Plaintiffs bring product liability suits against medical device manufacturers when outcomes fall short of expectations. Such as when a bone plate—a device surgically implanted to stabilize broken bones and enable proper healing—breaks. Now indulge us for a moment because Bexis and Yeary learned a lot about bone screws and orthopedic devices back in the day. And we know that bone plates are designed to stabilize fractured bones, not to permanently carry all the mechanical load that a bone normally bears. They are temporary supports meant to hold bone fragments in place long enough to allow natural healing to occur. If the bone never heals or is delayed in healing, the plate is stuck doing all the work indefinitely. That’s like asking a scaffold to permanently hold up a collapsed building, it’s going to fail eventually.  When a bone plate breaks in the absence of bone healing, the root cause is almost always biomechanical overload due to biological failure. These devices are robust, but not magic. They rely on the body’s cooperation, and that cooperation often fails when the patient doesn’t follow basic medical advice—especially the cardinal instruction to stop smoking.

Afterall, the success of any medical device implant hinges, not insignificantly, on the patient’s compliance with post-operative care. Among the most critical instructions given to patients with bone injuries is to abstain from smoking. This isn’t arbitrary advice; it’s grounded in decades of clinical evidence showing that nicotine constricts blood vessels, reduces oxygenation of tissue, and impairs bone healing. In short, continuing to smoke after surgery is like trying to extinguish a fire with gasoline—it fundamentally undermines the healing process the device is meant to support. If a plaintiff disregards this medical guidance, the argument that the bone plate “didn’t work” begins to look a lot like blaming the parachute for not opening—after jumping without pulling the cord.

So the plaintiff found out in Smith v. DePuy Synthes, Inc., 2025 WL 2145819 (E.D. La. Jul. 29, 2025). After falling and breaking her left leg, plaintiff’s surgeon implanted a bone plate and screws manufactured by defendant to realign plaintiff’s tibia.  Plaintiff admitted to smoking just under a pack of cigarettes a day, which her surgeon advised her to stop as smoking can impair healing and can increase the risk of a nonunion or delayed union of the bone by 30%.  Plaintiff never stopped smoking.  Id. at *1. 

Approximately six months after surgery, an x-ray revealed that the implanted plate had broken due to fatigue, but that the bone closest to plaintiff’s knee joint had healed. A second surgery was performed where the broken device was removed, and a nail and screws were used to repair unhealed bone in the lower part of the leg. That hardware was eventually removed as well, but by then x-rays showed a “well-healed fracture.”

Plaintiff brought all available claims under the Louisiana Products Liability Act (LPLA)–design defect, manufacturing defect, failure to warn, and breach of express warranty—as well as claims for breach of implied warranty and redhibition.  Defendant moved for summary judgment.  Because Louisiana has not included implied warranty claims in the LPLA, that claim is not cognizable under Louisiana law and was dismissed.  Id. at *8. A Louisiana redhibition claim allows plaintiff to recover the value of the product or other economic loss, but only if plaintiff proves the product is “useless for its intended purposes.” Id. As described above, and further below, the bone plates were far from useless because they allowed plaintiff’s bone to reman intact long enough for the uppermost part of her leg to heal.  Therefore, that claim was also dismissed.

Plaintiff’s LPLA claims did not fare any better. Plaintiff alleged that the bone plate’s design was defective because it had multiple screw holes along the shaft of the plate. The purpose was to allow the surgeon to customize the fit to the patient. Plaintiff argued the holes made the device weaker and that defendant should either have reduced the number of holes or provided the surgeon with fillers for the unused holes. What plaintiff did not do was present evidence of a reasonable alternative design. Plaintiff’s hired metallurgic expert offered no opinion as to a safer alternative design. Plaintiff’s surgeon offered testimony directly contradicting plaintiff’s suggested design. Namely, the screw holes are a necessary part of the design, there is no other bone plate product that offers “fillers,” there were no studies or scientific evidence showing fillers would actually work, and “it would be impossible to entirely eliminate the risk of stress [fractures].” Id. at *4. Under Louisiana law, failure to establish a reasonable alternative design is fatal to a design defect claim.

Plaintiff’s failure to warn claim failed both because defendant warned of the very risk that occurred and because any different warning would not have made a difference.  The possibility of device fracture is stated multiple times on the device’s package insert. Moreover, her surgeon described the risk as “common knowledge.” Id.at *5. Further, even if you drill down to a specific warning about weakness at the screw holes, plaintiff’s surgeon was also aware that is where plates break because it is the weaker part of the plate. Defendants need not warn the learned intermediary of risks he is already aware of.  Finally, plaintiff’s surgeon also testified that he could not recall ever reading the device’s package insert. Therefore, even a modified warning would not have made a difference because plaintiff’s surgeon would not have seen it.  Id.

Plaintiff’s manufacturing defect claim quickly went away because plaintiff’s expert did not review any manufacturing specifications for the bone plate, any testing of the plate, any engineering drawings, or any design documents.  Id. at *6. Therefore, plaintiff could offer no expert testimony of a manufacturing defect. Instead, plaintiff argued that there may have been a problem with the sterilization of the screws used in her surgery that led to her getting an infection. Putting aside the question of how that relates to the fracture of the bone plate and her injury, it also was not a defect because the screws were sold as “non-sterilized.” Any issue with sterilization was not the fault of defendant. Selling non-sterilized screws was not a defect, but rather an intentional product offering.

Finally, defendant was entitled to summary judgment on plaintiff’s express warranty claim because plaintiff failed to identify any express warranty made by defendant. “When the plaintiff cannot specify the express warranty made by the defendant, and make only general allegations that a product failed to conform to an express warranty, the defendant is entitled to summary judgment.” Id. at *7.

Plaintiff tried one last Hail Mary arguing that defendant should not be granted summary judgment because submitting an adverse event report about this incident to the FDA was an admission that the product may have caused or contributed to plaintiff’s injury. Plaintiff cited no authority to support this absurd contention, nor could the court find any. Which doesn’t surprise us. We direct you to the abundance of case law excluding adverse event reports and finding they are not evidence of causation.  

Product liability law was never designed to be a catch-all safety net for bad outcomes regardless of cause. It’s about fairly assigning responsibility, even when that responsibility lies with the one in the mirror. We expect people to wear seatbelts before suing over an airbag; we should expect them to lay down the cigarettes before suing over a fractured bone plate.