It seems fitting that if we are going to talk about a one-two punch, we acknowledge the passing of boxing legend Marvelous Marvin Hagler. The undisputed middleweight champion from 1980 to 1987 whose boxing career started in Massachusetts but who started out a New Jersey boy. Only Jersey Understands Jersey!
From New Jersey to Alabama and Lowery v. Sanofi-Aventis LLC, 2021 WL 872620 (N.D. Ala. Mar. 9, 2021). Today we're going to talk about the first hit to plaintiff's case – Daubert. Stay tuned for the knockout blow – preemption.
The product at issue is a Class III medical device that is a gel-like substance that is injected into the knee to reduce pain. This is the treatment that plaintiff underwent. He experienced pain and swelling after the injection that required surgery and antibiotics. His treaters determined he may have had septic arthritis or possibly a pseudoseptic reaction. Id. at *1-2. Sometime after plaintiff's injection, the manufacturer discovered that the lot plaintiff's device came from was contaminated and recalled it. Id. at *1. The basis of plaintiff's claims is that the contaminant caused his infection and various related injuries.
Plaintiff proffered testimony from two experts – a hospitalist practicing family medicine as a causation expert and a molecular biologist with experience in product development and regulatory compliance as an FDA expert. Id. at *2, *5. The first failed on qualifications and both failed on reliability.
Plaintiff's medical expert sought to assert medical opinions on infectious disease, orthopedics, and otolaryngology – but was not an expert in any of those fields. Id. at *7. The expert must be qualified to opine on the "specific issue before the court." Id. Specifically, plaintiff's medical expert sought to testify that plaintiff suffered from septic arthritis that was caused by the contaminant in the medical device. However, the expert does not use the medical device at issue, does not perform any orthopedic procedures on knees, never did any training in orthopedics, never did any research in the field of orthopedics or this type of injection, or on knee infections or pseudoseptic reactions. Id. at *8. The expert's lack of experience made him unsuited to determine whether plaintiff suffered from septic arthritis or to rule out alternative causes such as a pseudoseptic reaction.
The court further noted that not only was plaintiff's expert unqualified to opine on plaintiff's diagnosis but was also unqualified to opine as to the cause of the condition. Plaintiff's expert lacked the training and skills needed to determine the root cause of plaintiff's condition. Before being retained by plaintiff, this doctor had never even heard of the contaminant in defendant's device, let alone treated anyone infected by it. Id. at *9. Plaintiff's expert was a family doctor who by his own admission refers patients to specialists like orthopedists when faced with issues like those presented by this plaintiff. As the court correctly concluded, he was a "Jack of all trades, expert in none." Id. at *11.
However, even if qualified, his testimony would have been excluded for lack of reliability. To meet his burden of proof, plaintiff had to offer expert testimony to establish both general and specific causation. General causation lays the "scientific groundwork" that the substance can cause the harm alleged while specific causation establishes that the substance did cause the injury in this case. Id. at *12. You cannot have the latter without the former. The court discusses the issue in the terms of a differential diagnosis – the process of ruling in and ruling out possible causes of a diagnosis.
Here, plaintiff did not dispute that his expert does not offer a general causation opinion. So, in conducting his differential diagnosis, plaintiff's expert ruled out the pseudoseptic reaction, a known side effect of the device, as a cause of plaintiff's injury but failed to properly rule in the contaminant as a cause. His only basis for ruling in the contaminant was the initial impressions of plaintiff's treating doctors as noted in the medical records and temporal proximity. An expert cannot simply parrot what is in the medical records – otherwise, why would we need experts? And the temporal proximity between the injection and the symptoms is inherently unreliable. Id. at *14. This is especially true in a case like this where the temporal proximity could also point to an alternative cause like a pseudoseptic reaction. Neither parroting nor proximity are generally accepted scientific methodologies. Lacking any methodology or analysis, his "conclusion is nothing more than his own assertion." Id. at *15.
Moving on to plaintiff's FDA expert, the court concluded that she was qualified to offer the opinions she proffered except her opinion that the contaminated product put patients at risk of serious injury due to bacterial contamination. That is a medical opinion, and the expert was not a medical doctor. Id. at *18. However, as to her remaining opinions the court found there were "significant analytical gaps" between [the expert's] conclusions and the facts on which she bases her opinions." Id.
The crux of the FDA's expert opinions was that the device would be found to be adulterated under FDA regulations, that defendant violated FDA's Good Manufacturing Practices (GMPs) in the manufacturer and distribution of the device, and that defendant should have started testing earlier as required by the device's PMA. Id. But despite the repeated reference to FDA regulations and GMPs, nowhere did plaintiff's expert identify which GMPs or regulations defendant violated. Id. at *19. The closest plaintiff's expert came was citing general regulations with multiple sub-parts covering a variety of processes from manufacturing to packaging to record keeping. The FDA expert failed to connect the facts to the conclusion that FDA regulations were violated. This type of opinion would be of no assistance to the jury:
where her analysis jumps from her observations of Defendant's practices to conclusions as to its compliance without specifying which provision Defendant failed to comply with (let alone how it failed to do so), a jury would be left to perform guesswork.
Id. at *20. Nor should opinions be admissible if they only support claims not before the jury. Plaintiff's FDA expert opined that defendant should have done different testing of the device – testing that is not required by the FDA. But that only supports a claim that defendant should have done something different from or in addition to what the FDA requires which is a preempted claim. Which feels like a logical place to transition to punch number two. Next week – the summary judgment ruling.
Originally Published by Reed Smith, March 2021
This article is presented for informational purposes only and is not intended to constitute legal advice.
