Silver v. Bayer Healthcare Pharm.
| Decision Date | 10 June 2021 |
| Docket Number | C/A 2:19-cv-3495-DCN-MHC |
| Court | U.S. District Court — District of South Carolina |
| Parties | Jane René Silver, Plaintiff, v. Bayer Healthcare Pharmaceuticals, Inc.; South Carolina CVS Pharmacy, LLC; and McKesson Corporation, Defendants. |
REPORT AND RECOMMENDATION
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.[1] ECF No. 121. The Motion is ripe for review.
This Report and Recommendation is entered for review by the District Judge.[2]
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.[3] 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.[4]
BACKGROUND FACTS[5]
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)).[6] 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.[7] 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: [8] See April 2018 EOVIST Physician Label, https://www.accessdata.fda.gov/drugsatfdadocs/label/2018/022090s014lbl.pdf 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...
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