Holism is a concept modernly used most commonly in medicine –treating both the body and the mind.  We don’t see it too often in legal parlance as it’s come to be associated with a somewhat touchy-feely approach.  Not something litigators are often accused of being.  At its core, holism is a philosophy based on treating something as more than the sum of its parts.  So when we read in Schmidt v. C.R. Bard, 2014 U.S. Dist. LEXIS 146459 (S.D. Ga. Oct. 14, 2014) that on a motion to dismiss, the judge was “[r]eading Plaintiff’s Complaint holistically,” we were fairly sure we weren’t going to be happy with the results.  And we were right.

A holistic approach to pleadings is precisely what TwIqbal aims to prevent.  Either the complaint contains sufficient and specific factual allegations that go beyond speculation and legal conclusions or it doesn’t.  Using the TwIqbal standard, a complaint is only as good as its parts; its allegations. You can’t fix bad pleadings by reading into them more than what is there.  But we think that is exactly what the court did in this case.

The suit involves the implantation of a mesh device to repair a hernia.  Plaintiff ultimately had to have the device removed and alleges permanent injury as a result.  Id. at *1-2.  Assessing whether plaintiff sufficiently pleaded a design defect claim, the court starts off with a general statement we support:  “a bald assertion that the [device] was defective in design . . ., was unreasonably dangerous, and the foreseeable risks outweighed the [] benefits would be insufficient to survive a motion to dismiss.”  Id. at *8.  But then the court goes on to conclude, and repeatedly state, that plaintiff listed 9 possible design defects and therefore survives a motion to dismiss.  The court never identified what those 9 “defects” were, so we looked at the complaint ourselves.


Continue Reading Georgia Court Takes a Holistic Approach to Pleading

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.


Continue Reading A District Court Takes an Exacting Look at Parallel Violation Claims

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.


Continue Reading A Not So Peachy Decision Under Georgia Law

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