Friday, August 07, 2009
A Wisconsin federal judge has denied GlaxoSmithKline's claim of immunity from liability for a Paxil-induced injury case, allowing the plaintiffs product liability case to move forward.
On March 17, 2004 Gary Forst, then 60, attempted suicide after two weeks of taking Paxil by slashing his wrists with sheet metal and shooting himself in the head with a pneumatic drill bit. Mr. Forst survived, but was permanently disabled. He and his wife sued Paxil manufacturer, SmithKline Beecham, d/b/a GlaxoSmithKline ("GSK"). The Forst's are represented by the national law firm of Baum, Hedlund, Aristei & Goldman.
The Forsts' lawsuit documents GSK's awareness as early as 1989 that patients given Paxil engaged in suicidal behavior during clinical trials at a rate over six times greater than patients given placebo. GSK, in its failed attempt to get the Court to dismiss the case, argued that Paxil's FDA-approved label shielded GSK from liability for failing to warn doctors and patients of that elevated suicidal behavior risk, a legal defense called "preemption" - i.e., FDA's approval of the Paxil label, whether or not it accurately reported Paxil-induced suicidal risks, preempted Wisconsin state law requiring products to have safe warning labels.
Judge J.P. Stadtmueller of the U.S. District Court for the Eastern District of Wisconsin rejected GSK's preemption arguments, weighing his decision, in large part, on the U.S. Supreme Court's March 2009 decision in Wyeth v. Levine
. The case is Forst et al. v. SmithKline Beecham Corp
., case number 2:07-cv-00612.
The Court held, amongst other things:
• "Federal law does not prohibit drug manufacturers from updating their labels to warn of known risks when the FDA-approved labeling did not include the updated language. Instead, a drug manufacturer has a duty to advise consumers of risks because it 'bears responsibility for the content of its label at all times.'"
• "State tort claims are harmonious with Congress' regulatory goals and do not compel application of preemption."
• ". . . the court does not deem GSK's evidence sufficient to establish 'impossibility preemption.' First, the fact that the agency considered the association between all SSRI's and suicidality on a number of occasions between 1992 and 2004, the time of Mr. Forst's suicide attempt, does not establish that the FDA would not have approved a proposed change in Paxil's labeling."
• ". . . the fact that the FDA approved prior Paxil labeling without an enhanced warning does not mean that the agency would oppose a request by GSK to include such a warning."
• "State law litigation provides an additional oversight on drug labeling and helps flesh out which warnings are 'substantiated' and necessary for the protection of consumers."
• "GSK's 'overwarning' argument also assumes that the subject drug label warns of a non-existent risk," however, the Court stated that it "refuse[s] to find that Paxil does not increase suicidality as a matter of law."
In its motion, GSK argued that it deserved complete immunity from liability, claiming that it was prohibited
from disclosing to the public truthful information
about the suicidality risks associated with Paxil. In essence, GSK argued that, because the FDA did not "make" GSK warn about the suicidality risk, it could not have warned or disclosed these risks any sooner. The Forsts, in turn, argued that GSK was attempting to improperly abrogate its duties to the FDA and pointed out that the Supreme Court in Levine
made it abundantly clear that "it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times
The Forsts also presented evidence and argued in opposition to GSK's preemption motion that:
• GSK has known about Paxil's association with suicidality for over 15 years, but presented data to the FDA in a way that obscured the risk. When properly compiled, the original suicidal behavior data GSK submitted to the FDA to get permission to sell Paxil demonstrated a greater-than-six-fold increased risk of suicidal behavior for patients taking Paxil compared to patients given placebo.
• Notwithstanding this known risk, GSK never
proposed a suicide warning for its label.
• Senior officials and safety officers within the FDA have testified that the way GSK analyzed the Paxil clinical trial data concerning suicide related events was inappropriate and "scientifically illegitimate."
• A 1999 memo shows that one of GSK's own employees recognized GSK's error of improperly analyzing the data and told the company that it should correct the figures.
• Nevertheless, GSK did nothing to correct the erroneous figures even though it was aware the false figures were contained in submissions to the FDA, in Paxil's Summary Basis of Approval, in a heavily touted medical journal article published in 1995, which was used by GSK sales representatives "alleviate any concerns [doctors] may have regarding suicidal ideation."
• GSK also used misleading terminology to refer to suicide-related adverse events that obscured their having occurred during Paxil's clinical trials. For example, GSK used the term "emotional lability" in the label to describe suicide-related adverse events that had been reported. Nowhere in the label was there any reference to "suicides" or "suicide attempts" occurring in the clinical trials, although there were a number of them. GSK's use of this inappropriate terminology to describe suicide events completely
obscured the fact that suicidal events occurred at all
during the Paxil clinical trials.
• GSK's false promotion and concealment paid off. Paxil went on to become the most profitable drug in GSK's inventory, generating as much as $3.1 billion in annual sales
. While GSK was seeing enhanced profits with each sale of Paxil, its users were experiencing an enhanced risk of suicidal behavior.
• It was not until May 2006 that GSK, for the first time, released an analysis of its previously conducted clinical trials which confirmed the increased risk of suicidal behavior in adults and the company changed its label. This new analysis and warning mirrored the data GSK had in its possession since the 1990's.
The Court also unsealed a number of documents GSK claimed were "confidential" stating that "disclosure of additional safety and efficacy information about Paxil serves to promote public health rather than endanger it. Further, the fact that disclosure may allow competitors to paint Paxil in an unfavorable light to healthcare professionals is insufficient to render the information confidential."
The Forsts and their counsel are pleased with the Court's opinion. According to Baum Hedlund attorney, Bijan Esfandiari:
"GSK's failure to warn of Paxil's risks resulted in Mr. Forst suffering a traumatic brain injury that has left him largely wheel-chair bound and living in assisted care. This order confirms that companies who place sales above safety will be held accountable."
Baum, Hedlund, Aristei & Goldman has the longest track-record of handling SSRI (selective serotonin reuptake inhibitor antidepressants such as Prozac, Paxil and Zoloft) cases and has litigated more antidepressant cases than any other firm over the past 19 years.
The firm has successfully argued against preemption in numerous antidepressant product liability cases, including: Motus v. Pfizer, 127 F. Supp. 2d 1085 (C.D. Cal. 2000); Witczak v. Pfizer, 377 F.Supp.2d 726; Zikis v. Pfizer, Inc., 2005 WL 1126909 (N.D. Ill. 2005); Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876 (E.D. Tex. 2005); Miles v. Pfizer, Inc., Case No. 03-731-C (M.D. La. March 31, 2005) (order without opinion); Szybinski v. Pfizer, Inc., Case No. YC 047439 (Los Angeles Sup. Ct. July 12, 2005) (minute order striking FDA Amicus Briefs and denying preemption); Steinberg v. SmithKline Beecham Corp. Case No. 1-04-CV-029096 (Santa Clara Sup. Ct. January 25, 2007); Tucker v. SmithKline Beecham Corp., 596 F.Supp.2d 1225 (S.D.Ind. 2008); Knipe v.SmithKline Beecham, 583 F.Supp.2d 553 (E.D.Pa 2008); Collins v. SmithKline Beecham Corp., 2008 WL 744070 (Pa. Ct.Com.Pl. March 11, 2008); Turek v. SmithKline Beecham, Case No. 3596 (Pa. Ct.Com.Pl. March 18, 2009); Forst v. SmithKline Beecham Corp., 2009 WL 2256232 (E.D.Wis., July 29, 2009).
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Media Relations Director
Baum, Hedlund, Aristei & Goldman, PC
Los Angeles, CA