Amicus News
No. 10. September
3, 1996
MISSOURI SUPREME COURT
REJECTS PREEMPTION UNDER MEDICAL DEVICE AMENDMENTS
The Supreme Court of
Missouri, following the U.S. Supreme Courts Medtronic decision, has held
that the Medical Device Amendments do not preempt state law product liability
actions for injury caused by intraocular lens. Connelly v. IOLAB Corp.,
No. 78177 (August 20, 1996).
Plaintiff alleged that
she was injured by a 91Z intraocular lens, implanted into her eyes to replace
damages natural lenses. Her action in state court in Missouri against the
manufacturer claimed that the lense was defective and unreasonably dangerous,
and that the lens had an unacceptably high complication rate which IOLAB
concealed from plaintiff and her physicians. The trial judge, however, granted
IOLABs motion for summary judgment, ruling that all of plaintiffs causes
of action were preempted by the Medical Device Amendments to the federal
Food, Drug and Cosmetic Act.
On appeal to the Missouri
Supreme Court, AAJ filed an amicus curiae brief, contending that Congress
did not intend the Medical Device Amendments to eliminate state tort actions.
The Missouri Supreme
Court reversed the summary judgment, holding that none of plaintiffs causes
of action is preempted. The court noted that the 91Z lens had been classified
by the FDA as an investigational device, subject to a separate set of regulations
and FDA approval of a clinical investigation of safety and effectiveness.
However, the courts analysis did not depend upon the investigational status
of the device.
The court determined
that the preemption issue was controlled by the U.S. Supreme Courts recent
decision in Medtronic, Inc. v. Lohr, No. 95-754 (June 26, 1996). The plurality
opinion of Justice Stevens stated that the MDA preempted only device-specific
enactments of positive law by legislative or administrative bodies, not
the application of general rules of common law by judges and juries.
The Missouri court
also looked to the concurring opinion of Justice Breyer, which would find
common law actions preempted where (1) compliance with both the common law
standard and the federal regulation is impossible (conflict preemption)
or (2) where the federal regulatory scheme is so pervasive as to infer that
Congress left no room for supplementation by the states (field preemption).
In this case, the Missouri Supreme Court found that none of the premises
of plaintiffs causes of action would require IOLAB to violate a federal
regulation. Nor are the MDA regulations so pervasive as to preempt the field
of state common law actions.
For further information,
please contact Jeffrey White.
Phone: 202-965-3500
x310
FAX: 202-955-0920
E-Mail: jeffrey.white@justice.org
|
