Opinion
CIVIL 3:21-CV-1765
09-23-2024
RICHARD M. FORD, et al., Plaintiffs, v. ST. JUDE MEDICAL, LLC, et al., Defendants.
REPORT AND RECOMMENDATION
Martin C. Carlson United States Magistrate Judge
I. Introduction
This case comes before us on a motion to dismiss the plaintiffs' amended complaint filed by the defendants, St. Jude Medical, LLC and St. Jude Medical S.C., Inc. (collectively “St. Jude”). (Doc. 27). The plaintiffs, Richard Ford and his wife, Sandy Ford, brought this action in state court asserting tort claims stemming from injuries Mr. Ford received from a fall after his pacemaker failed in April of 2018. (Docs. 1, 22). The amended complaint asserts claims of negligence, strict liability, and breach of express and implied warranties against St. Jude, as well as a claim for loss for consortium brought by Sandy Ford. (Doc. 22).
The defendants have now moved to dismiss the amended complaint, arguing that Mr. Ford's tort claims are expressly preempted by federal law. (Doc. 27). They further assert that the plaintiff's tort claims fail as pleaded under state law. Finally, they contend that because Mr. Ford's claims fail, Mrs. Ford's claim for loss of consortium should be dismissed. The motion is fully briefed and is ripe for resolution. (Docs. 28, 31, 32). For the following reasons, we will recommend that the motion to dismiss be granted in part and denied in part.
II. Statement of Facts and of the Case
Richard Ford received a cardiac pacemaker manufactured and sold by St. Jude in January of 2007. (Doc. 22, ¶ 14). In February of 2015, after it was discovered that Mr. Ford's pacemaker required a new right ventricular lead and a battery change, Mr. Ford was implanted with a St. Jude Assurity Pacemaker and Tendril ST lead, the devices at issue in this case, at Wilkes-Barre General Hospital in Luzerne County, Pennsylvania. (Id., ¶¶ 15-16). The amended complaint asserts that a St. Jude representative affirmatively stated to Mr. Ford that the devices had a life span of twelve years. (Id., ¶ 82). In August of 2017, a representative from St. Jude interrogated his pacemaker and discovered that the voltage required to pace his heart had increased, and the representative set the threshold to 2.50, which was two times the voltage requirement, and the lead impedance measured at 440 ohms. (Id., ¶ 18).
On April 22, 2018, Mr. Ford experienced a syncopal episode which caused him to fall from his bed and strike his head on a dresser. (Id., ¶ 19). He was taken by ambulance to Wilkes-Barre General Hospital, where it was noted that he was bleeding and had trauma to his nose. (Id., ¶ 20). An EKG was done, which showed pacemaker failure. (Id., ¶ 21). His pacemaker was tested in the emergency room, and the results showed that the lead impedance had increased from the previous 400 ohms to 1200 ohms, meaning the Tendril ST lead had failed. (Id., ¶ 22). A St. Jude representative set the threshold to 5 pending surgery to replace the Tendril ST lead. (Id., ¶ 23). The following day, Mr. Ford underwent a right ventricular pacemaker lead change due to suspected corrosion and/or malfunction of the Tendril ST lead. (Id., ¶ 29). The amended complaint alleges that a St. Jude representative told Mr. Ford that he was aware of two other incidents that year in which the leads corroded and failed. (Id., ¶ 30). Following a successful surgery, Mr. Ford was discharged to a rehabilitation hospital. (Id., ¶¶ 31, 33). His discharge summary included diagnoses of traumatic brain injury status post fall, C2 fracture, and acute displaced comminuted fracture of the nasal bone. (Id., ¶ 34).
On May 10, 2018, Mr. Ford was discharged from the rehabilitation hospital to home with continued home health services for nursing, physical therapy, and occupational therapy to address ongoing deficits. (Id., ¶ 36). From April of 2018 until July of 2019, Mr. Ford was required to wear a cervical collar for his neck fracture, and in January of 2019, he underwent C1-C2 posterior fusion surgery. (Id., ¶¶ 37-38).
