drug-and-device-law

There aren't that many cases applying Wyoming law, but the recent Tolman v. Stryker Corp., ___ F. Appx. ___, 2016 WL 683315 (10th Cir. Feb. 19, 2016), does – and we like its reasoning.  The injured plaintiff was in an unrelated accident and tore up his leg pretty badly (comminuted fracture).  He had an intramedullary nail inserted to hold everything together while he healed, but since this is a product liability case, that didn't happen.  Instead plaintiff suffered a "[f]ailed gamma nail with nonunion."  Id. at *1.

Plaintiffs (husband and wife) tried to get by with some version of a malfunction theory/res ipsa loquitur, because they "never deposed their designated experts."  Id. at *2.  Bad move.  The trial court granted summary judgment and the Tenth Circuit eventually affirmed.  The mere fact that an implant – particularly a weight bearing implant – broke does not create a jury question that it was defective.

We can express all this in less technical terms:  [Plaintiff's] injury was not a clean break, but rather a "comminuted" fracture that broke the bone into several pieces.  Much of the damage healed before the nail broke, but the doctor was concerned that a particular part of the fracture was not healing adequately.  The doctor's concern was justified, and the inadequate healing contributed to the failure of the nail.

Id.

Plaintiff claimed that the defendant had "misinterpreted the medical records" and that nonunion was not a "secondary cause" preventing a malfunction from creating an "inference of defect."  Id.  The court of appeals, however, found that "characterization of the medical records is not plausible."  Id.

Plaintiff's fallback position was that the implant had "failed at its designed task, during its normally designated time frame" – in other words, any break was a defect.  Id.  Sorry, that theory doesn't go anywhere without an expert:

This argument might be persuasive, except that it has no foundation in the record.  The [plaintiffs] try to support it with a series of citations to [his] medical records, but the records speak neither to the "designed task" and "time frame" of the nail nor to the reasonableness of nonunion as a cause of the nail's failure.  [Plaintiffs] also try to support their assertions with a series of citations to their expert witness designations, but such designations are not evidence.

Id.  This is self-evidently true.  Plaintiffs probably didn't depose their expert because any orthopedic surgeon will tell you that any instrumented fracture repair is a race between bone healing on one hand, and metal fatigue on the other.  If, as in Tolman, there's nonunion, then any device will eventually break – forget about defects.  Several years ago, we discussed all of this in depth here, in our "Them's the Breaks" post.  Tolman is the latest addition to that list.



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