Ford v. St. Jude Medical

UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF PENNSYLVANIA

RICHARD M. FORD and SANDY S.

FORD,

husband and wife CIVIL ACTION NO. 3:21-CV-01765

Plaintiffs (MEHALCHICK, J.)

v.

ST. JUDE MEDICAL, LLC, AND ST.

JUDE MEDICAL S.C., INC.,

Defendants.

MEMORANDUM

Plaintiff Richard M. Ford (“Mr. Ford”) and Sandy S. Ford (“Mrs. Ford”) (collectively,

“the Fords” or “Plaintiffs”) initiated this action by filing a complaint in the Luzerne County

Court of Common Pleas against Defendants St. Jude Medical, LLC and St. Jude Medical

S.C., Inc., (collectively, “Defendants”). (Doc. 1-1). On October 18, 2021, Defendants

removed this case to federal court. (Doc. 1). The Fords’ operative amended complaint

(“Amended Complaint”) asserts claims of negligence, strict liability, and breach of express

and implied warranties against Defendants, as well as a claim for loss for consortium brought

by Mrs. Ford related to injuries Mr. Ford suffered when his pacemaker failed. (Doc. 22).

Before the Court is the Report and Recommendation (the “Report”) of the Honorable

Magistrate Judge Martin C. Carlson addressing a motion to dismiss the Amended Complaint

filed by Defendants. (Doc. 27; Doc. 37). The Report recommends the motion to dismiss be

granted in part and denied in part. (Doc. 37). The Court agrees with all the conclusions set

forth in the well-reasoned Report, except for the recommendation to deny Defendants’

motion to dismiss the loss of consortium claim. (Doc. 37). Accordingly, the motion to dismiss

will be GRANTED in part and DENIED in part. (Doc. 27). Plaintiffs’ objections will be

OVERRULED. (Doc. 40). Defendants’ objections will be OVERRULED in part and

SUSTAINED in part. (Doc. 38).

I. LEGAL STANDARDS

A. DISTRICT COURT REVIEW OF A REPORT AND RECOMMENDATION

“A district court may ‘designate a magistrate judge to conduct hearings, including

evidentiary hearings, and to submit to a judge of the court proposed findings of fact and

recommendations for the disposition’ of certain matters pending before the court.” Brown v.

Astrue, 649 F.3d 193, 195 (3d Cir. 2011) (quoting 28 U.S.C. § 636(b)(1)(B)). Within fourteen

days of being served a report and recommendation, “any party may serve and file written

objections to such proposed findings and recommendations as provided by rules of court.” 28

U.S.C. § 636(b)(1). When a party timely files objections, the district court is to conduct a de

novo review of the challenged portions of the Magistrate Judge’s findings unless the objection

is “not timely or not specific.” Goney v. Clark, 749 F.2d 5, 6–7 (3d Cir.1984); 28 U.S.C. §

636(b)(1). The Court may then “accept, reject, or modify, in whole or in part, the findings and

recommendations.” 28 U.S.C. § 636(b)(1). “Although the standard is de novo, the extent of

review is committed to the sound discretion of the district judge, and the court may rely on

the recommendations of the magistrate judge to the extent it deems proper.” Rahman v.

Gartley, No. CV 3:23-363, 2024 WL 555894, at *1 (M.D. Pa. Feb. 12, 2024) (citing United v.

Raddatz, 447 U.S. 667, 676 (1980)). For those sections of the report and recommendation to

which no objection is made, the court should, as a matter of good practice, “satisfy itself that

there is no clear error on the face of the record in order to accept the recommendation.” Fed.

R. Civ. P. Adv. Comm. Note Rule 72(b).

B. FAILURE TO STATE A CLAIM UNDER FED. R. CIV. P. 12(B)(6)

Rule 12(b)(6) of the Federal Rules of Civil Procedure authorizes a defendant to move

to dismiss for “failure to state a claim upon which relief can be granted.” Fed. R. Civ. P.

12(b)(6). To assess the sufficiency of a complaint on a Rule 12(b)(6) motion, a court must first

take note of the elements a plaintiff must plead to state a claim, then identify mere conclusions

that are not entitled to the assumption of truth, and finally determine whether the complaint’s

factual allegations, taken as true, could plausibly satisfy the elements of the legal claim. Burtch

v. Milberg Factors, Inc., 662 F.3d 212, 221 (3d Cir. 2011). In deciding a Rule 12(b)(6) motion,

the court may consider the facts alleged on the face of the complaint, as well as “documents

incorporated into the complaint by reference, and matters of which a court may take judicial

notice.” Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007).

