Baker Sterchi Cowden & Rice recently obtained dismissals for its client Bracco Diagnostics Inc. (“BDI”) in litigation focused on alleged claims of “Gadolinium Deposition Disease,” arising from the administration of linear gadolinium based contrast agents (GBCAs). Generally, plaintiffs in these cases brought failure to warn and design defect claims against BDI and other defendants. See e.g. Drescher v. Bracco Diagnostics Inc. et al, Sabol v. Bayer Healthcare Pharm, Inc. et al; Thomas v. Bracco Diagnostics, Inc. et al.
The courts’ key finding was that in each case, certain critical claims were found to be preempted. Essentially, the plaintiffs could not plead or prove that BDI (or any GBCA manufacturer) possessed newly acquired evidence of a causal link between the drug and the risk of harm. In contrast to plaintiffs’ lack of evidence, BDI demonstrated that the FDA had not found a link between the retention of gadolinium in humans and adverse health effects in persons with normal renal function. Thus, BDI (and its co-defendants) could not have been required to change their respective labels years earlier to address a still unproven assertion that linear GBCAs cause harm to humans with normal renal function.
In order for the plaintiffs’ claims to avoid being preempted, plaintiffs would have to argue that BDI was required to unilaterally change or redesign its drug formulation and/or change the drug’s labeling under the “changes being effected” (CBE) regulations of their products, which is not allowed without FDA approval unless it can be proven that the manufacturer had newly acquired information that supported an additional or strengthened warning and where there is evidence of a causal association between the drug and a risk of harm. In the total absence of such evidence, plaintiffs’ claims were dismissed.
Baker Sterchi attorneys Tom Sterchi and Paul Penticuff serve as national counsel for BDI in these and other GDD cases filed nationwide.
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