- zoloft: the approval I…
- zoloft: the approval II…
- zoloft: the approval III…
- zoloft: beyond the approval I…
- zoloft: beyond the approval II…
- zoloft: the epilogue…
- graphic reflections…
They submitted six studies [only one made the grade, and it was a very weak showing]:
|Placebo Controlled Clinical Trials
||outpatient||open label, relapse||whatever|
The FDA reviewers did not recommend approval. The committee was on its way to denying approval when the head of the FDA [Dr. Paul Leber] who had assured Pfizer he could get it approved entered the discussion with a speech and, as he predicted, he got "it through." It was hardly an exemplary day for the FDA. Reading it, I could easily see why the suit was filed. The plaintiff was right on target. Oh. by the way – it had been turned down already in Europe, but the FDA committee didn’t know that [because Pfizer didn't tell them].
This graph is number of prescriptions written by year. Zoloft passed Prozac in 2000 [about halfway through its patent life], and it continued to dominate the market share until going generic in 2006 [when it was replaced at the top by generic Zoloft]. It was a $30 B drug:
Lawyers and Settlementsby Gordon GibbMarch 24, 2014
A proposed Zoloft class-action lawsuit alleging Zoloft is a defective drug because it offers little more efficacy than a placebo, or so it is alleged, was recently tossed by a federal judge due to a time-barring issue and other legal implications. However all is not lost; the presiding magistrate left the door open a crack for a possible continuation of the complaint, with some revisions.
In Plumlee v. Pfizer Inc., Case No. 5:13-cv-00414, in the US District Court for the Northern District of California, plaintiff Laura Plumlee took Zoloft manufacturer Pfizer to task for marketing a drug that was alleged to be ineffective, with questionable efficacy, due to a claim that most clinical trials found that Zoloft was no more effective than a placebo, or so Plumlee claimed. Her lawsuit alleges that Pfizer purposely omitted, in Zoloft labeling, any studies that showed Zoloft to be ineffective, while favoring studies that showed Zoloft was, indeed, more effective than a placebo. Plumlee also alleged that Pfizer’s marketing and advertising was also misleading in touting Zoloft, an antidepressant, as effective.However, Plumlee’s claim was dismissed not on her argument of effectiveness, but due to time barring. It has been reported that Plumlee brought her defective drug lawsuit under two statutes observed by the state of California: that of the Unfair Competition Law, and the Consumer Legal Remedies Act and False Advertising Law.
Was plaintiff’s claim time-barred?
The two aforementioned statutes, under California law, carry limitations of four years and three years, respectively. In her ruling dismissing the plaintiff’s claim, US District Judge Lucy Koh ruled that Plumlee’s complaint went beyond the limitation boundaries, given the plaintiff’s claim that she last used Zoloft in 2008 but waited until January 2013 to bring her lawsuit.
lumlee challenged that such limitations were tolled until 2012, the point at which Plumlee first discovered that Zoloft had been misrepresented. The judge, however, held that Plumlee’s claim to discovering Zoloft’s inadequacies in “early 2012” was too general a frame of time. Judge Koh also was not satisfied with the detail supporting the time and surrounding circumstances of her discovery.To that end, the judge pointed to the existence of various scientific articles – cited by the plaintiff – that had been published long before Plumlee brought her drug defects lawsuit, and thus did not accept the plaintiff’s claim. However, the judge left the door open.
All is not lost for this Zoloft defective medical products action
In dismissing the plaintiff’s claim, Judge Koh is allowing Plumlee to amend her complaint going forward. It is telling, as well, that the California judge ruled that Pfizer has the freedom to access certain aspects of the plaintiff’s medical history. Plumlee had sought to block Pfizer’s access to her medical records. A previous magistrate’s ruling that allowed Pfizer access was supported by Judge Koh on grounds that Plumlee had waived any privilege of protecting her medical history when she argued that the statutes of limitations were tolled due to her learning of Zoloft’s alleged deficiencies only in early 2012.
Plumlee, according to various reports, had sought to represent a proposed class of plaintiffs who may have used Zoloft from the point at which it was introduced to market in 1991, through to present day. However, the judge suggested that Plumlee may not be typical of the class, given that she claims to have used Zoloft for a period of three years even though it did not appear to be working for her. Records also demonstrated that the lead plaintiff relied more upon Zoloft marketing and advertising, than the advice of her doctor.
Pundits suggest that in leaving the door open, the judge feels the proposed class-action lawsuit may have merit, in spite of deficiencies exhibited by Plumlee’s claim. The potential, thus, is for Plumlee to amend her claim that satisfies time-barred limitations and other deficiencies as articulated by the presiding judge. Could the proposed class-action lawsuit proceed with a different lead plaintiff?
Harmful drugs are often shown to carry risks, in spite of the position of the US Food and Drug Administration (FDA) that holds that a drug’s benefits outweigh the risks for the class or constituency of patients to which the drug is targeted. In the same vein, however, drug defects can also include deficiencies that suggest a drug is not worth the financial outlay, either by an individual or group, in exchange for potentially limited effectiveness.The aforementioned Zoloft lawsuit alleges Zoloft does not live up to its promises. The proposed class action, alleging defective medical products (Zoloft, as ineffective), could continue with amendments – but perhaps not in its present form.
Law360By Sindhu SundarSeptember 02, 2014
Pfizer Inc. on Friday defeated for the second time allegations that it greatly exaggerated the efficacy of its antidepressant Zoloft, when a federal judge in California ruled the proposed class action claims are time-barred and dismissed the suit with prejudice.
U.S. District Judge Lucy H. Koh, who in February had dismissed Laura Plumlee’s suit but allowed the plaintiff to amend her suit to address the court’s timeliness concerns, granted Pfizer’s motion to dismiss the suit with prejudice Friday…
Plumlee last bought Zoloft or its generic equivalent in 2008, and by the time she brought her suit in 2013, she had exceeded by at least seven months the statutes of limitations under the various California consumer protection laws she invoked, Judge Koh ruled.
"The court finds that each of plaintiff’s claims is time-barred and that despite being granted an opportunity to amend her complaint, plaintiff has still not met her burden of showing that the statutes of limitations have been tolled by the delayed discovery rule," Judge Koh said in her opinion.
Plumlee, who had filed her original suit in January 2013, claimed that she did not learn about Pfizer’s alleged over-representation’s about Zoloft’s effectiveness until she watched a "60 Minutes" segment in May 2012, according to the order.
"We are pleased with the decision and believe the court applied California law correctly in ruling to dismiss the case with prejudice," Pfizer spokesman Steven Danehy said in a statement Tuesday. "Pfizer has always believed that the plaintiff’s amended complaint fails to adequately address the deficiencies of the original complaint, which was previously dismissed."
An attorney for Plumlee could not immediately be reached for comment Tuesday.
Plumlee had sought to represent a proposed class of patients who used Zoloft made by Pfizer between the drug’s launch date in 1991 through the present. She claimed that Zoloft’s labeling failed to mention the studies showing it to be ineffective, that Pfizer favored researchers who showed Zoloft to be effective, and that the company’s advertisements misleadingly touted the drug as effective, among other allegations.She claimed for instance, that Pfizer buttered up doctors with blandishments including ski trips and "fancy" meals, to encourage them to prescribe Zoloft, according to court documents.