After recognizing the required elements that make up the legal claim, a court should

“begin by identifying pleadings that, because they are no more than conclusions, are not

entitled to the assumption of truth.” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). The plaintiff

must provide some factual ground for relief, which “requires more than labels and

conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell

Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). “[T]hreadbare recitals of the elements of

a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S.

at 678. Thus, courts “need not credit a complaint’s ‘bald assertions’ or ‘legal conclusions’. . . ”

Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir. 1997) (quoting In re Burlington Coat

Factory Sec. Litig., 114 F.3d 1410, 1429-30 (3d Cir. 1997)). Nor need a court assume that a

plaintiff can prove facts that the plaintiff has not alleged. Associated Gen. Contractors of Cal. v.

Cal. State Council of Carpenters, 459 U.S. 519, 526 (1983).

A court must then determine whether the well-pleaded factual allegations give rise to

a plausible claim for relief. “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.” Palakovic v. Wetzel, 854 F.3d 209, 219-20 (3d Cir. 2017) (quoting

Iqbal, 556 U.S. at 678) (internal quotation marks omitted); see also Sheridan v. NGK Metals

Corp., 609 F.3d 239, 262 n.27 (3d Cir. 2010). The court must accept as true all allegations in

the complaint, and any 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, 20 F.3d

1250, 1261 (3d Cir. 1994). This “presumption of truth attaches only to those allegations for

which there is sufficient factual matter to render them plausible on their face.” Schuchardt v.

President of the U.S., 839 F.3d 336, 347 (3d Cir. 2016) (internal quotation and citation omitted).

The plausibility determination is context-specific and does not impose a heightened pleading

requirement. Schuchardt, 839 F.3d at 347.

C. PREEMPTION AND THE MDA

The Medical Device Amendments (“MDA”), 21 U.S.C. § 360c et seq., to the Food,

Drug, and Cosmetic Act (“FDCA”) impose federal oversight over the approval of medical

devices. See 21 U.S.C. § 360c. The MDA applies to pacemakers as “Class III” medical

devices. 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 medical devices are those that are “(I)[]

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, or (II) present[]

a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c. Class III medical devices

must go through a premarket approval (“PMA”) process in order to assure safety and

effectiveness. See 21 U.S.C. § 360c. After the PMA, manufacturers cannot “make, without

FDA permission, changes in design specifications, manufacturing processes, labeling, or any

other attribute, that would affect safety or effectiveness.” Riegel v. Medtronic, Inc., 552 U.S.

312, 319 (2008) (citing 21 U.S.C. § 360e(d)(6)(A)(i)).

The MDA also contains a preemption provision. 21 U.S.C. § 360k(a). According to

the preemption provision, state tort claims against medical manufacturers are barred when

such claims implicate requirements that are different from or additional to the federal

standards. See Conley v. St. Jude Medical, LLC, 482 F. Supp. 3d 268, 275 (M.D. Pa. 2020) (the

MDA bars state tort claims “insofar as such claims would impose requirements ‘different

from, or in addition to the requirements imposed by federal law.’”) (quoting Riegel, 552 U.S.

at 330).

The preemption provision includes an exception that allows for “parallel” state tort

claims – that is, claims based upon state requirements that are parallel to, rather than

additional to, federal requirements. See Gross v. Stryker Corp., 858 F. Supp. 2d 466, 492 (W.D.

Pa. 2012) (“In Riegel, the Supreme Court found that ‘[21 U.S.C.] § 360k does not prevent a

State from providing a damages remedy for claims premised on a violation of FDA

regulations’ because the state duties would parallel, rather than add to, federal

requirements.’”) (quoting Riegel, 552 U.S. at 330). “To properly allege parallel claims, the

complaint must set forth facts showing ‘action or inaction in [defendants'] efforts to take part

in the [premarket approval (“PMA”) process] process or implement its results.’” Gross, 858 F.

Supp. 2d at 492 (quoting Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1301 (D. Colo. 2008).

