Ramon D. Johnson, II v. Novartis Pharmaceuticals Corporation, et al.

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.)

2. 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.

3. 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.

4. 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. n