Opinion
C/A 2:19-cv-3495-DCN-MHC
06-10-2021
Jane René Silver, Plaintiff, v. Bayer Healthcare Pharmaceuticals, Inc.; South Carolina CVS Pharmacy, LLC; and McKesson Corporation, Defendants.
REPORT AND RECOMMENDATION
Molly H. Cherry, United States Magistrate Judge.
This case is about Eovist, a gadolinium-based contrast agent (“GBCA”) approved by the federal Food and Drug Administration (“FDA”) and administered intravenously by medical professionals for certain diagnostic purposes. Presently before the Court is a Motion to Dismiss, ECF No. 98 (“Motion”), filed pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure by Defendant Bayer Healthcare Pharmaceuticals, Inc. (“Bayer”). Plaintiff, proceeding pro se, filed a Response in opposition to the Motion. See ECF No. 115. Bayer filed a Reply. ECF No. 121. The Motion is ripe for review.
Plaintiff, without seeking leave from the Court, also filed a Sur-reply. ECF No. 122. For purposes of making this Report and Recommendation, the undersigned has not considered the Sur-reply, as it is not properly before the Court. See Stanfield v. Charleston Cnty. Court, No. 2:15-CV-0756-PMD-MGB, 2015 WL 4929186, at *4 n.2 (D.S.C. Aug. 18, 2015) (explaining that “neither the Federal Rules of Civil Procedure nor the Local Civil Rules permit the filing of a sur-reply without leave of the Court”). Nevertheless, having reviewed the Sur-reply, the undersigned concludes that the arguments contained therein would not alter the recommendation set forth herein.
This Report and Recommendation is entered for review by the District Judge.
All pretrial proceedings in this case were referred to the undersigned United States Magistrate Judge pursuant to the provisions of 28 U.S.C. § 636(b)(1)(A) and (B) and Local Rule 73.02(B)(2)(e), D.S.C.
PROCEDURAL HISTORY
Plaintiff, proceeding pro se, filed her original Complaint in this Court on December 17, 2019, naming the following three defendants: (1) Bayer; (2) CVS HealthOne; and (3) McKesson Specialty. ECF No. 1. On June 16, 2020, Defendant Bayer filed a motion to dismiss for failure to state a claim. ECF No. 23. On July 13, 2020, Plaintiff filed a Response in opposition to Bayer's first motion to dismiss. ECF No. 35.
On August 19, 2020, Plaintiff filed a Motion to Amend the Complaint, seeking to change the name of the Defendant CVS HealthOne to “South Carolina CVS Pharmacy, LLC.” ECF No. 56 at 1-2. On September 29, 2020, the Court entered an Order granting Plaintiffs Motion to Amend the Complaint to change Defendant “McKesson Specialty” to “McKesson Corporation” and to name “South Carolina CVS Pharmacy, LLC” as a new defendant in place of “CVS HealthOne.” ECF No. 65 at 7. Plaintiffs Motion to Amend did not seek to add any causes of action, nor did the Court authorize any other amendments to the Complaint. ECF Nos. 56 and 65.
On November 17, 2020, Plaintiff filed her Amended Complaint against Defendants Bayer, South Carolina CVS Pharmacy LLC (“SC CVS”), and McKesson Corporation (“McKesson”). In her Amended Complaint, Plaintiff added numerous “claims, ” asserting the following nine causes of action against each Defendant: (1) a product liability claim premised on (a) design defect, (b) manufacturing defect, and (c) warnings defect; (2) punitive damages; (3) breach of express warranty; (4) strict liability; (5) criminal and gross negligence; (6) tolling, fraudulent concealment, and omission; (7) mens rea; (8) nonfeasance and malfeasance; and (9) personal injury. ECF No. 75 at 9. Plaintiff attached almost 1200 pages of documents to the Amended Complaint that were not part of her initial Complaint, nor otherwise approved by the Court to be included with the Amended Complaint. ECF Nos. 75-1-75-13. Bayer subsequently filed the pending Motion to Dismiss.
Plaintiffs claims for (2) punitive damages; (5) criminal negligence; (6) tolling, fraudulent concealment, and omission; (7) mens rea; (8) nonfeasance and malfeasance and (9) personal injury are not, in fact, viable causes of action under the law but, instead, are remedies, criminal claims, elements of claims, or legal arguments, as addressed in detail below.
Bayer's first motion to dismiss was mooted when Plaintiff filed her Amended Complaint. See ECF No. 80.
The facts, and all inferences therefrom, are construed in the light most favorable to Plaintiff for purposes of ruling on Bayer's Motion to Dismiss. See E.I. du Pont de Nemours & Co. v. Kolon Indus., Inc., 637 F.3d 435, 440 (4th Cir. 2011).
Plaintiff alleges that on December 30, 2016, she “contracted with Defendants to provide a safe Gadolinium Based Contrast Agent (GBCA) for a basic MRI at her local hospital, Tidelands Waccamaw Hospital [in] . . . Murrells Inlet, ” South Carolina. ECF No. 75 at 3. Plaintiff was concerned about metals retention, and she had previously declined a procedure recommended by her cardiologist when she learned of possible retention. Id. at 21. “After questioning the Radiologist about possible retention of [GBCA], Plaintiff was assured that there had never been a case of Retention in a person with healthy kidneys and the agent would be out of her system in two hours.” Id. at 4, 6. The radiologist “proceeded to tell Plaintiff that there was no way to tell if her liver lesions were cancerous unless the [GBCA] Eovist was used.” Id. at 4, 6. Plaintiff alleges that she was injected with Eovist on December 30, 2016. Id. at 6.
Plaintiff alleges that Eovist, a linear ionic product, was approved by the FDA in 2008, id. at 5-6, “is manufactured, sold and marketed by Bayer, ” and is “distributed by McKesson and retailed by CVS, ” id. at 4, 6. She further alleges that “[p]rior to December 30, 2016, Defendants had known Gadolinium is retained in people with normal kidney function but didn't understand why and still don't.” Id. at 31. According to Plaintiff, in December 2016 “there was no Warning on the Eovist Label that a person with normal kidneys could retain the heavy metal GBCA Eovist that was injected into the Plaintiff.” Id. at 4. She alleges that the lack of warning “caused Plaintiffs doctor to falsely reassure her that there was no danger for patients with healthy kidneys.” Id. at 16. Plaintiff also contends that the label failed to warn that patients are more likely to retain gadolinium when they use linear GBCAs than when they use macrocyclic GBCAs. Id. at 6, 16.
According to Plaintiff, within a week of receiving Eovist she experienced “unexplained symptoms, ” including “[e]xplosive flatulence, random sour spittle, random knuckle bleeding, random red eyes, groin pain, rib pain, brain fog, ” swelling, fibrosis, stiff muscles, skin tightening, and increased sensitivities to pesticides, among other effects. Id. at 7. Plaintiff alleges that she lost her job in June 2017 because she was no longer able to complete the tasks she had easily done prior to the injection. Id. Also in June 2017, Plaintiffs doctor determined “that the technician had overdosed the Plaintiff with Eovist.” Id. at 7-8.
