By Jonathan Stempel<\/p>\n
Aug 3 (Reuters) – California’s highest court on Monday ruled in favor of Gilead Sciences in a closely watched case addressing whether manufacturers of drugs that are considered safe must try developing \u200cdrugs that could be safer.<\/p>\n
In a 6-1 decision, the California Supreme Court ordered the dismissal of negligence \u200cclaims against Gilead by an estimated 24,000 patients using an HIV drug it produced, over its decision more than 20 years ago to stop \u200bdeveloping an alternative drug that had fewer side effects.<\/p>\n
“What today’s decision declines to do is recognize, for the first time anywhere, sweeping liability for injuries caused by a concededly nondefective drug because the manufacturer allegedly failed to make a different drug available sooner,” Justice Joshua Groban wrote for the majority. “Imposing such liability would create substantial burdens and would risk adverse consequences for \u200cpharmaceutical innovation, public health, and patient safety.”<\/p>\n
Lawyers \u2060for the patients did not immediately respond to requests for comment.<\/p>\n
“Today’s decision is a victory for all those working to develop improved medical treatments and new medicines,” Gilead said in a \u2060statement. “The California Supreme Court’s decision supports American innovation, allowing companies to continue pursuing breakthroughs for patients and consumers.”<\/p>\n
The case was closely followed in the pharmaceutical industry, addressing whether drugmakers should sacrifice profit on successful products by being required to spend money to \u200bdevelop and \u200bquickly commercialize alternative products, sometimes called a “duty to innovate.”<\/p>\n
Critics have \u200bsaid imposing that duty would make drug development \u200ctoo costly, punish manufacturers by capping profits from successful drugs, and deprive patients of needed treatments that work.<\/p>\n
HIV drugs accounted for 70% of Gilead’s $29.4 billion in 2025 revenue.<\/p>\n
DRUG SOUGHT BY PATIENTS NOT DIFFERENT ENOUGH<\/p>\n
The case was brought by HIV patients who took Gilead drugs made with tenofovir disoproxil fumarate, or TDF.<\/p>\n
Those drugs won U.S. approval in 2001 despite possible side effects including kidney dysfunction and bone problems.<\/p>\n
Gilead soon began testing tenofovir alafenamide fumarate, or TAF, which was similar to \u200cTDF but had fewer side effects.<\/p>\n
The Foster City, California-based company stopped \u200bdeveloping TAF in 2004, however, after concluding its effectiveness and safety were \u200bnot different enough to justify the expense.<\/p>\n
The patients \u200bsaid TDF’s side effects required Gilead to do better.<\/p>\n
They also accused Gilead of delaying TAF’s commercialization \u200cfor nearly a decade to maximize profit, and \u200btiming it to TDF’s patent \u200bexclusivity expiring in 2017.<\/p>\n
During oral arguments in May, patients’ lawyer Holly Boyer said Gilead was “willing to accept the suffering of tens of thousands of patients with HIV forced to endure a drug that was destroying their \u200bkidneys and breaking their bones, all so \u200cthat Gilead could make more money, $27 billion more.”<\/p>\n
Gilead’s lawyer, Joshua Rosenkranz, countered that the company focused on \u200bTDF because it achieved “the holy grail” of being a once-a-day pill that saved millions of lives.<\/p>\n
(Reporting \u200bby Jonathan Stempel in New York; Editing by Bill Berkrot)<\/p>\n","protected":false},"excerpt":{"rendered":"By Jonathan Stempel Aug 3 (Reuters) – California’s highest court on Monday ruled in favor of Gilead Sciences…\n","protected":false},"author":2,"featured_media":422870,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[7,9,8,2081,6848,168754,168755,168756],"class_list":["post-422869","post","type-post","status-publish","format-standard","has-post-thumbnail","category-california","tag-california","tag-california-headlines","tag-california-news","tag-california-supreme-court","tag-decision","tag-gilead-sciences","tag-hiv-patients","tag-side-effects"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/posts\/422869","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/comments?post=422869"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/posts\/422869\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/media\/422870"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/media?parent=422869"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/categories?post=422869"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ca\/wp-json\/wp\/v2\/tags?post=422869"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}