Parallel claims require a high degree of specificity about what actions or inactions by a

defendant violated federal law. See Gross, 858 F. Supp. 2d at 493 (finding that the parallel

claims exception is inapplicable when “(1) [p]laintiff fails to adequately plead a sufficient,

specific basis for his purported parallel claims, and (2) [p]laintiff's claims arise from generalized

common theories of liability and not state statutes that provide a private cause of action for

FDCA violations”) (emphasis added). However, when plaintiffs fail to allege facts with such

required specificity, leave to amend may be appropriate. See Freed v. St. Jude Med., Inc., No.

CV 17-1128, 2017 WL 4102583, at *8 (D. Del. Sept. 15, 2017) (“[t]he [plaintiffs] do not

presently allege facts necessary to overcome federal preemption[. . . ,]” but noting “[t]hey may

be able to do so with an amendment.”).

D. COMMENT K

Pennsylvania has adopted the Restatement (Second) of Torts, which includes § 402

Comment k (“Comment k”). See Restatement (Second) of Torts § 402A cmt. k (1965).

“Comment k of Section 402A, [] limits liability for ‘unavoidably unsafe’ products.” Kline v.

Zimmer Holdings, Inc., No. CIV.A. 13-513, 2013 WL 3279797, at *4 (W.D. Pa. June 27, 2013);

see also Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996). Comment k limits liability for such

products because “[t]here are some products, which, in the present state of human knowledge,

are quite incapable of being made safe for their intended and ordinary use,” but that when

“properly prepared, and accompanied by proper directions and warning, [the product] is not

defective, nor is it unreasonably dangerous.” Restatement (Second) of Torts § 402A cmt. K; see

Kline, 2013 WL 3279797, at *4. The Pennsylvania Supreme Court has explicitly held that

Comment k applies to prescription drugs and the Pennsylvania Superior Court has extended

Comment k to medical devices, noting that there is “no reason why the same rational[e]

applicable to prescription drugs may not be applied to medical devices.” see Kline, 2013 WL

3279797, at *4 (quoting Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006)). A

growing body of district courts in the Third Circuit have predicted that the Pennsylvania

Supreme Court will extend Comment k’s bar on strict liability claims to medical devices as

well. See Gross, 858 F. Supp. 2d at 482 (“Most importantly, courts within the Third Circuit

have barred strict liability claims against [defendant] and other analogous medical device

manufacturers by applying comment k to § 402A.”); McGrain v. C.R. Bard, Inc., 551 F. Supp.

3d 529, 537 (E.D. Pa. 2021) (“many federal courts, including this one, have predicted that the

Pennsylvania Supreme Court would extend Comment k to medical devices.”) (citing Lopez v.

Ethicon Inc., No. CV 20-2694, 2020 WL 5569770, at *5 (E.D. Pa. Sept. 17, 2020); Cf. Ebert v.

C.R. Bard, Inc., 459 F. Supp. 3d 637, 652–53 (E.D. Pa. 2020) (predicting that “Pennsylvania's

highest court [will]. . . analyze comment k's applicability to prescription medical devices on a

case-by-case basis, determined largely by each case's developed factual record and the

individual characteristics of the medical device at issue”).

District courts in Pennsylvania have also discussed Comment k regarding a breach of

implied warranties claim and note that these implied warranties claims fail for the same

reason as the strict liability claims. McDonnell v. Flowonix Med. Inc., No. CV 21-1404, 2022

WL 221612, at *7 (E.D. Pa. Jan. 25, 2022) (“Courts in this Circuit, relying on Makripodis,

have concluded that Comment k is equally applicable to strict liability and breach of implied

warranty.”) (citing Terrell v. Davol, Inc., No. 13-5074, 2014 WL 3746532, *6 (E.D. Pa. July

30, 2014); See, e.g., Gross, 858 F. Supp. 2d at 491 n.35; Soufflas v. Zimmer, Inc., 474 F. Supp. 2d

737, 752 (E.D. Pa. 2007)); Cogswell v. Wright Med. Tech., Inc., No. 15-295, 2015 WL 4393385,

at *5 (W.D. Pa. July 16, 2015) (holding that Comment k bars implied warranties claims and

stating “[a] number of Pennsylvania federal courts have extended [Comment k’s] reasoning

to preclude implied warranty of fitness and merchantability claims for medical devices as

well.”); Kester v. Zimmer Holdings, Inc., No. 210-CV-00523, 2010 WL 2696467, at *11 (W.D.

