Ms. Gross filed suit against Pliva, along with Pfizer,
Wyeth, and Schwartz, alleging she sustained injuries from taking the
prescription drug metoclopramide, which is used to patients with slow emptying
of the stomach or intestinal tract often caused by cancer treatment or surgery.
The Complaint sought damages on theories of negligence, breach of warranty,
strict liability, and misrepresentation. The claims against Pfizer, Wyeth, and
Schwartz were previously dismissed as those companies manufactured “Reglan” the
brand-name form, as opposed to the generic version of the drug, “metoclopramide”
that Ms. Gross actually took and Pliva manufactured.
In April 2011, the U.S. District Court stayed the
proceedings in Gross in light of the pending Supreme Court decision in
Mensing, a case with substantially similar facts. The Supreme Court was
considering a state tort law claim based on the alleged failure of a
manufacturer to provide adequate warning labels for generic metoclopramide.
Mensing, 131 S.Ct. at 2572. Judge Williams described the Supreme Court
holding in Mensing as follows:
Under FDA regulations, generic drug manufacturers are
required to make their warning labels identical to those provided by the
brand-name manufacturers. Id. at 2577. Because FDA regulations do not allow
generic manufacturers to independently change or strengthen their product
labeling, the Court found that it would be impossible for a generic
manufacturer to comply with both federal law and state tort law. Id. at
2578. As a result, the Court held that the federal regulations preempt state
law failure to warn claims.
Gross, at *2.
In light of the Supreme Court’s opinion in Mensing,
Pliva sought dismissal of Plaintiff’s claims on the pleadings pursuant to
Fed. R. Civ. Proc. 12. Pliva argued that all of Plaintiff’s state tort law
claims were preempted by federal drug regulation and as such the case should
properly be dismissed.
Plaintiff argued that Mensing only preempted failure to
warn claims, and that she was entitled to pursue claims that Pliva was
negligent for continuing to sell metoclopramide with an inadequate label,
continuing to put a dangerous product into the stream of commerce, and
negligent in concealing safety information. The Court rejected Plaintiff’s
contention that her case was not entirely preempted noting that the Supreme
Court itself had rejected similar arguments.
Specifically the Court noted that under Maryland law
the Plaintiff’s product liability claims must be based on a design defect, a
manufacturing defect, or a failure to warn. There was no claim of
manufacturing defect, and “[d]esign defect claims are generally incompatible
with actions concerning prescription medications because these medications
are thought to be ‘unavoidably unsafe.’” King v. Pfizer Pharm. Co., Inc.,
No. RWT 11cv00127, 2011 WL 3157305, at *2 (D. Md. Jul. 25, 2011). Therefore,
the Court held that Plaintiff’s allegations regarding the continued sale of
the generic drug must come under the failure to warn umbrella. As such, the
claims were preempted by federal drug regulation.
The Court then addressed briefly the unfortunate nature
of Plaintiff’s position of no redress, and stated as follows regarding the
judiciary’s ability to remedy the same: “Federal drug regulations have
foreclosed Plaintiff’s means of seeking a judicial remedy in the instant
action, and legislative action remains the most appropriate means of redress
at this juncture.” Gross, at *9.
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