Today’s decision is that simple. Actually, it’s that simple and it’s that surprising that plaintiffs tried to side-step this golden rule of complex drug/device products liability litigation. You must have expert testimony.

In Chatman v. Zimmer, Inc., 2016 U.S. Dist. LEXIS 78657 (S.D. Miss. Jun. 16, 2016), plaintiff alleged she suffered injury as a result of implantation and subsequent failure of her knee implant.  The device was implanted in 2006 and in 2013 plaintiff started experiencing pain that led to revision surgery. Id. at *2. Rather than producing an expert to opine regarding product defect or medical causation, plaintiff informed the court she would be relying on “her own accounting of the events, records from her treating physicians, and a recall notice.” Id. at *3. We don’t need to know anything else. There is no way any of those three sources could satisfy the requirement that plaintiff produce expert testimony as to the alleged defect.

The court first threw out the recall notice because it pertained to a different knee replacement device than that implanted in plaintiff. Plaintiff apparently cited to cases involving commercial products to argue the admissibility of substantially similar circumstances. But this wasn’t similar circumstances, it was an entirely different product. Therefore, the recall is irrelevant. Id. at *5.

So plaintiff is down to “her own accounting” and her “medical records.” Plaintiff’s “own accounting” cannot establish product defect or medical causation. Plaintiff did not appear to be either a biomedical engineer or an orthopedic surgeon. The fact that her knee implant eventually failed after seven years and that she experienced pain are facts – but they have no connection to liability without expert testimony on defect and cause.

That leaves her medical records and presumably the testimony of her treating physicians. The only information from those records provided in the opinion is the post-operative diagnosis after the revision surgery of “Failed Right Knee Total Arthroplasty.”Id. at *3.   A couple of things about this. First, it suggests to us that there was nothing said about causation in either the records or the testimony, or we’d be hearing about it. Second, and more importantly, a surgeon’s notation that a medical device has failed says absolutely nothing about defect.

Medical devices fail. A device like a knee implant is subject to wear and tear and the forces of the body. Over time metal can bend, move, and even fracture. That is why there are known risks associated with the implant of any device – including things like device loosening such as the plaintiff experienced in this case. Id. at *7. But given the number of knee replacements that are performed every year, the benefits (pain relief, mobility) seem to outweigh the risks. So, device failure, of a known variety, after seven years, is hardly evidence of a defect. At most, it is evidence that plaintiff experienced one of the unfortunate, although known and foreseeable, complications of knee replacement surgery.

The absence of any expert testimony on defect or causation was enough to sink this case, but defendant also produced experts of its own. The defense experts were able to provide the court with information on things such as known risks, success rates with the device, and inspection of the actual device. Id. That was unnecessary to show that plaintiff hadn’t met her burden, but it didn’t hurt. And, it allowed the court to conclude that the undisputed evidence demonstrated: no design or manufacturing defect; no failure to warn; and no breach of warranty. No experts, no case.