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We Like Sykes Again

By James M. Beck and Mark Herrmann

A year ago, on March 31, 2007, we published a post titled "We Like Sykes" about the Pennsylvania federal decision in Sykes v. Glaxo-SmithKline, et al., No. 06-1111, slip op. (E.D. Pa. Mar. 28, 2007). In that decision, Judge Stengel granted summary judgment in favor of the vaccine manufacturers (as preempted by the National Vaccine Injury Compensation Act) and held that the Sykes' failure-to-warn claim against Bayer was preempted by federal law. Judge Stengel transferred the remaining claims to the Eastern District of Virginia, where Lisa Sykes had received an injection of HypRho-D to protect her son (who was in utero) from developing hemolytic disease of the newborn.

Last month, the transferee court in Virginia granted in large part Bayer's motion for judgment on the pleadings. Sykes v. Bayer Pharmaceuticals Corp., No. 3:07 CV-660, slip op. (E.D. Va. Feb. 12, 2008) (here's a link).

The court first dismissed the Sykes' strict liability claims, because Virginia does not generally recognize strict liability product liability claims. Id. at 4-5.

The court then addressed the Sykes' claim that Bayer negligently failed to package HypRho-D in a single-dose vial, which would have eliminated the need to use the preservative that allegedly injured the newborn. The court never used the "p-word" -- preemption -- but it held that the FDA requires all immune globulins to contain a preservative, so the Sykes' claim that Bayer could have avoided using a preservative could not survive. Id. at 5. We read that as a preemption victory (and we're putting the case in the Drug Preemption Scorecard) even though the court didn't precisely analyze the issue as conflict preemption. In the future, we won't be timid about characterizing Sykes II as the dismissal of a design defect claim on the ground of preemption.

The court next rejected the Sykes' claim of failure to test because Virginia does not recgonize failure-to-test claims. Id. at 6-7. As we've posted before, that puts Virginia squarely in the majority, as basically every case decided in the last 15 years has rejected stand-alone failure-to-test claims.

Finally, the court denied the Sykes' motion for leave to amend their complaint to plead failure to warn, failure to test, negligent misrepresentation, fraud, negligent infliction of emotional distress, gross negligence, and for punitive damages -- all because the amendment would have been futile. Id. at 8-11.

The court did allow the Sykes to amend to plead claims for negligent design and express warranty (without, of course, ruling on the merits of those claims).

Perhaps that means we'll be writing about Sykes III next March.

Heaven help us.

Full post as published by Drug and Device Law on March 28, 2008 (boomark / email).