New York (July 28, 2010) -- For the second time this week a state appeals court has affirmed the dismissal of a suit over Wyeth Inc.'s fen-phen, this time finding that the plaintiff could not prove causation because she did not actually suffer from one of the drug's nondisclosed risks.
In a ruling Tuesday, the Superior Court of Pennsylvania held that Pennsylvania law does not allow a plaintiff to prove proximate causation where a drug manufacturer’s warning disclosed a risk of injury and the plaintiff sustained that very injury, but the manufacturer failed to disclose another risk of injury that the plaintiff did not sustain.
The decision came in the failure-to-warn case of plaintiff Nancy Cochran, who sued Wyeth after being diagnosed with primary pulmonary hypertension in April 2004.
Cochran ingested the prescription drug — sold under the brand name Redux — from November 1996 to August 1997.
The doctor who prescribed her the medication, Dr. Stephen Anthay, informed Cochran that Redux may cause PPH, but was unaware at the time of the risk that the drug could cause valvular heart disease.
Cochran had argued that Redux’s warnings were faulty because they failed to warn of the danger of VHD, even though she did not develop that disease. She contended that as early as 1994, Wyeth had reason to suspect that Redux could cause VHD, and that Anthay wouldn't have prescribed the drug to her had he been adequately warned that Redux could cause the disease.
Wyeth pulled Redux from the market in September 2007 after the U.S. Food and Drug Administration requested the company issue a “black box” warning detailing the risks of VHD.
A trial court sided with Wyeth in September 2009, ruling that Wyeth’s warnings with regard to PPH were adequate because the company informed Anthay that Redux may cause PPH.
Because Cochran suffered from PPH and not VHD, the trial court said, she could not establish that Wyeth’s failure to warn of the risk of VHD was the proximate cause of her particular injury.
In its ruling Tuesday, the appeals court agreed with Wyeth's contention that in order to establish proximate causation, Cochran must prove that the company's warnings failed to disclose the risk of her particular injury, PPH.
Although Anthay testified that he would not have prescribed Redux to Cochran had known of the risk of VHD, that did not alter the fact that Wyeth failed to disclose the risk of VHD and she suffered from PPH.
“In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation,” the appeals court said. “Therefore, as a matter of law, there is no proximate, causal connection between Wyeth’s failure to disclose the risk of VHD and appellant’s specific injury.”
The decision marks the pharmaceutical giant's second victory in a trio of related cases that were argued together before the Superior Court.
On Monday, the appeals court ruled that Pennsylvania law does not recognize causes of action for negligently failing to test a drug or failing to withdraw it from the market.
The appeals court also found that the appellant's alleged claims of “negligent marketing” and “negligent failure to withdraw Pondimin from the market” failed, since they were not recognized as causes of action under Pennsylvania law.
Thousands of cases over Wyeth's Pondimin were settled as part of a global resolution in 1999, with the drugmaker eventually agreeing to damages of around $13 billion.
The U.S. Court of Appeals for the Third Circuit affirmed an award of $567 million in attorneys' fees in the multidistrict litigation in 2009.
Cochran was represented in the current matter by Eisenberg Rothweiler Winkler Eisenberg & Jeck PC, Williams Love O'Leary & Powers PC and the Law Offices of Howard J. Bashman.
The case is Cochran v. Wyeth Inc., case number 2838 EDA 2008, in the Superior Court of Pennsylvania.