We talk a lot about preemption here.  Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts.  That isn’t surprising.  Preemption can end a litigation, and we all want to hit the game-winning home run.

But plaintiffs know that too.  So, rather than taking preemption head on, we often find ourselves dealing instead with plaintiff’s attempts to get around it via “parallel violations” claims.  Now, we have problems with the very existence of such claims.  Among other things, they often appear to be improper attempts to bring private rights of action under the FDCA.  But, unfortunately, they exist, and courts recognize them.  Given that reality, however, we’d like courts to at least view them with a scrutinizing eye.  The court in Cline v. Advanced Neuromodulation Sys., Inc., 2014 U.S. Dist. LEXIS 56669 (N.D. Ga. Mar. 31, 2014), did just that.

In Cline, the plaintiff had an opportunity for limited discovery (which we’ll discuss later) into the PMA specifications that came with the approval of an implantable pulse generator (“IPG”) implanted into plaintiff. Plaintiff then filed her third amended complaint in an attempt to state parallel violation claims related to the failure of her IPG.  It didn’t go exceedingly well.  The court lowered the microscope to look at those claims for what they really were, and almost all them did not survive.


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As always, discussion of the pelvic mesh litigation comes from the non-Reed Smith side of the blog.

This summer we blogged about many pre-trial and in limine rulings in the Pelvic Mesh MDL. Most were quite favorable.  One of those decisions that we thought was pretty good was Cisson v. C.R. Bard, Inc., see post, which threw out a duty to test claim and applied a stringent state-of-the-art standard.  Back in July, we thought that ruling was helpful to the defendant and would serve it well at trial.  Well, we’re clearly not seers.  While we sometimes like to look into our crystal ball, our predictions are usually based on nothing more than wishful thinking (we like to think it’s more than that, but usually it’s not).  The Cisson case went to trial and the jury returned a verdict against the defendant awarding both compensatory and punitive damages.  Defendant moved for judgment as a matter of law during trial and the court deferred until post-verdict.  Unfortunately, the court upheld the verdict and in so doing made some not so great rulings.

A quick background of the case.  Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain.  Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed.  Plaintiff alleged that she continue to experience pain and evidence was presented that she suffered extrusion, erosion, excessive scarring, and inflammation. Cisson v. C.R. Bard, Inc., 2013 U.S. Dist. LEXIS 149976 at *3-4 (Oct. 18, 2013).  Plaintiff presented two claims to the jury – design defect and failure to warn.


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A couple of readers dropped us notes after reading yesterday’s post about the situation with informal treating physician interviews in New Jersey.

Brad Wolff at Swift Currie kindly updated us on Georgia, which isn’t as much of a lost cause as we thought.  While the recent Georgia Supreme Court opinion in Baker v. Wellstar Health

This, that, and the other thing.

Potpourri.

Odds and sods.

Whatever. This post is about stuff that we learned about recently that relate to our prior posts. Other than that, they have nothing in common with each other.

Together, they add up to enough material for a decent post.

Rebel Flag Still Flies In Georgia