However, contrary to DOJ's understanding, the agreements provide that confidential documents are those that contained "proprietary or trade secret information." (Emphasis added.) That is, the agreements provide for protection of "proprietary" information beyond "trade secrets." Thus, DOJ's contention that the agreements obligate it to apply only the OPRL exemptions related to trade secrets is unavailing.
The success of [DOJ’s] syllogism depends on the correctness of DOJ's predicate premise that the exhibits are nothing more than examples of conduct described in the publicly available documents to which it refers. . . . [W]e conclude that that premise is incorrect as to the great majority of the exhibits.. . .Even as redacted, those exhibits reveal more than generic examples of conduct. In other words, the specific, underlying details in those exhibits have not been revealed by the publicly available sources on which DOJ relies--and it is that underlying detail that Pfizer contends is a trade secret. Accordingly, . . . we reject DOJ's contention that the "information had already been made public or that similar information was readily available."
Even if plaintiff could rely on the theories of negligence and strict liability to prove his case, it is well-established that the LPLA establishes the exclusive theories of liability for manufacturers for damages caused by their products and state law claims are therefore barred under Louisiana law. Louisiana does not recognize any claim for violations of FDA regulations. The only remedies available to plaintiffs in this case are provided in the LPLA.
Plaintiffs would only be able to prevail on the New Jersey PLA claims if they proved that the lead wire, as designed, manufactured, and distributed, was defective and unreasonably dangerous. It follows that liability would necessitate a finding that the lead wire - designed, manufactured, and labeled in a way that the FDA deemed safe and effective - was both defective and unreasonably dangerous. Such a determination would necessarily constitute a requirement different from, or in addition to, the standard required by federal authorities.
But a plaintiff must successfully plead a claim before obtaining discovery, and not the other way around. Such a premature request for discovery is inapposite to Rules 8 and 11(b) of the Federal Rules of Civil Procedure.. . .Although courts have acknowledged that plaintiffs might have limited access to crucial information, this Court's research suggests that no courts have let cases enter discovery based on the type of generalized allegations that are present here.
It is well established that a medical device manufacturer is not responsible for the practice of medicine. . . . [i]t is both impractical and unrealistic to expect . . . manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams.
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