Briggs v. Endologix, Inc.
| Decision Date | 30 March 2023 |
| Docket Number | Civil Action 3:22-cv-00290 |
| Parties | DWIGHT BRIGGS, et al., Plaintiffs. v. ENDOLOGIX, INC., et al., Defendants. |
| Court | U.S. District Court — Southern District of Texas |
MEMORANDUM AND RECOMMENDATION
Pending before me is a Motion to Dismiss filed by Defendants Endologix, Inc. (“Endologix”), Endologix LLC, and Deerfield Management Company, LP (“Deerfield”). Dkt. 30. Having reviewed the briefing, the record, and the applicable law, I recommend that the motion be granted in part and denied in part.
Plaintiff Dwight Briggs (“Briggs”) suffers from an aortic arterial aneurysm. “An aneurysm occurs when an artery wall weakens, which allows the artery to abnormally balloon or widen.” Dkt. 21 at 3. “An aortic arterial aneurysm (‘AAA') is a serious medical condition because a rupture of the aortic artery can cause fatal internal bleeding.” Id. To prevent a rupture patients like Briggs “may require surgery to repair treat, and/or reinforce the artery wall.” Id. at 3-4. “Implantable aneurysm repair grafts are a type of medical device that . . . function similar to a hose inserted into a damaged artery, which permits blood to flow through the ‘hose' thereby avoiding the damaged portion of the artery.” Id. at 4. “A surgeon implants an aneurysm repair graft device by inserting the device through an artery in the patient's leg and threading it up into the aorta/aneurysm.” Id. As with any surgery, there are risks attendant to an aneurysm repair. One of those attendant risks is an endoleak. An endoleak is “when blood continues to remain or flow into the aneurysm cavity after the endovascular repair.” Id.
There are four types of endoleaks, ranging from type I-IV. Type I endoleaks occur when there is a gap between the repair graft and the vessel wall that allows blood to flow into the aneurysm cavity. Type II endoleaks occur when blood from a collateral vein flow[s] into the aneurysm cavity. These are the most common type[s] of endoleak and are typically considered to be benign and are not a result of a defect in the graft. Type III endoleaks are attributed to device failures and occur when there is either a separation between the graft components (Type IIIa) or when there is a tear or hole in the graft material (Type IIIb). Type III endoleaks can result in aneurysm expansion and rupture. For this reason, Type III endoleaks require urgent or emergency medical attention. Type IV endoleaks occur when blood flows through the pores of the graft material and often resolve without intervention.
Id. at 4-5. The Second Amended Complaint contains this handy diagram, which visually depicts the difference between Type I-IV endoleaks:
(Image Omitted)
On December 20, 2016, Briggs had surgery to repair an AAA. His surgeon selected an implantable Ovation iX stent graft (“the device”) manufactured by Endologix for the repair. “The device was intended to treat AAAs by providing a new path for the blood to flow so it does not fill and expand the aneurysm.” Id. at 11. Briggs's surgery was unremarkable, but about a month after the surgery, one physician told Briggs that he “had a ‘small type II endoleak.'” Id. at 6. One month later though, a different physician told Briggs “that he had no endoleak at all.” Id. Briggs acknowledges that “conflicting diagnoses would [normally] cause a patient to be immediately concerned about the status of the device.” Id. Yet, Briggs asserts that he was “continuously and repeatedly told from 2016 to 2020 that there was ‘no problem' with [Briggs's] device and that any Type II endoleak, if it existed would correct on its own.” Id. On October 7 2020, however, a third physician diagnosed Briggs “with a Type III endoleak because of a ‘material weakness' in the graft material” of his Ovation iX stent graft. Id. Briggs has since undergone two stent repair procedures to repair the Type III endoleak and will need routine computed tomography (“CT”) angiograms every six months to monitor the leak.
