The deposition testimony of each of the physicians and the MRI technician leave no doubt that they were well aware of the possibility of adverse effects as noted in the FDA approved warnings and had for years been well aware of the specific risk of an anaphylactic reaction to the contrast agent. Each confirmed that they had considered the risks versus the necessity to diagnose and treat a possible stroke and determined that the MRI with the contrast agent should be ordered.
the [learned intermediary] doctrine is applicable to the warnings being provided to the physicians and health care professionals and it is not relevant for purposes of this action whether the defendants provided specific warnings directly to the plaintiff. What the testimony and existence of the Consent Form does confirm is that the health care professionals had specific information concerning the adverse reactions as evidenced by the inclusion of these reactions within a form created by the hospital. Therefore, the plaintiff’s reliance upon the unsigned form to create a genuine issue of facts is misplaced.
In an action involving the complications of prescription medication . . . where the claims are either scientific or medical, an expert opinion is required to discuss the development, manufacture, testing, handling and marketing of the product alleged to be defective. Id. at *19-20.
A finding of a defect in the drug is not within the common knowledge of an ordinary person. Without an expert as to the allegations that the product was in some manner defective causing serious unexpected and unforeseen physical injuries, the plaintiff has not been able to forge a sufficient link in the causal chain that would assist a jury in reaching an educated finding that the injuries were caused by a defect in the [drug] which was administered to her. Id. at *23.
[T]he plaintiff’s allegations about the adverse effect of the drug which is noted in the product labeling information approved by the FDA does not, by itself, rise to the level of a defective product. Many courts have recognized that prescription drugs can cause adverse effects but do not create liability in every instance where there is an adverse effect. This is especially relevant for an action in which the plaintiff alleges she has suffered the adverse effects noted in the product labeling. This recognition impacts the plaintiff’s obligation to prove not only that there are adverse impacts but that the plaintiff suffered because the drug was defective and the defect caused other adverse impacts or heightened in some manner the adverse impacts already recognized and addressed through precautions or warnings.