Full opinion text
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”). 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. Presently before the Court are several motions brought by Novartis. These in-elude 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 anky-losing 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 Are-dia 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 plaintiffs 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. A. Plaintiffs 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 years. By 1995, at the age of twenty-nine, plaintiff had a history of Schmorl’s nodes, vertebral compression deformity, vertebral bone spur, and osteochonditis. (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)).) Plaintiffs 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 patiént for doctors. (Def. 56.1 ¶¶ 101, 107.) In light of plaintiffs 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 Pis. 56.1 ¶ 10.) After conducting various examinations, Dr. Samuel concluded that plaintiff did not have cancer. (Def. 56.1 ¶ 11; Pis. 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. It 12; Pls. 56.1 ¶ 12.) Dr. Samuel hoped "to strengthen plaintiffs 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,- Fosa-max, an approved drug for strengthening the bones of patients with osteoporosis. (Def. 56.1 ¶¶ 13-14; Pls. 56.1 ¶¶ 13-14.) Plaintiffs 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; Pis. 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.) Plaintiff, after thinking it over, decided to make the switch. (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 gastroin-testinally (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.) 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, plaintiffs 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.) In 2002, plaintiff was diagnosed with arthritis and early osteoarthritis. (Def. 56.1 ¶ 29 Pls. 56.1 ¶ 29.) That same year, he suffered back pain so severe that he was on bed rest for two weeks. (Def. 56.1 ¶ 30; Pls. 56.1 ¶ 30.) In December 2002, plaintiff, under Dr. Samuel’s guidance, began taking Zometa, “an intravenous bis-phosphonate indicated for hypercalcemia of malignancy, the treatment of bone metastases from certain types of cancer, multiple myeloma, and Paget’s disease.” (Def. 56.1 ¶ 23; see also id. ¶ 104.) Bee took Zometa through September 2004. (Id. ¶ 24; Pls. 56.1 ¶ 24.) He received all of his infusions in New York. (Def. 56.1 ¶ 97; Pls. 56.1 ¶ 97.) It seems that after plaintiff stopped taking Zometa, his skeletal disease continued to progress, and his pain, while fluctuating in intensity levels, continued. (Def. 56.1 ¶ 33; Pls. 56.1 ¶ 33.) In 2005, plaintiff was diagnosed with right deep vein thrombosis, a pulmonary embolism, chronic obstructive pulmonary disease, and peptic ulcer disease. (Def. 56.1¶¶ 31-32; Pls. 56.1 ¶¶ 31-32.) In May 2007, plaintiff had another spinal fusion surgery in which more of his vertebrae were fused together and additional instruments were implanted into his spine for support. (Def. 56.1 ¶ 34; Pls. 56.1 ¶ 34.) B. Plaintiffs Dental History From 1999 through 2003, plaintiff experienced various dental difficulties. Specifically, he had periodontal disease, bleeding gums, multiple dental caries, dental fillings, painful and sensitive teeth, a root canal, and a mobile tooth. (Def. 56.1 ¶ 37; Pls. 56.1 ¶37.) In May 2003, Bee informed Dr. O’Lear that he was experiencing pain in his lower-right mouth; Dr. O’Lear noticed that several of the teeth he had previously restored in plaintiff’s mouth were missing fillings, and further, that other teeth might be in need of root canals. (Def. 56.1 ¶ 38; Pls. 56.1 ¶ 38.) Several months later, Dr. O’Lear referred plaintiff to an oral surgeon, Dr. Thomas Arcati (“Dr. Arcati”), upon discovering that plaintiff had “rampant caries.” (Def. 56.1 ¶ 39; Pls. 56.1 ¶ 39.) According to Dr. Arcati, plaintiff failed to disclose that he was taking Zometa. (Def. 56.1 ¶ 118; Pls. 56.1 ¶ 118.) Dr. Ar-eati also testified that he was aware of a relation between bisphosphonates and ONJ as of September 2003, and stated that he would not have extracted