Mr. Ford asserts that the malfunction or failure of the pacemaker and the Tendril ST lead caused his injuries. Thus, the plaintiffs filed this action in the Luzerne County Court of Common Pleas, and the defendants removed this case to federal court. (Doc. 1). The defendants subsequently filed a motion to dismiss the complaint, and the plaintiffs then filed an amended complaint, which is now the operative pleading in this case. (Doc. 22). The amended complaint asserts claims of negligence, strict liability, breach of express and implied warranties, and a loss of consortium claim. (Id.) The defendants have again moved to dismiss the complaint. (Doc. 27).
The plaintiffs initially brought this suit against a host of other defendants, all of whom have since been dismissed by stipulation. (See Docs. 10, 14).
In their motion, the defendants contend that the plaintiff's state law tort claims are preempted by federal law. Specifically, the defendants argue that the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., preempt Ford's state law tort claims. Additionally, they contend that Ford's strict liability claims are barred in Pennsylvania under the Restatement (Second) of Torts. They further assert that the plaintiff's claims for breach of express and implied warranty fail as pleaded. Finally, they contend that Mrs. Ford's claim is derivative of Mr. Ford's claims, and as such, should be dismissed.
For their part, the plaintiffs assert that the state law tort claims are “parallel” claims to the federal requirements governing medical devices and therefore, are not preempted by federal law. They additionally argue that the amended complaint meets federal pleading standards with respect to these state tort claims.
After consideration, we conclude that the plaintiff's strict liability claims are expressly preempted and should be dismissed with prejudice. We similarly conclude that the negligence and breach of implied warranties claims are preempted, but we recommend that these claims be dismissed without prejudice to afford the plaintiffs one final opportunity to amend their complaint to include factual allegations that state parallel claims that would not be subject to preemption. Additionally, we conclude that the breach of express warranties claim is not preempted by federal law, and further, that the amended complaint adequately states a claim upon which relief can be granted. Accordingly, we recommend that the motion be denied as to this claim. Finally, because we conclude that the breach of express warranties claim is adequately pleaded, the court should decline to dismiss the loss of consortium claim as derivative.
III. Discussion
A. 12(b)(6) Motion to Dismiss - Standard of Review
A motion to dismiss tests the legal sufficiency of a complaint. It is proper for the court to dismiss a complaint in accordance with Rule 12(b)(6) of the Federal Rules of Civil Procedure only if the complaint fails to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). With respect to this benchmark standard for the legal sufficiency of a complaint, the United States Court of Appeals for the Third Circuit has aptly noted the evolving standards governing pleading practice in federal court, stating that:
Standards of pleading have been in the forefront of jurisprudence in recent years. Beginning with the Supreme Court's opinion in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), continuing with our opinion in Phillips [v. County of Allegheny, 515 F.3d 224, 230 (3d Cir. 2008)], and culminating recently with the Supreme Court's decision in Ashcroft v. Iqbal, BU.S-, 129 S.Ct. 1937 (2009), pleading standards have seemingly shifted from simple notice pleading to a more heightened form of pleading, requiring a plaintiff to plead more than the possibility of relief to survive a motion to dismiss.Fowler v. UPMC Shadyside, 578 F.3d 203, 209-10 (3d Cir. 2009).
In considering whether a complaint fails to state a claim upon which relief may be granted, the court must accept as true all allegations in the complaint and all reasonable inferences that can be drawn therefrom are to be construed in the light most favorable to the plaintiff. Jordan v. Fox, Rothschild, O'Brien & Frankel, Inc., 20 F.3d 1250, 1261 (3d Cir. 1994). However, a court “need not credit a complaint's bald assertions or legal conclusions when deciding a motion to dismiss.” Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir. 1997). Additionally, a court need not “assume that a . . . plaintiff can prove facts that the . . . plaintiff has not alleged.” Associated Gen. Contractors of Cal. v. California State Council of Carpenters, 459 U.S. 519, 526 (1983). As the Supreme Court held in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), in order to state a valid cause of action, a plaintiff must provide some factual grounds for relief which “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of actions will not do.” Id., at 555. “Factual allegations must be enough to raise a right to relief above the speculative level.” Id.
