Silver v. Bayer Healthcare Pharm.

Decision Date30 September 2021
Docket Number2:19-cv-3495-DCN-MHC
CourtUnited States District Courts. 4th Circuit. United States District Court of South Carolina
PartiesJANE RENE' SILVER, Plaintiff, v. BAYER HEALTHCARE PHARMACEUTICALS, INC., Defendant.
ORDER

DAVID C. NORTON, UNITED STATES DISTRICT JUDGE.

This matter is before the court on Magistrate Judge Molly H Cherry's report and recommendation (“R&R”), ECF No. 125, that the court grant in part and deny in part defendant Bayer Healthcare Pharmaceuticals, Inc.'s (Bayer) motion to dismiss, ECF No. 98. For the reasons set forth below, the court adopts in part and rejects in part the R&R and grants in part and denies in part Bayer's motion to dismiss.

I. BACKGROUND

The R&R ably sets forth the facts and procedural history of this case, and the parties do not object to the R&R's rendition of those facts. Therefore, the court dispenses with a lengthy recitation thereof and instead briefly recounts those facts material to its review. This case is about Eovist, a gadolinium-based contrast agent (“GBCA”) approved by the Food and Drug Administration (“FDA”) and administered intravenously by medical professionals for diagnostic purposes. Eovist is intended to enhance the quality of magnetic resonance imaging (“MRI”) of the liver to diagnose serious conditions such as cancer. The FDA approved Eovist for use in 2008. It is manufactured, sold and marketed by Bayer.

In 2016, doctors referred plaintiff Jane Rene' Silver (Silver) to a local hospital for an MRI to further examine lesions that had been discovered on her liver by an ultrasound. Silver's radiologist was concerned that the lesions were cancerous but expressed that the “only way” to know “is by using the GBCA Eovist.” ECF No. 75, Amend Compl. ¶ 1. Despite her concern that Eovist would be retained in her system, Silver contracted with Bayer to provide Eovist for a basic MRI at her local hospital, Tidelands Waccamaw Hospital in Murrells Inlet, South Carolina. She was injected with Eovist on December 30, 2016. Silver alleges that within a week, she began experiencing “unexplained symptoms, ” including [e]xplosive flatulence, random sour spittle, random knuckle bleeding, random red eyes, groin pain, rib pain, brain fog, edema in the right arm . . . fibrosis covering a finger and part of a hand, very stiff muscles[, ] and skin tightening.” Amend. Compl. ¶ 2. Silver alleges that in June 2017, she lost her job because she was unable to complete tasks that she had previously been able to do before the injection.

Six months after she received the Eovist injection, Silver claims to have discovered that she had retained gadolinium-a metal element found in Eovist and other similar GBCAs-in her system. Silver alleges that this retention caused her to develop “Gadolinium Deposition Disease” (“GDD”). Even before she was injected with Eovist, Silver had expressed concern about possible metal retention to her radiologist. Silver also alleges that two years after Silver received an injection, Bayer added a label to Eovist-effective April 26, 2018-warning about the long-term retention of gadolinium in people with healthy kidneys. The Eovist label that was in effect on December 30, 2016-the date Silver received the Eovist injection-had been approved by the FDA in March 2015.

On December 17, 2019, Silver, proceeding pro se, filed the instant action against Bayer, CVS Health One, and McKesson Specialty. ECF No. 1. CVS Health One and McKesson Specialty were ultimately dismissed from the case. ECF No. 129. On November 17, 2020, Silver filed her second amended complaint, now the operative complaint, alleging: (1a) design defect; (1b) manufacturing defect; (1c) 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/or misfeasance; and (9) personal injury.[1] Amend. Compl. at 9. Pursuant to 28 U.S.C. §§ 636(b)(1)(A) and (B) and Local Civil Rule 73.02(B)(2)(g) (D.S.C), all pretrial proceedings in this case were referred to Magistrate Judge Cherry.

On January 15, 2021, Bayer filed a motion to dismiss on all of Silver's claims. ECF No. 98. Silver responded to the motion on March 16, 2021, ECF No. 115, and Bayer replied on April 30, 2021, ECF No. 121.[2] On June 10, 2021, Magistrate Judge Cherry issued the R&R, recommending that the court grant in part and deny in part the motion to dismiss. ECF No. 125. On July 27, 2021, Bayer filed objections to the R&R. ECF No. 140. Silver responded to the objections on August 27, 2021, ECF No. 143, and Bayer replied on August 31, 2021, ECF No. 144. Silver did not object to the R&R, and the time to do so has now expired.[3] As such, the matter is now ripe for the court's review.