plaintiffs teeth had he known that plaintiff was taking Zometa. (Def. 56.1 ¶ 119.) After examining plaintiffs mouth, Dr. Arcati determined that surgery was needed; of the sixteen non-restorable teeth in plaintiff’s mouth, Dr. Arcati extracted eight of those in October 2003 and the remaining eight in November 2003. (Def. 56.1¶¶ 40-41; Pls. 56.1 ¶¶ 40-41.) Dr. Arcati found plaintiff to be healing well following both surgeries. (Def. 56.1 ¶ 42; Pls. 56.1 ¶ 42.) A little over three months later, in March 2004, plaintiff visited Dr. Arcati again, this time with exposed bone that required Dr. Arcati to smooth a large bone spicule in plaintiffs mandible. (Def. 56.1¶ 43; Pls. 56.1 ¶ 43.) Plaintiffs contend this was not the only visit that Bee made to Dr. Arcati in March 2004; instead, they claim that Bee visited him approximately six times “with exposed bone, jaw pain and other related issues.” (Pls. 56.1¶43.) During this time, Dr. Arcati encouraged plaintiff to quit smoking; he also noted that the area from which he had removed the spicule was healing well. (Id. ¶ 44; see also Def. 56.1 ¶ 44.) In late March 2004, plaintiff had exposed bone on both his right mandible and left maxilla; he returned to Dr. Arcati, who instructed plaintiff to return for weekly treatment. (Def. 56.1 ¶¶ 45-46; Pls. 56.1¶¶ 45-46.) Because of travel limitations, plaintiff did not see Dr. Arcati again until late April. (Pls. 56.1 ¶ 47.) At that time, Dr. Arcati referred plaintiff to Dr. Salvatore Ruggerio (“Dr. Ruggiero”), an oral surgeon, whom plaintiff visited approximately two and a half months later. (Def. 56.1 ¶ 48; Pls. 56.1 ¶ 48.) After examining plaintiff, Dr. Ruggiero concluded that plaintiffs exposed bone likely was attributable to bisphosphonate use. (Def. 56.1 ¶ 49; Pls. 56.1 ¶49.) Bee, who was taking Zometa at the time, went for two more infusions of Zometa during his treatment with Dr. Ruggiero. (Def. 56.1 ¶ 50; Pls. 56.1 ¶ 50.) According to plaintiffs, Bee asked Dr. Ruggiero if stopping of the Zometa treatments would help his condition; plaintiffs contend that the doctor informed him it would not, as “once it’s in your system it’s always going to be there.” (Pls. 56.1 ¶ 50.) It appears that Bee also informed Dr. Samuel of Dr. Ruggiero’s determination that plaintiffs exposed bone was due to the bisphospho-nates; when Dr. Samuel saw the exposed bone in plaintiffs mouth, he ultimately decided to cease treatment, which occurred in September 2004. (Def. 56.1 ¶ 110; Pls. 56.1¶ 110.) In November 2004, plaintiff went back to Dr. Arcati; when Dr. Arcati saw him the following month, the exposed bone in plaintiffs maxilla had healed, and the exposed bone in his right mandible area was improving. (Def. 56.1 ¶¶ 51-52; Pls. 56.1 ¶¶ 51-52.) Dr. Arcati instructed plaintiff to return in a few days for another de-bridement. (Def. 56.1 ¶ 53; Pls. 56.1 ¶ 53.) After December 2004, plaintiff did not see Dr. Arcati for nearly three years. (Def. 56.1 ¶ 54; Pls. 56.1 ¶54.) During that next visit (on November 16, 2007), Dr. Arcati saw and debrided a large sequest-rum on plaintiffs right mandible. (Def. 56.1¶ 55; Pls. 56.1 ¶ 55.) A bone pathology report issued at that time noted that there was necrotic bone with “associated bacterial debris and inflammation consistent with bisphosphonate related osteone-crosis.” (Def. 56.1 ¶ 56; Pls. 56.1 ¶56.) Approximately a week later, Dr. Arcati observed plaintiffs soft tissue to have healed; Dr. Arcati stated it was the “healthiest this area has looked.” (Def. 56.1 ¶ 57; Pls. 56.1 ¶ 57.) Since that time, plaintiff has not suffered any further exposed bone in his mouth. (Pls. 56.1 ¶ 58.) C. Aredia, Zometa, and the FDA The United States Food and Drug Administration (the “FDA”) approved Are-dia — an intravenous bisphosphonate manufactured by Novartis — as safe and effective for treatment of hypercalcemia of malignancy in 1991, as well as for Paget’s disease (in 1994), multiple myeloma (in 1995), and bone metastases arising from breast cancer (in 1996). (Def. 56.1 ¶¶ 59-60; Pls. 56.1¶¶ 59-60.) Approximately a decade after approving Aredia, the FDA approved Zometa — also a Novartis-manufactured