By the time of a Fourth Amended Complaint, a plaintiff is bound to get things right, right?  Wrong.  In Greenwood v. Arthrex, Inc. et al., 2023 WL 3570436,(W.D.N.Y. May 19, 2023), the plaintiff claimed that a medical device burned her during surgery.  She filed one, two, three, four, and, ultimately, five complaints under New York law.  The defendant moved to dismiss the plaintiff’s Fourth Amended Complaint in its entirety.  The claims remaining by this point included design defect, manufacturing defect, and failure to warn.  Those are, of course, the usual product liability claims, and they failed here for the usual reasons.  

The court referrred to the design defect claim as an “alternative design defect claim,” which tells you where the analysis is headed. To state a design defect claim under New York law, a plaintiff “must demonstrate (1) the product as designed posed a substantial likelihood of harm; (2) it was feasible to design the product in a safe manner; and (3) the defective design was a substantial factor in causing Plaintiff’s injury.”  Although the design defect claim in Greenwood alleged possible design flaws and a causal connection between those design flaws and the injury, the claim flunked because it did not set forth an alternative design.  The plaintiff simply asserted that an alternative design was “self-evident”  without stating what the alternative design was. The court reasoned that “Without presenting an example of this ‘self-evident’ option, the feasibility of that option cannot be assessed.”  The plaintiff’s “essentially unamended allegation merely restates that a safer device could have been made but it fails to state what such a device looks like or how it would function.”  The plaintiff needed an alternative pleading to show an alternative device, but could not come up with one.  The court dismissed the design defect claim.

The Greenwood court observed that “Ordinarily, to state a design defect claim Plaintiff must allege that the device met all design specifications but a manufacturing claim requires proof of deviation from the design specifications.  Those two concepts are mutually exclusive.  And yet plaintiffs almost automatically lob both of these mutually exclusive claims in every product liability complaint.  And still, many plaintiffs, such as the plaintiff in Greenwood, manage to get both claims wrong.  A manufacturing defect claim cannot be pleaded without some facts establishing a deviation from design specifications.  The plaintiff in Greenwood claimed that the manufacturer “failed to test properly the device or use appropriate alloys and insulation causing her injury.”  But the complaint nowhere compared the device at issue  with other devices made by the defendant. In truth, all the complaint said was that the device used in the plaintiff’s surgery “malfunctioned without stating the exact malfunction or speculating upon a cause or theory for the malfunction.”  A bare malfunction allegation is not enough to support a claim for manufacturing defect or any other theory.

As with the design defect and manufacturing defect claims, the failure to warn claim had not improved with amendment. The plaintiff suggested no alternative warning.  Instead, the plaintiff relied on a theory that the defendant had provided no warning at all, which was inadequate as a matter of law.  But the complaint never alleged what the manufacturer knew and when it knew it (e.g., the potential for malfunction), 

The Greenwood court concluded that all three product theories failed under both strict liability and negligence analyses.  Moreover, the plaintiff’s Fourth Amended Complaint had proved the futility of further amendment, so the court dismissed the case with prejudice.