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 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.

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