We are six weeks into 2021 and for most, it stills feels a lot like 2020. We are starting to hear about restrictions being lifted or modified to allow for more . . . well more anything. But that’s happening just as almost the entire country is being overwhelmed by a polar vortex. Ice, snow, and sub-zero temperatures are being reported from Washington to Texas to Virginia. So, just as your favorite restaurant may be opening back up, you may be too busy shoveling snow or too content by the fireplace to venture out right now. If the winter is determined to keep us in a bit of a 2020 shut-in re-run, why not talk about a 2020 case.
The decision granting summary judgment to the product manufacturers in Estate of William O’Dowd v. Sims, 2020 WL 8414373 (N.J. Super. Law Div. Jun. 8, 2020) just recently popped up on Westlaw and reaffirms the importance of product identification in an over-the-counter drug case. Plaintiff was a diabetic who underwent foot surgery, after which he continued to experience discomfort. His doctor advised him to get “some padding.” Id. at *2. According to the complaint, plaintiff then purchased callus removers. Continuing to experience problems, plaintiff returned to the doctor and was diagnosed with an ulceration due to the medication on the corn remover and it appears that plaintiff eventually had to have an amputation. Id. This all occurred in 2015. The lawsuit was initiated two years later and one and half-years after filing, plaintiff died of an unrelated cause. Id. at *1-2. Plaintiff’s sole allegation against the manufacturer was that the product’s packaging did not contain an adequate warning.
Importantly, however, plaintiff did not retain the actual product he used or its packaging and he died before being deposed. Those two events proved fatal to his case. The opinion details several meetings with counsel during which different packages were shown to him (i.e., asbestos-style coaching) in an attempt to identify the product. Id. at *3. According to plaintiff’s counsel, plaintiff identified the color of defendant’s packaging “as being more representative of the product he used.” Id. Does not sound like a definitive identification, but the real problem was the lack of any sworn testimony or records to support even that tentative recollection.
On analysis, the court was rightfully concerned that there was a major evidentiary deficiency in plaintiff’s case. Plaintiff could not attest to what the packaging looked like and neither could any other witness. The only thing the estate could offer was the inadmissible hearsay testimony of family members (some of it conflicting) and counsel. Id. Leading the court to conclude:
[T]he most important [question] is whether Plaintiffs can apprise the Court with a credible identification of the actual product at issue. The case against Defendants . . . is one for failure to adequately warn a patient . . . of the product’s risks. This count necessarily relies on a credible identification of the packaging actually used by a plaintiff so that a jury may evaluate that particular packaging’s ability to warn the consumer of its risks. The Court is satisfied that Plaintiffs are unable to properly identify – with admissible evidence – the specific packaging used by [plaintiff].
Id. at *6.
The court goes on to examine each statement offered by the estate on product identification and explains why each is inadmissible hearsay not subject to any exception. Id. at *6-7. Plaintiffs asked the court to consider all of the family hearsay statements together to conclude that they were trustworthy. But that missed the mark because hearsay statements must be independently evaluated. “[T]here is no lots of hearsay exception to the hearsay rule that supports trustworthiness. Plaintiffs cannot offer hearsay to support the credibility of other hearsay.” Id. at *6. As for the statements made to counsel where multiple packages were shown to plaintiff, the court could not conclude those were trustworthy as they were made while preparing for litigation nearly two years after the product was used. Id. at *7. The estate also sought to rely on (i) plaintiff’s interrogatory responses, but those were not verified by plaintiff, and (ii) on his handwritten notes which were not admissible because he would not be testifying. Id. The court was left with no particular product that it was comfortable having a jury consider. Therefore, summary judgment was granted.
But the court made a few additional findings. Such as, plaintiff’s expert could not opine on a product without product identification. An expert opinion must be founded on “facts or data.” Id. at *4. Here, plaintiff’s expert had neither. He had never spoken to plaintiff before he died. The only “fact” the expert relied on was plaintiff’s counsel’s identification of the product which was inadmissible. Also, without product identification any “heeding presumption” issue was immaterial. Id. at *8. Next, plaintiff’s warning claim was also preempted under the applicable monograph for the OTC product. Id. at *8-9. The monograph prohibits statements outside its scope even if truthful and not misleading. Id. at *9. Therefore, “[p]laintiffs cannot have expected Defendants to violate federal law to change the wording of the label.” Id. Finally, the court concluded that the OTC product qualified for New Jersey’s presumption of adequacy for FDA-approved warnings. Plaintiff first tried to argue that OTC warnings fall under the monograph but are not approved by the FDA, which the court rejected based on a review of relevant regulations identifying the FDA’s warning label requirements. Id. at *9. Plaintiff also argued that the language on defendant’s packaging did not exactly mirror the FDA’s required language. But the court was unwilling to accept that “a deviation in grammar or syntax constitutes such a disruption that a drug is not in compliance with FDA requirements.” Id.
It may be snowing or sleeting, or icing where you are, but that won’t last. Needing product identification however is a re-run we’ll never tire of.