In keeping with the principles of Twombly, the Supreme Court has underscored that a trial court must assess whether a complaint states facts upon which relief can be granted when ruling on a motion to dismiss. In Ashcroft v. Iqbal, 556 U.S. 662 (2009), the Supreme Court held that, when considering a motion to dismiss, a court should “begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth.” Id., at 679. According to the Supreme Court, “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id., at 678. Rather, in conducting a review of the adequacy of a complaint, the Supreme Court has advised trial courts that they must:
[B]egin by identifying pleadings that because they are no more than conclusions are not entitled to the assumption of truth. While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations. When there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.Id., at 679.
Thus, following Twombly and Iqbal, a well-pleaded complaint must contain more than mere legal labels and conclusions; it must recite factual allegations sufficient to raise the plaintiff's claimed right to relief beyond the level of mere speculation. As the United States Court of Appeals for the Third Circuit has stated:
[After Iqbal, when presented with a motion to dismiss for failure to state a claim, district courts should conduct a two-part analysis. First, the factual and legal elements of a claim should be separated. The District Court must accept all of the complaint's well-pleaded facts as true, but may disregard any legal conclusions. Second, a District Court must then determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a “plausible claim for relief.” In other words, a complaint must do more than allege the plaintiff's entitlement to relief. A complaint has to “show” such an entitlement with its facts.
Fowler, 578 F.3d at 210-11.
As the Court of Appeals has observed:
The Supreme Court in Twombly set forth the “plausibility” standard for overcoming a motion to dismiss and refined this approach in Iqbal. The plausibility standard requires the complaint to allege “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570, 127 S.Ct. 1955. A complaint satisfies the plausibility standard when the factual pleadings “allow[ ] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 129 S.Ct. at 1949 (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). This standard requires showing “more than a sheer possibility that a defendant has acted unlawfully.” Id. A complaint which pleads facts “merely consistent with” a defendant's liability, [ ] “stops short of the line between possibility and plausibility of ‘entitlement of relief.' ”
Burtch v. Milberg Factors, Inc., 662 F.3d 212, 220-21 (3d Cir. 2011), cert. denied, 132 S.Ct. 1861 (2012).
In practice, consideration of the legal sufficiency of a complaint entails a three-step analysis:
First, the court must “tak[e] note of the elements a plaintiff must plead to state a claim.” Iqbal, 129 S.Ct. at 1947. Second, the court should identify allegations that, “because they are no more than conclusions, are not entitled to the assumption of truth.” Id., at 1950. Finally, “where there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement for relief.”
Santiago v. Warminster Twp., 629 F.3d 121, 130 (3d Cir. 2010) (quoting Iqbal, 129 S.Ct. at 1950).
In considering a motion to dismiss, the court generally relies on the complaint, attached exhibits, and matters of public record. Sands v. McCormick, 502 F.3d 263, 268 (3d Cir. 2007). The court may also consider “undisputedly authentic document[s] that a defendant attached as an exhibit to a motion to dismiss if the plaintiff's claims are based on the [attached] documents.” Pension Benefit Guar. Corp. v. White Consol. Indus., 998 F.2d 1192, 1196 (3d Cir. 1993). Moreover, “documents whose contents are alleged in the complaint and whose authenticity no party questions, but which are not physically attached to the pleading, may be considered.” Pryor v. Nat'l Collegiate Athletic Ass'n, 288 F.3d 548, 560 (3d Cir. 2002); see also U.S. Express Lines, Ltd. v. Higgins, 281 F.3d 382, 388 (3d Cir. 2002) (holding that “[a]lthough a district court may not consider matters extraneous to the pleadings, a document integral to or explicitly relied upon in the complaint may be considered without converting the motion to dismiss in one for summary judgment”). However, the court may not rely on other parts of the record in determining a motion to dismiss, or when determining whether a proposed amended complaint is futile because it fails to state a claim upon which relief may be granted. Jordan v. Fox, Rothschild, O'Brien & Frankel, 20 F.3d 1250, 1261 (3d Cir. 1994).
B. The Defendants' Motion to Dismiss Should be Granted in Part and Denied in Part.
As we have noted, the amended complaint asserts claims of negligence, strict liability, and breach of warranties stemming from the failure of Mr. Ford's pacemaker, which they allege caused his injuries in April of 2018. For their part, the defendants argue that these claims are preempted by federal law, and further, that the plaintiffs have not adequately pleaded these claims. As we will discuss below, we agree that the negligence, strict liability, and breach of implied warranties claims are preempted by federal law. However, we conclude that the breach of express warranties claim is not preempted by federal law, and further, the amended complaint adequately states a claim under Pennsylvania law. Finally, because we conclude that the breach of express warranties claim is adequately pleaded, the court should decline to dismiss the loss of consortium claim as derivative.
