Bee v. Novartis Pharm. Corp.

Citation18 F.Supp.3d 268
Decision Date09 May 2014
Docket NumberNo. 12–CV–1421 JFBWDW.,12–CV–1421 JFBWDW.
PartiesBrian BEE & Donna Bee, Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORP., Defendant.
CourtUnited States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)

18 F.Supp.3d 268

Brian BEE & Donna Bee, Plaintiffs
v.
NOVARTIS PHARMACEUTICALS CORP., Defendant.

No. 12–CV–1421 JFBWDW.

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

Signed May 9, 2014.


18 F.Supp.3d 273

John Julian Vecchione of Valad and Vecchione, Fairfax, VA, for Plaintiffs.

Robert E. Johnston, Donald McMinn, and James Sullivan of Hollingsworth LLP, Washington, DC, and David Richman of Rivkin Radler LLP, Uniondale, NY, for Defendant.

MEMORANDUM AND ORDER

JOSEPH F. BIANCO, District Judge:

Plaintiffs Brian Bee (“Bee” or “plaintiff”) and Donna Bee (“D. Bee”) (collectively, “plaintiffs”) bring this products liability action against Novartis Pharmaceuticals Corporation (“Novartis,” “NPC,” or “defendant”), alleging that Novartis's drugs Zometa and Aredia, prescribed to Bee as part of a regimen to treat his ankylosing spondylitis, osteoporosis, and bone pain, caused him to develop osteonecrosis of the jaw (“ONJ ”).1 Plaintiffs allege claims of strict liability, negligent manufacture, negligent failure to warn, breach of express warranty, breach of implied warranty, and loss of consortium against defendant. They assert that Novartis (1) negligently (i) tested Aredia and Zometa and (ii) failed to warn about the drugs' potential risks and precautions that could be taken to minimize such risks; (2) is strictly liable for (i) Aredia's and Zometa's allegedly defective design and manufacturing, and (ii) its failure to warn of the possible risk of ONJ; and (3) breached its products' express and implied warranties.2

Presently before the Court are several motions brought by Novartis. These include

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six Daubert motions seeking to exclude the testimony of plaintiffs' case-wide experts, and a motion for summary judgment. Because Novartis's six Daubert motions against plaintiffs' case-wide experts address issues beyond the scope of the pending summary judgment motion, the Court limits its analysis here to those arguments raised in the motion for summary judgment. Where certain of these arguments touch upon other Daubert motions raised previously in this litigation, these are addressed as necessary for purposes of resolving the summary judgment motion.

Turning to the summary judgment motion itself, Novartis contends that summary judgment in its favor is warranted because the uncontroverted evidence in the record shows that (1) Novartis had no duty to warn of risks associated with taking Aredia and Zometa for treatment of ankylosing spondylitis or osteoporosis ; (2) Novartis adequately warned prescribers about the risk of ONJ associated with the challenged medications once it became aware of such a risk; (3) plaintiffs cannot show that Novartis's warning as to ONJ was the proximate cause of Bee's injury; (4) plaintiffs have no evidence that Aredia and Zometa substantially caused Bee's ONJ, nor do they offer admissible expert testimony in support of the same; (5) plaintiffs proffer no evidence showing that either Aredia or Zometa differed in any way from design specifications; (6) because Novartis provided an adequate warning, plaintiffs' strict liability, negligence, and breach of implied warranty claims, which rely on allegations that Aredia and Zometa's warnings were defective, must fail; (7) plaintiffs point to no evidence showing that Novartis made an express warranty upon which Bee or his doctor relied; and (8) because a loss of consortium claim is a derivative claim, and plaintiff's other claims all fail, summary judgment is warranted to defendant as to this claim.

After careful consideration of the parties' arguments and a full review of the record, the Court denies Novartis's motion for summary judgment its entirety for the following reasons.

I. Background

This case is part of “Wave III” of a multidistrict litigation in the United States District Court for the Middle District of Tennessee (“the MDL Court”). The Court has taken the facts set forth below from the parties' depositions, affidavits, exhibits, and respective Rule 56.1 Statements of Facts. The Court construes the facts in the light most favorable to the non-moving party. See Capobianco v. City of New York, 422 F.3d 47, 50–51 (2d Cir.2005). Unless otherwise noted, where a party's 56.1 statement is cited, that fact is undisputed or the opposing party has not pointed to any evidence in the record to contradict it.3

A. Plaintiff's General Medical History

Plaintiffs Brian and Donna Bee are New York residents. (Def. Rule 56.1 Statement (“Def. 56.1”) ¶ 96; Pls. Rule 56.1 Response (“Pls. 56.1”) ¶ 96.) Plaintiff has suffered from several medical conditions over the

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years.4 By 1995, at the age of twenty-nine, plaintiff had a history of Schmorl's nodes,5 vertebral compression deformity, vertebral bone spur,6 and osteochonditis.7 (Def. 56.1 ¶ 2.) That same year, doctors also diagnosed plaintiff with ankylosing spondylitis, “ ‘a chronic systemic inflammatory disease that primarily attacks the axial skeleton and adjacent structures.’ ” (Id. ¶ 7 (quoting Michael Weisman, Ankylosing Spondylitis 5 (2011)).) Plaintiff's medical problems continued as he entered his thirties, being diagnosed in July 1996 with multiple collapsed vertebrae, and in September 1996, with osteoporosis. (Id. ¶¶ 8–9.)