Six months after Plaintiff received the Eovist injection, she discovered that “she had retained the GBCA.” Id. at 4. Plaintiff alleges that this retention caused “Gadolinium Deposition Disease” (“GDD”). See Id. at 5; see also Id. at 16, 29, 35. According to Plaintiff, her doctor prescribed “80 sessions of Hyperbaric Oxygen, ” but she was unable to get the treatment. Id. at 8. Plaintiff alleges that she was not able to begin “proper treatment to attempt to eliminate the Gadolinium” until almost eleven months after the injection “because of obfuscation and disregard by medical professionals and Defendants in regard to GBCA retention and its effects.” Id. She alleges that she had “to relocate to Hilton Head for five months to receive chelation treatments and access a hyperbaric oxygen chamber several times each week, while also having necessary psychotherapy sessions, ” and she had to refinance her home and deplete her entire life's savings in order to pay for the treatments. Id. at 9. She asserts that “she is far from being close to the mental and physical abilities she had prior to the injection of Eovist on December 30, 2016.” Id.
Plaintiff alleges that it was not until two years after she received an injection of Eovist that a warning was added to the label regarding long-term retention of gadolinium in people with healthy kidneys. Id. at 5, 16, 19 (citing April 26, 2018 Drug Safety-related Labeling Changes for Eovist (NDA-022090)). The version of the Eovist label that was in effect on December 30, 2016, the date Plaintiff received the Eovist injection, had been approved in March 2015. The label was next updated on April 26, 2018, to add the following statement under the highlighted “WARNINGS AND PRECAUTIONS” on the first page of the physician's label: “Gadolinium is retained for months or years in brain, bone, and other organs. (5.3)[.]” See April 2018 EOVIST Physician Label, https://www.accessdata.fda.gov/drugsatfdadocs/label/2018/022090s014lbl.pdf
Also available at https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index. cfm?event'searchdetail.page&DrugNameID=1552 (last visited 5/24/2021).
SeeMarch 2015 EOVIST Physician Label, availableat https://www.accessdata.fda.gov/drugsatfdadocs/label/2015/022090s011lbl.pdf The Court can take judicial notice of the fact that this label, which is available on the FDA's public website, was approved in March 2015. See Goldfarb v. Mayor & City Council of Baltimore, 791 F.3d 500, 508 (4th Cir. 2015) (To determine a motion to dismiss, “a court may properly take judicial notice of ‘matters of public record' and other information that, under Federal Rule of Evidence 201, constitute ‘adjudicative facts.'”) (citing Philips v. Pitt Cnty. Mem 'l Hosp., 572 F.3d 176, 180 (4th Cir. 2009); Fed.R.Evid. 201(b) (stating, in relevant part, that a “court may judicially notice a fact that is not subject to reasonable dispute because it” “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned”)).
Pursuant to the relevant FDA regulation, this highlighted “Warnings and Precautions” section of the label contains a “concise summary of the most clinically significant information required under [the longer ‘Warnings and Precautions' section, pursuant to 21 C.F.R. § 201.57(c)(6)], with any appropriate subheadings, including information that would affect decisions about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug, and measures that can be taken to prevent or mitigate harm.” 21 C.F.R. § 201.57(a)(10) (emphasis added).
In addition, the following language was added under the longer, more detailed WARNINGS AND PRECAUTIONS section starting on page 3 of the label:
5.3 Gadolinium Retention
Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (for example, brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate di sodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)].
Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function [see Warnings and Precautions (5.1)]. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention [see Adverse Reactions (6.2)].
While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies particularly closely spaced studies, when possible. Id. at 4; see ECF No. 75 at 20; ECF No. 75-3 at 10. The revised label also adds the following “General Precaution” regarding Gadolinium Retention:
Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions (5.3)].April 2018 EOVIST Physician Label at 13; ECF No. 75-3 at 19. According to Plaintiff, these warnings came “[t]wo years too late.” ECF No. 75 at 21.
LEGAL STANDARD
“The purpose of a Rule 12(b)(6) motion is to test the sufficiency of a complaint.” Williams v. Preiss-Wal Pat III, LLC, 17 F.Supp.3d 528, 531 (D.S.C. 2014). Pursuant to Rule 8 of the Federal Rules of Civil Procedure, a pleading must contain “a short and plain statement of the claim showing that the pleader is entitled to relief, ” Fed.R.Civ.P. 8(a)(2), such that the defendant will have “fair notice of what the claim is and the grounds upon which it rests, ” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (internal quotation marks omitted). “[T]he facts alleged ‘must be enough to raise a right to relief above the speculative level' and must provide ‘enough facts to state a claim to relief that is plausible on its face.'” Robinson v. Am. Honda Motor Co., 551 F.3d 218, 222 (4th Cir. 2009) (quoting Twombly, 550 U.S. at 555, 570). “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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
When considering a Rule 12(b)(6) motion, the court is required to accept the allegations in the pleading as true and draw all reasonable factual inferences in favor of the party opposing the motion. E.I. du Pont de Nemours & Co. v. Kolon Indus., Inc., 637 F.3d 435, 440 (4th Cir. 2011). Moreover, the court must evaluate “the complaint in its entirety, as well as documents attached or incorporated into the complaint.” Id. at 448. The court may consider a document not attached to the complaint, so long as the document “was integral to and explicitly relied on in the complaint, ” and there is no authenticity challenge. Id. (quoting Phillips v. LCI Int'l, Inc., 190 F.3d 609, 618 (4th Cir. 1999)). “A complaint should not be dismissed as long as it provides sufficient detail about the claim to show that the plaintiff has a more-than-conceivable chance of success on the merits.” Goldfarb v. Mayor & City Council of Balt., 791 F.3d 500, 511 (4th Cir. 2015) (internal quotation marks and brackets omitted).
“While no absolute bar exists, a motion to dismiss under Rule 12(b)(6) does not typically resolve the applicability of defenses to a well-pled claim.” Id. at 508; (citing Tobey v. Jones, 706 F.3d 379, 387 (4th Cir. 2013) (stating that a motion to dismiss under Rule 12(b)(6) “does not resolve contests surrounding facts, the merits of a claim, or the applicability of defenses”)). However, “in the relatively rare circumstances where facts sufficient to rule on an affirmative defense are alleged in the complaint, the defense may be reached by a motion to dismiss filed under Rule 12(b)(6). This principle only applies, however, if all facts necessary to the affirmative defense clearly appear on the face of the complaint.” Goodman v. Praxair, Inc., 494 F.3d 458, 464 (4th Cir. 2007) (en banc) (emphasis in original) (internal quotation marks and bracket omitted).
