Today we report on a recent decision dismissing manufacturing-defect, warranty, and failure-to-warn claims arising from an allegedly defective breast implant. Although the decision, D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), does not stray far from the beaten path, it covers ground worth revisiting. The decision is a useful (if cursory) reminder

Today’s case, Knudsen v. Ethicon, Inc., 2021 WL 390825 (M.D. Fla. 2021), involves product-liability claims against a surgical-mesh manufacturer. In a short decision, the court dismissed manufacturing-defect and implied-warranty claims as inadequately pleaded under Michigan law. Although not fully developed, the court’s reasons for dismissing the claims exhibit both insight into manufacturing-defect claims and

This blogger’s work from home experience has included a lot of time with two teenagers.  Granted, two relatively smart, funny, and generally OK to be around teenagers.  But teenagers, nonetheless.  So, I’ve been witness to some true common senseless moments.  Like twenty minutes of trying to start the lawnmower before checking if it had gas. 

Early on in law school we were taught the virtues of alternate pleading. Different theories against the same defendant, or different theories against different defendants, were perfectly acceptable even if inconsistent.

There is something counterintuitive about that. It seems to lift the veil in front of the law, revealing it to be an opportunistic enterprise

So said the Connecticut state appellate court last week.  It’s a pretty simple equation.  Like No shoes, no shirt, no service.  No pain, no gainNo risk, no reward.  In other words, you can’t get one without the other.  In Ferrari v. Johnson & Johnson, Inc., — A.3d —, 2019 WL 2167849

This post is from the non-Reed Smith side of the blog.

Search for Medtronic on this blog and you’re going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They’ve certainly led the charge. So, if we say today’s

Two weeks ago we told you that an interesting decision was rendered in Sparks v. Oxy-Health, LLC, et al, Case No. 5:13-cv-649-FL, slip op. (E.D.N.C. Sept. 15, 2015), but we could not talk about it because the opinion had been sealed.  The parties have informed the court that no redactions were necessary and now the order has been unsealed and we are free to blog about it.

We want to start our post by acknowledging that the underlying circumstances of this case are tragic.  It is simply a sad story for the individuals involved.  For that reason, we are going to deal with the legal issues in a very straight forward manner.  From a legal perspective, plaintiffs did not have the evidence required to sustain a products liability or a consumer fraud case under North Carolina law.  It is the import of the judge’s reasoning and the precedential value of the case that we center on and bring to your attention.

The lawsuit was brought by parents on behalf of their deceased son.  Their son was 19 years old and autistic.  The medical device at issue is a portable mild hyperbaric chamber.  Hyperbaric chambers are designed to increase atmospheric pressure.  Sparks, slip op. at 6.  The one at issue in this case was §510k cleared by the FDA for the treatment of “acute mountain sickness” (condition that affects climbers who climb in excess of 8,000 feet).  Id. at 7-8.  In certain medical communities, a recognized off-label use for hyperbaric chambers is the treatment of autism.  Id. at 8.  A prescription is required for this treatment.  Id.  For several years, plaintiffs took their son to clinics where he would receive hyperbaric chamber treatments.  During clinic treatments, plaintiffs’ son was not left alone. Either a family member or a technician monitored and stayed with him throughout the treatment.  Id. at 9.   In 2011, plaintiffs decide to purchase a hyperbaric chamber from the clinic for in-home use.  Id.  The chamber had been in use in plaintiffs’ home for four months before their son’s death.  On the night of his death, decedent was placed in the chamber by his brother who left the room and went to bed.  Id. at 11-12.  Decedent’s father was not home that night and his mother fell asleep downstairs.  Id. at 12.  When she woke, she checked on her son and found the chamber had deflated and that her son had asphyxiated.  It was later discovered that the hose that pumps air into the chamber had become disconnected when a book shelf had depressed the disconnect button on the hose valve.  Id. at 12-13.


Continue Reading Summary Judgment Win Unsealed

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.


Continue Reading Halloween and Broken Devices Don’t Make a Defect

We haven’t written much about res ipsa loquitur on the blog, and today’s case doesn’t really qualify as a drug or device case per se, but it’s an interesting opinion and we thought it was worth sharing.  The case is Hubbard v. Mellion, No. 108461, 2013 Kan. App. LEXIS 45 (May 17, 2013), and it’s an appellate decision reversing summary judgment in favor of a physician in a medical negligence case, on the basis of the appellate court’s finding that the lower court should have applied the doctrine of res ipsa loquitur.  The case arose when plaintiff Hubbard underwent spinal surgery (involving various –otomies and –ectomies) to repair a herniated lumbar disc.  During the procedure, the surgeon used a device known as a pituitary rongeur, which is a forceps-type instrument that’s used to remove part of the disc. Unfortunately, during Ms. Hubbard’s surgery, the tip broke off of one arm of the rongeur, and became lodged in her disc space.  Hubbard, 2013 Kan. App. LEXIS at * 6.  The surgeon tried to retrieve the tip but was unable to. Id.  Ms. Hubbard claimed that she experienced continual pain as a result of having the fragment in her spine, and eventually underwent another surgery to remove it.  Id. She later filed a negligence action in which she named the surgeon and the hospital, as well as the manufacturer of the rongeur, alleging that the latter was negligent for supplying a device that was in a dangerous and defective condition.  However, as we’ve seen plaintiffs do in other medical device cases, plaintiff later decided to pursue the surgeon alone, and backed away from her defect theory.  Really far away.  Did a 180, in fact.  Not only did plaintiff dismiss the manufacturer, her expert metallurgist authored a report in which he “ruled out the possibility that the rongeur failed due to a manufacturer’s defect, ruled out the possibility that the rongeur failed because it had been improperly maintained, and ruled out the possibility that the rongeur had failed due to normal wear and tear.” Id. at *11.  The plaintiff’s expert’s sole causation opinion was that the rongeur tip had broken off due to user error – specifically, because the surgeon had applied too much force when using the instrument.  Id. at *12.

The surgeon moved for summary judgment on the basis that plaintiff’s experts – a metallurgist, a neurosurgeon, and a quality management team leader from the rongeur manufacturer (id. at *11-12) – were not qualified to opine on the standard of care for a surgeon performing this type of procedure.  Id. at * 14-15.  The trial court agreed, and held that although these experts established that operator error had caused the rongeur to break, plaintiff had not shown that this error was outside the established standard of care.  Id. at *15.  On appeal, plaintiff argued that she was not required to present expert testimony on the standard of care because there were two exceptions to the requirement that applied in this case:  the “common knowledge” exception and/or the doctrine of res ipsa loquiturId. at *20.


Continue Reading Res Ipsa Loquitur, or Maybe Not