CORNETT V. JOHNSON & JOHNSON, ET AL.
A-4694-08T1/A-5539-08T1 07-23-10 (consolidated)
At issue is whether state law claims against a manufacturer
of a medical device that has been given premarket approval by
the U.S. Food & Drug Administration (FDA) are federally
preempted as well as time-barred.
We affirm in part and reverse in part the Law Division's
Rule 4:6-2(e) dismissal of plaintiffs' master complaint alleging
strict product liability, breach of express and implied
warranty, and derivative claims for alleged defects in
defendant's Cypher coronary stent as federally preempted by the
Medical Device Amendments of 1976 (MDA or Act), 21 U.S.C.A.
§§360c-360m, to the Food, Drug, and Cosmetic Act (FDCA), 21
U.S.C.A. §§301-399. Although the MDA contains an express
preemption provision against state standards for devices that
would be stricter than the requirements applicable to such
devices under the Act, it preempts only state claims that apply
substantive standards of liability different from the device-
specific federal requirements. Therefore, a state cause of
action is not preempted where it imposes only requirements that
are "parallel," rather than additional, to the existing federal
requirements under the MDA and FDCA. Additionally, a state
claim can be impliedly preempted if it could not be articulated
but for the existence of a federal requirement that was
allegedly violated.
Here, claims under New Jersey's Product Liability Act,
N.J.S.A. 2A:58C-1 to -11 (PLA), for design defect, punitive
damages and failure to warn based solely on the product's
labeling, are federally preempted as they impose different
requirements than the FDA. However, the remainder of their
failure to warn claims concerning both approved and off-label
uses, as well as their claims for manufacturing defect and
breach of express warranty, and derivative claims, as pled, are
parallel to and are not expressly or impliedly preempted by the
MDA.
Additionally, we affirm the Law Division's dismissal of one
of plaintiffs' 48 cases, as it correctly applied Kentucky's
statute of limitations, rather than New Jersey's, under
applicable choice of law principles. In any event, Cornett's
case was time-barred under either statute of repose since,
pursuant to this State's equitable discovery rule, a consensus
of the medical community is not required and, under these facts,
a lay person could have reasonably suspected a possible
connection between the stent and decedent's sub acute stent
thrombosis that developed five months after the Cypher's
implantation and eventually lead to his death just weeks later.
