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None of us are perfect.  Briefs get filed with typos.  Letters go out mis-dated.  It happens.  Emailing and texting are prone to informality, abbreviations, and let’s face it, bad grammar, that should be guarded against creeping into professional writing.  Above all else, there is the potential pitfall of the “cut and paste.”  Afterall, who wants to reinvent the wheel.  We are often faced with making the same arguments in multiple cases.  Why start from scratch when you have a brief or a memo on point in your saved documents.  So, cutting and pasting can be an effective tool – as long as you proofread, proofread, and proofread again.  Be like Santa, check your brief twice (at least).  Because if you don’t, there is a pretty good chance your recycling efforts could lead to citing inapplicable law, the wrong party’s name, or even the wrong facts.  When that happens, you have signaled to your opposing counsel and the court that you are sloppy and inattentive.  You lose credibility which can damage otherwise solid legal arguments.

We are not saying that plaintiffs’ arguments in Celino v. Biotronik, Inc., 2021 WL 1699847 (E.D. La. April 29, 2021) had merit.  They did not.  But on top of not being legally sound, they were extraordinarily sloppy.  In citing plaintiffs’ amended complaint and briefing, the court used [sic] nearly thirty times.  Plaintiffs’ counsel clearly did not proofread once, let alone twice.  In support of their manufacturing defect claim, counsel argued that one of the decedent’s Sprint Quattro defibrillator leads broke.  Unfortunately, the decedent never had that type of lead implanted and in fact, that brand of lead is not manufactured by the defendant.  Id. at *10.  Plaintiffs’ counsel made the same mistake on express warranty when they argued that the wrong party was present during the surgery.  Id. at *14.  The errors did not go unnoticed by the court.   This “undermine[s] the credibility of…counsel, who is obligated under Rule 11 not to file a pleading containing factual assertions that do not have evidentiary support or will not have such support after discovery.” Id. at *16n.51 (citation omitted).

Putting aside the blatant errors, the court largely was left to infer or imply the bases for plaintiffs’ claims, but “an implication [is] not an allegation.  And it is difficult to review a complaint that offers no clear theory of what happened.”  Id. at *3.  The court had already allowed plaintiffs to amend their complaint, but it continued to fall woefully short of TwIqbal pleading standards:

The Court has made every effort to glean the relevant allegations from the amended complaint—and to address [plaintiffs’] arguments made in opposition to the motion. But the Court’s efforts to do so have been hampered by the fact that both documents are internally inconsistent and lack any meaningful structure. Consequently, despite the fact that [plaintiffs] are represented by counsel, the Court has been forced to structure this opinion (and its analysis of the motion) by doing its best to understand the arguments [plaintiffs] were trying to raise, rather than responding to each individual point made in their opposition. The Court will not, however, construe [plaintiffs’] pleadings liberally, as it would for a pro se party. They have retained counsel. It is counsel’s responsibility to advocate for her clients.

Id. at *16n.5.  Sloppiness may not be what ultimately led to the dismissal of all claims, but it sure did not help matters.  We all make mistakes, but we hope none as pervasive as what the court saw here.  Consider this our PSA for proofreading and attentiveness.  Now on to the substance.

Plaintiffs’ decedent had a defibrillator manufactured by defendant implanted in 2008.  The battery depleted and the device had to be replaced in 2013 with a second defibrillator also made by defendant.  That defibrillator eventually experienced some problems which required that it be replaced in 2019 by a different brand of device.  Decedent passed away two months after that surgery.  Id. at *1-2.   As best the court could gather, plaintiffs were arguing that the issues with the first two devices necessitated the additional surgeries which led to decedent’s death.  Id. at *3.  The case was governed by the Louisiana Products Liability Act (“LPLA”) which allows products claims for manufacturing defect, design defect, failure to warn, and express warranty.  Each of those claims was dismissed as either preempted or insufficiently pleaded or both.

Before the court got to the claims it had to deal with plaintiffs’ allegation that it was “unclear” whether the device had undergone premarket approval.  Id. at *7.  Fortunately, the FDA records were clear.  The court took judicial notice of those publicly available records and decided as a matter of law that the devices has received premarket approval from the FDA.  Id.

On manufacturing defect, plaintiffs offered “a laundry list” of FDA regulations supposedly violated but failed to explain “what state-law claim is parallel to that violation, and how the violation caused the injury.”  Id. at *8.  Plaintiffs gave the court nothing by which it could determine if a parallel claim existed.  Further, decedent had three defibrillators implanted but plaintiffs failed to distinguish among the products in their allegations.  For example, plaintiffs alleged one of the leads failed, but not which one.  Id. at *9.  Finally, to sufficiently plead a manufacturing defect claim, plaintiffs were also required to identify how the device deviated from defendant’s specifications or performance standards.  They did not.

As to design defect, plaintiffs’ amended complaint “[a]t best [ ] merely recites some of the elements of a LPLA design defect claim—and fails to point to an alternative design.”  Id. at *12.  A conclusory allegation that an alternative design exists and would have prevented the alleged injury is not enough.  However, there is a Fifth Circuit case that found that in pharmaceutical design defect cases, “detailed factual allegations” are not needed to survive a motion to dismiss.  Id. at *11 (citing Flagg v. Stryker Corp., 647 F. App’x 314, 317 (5th Cir. 2016)).  So, as to design defect only plaintiffs were given leave to file a second amended complaint.

Louisiana recognizes the learned intermediary rule for failure to warn claims and therefore, plaintiffs’ complaint must allege that decedent’s doctors would not have used defendant’s devices had they been properly warned.  It did not.  Id. at *13.

Plaintiffs’ breach of express warranty claim is both preempted and insufficiently pled.  Plaintiffs point to statements made by the defendant regarding the product.  Id.  Missing from the complaint, however, is any allegation that the warranty goes beyond FDA-approved statements.  To prove a breach, plaintiffs must establish that the warranty was untrue.  But if the warranty was approved during the PMA process, any state law breach of warranty claim would conflict with that approval and is therefore preempted.  Id. at *14.   Additionally, an LPLA express warranty claim requires proof that the warranty induced decedent and/or her doctors to use the device.  Id.  Plaintiffs’ complaint contained no such allegation.

Plaintiffs’ claim for violation of the Louisiana Unfair Trade Practices and Consumer Protection Law was dismissed as subsumed by the LPLA, the exclusive remedy for products liability.  Id. at *15.  And finally, plaintiffs brought a claim alleging defendant breached a contract to provide monitoring services for recipients of its defibrillators.  Assuming the claim was not a products liability claim, it still failed because plaintiffs failed to allege anything other than that defendant offered “bad” service.  Plaintiffs failed to identify what obligations the service contract placed on defendant or how defendant failed to perform those obligations.  So, that claim was also dismissed.  Id. at *15-16.

Plaintiffs are getting one more try to sufficiently plead a non-preempted design defect claim.  The court sidestepped the fraud and Buckman issue this time because the claim failed under TwIqbal, but that will likely be center stage if plaintiffs re-file.  It looks like plaintiffs’ argument will be that PMA preemption should not apply because defendant was not truthful with the FDA during the PMA process.  Here is what we think of that argument:

[T]he sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval.  Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review.  The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466, 471-72 (D. Mass. 2012).