MARTIN L.C. FELDMAN, District Judge.
Before the Court is Covidien's Rule 12(b)(6) motion to dismiss Yvette Oliver's complaint. For the reasons that follow, the motion is GRANTED in part and DENIED in part.
This products-liability action arises from Covidien's marketing of a vessel-sealing device called LigaSure.
In summer 2018, Yvette Oliver saw her doctor, complaining of stomach pain. She later underwent a hysterectomy. During that procedure, her doctor used a Covidien LigaSure to seal a blood vessel. Although Oliver had high blood pressure, her doctor did not fortify the vessel seal with a suture. The seal did not hold, and Oliver began bleeding internally. This lawsuit followed.
Oliver sued Covidien for negligence and violations of the Louisiana Products Liability Act (LPLA), LA. REV. STAT. §§ 9:2800.52-9:2800.60. She says that Covidien overstated the LigaSure's vessel-sealing capabilities. In her view, Covidien should have warned surgeons against using the LigaSure on patients with high blood pressure without first placing a suture tie on "prominent" vessels.
Now, Covidien moves to dismiss Oliver's complaint for failure to state a claim.
A complaint must contain a short and plain statement of the claim showing that the pleader is entitled to relief. FED. R. CIV. P. 8(a)(2). A party may move to dismiss a complaint that fails this requirement.
In considering a Rule 12(b)(6) motion, the Court "accept[s] all well-pleaded facts as true and view[s] all facts in the light most favorable to the plaintiff."
To overcome a Rule 12(b)(6) motion, "`a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.'"
"A complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations[.]"
Jurisdiction is based on diversity, so the Court applies the substantive law of the forum, Louisiana.
Covidien contends that Oliver fails to state any claims against it. According to Covidien, Oliver's negligence claim is not cognizable, and her LPLA claims are inadequately pleaded. Oliver rejoins that she has alleged facts creating an inference that the elements of each claim are met.
The LPLA creates a cause of action against a product manufacturer "for damage proximately caused by a characteristic of the product that renders the product unreasonably dangerous when such damage arose from a reasonably anticipated use of the product." LA. REV. STAT. § 9:2800.54(A). This liability is exclusive: A claimant cannot otherwise sue a manufacturer for damage caused by its product.
An LPLA claimant must prove four elements: "(1) that the defendant is a manufacturer of the product; (2) that the claimant's damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product `unreasonably dangerous'; and (4) that the claimant's damage arose from a reasonably anticipated use of the product by the claimant or someone else."
A product can be "unreasonably dangerous" in four ways: (1) defective construction or composition, LA. REV. STAT. § 9:2800.55; (2) defective design, LA. REV. STAT. § 9:2800.56; (3) inadequate warning, LA. REV. STAT. § 9:2800.57; and (4) nonconformity with an express warranty, LA. REV. STAT. § 9:2800.58. Oliver says the LigaSure was "unreasonably dangerous" in each way, and the Court turns now to her allegations.
In count one of her complaint, Oliver tries to state a negligence claim.
The Court agrees.
In count two of her complaint, Oliver tries to state an inadequate-warning claim. She says Covidien's warning was inadequate because it did not direct doctors to use suture ties on patients with high blood pressure. Covidien contends that these allegations, accepted as true and viewed in Oliver's favor, do not establish causation under the learned intermediary doctrine.
The learned intermediary doctrine applies to inadequate-warning claims.
Oliver has not alleged causation. Read together and in her favor, Oliver's allegations do not create a reasonable inference that, but for Covidien's inadequate warning, her treating physician would either (a) not have used the LigaSure or (b) used it differently.
In count three of her complaint, Oliver tries to state a design-defect claim. She says the design of the LigaSure was defective because "it did not include exceptions for more prominent blood vessels with enlarged uteri such that suture ties should . . . be used." Covidien contends that Oliver fails to state a claim because she fails to allege the existence of a safer alternative design.