Pro se pleadings are given liberal construction and are held to a less stringent standard than formal pleadings drafted by attorneys. Erickson v. Pardus, 551 U.S. 89, 94 (2007). However, principles requiring generous construction of pro se complaints do “not require courts to conjure up questions never squarely presented to them.” Beaudett v. City of Hampton, 775 F.2d 1274, 1278 (4th Cir. 1985). Giving liberal construction does not mean that the court can ignore a pro se plaintiffs clear failure to allege facts that set forth a cognizable claim. See Weller v. Dept. of Soc. Servs., City of Baltimore, 901 F.2d 387, 391 (4th Cir. 1990) (“Only those questions which are squarely presented to a court may properly be addressed.”). Thus, even under this less stringent standard, a pro se complaint is still subject to summary dismissal. Estelle, 429 U.S. at 106-07.
DISCUSSION
Bayer moves to dismiss Plaintiffs Amended Complaint in its entirety for failure to state a claim upon which relief can be granted. Specifically, relying on its affirmative defense, Bayer argues that all of Plaintiff s claims against Bayer are preempted by federal law. Alternatively,
Bayer argues that Plaintiff has failed to plead facts sufficient to state any plausible claim under state law.
I. Preemption
“A fundamental principle of the Constitution is that Congress has the power to preempt state law.” Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372 (2000). In the pharmaceutical context, “federal preemption occurs when it is ‘impossible for a private party to comply with both state and federal requirements.'” Knight v. Boehringer Ingelheim Pharms., Inc., 984 F.3d 329, 337 (4th Cir. 2021) (quoting Merck Sharp & Dohme Corp. v. Albrecht, -- U.S. --, 139 S.Ct. 1668, 1672 (2019)); see PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011). Bayer claims that impossibility preemption is applicable to Plaintiffs alleged warning and design defect claims because it would have been impossible for Bayer to comply with both federal regulations and South Carolina law.
“[F]ederal courts sitting in diversity apply state substantive law and federal procedural law.” Gasperini v. Ctr. for Humanities, Inc., 518 U.S. 415, 427 (1996); see also Erie R. Co. v. Tompkins, 304 U.S. 64, 78 (1938). Because Plaintiff alleges that she was injected with Eovist while in South Carolina, Plaintiffs substantive claims are governed by South Carolina law. No. party contests that South Carolina law applies.
A. Preemption of Warning Defect Claim
“It is a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.” Wyeth v. Levine, 555 U.S. 555, 570-71 (2009). Accordingly, the brand name drug manufacturer “is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.” Id. at 571 (citations omitted).
Federal law requires FDA approval of a New Drug Application prior to marketing a new drug in the United States. Following the FDA's approval of a new drug, “[t]here are two ways that a brand name drug manufacturer can change a drug's label that are pertinent here: (1) secure FDA approval or (2) make a change under the Changes Being Effected (CBE) regulations.” In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. & Prod. Liab. Litig., 185 F.Supp.3d 761, 768 (D.S.C. 2016) (citing 21 C.F.R. §§ 314.70(b), 314.70(c)(6)(iii)). “[I]f a drug manufacturer must obtain FDA approval to take action to comply with state law, then the state law is preempted.” Id. (citing Mensing, 564 U.S. at 623-24 (“[W]hen a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”)).
1. The CBE Regulation
Under FDA regulations, manufacturers cannot unilaterally change the Medication Guide without prior FDA approval because doing so is considered a “major” change. Knight, 984 F.3d at 337 (citing 21 C.F.R. § 314.70(b) (explaining that “any change to a Medication Guide” requires “supplement submission and approval prior to distribution of the product made using the change”)). However, under certain circumstances, the FDA's CBE regulation permits a drug manufacturer to make unilateral changes to warnings on a drug's physician label. See Id. at 337-38; 21 C.F.R. § 314.70(c)(6).
The CBE regulation “permits drug manufacturers to change a label to ‘reflect newly acquired information' if the changes ‘add or strengthen a . . . warning' for which there is ‘evidence of a casual association,' without prior approval from the FDA.” Albrecht, 139 S.Ct. at 1679 (internal citations omitted). However, the manufacturer's ability to make changes under the CBE regulation is not plenary; rather, the changes must be based on “newly acquired information” and, in relevant part, be to “add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under [21 C.F.R.] § 201.57(c).” 21 C.F.R. § 314.70(c)(6)(iii)(A). Relevant here, 21 C.F.R. § 201.57(c) provides that the “Warnings and precautions” section of the label
must describe clinically significant adverse reactions (including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the drug), other potential safety hazards (including those that are expected for the pharmacological class or those resulting from drug/drug interactions), limitations in use imposed by them (e.g., avoiding certain concomitant therapy), and steps that should be taken if they occur (e.g., dosage modification). . . . In accordance with [21 C.F.R.] § 314.70 . . ., the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.21 C.F.R. § 201.57(c)(6)(i) (emphasis added).
Section 201.57(c)(7) defines an “adverse reaction” as “an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” 21 C.F.R. § 201.57(c)(7). The parties have not pointed to, and the undersigned has not found, definitions in the applicable regulations for the following terms used in 21 C.F.R. § 201.57(c): “clinically significant, ” “safety hazard, ” or “hazard.” However, in the FDA's preamble to the Final Rule setting forth § 201.57, the FDA's response to public comments suggests that “clinically significant” means “hav[ing] significant impact on therapeutic decisionmaking.” Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 FR 3922-01, 3946 (Jan. 24, 2006). A plain reading of the regulation, therefore, suggests that an “adverse reaction” is a type of “safety hazard” and that any type of “hazard” may trigger the requirement to update a warning label pursuant to 21 C.F.R. § 314.70, so long as that “hazard” is “clinically significant” (i.e., has significant impact on therapeutic decisionmaking) and there is reasonable evidence of a causal association with a drug. See 21 C.F.R. § 201.57(c)(6)(i).
Applicable regulations define “newly acquired information” for purposes of the CBE regulation as follows:
Newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.21 C.F.R. § 314.3(b). Such information “is not limited to new data, but also encompasses new analyses of previously submitted data.” Wyeth, 555 U.S. at 569 (internal quotation marks omitted). This “rule accounts for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments.” Id. Nonetheless, the new analysis must reveal “risks of a different type or of greater severity or frequency” to constitute “newly acquired information.” Id. (internal citation and quotation marks omitted).
“[A]ny claim that a drug label should be changed based on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.” In re Lipitor, 185 F.Supp.3d at 769. However, claims that a drug label should be changed based on “newly acquired information” not submitted to the FDA are not preempted by federal law. Id.
