McGrath v. Bayer Healthcare Pharm. Inc.

393 F.Supp.3d 161

Denise MCGRATH, Plaintiff,

v.BAYER HEALTHCARE PHARMACEUTICALS INC.; Bayer Corporation; Bayer HealthCare LLC; Bracco Diagnostics, Inc.; and McKesson Corporation, Defendants.

18 CV 2134 (RJD)(VMS)

United States District Court, E.D. New York.

Signed June 24, 2019

Todd A. Walburg, Lieff Cabraser Heimann & Bernstein, San Francisco, CA, Todd Alan Walburg, Pro Hac Vice, Margot P. Cutter, Pro Hac Vice, Cutter Law, P.C., Curtis Brooks Cutter, Curtis Brooks Cutter, Pro Hac Vice, Kershaw Cutter & Ratinoff LLP, Sacramento, CA, for Plaintiff.

Brian Joseph Mooney, James Reginald Reilly, Peter J. Turcotte, Gordon & Rees LLP, San Francisco, CA, Melissa Dziak, Pro Hac Vice, Cipriani & Werner PC, Binghamton, NY, Paul Scott Penticuff, Pro Hac Vice, Thomas N. Sterchi, Thomas Sterchi, Pro Hac Vice, Baker Sterchi Cowden and Rice, LLC, Kansas City, MO, for Defendant Bracco Diagnostics Inc.

Habib Nasrullah, Pro Hac Vice, Wheeler Trigg O'Donnell LLP, Denver, CO, for Defendants McKesson Corporation, McKesson Medical-Surgical Inc.

Jennifer Greenblatt, Edward Dumoulin, Goldman Ismail Tomaselli Brennan & Baum LLP, Chicago, IL, for Defendants Bayer HealthCare Pharmaceuticals Inc., Bayer Corporation, and Bayer HealthCare LLC.

MEMORANDUM & ORDER

DEARIE, District Judge:

Plaintiff Denise McGrath ("Plaintiff" or "McGrath") brings failure-to-warn strict liability and negligence claims against Bayer Pharmaceuticals ("Bayer"), Bracco Diagnostics and McKesson Corporation (together, "Defendants") relating to injuries sustained as a result of exposure to Magnevist, an FDA-approved gadolinium-based contrast agent ("GBCA"), administered to patients to enhance the quality of MRIs. Plaintiff claims that prior to receiving Magnevist she was "never warned about the risks of gadolinium retention" for patients with normal renal function or advised of alternative treatment options. Second Amended Complaint ("SAC"), ECF No. 86, ¶ 10. Plaintiff alleges that she retained gadolinium in multiple organs causing "fibrosis in organs, bone, and skin" as well as "muscle pain, muscle weakness, brain fog and other injuries." Id. ¶ 5. Bayer moves to dismiss the Complaint because (i) Plaintiff's failure-to-warn claims are preempted by the FDA's regulatory scheme governing pharmaceutical labeling, and (ii) Plaintiff fails to state a plausible claim that she suffered a legally cognizable injury, or that her injury was reasonably foreseeable. For the reasons that follow, Bayer's motion to dismiss is granted.

BACKGROUND

In 2015, Plaintiff received at least one injection of Magnevist and alleges that tests performed anywhere from one to three months following the injection confirmed she retained gadolinium in her body. Id. ¶¶ 3-4, 10. Plaintiff claims she now suffers from fibrosis, muscle pain, muscle weakness, brain fog and other unspecified injuries caused by the presence of toxic levels of gadolinium in her body. Id. ¶ 5. Plaintiff further claims Defendants knew or should have known of the risks associated with gadolinium retention for patients with normal renal function, and failed to include an appropriate warning on the Magnevist label. Plaintiff alleges that had she been aware of such risks, she would not have exposed herself to GBCAs prior to undergoing MRIs.

Following the FDA's approval of Magnevist in 1988 Plaintiff claims that notwithstanding numerous "reports, studies, assessments, papers, peer reviewed literature, and other clinical data" describing gadolinium retention, Bayer nevertheless failed to warn "Plaintiff and her healthcare providers ... of the risks posed by GBCAs." Id. ¶¶ 31-32, 34 (emphasis added). Instead, Plaintiff alleges that "claims to the public and healthcare providers" about the possibility of gadolinium retention "have been misleading and false" because they fail to "advise consumers and their healthcare providers of the causal relationship between linear [GBCAs] and gadolinium retention resulting in fibrosis ," id. ¶¶ 34, 40 (emphasis added). Plaintiff goes on to cite a number of medical studies relating to gadolinium retention, which Plaintiff claims expose Bayer's knowledge of the risks associated with gadolinium retention prior to 2015. For example, Plaintiff alleges a 1989 report showed that gadolinium remained in human tissue in the days following an MRI. Id. ¶ 50. By 2004, a "major study" revealed gadolinium deposition in patients with normal renal function. Id. ¶ 45. And, in 2013, Japanese researchers found evidence of gadolinium retention in the brains of patients with normal renal function, which was "confirmed by scientists at the Mayo Clinic in 2014." Id. ¶¶ 70-71. Plaintiff alleges the Mayo Clinic study prompted the FDA to issue a "public safety alert" stating it was evaluating the risk of brain deposits from repeated exposure to GBCAs. Id. ¶¶ 71-72.