intravenous bis-phosphonate — as a safe and effective treatment for hypercalcemia of malignancy; the FDA also approved Zometa’s labeling. (Def. 56.1 ¶ 61; Pls. 56.1 ¶ 61.) In 2002, the FDA approved Zometa for treatment of multiple myeloma. (Def. 56.1 ¶ 62; Pls. 56.1¶ 62.) Both Zometa and Aredia presently remain on the market as FDA-approved drugs, although their labeling has changed over the years. (Pls. 56.1 ¶¶ 63-64.) Neither Aredia nor Zometa are approved for the treatment of osteoporosis, ankylosing spondylitis, or general bone pain. (Def. 56.1 ¶ 69.) Plaintiffs note, however, that the main ingredient in Zometa, zoledronie acid, is the same active ingredient in a different drug, Reclast, which has been approved for osteoporosis. (Pls. 56.1 ¶ 69.) Plaintiffs contend that Novartis’s sales persons were encouraging the use of Zometa for osteoporosis on account of this ingredient. (Id.) Defendant counters that the dose and dosing regimen for Reclast differs from that of Zometa, and further, that “[n]either Reclast nor Zometa was FDA approved for the treatment of osteoporosis during the time that [plaintiff] was treated with Aredia and Zometa.” (Def. Mem. in Supp. of Mot. for Summ. J. in the Bee Case (“Def. Summ. J. Mot.”) at 6 n. 8). Aredia and Zometa are “medicine[s] proven to reduce the incidence of pathologic fractures and spinal cord compression in patients with multiple myeloma and whose cancers have spread to the bone.” (Def. 56.1 ¶ 70; Pls. 56.1 ¶ 70.) Although the parties contest the extent to which Zometa has successfully served as an anti-cancer treatment (compare Def. 56.1 ¶ 71, with Pls. 56.1 ¶ 71), or the extent to which either Aredia or Zometa have extended patients’ lives or significantly impacted the treatment of metastatic cancer to the bone (compare Def. 56.1 ¶ 73, with Pls. 56.1 ¶ 73), plaintiffs’ expert, Dr. Robert Marx (“Dr. Marx”), has acknowledged both Are-dia and Zometa to have “dramatically extended life, reduced skeletal complications, reduced pain, and thus improved the quality of life” for patients who have taken these drugs (Def. 56.1 ¶ 72; Pls. 56.1 ¶ 72). In sum, Aredia and Zometa have been approved for treatment of various conditions; plaintiff, however, did not have one of the conditions for which these drugs had specifically been approved at the time he was taking the medications. (Def. 56.1 ¶ 74; Pls. 56.1 ¶ 74.) D. Novartis’s Response to Reports of Osteonecrosis of the Jaw The medical condition of ONJ is not a recent medical development. Medical literature reports the existence of ONJ, or at least a condition similar to it, as early as at least the 19th century, well before Aredia or Zometa came onto the market in approximately 1977. (Def. 56.1 ¶¶75, 78; Pls. 56.1 ¶ 75.) There were no reports of ONJ during the animal studies of Aredia and Zometa. (Def. Summ. J. Mot. at 7.) Defendant contends that there also were no reported events in the clinical trials leading to the FDA’s approval of these drugs for their labeled indications. (Def. 56.1 ¶ 76.) Defendant also contends that it did not receive its first report of a patient who was taking Aredia and/or Zometa and developed ONJ until December 6, 2002. (Id. ¶ 79.) Plaintiffs dispute this, asserting that “there were at least 6 incidents of ONJ in [Novartis’s] clinical trials” (Pls. 56.1 ¶ 76), and that “Novartis had cases of ONJ in its Aredia and Zometa clinical trials going back to 1991” (id. ¶ 79). Within fifteen days of receiving the ONJ-patient news in December 2002, Novartis reported the adverse event to the FDA and began an investigation, reviewing the animal and other studies conducted prior to the marketing of Aredia and Zometa, to determine whether osteonecro-sis of any site — not simply the jaw — had occurred during the pre-clinical studies. (Def. 56.1 ¶ 80; Pls. 56.1 ¶ 80.) Additionally, in June 2003, Novartis reviewed several medical databases, including Medline, Embase, Biosos, Current Contents, and International Pharmaceuticals Abstracts, to determine whether any publications addressed the occurrence of osteonecrosis arising in animals taking bisphosphonates. (Def. 56.1 ¶ 81; Pls. 56.1 ¶81.) Defendant