Sundaramurthy v. Abbott Vascular, Inc.
| Decision Date | 18 March 2022 |
| Docket Number | CIVIL ACTION NO. 4:21-40055-TSH |
| Citation | 594 F.Supp.3d 117 |
| Parties | Malaiperuma SUNDARAMURTHY, Plaintiff, v. ABBOTT VASCULAR, INC., Defendant. |
| Court | U.S. District Court — District of Massachusetts |
David M. Hass, Law Offices of Burton J. Hass, Malden, MA, for Plaintiff.
Benjamin W. O'Grady, Rebecca L. Gobeil, Gordon Rees Scully Mansukhani, LLP, Boston, MA, Brian J. Mooney, Pro Hac Vice, Gordon & Rees LLP, San Francisco, CA, for Defendant.
ORDER AND MEMORANDUM ON ABBOTT'S MOTION TO DISMISS (Docket No. 10) and PLAINTIFF'S MOTION TO AMEND (Docket No. 26)
HILLMAN, D.J.
Plaintiff Malaiperuma Sundaramurthy commenced this action against defendant Abbott Vascular, Inc. ("Abbott") in Massachusetts state court, alleging products liability claims under Massachusetts law. Abbott removed the case to federal court. (Docket No. 1). Thereafter, Abbott moved to dismiss for failure to state a claim. (Docket No. 10). Although the Court agreed that the complaint, as pled, failed to state a claim, the Court allowed the plaintiff an opportunity to move to amend. (Docket No. 25). The plaintiff has now done so. (Docket No. 26). For the following reasons, the Court grants in part and denies in part the plaintiff's motion to amend. The Court also grants in part and denies in part Abbott's motion to dismiss.
The following facts are drawn from the proposed amended complaint attached to the plaintiff's motion to amend. (Docket No. 26-2). The plaintiff suffered a heart attack
in June 2018. At St. Vincent Hospital for treatment, doctors inserted a catheter into one of the plaintiff's arteries. At the tip of the catheter was a balloon. Once the balloon was inside the plaintiff's artery, doctors inflated the balloon to remove blockage. Doctors then inserted three stents -- mesh-like devices made of metal -- to keep the artery open. When the stents could not keep the artery open, doctors decided to insert a fourth stent. To do so, they used a stent system, branded as the Graftmaster stent system, manufactured by Abbott. The balloon part of the Graftmaster stent system failed to retract inside the plaintiff's artery, preventing the fourth stent from opening properly. As a result, the plaintiff suffered injury.
The plaintiff alleges that Abbott negligently and carelessly designed and manufactured the stent
system inserted into his artery, such that the stent system was defective and unsafe according to the Food and Drug Administration's Current Good Manufacturing Practices ("CGMP"). The plaintiff points to sections of the CGMP requiring manufacturers to develop, implement, and maintain quality control systems for the design and manufacture of devices. See 21 C.F.R. §§ 820.1, 820.5, 820.20, 820.25.
The plaintiff alleges that Abbott used a manufacturing process that exposed some of its balloons to excess heat during manufacturing. The excess heat weakened the material "proximal to the balloon bond." The weakened balloons, then, exhibited difficulty deflating or were unable to deflate. After Abbott received reports of injury due to defective balloons, Abbott recalled one type of its catheters, but not the Graftmaster stent
system. After Abbott received additional reports of injuries, Abbott recalled more of its catheters, but still not Graftmaster stent system. The plaintiff alleges that Abbott failed to warn him of these problems, including by failing to provide him with an instruction manual for the stent system.
The plaintiff asserts three claims against Abbott. Count I of the plaintiff's proposed amended complaint alleges that Abbott was negligent with respect to the design, manufacture, and warnings of its stent system. Count II alleges that Abbott breached the implied warranty of merchantability with respect to the warnings of its stent system. Count III alleges that Abbott breached an express warranty.
The plaintiff also names two new defendants in the proposed amendment complaint. He alleges that he contracted with Harold Moore, a cardiologist with a practice in Milford, Massachusetts, and VHS Acquisition Subsidiary Number 7, Inc., d/b/a St. Vincent Hospital ("St. Vincent"), the hospital where he had his surgery, for professional services related to medical care and treatment. He alleges that, although Moore and St. Vincent have custody and control of the coronary catheter and balloon used in his procedure, they have refused to allow him to examine the equipment or otherwise share information regarding the procedure. He further alleges that Moore and St. Vincent withheld information concerning Abbott's stent recalls. Finally, without specifically asserting a cause of action against either Moore or St. Vincent,1 the plaintiff alleges that they engaged in a conspiracy to keep quiet about the problems observed during the procedure, and that they breached the implied covenant of good faith and fair dealing.