In 2017, two years after Plaintiff's treatments, "the FDA's medical advisory committee voted 13 to 1 in favor of adding a warning on [GBCA] labels that gadolinium can be retained in some organs, including the brain, even in patients with healthy kidneys." Id. ¶¶ 73-74; Defs.' Br., Ex. B, ECF No. 79-5. The amendment reflects new information supporting the fact of gadolinium retention in patients with normal renal function but does not reference any risks associated with gadolinium retention. Plaintiff claims Defendants' failure to warn her and her healthcare providers of the risks associated with gadolinium retention in patients with normal renal function was "a substantial factor" in bringing about her injuries.

After the parties briefed Bayer's motion to dismiss, the Court heard oral argument and pointed out that the absence in the Complaint of "newly-discovered scientific evidence" or "literature that makes the causal connection" between gadolinium retention and fibrosis undercut Plaintiff's failure-to-warn claims and made a strong case for preemption. May 3, 2019 Oral Argument, ECF No. 87-1, at 10:25, 15:6-7. Plaintiff represented at oral argument that literature making the requisite causal connection was available, and on May 27, 2019, filed a Second Amended Complaint. However, the added allegations do not plausibly allege the causal connection required to justify a unilateral label change under the CBE regulation, and, in any event, the information was not available in 2015 when Plaintiff was administered Magnevist. Plaintiff thus fails to state a failure-to-warn claim that is not preempted: her allegations regarding the causal association between Magnevist injections, gadolinium retention and a significant adverse reaction—such as fibrosis—are conclusory and grounded in hypothesis rather than scientific evidence capable of raising at least a reasonable expectation that Plaintiff is entitled to the relief she seeks.

LEGAL STANDARD

In deciding a motion to dismiss, the court must "accept all allegations in the complaint as true and draw all inferences in the non-moving party's favor." LaFaro v. N.Y. Cardiothoracic Grp., PLLC, 570 F.3d 471, 472 (2d Cir. 2009). Ultimately, the Complaint must allege sufficient facts which, taken as true, state a plausible claim for relief. Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 656 (S.D.N.Y. 2017) (citing Keiler v. Harlequin Enterprises ltd., 751 F.3d 64, 68 (2d Cir. 2014) ). A claim is plausible when the pleaded factual content "allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). To do so, the Plaintiff must plead more than the mere possibility that she is entitled to relief, but need not go so far as to demonstrate that relief is probable. This "plausibility standard" requires the plaintiff state "more than labels and conclusions" or "a formulaic recitation of the elements of a cause of action." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), and instead plead facts sufficient to "raise a reasonable expectation that discovery will reveal evidence supporting [her] claim for relief," Pension Benefit Guar. Corp. ex rel. St. Vincent Catholic Med. Ctrs. Retirement Plan v. Morgan Stanley Inv. Mgmt. Inc., 712 F.3d 705, 729 (2d Cir. 2013). "[W]hen considering a preemption argument in the context of a motion to dismiss, the factual allegations relevant to preemption must be viewed in the light most favorable to the plaintiff. A district court may find a claim preempted only if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted." Utts, 251 F. Supp. 3d at 672 (quoting Galper v. JP Morgan Chase Bank, N.A., 802 F.3d 437, 444 (2d Cir. 2015) ).

DISCUSSION

I. Motion to Dismiss Plaintiff's Failure-to-Warn Claims as Preempted

a. Legal Standard

Though Plaintiff claims that as of 2015 the Magnevist label should have warned against the risk of injury from gadolinium retention, Bayer argues it would have been impossible to implement such a warning using the "Changes Being Effected" ("CBE") regulation, and thus Plaintiff's failure-to-warn claims are preempted by the CBE regulation and the FDA's warning labeling scheme. The CBE regulation set forth in 21 C.F.R. § 314.70(c)(6)(iii) allows drug manufacturers to change a drug label unilaterally, and without FDA preapproval, "if the changes add or strengthen a contraindication, warning, precaution, or adverse reaction" or "add or strengthen an instruction about dosing and administration that is intended to increase the safe usage of the drug product in order to reflect newly acquired information." Id. If a plaintiff shows that "defendants could unilaterally change the label ... without FDA approval," the burden shifts to the manufacturer to show "by clear evidence that the FDA would not have approved the labeling change." Utts, 251 F. Supp. 3d at 661. On the other hand, a drug manufacturer can show that a plaintiff's failure-to-warn claims are preempted by the FDA's regulatory scheme for...