Pharmaceutical Company Sues Over Breached Drug Studies Contract

Plaintiff Eagle Pharmaceuticals, Inc. filed suit against MRIGlobal on Monday in the District of New Jersey. Eagle is a pharmaceutical company that“develops medications that can treat or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic substances,” while MRIGlobal is a “contract research organization with expertise in medical countermeasures designed to protect against threats to public health.” The plaintiff has filed suit as a result of an alleged breached contact between the two parties.

According to the filing, Eagle is currently experimenting with one of their medications, Ryanodex, to evaluate whether it can be used to treat and prevent neurological damage in patients exposed to chemical nerve agents. Though the medication is Food and Drug Administration (FDA)-approved for other purposes, the nature of its potential new use makes testing it in humans unethical. The plaintiff is conducting tests under the FDA’s animal rule, the complaint explained; if the tests run on animals indicate that the drug is “reasonably likely to produce clinical benefit in humans,” the FDA will then grant the plaintiff approval.

In order to obtain the FDA’s approval for the animal testing, the plaintiff said they entered into an agreement with MRIGlobal where they relied on the defendants’ studies for testing the new drug. For the drug to be approved by the FDA, Eagle needed to submit five studies, which per the aforementioned agreement between the plaintiff and the defendant were to be conducted by MRIGlobal.

Eagle explains that only “one draft and one final report” for each of the studies was conducted and deliverable, despite the necessary five studies for the FDA submission. Further auditing by the plaintiff showed that MRIGlobal did not follow the proper protocols for the study, which “significantly affected the outcome of the studies” and violated the agreement that MRIGlobal had with Eagle.

When MRIGlobal submitted invoices to Eagle for the studies they had conducted, there were expenses included that were “neither reasonably incurred nor for the services correctly performed by MRIGlobal.” The plaintiff believes that the defendant not only wrongly overcharged them for the studies, but also compromised their studies by failing to follow previously agreed upon protocols.

Eagle is charging MRIGlobal with breach of contract, breach of covenant of good faith and fair dealing, and detrimental reliance under Delaware law. The plaintiff is seeking favorable judgement on all counts, pre and post-judgement interest, damages, litigation fees, and any other relief deemed proper by the Court.

The plaintiff is represented by Pepper Hamilton.