Moreover, the FDA is empowered to reject labeling changes that a manufacturer has unilaterally made under the CBE regulation. See 21 C.F.R. §§ 314.70(c)(6), (7); see also Albrecht, 139 S.Ct. at 1677 (“[T]he FDA retains authority to reject labeling changes made pursuant to the CBE regulation in its review of the manufacturer's supplemental application, just as it retains such authority in reviewing all supplemental applications.”) (quoting Wyeth, 555 U.S. at 571). However, absent “clear evidence” that the FDA would not have approved a change to the label, courts should not find that federal preemption foreclosed amendments to the label under the CBE regulation. Wyeth, 555 U.S. at 571.
a. Plaintiff's Pleadings Regarding Warning and Newly Acquired Information
Bayer argues that Plaintiff has failed to plead “newly acquired information” that would have allowed Bayer to unilaterally add Plaintiff s desired warning to Eovist's FDA-approved label. ECF No. 98-1 at 9. According to Bayer, “Plaintiff must allege new information that arose after March 2015 that satisfied the CBE regulation and permitted Bayer to add Plaintiffs desired warning to Eovist's label by December 2016.” Id. at 11; see Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (“[T]o state a claim for failure-to-warn that is not preempted by the [Food, Drug, and Cosmetic Act (FDCA)], a plaintiff must plead a labeling deficiency that [the pharmaceutical company] could have corrected using the CBE regulation.”) (citation and internal quotation marks omitted).
i. Warning
As an initial matter, the undersigned notes that there is some dispute regarding what Plaintiffs “desired warning” is. Bayer, without citing to Plaintiff s Amended Complaint, describes Plaintiffs “desired warning” simply and solely as a warning “that gadolinium retention from intravenous use of GBCAs causes adverse health effects in patients with normal kidney function.” ECF No. 98-1 at 11. Plaintiff, however, suggests in her Response that the allegations in her Amended Complaint are more robust, arguing the label should also have warned that gadolinium is retained in patients with healthy kidneys for unknown lengths of time and that linear products pose a higher risk of retention than macrocyclic products. See ECF No. 115 at 14, 17-18.
A review of the Amended Complaint reveals that Plaintiff asserts a plethora of warnings that were allegedly required by state law, including warnings that gadolinium can be retained in the body of a person with healthy kidneys, that linear GBCAs result in higher retention than macrocyclic GBCAs, and that Eovist can cause “Gadolinium-induced diseases for which there are no known cures.” See ECF No. 75 at 6-7, ¶ 1(a), (b) and (e); see also Id. at 16 (alleging that Eovist “had no adequate warning for prospective users that indicated the product could potentially cause injury unless one's kidneys were not functioning” or “that the linear product is less safe than other alternatives”).
Plaintiff also alleges that she was not warned that “[t]ransmetallation can occur if patient has consumed Zinc supplements”; “[cumulative doses increases the Risk of Retention diseases, such as NSF”; GBCAs can be retained in people with impaired ability to remove toxins; there is an increased risk of NSF in people on any sort of dialysis; the drug is “known to disassociate in patient[s] if they are acidic”; and “oxidation agents should be avoided.” ECF No. 75 at 6-7, ¶¶ 1(c), (d), (f), (g), (h) and (i). Because Plaintiffs argument centers on the three warnings identified above and there is no allegation of newly acquired information sufficient to satisfy the CBE regulation requirements as to the warnings identified in this footnote, the undersigned recommends granting Bayer's Motion to Dismiss as to the warning defects alleged in ¶¶ 1(c), (d), (f), (g), (h) and (i) of the Amended Complaint. See Id. at 6-7.
ii. Newly Acquired Information
Plaintiff argues that her Amended Complaint does, in fact, allege newly acquired information regarding gadolinium retention, linear GBCAs and Gadolinium-induced diseases that arose between March 2015 and December 2016. ECF No. 115 at 14. Specifically, Plaintiff cites a January 2016 literature review noting that “recently, residual gadolinium has been detected in patients with normal renal function” and that “this phenomenon has been linked to previous administration of linear GBCA, but not macrocyclic agents.” ECF Nos. 75 at 16-17; 75-2 at 36. She also relies on a study published in March 2015 finding that “intravenous administration of GBCA is associated with dose-dependent deposition in neuronal tissue that is unrelated to renal function, age, or interval between exposure and death.” ECF No. 75-2 at 81; see also ECF Nos. 75 at 32, 75-4 at 52 (April 2016 literature review noting “rapidly growing body of data that demonstrate that gadolinium accumulates in tissues (including brain, bone and kidneys) of patients exposed to GBCAs during [MRIs], despite normal renal function”). She cites a small case study published in October 2016 reporting on apparent gadolinium toxicity in patients with normal renal function. ECF Nos. 75 at 31, 75-4 at 24; see also ECF Nos. 75 at 31, 75-4 at 30 (August 2016 article reviewing disorders related to gadolinium retention, describing “gadolinium deposition disease” as “a new entity that represents symptomatic deposition of gadolinium in individuals with normal renal function, ” and noting that “macrocyclic agents are more stable than linear agents and have been shown to have fewer instances of disease or deposition state”).
The undersigned has not considered the many new exhibits that Plaintiff attached to her Response, as the Court's review on a motion to dismiss generally is limited to the allegations in the complaint and the documents attached thereto. See Kolon Indus., Inc., 637 F.3d at 448.
Viewing the Amended Complaint in the light most favorable to Plaintiff, the undersigned finds that Plaintiffs Amended Complaint alleges newly acquired information that arose after the FDA's approval of the March 2015 label and before Plaintiff was administered Eovist in December 2016 regarding reasonable evidence of a causal association between Eovist, a linear GBCA, and a “clinically significant hazard.” See 21 C.F.R. §§ 201.57(c)(6)(i), 314.70(c)(6)(iii)(A); see also supra, notes 8 & 10. To be clear, the undersigned makes no finding on the merits of whether the aforementioned information constitutes “newly acquired information” or otherwise satisfies the requirements under the applicable regulations. See Tobey, 706 F.3d at 387 (stating that a motion to dismiss under Rule 12(b)(6) “does not resolve contests surrounding the facts, the merits of a claim or the applicability of defenses”). However, at this stage in the proceedings, Plaintiff has set forth sufficient allegations of newly acquired information for purposes of a labeling deficiency claim. See Dennis v. Bayer Healthcare Pharms. Inc., No. 318CV00491KDBDCK, 2020 WL 534307, at *8 (W.D. N.C. Feb. 3, 2020) (denying motion to dismiss and finding that Plaintiffs citations to two studies documenting gadolinium retention satisfied newly acquired information requirement for purposes of the motion); cf. Goodell v. Bayer Healthcare Pharm. Inc., No. 18-CV-10694-IT, 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019) (dismissing plaintiffs claims based on inadequate label on preemption grounds because the complaint was void of “allegations that Bayer has new information . . . that it could have or should have amended the label pursuant to the CBE regulation”).
Bayer argues that articles related to the mere retention of gadolinium in patients' bodies does not evidence any hazard “caused by” retention, much less a clinically significant hazard caused by retention. ECF No. 98-1 at 13. However, Plaintiff alleges that retention alone is a clinically significant hazard, not just that retention “caused” a different clinically significant hazard. Moreover, Plaintiff cites at least two articles, including a small case study, documenting gadolinium toxicity in patients with normal renal function. ECF Nos. 75 at 31, 75-4 at 24, 30. As such, the undersigned finds, at this stage of the proceedings, that Plaintiff has set forth sufficient allegations, as well as cited articles, to support her claim of newly acquired evidence showing a causal association between linear GBCAs and a clinically significant hazard.
