Photo of Stephen McConnell

Happy Valentine’s Day. To celebrate, we will discuss a court decision that we love.

Preemption and the Ohio Product Liability Act (OPLA) are two of the best friends a drug/device defense lawyer has.  Both show up in Groeschen v. Alcon Laboratories, Inc., 2024 Ohio Misc. LEXIS 2 (Ohio Ct. Comm. Pleas Feb. 2, 2024). As the Groeschen court explained, this case has a “lengthy history.”  In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss.  The plaintiff alleged that the lenses malfunctioned as the result of some unspecified defective manufacturing process or chemical contamination, and that the defendants failed to warn him of the potential injuries.  

The manufacturer moved to dismiss the complaint, and then the First Amended Complaint.  In 2021, the court granted that motion to dismiss, in part, with preemption being the basis for dismissal. The court also ordered a more definite statement with respect to the manufacturing defect claim. That more definite (except it really wasn’t – more on that later) statement arrived in the form of a Second Amended Complaint.  The manufacturer again moved to dismiss. Meanwhile, discovery took place. The defendants met their discovery obligations.  The plaintiff … not so much.  The manufacturer then moved for summary judgment. The grounds for the summary judgment motion were fairly straightforward: the plaintiff had no evidence.  After the court denied the plaintiff’s request foradditional time to conduct discovery, the  plaintiff voluntarily dismissed the Second Amended Complaint. The court never ruled on either the motion to dismiss the Second Amended Complaint or the motion for summary judgment. 

Thus concluded Groeschen I

Now we get to Groeschen II.  In 2023, the plaintiff refiled the case. There was a Complaint.  Then there was a First Amended Complaint.  If you’re keeping count throughout the life of this case in its various iterations, we are now up to the fifth pleading overall.  And yet the claims were essentially the same, including the claims (negligence, products liability, breach of implied warranty) that were previously held to be preempted.  

Have you heard the definition of insanity as doing the same thing and expecting a different result?

The manufacturer moved to dismiss the latest (but not greatest) complaint.  We’re guessing that it was easy enough to dust off the old motion to dismiss and summary judgment motion, change a few dates, and then file and serve. There is nothing insane about doing the same thing and expecting the same result. 

The contact lenses were a class III medical device, meaning that they had gone through the rigorous Pre Market Approval (PMA) process, and meaning that any legal claim attempting to impose “any requirement” that “is different from, or in addition to” and FDA requirement would be preempted.  There was no getting around the fact that the plaintiff’s claims insisted that the medical device at issue – the lenses— should have been manufactured, designed, or labeled differently from the manner approved by the FDA. 

Well, maybe there was one possible way of getting around preemption, and by now almost all of you can predict that the plaintiff resorted to the Riegel parallel claim exception.  (Has any SCOTUS dictum visited more mischief? Inspired more frivolity by hapless plaintiff lawyers?  Made necessary more indignant blogposts?) If the plaintiff could point to a violation of FDA regulations that parallels a state law violation, his claims could conceivably squeeze through the “narrow gap” and evade preemption. But such parallel claims require more than conclusory violation claims. This was the issue that prompted the Groeschen I court way back in 2021 to ask the plaintiff to author a more definite statement. But in multiple complaints, the plaintiff failed to plead any violation of any particular federal specification.  Nor did the plaintiff identify particular Ohio state-law duties that parallel any FDA requirement.  Inevitably ineluctably indubitably, the Groeschen II court pushed the trap door button: “Plaintiff’s inability to allege the elements of a parallel claim capable of surviving preemption after five complaints in two cases over six years requires dismissal of all of Plainitff’s claims against [the manufacturer] as preempted.”

The court almost sounds exasperated. 

Maybe it was. We say that because, after hammering the plaintiff on preemption grounds, the Groeschen court held that even if preemption did not apply, the plaintiff’s claims for negligence, breach of warranties, and “common law tort claims for breach of implied warranty/strict liability” were abrogated by the OPLA, which precludes separate common-law claims.  The claims that otherwise could proceed via the OPLA still fail, because they fail to specify any particular design, warning, or manufacturing defect.  Moreover, the OPLA precludes consumer fraud claims in product liability cases. Lastly, the OPLA (bless it) bars punitive damages against FDA-approved products. 

The plaintiff lost, and the court’s reliance on multiple grounds makes an appeal by the plaintiff all the more difficult. 

Groeschen is a good decision that was a long time coming. We are grateful to our esteemed colleagues and friends at Greenberg TraurigMarcella Ducca and Greg Ostfeld — for bringing this case to our attention, and even more grateful for their excellent efforts in earning such a fine result.