contends that it was unable to identify any articles specifically mentioning osteonecro-sis as being caused or occurring with the use of bisphosphonates in animals. (Def. 56.1 ¶ 81.) Plaintiffs counter this, arguing that Novartis’s head of Zometa’s preclinical studies testified that Novartis had a 1981 study showing ONJ as occurring in rats with exposure to bisphosphonates as early as 1986. (Pls. 56.1 ¶ 81.) According to defendant, before January 2003, no cases, specifically identified as osteonecro-sis of the maxillofacial area (including the jaw), had appeared in Novartis’s worldwide post-marketing safety database. (Def. 56.1 ¶ 82.) Defendant also states that, as of 2002, it understood that bis-phosphonates were being considered as a potential preventative treatment for osteo-necrosis. (Def. 56.1 ¶ 85.) On September 26, 2003, Novartis informed the FDA that it had decided to revise the Adverse Reactions section of Aredia and Zometa’s labeling so that it reflected the recent reports of ONJ with the intravenous intake of bisphosphonates. (Def. 56.1 ¶ 83; Pls. 56.1 ¶ 83.) Specifically, Novartis informed the FDA that it was altering its labeling language. (Def. 56.1 ¶ 86.) Such label alteration is permissible pursuant to the FDA’s “Changes Being Effected” regulations (“CBE”). (Def. 56.1 ¶ 87; Pls. 56.1 ¶ 87.) Novartis made its label change under a “CBE 0,” which allowed it to make the label change as quickly as possible under FDA regulations. (Def. 56.1 ¶ 88; Pis. 56.1 ¶88.) The FDA accepted this label change as submitted. (Def. 56.1 ¶ 89; Pls. 56.1 ¶89.) In February 2004, Novartis made an additional revision to the informative language associated with Zometa; specifically, it edited the Post-Marketing Experience section of the Zometa label to state: “Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged.” (Def. 56.1 ¶ 90; Pls. 56.1 ¶ 90.) On February 27, 2004, the FDA approved the following label revision: Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates. The majority of the reported cases are in cancer patients attendant to a dental procedure. Osteonecrosis of the jaws has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anemia, coagulo-pathies, infection, preexisting oral disease). Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged. (Def. 56.1 ¶ 91; Pls. 56.1 ¶ 91.) On September 24, 2004, Novartis updated Zometa’s drug label again to warn physicians about the possible link between Zometa use and ONJ. (Def. 56.1 ¶¶ 92-93.) That same month, Novartis also sent a “Dear Doctor” letter to over 17,200 hematologists, urologists, oral surgeons, and oncologists, both alerting physicians to the change in Zometa’s labeling, and highlighting the relevant label language, including: Precautions: Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates ... A dental examination with appropriate dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g., cancer, chemotherapy, corticosteroids, poor oral hygiene). While on treatment, these patients should avoid invasive dental procedures if possible_ For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. (Def. 56.1 ¶ 93.) Members of the medical community received this letter. (Def. 56.1 ¶ 94; Pls. 56.1 ¶ 94.) However, plaintiff asserts that, by the time of these warnings in September 2004, he had had tooth extractions and had developed a case of os-teonecrosis of the jaw. II. PROCEDURAL HISTORY On February 2, 2007, plaintiffs filed the instant action against defendants in the district court for the District of Columbia. The Judicial Panel on Multidistrict Litigation subsequently transferred this case to the Middle District of Tennessee (“the MDL Court”), pursuant to 28 U.S.C. § 1407, on April 13, 2007, pursuant to a Conditional Transfer Order. On January 9, 2012, the Judicial Panel on Multidistrict Litigation directed remand of the case to the transferor court (ie., the district court for the District of Columbia). On March 6, 2012, plaintiffs filed an unopposed motion to transfer the case to the Eastern District of New York. Judge John ■ D. Bates granted the motion, and the case was transferred to this Court on March 22, 2012. Magistrate