1. Preemption under the MDA to the FDCA
In 1976, Congress passed the Medical Device Amendments, 21 U.S.C. § 360c et seq., to the FDCA, in order to impose federal oversight over the approval of medical devices by the Food and Drug Administration (“FDA”). See Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). The MDA classifies different medical devices requiring different levels of oversight, and the level of oversight depends on the risk presented by the device. Riegel, 552 U.S. at 316. Pacemakers are classified as “Class III” medical devices, which are devices that are “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.” 21 U.S.C. § 360c(C); Medtronic Inc., v. Lohr, 518 U.S. 470, 477 (1995) (citing 21 C.F.R. § 870.3610 (1995)) (“Pacemakers are Class III devices”). Class III devices are subject to a premarket approval (“PMA”) process set forth in § 360e “to provide reasonable assurance of its safety and effectiveness.” 21 U.S.C. § 360c(C).
Once the FDA approves a device through the PMA process, “the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). Thus, if a manufacturer wants to make a change, it must submit an application for supplemental premarket approval, which must be approved by the FDA and is evaluated under substantially the same criteria as the initial application. Id. (citing § 360e(d)(6); 21 C.F.R. § 814.39(c)).
The MDA contains a broad express preemption provision, which states:
Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a). This preemption provision “bars state tort claims” against medical device manufacturers “insofar as such claims would impose requirements ‘different from, or in addition to the requirements imposed by federal law.'” Conley v. St. Jude Medical, LLC, 482 F.Supp.3d 268, 275 (M.D. Pa. 2020) (quoting Riegel, 552 U.S. at 330)). However, this provision “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,' rather than add to, federal requirements.” Riegel, 552 U.S. at 330 (citing Lohr, 518 U.S. at 495, 513).
Thus, the Riegel Court established a two-step test to determine whether a claim is expressly preempted by the MDA. A court must first “determine whether the Federal Government has established requirements applicable to” the medical device at issue. Id. at 321. If it has, the next inquiry is to determine “whether the [plaintiff's] common-law claims are based upon [state] requirements with respect to the device that are ‘different from, or in addition to,' the federal ones, and that relate to safety and effectiveness.” Id. at 322 (citing § 360k(a)). On this score, regarding the first question, it is well settled that Class III medical devices subject to the premarket approval process are subject to “‘requirements' under the MDA.” Id.;
Gross v. Stryker Corp., 858 F.Supp.2d 466, 485 (W.D. Pa. 2012) (quoting Riegel, 552 U.S. at 322-23) (“PMA devices are subject to ‘requirements' that are ‘specific to individual devices'”); see also Freed v. St. Jude Medical, Inc., 364 F.Supp.3d 343, 351 (D. Del. 2019). Therefore, this element of a preemption claim is satisfied, To state a “parallel” claim that is not subject to preemption, “a plaintiff must generally allege ‘specific violations of federal law that establish a parallel state duty.'” Conley, 482 F.Supp.3d at 275 (quoting Gross, 858 F.Supp.2d at 491). However, “[t]he parallel claim exception to preemption . . . requires more than just a change of terminology; a plaintiff ‘cannot simply incant the magic words “[Defendant] violated FDA regulations” in order to avoid preemption.'” Clements v. Sanofi-Aventis, U.S., Inc., 111 F.Supp.3d 586, 598 (D.N.J. 2015) (quoting In re Medtronic, 592 F.Supp.2d 1147, 1158 (D. Minn. 2009)). Indeed, there must be a great enough level of specificity to sufficiently allege a parallel claim, “rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.” Gross, 858 F.Supp.2d at 496 (citation omitted). Thus, “[i]n the context of MDA preemption, Twombly and Iqbal make a plaintiff's job more difficult than it would be in a typical product liability case.” Id. at 494 (quoting White v. Stryker Corp., 818 F.Supp.2d 1032, 1036-37 (W. D. Ky. 2011)).