Bayer cites many cases outside of the Fourth Circuit that have found the opposite-that is, that a plaintiffs claim was preempted despite allegations of newly acquired information related to gadolinium retention. See, e.g., McGrath v. Bayer HealthCare Pharm. Inc., 393 F.Supp.3d 161, 168 (E.D.N.Y. 2019); Mahnke v. Bayer Corp., No. 2:19-cv-07271, 2019 WL 8621437, at *3-5 (CD. Cal. Dec. 10, 2019); Klein v. Bayer HealthCare Pharm. Inc., No. 2:18-cv-01424, 2019 WL 3945652 (D. Nev. Aug. 21, 2019). These cases, however, appear to limit their analyses of the standard for inclusion in the labeling under 21 C.F.R. § 201.57(c) to a “clinically significant adverse reaction, ” as opposed to the broader “clinically significant hazard” set forth in the regulation. Section 201.57(c)(6)(i) provides, that the full “Warning and Precautions” section of the label “must describe clinically significant adverse reactions . . ., other potential safety hazards (including those that are expected for the pharmacological class or those resulting from drug/drug interactions), limitations in use imposed by them . . ., and steps that should be taken if they occur (e.g., dosage modification). . . . In accordance with [21 C.F.R.] § 314.70 . . ., the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.” 21 C.F.R. § 201.57(c)(6)(i) (emphasis added). Rather than quote the “clinically significant hazard” language used in the second sentence of the regulation, these cases, when articulating the standard, omit any mention of a “hazard” and instead use only “adverse reaction” from the first sentence. See Sabol v. Bayer Healthcare Pharm., Inc., 439 F.Supp.3d 131, 147 (S.D.N.Y. 2020) (“The newly acquired information must provide ‘reasonable evidence of a causal association' of a ‘clinically significant adverse reaction[ ]' to a drug.”) (emphasis added) (citing 21 C.F.R. § 201.57(c)(6)(i))); Klein, 2019 WL 3945652, at *5 (same). Indeed, at least one case appears to misquote the regulation altogether. See McGrath, 393 F.Supp.3d at 167 (“Moreover, newly acquired information ‘must provide reasonable evidence of a causal association of a clinically significant adverse reaction linked to a drug.'”) (emphasis in original) (citing 21 C.F.R. § 201.57(c)(6)(i)). Accordingly, the undersigned does not find these cases persuasive on this point, as they appear to be applying a somewhat different standard than the one set forth in the regulation.
b. Whether Bayer Can Show Clear Evidence That the FDA Would Have Rejected Plaintiff's Desired Labeling Changes
Bayer argues that, even if Plaintiff has adequately pled newly acquired information, her warning defect claims are still preempted for the independent reason that “there is clear evidence that the FDA would not have approved a warning about the alleged adverse health consequences of a GBCA injection.” ECF No. 98-1 at 15. Bayer points to the portion of the April 2018 revised GBCA label that states “clinical consequences of gadolinium retention have not been established in patients with normal renal function.” Specifically, Bayer contends that the Amended Complaint and “judicially-noticeable FDA materials” attached to Bayer's motion to dismiss clearly demonstrate that the FDA considered precisely the risk Plaintiff claims should have been described in Eovist's warnings, and then approved a label explicitly denying that scientific evidence demonstrated that risk, such that there is clear evidence that the FDA would have rejected Plaintiffs desired label change. Id. Accordingly, Bayer contends, all of Plaintiff s warning defect claims should be dismissed as preempted.
“The impossibility pre-emption defense places the burden on [Bayer]-and not Plaintiff- to support that defense with ‘clear evidence,' which is evidence provided by [Bayer] that ‘shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug's label to include that warning.” Gremo v. Bayer Corp., 469 F.Supp.3d 240, 254 (D.N.J. 2020) (quoting Albrecht, 139 S.Ct. at 1672). However, the production or consideration of evidence outside of the complaint is generally inappropriate at this stage of the proceedings. See Tobey, 706 F.3d at 387; cf. Kolon Indus., Inc., 637 F.3d at 440, 448. Accordingly, the undersigned largely agrees with courts that have found that “[w]hether or not the FDA would have rejected the label requested is not something that can be decided on the pleadings.” Dennis, 2020 WL 534307, at *8 (W.D. N.C. case denying Bayer's motion to dismiss on preemption grounds); Gremo, 469 F.Supp.3d at 254 (“Even though ‘a judge, not the jury, must decide the pre-emption question,' that question is not properly before the Court to answer at this time.”) (quoting Merck, 139 S.Ct. at 1676). Nevertheless, in instances where “all facts necessary to the affirmative defense clearly appear on the face of the complaint, ” the undersigned finds that the Court could otherwise determine the issue of preemption at this stage. See Goodman, 494 F.3d at 464 (emphasis in original).
In its Reply, Bayer attempts to distinguish Gremo by arguing that “unlike in the many opinions cited [by Bayer], the [Gremo] court declined to take judicial notice of the defendants' exhibits demonstrating the FDA's actions regarding GBCA safety, whereas Bayer has explained why doing so is appropriate.” ECF No. 121 at 5. Indeed, in addition to asking the Court to take judicial notice of the FDA-approved Eovist label in effect in December 2016 and the April 2018 and August 2018 revised labels, see ECF Nos. 98-3, 98-4 & 98-6, Bayer also asks the Court to take judicial notice of an FDA Drug Safety Communication (ECF No. 98-2), a Medical Imaging Drugs Advisory Committee Meeting Briefing Document (ECF No. 98-7), and an Advisory Committee Meeting Notice (ECF No. 98-8) and Agenda (ECF No. 98-9). Bayer contends that these documents clearly demonstrate that the FDA would have rejected Plaintiffs desired warning label. However, the Fourth Circuit has cautioned that judicial notice should not “be used as an expedient for courts to consider ‘matters beyond the pleadings' and thereby upset the procedural rights of litigants to present evidence on disputed matters.” Waugh Chapel S., LLC v. United Food & Com. Workers Union Loc. 27, 728 F.3d 354, 360 (4th Cir. 2013) (citations omitted); see Goldfarb, 791 F.3d at 511 (vacating order granting motion to dismiss and refraining “from mining the exhibits” of a motion to dismiss “to determine what, if anything, [the court] could take judicial notice of). Given the foregoing Fourth Circuit law, it is unsurprising that the Western District of North Carolina concluded, in ruling on a motion to dismiss filed by Bayer, that “[w]hether or not the FDA would have rejected the label requested is not something that can be decided on the pleadings.” Dennis, 2020 WL 534307, at *8. The undersigned finds that while it is appropriate to take judicial notice of the dates of the various Eovist labels, the Court, at this early stage of the litigation, should decline to take judicial notice of other FDA statements and meeting documents, particularly where the Court is asked to take notice of Bayer's interpretation of those documents. See Ohio Valley Envt'l Coal. v. Aracoma Coal Co., 556 F.3d 177, 216 (4th Cir. 2009) (declining to take judicial notice of permit decision documents and other exhibits because the party seeking notice sought “notice of its own interpretation of the contents of those documents” and not just notice of their existence).