Judge William D. Wall handled pretrial matters and discovery. On November 19, 2012, defendant filed a motion “to advise the Court of pending summary judgment motions and to request consolidated Daubert briefing.” (ECF No. 20.) Before the case was transferred, the parties had engaged in summary judgment and Daubert briefing, in accordance with the MDL Court’s scheduling order. Thus, defendant asked this Court to consider the pending motions and to hold argument to address the same. Plaintiffs agreed that this Court should address the pending motions. On January 2, 2013, this Court held a telephone conference with the parties to discuss the pending motions, and it set a briefing schedule for the consolidated motions. The parties submitted their respective motions in compliance with the scheduling order. The Court held oral on May 3, 2013. This matter is fully submitted, and the Court has considered all of the parties’ submissions. III. Standard of Review Pursuant to Federal Rule of Civil Procedure 56(a), a court may grant a motion for summary judgment only if “the movant shows that 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); Gonzalez v. City of Schenectady, 728 F.3d 149, 154 (2d Cir.2013). The moving party bears the burden of showing that he or she is entitled to summary judgment. Huminski v. Corsones, 396 F.3d 53, 69 (2d Cir.2005). “A party asserting that a fact cannot be or is genuinely disputed must support the assertion by: (A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials; or (B) showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact.” Fed.R.Civ.P. 56(c)(1). The court “is not to weigh the evidence but is instead required to view the evidence in the light most favorable to the party opposing summary judgment, to draw all reasonable inferences in favor of that party, and to eschew credibility assessments.” Amnesty Am. v. Town of W. Hartford, 361 F.3d 113, 122 (2d Cir.2004) (quoting Weyant v. Okst, 101 F.3d 845, 854 (2d Cir.1996)); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (summary judgment is unwarranted if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party”). Once the moving party has met its burden, the opposing party “ ‘must do more than simply show that there is some metaphysical doubt as to the material facts.... [TJhe nonmoving party must come forward with specific facts showing that there is a genuine issue for trial.’ ” Caldarola v. Calabrese, 298 F.3d 156, 160 (2d Cir.2002) (alteration and emphasis in original) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986)). As the Supreme Court stated in Anderson, “[i]f the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.” 477 U.S. at 249-50, 106 S.Ct. 2505 (citations omitted). Indeed, “the mere existence of some alleged factual dispute between the parties alone will not defeat an otherwise properly supported motion for summary judgment.” Id. at 247-48, 106 S.Ct. 2505 (emphasis in original). Thus, the nonmoving party may not rest upon mere conclusory allegations or denials but must set forth “ ‘concrete particulars’ ” showing that a trial is needed. R.G. Grp., Inc. v. Horn & Hardart Co., 751 F.2d 69, 77 (2d Cir.1984) (quoting SEC v. Research Automation Corp., 585 F.2d 31, 33 (2d Cir.1978)). Accordingly, it is insufficient for a party opposing summary judgment “ ‘merely to assert a conclusion without supplying supporting arguments or facts.’ ” BellSouth Telecomms., Inc. v. W.R. Grace & Co., 77 F.3d 603, 615 (2d Cir.1996) (quoting Research Automation Corp., 585 F.2d at 33). IV. Discussion A. Failure to Warn (Strict Liability and Negligence) Plaintiffs assert that Novartis (1) negligently failed to test Aredia and Zometa, (2) negligently failed to warn about (i) the drugs’ potential risks or (ii) available precautions to minimize such risks, and (3) failed to adequately warn as to the risk of ONJ. Plaintiffs also bring a cause of action sounding in strict liability, i.e., that Novartis defectively designed and manufactured Aredia and Zometa. Defendant counters that (1) Novartis had no duty to warn Bee’s physicians as to off-label uses of the drugs, (2) the warnings that Novartis gave were