2. The Plaintiffs' Claims, with the Exception of the Breach of Express Warranties Claim, are Preempted by Federal Law.
a. Strict Liability
After consideration, we conclude that Mr. Ford's strict liability claim is preempted by the MDA. The plaintiffs' amended complaint asserts design defect and manufacturing defect claims, alleging that the Assurity pacemaker and the Tendril ST lead were designed and manufactured by St. Jude in such a way that rendered them unsafe and increased the risk of corrosion and malfunction. The complaint further alleges that the defendants failed to modify the Tendril ST lead in accordance with the PMA supplement and conditions of approval.
The plaintiffs withdrew their claims based on a failure to warn theory. (Doc. 31, at 20.
Such allegations have been held to be insufficient to fall within the narrow range of claims that are considered “parallel” claims and therefore, not subject to preemption. See e.g., Conley, 482 F.Supp.3d at 280 (dismissing the plaintiff's manufacturing defect claim as preempted where “[t]he amended complaint neither identifies a specific manufacturing defect, nor specifically alleges how Defendant's practices ran afoul of FDA requirements”); McPhee v. DePuy Orthopedics Inc., 989 F.Supp.2d 451, 458-59 (W.D. Pa. 2012) (dismissing the plaintiff's strict liability claims as preempted where the plaintiff's claims “are premised on the assertion that Defendant placed the device in the stream of commerce in a defective and dangerous condition”); Bentzley v. Medtronic, Inc., 827 F.Supp.2d 443, 453 (E.D. Pa. 2011) (collecting cases) (finding that the plaintiff's strict liability claims based on design and manufacturing defects were preempted “because of their potential conflict with FDA labeling, design, and manufacturing requirements”). Indeed, while the plaintiffs contend that they have pleaded allegations indicating that St. Jude failed to follow good manufacturing practices (“GMPs”), courts have held that such allegations are simply too vague to state a parallel claim that avoids preemption. See Conley, 482 F.Supp.3d at 280 (citing Kubicki v. Medtronic, Inc., 293 F.Supp.3d 129, 178 (D.D.C. 2018) and Gross, 858 F.Supp.2d at 497). Thus, we conclude that the strict liability claims are preempted under the MDA.
However, even if we were to conclude that the allegations in the amended complaint stated a “parallel” claim and thus, the strict liability claims were not preempted, we conclude that these claims fail under Pennsylvania law. Pennsylvania has adopted the Restatement (Second) of Torts. Section 402A governs liability of a seller who sells a product in a defective or unreasonably dangerous condition. § 402A. However, comment k to Section 402A exempts a seller of an unavoidably unsafe product from strict liability so long as the product is “properly prepared and marketed, and proper warning is given, where the situation calls for it . . .” § 402 A cmt. k. While the Pennsylvania Supreme Court has extended comment k to preclude strict liability claims against manufacturers and sellers of prescription drugs, Baldino
v. Castagna, 478 A.2d 807, 810 (1984), it has not expressly extended this protection to manufacturers and sellers of medical devices. However, many courts within this circuit have predicted that the Pennsylvania Supreme Court would extend the exemption provided in comment k to strict liability claims sounding in design defect and manufacturing defect against manufacturers of medical devices. See e.g., McGrain v. C.R. Bard, Inc., 551 F.Supp.3d 529, 537 (E.D. Pa. 2021) (relying on the decision in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), and holding that comment k applied to design defect and manufacturing defect strict liability claims against medical device manufacturer); Rosenberg v. C.R. Bard, Inc., 387 F.Supp.3d 572, 579-81 (E.D. Pa. 2019) (same); Wilson v. Synthes USA Prods., LLC, 116 F.Supp.3d 463, 465-67 (E.D. Pa. 2015) (collecting cases and relying on Hahn to bar strict liability claims against medical device manufacturers); McPhee, 989 F.Supp.2d 451 at 461 (relying on Hahn and finding the plaintiff's strict liability claims were not viable under Pennsylvania law); Gross, 858 F.Supp.2d at 482 (collecting cases and holding that comment k bars manufacturing defect strict liability claims against medical device manufacturers). But see Cohen v. Johnson & Johnson, -F.Supp.3d---, 2022 WL 5109167, at *7 (W.D. Pa. Oct. 5, 2022) (declining to extend comment k to medical devices); Patchkoski v. W.L. Gore & Associates, Inc., 2020 WL 4335016, at *10 (M.D. Pa. July 28, 2020) (same).
