Law

            That brings us to today's case – Yosowitz v. Coviden, Civil Action No. H-15-2902 (S.D. Tex. Apr. 25, 2016).  Plaintiff underwent a surgical procedure to repair intracranial aneurysms during which defendant's embolization device was implanted.  Plaintiff alleges that a defect in the device caused her to suffer a blocked blood vessel which led to mini-strokes and resultant injuries.  Yosowitz, slip op. at 1-2. The device was a Class III, Pre-Market Approved device.  So, the court's first stop in its decision was a fairly thorough of PMA preemption law.  Id. at 7-13.  Following that discussion, you'll see this section heading:  Plaintiffs' Claims are All Preempted or Fail to Properly Allege a Claim which was followed by Plaintiffs Have Not Pleaded Any Parallel Claim. Id. at 13.  Pretty much guaranteed we were going to like the rest of the opinion.

             Applying all that preemption law to the claims in Yosowitz, the court started with the state law claims for negligence, strict liability, breach of express warranty and breach of implied warranty.  Since all four impose requirements on medical devices, they must not be different from or in addition to the requirements imposed by the FDCA.  Id. at 16-17.  To establish that, plaintiff's allegations must identify the "specific PMA requirements that have been violated."  Id. at 14.  "[S]cattered allegations of federal law violations" do not suffice.  Id. at 13. 

The court summed up plaintiff's negligence claims as failure to manufacture, market and label a product that was (1) safe and/or (2) consistent with the original design and/or (3) consistent with FDA regulations.  Id. at 18.  As to point 1, the device received FDA PMA approval – any state law that required defendant to manufacture or label its device in a way other than the way the FDA approved it, is preempted.  Id. at 18.  Plaintiff tried to argue that points 2 and 3 were parallel claims, but the court found the unsupported allegations failed to provide any information on how the device's design differed or was inconsistent with federal regulations.  Id. at 21.  All the negligence claims were dismissed.

Plaintiff's strict liability claim did not contain any allegations that defendant failed to comply with any federal regulations – therefore, any requirement plaintiff sought to impose on defendant would be different from or in addition to federal regulations.  Id. at 22.   All the strict liability claims were dismissed.

With breach of express warranty, there again is no allegation of a violation of any federal regulation.  So, any finding of breach of warranty would necessarily involve a decision by a jury that the device was "unsafe and ineffective."  Id. at 24.  "The FDA determined otherwise through the PMA process, so the state claim is based on different or additional requirements and is expressly preempted."  Id.  Moreover, plaintiff's complaint failed to allege the actual representations constituting the express warranty or when and how the plaintiff received notice of them.  Id. at 24-25.  Finally, if the alleged representations were made in the label, warnings or instructions for use – they were FDA approved.  Another basis for express preemption.  Id. at 25. 

Plaintiff's breach of implied warranty claim suffered from the same problems, because plaintiff only alleged that she "believes" there was a violation that was a cause of her injuries.  Id. at 26.  Belief may be strong enough for Santa Claus and the Tooth Fairy, but it's not enough to satisfy federal pleadings standards.  All the breach of warranty claims were dismissed.

With the traditional state law claims disposed of, plaintiff's remaining claim was for failure to comply with the FDCA and its implementing regulations.  Had plaintiffs never heard of Buckman?  Is this anything other than a private cause of action to enforce FDCA regulations?  This claim is impliedly preempted.  Id. at 27-28.  Even if it weren't preempted, it doesn't contain any allegations of how defendant failed to comply the regulations nor any allegations of a causal connection between failure and the plaintiff's injuries.  Id. at 28. 

And with that, the case was dismissed with prejudice.  An excellent result for which extend congratulations to our friends Lori Cohen and Victoria Lockard at Greenberg Trauig who passed this along to us.