Pa. June 16, 2010) (“As with strict products liability claims [. . . ], Pennsylvania courts have

held that the nature of prescription drugs and prescription medical devices precludes claims

for breach of implied warranty”) (citing Parkinson v. Guidant Corp., 315 F. Supp. 2d 741, 753

(W.D. Pa. 2004)); Carson v. Atrium Med. Corp., 191 F. Supp. 3d 473, 478 (W.D. Pa. 2016)

(dismissing a breach of an implied warranties claim as materially similar to the strict liability

claim and stating “since this Court has determined, both in this case and in previous cases,

that medical devices fall under the umbrella of Comment k, and thus are unavoidably unsafe

products, there can be no breach of implied warranty”); Horsmon v. Zimmer Holdings, Inc., No.

CIV.A. 11-1050, 2011 WL 5509420, at *3 (W.D. Pa. Nov. 10, 2011) (dismissing a breach of

an implied warranty claim “[b]ecause Pennsylvania law precludes breach of implied warranty

claims for medical devices” through Comment k).

II. DISCUSSION

Since the Report explains the factual and procedural background of this case in detail,

this Court will only include here what is relevant for the purposes of this Memorandum.1 This

case arises from injuries Mr. Ford suffered when he fell due to a pacemaker failure. (Doc. 22,

¶ 24). Plaintiffs’ operative Amended Complaint asserts claims against Defendants for strict

liability, negligence, breach of implied and express warranties, and loss of consortium. (Doc.

22). The Report concludes that Plaintiffs’ negligence, strict liability, and breach of implied

warranties claims fail because they are preempted by federal law. (Doc. 37, at 10). However,

1 Pennsylvania law applies to the tort and contract claims in this case, so the Court will

rely on both state law and federal application of state law. See Kline v. Zimmer Holdings, Inc.,

662 F. App'x 121 (3d Cir. 2016) (applying state law to medical products liability claims for

negligence, design and manufacturing defects, and loss of consortium).

according to the Report, Plaintiffs’ breach of express warranties claim should survive because

it is not preempted by federal law and Plaintiffs have adequately stated a claim under

Pennsylvania law. (Doc. 37, at 10). Magistrate Judge Carlson recommends the loss of

consortium claim also survives as a derivative claim to the breach of express warranties claim.

(Doc. 37, at 24). The parties each filed objections to the Report. (Doc. 38; Doc. 39; Doc. 40).

Defendants object to the Report with respect to two discrete issues. (Doc. 38, at 5).

First, Defendants submit that the breach of implied warranties claim should be dismissed with

prejudice, rather than without prejudice. (Doc. 38, at 5). Second, Defendants contend that

loss of consortium claim should be dismissed without prejudice because the only surviving

claim, the breach of express warranties claim, cannot support a derivative loss of consortium

claim. (Doc. 38, at 5). Plaintiffs object to the Report’s recommendation in one respect, arguing

that Comment k does not bar their strict liability claims and contending that their strict

liability claims should be dismissed without prejudice and that they be granted an opportunity

to file a second amended complaint. (Doc. 40, at 20).

A. PLAINTIFFS’ STRICT LIABILITY CLAIMS

According to the Report, Plaintiffs’ strict liability claims should be dismissed with

prejudice because (1) they are preempted by federal law and (2) “many courts within this

circuit have predicted that the Pennsylvania Supreme Court would extend the exemption

provided in [C]omment k to strict liability claims sounding in design defect and

manufacturing defect against manufacturers of medical devices.” (Doc. 37, at 16). In

recommending dismissal of the strict liability claims, the Report found persuasive several

Third Circuit district courts applying Comment k to medical devices and barring strict liability

claims for manufacturing and design defects against manufacturers. (Doc. 37, at 16) (citing

McGrain, 551 F. Supp. 3d at 537; Rosenberg v. C.R. Bard, Inc., 387 F. Supp. 3d 572, 579-81

(E.D. Pa. 2019); Wilson v. Synthes USA Prods., LLC, 116 F. Supp. 3d 463, 465-67 (E.D. Pa.