We find the decisions of courts extending the exemption provided in comment k to medical devices persuasive. On this score, in McGrain, the court discussed a number of Pennsylvania Supreme Court decisions, including Hahn v. Richter, 673 A.2d 888 (Pa. 1996), and Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), to support its prediction that the Pennsylvania Supreme Court would extend comment k to a manufacturing defect claim involving medical devices. At the outset, the court recognized that Hahn's prohibition of strict liability claims for prescription drugs only discussed strict liability in the context of failure to warn claims. McGrain, 551 F.Supp.3d at 534-36. The court went on to note the Pennsylvania Supreme Court's broad statements in both Hahn and Lance that comment k denies the application of strict liability in the area of prescription drugs. Id. at 536.
In McGrain, as in the instant case, the plaintiff relied on the Pennsylvania Supreme Court's decision in Tincher v. OmegaFlex, Inc., 104 A.3d 328 (Pa. 2014), in which the Court found that “[n]o product is expressly exempt [from strict liability], and, as a result, the presumption is that strict liability may be available with respect to any product . . .” Tincher, 104 A.3d at 386 (alterations in McGrain). However, as the McGrain court aptly pointed out, the Pennsylvania Supreme Court immediately followed this statement “with a ‘but see' citation to Hahn,” indicating “an exception to the general proposition that ‘no product is expressly exempt.'” McGrain, 551 F.Supp.3d at 537. Finally, the court noted that the Pennsylvania Superior Court in Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006), applied comment k to bar strict liability claims in the medical device arena. Id. at 536.
We find this analysis, as well as the host of other federal district court cases extending comment k in this context, persuasive and conclude that comment k to § 402A bars the plaintiffs' manufacturing and design defect claims against St. Jude. Therefore, even if these strict liability claims were not preempted by federal law, they are not cognizable under Pennsylvania law. Accordingly, we recommend that Count II of the amended complaint be dismissed with prejudice.
Because we conclude that these claims fail under Pennsylvania law, allowing leave to amend this count of the amended complaint would be futile. See In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1434 (3d Cir. 1997).
b. Negligence
Next, the amended complaint asserts a negligence claim against St. Jude, alleging that the defendants had a duty to design, manufacture, and distribute a safe product, and that they breached their duty because the Assurity pacemaker and the Tendril ST lead malfunctioned and caused Mr. Ford's injuries. The allegations underlying this negligence claim are virtually identical to the allegations underlying the strict liability claims. Accordingly, we conclude that this negligence claim, like the strict liability claim, is preempted as it implicates the safety and effectiveness of the devices at issue. See Riegel, 552 U.S. at 324; Conley, 482 F.Supp.3d at 277;
Gross, 858 F.Supp.2d at 491. Thus, our inquiry turns to whether the amended complaint alleges sufficient facts to state a parallel claim to avoid preemption. We conclude that it does not.
In order to state a claim in Pennsylvania for negligence, a plaintiff must allege (1) that the defendant owed a legal duty to the plaintiff; (2) the defendant breached that duty; and (3) the breach of duty caused the plaintiff's injury. See Jones v. Levin, 940 A.2d 451, 454 (Pa. Super. Ct. 2007). In the context of federal preemption of a claim involving a medical device, “the Third Circuit has held that to state a valid parallel claim for negligence, ‘the “duty” element must arise from federal requirements applicable to a medical device.'” Conley, 482 F.Supp.3d at 277 (quoting Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 776 (3d Cir. 2018)).
