San Francisco has become a sea of orange and black.  As we post this missive, hundreds of thousands of Giants fans are flooding into the city for the third World Series parade in five years.  The 2010 parade was unlike anything we have ever seen in terms of size and ebullience.  Truth be told, we are Oakland Athletics fans, so while we are delighted at the triumph of the men in orange and black, our delight pales by comparison to the euphoria that would accompany another World Series title for the green and gold.  We attended the 2010 Giants parade therefore not because we are avid fans, but because the parade route runs one block north of our office and because we were firm in our belief that the Giants would never win another World Series for as long as we live.  Boy, were we wrong on that one!

Of course, it is also Halloween, the other reason why orange and black is San Francisco’s color scheme du jour.  We are unsure of the origins of Halloween and its signature colors, although we are very sure that the Giants’ victory had nothing to do with All Hallows’ Eve, Celtic harvest festivals, or superstition.  Indeed, we are confident that the confluence of orange and black celebration on this one day is a coincidence, albeit one accompanied by ghouls, goblins, costumes of all sorts, children begging for candy, and skeletons displayed in front of our homes.

Which brings us to the topic of bones, the subject of an interesting case from the Western District of Louisiana holding that a medical device is not defectively constructed just because it broke.  In Lirette v. DePuy Mitek, LLC, No. 2:13-cv-2892, 2014 U.S. Dist. LEXIS 149725 (W.D. La. Oct. 20, 2014), the plaintiff injured her knee while jumping rope and underwent ACL reconstruction with a prosthetic graft in her shin bone.  The graft product, however, allegedly “split open” in the plaintiff’s knee, resulting in multiple additional surgeries to relieve her pain and to remove “pieces of loose matter” that appeared to be pieces of the “split” device.  Id. at **2-3.

The plaintiff sued the product manufacturer under the Louisiana Products Liability Act (“LPLA”), a law that we like, mainly because of its strong exclusivity (and alternative design) provisions.  If you want to file a products liability claim in Louisiana, you get a claim for defect in design, defect in construction, inadequate warnings, or breach of express warranty – and that’s all.  Id. at *7.  The plaintiffs initially pleaded all four theories, but on the third round of pleading (much more common after TwIqbal), they were left with just one products liability claim for allegedly defective construction.  Id. at **8-9.

It would seem that an allegation that the device broke would be a good start for a claim of defective construction.  The problem for the plaintiffs was that they alleged nothing further, i.e., their allegation that the device broke was the beginning, middle, and end of their claim.  They alleged, for example, that the “unreasonably dangerous condition” of the device caused it to “tear apart and split” and that it was not intended to do so.  Id. at **10-11.  This “unusual occurrence,” according to an amended complaint, gave rise to an “inference of a manufacturing defect.”  Id. at **11-12.  It also allegedly gave rise to “inference of negligence” or the doctrine of res ipsa loquitur.  Id. at *11.

Not even close.

The district court did not bite on the plaintiff’s invitation to draw these “inferences” from the pleadings.  Under the LPLA, a product is unreasonably dangerous in construction if it deviated in a material way from the manufacturer’s specifications for the product or from otherwise identical products made by the same manufacturer.  Id. at *9.  Thus, a plaintiff has not stated a claim for a manufacturing defect “absent factual allegations addressing how the product deviated from the defendant’s normal production standards.”  Id.

The plaintiffs failed to meet that pleading burden.  They alleged, as already noted, that the device “split.”  However,

the plaintiffs do not show how this split and fragmentation was caused by a deviation from the manufacturer’s specifications or standards.  It is not sufficient to allege that because a product broke, it must have deviated from performance standards.  Products can break for any number of reasons, including user negligence; every broken product does not automatically give rise to a cause of action under the LPLA.

Id. at *13 (emphasis added).  Other courts have come to the same conclusion, including in the multiple opinions listed here.  It is the correct result, and the Western District of Louisiana’s statement of its rationale is a solid base hit.

By the way, how did the court know that “products can break for any number of reasons”?  In our minds, the statement is self-evident, but the district court may also have been informed by the 24 adverse event reports that the plaintiffs attached to their opposition.  That was not the most brilliant of moves on the plaintiffs’ part.  Rather than support an “inference” of a manufacturing defect, the reports only reinforced that there are any number of reasons for product failures—misuse, ordinary wear and tear, problems with user technique, etc.—none of which involves a product defect.  As the district court pointedly observed, “None of the FDA adverse event reports—including the report filed about the plaintiff[’]s sheath—found that a defect in construction caused the sheath’s failure.”  Id. at **13-14.

Finally, the district court rejected the plaintiffs’ allegations of res ipsa loquitur.  It seems that res ipsa loquitur can be used in the context of a claim under the LPLA, although we may have to explore exactly how that could be in another post.  Id. at *14.  The doctrine, however, does not apply at the pleadings stage, and the plaintiffs’ separate action for negligence against the surgeon prevented the plaintiffs from excluding an inference that someone else might be at fault.  Id. at *15.

After two chances to amend, the plaintiffs could allege no more than the device broke, which fell short of stating a products liability claim.  The district court therefore denied further leave to amend as futile.  As they say in baseball, strike three and you’re out.