2015); Gross, 858 F. Supp. 2d at 482).

Plaintiffs do not object to the dismissal on preemption grounds, but instead object to

the dismissal with prejudice, arguing that Comment k does not apply to strict liability

manufacturing or design defect claims and that they could feasibly state a parallel claim if

granted leave to amend. (Doc. 40, at 12). First, Plaintiffs assert that Comment k preserves

manufacturing defect claims because “Comment k insulates sellers from strict liability for

[only those] products that are ‘properly prepared.’” (Doc. 40, at 13). Plaintiffs cite a previous

opinion by this Court in Wallace v. Boston Scientific Corp., which denied a motion to dismiss a

strict liability claim based upon a manufacturing defect. (Doc. 40, at 13); see No. 3:18-CV-

01839, 2018 WL 6981220, at *6 (M.D. Pa. Nov. 29, 2018), report and recommendation adopted,

No. 3:18-CV-1839, 2019 WL 137605 (M.D. Pa. Jan. 8, 2019). The Wallace Court

recommended denying the motion to dismiss because “the Pennsylvania Supreme Court has

had ample opportunity to preclude manufacturing defect claims and has not yet done so,”

suggesting that Comment k does not preclude such claims. (Doc. 40, at 13). Second, Plaintiffs

contend that Comment k also does not apply to design defect claims. (Doc. 40, at 13).

However, Plaintiffs fail to address the Report’s conclusion that design defect claims are barred

by Comment k with any degree of specificity. (Doc. 40, at 13). Instead, they repeat their

argument that manufacturing defect claims are not necessarily barred by Comment k and

assert that the application of Comment k to strict liability design defect claims is at odds with

three cases in this district: Goodling v. Johnson & Johnson, 2022 WL 414285 (M.D. Pa. 2022);

Russell v. Ethicon Inc., 2020 WL 5993774 (M.D. Pa. 2020); and Patchcoski v. WL. Gore &

Associates, Inc., 2020 WL 4335016 (M.D. Pa. 2020). Notably, the three cases that Plaintiffs

cite for its contention that Comment k does not bar strict liability design defect claims do not

claim that the Pennsylvania Supreme Court has yet ruled on Comment k’s application to such

claims one way or the other. See, e.g., Goodling, 2022 WL 414285, at *4; Russell, 2020 WL

5993774, at *7; Patchcoski, 2020 WL 4335016, at *7.

Plaintiffs do not explain in any detailed manner why this Court should break from the

many other courts in this Circuit, discussed supra, that have come to the opposite conclusion

and extended Comment k to bar all strict liability claims, including those for manufacturing

and design defects in medical devices. (Doc. 40); see Kohn v. Ethicon, Inc., 2020 WL 733126,

at *4 (E.D. Pa. Feb. 13, 2020) (predicting that Pennsylvania law would bar strict liability

claims in medical device cases and citing to other cases predicting the same); Rosenberg, 387

F. Supp. 3d at 576–81. In opposition, Defendants maintain that Comment k does apply to

medical devices, suggesting that the body of law dismissing such claims is large, robust, and

recent. (Doc. 42, at 6). They point out that several district courts in this Circuit have, as

recently as 2022, applied Comment k to medical devices and dismissed strict liability claims

on that basis. (Doc. 42, at 6-7).

Plaintiff’s objections as they relate to the strict liability claims will be overruled. First,

as the Report correctly concludes, many district courts in this Circuit have applied Comment

k to medical devices to bar all strict liability claims. McGrain, 551 F. Supp. 3d at 537;

Rosenberg, 387 F. Supp. 3d at 577-81 (“comment k's plain language appears to include

prescription medical devices because ‘prescription’ medical devices, by definition, are

products that require a physician's prescription, just as ‘prescription’ drugs also, by definition,

require a physician's prescription”); Wilson, 116 F. Supp. 3d at 465-67 (finding that Comment

k applies to medical devices and stating “I find this attempt to distinguish medical devices

from prescription drugs to be unpersuasive, as both medical devices AND prescription drugs

could be manufactured in different ways to make them more fit for their purpose.”); Gross,

858 F. Supp. 2d at 482 (holding that Comment k applies to medical device strict liability

claims). The Court agrees with the Report that the reasoning in such cases is persuasive. See

Rosenberg, 387 F. Supp. 3d at 579-81 (barring strict liability claims for medical devices because

both case law and Comment k’s plain language support doing so); McGrain, 551 F. Supp. 3d

at 537 (“In the absence of further guidance from the Pennsylvania Supreme Court[. . . ], this

[c]ourt predicts, as have other courts, that the Pennsylvania Supreme Court would preclude

strict liability manufacturing defect claims against medical device manufacturers”).