II. STANDARD

A magistrate judge makes only a recommendation to the court. Mathews v. Weber, 423 U.S. 261, 270 (1976). The recommendation carries no presumptive weight, and the responsibility to make a final determination remains with the court. Id. at 270-71. The court may “accept, reject, or modify, in whole or in part, the findings or recommendations made by the magistrate judge . . . or recommit the matter to the magistrate judge with instructions.” 28 U.S.C. § 636(b)(1). The court is charged with making a de novo determination of any portion of the R&R to which a specific objection is made. Id. However, in the absence of a timely filed, specific objection, the court reviews the R&R only for clear error. Diamond v. Colonial Life & Accident Ins. Co., 416 F.3d 310, 315 (4th Cir. 2005) (citation omitted). Furthermore, [a] party's general objections are not sufficient to challenge a magistrate judge's findings.” Greene v. Quest Diagnostics Clinical Labs., Inc., 455 F.Supp.2d 483, 488 (D.S.C. 2006) (citation omitted). When a party's objections are directed to strictly legal issues “and no factual issues are challenged, de novo review of the record may be dispensed with.” Orpiano v. Johnson, 687 F.2d 44, 47 (4th Cir. 1982) (citation omitted). Analogously, de novo review is unnecessary when a party makes general and conclusory objections without directing a court's attention to a specific error in a magistrate judge's proposed findings. Id.

A Rule 12(b)(6) motion for failure to state a claim upon which relief can be granted “challenges the legal sufficiency of a complaint.” Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009) (citations omitted); see also Republican Party of N.C. v. Martin, 980 F.2d 943, 952 (4th Cir. 1992) (“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.”). To be legally sufficient, 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). A Rule 12(b)(6) motion should not be granted unless it appears certain that the plaintiff can prove no set of facts that would support his claim and would entitle him to relief. Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1134 (4th Cir. 1993). When considering a Rule 12(b)(6) motion, the court should accept all well-pleaded allegations as true and should view the complaint in a light most favorable to the plaintiff. Ostrzenski v. Seigel, 177 F.3d 245, 251 (4th Cir.1999); Mylan Labs., Inc., 7 F.3d at 1134. “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.' Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id.

Petitioner is proceeding pro se in this case. Pro se complaints and petitions should be construed liberally by this court and are held to a less stringent standard than those drafted by attorneys. See Gordon v. Leeke, 574 F.2d 1147, 1151 (4th Cir. 1978), cert. denied, 439 U.S. 970, 99 (1978). A federal district court is charged with liberally construing a complaint or petition filed by a pro se litigant to allow the development of a potentially meritorious case. See Hughes v. Rowe, 449 U.S. 5, 9 (1980). Liberal construction, however, does not mean that the court can ignore a clear failure in the pleading to allege facts that set forth a cognizable claim. See Weller v. Dep't of Soc. Servs., 901 F.2d 387, 390-91 (4th Cir. 1990).

III. DISCUSSION

The Magistrate Judge recommended that the court grant the motion to dismiss in Bayer's favor on the following claims: manufacturing defect (Count 1b); punitive damages (Count 2); breach of express warranty (Count 3); tolling, fraudulent concealment, and omission (Count 6); mens rea (Count 7); nonfeasance and malfeasance (Count 8); and personal injury (Count 9). No. party filed objections to the R&R with respect to these counts. Therefore, the court “must only satisfy itself that there is no clear error on the face of the record in order to accept the recommendation.” Diamond, 416 F.3d at 315 (internal quotations and citation omitted). After reviewing the record in this case, the applicable law, and the R&R, the court finds no clear error in the R&R's finding that Silver failed to state a claim as to these counts. The court therefore adopts the R&R and dismisses Counts 1b, 2, 3, 6, 7, 8, and 9.

The Magistrate Judge further recommended that the court deny the motion to dismiss on the following claims: pre-FDA-approval design defect (Count 1a); warning defect (Count 1c); strict liability (Count 4); and gross negligence (Count 5). Bayer only objects to the R&R as to these counts. The...

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