adequate, (3) no evidence in the record shows that, had a different warning issued, Bee’s use of Aredia or Zometa might have been different, and (4) plaintiffs proffer no evidence that Aredia and Zometa substantially caused Bee’s ONJ. In order to establish a prima facie case for failure to warn under New York law, a plaintiff must show the following: (1) the manufacturer had a duty to warn; (2) the manufacturer breached the duty to warn in a manner that rendered the product defective, i.e., reasonably certain to be dangerous; (3) the defect was the proximate cause of the plaintiff’s injury; and (4) the plaintiff suffered loss or damage. See McCarthy v. Olin Corp., 119 F.3d 148, 156 (2d Cir.1997) (citing Becker v. Schwartz, 46 N.Y.2d 401, 410, 413 N.Y.S.2d 895, 386 N.E.2d 807 (1978)); see also In re Fosamax Prods. Liab. Litig., 924 F.Supp.2d 477, 486 (S.D.N.Y.2013); Mustafa v. Halkin Tool, Ltd., No. 00-CV-4851, 2007 WL 959704, at *17 (E.D.N.Y. Mar. 29, 2007). These prima facie elements of a failure to warn claim remain the same under New York law regardless of whether they sound in negligence or strict liability. See Martin v. Hacker, 83 N.Y.2d 1, 8 n. 1, 607 N.Y.S.2d 598, 628 N.E.2d 1308 (1993); see also Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir.1991) (“ ‘Regardless of the descriptive terminology used to denominate the cause of action ... where the theory of liability is failure to warn, negligence and strict liability are equivalent.’ ” (quoting Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 97 (1979))). Generally, a manufacturer has a duty to warn (1) “against latent dangers resulting from foreseeable uses of its product of which it knew or should have known,” and (2) “of the danger of unintended uses of a product provided these uses are reasonably foreseeable.” Liriano v. Hobart Corp., 92 N.Y.2d 232, 237, 677 N.Y.S.2d 764, 700 N.E.2d 303 (1998); see also State Farm Fire & Cas. Co. v. Nutone, Inc., 426 Fed.Appx. 8, 10 (2d Cir.2011). “This duty is a continuous one, and requires that the manufacturer be aware of the current information concerning the safety of its product.” Krasnopolsky v. Warner-Lambert Co., 799 F.Supp. 1342, 1345-46 (E.D.N.Y.1992). “Liability for failure to warn may be imposed based upon either the complete failure to warn of a particular hazard or the inclusion of warnings that are insufficient.” Fisher v. Multiquip, Inc., 96 A.D.3d 1190, 949 N.Y.S.2d 214, 218 (2012) (citation and internal quotation marks omitted). Typically, summary judgment is appropriate where a plaintiff has not introduced any evidence that a manufacturer knew or should have known of the danger at issue. See Colon ex rel. Molina v. BIC USA, Inc., 199 F.Supp.2d 53, 93-94 (S.D.N.Y.2001); see also Wolfgruber, 423 N.Y.S.2d at 97-98 (granting defendant summary judgment in failure to warn case when there were no disputed facts). On the other hand, “the adequacy of a warning generally is a question of fact,” best reserved for trial. Kandt v. Taser Int’l, Inc., No. 09-CV-0507, 2012 WL 2861583, at *3 (N.D.N.Y. July 10, 2012) (emphasis added) (quoting Fisher, 949 N.Y.S.2d at 218); see also Urena v. Biro Mfg. Co., 114 F.3d 359, 366 (2d Cir.1997) (“ ‘The adequacy of the instruction or warning is generally a question of fact to be determined at trial and is not ordinarily susceptible to the drastic remedy of summary judgment’” (quoting Beyrle v. Finneron, 199 A.D.2d 1022, 606 N.Y.S.2d 465, 465 (1993))). When evaluating failure to warn liability, a court must conduct an “intensely fact-specific” analysis, “including but not limited to such issues as feasibility and difficulty of issuing warnings in the circumstances; obviousness of the risk from actual use of the product; knowledge of the particular product user; and proximate cause.” Anderson v. Hedstrom Corp., 76 F.Supp.2d 422, 440 (S.D.N.Y.1999) (quoting Liriano, 92 N.Y.2d at 243, 677 N.Y.S.2d 764, 700 N.E.2d 303) (internal quotation marks omitted). Where a manufacturer owes a duty to warn, it can satisfy this obligation by “warn[ing] of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist.” Davids v. Novartis Pharm. Corp., 857 F.Supp.2d 