Accordingly, this Court agrees with the Report’s reasoning and conclusion that Comment k

applies to all strict liability claims, including those for medical devices. (Doc. 37, at 18). This

Court will therefore adopt the Report’s recommendation that the strict liability claims be

dismissed with prejudice. (Doc. 37, at 18). Defendants motion to dismiss Plaintiffs’ strict

liability claims is GRANTED. (Doc. 27); see McGrain, 551 F. Supp. 3d at 537. Count III is

DISMISSED. (Doc. 22).

A. PLAINTIFFS’ BREACH OF IMPLIED WARRANTIES CLAIM

The Report recommends that Plaintiffs’ breach of implied warranties claim be

dismissed because such claims are preempted by federal law. (Doc. 37, at 25). According to

the Report, and as noted supra, the MDA imposes federal oversight over the approval of

medical devices including pacemakers and bars state tort claims when “such claims would

impose requirements different from, or in addition to the requirements imposed by federal

law.” (Doc. 37, at 11-12) (quoting Conley, 482 F. Supp. 3d at 275 (internal quotations

omitted)) (citing 21 U.S.C. § 360c(C)). The Report provides that Pennsylvania law imposes

its own standards on medical devices which are different or in addition to the federal

standards, through its adoption of the “Uniform Commercial Code formulations of the

implied warranty of fitness for a particular purpose and the implied warranty of

merchantability.” (Doc. 37, at 21) (quoting Bentzley, 827 F. Supp. 2d at 454); see also 13 Pa.

Cons. Stat. §§ 2314, 2315). The Report concludes that allowing a breach of implied warranties

claim based upon the different or additional Pennsylvania standards would violate the

preemption provision of the MDA. (Doc. 37, at 21). This Court agrees.

Defendants object to the Report’s apparent recommendation that the breach of implied

warranties claim be dismissed without prejudice, arguing that the claim should be dismissed

with prejudice.2 (Doc. 38, at 5). Defendants submit that the breach of implied warranties claim

falls within “the purview of Restatement (Second) of Torts, § 402A Comment k,” which bars

certain causes of action against manufacturers of medical devices. (Doc. 38, at 6); see

Henneman v. Zimmer Holdings, Inc., 2012 WL 3528004, at *1 (M.D. Pa. July 11, 2012).

Plaintiffs respond that some courts in the Third Circuit, including this Court in one case, have

2 Although in discussing the breach of implied warranties claims, the Report concludes

that: “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.” (Doc. 37, at 21) (emphasis added), in the final Recommendation

section, the Report states: “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.” (Doc. 37, at 25) (emphasis added).

This Court agrees with Magistrate Judge Carlson’s conclusion in the Discussion section that

the breach of implied warranties claim be dismissed with prejudice, but in the interest of

thoroughness and treatment of all arguments by the parties, will will consider Defendants’

objections to dismissal without prejudice.

“concluded that Comment k does not preclude a manufacturing defect claim.” (Doc. 41, at

5). Therefore, Plaintiffs contend, because their “breach of implied warranty claim is based in

part upon [their] manufacturing defect claim,” the breach of implied warranty claim should

also not be subject to Comment k. (Doc. 41, at 5). Thus, Plaintiffs argue that their breach of

implied warranties claim should not be dismissed with prejudice. (Doc. 41, at 5). It is worth

noting that again, Plaintiffs do not dispute that this claim is preempted. (Doc. 41).

Also discussed supra, the MDA governs federal medical device regulations, including

pacemakers, and preempts any claim against a manufacturer based upon different or

additional state standards. See 21 U.S.C. § 360. 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; Borden, Inc. v. Advent Ink Co., 701 A.2d 255 (Pa. Super. Ct. 1997). In

Pennsylvania, a breach of implied warranty claim is based on state standards. Bentzley, 827 F.

