We’ve brought you some great news from the gadolinium contrast agent litigation last year and the hits just keeping on coming. This time out of federal court in Arizona. And while the court is giving plaintiff another stab at re-pleading her case, we are doubtful plaintiff will be able to cure the deficiencies identified in this decision.
The case is Drescher v. Bracco Diagnostics Inc., 2020 WL 699878 (D. Ariz. Jan. 31, 2020). 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.
The court first addressed defendants’ argument that plaintiff’s failure to warn claims were preempted because defendant could not have unilaterally change the drug’s labeling under the “changes being effected” (CBE) regulations. Under Arizona law, prescription drug manufacturers have a duty to warn of “foreseeable risks of harm from using their products.” Id. at *3. However, to warn users of gadolinium of risks of retention in situations of normal kidney function would have required manufacturers to change their labels. Only if they could do that without FDA approval will plaintiff’s claims survive preemption. The CBE regulations permit a label change without prior FDA approval where the manufacturer has “newly acquired information,” that supports an additional or strengthened warning where there is “evidence of a causal association between the drug and a risk of harm.” Id. (citations omitted).
The court then looked to see whether plaintiff’s complaint contained sufficient allegations to demonstrate that defendants could have used the CBE process. It did not. The complaint contained allegations about studies involving gadolinium and compromised renal function (not plaintiff’s condition), studies performed before the FDA approval of the drug’s original label (not newly acquired information), studies conducted after plaintiff’s last exposure to the drug (not relevant), non-human studies and patient reports (non-causal data). Id. at *4. As the plaintiff had no evidence signaling a causal link between gadolinium and harm to patients with normal kidney function, the court was not willing to “accept as true Plaintiff’s conclusory allegations of causation that are contradicted by the supporting facts and studies included in the Amended Complaint and its attachments.” Id. at *5.
Further evidence of a lack of a causal connection is found in the 2018 FDA approved label change. Plaintiff attached the 2018 label to her amended complaint which includes the following: “Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.” Id. (emphasis added). Leading the court to find that “[t]he FDA’s conclusion that no known causal association existed in 2017 precludes finding that Defendants could have made a CBE label change years earlier.” Id. at *6.
It’s also worth pointing out that this failure to adequately plead causation would also have been fatal to plaintiff’s failure to warn claims outside the preemption arena. Causation is an essential element of a failure to warn claim without which plaintiff would not have made it passed TwIqbal. See id. at n.4.
Moving onto to design defect – defendants again argued preemption based on an inability to alter the FDA-approved design of their drug. The court began its analysis by determining that Arizona would adopt and apply Restatement (Third) of Torts §6(c), which provides:
A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Id. at *8. Therefore, to comply with Arizona law, defendants would be required to redesign their drug which would constitute a major change which is not allowed. Id. (“[o]nce a drug . . . is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.”).
Plaintiff tried to argue a safer alternative design but what she was actually asking for was a different product. Plaintiff argued that macrocyclic GBCAs carried less of a risk than linear GBCAs which is what defendants’ products were. Id. But again, changing a linear GBCA to a macrocyclic GCBA would be a major change that is not allowed without FDA approval.
With all plaintiff’s failure to warn and design defect claims dismissed as preempted, the court could have stopped there. But, since plaintiff was getting a chance to re-plead, the court also opined on the insufficiency of plaintiff’s foreseeability allegations. Under Arizona law, manufacturers are required to warn of foreseeable risks and design their products to avoid foreseeable risks. Id. at *9. Plaintiff cited a dozen places in her complaint where she used the word “foreseeable” but that’s not the same thing as actually pleading facts that support foreseeability. The court found all of the allegations conclusory or contradicted by the evidence. Id. As noted above, the studies cited by plaintiffs weren’t really germane to the issues alleged in the complaint. Because plaintiff failed to cite a single study “confirming injury to a single patient with normal kidney function due to GBCA exposure,” plaintiff failed to “demonstrate that Defendants should have known their products posed an unreasonable danger or a foreseeable risk of harm.” Id. at *10. That combined with the FDA’s 2017 conclusion that GBCAs are not unreasonably dangerous, led the court to discount plaintiff’s unsupported allegations to the contrary. Id.
Finally, the court tossed out plaintiff’s punitive damages claim as barred by Arizona’s statute that provides that a prescription drug manufacturer is not liable for punitive damages if the drug was manufactured and labeled in accordance with its FDA approval. Id. Because plaintiff did not plead that defendants were not in compliance with their FDA approvals, plaintiff could not bring a punitive damages claim.
The court ended its decision with some guidance to plaintiff should she decide to amend her complaint again. But, even the court thought her chances were “slim” and admonished plaintiff to re-plead only if she had additional factual support for at least one claim. Id. at *11. Since we believe a lack of evidence of causation will sink any claim attempted, we think this one is likely over despite the door being left slightly ajar.