In the Court's previous order on Abbott's motion to dismiss, the Court concluded that the claims pled in the plaintiff's original complaint were preempted by the Medical Device Amendments ("MDA"), 21 U.S.C. § 360 et seq. , to the Food Drug and Cosmetic Act ("FDCA"). (Docket No. 25). For certain medical devices, the MDA expressly preempts state law claims seeking to impose safety and effectiveness requirements "different from, or in addition to" federal requirements applicable to those devices. See 21 U.S.C. § 360k(a) ; Riegel v. Medtronic, Inc. , 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). State law claims that impose requirements "parallel" to federal requirements, however, are not preempted. See Riegel , 552 U.S. at 330, 128 S.Ct. 999. State law claims are "parallel" to federal requirements when they are premised on a violation of federal requirements. See id. Claims that are not merely "parallel" to federal requirements but seek to "enforce" federal requirements are impliedly preempted. See Plourde v. Sorin Group USA, Inc. , 23 F.4th 29, 33 (1st Cir. 2022).
To determine whether a state law claim is expressly preempted, courts ask (1) whether there are federal requirements applicable to the device in question, and (2) whether the state law claims are based on requirements that are different from, or in addition to, those federal requirements. See Riegel , 552 U.S. at 321-22, 128 S.Ct. 999. The device in question here -- the Graftmaster stent system -- is subject to federal requirements. It received premarket approval from the FDA in 2001 under a Humanitarian Device Exemption and, thus, must be designed, manufactured, and labelled according to the specifications approved by the FDA. See 21 C.F.R. § 814.108. The plaintiff's original complaint alleged, generally, that Abbott negligently designed and manufactured the Graftmaster stent system and failed to warn him of its problems. Claims premised on such general allegations are preempted. See, e.g., Funk v. Stryker Corp. , 631 F.3d 777, 782 (5th Cir. 2011). Because the plaintiff did not allege a violation of an FDA requirement, the plaintiff sought to impose requirements that were different from, or in addition to, federal requirements. See, e.g., Weber v. Allergan, Inc. , 940 F.3d 1106, 1111 (9th Cir. 2019).
The plaintiff's proposed amended complaint is more specific and alleges a violation of federal regulations applicable to the Graftmaster stent system. The plaintiff alleges that Abbott negligently designed and manufactured its devices in such a way that made them unsafe and defective according to the CGMP; specifically, the sections of the CGMP related to quality assurance. See 21 C.F.R. §§ 820.1, 820.5, 820.20, 820.25. The plaintiff alleges that Abbott's manufacturing process exposed some balloons to excess heat, and that balloons weakened from excess heat have difficulty deflating. The plaintiff alleges that the balloon used in his procedure failed to deflate inside his artery, causing him injury. The plaintiff further alleges that Abbott received reports of injuries due to defective balloons but did not recall the Graftmaster stent
system
While not all courts agree that a plaintiff can state a parallel claim by alleging a violation of a general FDA regulation, such as the CGMP, as opposed to a device-specific requirement, see Weber , 940 F.3d at 1114 (citing cases), the Fifth, Sixth, Seventh, and Eleventh Circuits have held that an alleged violation of the CGMP can be sufficient at the pleading stage, see Mink v. Smith & Nephew, Inc. , 860 F.3d 1319, 1331 n.3 (11th Cir. 2017) ; Bass v. Stryker Corp. , 669 F.3d 501, 511-12 (5th Cir. 2012) ; Bausch v. Stryker Corp. , 630 F.3d 546, 555 (7th Cir. 2010) ; Howard v. Sulzer Orthopedics, Inc. , 382 Fed. Appx. 436, 440 (6th Cir. 2010). Considering that the First Circuit has not addressed the issue, the Court agrees with the approach in those other circuits. See Carrelo v. Advanced Neuromodulation Systems, Inc. , 777 F. Supp. 2d 303, 313 n.4 (D. P.R. 2011). "[I]f a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with ... the CGMPs themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim." Bass , 669 F.3d at 512.
With respect to a manufacturing defect, the plaintiff has adequately pled a plausible parallel claim. See Bausch , 630 F.3d at 558 (). Reading the plaintiff's complaint "as a whole," Garcia-Catalan v. United States , 734 F.3d 100, 103 (1st Cir. 2013), the plaintiff has plausibly alleged that Abbott exposed some balloons to excess heat, that Abbott's manufacturing process failed to address this error despite repeated reports of injury, that Abbott's failure violated the CGMP as it relates to quality assurance, and that Abbott's violation ultimately caused him injury. Thus, the Court will allow the plaintiff to amend his complaint to proceed on his manufacturing defect theory. The...
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