Here, the complaint generally alleges that the defendants owed Mr. Ford a duty but makes only a cursory reference to the PMA process and good manufacturing practices (“GMPs”). However, courts in this circuit have held that such conclusory references to federal regulations, as well as general references to GMPs, are insufficient to establish a duty arising from federal requirements. See e.g., Conley, 482 F.Supp.3d at 277-78 (finding that “general citations to the GMPs or federal regulations are not specific enough to state a parallel claim”); Gross, 858 F.Supp.2d at 494-96 (“Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court's reasoning in Riegel, as well as the pleading requirements articulated in Twombly, Iqbal, and Fowler”). Therefore, we conclude that the complaint fails to state a parallel claim for negligence, and thus, this claim is preempted and should be dismissed. However, we recommend that this negligence claim be dismissed without prejudice to one final attempt by the plaintiffs to amend their complaint to set forth factual allegations that state a valid parallel claim in an effort to avoid preemption.
c. Breach of Express and Implied Warranties
The plaintiffs also assert a claim against St. Jude for breach of express and implied warranties. As to the breach of express warranties claim, the amended complaint asserts that it was expressly represented to the plaintiffs that the Assurity pacemaker and Tendril ST lead were reasonably fit for their intended purpose, that they were safe and effective, and that the pacemaker and lead would last twelve years. Mr. Ford contends that he and his physicians reasonably relied on these statements made by St. Jude representatives. Regarding the claims of breach of implied warranties, the complaint asserts that the defendants impliedly represented that the devices were fit for their usual purpose, safe, effective, and merchantable, and that these warranties were breached and resulted in Mr. Ford's injuries. As we will discuss below, we conclude that the plaintiffs' breach of implied warranties claims are preempted by the MDA, but that the breach of express warranties claims are not expressly preempted.
First, with respect to the breach of implied warranties claims, it is well settled that “Pennsylvania has adopted the Uniform Commercial Code formulations of the implied warranty of fitness for a particular purpose and the implied warranty of merchantability.” Bentzley, 827 F.Supp.2d at 454 (citing 13 Pa. Cons. Stat. §§ 2314, 2315). Accordingly, courts have held in this context that “it is evident that Pennsylvania state law imposes its own standards on the merchantability of goods.” Gross, 858 F.Supp.2d at 490 (citing Turney Media Fuel, Inc. v. Toll Bros., 725 A.2d 836, 840 (Pa. Super. Ct. 1999)); see also Bentzley, 827 F.Supp.2d at 454 (quoting Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 434 (E.D. Pa. 2004)) (“Implied warranties in Pennsylvania are ‘centered around the accepted standards of design and manufacture of products in the state of Pennsylvania'”).
Given that Pennsylvania law imposes its own standards, allowing a breach of implied warranties claim involving a medical device that is subject to federal requirements would impose standards that are different from, or in addition to, the federal requirements. Accordingly, such claims are also expressly preempted by the MDA, and this claim should be dismissed with prejudice. See Riegel, 553 U.S. at 328-29; Freed, 364 F.Supp.3d at 355-56; Gross, 858 F.Supp.2d at 490-91; Bentzley, 827 F.Supp.2d at 454. Further, the complaint has not set forth any allegations that make out a parallel claim which would avoid preemption, and thus, this claim should be dismissed.
The breach of express warranties claim, however, is not expressly preempted by the MDA. On this score, the complaint asserts that a St. Jude representative expressly represented to Mr. Ford that the Assurity pacemaker and Tendril ST lead were safe and effective, and that the devices had a life span of twelve years. The amended complaint further alleges that Mr. Ford chose to accept the devices based on these representations by St. Jude, and that these warranties were breached when the devices lasted less than five years until it malfunctioned and needed to be replaced.
Under Pennsylvania law, an express warranty can be created by a seller by making the following representation:
(1) Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise; [and]
(2) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.
Express warranties “do not independently arise by operation of state law.” Bentzley, 827 F.Supp.2d at 454. Rather, “the parties, not the state, ‘define[] the substantive obligations of the contract and hence any express warranties.'” Id. at 454-55 (quoting Michael v. Shiley, Inc., 46 F.3d 1316, 1324-25 (3d Cir. 1995)). Accordingly, courts have held that express warranty claims involving medical devices are not preempted by the MDA since such claims do not involve state requirements that are different from or add to the federal requirements governing such devices. See e.g., In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F.Supp.3d 679, 718-19 (D.N.J. 2021); McLaughlin v. Bayer Corp., 172 F.Supp.2d 804, 823 (E.D. Pa. 2016); Bentzley, 827 F.Supp.2d at 454-55; Davenport, 302 F.Supp.2d at 433; Steele v. Depuy Orthopaedics, Inc., 295 F.Supp.2d 439, 455 (D.N.J. 2003).