Bee's youth, as well as the severity of his medical condition, made him a unique patient for doctors. (Def. 56.1 ¶¶ 101, 107.) In light of plaintiff's poor bone condition, doctors referred Bee to an oncologist, Dr. Edward Samuel (“Dr. Samuel”), in August 1996 to determine whether a malignancy had caused his vertebrae to weaken and collapse; tests, however, were negative. (Id. ¶ 10; see also Pls. 56.1 ¶ 10.) After conducting various examinations, Dr. Samuel concluded that plaintiff did not have cancer. (Def. 56.1 ¶ 11; Pls. 56.1 ¶ 11.) Nevertheless, Dr. Samuel—whose practice consisted predominantly of cancer patients (see Def. 56.1 ¶ 102)—offered to treat plaintiff by using some of the same methods he applied to his cancer patients. (Id. ¶ 12; Pls. 56.1 ¶ 12.) Dr. Samuel hoped to strengthen plaintiff's bones in order to prevent further fractures or associated pain. (Def. 56.1 ¶ 107; Pls. 56.1 ¶ 107.) In October 1996, Bee was prescribed the oral bisphosponate, Fosamax, an approved drug for strengthening the bones of patients with osteoporosis. (Def. 56.1 ¶¶ 13–14; Pls. 56.1 ¶¶ 13–14.)

Plaintiff's health problems continued. After October 1996, he continued to lose height, and bone scans showed several of his vertebrae to be deteriorating. (Def. 56.1 ¶ 15; Pls. 56.1 ¶ 15.) The tests also showed formation of new Schmorl's nodes and increasingly abnormal bone signals. (Def. 56.1 ¶ 16; Pls. 56.1 ¶ 16.)

As time passed, Fosamax proved to be a difficult drug for plaintiff; it hurt his stomach and he had trouble regularly taking it. (Def. 56.1 ¶ 17; Pls. 56.1 ¶ 17.) Accordingly, on August 27, 1997, Dr. Samuel, based on his medical judgment and the available literature at the time, decided to switch plaintiff to Aredia, a drug that would similarly aid Bee's pain and bone problems, but which did not have the same side effects as Fosamax. (Pls. 56.1 ¶ 18; see also Def. 56.1 ¶¶ 18, 104.)8 Plaintiff, after thinking it over, decided to make the

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switch.9 (See Pls. 56.1 ¶ 104.) In contrast to Fosamax, an oral medication, Aredia was an intravenous bisphosphonate “indicated for the treatment of hypercalcemia of malignancy, bone metastases from certain types of cancer, multiple myeloma, and Paget's disease.” (Def. 56.1 ¶ 19.) Although plaintiff did not have any of these specific conditions (see Pls. 56.1 ¶ 19), it was hoped that Aredia would allow him to receive the bisphosphonates he needed without causing the problems he experienced when trying to ingest them gastrointestinally (id. ¶ 18). For a cancer patient, the recommended dose of Arcadia is a 90 mg intravenous infusion over ninety minutes; plaintiff received such cancer-level doses from August 27, 1997 through October 2002. (Def. 56.1 ¶¶ 20–21; Pls. 56.1 ¶¶ 20–21.)10 Plaintiff received all of his Aredia infusions in New York. (Def. 56.1 ¶ 97; Pls. 56.1 ¶ 97.)

As plaintiff underwent these medical treatments, his health status altered over the years. For instance, by 1998, plaintiff's osteoporosis had worsened to severe osteoporotic bone disease. (Def. 56.1 ¶ 25; Pls. 56.1 ¶ 25.) By June of 2000, plaintiff developed a hunched back, or “90 degree severe kyphosis,” which required surgery that included fusing several of his spinal vertebrae and implanting surgical rods. (Def. 56.1 ¶ 26; Pls. 56.1 ¶ 26.) Plaintiff subsequently received the corticosteroid prednisone ; although defendant contends that plaintiff received this “periodically” (Def. 56.1 ¶ 27), plaintiffs assert that Bee only had two treatments of the drug during 2000 and 2002, and that Dr. Samuel “prescribed [p]rednisone for Bee for a short period in July 2001 because of an acute severe exacerbation of Bee's back pain accompanied by left sided sciatica” (Pls. 56.1 ¶ 27). Plaintiff was advised that prednisone could possibly have an adverse impact on his osteoporosis should it be taken for an extended period of time. (Def. 56.1 ¶ 28 Pls. 56.1 ¶ 28.)

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