Background
Alison Beavan, a Maryland resident with a long history of ocular disease including uveitis and macular conditions, received an injection of Ozurdex — a steroid pellet manufactured by Allergan U.S.A. — into her left eye on November 6, 2018. The unit used was from lot E82852, one of twenty-two lots Allergan subsequently recalled after discovering that a silicone particulate could detach during administration and be ejected into a patient’s eye. Within days of the injection, Beavan suffered a total retinal detachment. By the time of litigation she was completely blind in her left eye with no light perception.
Beavan sued under New Jersey’s Product Liability Act, asserting manufacturing defect, design defect, and failure-to-warn claims. She designated two causation experts: Dr. Maziar Lalezary, a retained board-certified ophthalmologist who submitted a written report applying a differential diagnosis methodology, and Dr. William Phillips, her treating physician, who testified at deposition but for whom no written expert report was served. Both experts opined that a silicone particulate from the recalled Ozurdex unit caused her retinal detachment, anterior chamber migration, corneal edema, and ultimate vision loss — despite acknowledging that no one directly observed a particulate in her eye.
Allergan moved to bar both experts as unreliable under N.J.R.E. 702 and 703 and as inadmissible “net opinions,” and also sought summary judgment. The trial court denied both motions but did so without conducting the gatekeeping analysis prescribed by the New Jersey Supreme Court in In re Accutane Litigation, 234 N.J. 340 (2018). The Appellate Division reversed, concluding the experts rendered net opinions and granting summary judgment to Allergan. The Supreme Court granted certification.
The Court’s Holding
Writing for a unanimous court, Justice Patterson reversed the Appellate Division and remanded to the trial court. The Court held that Accutane mandates a “rigorous” gatekeeping inquiry by the trial court — not the appellate court — whenever a party challenges the reliability of opposing expert testimony under N.J.R.E. 702 and 703. Because the trial court never conducted that analysis, neither it nor the Appellate Division had an adequate record on which to rule on admissibility. The Court strongly encouraged the trial court on remand to hold a pretrial hearing under N.J.R.E. 104. The Court also clarified that Accutane‘s framework applies to differential diagnosis opinions just as it does to any other expert methodology — there is no carve-out — and that the gatekeeping inquiry must be applied to both steps of a differential diagnosis (ruling in plausible causes, then ruling them out).
On the net opinion question, the Court reversed the Appellate Division as to Dr. Lalezary, finding his report adequately set forth the “why and wherefore” of his opinions and was not a circular or unsupported conclusion. As to Dr. Phillips, the Court declined to reach the net opinion question because no written report existed in the record. On remand, the trial court must first decide whether to permit Beavan to serve a late expert report from Dr. Phillips and, if so, whether his proposed testimony is admissible.
Because the Appellate Division’s grant of summary judgment to Allergan was entirely premised on its exclusion of the expert testimony, the Court reversed that ruling as well — without prejudice to either party seeking summary judgment again after the trial court resolves expert admissibility on remand.
Key Takeaways
- The Accutane gatekeeping framework applies in every New Jersey civil case where expert reliability is contested — including cases relying on differential diagnosis — and the analysis must be conducted by the trial court, not resolved for the first time on appeal.
- A differential diagnosis methodology is not self-validating under New Jersey law; experts relying on it must satisfy Accutane‘s reliability inquiry at both the “rule-in” and “rule-out” stages.
- Treating physicians are not exempt from the written-report requirement when they are designated to offer expert causation opinions; failure to serve a report leaves the admissibility question unresolved and may result in exclusion or delay on remand.
- A retained expert’s report that explains the factual basis for each opinion and the reasoning connecting evidence to conclusions satisfies the net opinion rule even when direct physical evidence of the alleged defect is unavailable.
- Summary judgment entered solely because expert testimony was excluded must be reversed when the exclusion ruling is itself reversed, preserving both parties’ right to re-litigate the motion on a complete record.
Why It Matters
This decision reinforces that New Jersey trial courts cannot rubber-stamp or summarily reject expert causation opinions in product liability cases — they must engage in the structured, on-the-record gatekeeping analysis Accutane requires. By explicitly rejecting any differential-diagnosis exception to that framework, the Court closes a potential argument that a doctor’s “rule out other causes” reasoning is inherently sufficient without methodological scrutiny. Plaintiffs’ counsel must ensure both retained and treating expert opinions are supported by written reports and a documented methodology capable of withstanding an Accutane hearing.
For pharmaceutical and medical-device defendants, the ruling is a double-edged reminder: bare appellate record review is insufficient to dispose of contested expert testimony, but a properly developed gatekeeping record at the trial level remains a viable path to exclusion and potentially dispositive summary judgment. The case will return to the trial court for what the Supreme Court described as the “rigorous” proceeding Accutane envisions — a hearing that could still result in exclusion of both plaintiff’s experts and dismissal of her claims.