We further conclude that, at this early pleading stage, the amended complaint adequately states a breach of express warranties claim. As we have explained, section 2313 allows for the creation of an express warranty where a seller of a good makes an affirmative representation relating to or describing the good and that representation forms part of the basis of the bargain. 13 Pa. Cons. Stat. § 2313(a)(1), (a)(2). “[A]n express warranty must be ‘directed at consumers in order to induce purchases of the product.'” Mills v. Ethicon, Inc., 406 F.Supp.3d 363, 388 (D.N.J 2019) (quoting Sowers v. Johnson & Johnson Med., 867 F.Supp. 306, 314 (E.D. Pa. 1994) (internal citations omitted)). A plaintiff must demonstrate “that a promise or affirmative statement was made, how or by whom the promise was made, or what in fact was promised” in order to adequately state a claim for breach of express warranty. Gross, 858 F.Supp.2d at 501-02,
In the instant case, the amended complaint asserts allegations that a St. Jude representative made affirmative statements to Mr. Ford regarding the safety, effectiveness, and longevity of the Assurity pacemaker and Tendril ST lead. The amended complaint further states that Mr. Ford relied on these express representations in his decision to have the devices implanted. Subsequently, the pacemaker and lead malfunctioned only three years later, resulting in Mr. Ford's injuries. Accordingly, at this stage, we conclude that the amended complaint sufficiently sets forth allegations of a breach of express warranty. Accordingly, we recommend that the motion to dismiss be denied as to this claim.
Finally, these recommendations dictate the course this court should follow with respect to the loss of consortium claim advanced by Mrs. Ford. In this regard, it is well-settled that: “[a] spouse's consortium claim derives only from the injured spouse's right to recover.” Harris v. Oz Directional Drilling, Inc., No. 3:13-CV-2580, 2016 WL 4578150, at *5 (M.D. Pa. June 30, 2016), report and recommendation adopted, No. 3:13-CV-2580, 2016 WL 4698635 (M.D. Pa. July 19, 2016) (quoting Quitmeyer v. Se. Pa. Transp. Auth., 740 F.Supp. 363, 370 (E.D. Pa. 1990)). Because we have concluded that Mr. Ford's breach of express warranties claim survives the motion to dismiss, it follows that Mrs. Ford's loss of derivative consortium claim also survives to the extent that her spouse's claim proceeds forward. Therefore, the court should decline to dismiss the loss of consortium claim in Count IV.
IV. Recommendation
For the foregoing reasons, IT IS RECOMMENDED THAT the defendants' motion to dismiss (Doc. 27) be GRANTED IN PART AND DENIED IN PART as follows:
1. The motion should be GRANTED with respect to Count I, and the plaintiffs' negligence claim should be dismissed without prejudice to allow one final opportunity to amend the complaint;
2. The motion should be GRANTED with respect to Count II, and the plaintiffs' strict liability claims should be dismissed with prejudice;
3. The motion should be GRANTED with respect to the breach of implied warranties claim in Count III, and this claim should be dismissed without prejudice to allow one final opportunity to amend the complaint;
4. The motion should be DENIED as to the breach of express warranties claim in Count III; and
5. The motion should be DENIED with respect to the loss of consortium claim in Count IV.
The parties are further placed on notice that pursuant to Local Rule 72.3:
Any party may object to a magistrate judge's proposed findings, recommendations or report addressing a motion or matter described in 28 U.S.C. § 636 (b)(1)(B) or making a recommendation for the disposition of a prisoner case or a habeas corpus petition within fourteen (14) days after being served with a copy thereof. Such party shall file with the clerk of court, and serve on the magistrate judge and all parties, written objections which shall specifically identify the portions of the proposed findings, recommendations or report to which objection is made and the basis for such objections. The briefing requirements set forth in Local Rule 72.2 shall apply. A judge shall make a de novo determination of those portions of the report or specified proposed findings or recommendations to which objection is made and may accept, reject, or modify, in whole or in part, the findings or recommendations made by the magistrate judge. The judge, however, need conduct a new hearing only in his or her discretion or where required by law, and may consider the record developed before the magistrate judge, making his or her own determination on the basis of that record. The judge may also receive further evidence, recall witnesses or recommit the matter to the magistrate judge with instructions.