United States: The Canary In The Coal Mine Isn't Looking So Good Anymore

Last Updated: December 7 2018
Article by John Sullivan

This post comes from the Cozen O'Connor side of the blog only.

Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage and again as a part of our preemption scorecard. Canary was a winner.

That decision, however, dismissed only plaintiff's product liability claims, letting her fraud claim move forward. Last month, the court issued a summary judgment decision on that fraud claim. Canary is not such a winner anymore.

Backing up a little bit, the product was Medtronic's PrimeAdvanced spinal cord stimulator. It was implanted in plaintiff to address her neck and back pain. Canary v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 192794, at *2 (E.D. Mich. Nov. 13, 2018). Yet, after the surgery, plaintiff complained that she was experiencing hives all over her body, abdominal pain and bowel inflammation. Id. at *3-4. Almost a month later, she had the device removed. She claimed that her problems stopped. Id. at *4.

During discovery, however, plaintiff produced no causation opinion from an expert—to be clear, no expert on either general or specific causation. Instead, she relied exclusively on the testimony of her treating doctors. Their testimony, however, was only marginally helpful to her, as it was laced with words like "possible" and "plausible" and missing any declaration that the opinions were reached to a degree of medical certainty or even probability. Yet the court allowed her fraud claim to survive summary judgment.

In particular, Plaintiff's internal medicine doctor testified that the device was a possible cause, one of the top possibilities, and that allergy and skin testing was needed. But he offered no opinion to a reasonable degree of medical certainty:

Dr. Thammineni, the internal medicine doctor who treated Plaintiff when she was admitted to the intensive care unit on May 28, 2013, explained during his deposition that while he stated that Plaintiff had "contact dermatitis secondary to spinal cord stimulator" in his notes, he recommended that she get allergy and skin testing to ascertain exactly what caused the reaction. When Dr. Thammineni was asked if the spinal cord stimulator was more of a possibility than other causes, he responded with a "yes." And when asked "[c]an you say to a reasonable degree of medical certainty that the hives were caused by the implantation of the spinal cord stimulator on May 16th and not some other source," he stated that the stimulator was "one of the top possibilities."

Id. at *6.

Plaintiff's dermatologist testified that something at the time of the surgery triggered the hives, that the timing of the implant and removal created an "association," but that there was no test to determine the cause of the hives:

There was something around the time of the surgery that triggered a hive-like reaction. The device was used, but other things were used at the time of the procedure, such as prep and — however, when the device was removed, her hives and itching in that area went away, so there's an association with that. Unfortunately, there's no test for [these types of] reactions in this situation.

Id. at *6-7. She did not testify on causation to a reasonable degree of medical certainty.

Finally, plaintiff's allergist stated that it was "plausible" that plaintiff had an allergic reaction to the device, and later said that she "believed" the device caused the hives:

Q: You stated it was plausible that she had an allergic reaction to the device; is that correct?

A: I think everything is plausible, but, yes.

Q: Okay. The fact that she reported she had hives after the device, and her hives stopped after the device was removed, would that further support the conclusion that it was plausible that the device caused a reaction?

[Defense counsel]: Object to the form.

The witness: I would — yes.

[Plaintiff's counsel]: And earlier you testified regarding the correlation and the difference between general hives versus local hives.

A: Yes.

Q: Do you believe the stimulator caused the local hives she reported to you?

A: Yes.

[Defense counsel]: Object to the form.

[Plaintiff's counsel]: That was a yes?

A: Yes.

Id. at *7. Again, there is no indication that the allergist testified that her "belie[f]" was held to a reasonable degree of medical certainty, or to any degree of certainty or even probability.

The court, discussing two cases involving less complex science, one of which did actually involve a plaintiff's general causation expert, held that this treater testimony, along with the general sequence of events, was enough. In fact, while Medtronic had two experts opine to a reasonable degree of medical certainty that the device did not cause the allergic reaction—the only two causation experts in the case—the court noted that these experts "did not eliminate the possibility that it could have done so." Id. *15.

If the analysis comes down to this, it's not clear that a defendant could ever win summary judgment. Almost any causation issue would be trial ready, despite what could be a lack of any real science behind it or an expert to opine on that science to a reasonable degree of medical certainty.

The Canary doesn't look so good anymore. Time to get out of the coal mine.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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