court anywhere in the country has ever suggested.”
The scientific dispute underlying the litigation against Gilead’s TDF-containing drug, Truvada, may be somewhat less contentious than other pharmaceutical litigation. According to Gilead, the underlying merits of the plaintiffs’ lawsuit are not part of the appeal to the state Supreme Court. In fact, the plaintiffs don’t label the medicine as defective, but they do allege it comes with hazards.
“It soon became apparent … that for a certain percentage of patients, TDF drugs resulted in permanent health consequences,” Robert Miller Jr. of the Miller & Zois law firm said in an online post. “Specifically, TDF drugs like Viread and Truvada are highly toxic to the kidneys and bones and can cause permanent kidney failure and bone fractures.”
The plaintiffs allege that the company should have developed another drug, tenofovir alafenamide (TAF), sooner under the theory that TAF was an alternative to TDF with less likelihood of causing the same side effects.
But the company has argued that evidence at the time (2004) could not predict the long-term safety of TAF, when Gilead halted development of TAF and focused on the further development of TDF medications.
“Both TDF- and TAF-containing medicines are approved by the (federal Food and Drug Administration), are recommended in the U.S. Department of Health & Human Services HIV treatment guidelines, and successfully help treat and prevent HIV in millions of people,” Gilead’s statement to the Record says.
The company did take another look at TAF in 2010, carrying out five years of new research and clinical trials. Gilead received FDA approval to market TAF medications in 2015.
In regard to TDF drugs, the parties in the litigation acknowledge that the potential side effects caused by the drug – including bone, kidney or teeth injuries – were properly listed. But the plaintiffs allege that the extent of the side effects make the medication too risky for patients.
Other observers worry that a Supreme Court ruling in favor of the plaintiffs would expand the definition of product liability to include an obligation for companies to bring alternative medications to market more quickly. Putting such scrutiny on the innovation process itself could lead businesses to take a less active role in innovation and new product development, they say.
“Whereas the common law requires manufacturers to produce non-defective, reasonably safe products, the Court of Appeal has added a duty to develop and commercialize, without delay, a different product that is safer for some consumers,” a recent Gilead court brief states. “This duty weaponizes innovation across industries, undermining public welfare by inhibiting research and development of lifesaving and life-changing products.”