LPLA design-defect claims are governed by LA. REV. STAT. § 9:2800.56. To state a claim under that provision, Oliver must allege facts showing that the LigaSure was "unreasonably dangerous" because, at the time it left Covidien's control, (1) there was an alternative design for the product that was capable of preventing her damage; and (2) the likelihood that the product's design would cause her damage and the gravity of that damage outweighed the burden on Covidien of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product. La. REV. STAT. § 9:2800.56.
She has not so alleged. Oliver's complaint lacks factual allegations creating a reasonable inference that a safer alternative design existed. Because Oliver fails to allege facts establishing a safer alternative design, she fails to state a design-defect claim.
In count four of her complaint, Oliver tries to state a warranty-defect claim. She says that Covidien's "statements" about the LigaSure "falsely convey[ed]" that the device was safe to use without placing suture ties on "complex" blood vessels. Her doctors chose the LigaSure, she says, because of unidentified "warranties and representations" about the "safety" of the device. Covidien contends that Oliver's allegations of causation are inadequate.
Oliver's warranty-defect claim is governed by LA. REV. STAT. § 9:2800.58. To state a claim under that provision, Oliver must allege that: (1) Covidien made an express warranty about its LigaSure product; (2) the product did not conform to the express warranty; (3) the express warranty induced Oliver or her doctor to use the product; and (4) Oliver's damage was proximately caused because the express warranty was untrue.
An "express warranty" is "a representation, statement of alleged fact or promise about a product or its nature, material or workmanship that represents, affirms or promises that the product or its nature, material or workmanship possesses specified characteristic or qualities or will meet a specified level of performance." LA. REV. STAT. § 9:2800.53(6).
Oliver fails to state a claim for two reasons. First, she fails even to identify an express warranty. She instead invokes vague "guarantees" that the LigaSure was "safe, free of defects[,] and reasonably fit for its intended purpose." These are not express warranties.
In count five of her complaint, Oliver tries to state a construction-defect claim. She says the LigaSure was unreasonably dangerous in construction or composition because it "deviated in a material way" from "performance standards." She does not identify the "standards" or the defect. True, she says that "surgeons were instructed not to isolate blood vessels prior to attempting to seal the vessel." But this is a complaint about the LigaSure's warning—not its construction.
To state a construction-defect claim, Oliver must allege facts establishing that, at the time the LigaSure left Covidien's control, it "deviated in a material way" from Covidien's "specifications or performance standards" for (a) the LigaSure or (b) "otherwise identical" Covidien-manufactured products. LA. REV. STAT. § 9:2800.55. She fails to do so.
First, Oliver fails to identify the relevant "specifications or performance standards." LA. REV. STAT. § 9:2800.55. Second, she fails to allege any facts which, accepted as true and viewed in her favor, show that the LigaSure suffered a construction defect. Accordingly, she fails to state a construction-defect claim.
Because the Court concludes that all of Oliver's claims fall short of the Rule 8(a)(2) pleading standard, only one question remains—whether dismissal should be with or without leave to amend.
Oliver requests leave to amend her complaint, and Covidien counters that amendment would be futile.
The Court should grant leave to amend freely when justice so requires. FED. R. CIV. P. 15(a). Rule 15(a) "evinces a bias in favor of granting leave to amend."
The Court has a "substantial reason" to deny Oliver leave to amend her negligence claim—futility.
As to the other claims, however, the Court lacks a "substantial reason" to deny Oliver leave to amend.
Accordingly, IT IS ORDERED: that the Rule 12(b)(6) motion to dismiss is GRANTED in part and DENIED in part as follows: Oliver's negligence claim (count I) is DISMISSED with prejudice; Oliver's inadequate-warning (count II), design-defect (count III), warranty-defect (count IV), and construction-defect (count V) claims are DISMISSED without prejudice. Oliver is granted 21 days to amend her complaint to try to state plausible claims. If she fails to timely amend, the Court will dismiss her complaint with prejudice and without further notice.