Almost two months ago we posted on the magistrate’s Report and Recommendation in Drescher v. Bracco Diagnostics Inc., 2020 WL 699878 (D. Ariz. Jan. 31, 2020). Back when our co-workers didn’t include furry, four-legged friends. When we weren’t also re-learning high school geometry. And when pajamas and slippers weren’t acceptable work attire. Many things have definitely changed. Fortunately, the result of Drescher isn’t one of them.
Following the magistrate’s dismissal of all claims, over plaintiff’s objections, the court adopted the magistrate’s findings in full and authored a thoughtful opinion of its own. Drescher v. Bracco Diagnostics Inc., 2020 WL 1466296 (D. Ariz. Mar. 26, 2020). As a reminder, plaintiff underwent MRIs in 2013, 2015, and 2016 before each of which she was injected with a linear gadolinium-based contrast agent (GBCA) manufactured by defendants. Plaintiff had normal kidney function at the time of her GBCA injections. She alleges that she has retained gadolinium in her organs that is causing fibrosis and related symptomology. Plaintiff brought causes of action for failure to warn and defective design under both negligence and strict liability. Id. at *1-2. Plaintiff raised three objections to the magistrate’s recommendation.
First, plaintiff claimed that the magistrate did not draw all reasonable inferences in her favor. But plaintiff failed to identify what those inferences should have been. Id. at *4. That’s because plaintiff only made conclusory causation allegations that not only weren’t supported by the facts, but were actually contradicted by them:
Rather, the information provided by Plaintiff shows that the FDA found, after inquiry and studies, that it could not establish a causal association between adverse health effects reported by patients with normal kidney function and gadolinium retention.
Id. Because plaintiff’s allegations were merely speculative or not facially plausible, the magistrate correctly applied the TwIqbal standard in dismissing the case.
Second, plaintiff took issue with the magistrate’s finding that the FDA found no causal nexus between GBCA and adverse health effects in patients with normal kidney function. Id. Plaintiff argued that FDA’s 2018 label change was “reasonable evidence” of a causal association. But the label change stated: “adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.” Id. at *5. Essentially, plaintiff was asking the court to overlook the FDA’s findings and “to draw an inference that is both unsupported and explicitly contradicted by the record before it.” Id. The court was unwilling to do so.
Finally, plaintiff argued that the magistrate erred in finding that her design defect claim was barred by Restatement (Third) of Torts §6(c). The court begins its analysis by addressing what plaintiff failed to – that her design defect claim was also dismissed as preempted. The court agreed with the magistrate that a design defect claim would require defendant to alter the formulation of its product, something not allowed without FDA approval. Id. Plaintiff’s argument that defendant should have sold a different type of GBCA, or stopped selling its GBCA, was also preempted under Mutual Pharm Co., Inc. v. Bartlett, 570 U.S. 472, 488 (2013).
The court then turned to §6(c) and its requirement that defendant’s “duties with respect to product design apply only to foreseeable risks of harm.” Id. at *6. Based on the record provided by plaintiffs, the court was unable to draw an inference that the risks of GBCAs to patients with normal kidney function were foreseeable given the FDA’s findings. Id.
So, the court adopted the magistrate’s report and recommendation in full. We emphasize that because the magistrate’s report ended with an admonishment to plaintiff that she should only file an amendment complaint if she had additional factual support for at least one claim. We hope plaintiff takes that part to heart. We don’t think any more time or resources should be spent turning this into a trilogy.