Here, however, viewing the Amended Complaint and all reasonable inferences therefrom in the light most favorable to Plaintiff, the undersigned cannot conclude from the face of the Amended Complaint that the FDA would have rejected, prior to December 2016, the warnings that Plaintiff alleges should have been contained on the Eovist label. See Dennis, 2020 WL 534307, at *8. Accordingly, the undersigned recommends that Bayer's Motion to dismiss the warning claim as preempted be denied at this time.
The undersigned notes, however, that Bayer may very well be able to establish its full preemption defense at a later stage of litigation. See, e.g., Knight, 984 F.3d at 337 (finding that post-trial motion for judgment as a matter of law should have been granted on preemption grounds because evidence did not establish that manufacturer had “newly acquired information” that would have justified a unilateral change to physician label).
B. Preemption of Design Defect Claims
Bayer argues that Plaintiffs defective design claim is preempted for two reasons: (1) FDA regulations prohibit pharmaceutical manufacturers from unilaterally altering drug designs, and (2) Plaintiff relies on a “stop-selling” theory, which is preempted. ECF No. 98-1 at 18-20 (citing, e.g., Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015)).
A plaintiff proceeding under a design defect claim in South Carolina must “point to a design flaw in the product and show how his alternative design would have prevented the product from being unreasonably dangerous.” Graves v. CAS Med. Sys., Inc., 735 S.E.2d 650, 658 (S.C. 2012) (quoting Branham v. Ford Motor Co., 701 S.E.2d 5, 16 (S.C. 2010)). In her design defect claim, Plaintiff alleges that there were “three parts that were defective in the creation of . . . Eovist”: (1) “it is a linear design, which many studies and scientific papers have proven to be less safe and less stable” and leads to retention “more often than Macrocyclic design”; (2) “it is designed to clear half from the Liver and half from the Kidneys, ” but “it is recommended for Liver Scans, in which people with compromised Livers are being scanned”; and (3) “there was no warning of its insufficiency, . . . its history of being retained in those with healthy kidneys was not disclosed, ” and the warning “did not state that the Linear products were not as stable or safe as Macrocyclic products.” ECF No. 75 at 10. Plaintiff also alleges that “Linear products should have been banned.” Id. at 13. Plaintiffs manufacturing defect claim alleges that “Defendants had an ethical and moral obligation to correct the label or withdraw the linear product Eovist while they addressed the issue of retention.” Id. She alleges that because there are “many other alternatives and safer choices of GBCAs, such as a Macrocyclic Bound Product, it was not necessary for Defendants to choose to continue to produce this harmful product” and they should “withdraw” Eovist from use in U.S. medical facilities. Id. 1. Any claim based on a stop-selling theory is preempted.
As an initial matter, the undersigned agrees that any claim that Bayer should have simply stopped selling Eovist is preempted. See In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. & Prod. Liab. Litig., 185 F.Supp.3d 761, 771 (D.S.C. 2016) (explaining that the “U.S. Supreme Court has explicitly ‘reject[ed] this ‘stop-selling' rationale as incompatible with [its] pre-emption jurisprudence,' noting that such a rationale would render impossibility preemption ‘all but meaningless.'”) (alterations in original) (quoting Bartlett, 570 U.S. at 488).
2. Any claim that Bayer should have changed the design after FDA approval is preempted.
In Bartlett, the Supreme Court recognized that “once a drug-whether generic or brand-name-is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application'” without FDA approval. 570 U.S. at 477 (quoting 21 C.F.R. § 314.70(b)(2)(i)). Minor changes, however, need only be reported in an annual report to the FDA. 21 C.F.R. § 314.70(d).
The alternative design proposed by Plaintiff-switching from using a linear design to a macrocyclic design-is a change to the qualitative formula, which is a major change. See Smith v. GE Healthcare Inc., No. 3:19-CV-00492, 2020 WL 1880787, at *5 (W.D. La. Mar. 31, 2020), report and recommendation adopted, No. 3:19-CV-00492, 2020 WL 1875644 (W.D. La. Apr. 15, 2020). After the FDA approves the drug, a design defect claim proposing major changes is preempted. See Yates, 808 F.3d at 298 (finding that the plaintiffs “post-approval design defect claim [was] clearly preempted by federal law”).
After the FDA approved the drug, Bayer could not have independently adopted an alternative design for Eovist because federal drug regulations prevented Bayer from altering its composition without FDA approval. Accordingly, the undersigned finds that, to the extent Plaintiff alleges that state law required Bayer to change the design of Eovist after it was approved by the FDA in 2008, such a claim also is preempted. See Mensing, 564 U.S. at 623-24 (“[W]hen a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”).
3. Plaintiff's pre-approval design defect claim.
Plaintiff appears to allege a design defect “in the creation of . . . Eovist” in that “it is a linear design, which many studies and scientific papers have proven to be less safe and less stable” and leads to retention “more often that Macrocyclic design.” ECF No. 75 at 10. Thus, viewing the Amended Complaint liberally, it appears that Plaintiff is bringing a defect claim based on the way Eovist was designed before it was approved by the FDA.
“The Supreme Court has not addressed whether federal law preempts design-defect claims against a brand-name manufacturer on grounds that, prior to initial FDA approval, the drug should have had a different composition.” Holley v. Gilead Scis., Inc., 379 F.Supp.3d 809, 822 (N.D. Cal. 2019). Moreover, courts are split on whether a pre-approval design defect claim is preempted by federal law. Compare Yates, 808 F.2d at 299-300 (holding that a claim for breach of a pre-approval design duty was speculative and was preempted), with Holley, 379 F.Supp.3d at 823 (collecting cases and finding that of the district courts not bound by Yates, a majority has found no pre-approval preemption). The Fourth Circuit has not addressed the issue.
Bayer cites Yates for the proposition that all of Plaintiff s design defect claims, including specifically pre-approval design defect, are preempted. ECF No. 98-1 at 19. However, the Yates case was decided at the summary judgment stage, after a determination that the plaintiffs arguments regarding a pre-approval duty was too speculative and, in essence, amounted to a stop-selling claim, which is preempted. 808 F.3d at 300.
Here, it may well be that, even if Eovist were capable of re-design, as alleged by Plaintiff, any claim that Bayer should have changed Eovist's design before seeking FDA approval would likewise be preempted. This issue, however, cannot be determined from the face of the Amended Complaint and is a matter for post-discovery dispositive motion practice, not a motion to dismiss based upon an affirmative defense. See Small v. Amgen, Inc., No. CV 2:12-476-FTM29-CM, 2016 WL 4942078, at *2 (M.D. Fla, Jan. 25, 2016). Accordingly, the undersigned recommends denying Bayer's Motion on this basis at this time.
