A federal judge in California dismissed a case brought by the family of a 13-year-old girl who committed suicide while taking the antidepressant, citing a controversial rule that FDA approval of a drug preempts state lawsuits challenging safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a notion the US Supreme Court is expected to decide after agreeing to review a different case.

In the Paxil case, US District Court Judge Frank Damrell, Jr. dismissed the suit “on the grounds that, under state law, all of the claims required showing that Glaxo should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality.” And so he decided the lawsuit created “a direct conflict with the federal labeling requirements for Paxil established” by the FDA, “preempting the plaintif’s claims, according to a statement issued by Glaxo’s attorneys.

The lawyers at King & Spalding argued that, at the time of the teenager’s suicide in 1997, “there was no reasonable scientific evidence to support” the warning proposed for Paxil, which the FDA had actually rejected. UPDATE: Ron Goldman, an attorney for the girl’s family, says the ruling was narrow, because Damrell focused on suidice data in adults prior to 1997, although he maintains “the science was there from the beginning that this drug could induce suicidality in some people.” He plans to file a motion to reconsider and, if necessary, an appeal.

UPDATE: For more comment from both sides, keep reading. And here is the ruling with Damrell’s explanation…

“A direct conflict of law exists in this case because (Glaxo) could not have been in compliance with federal law in February 1997 and have included the suicidality warning plaintiffs urge. In other words, had (Glaxo) included the warning that plaintiffs insist upon, (Glaxo) would have risked misbranding Paxil in violation of the Food, Drug & Cosmetic Act. Therein lies the actual and direct conflict presented in this case - comply with federal law and be held liable under state law tort claims, or, to avoid state tort liability, add a warning without reasonable evidence and violate federal law…

Read more »

The country’s outgoing Health Minister, Mongkol na Songkhla, defended stuck by his controversial policy of challenging patent rights and, in an interview with Reuters, says the poor would lose if the policy is revered by a new pro-business government that’s due to take power next month.

Mongkol, a hero to health activists and vilified by drugmakers for overriding patents on two AIDS drugs and a heart medicine, is now targeting four cancer drugs in his final days in office. Shortly after a Dec. 23 election marking Thailand’s return to democracy, Mongkol approved compulsory licences allowing Bangkok to make or buy generic versions of the cancer meds.

But Thai negotiators will seek a final round of talks before using the licenses. “They have already met twelve times. If they cannot achieve what they want, they can use the signed papers,” Mongkol, 66, tells Reuters. The drugs include the Femara breast cancer drug sold by Novartis, the Taxotere breast and lung cancer med made by Sanofi-Aventis, and Roche’s Tarceva lung cancer drug. The government argues it can’t afford patented drugs for its national health plan, which covers 80 percent of its 63 million people. Last week, however, Bangkok struck a deal with Novartis over Gleevec.

Read more »