In light of the recent Supreme Court ruling in Riegel v. Medtronic, the viability of the claims against the manufacturers (Boston Scientific and Cordis and J&J) of drug eluting stents (DES) has been unknown. The DES litigation in Palm Beach County, in the case of O'Shea v. Cordis, was one of the first cases to raise these issues post-Riegel. Judge Kelley carefully considered these complex issues and even recognized that : " The difficulty is determining what is and what is not a parallel claim." The Order was split and found that certain claims are preempted and also found that several claims were not preempted.
The following claims are preempted:
1. All common law negligence and strict liability claims to the extent the claims are based upon approved FDA design and labelling;
2. Unfair Trade Practices
3. Fraud on FDA or Fraud based upon approved labelling or brochures.
The following claims are not preempted:
1. Negligence claims based upon "Good Manufacturing Standards";
2. Express Warranty claims
3. Fraud on the physician/ patient
The Order leaves open confusion with regard to "parallel claims". Primarily, the Order does not address whether claims based on federal regulations, other than Good Manufacturing Practices, are preempted. Reigel suggests that claims based upon a breach of federal law (duty) are not preempted. The language in the opinion suggests that claims based on federal regs, in adddition to GMP, but the Court did not specifically address the impact of federal regulations outside of GMP. The Plaintiffs steering committee, which I am a member of, is in the process of deciding the next step in this important battle.
The following claims are preempted:
1. All common law negligence and strict liability claims to the extent the claims are based upon approved FDA design and labelling;
2. Unfair Trade Practices
3. Fraud on FDA or Fraud based upon approved labelling or brochures.
The following claims are not preempted:
1. Negligence claims based upon "Good Manufacturing Standards";
2. Express Warranty claims
3. Fraud on the physician/ patient
The Order leaves open confusion with regard to "parallel claims". Primarily, the Order does not address whether claims based on federal regulations, other than Good Manufacturing Practices, are preempted. Reigel suggests that claims based upon a breach of federal law (duty) are not preempted. The language in the opinion suggests that claims based on federal regs, in adddition to GMP, but the Court did not specifically address the impact of federal regulations outside of GMP. The Plaintiffs steering committee, which I am a member of, is in the process of deciding the next step in this important battle.
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