Defendant in Beavan v. Allergan U.S.A., Inc., 2014 N.J. Super. Unpub. LEXIS 2898 (N.J. App. Nov. 21, 2024) made two solid arguments for summary judgment – preemption based on the FDCA’s recall regulations and plaintiff’s lack of admissible expert testimony. The trial court rejected both. The appellate court, however, saw the merit in the expert argument and that was all defendant needed to secure a dismissal.
Defendant manufactures a prescription drug that is used in the treatment of various eye diseases. The drug is administered by injection. A routine product inspection revealed that approximately 2.2% of the units of a particular lot of the drug contained a silicone particulate which could be dispensed when the drug was injected. Defendant sought FDA approval to send out a Dear Health Care Provider letter (“DHCP letter”), but the FDA concluded the issue was not a “safety concern.” Instead, and with the FDA’s approval, defendant issued a drug recall and a notice to physicians that there was a low risk of a mild reaction. Id. at *2-4. Plaintiff received an injection of defendant’s drug from the lot that was recalled. After which she was diagnosed with retinal detachment. Plaintiff filed her complaint alleging claims for design, manufacturing, and warning defects under New Jersey’s Products Liability Act.
Defendant’s preemption argument centered on the FDA’s recall regulations which it contended preempted the state from regulating prescription drug recalls. The court disagreed finding that the voluntary nature of the recall defeated defendant’s implied preemption argument. Because a manufacturer can add a warning to its labeling, which includes via DHCP letters, without FDA approval, defendant was not foreclosed from warning physicians about the manufacturing defect and therefore, there was no preemption under Wyeth v. Levine, 555 U.S. 555 (2009), and its progeny. Further, while the NJ PLA affords defendants a presumption that their FDA-approved labeling is adequate, the presumption is rebuttable with allegations that the manufactured acquired knowledge of harmful effects after the sale of the product and failed to disclose them. In other words, NJ recognizes a post-sale duty to warn. Here, defendant’s DHCP letter was sufficient to rebut the adequacy presumption and therefore a sufficient basis on which to assert a non-preempted failure to warn claim.
But that is where the bad news ends because plaintiff’s experts took a leap of faith and assumed that the injection plaintiff received contained the defect. You know what they say about people who assume. While both of plaintiff’s experts testified that the silicone particulate caused plaintiff’s injuries, neither offered any evidence that the “injection plaintiff received was defective and no evidence of a particulate in her eye.” Id. at *34. Therefore, plaintiff’s theory of causation was “based on evidence that does not exist and would leave a jury to speculate whether there was ever a particulate in the applicator or particulate injected into plaintiff’s eye.” Id. New Jersey’s net opinion rule prohibits the admission of an expert’s conclusions that are not supported by “factual evidence or other data.” Id. at *32.
Not only did Plaintiff’s experts based their conclusions on an unsupported assumption, they failed to rule out that plaintiff’s injuries could have been caused by various other factors—such as a different silicone insert used in her treatment that became dislocated at the same time she suffered her injury or that retinal detachment is a risk of some of plaintiff’s pre-existing and underlying eye diseases. Id. at *34-35. The court also acknowledged that New Jersey has recently adopted the Daubert factors for expert admissibility and that plaintiff’s experts would not pass under that standard either. Id. at *35-36.
The case was reversed and remanded for summary judgment to be entered on the grounds of no expert evidence of specific or general causation. We would have liked a better preemption outcome, but we are not greedy. A lack of causation is good enough for us any day.