II. Whether Plaintiff Has Sufficiently Pled Any State Law Claims Against Bayer
Bayer contends that Plaintiffs claims are independently barred by South Carolina law for the following reasons: (1) Plaintiff fails to plead an injury supporting any of her claims or show that Bayer could have foreseen any of her alleged symptoms of gadolinium retention; (2) Plaintiff fails to allege any reasonable alternative design for Eovist; (3) Plaintiff fails to allege that her particular dose of Eovist deviated from Bayer's manufacturing standards; (4) Plaintiff fails to allege any warranty Bayer provided; (5) Plaintiffs claims for “Mens Rea, ” “Nonfeasance & or
Misfeasance, ” “Criminal and Gross Negligence, ” and “Personal Injury” fail because “they allege criminal violations that a private party cannot charge or are legally meaningless”; and (6) if her other claims are dismissed, her claims for “Tolling, Fraudulent Concealment, Omission” and “Punitive Damages” should also be dismissed.
1. Plaintiff Has Pled a Cognizable Injury and Reasonable Foreseeability
In any products liability action, a plaintiff must establish three things: “(1) [s]he was injured by the product; (2) the product was in essentially the same condition at the time of the accident as it was when it left the hands of the defendant, and (3) the injury occurred because the product was in a defective condition unreasonably dangerous to the user.” Graves v. CAS Med. Sys., Inc., 735 S.E.2d 650, 658 (S.C. 2012) (internal quotation marks omitted). Bayer contends that Plaintiff has failed to plead fact showing a cognizable injury that was reasonably foreseeable. The undersigned disagrees.
In a products liability case based on the theory of strict liability, a plaintiff must establish these three elements, Branham v. Ford Motor Co., 701 S.E.2d 5, 8 (S.C. 2010), while under a negligence theory, the plaintiff bears the additional burden of demonstrating that a defendant did not exercise due care in some respect, id. at 9 (“[U]nlike strict liability, the focus is on the conduct of the seller or manufacturer, and liability is determined according to fault.”) (citation and internal quotation marks omitted).
Plaintiff alleges that her tissues have retained gadolinium, which has resulted in fibrosis, brain fog, edema, neuropathy, and bone pain. ECF No. 75 at 7; see ECF No. 75-4 at 2-3. The undersigned finds that Plaintiff has plausibly pled a cognizable injury. See Dennis, 2020 WL 534307, at *6; Goodell, 2019 WL 4771136, at *5 (“Plaintiff has sufficiently pleaded the presence of an objective symptom by plausibly claiming that gadolinium remains in his body. Whether the gadolinium retention creates a ‘reasonable probability' of future injury is a fact-intensive inquiry not appropriate for resolution on the pleadings.”); Pierik v. GE Healthcare Inc., No. 1:18-CV-07733, 2019 WL 4686551, at *2 (N.D. Ill. June 18, 2019) (finding that “plaintiffs have alleged plausible injuries in the form of Ms. Pierik's fibrosis resulting from gadolinium retention”). Bayer's argument that gadolinium retention is not an injury prematurely challenges the merits of Plaintiffs claims. “Whether gadolinium retention is an injury or whether there is any causal link between gadolinium deposition and any disease cannot be resolved on the pleadings.” Dennis, 2020 WL 534307, at *6.
Bayer's dispute over the reasonable foreseeability of Plaintiff s alleged injuries is also premature on a motion to dismiss. See Pierik, 2019 WL 4686551, at *2 (declining to consider defendant's foreseeability argument premised on “FDA actions outside of the pleadings” because the court “cannot consider those extraneous facts to find plaintiffs' claims implausible”). Plaintiff alleges in her Amended Complaint that Bayer was aware of the risk gadolinium presented to patients with normal kidney function but failed to alert patients or medical providers of the risk. She cites to specific articles, journals, and other information that she claims made this injury foreseeable. ECF No. 75 at 22-24. Accepting the allegations of the Amended Complaint as true and drawing all inferences in Plaintiffs favor, the undersigned finds that Plaintiff has sufficiently pled a cognizable injury and reasonable foreseeability.
2. Design Defect Claim (Count 1a)
Bayer argues that Plaintiff has failed to state a design defect claim because she failed to allege a reasonable alternative design for Eovist. A plaintiff proceeding under a design defect claim in South Carolina must “point to a design flaw in the product and show how his alternative design would have prevented the product from being unreasonably dangerous.” Graves, 735 S.E.2d at 658 (citation omitted). In her Amended Complaint, Plaintiff alleges that the design of Eovist” was flawed because it is a linear design, “which many studies and scientific papers have proven to be less safe and less stable” and leads to retention “more often that Macrocyclic design.” ECF No. 75 at 10. She further alleges that there are “many other alternatives and safer choices of GBCAs, such as a Macrocyclic Bound Product.” Id. at 13. Accepting the allegations in the Amended Complaint as true and drawing all reasonable inferences in Plaintiffs favor, the undersigned concludes that these allegations are sufficient to state a design defect claim.
As discussed previously, however, Plaintiffs design defect claim is limited to a pre-approval defect claim, as any alleged state law duty to change the design or to stop selling Eovist after the FDA approved the drug is preempted.
3. Manufacturing Defect Claim (Count 1b)
Under South Carolina law, to state a manufacturing defect claim, a plaintiff must allege that a particular product was defectively manufactured. Watson v. Ford Motor Co., 699 S.E.2d 169, 174 (S.C. 2010). “There is not an abundance of case law in South Carolina about how a manufacturing defect differs from other defects, ” but other courts have defined a manufacturing defect as existing “when a product does not conform to the design standards and blueprints of the manufacturer and the flaw makes the product more dangerous and therefore unfit for its intended or foreseeable uses.” Fisher v. Pelstring, 817 F.Supp.2d 791, 818 (D.S.C. 2011) (internal quotation marks and citation omitted) (collecting cases). The undersigned agrees with Bayer that Plaintiff has failed to plead a plausible claim for manufacturing defect. Accordingly, the undersigned recommends that this claim be dismissed.
4. Breach of Express Warranty Claim (Count 3)
Under South Carolina law, an express warranty is created in the following ways:
(a) Any affirmation of fact or promise, including those on containers or labels, made by the seller to the buyer, whether directly or indirectly, which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods conform to the affirmation or promise.
(b) 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.
(c) Any sample or model which is made part of the basis of the bargain creates an express warranty that the whole of the goods shall conform to the sample or model.S.C. Code Ann. § 36-2-313(1). To establish a breach of an express warranty, a plaintiff must show “the existence of the warranty, its breach by the failure of the goods to conform to the warranted description, and damages proximately caused by the breach.” Fisher, 817 F.Supp.2d at 818-19 (quoting First State Sav. & Loan v. Phelps, 385 S.E.2d 821, 825 (S.C. 1989)).
Plaintiff alleges that an “[e]xpress warranty occurred when the Radiologist did not know of anyone with Healthy kidneys retaining the GBCA Eovist” and “[h]e then mis-informed the Plaintiff and “expressed the warranty that the Defendants had done their research.” ECF No. 75 at 19. While Plaintiff alleges an express affirmation on the part of the radiologist, she does not similarly allege any affirmation or promise by Defendants. Rather, as Bayer argues, “she relies entirely on claimed omissions and supposed ‘implications]' from Eovist's label, . . . which cannot give rise to an express warranty claim.” ECF NO. 98-1 at 25 (brackets in original) (citing ECF No. 75 at 19-21). Because Plaintiff does not identify any express warranty made by Bayer, she has failed to state a claim for breach of express warranty against Bayer. Accordingly, that claim should be dismissed.