Briggs and his wife, Konnie Briggs, instituted suit in Texas state court alleging claims of strict liability for manufacturing, design, and marketing defects (“failure to warn”); negligent design, manufacturing, production, preparation, installation, assembly, testing and/or inspection of the subject device; negligent failure to warn/breach of duty to warn plaintiff of defective condition of subject device; negligence; negligence per se; fraud; marketing defect; and loss of consortium. Plaintiffs allege that Briggs's two procedures, dozens of doctor visits, and the need for CT angiograms every six months are the “direct and proximate result of the failed and defective Endologix device.” Id. at 8. Defendants removed the case to federal court and moved to dismiss. While Defendants' first motion to dismiss was pending, Plaintiffs amended their complaint. The operative pleading is thus the Second Amended Complaint (Dkt. 21).
With regard to the Second Amended Complaint, Defendants contend that Plaintiffs' claims against all Defendants must be dismissed because: (1) they are barred by Texas's two-year statute of limitations for strict liability and negligence claims; (2) they were discharged during Endologix's Chapter 11 bankruptcy proceeding; (3) they are expressly and impliedly preempted under the Medical Device Amendments to the Federal Food Drug and Cosmetic Act; and (4) Plaintiffs have failed to allege sufficient facts to give rise to a plausible lawsuit. Once briefing was completed, I held a hearing on Defendants' motion. The parties were represented by competent and professional counsel who very helpfully narrowed the issues for me. During that hearing, Plaintiffs' counsel explicitly conceded that: (1) Plaintiffs do not have claims for fraud, negligence per se, or design defect; and (2) Plaintiffs do not have any claims against Deerfield.[1] Plaintiffs' counsel also acknowledged that the many negligence claims are duplicative. Accordingly, the only claims that Plaintiffs continues to assert after the hearing are strict liability and negligence claims for failure to warn and manufacturing defect, and loss of consortium. I will now address each of Defendants' arguments for dismissal in turn.
Rule 12(b)(6) allows dismissal if a plaintiff fails “to state a claim upon which relief can be granted.” FED. R. CIV. P. 12(b)(6). The United States Supreme Court has emphasized that the complaint must contain “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). Rule 8 “does not require ‘detailed factual allegations,' but it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 555). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. “The plausibility standard is not akin to a ‘probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (quoting Twombly, 550 U.S. at 556). Ultimately, a Rule 12(b)(6) motion to dismiss “is viewed with disfavor and is rarely granted.” Turner v. Pleasant, 663 F.3d 770, 775 (5th Cir. 2011) (quotation omitted).
Under Texas law, when a plaintiff alleges a defective product, “whether a plaintiff seeks recovery because of negligence or a theory of strict liability in tort, the burden is on the plaintiff to prove that the injury resulted from a defect in the product.” Ford Motor Co. v. Miles, 141 S.W.3d 309, 315 (Tex. App.-Dallas 2004, pet. denied). “A manufacturing defect exists when a product deviates, in its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous.” Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797, 800 (Tex. 2006) (quoting Ford Motor Co. v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004)).[2] “[A] touchstone of a manufacturing defect claim is proof that the allegedly defective product differs from other products in the same product line.” Casey v. Toyota Motor Eng'g & Mfg. N. Am., Inc., 770 F.3d 322, 329 (5th Cir. 2014). In other words, to adequately allege a manufacturing defect, Plaintiffs “must show that the [Ovation iX stent graft used in Briggs's surgery] differs from the [Oviation iX stent grafts] that [Endologix] produced in the same time period and [that were implanted] in other [patients].” Id. Plaintiffs here allege:
The Ovation iX device at issue and its various component parts were in a defective and unreasonably dangerous condition at the time they left the hands of Defendant Endologix in that it deviated from product specifications and/or applicable federal requirements for these medical devices because of the use of defective or inadequate materials of the graft component adjacent to the polymer fill channel, posing a serious risk of injury, such as a Type III endoleak, and death.
This conclusory assertion is insufficient to plausibly allege a manufacturing defect under Texas law. To start, Plaintiffs do not identify which “product specifications and/or applicable federal requirements” Briggs's device deviated from that rendered his device defective. Rather, Plaintiffs appear to hang their hat on a Class I recall of the Ovation iX stent graft. But the recall applied to the entire Ovation iX product line that was manufactured as designed. Plaintiffs never allege that the Ovation iX stent graft that Briggs received differed from its intended design or from other Ovation iX stent...
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