267, 286 (E.D.N.Y.2012) (quoting Sita v. Danek Med., Inc., 43 F.Supp.2d 245 (E.D.N.Y.1999)) (alternation in original and internal quotation marks omitted). In the prescription drug context, courts have recognized that a manufacturer’s duty to warn extends to a patient’s doctor (and not to the patient himself) pursuant to the “learned intermediary” rule. See Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir.1993); Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 91 (2d Cir.1980) (stating that “the manufacturing defect is to warn the doctor, not the patient”). The logic underlying this rule is that “[t]he doctor acts as an ‘informed intermediary’ between the manufacturer and the patient, evaluating the patient’s needs, assessing the risks and benefits of available drugs, and prescribing and supervising their use.” Davids, 857 F.Supp.2d at 286 (quoting Glucksman v. Halsey Drug Co., Inc., 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1990)) (internal quotation marks omitted). Thus, if a defendant fails to adequately warn a patient’s physician of the dangers presented by a given pharmaceutical, and the patient suffers an injury on account of such failure to warn, a failure to warn claim may lie. That being said, where a treating physician elects “not to inform a patient of a side effect,” this “acts as an intervening cause which shields the drug manufacturer from any possible liability under a failure to warn theory.” Krasnopolsky, 799 F.Supp. at 1346. Similarly, where a defendant can show, via “specific facts,” that any given warning would have been futile&emdash;either because any such warnings would not have been heeded or because the injury would have occurred, regardless of the given warnings&emdash;a defendant will have successfully rebutted the general presumption that “ ‘a user would have heeded warnings if they had been given, and that the injury would not have occurred.’ ” Adesina v. Aladan Corp., 438 F.Supp.2d 329, 338 (S.D.N.Y.2006) (quoting G.E. Capital Corp. v. A.O. Smith Corp., No. 01-CV-1849, 2003 WL 21498901, at *5 (S.D.N.Y. July 1, 2003)); see In re Fosamax, 924 F.Supp.2d at 486 (explaining that heeding presumption “may only be rebutted by specific facts showing that the warning would have been futile”). If a defendant can make such a showing, a plaintiff will not be able to establish the proximate causation element of a failure to warn claim. 438 F.Supp.2d at 338. Novartis argues that it is entitled to summary judgment as to the failure to warn claims because plaintiffs cannot show (1) that Novartis had a duty to warn, (2) that Novartis breached that duty, or (3) that Bee’s injury was proximately caused by the alleged breach. Based on the evidence in the record, construed most favorably to plaintiffs, the Court concludes that genuine issues of material fact preclude summary judgment on these grounds. The Court addresses each element in turn. 1. Duty to Warn a. The Parties’ Arguments At the outset, Novartis claims that any alleged duty to warn only extended to plaintiffs prescribing physicians (and not to any members of the dental community, such as plaintiffs dentists) pursuant to the learned intermediary doctrine. (See Def. Summ. J. Mot. at 11.) Novartis also contends that it had no duty to warn of the contested risks at issue here because plaintiff was engaged in off-label use of Aredia and Zometa. (See id.) That is, Aredia’s and Zometa’s labels clearly indicated the FDA-approved use for these particular drugs, and neither osteoporosis nor anky-losing spondylitis were listed as conditions for which these drugs were to be prescribed. (See id.) Accordingly, defendant argues that Bee’s use of these drugs — for non-FDA approved purposes — was not foreseeable, and thus, Novartis held no duty to warn Bee’s physicians as to these drugs’ associated risks. (See id. at 11 (“[BJecause [Novartis] has warned that Aredia and Zometa are only intended for FDA approved uses, [plaintiffs] use of these drugs was unforeseeable and [Novartis] owed no duty to warn the prescri-ber of these drags to [plaintiff] of risks associated with his Aredia and Zometa uses.”); Def. Reply in