5. Claims for Mens Rea (Count 7) and Gross and Criminal Negligence (Count 5)
The undersigned agrees with Bayer that Plaintiff cannot plead a cognizable claim for “mens rea” or “criminal negligence.” Mens rea is a legal term used to describe a criminal state of mind and is not a recognized cause of action under South Carolina law. Similarly, South Carolina does not appear to recognize a civil claim for criminal negligence. See Shields v. S.C Dep't of Highways & Pub. Transp., 401 S.E.2d 185, 190 (S.C. Ct. App. 1991) (Littlejohn, J. dissenting) (“The terms ‘negligence,' ‘gross negligence,' ‘willfulness,' ‘wantonness' and ‘recklessness' are well known to the law of torts in this state. Traditionally, ‘criminal negligence' has neither been alleged nor defined by the trial judges in tort cases. I am unaware of any definition in the statute or in our cases of ‘criminal negligence' as relate[d] to civil litigation.”). Accordingly, the undersigned recommends dismissing Plaintiffs Mens Rea claim (Count 7) and construing Count 5 as a claim for gross negligence only.
“Gross negligence is the intentional conscious failure to do something which it is incumbent upon one to do or the doing of a thing intentionally that one ought not to do.” Bass v. S.C. Dep't of Soc. Servs., 780 S.E.2d 252, 258-59 (2015). In Count 5, Plaintiff alleges that despite knowing of the “danger of Gadolinium” for more than ten years, Bayer did not warn of retention until 2018. ECF No. 75 at 22-24. She cites to various articles and testimony regarding gadolinium toxicity, and she claims that Bayer was grossly negligent for its “lack of regard for human life and quality of life with [its] failure to warn.” Id. Construing the pleadings liberally and accepting the well-pled allegations as true, the undersigned concludes that Plaintiff has stated a claim for gross negligence against Bayer.
6. Claim for “Nonfeasance or Misfeasance ” (Count 8) and Personal Injury (Count 9)
The undersigned agrees with Bayer that neither nonfeasance, misfeasance, nor personal injury appears to be a cognizable claim under South Carolina law. To the extent that Count 8 can be construed as a claim for negligent failure to warn, it is duplicative, as Plaintiff has already stated that claim in Count 1. See ECF No. 75 at 27-28 (alleging, in Count 8, that nonfeasance is “a failure to act that results in harm to another party” and that “there was NO warning . . . until . . . [t]wo years too late for Plaintiff). Accordingly, the undersigned recommends dismissing Counts 8 and 9 as against Bayer.
7. Count 2 (Punitive Damages) and Count 6 (Tolling, Fraudulent Concealment, Omission)
Finally, Bayer moves for dismissal of Count 2 and Count 6. These two counts are not viable causes of action but, instead, are a remedy (Count 2) and a legal argument applicable in the context of a statute of limitations defense (Count 6). Review of Plaintiff s claim for “Punitive Damages” reveals that Count 2 merely requests a specific type of relief to which Plaintiff claims entitlement, and it does not state a separate, plausible cause of action. See Robinson v. Anmed Encompass Health Rehab. Hosp., LLC, No. 819CV01324-DCC-JDA, 2019 WL 7756182, at *7 (D.S.C. Oct. 17, 2019) (recommending dismissal of freestanding claim for punitive damages on the basis that “punitive damages is not a recognized cause of action, but rather it is a type of damage that can be recovered under certain common law torts and other statutory causes of action”), report and recommendation adopted, 2020 WL 419627 (D.S.C. Jan. 27, 2020). Similarly, Count 6 appears to be a request that the Court toll the statute of limitations, but it does not assert a separate, plausible cause of action. See ECF No. 75 at 25 (“Plaintiff hereby asks the court to extend the expiration of the statute of limitations of this case until further research makes the unknowns known and the questions therein resolved.”) (emphasis in original). Although these two counts are not viable causes of action, they are not otherwise inappropriate to include in the body or language of a pleading. Accordingly, while the undersigned recommends dismissing Counts 2 and 6 for failure to state a claim, the undersigned does not recommend striking the concepts altogether from the Amended Complaint.
CONCLUSION
For the reasons set forth above, it is RECOMMENDED that Bayer's Motion to Dismiss (ECF No. 98) be GRANTED, in part, and DENIED, in part. Specifically, the undersigned recommends that the Motion be GRANTED as to Plaintiffs claims for manufacturing defect (Count 1b), punitive damages (Count 2), breach of express warranty (Count 3), “Tolling, Fraudulent Concealment, Omission” (Count 6), “Mens Rea” (Count 7), nonfeasance and malfeasance (Count 8), and personal injury (Count 9), such that those claims should be DISMISSED. The undersigned recommends that the Motion be DENIED as to the remaining claims as set forth herein. If this recommendation is accepted by the district judge, then the following claims will remain: Count 1's product liability claim based on alleged warning defects and a pre-FDA-approval design defect, Count 4's strict liability claim, and Count 5's claim only for gross negligence.
As explained above, because punitive damages are an appropriate remedy to plead at this stage, the undersigned does not recommend striking the concept altogether from the Amended Complaint, just the separate cause of action.
As explained above, because the tolling argument can be made, as appropriate, regarding any statute of limitations defense, the undersigned does not recommend striking the concept altogether from the Amended Complaint, just the separate cause of action.
IT IS SO RECOMMENDED.
Notice of Right to File Objections to Report and Recommendation
The parties are advised that they may file specific written objections to this Report and Recommendation with the District Judge. Objections must specifically identify the portions of the Report and Recommendation to which objections are made and the basis for such objections. “[I]n the absence of a timely filed objection, a district court need not conduct a de novo review, but instead must ‘only satisfy itself that there is no clear error on the face of the record in order to accept the recommendation.'” Diamond v. Colonial Life & Acc. Ins. Co., 416 F.3d 310 (4th Cir. 2005) (quoting Fed.R.Civ.P. 72 advisory committee's note).
Specific written objections must be filed within fourteen (14) days of the date of service of this Report and Recommendation. 28 U.S.C. § 636(b)(1); Fed.R.Civ.P. 72(b); see Fed.R.Civ.P. 6(a), (d). Filing by mail pursuant to Federal Rule of Civil Procedure 5 may be accomplished by mailing objections to:
Robin L. Blume, Clerk
United States District Court
Post Office Box 835
Charleston, South Carolina 29402
Failure to timely file specific written objections to this Report and Recommendation will result in waiver of the right to appeal from a judgment of the District Court based upon such Recommendation. 28 U.S.C. § 636(b)(1); Thomas v. Arn, 474 U.S. 140 (1985); Wright v. Collins, 766 F.2d 841 (4th Cir. 1985); United States v. Schronce, 727 F.2d 91 (4th Cir. 1984).