Supp. 2d at 454 (“[i]mplied warranties in Pennsylvania are ‘centered around the accepted

standards of design and manufacture of products in the state of Pennsylvania.’”) (quoting

Davenport v. Medtronic, Inc., 302 F. Supp. 2d 419, 434 (E.D. Pa. 2004); see also 13 Pa. Cons.

Stat. §§ 2314, 2315. These standards are different than the federal standards. See Gross, 858 F.

Supp. 2d at 490 (“it is evident that Pennsylvania state law imposes its own standards on the

merchantability of goods.”). Therefore, because Plaintiffs’ breach of implied warranties claim

is based upon state standards that are different from or additional to federal standards, this

claim is preempted by the MDA. See Gross, 858 F. Supp. 2d at 500-01 (dismissing breach of

implied warranties claim because Pennsylvania imposes requirements that are additional to

federal requirements for medical devices). This Court agrees with the Report’s

recommendation that this claim should be dismissed. (Doc. 37, at 21). Accordingly,

Defendants’ motion to dismiss the breach of implied warranties claim is GRANTED. (Doc.

27); see Gross, 858 F. Supp. 2d at 500-01. Plaintiffs’ breach of implied warranties claim is

DISMISSED with prejudice. (Doc. 22).3

B. NEGLIGENCE AND BREACH OF EXPRESS WARRANTIES CLAIMS

The parties do not object to the Report’s recommendations that (1) the motion be

granted with respect to the negligence claim and the negligence claim be dismissed without

prejudice and (2) the motion be denied as to the breach of express warranties claim. (Doc. 37,

at 25; Doc. 38; Doc. 40). After reviewing the relevant filings, the Court finds no error in

Magistrate Judge Carlson’s conclusion that the negligence claim should be dismissed without

prejudice and that motion to dismiss be denied as to the breach of express warranties claim.

(Doc. 37, at 18-20, 22-25). The Court finds Magistrate Judge Carlson’s analysis to be well-

reasoned and supported by the applicable law. (Doc. 37, at 18-20, 22-25). Accordingly, the

Report’s recommendations (1) that Defendants’ motion to dismiss be granted with respect to

the negligence claim and (2) that Defendants’ motion to dismiss be denied as to the breach of

express warranties claim is adopted. (Doc. 37, at 25). Defendants’ motion to dismiss the

negligence claim is GRANTED. (Doc. 27). Plaintiffs’ negligence claim is DISMISSED

3 As discussed supra in the Comment k legal standard section, Comment k likely

applies to implied warranties claims for medical device defects. As such, this claim is also

barred by Comment k for the same reasons that the strict liability claim is barred by Comment

k. See McDonnell, 2022 WL 221612, at *7 (finding that Comment k bars implied warranties

claims for medical device defects) (citing Terrell, 2014 WL 3746532, *6); Gross, 858 F. Supp.

2d at 491 n.35 (same); Soufflas, 474 F. Supp. 2d at 752 (same); Cogswell, 2015 WL 4393385, at

*5 (same); Kester, 2010 WL 2696467, at *11 (same).

without prejudice. (Doc. 22). Defendants’ motion to dismiss the express warranties claim is

DENIED. (Doc. 27).

C. LOSS OF CONSORTIUM DERIVATIVE CLAIM

According to the Report, Defendants’ motion to dismiss Plaintiffs’ loss of consortium

claim should be denied. (Doc. 37, at 24-25). The Report reasons that the loss of consortium

claim attaches as a valid derivative to the surviving breach of express warranties claim. (Doc.

37, at 24). Defendants’ object to the denial of their motion to dismiss Mrs. Ford’s loss of

consortium claim. (Doc. 38, at 7). Defendants submit that a loss of consortium claim survives

only as a derivative claim, meaning “when the claims of the injured party fail, so too must the

consortium claim of the spouse.” (Doc. 38, at 7). Defendants further argue that because

Plaintiffs’ only surviving claim is the breach of express warranties claim, which Defendants

contend sounds in contract, the loss of consortium claim must be dismissed. (Doc. 38, at 7).

