Whether Respondent committed fraud by hiding adverse events related to implantable opioids-infusion pumps

Questions Presented for Review This case involves implantable opioids-infusion pumps produced by Medtronic Inc. (“Respondent”). The pumps have Pre-Market Approval (“PMA”) granted by the Federal Drug Administration (“FDA”) for newly-developed technology. PMA is conditioned on strict adherence to numerous FDA conditions, including requirements to analyze and report adverse events to the FDA. Petitioner, 65 years old, had 3 pumps fail and therefore explanted from her body. According to PMA requirements, the explanted pumps should have been acknowledged and analyzed by Respondent. However, Respondent claims that it has no records of any pumps ever being returned for analysis. Petitioner alleges Respondent violated PMA mandates and committed fraud by hiding the failed devices and not reporting adverse events to the FDA. The Ninth Circuit Court of Appeal affirmed the district court’s ruling granting respondent’s Motion to Dismiss (“MDT12(b)”) as to both Petitioner’s original complaint and Petitioner’s First Amended Complaint (“FAC”), thus dismissing Petitioner’s causes of action for fraud and deceit. The Ninth Circuit found that: (1) to have a claim, the Petitioner must identify the specific nature of the pumps’ defects and (2) PMA requires Respondent only to report, but not to analyze adverse events to the FDA. In sum, the Appellate Court held that the issue of whether Respondent committed fraud by hiding “adverse events” was moot because Petitioner was unable to establish the exact physical defect experienced by the pumps. Petitioner’s argument that the trial court dismissed iti Petitioner’s allegations of fraud prematurely without affording Petitioner a chance for discovery was also rejected as moot by the Ninth Circuit. Four questions presented: 1. What is the scope of the FDA’s requirements of reporting of adverse events and whether Title 21 §803.50; Title 21 §803.56; and Title 21 §814.84 explicitly and implicitly require a company to not only report, but also analyze each adverse event and the company’s remedial actions for fixing and improving future product design and reliability? 2. What are the proper criteria for a product liability cause of action where the product at-issue has PMA? According to the Appellate court, Petitioner must know the specific nature of the pump’s physical defect and allege specific violations of a procedural nature, i.e. Petitioner’s allegations of failure to report and analyze the adverse events was not sufficient to state a claim. 3. What is the proper stage at which allegations of fraud can be dismissed? Whether dismissing allegations of fraud at the pleading stage is unjust and prejudicial as it denies Petitioner of an opportunity to conduct reasonable discovery concerning the alleged fraud, which is often discreet, secret and difficult to uncover? 4. What is the standard for failure-to warn claims and causes of action based on detrimental reliance? Both standards are extremely subjective and represent a matter of fact, which should be left for the jury to decide. Additionally, in the instant matter, Petitioner relied on the advice of her doctor, who was also misled iv by Respondent. The issue of what is reasonable (especially when a doctor is involved) is measured by the “reasonable man” standard and should be left to the trier of fact to determine.