Today’s guest post comes from Reed Smith partner, Matt Jacobson. He discusses a new medical device case that puts the “Tw” in TwIqball – as in twisting a screw. The result is a total defense win, albeit with the “twist” that the plaintiff can try again, if he can. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.
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Have you ever heard that old idiom “having a screw loose” and wondered where it came from? My guess is most of you have heard the saying, but never thought twice about its origin (well maybe Bexis has). But since I have your attention, here is a small history lesson. During the industrial revolution, if a screw from a machine came loose it meant that the machine was not behaving normally. Since these machines were built for mass production, having a screw come loose would cause the entire machine to shut down, halting the process. At least one person claims that Eli Whitney, famed for inventing the cotton gin, was the person to say this phrase first. But I cannot verify that fact no matter how many internet searches I ran, so that will remain a mystery.
Now you may be thinking “What does this slang phrase have to do with the law?”. Well, try everything in Ruiz v. Medtronic, Inc., No. 2:24-cv-00489-TLN-SCR, 2025 U.S. Dist. LEXIS 12359 (E.D. Cal, January 23 2025). In this case, the plaintiff had a screw loose. Literally, not figuratively. Someone else might also have a screw loose (figuratively, not literally), but you can decide that for yourself.
The plaintiff underwent a hysterectomy, and during the surgery a certain tool was used. After surgery plaintiff experienced pain, and an x-ray revealed that a screw from the tool had come loose and was inside plaintiff’s pelvic cavity. Plaintiff had a second surgery to remove the screw. Right before the statute of limitations was set to expire, plaintiff sued the manufacturer of the tool in California state court. The case was removed on diversity grounds to the Eastern District of California. Plaintiff alleged three causes of action, which are all too familiar—strict liability, negligence, and breach of warranty. The manufacturer moved to dismiss for failure to state a claim, and plaintiff’s case got Twiqballed.
The Blog has written a lot on Twiqbal, for example here, here, here, and here, and is still very encouraged when courts get it right.
In the motion to dismiss, the manufacturer claimed that the only factual allegations in the complaint “are the date of the alleged injury, the place of injury, and the elements of each claim under California law.” Id. at *5. Plaintiff opposed the motion “contending the level of specificity Defendants suggest is ‘unrealistic’ and not required at this stage.” Id. The court agreed with the defense.
The court went though each of plaintiff’s three claims systematically. Starting with the strict liability claim, the court said “[a] manufacturer is strictly liable for injuries caused by three different types of defects: (1) a manufacturing defect, (2) a design defect, or (3) a warning defect.” Id. at *6 (citing Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549 (Cal. 1991)). First, as to the manufacturing defect claim, the court found that plaintiff sufficiently alleged that the tool was used during the procedure, and that causation was pled, but plaintiff failed to sufficiently plead that the tool differed from the manufacturers’ intended result or from other similar units of the same product line. Id. at *8. The court found that “Plaintiff acknowledges she must explain how the . . . tool deviated from the manufacturer’s intended design but does not cite to any allegations in the complaint that describe the manufacturing defect. [citation omitted] Instead, Plaintiff merely reiterates her allegation that the product was defective when it left the control of each Defendant. [citation omitted] This bare conclusion is not enough to sufficiently allege a strict liability claim premised on a manufacturing defect.” Id. at *8-9. This is important because, as later discussed, a second, strict liability design defect is not an allowable claim for prescription medical products in California. Many plaintiffs often try to plead design defects as “manufacturing” claims in California, and the court showed how defendants can win that issue when plaintiffs do.
Second, the design defect claim faired no better. Relying on Lucas v. City of Visalia, 726 F. Supp. 2d 1149 (E.D. Cal. 2010), the court found that plaintiff neither described how the product at issue failed to meet the ordinary consumer’s safety expectations nor explained how the particular product design caused plaintiff harm. Id. at *11. The court found that “[w]hile she does allege a pin or screw separated from the . . . tool, there are no allegations regarding how this failed to meet the minimum expectations of the ordinary consumer.” Id. It is interesting that the court did not throw out the strict liability design defect claim as impermissible (as discussed here), since as just alluded to, it is not a claim recognized in California. See Brown v. Superior Court, 751 P.2d 470, 478 (Cal. 1988).
Finally, the court tackled a failure to warn defect theory and found that plaintiff’s allegations were entirely conclusory. Ruiz, 2025 U.S. Dist. LEXIS 12359 at *13. Allegations that the manufacturer should have warned that the tool was “’defective and dangerous” and that the manufacturer should have known the device was dangerous at the time of manufacture were bare legal conclusions unsupported by any factual allegations. Id. The court did give plaintiff a chance to amend her strict liability claim based on the three types of defects (not sure why on the design defect), but that is standard operating procedure.
As to plaintiff’s next claim for negligence, the court found that “[t]he theories of negligence and strict liability parallel and supplement each other.” Thus, plaintiff’s negligence claim suffered the same fate as her strict liability claim: “Plaintiff’s First Amended Complaint fails to set forth factual allegations describing the manufacturing defect, how the defect differed from its intended design, and about what Defendants failed to warn Plaintiff’s surgeons. Without such factual allegations, Plaintiff does not sufficiently allege a negligent products liability claim.” Id. at *14-15. The court also gave plaintiff a chance to amend her negligence claim.
As to plaintiff’s third and final claim for breach of warranty, spoiler alert, that also failed. The court noted that California recognizes both express and implied warranty claims. As to the express warranty theory, plaintiff alleged in the complaint that “Defendants . . . expressly . . . warranted that the subject product and all of its related parts and components would be of merchantable quality and reasonably fit for their intended purpose.” Id. at *16. The court found that based on this allegation it was unclear what statements were “the basis of the bargain,” what warranty was breached, and whether plaintiff was attempting to allege privity or reliance on the warranty. Id. at *17. The court gave plaintiff another chance to replead sufficient facts.
As to implied warranty, the court relied on Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039 (Cal. App. 2008) and reasoned that “because the [plaintiff] relied on her physician’s skill and judgment to select a suitable medical device and was not privy to the original transaction with the manufacturer, the [plaintiff] could not establish privity.” Id. at *18-19. Because there was no way privity could be established given California law on the point, this claim was dismissed with out leave to amend.
The court enforced the exact policy Twombly and Iqbal were supposed to encourage—well plead complaints or dismissal. The court was a well-oiled machine—no screws loose there.