In Heisner v. Genzyme, No. 08-C-593, 2009 U.S. Dist. LEXIS 37322 (N.D. Ill. Apr. 30, 2009), Heisner allegedly died as a result of an allergic reaction to Seprafilm, an anti-adhesive surgical barrier implanted in her body during a surgery. Seprafilm is a Class III medical device approved by the FDA through the premarket approval process.
Heisner's surviving spouse and estate filed the usual product liability claims against Genzyme, which manufactured Seprafilm. The trial court granted Genzyme's motion to dismiss on the ground of federal preemption.
Two items merit quick note: First, plaintiff asserted that his claims were "parallel" to, rather than "different from or in addition to" the federal requirements applicable to Seprafilm, because Genzyme had allegedly failed to report to the FDA (1) the death of plaintiff's decedent, and (2) a clinical trial protocol and related warnings finalized after Heisner's death. The trial court didn't have to address the "parallel requirements" issue, because events that took place after Heisner's death could not possibly have proximately caused Heisner's injury. Id. at *5.
Second, plaintiff's express warranty claims were based on statements made by Genzyme in (1) the package inserts for Seprafilm, and (2) the PMA protocol for certain Seprafilm clinical trials -- both of which had been approved by the FDA. Because the alleged warranties were based on statements that had been approved by the FDA, the court found those allegations of breach of warranty to be preempted. Id. at *8.
We'll include this one in the ever-expanding (New) Medical Device Preemption Scorecard.
Posted by Beck/Herrmann at 8:00 AM Labels: Medical Device, Preemption
Heisner's surviving spouse and estate filed the usual product liability claims against Genzyme, which manufactured Seprafilm. The trial court granted Genzyme's motion to dismiss on the ground of federal preemption.
Two items merit quick note: First, plaintiff asserted that his claims were "parallel" to, rather than "different from or in addition to" the federal requirements applicable to Seprafilm, because Genzyme had allegedly failed to report to the FDA (1) the death of plaintiff's decedent, and (2) a clinical trial protocol and related warnings finalized after Heisner's death. The trial court didn't have to address the "parallel requirements" issue, because events that took place after Heisner's death could not possibly have proximately caused Heisner's injury. Id. at *5.
Second, plaintiff's express warranty claims were based on statements made by Genzyme in (1) the package inserts for Seprafilm, and (2) the PMA protocol for certain Seprafilm clinical trials -- both of which had been approved by the FDA. Because the alleged warranties were based on statements that had been approved by the FDA, the court found those allegations of breach of warranty to be preempted. Id. at *8.
We'll include this one in the ever-expanding (New) Medical Device Preemption Scorecard.
Posted by Beck/Herrmann at 8:00 AM Labels: Medical Device, Preemption
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