In Pliva, Inc. v. Mensing 564 U.S. 604 (2011)
the only question before this Court was whether a
state law duty for a generic drug manufacturer to
provide a safer label was preempted by a federal
duty for that generic drug manufacturer to ensure its
label was the same as the label for the brand name.
This Court held that the state law duty to provide a
safer label was preempted by the federal duty of
"sameness " for generic drug manufacturers. As part
of this decision this Court stated the different duties
of brand name and generic drug manufacturers as:
A brand name manufacturer seeking new
drug approval is responsible for the accuracy
and adequacy of its label. A manufacturer
seeking generic drug approval, on the other
hand, is responsible for ensuring that its
warning label is the same as the brand
name's. Mensing at 516 (citations omitted).
The finding in Mensing, along with its description of
the manufacturers ' duties, lead naturally to the first
two of the five questions that are at issue in the
instant case:

(1) Whether a brand name drug manufacturer
who designed the label that is distributed as part of a
generic drug product can be held liable when it is
that label that is the defective part of the product
that caused the injury.

(2) Whether a generic drug manufacturer can be
held liable for state law claims that are not based on
a duty to provide a safer label, but are instead based
on other state law duties or the condition of the
product as distributed, (e.g. In Texas, a strict liability
marketing defect claim merely looks at the product
itself and determines if it is defective.)

(3) Whether the relevant information rebuttal to
the Texas presumption of no liability for a drug
manufacturer with an FDA approved label is
preempted, and whether if it is preempted does that
render the presumption of no liability also preempted
or unconstitutional.

(4) Whether Petitioner alleged facts supporting
the unapproved indication rebuttal to the Texas
presumption of no liability for a drug manufacturer
with an FDA approved label, and whether the
District Court was derelict in it duties or abused its
discretion in deciding Petitioner had not.

(5) Whether the District Court abused its
discretion in not granting Petitioner leave to amend
his complaint when the amended complaint was
submitted in accordance with instruction provided on
the District Court 's own website and with prevailing
precedents.

Whether a brand name drug manufacturer can be held liable for the defective label of a generic drug product