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This guest post comes courtesy of Scott Kaiser at Shook Hardy.  He deserves all the credit and all the blame, as the case may be – but it looks like credit to us.


Indiana now has its first appellate decision concerning MDA preemption. McGookin v. Guidant Corp., ___ N.E.2d ___, No. 71A04-1001-CT-101, Slip op. (Ind. Ct. App. Jan. 21, 2011).

The decision is a straightforward affirmation of two familiar themes: that Riegel (not Wyeth or other non-medical device cases) provides the preemption rules governing Class III medical devices; and that “may” does not mean “must” when determining what constitutes a federal requirement under the MDA’s express-preemption clause.

McGookin involved the unfortunate and unexplained death of a 14-month old infant born with complete heart block.  According to the medical records and product testing introduced at trial, the “device provided therapy at all times.” Slip op. at 3. The crux of Plaintiffs’ case was not a design or manufacturing defect. Rather, Plaintiffs’ theory of defect was that the pacemaker’s labeling did not adequately warn that the pacemaker had not been tested on infants or in the particular implantation configuration in this case – i.e. abdominal implant with a unipolar epicardial lead.

The case was tried in August 2009. The jury returned a defense verdict.

Plaintiffs appealed, complaining that the trial court’s preemption ruling erroneously prevented Plaintiffs from arguing that Guidant could have and should have offered a different label than the one approved by the FDA:

Although Guidant’s label complied with the FDA requirements of its premarket approval, other FDA regulations gave Guidant the ability to add to or strengthen those regulations without prior FDA approval.  The Indiana Product Liability Act incorporates a “reasonableness” component in determining whether warnings are inadequate.  Therefore, it becomes a jury question as to whether Guidant acted reasonably in failing to add to or strengthen its warnings pursuant to 21 C.F.R. § 814.39(d).  The label, for example, could have informed consumers and physicians that the pacemaker had not been tested in infants or with epicardial leads, or with an abdominal implant.  The label could have stated that use with epicardial leads in infants was contraindicated.  The trial court therefore erred in granting Guidant’s motion for summary judgment and ruling that any attempt to impose liability on Guidant under substantive legal theories . . . predicated on challenges to conduct of Guidant allowed by and not in violation of any applicable federal requirements are preempted.

The Court of Appeals of Indiana rejected Plaintiff’s argument and affirmed the judgment.  Noting that Plaintiffs “do not allege that Guidant violated federal requirement,” the Court of Appeals of Indiana described what Plaintiffs were really alleging:  “they contend that Guidant should be liable for its failure to add warnings that are permitted, but not required, by federal law.  We cannot imagine a plainer example of an attempt to impose a standard of care in addition to the FDA’s specific federal requirements.”  Slip. op. at 13.