A loss of consortium claim is a derivative claim, meaning its validity is based upon the

availability of recovery for another claim. See Kline v. Zimmer Holdings, Inc., 662 F. App'x 121,

121 n.1 (3d Cir. 2016) (dismissing a loss of consortium claim without a separate analysis when

all other claims failed because a loss of consortium claim is derivative). Typically, a loss of

consortium claim must attach to a valid tort claim. See 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) (“it

is well-settled that: ‘[a] spouse's consortium claim derives only from the injured spouse's right

to recover [under state law] in tort.’”) (quoting Quitmeyer v. Se. Pennsylvania Transp. Auth.

("SEPTA"), 740 F. Supp. 363, 370 (E.D. Pa. 1990)); see also Thomas v. Shutika, No. 4:12-CV-

692, 2012 WL 4050005, at *3 (M.D. Pa. Aug. 24, 2012), report and recommendation adopted,

No. 4:12-CV-692, 2012 WL 4050021 (M.D. Pa. Sept. 13, 2012) (“The defendants' praecipe

[sic] to withdraw this motion to dismiss correctly acknowledges the viability of this derivative

state law tort loss of consortium claim in this case”). However, in limited circumstances a loss

of consortium claim can derive from a contract claim. See Pastin v. Allstate Ins. Co., No.

2:17CV1503, 2018 WL 10229728, at *4 (W.D. Pa. Aug. 17, 2018) (“Under Pennsylvania law,

a loss of consortium claim can be a derivative claim of a breach of contract claim.”). For a

loss of consortium claim to attach to a contract claim, the spouse asserting the loss of

consortium claim must be a party to the same contract from which the loss of consortium

claim derives. See Perloff v. Transamerica Life Ins. Co., 393 F. Supp. 3d 404, 411–12 (E.D. Pa.

2019) (holding that a loss of consortium claim can attach to a contract claim and stating

“although the breach of contract claim survives, a loss of consortium claim may only be based

on a breach of contract where the spouse asserting loss of consortium is a party to the

contract.”); see also Pastin, 2018 WL 10229728, at *4 (allowing a loss of consortium claim to

proceed based upon a contract claim when the asserting spouse was party to the insurance

contract upon which the claim was based).

Here, Mrs. Ford does not allege that she was a party to the contract upon which Mr.

Ford’s breach of express warranties claim is based, and in the Amended Complaint, only Mr.

Ford asserts the breach of express warranties claim. (Doc. 22, at 30-35). Further, Plaintiffs

aver that Defendants made representations about the pacemaker’s safety and effectiveness “to

Richard M. Ford” and that these representations and warranties “were relied by [] Richard

M. Ford when the product was used for its intended purposes.” (Doc. 22, ¶¶ 82, 85). Nowhere

in the Amended Complaint do Plaintiffs allege that Mrs. Ford also relied upon the express

warranties. (Doc. 22, at 30-35). As such, the undersigned will not adopt the Report’s

recommendation to deny the motion to dismiss the loss of consortium claim. Accordingly,

the loss of consortium claim is DISMISSED without prejudice. See Yauger v. Mid-Century Ins.

Co., No. CV 23-4075-KSM, 2024 WL 555883, at *5 (E.D. Pa. Feb. 12, 2024) (dismissing a

loss of consortium claim without prejudice when it was not clear whether the spouse asserting

the derivative claim was party to the contract from which the loss of consortium claim

derived).

III. CONCLUSION

The Court has reviewed the Report and Recommendation of Magistrate Judge

Carlson and agrees with its well-reasoned conclusions in all respects except for the loss of

consortium claim. (Doc. 37). Plaintiffs’ objections to the Report are OVERRULED. (Doc.

40). Defendants’ objection that the loss of consortium claim be dismissed without prejudice

is SUSTAINED. (Doc. 38). Defendants’ motion to dismiss is GRANTED in part with

respect to the strict liability, breach of implied warranties, negligence, and loss of consortium

claims in Counts I, II, III, and IV. (Doc. 27). Defendants’ motion to dismiss is DENIED in

part with respect to the breach of express warranties claim in Count III. (Doc. 27). Plaintiffs’

strict liability and breach of implied warranties claims are DISMISSED with prejudice. (Doc.

22). Plaintiffs’ negligence and loss of consortium claims are DISMISSED without prejudice.

(Doc. 22). An appropriate Order follows.

BY THE COURT:

Date: September 23, 2024 s/ Karoline Mehalchick

KAROLINE MEHALCHICK

United States District Judge