United States District Court, D. Maryland
BETH P. GESNER, Magistrate Judge.
The above-referenced case was referred to the undersigned for all proceedings with the consent of the parties (ECF Nos. 20, 22), pursuant to 28 U.S.C. 636(c) and Local Rule 301.4. (ECF No. 16.) Currently pending is Defendants' Motion for Summary Judgment ("Motion") (ECF No. 39), plaintiff's Opposition to Defendants' Motion for Summary Judgment (ECF No. 45), Plaintiff's Memorandum of Grounds and Authorities in Support of Plaintiff's Opposition to Defendants' Motion for Summary Judgment ("Opposition") (ECF No. 46), and Defendants' Reply Memorandum in Support of Their Motion for Summary Judgment (ECF No. 49). Oral argument was held before the undersigned on March 30, 2015. For the reasons discussed herein, Defendants' Motion for Summary Judgment (ECF No. 39) is GRANTED.
The following is a summary of the evidence in this case, viewed in the light most favorable to plaintiff. In October 2007, plaintiff Brenda Louise Morris ("plaintiff") was prescribed Aldara cream (hereinafter "Aldara") for treatment of Bowen's disease, a form of skin cancer which had manifested on plaintiff's nose. (Pl.'s Compl. ¶ 7, ECF No. 1 at 3; Pl.'s Resps. to Reqs. for Admis. Nos. 4 and 5, ECF No. 39-3 at 3.) Pursuant to her dermatologist's orders, plaintiff applied Aldara to her nose two times daily for a period of eight weeks. (Pl.'s Ans. to Interrogs. No. 2, ECF No. 39-4 at 2-3.) Shortly after plaintiff began applying Aldara to her nose, she developed burning lesions on her entire body. (Pl.'s Ans. to Interrogs. No. 7, Id. at 4.) Plaintiff sought medical attention and was ultimately diagnosed with severe cutaneous Lupus, which was determined to be proximately caused by plaintiff's use of Aldara. (ECF No. 39-5 at 15.) Plaintiff recently underwent neurological and neuropsychological testing which indicated that she also suffers from Posterior Reversible Encephalopathy Syndrome. (Kozachuk Aff. ¶ 7, ECF No. 46-2 at 2.) It was opined that this condition was also proximately caused by plaintiff's use of Aldara. (Kozachuk Aff. ¶ 9, Id.)
Aldara is currently approved by the United States Food and Drug Administration (hereinafter "FDA") for treatment of three conditions: (1) actinic keratosis, (2) superficial basal cell carcinoma, and (3) external genital warts. (ECF No. 46 at 2; Kavanaugh Aff. ¶ 6, ECF No. 39-1 at 3.) The use of Aldara to treat Bowen's disease is an "off-label" use, as Aldara has not been proven safe and effective in the treatment of that disease. (Pl.'s Compl. ¶ 19, ECF No. 1 at 11; ECF No. 39-5 at 8, 11-14.)
In November 2010, plaintiff sued her dermatologist for negligence and medical malpractice in the United States District Court for the District of Maryland, alleging that he breached the applicable standard of care by prescribing Aldara for an off-label use. (ECF No. 39-6 at 2-3.) Plaintiff's case was dismissed for lack of subject matter jurisdiction. (ECF No. 39-7 at 2-3.)
Thereafter, in December 2010, plaintiff filed suit against her dermatologist in the Circuit Court for Howard County, once again alleging that he breached the applicable standard of care by prescribing Aldara for an off-label use. (ECF No. 39-8 at 2-3.) Upon consideration of defendant's Motion to Dismiss, however, plaintiff's case was dismissed for failure to comply with the Maryland Health Claims Malpractice Act. (ECF No. 39-9 at 2; ECF No. 39-10 at 2-3.)
In October 2011, plaintiff once again filed suit against her dermatologist in the Circuit Court for Howard County. (ECF No. 39-11 at 3.) Plaintiff's First Amended Complaint not only asserted that defendant prescribed Aldara for an off-label use, but also acknowledged that the FDA and defendants warn against prescribing Aldara for off-label use due to the potential for severe side effects. (ECF No. 39-12 at 3.) The Circuit Court dismissed plaintiff's case in February 2012. (ECF No. 39-13 at 2.)
Plaintiff subsequently filed the instant lawsuit in April 2013 against (1) Minnesota Mining and Manufacturing Company, (2) Minnesota Mining and Manufacturing Company a/k/a 3M, (3) 3M Pharmaceuticals, a division of Minnesota Mining and Manufacturing Company, and (4) 3M Health Care Limited, asserting claims for negligence, negligence per se, product liability, breach of warranty, "conscious indifference, " and malice. (Pl.'s Compl., ECF No. 1 at 1, 7-11.) Plaintiff now alleges that defendants failed to provide adequate warnings concerning the risks, consequences, and side effects associated with the use of Aldara. (Pl.'s Compl. ¶¶ 7-9, 14, 16, Id. at 3-7, 9-10.) Further, plaintiff alleges that defendants warranted that Aldara was safe and effective for treating Bowen's disease when they knew it was not. (Pl.'s Compl. ¶ 19, Id. at 11.)
II. Summary Judgment Standard
Summary judgment is appropriate when "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). A genuine dispute remains "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is properly considered "material" only if it might affect the outcome of the case under the governing law. Id. The party moving for summary judgment has the burden of demonstrating the absence of any genuine issue of material fact. Fed.R.Civ.P. 56(a); Pulliam Inv. Co., Inc. v. Cameo Props., 810 F.2d 1282, 1286 (4th Cir. 1987). On those issues for which the non-moving party will have the burden of proof, however, it is his or her responsibility to oppose the motion for summary judgment with affidavits or other admissible evidence specified in Federal Rule of Civil Procedure 56. Fed.R.Civ.P. 56(c); Mitchell v. Data Gen. Corp., 12 F.3d 1310, 1315-16 (4th Cir. 1993). If a party fails to make a showing sufficient to establish the existence of an essential element on which that party will bear the burden of proof at trial, summary judgment is proper. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).
When reviewing a motion for summary judgment, the court does not evaluate whether the evidence favors the moving or non-moving party, but considers whether a fair-minded jury could return a verdict for the non-moving party on the evidence presented. Anderson, 477 U.S. at 252. In undertaking this inquiry, the court views all facts and makes all reasonable inferences in the light most favorable to the non-moving party. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). The non-moving party, however, may not rest on its pleadings, but must show that specific, material facts exist to create a genuine, triable issue. Celotex, 477 U.S. at 324. A "scintilla" of evidence in favor of the non-moving party, however, is insufficient to prevent an award of summary judgment. Anderson, 477 U.S. at 252. Further, "mere speculation" by the non-moving party or the "building of one inference upon another" cannot create a genuine issue of material fact. Cox v. Cnty. of Prince William, 249 F.3d 295, 299-300 (4th Cir. 2001). Summary judgment should be denied only where a court concludes that a reasonable jury could find in favor of the non-moving party. Anderson, 477 U.S. at 252.
Defendants contend that they are entitled to summary judgment on all claims asserted against them by plaintiff. (ECF No. 39 at 3.) Specifically, defendants argue that summary judgment is proper because: (1) plaintiff's claims are barred by the learned intermediary doctrine; (2) plaintiff's claims are barred by limitations; (3) plaintiff is asserting claims against the wrong defendant; and (4) plaintiff has no evidence to support the essential elements of her claims. (Id. at 9-14.) In her Opposition, plaintiff challenges each of these arguments. ...