Supp. of Summ. J. (“Def. Reply”) at 2-3; id. at 3 (“[Novartis] owed no duty to warn a doctor prescribing [plaintiff] these drugs about the risks associated with his off-label Aredia and Zometa use.”).) An additional argument Novartis raises in support of ONJ-unforeseeability here is that this case is distinguishable from other Aredia/Zometa lawsuits in that, unlike those other cases, Bee was not a cancer patient at the time he took the drugs. (See Def. Mot. to Advise Court of Pending Summ. J. Mots. & Request Consol. Briefing (“Def. Mot. to Advise”) at 5 (“Mr. Bee’s claim presents issues that no other plaintiffs trial case has addressed because his doctor prescribed Aredia and Zometa for severe osteoporosis related to a rare orthopedic condition, ankylosing spondylitis. This is not one of the metastatic cancers to bone for which Novartis developed, labeled, and sold Aredia and Zometa and for which the litigation-wide experts identified by the Plaintiffs’ Steering Committee developed their reports.”).) Thus, because Bee was a non-cancer patient using these drugs in an off-label context, Novartis again contends that it held no duty to warn. Plaintiffs counter that Novartis had a duty to warn because it was foreseeable that a patient treated with Aredia and/or Zometa might develop ONJ. (See Pls. Opp’n at 18-20.) Plaintiffs assert that the issue of foreseeability goes not to whether the drugs here were used in an intended or off-label fashion (as defendant so frames it), but instead, to whether there was a risk of developing ONJ if and when a patient was treated with these drugs. In other words, if a patient might develop ONJ after taking Zometa and/or Aredia— particularly if such a patient had dental procedures performed while taking such medications — and such a risk was foreseeable, defendant had a duty to warn, period (ie., regardless of whether the drug use was in an off-label context). (See id. at 19-20 (“Novartis knew very early on that for most patients ONJ is triggered by a tooth extraction or other invasive dental procedure.... Novartis knew that the risk of ONJ in users of its drugs was greatly increased when the patient had a tooth extracted or oral surgery.”)-) Turning to the scope of this duty, plaintiffs assert that Novartis’s duty extended not only to Bee’s prescribing physicians, but also to the “oral maxillofacial and dental communities.” (See Pls. Opp’n at 19 (citing Lindsay, 637 F.2d at 92).) Plaintiffs contend that, because it is foreseeable that patients with more tooth decay than the average individual likely will go to the dentist, Novartis — which “knew very early on” that a tooth extraction, or other form of invasive dental procedure, would trigger ONJ in most patients with the condition of ONJ, and that the risk of ONJ increased in users of Novartis’ drugs where such users had dental medical procedures — held a duty to warn that extended to plaintiffs dentists and oral surgeons. (Id. at 19-20 (citing Decl. of John J. Vecchione (“Vecchione Decl.”) Ex. 32, Email of Carsten Goessel (“Goessel Email”)); see also id. at 20 (stating that Novartis kept “the information oncologists and oral maxillofacial surgeonfs] had apart from one another” (citing Vecchione Decl. Ex. 23, Email from Stefano Fratarcangeli (“Fratarcangeli Email”))).) b. Analysis As is apparent from their respective framing of the issue, the parties dispute both whether the alleged risk at issue (ONJ) was foreseeable, and the scope of foreseeability. As previously set forth, Novartis argues that the question of foreseeability goes to the particular purpose for which plaintiff was taking the drugs— here, in an off-label capacity for a non-cancer patient’s treatment of ankylosing spondylitis and osteoporosis. Plaintiffs, on the other hand, assert that the issue of foreseeability goes simply to whether a patient taking these particular drugs stood the risk of developing ONJ, regardless of whether he or she had cancer, and regardless of whether it was an intended-or-off-label-use context. “There are differences with respect to whether warnings are required for the off-label use of a drug.” Blain v. Smithkline Beecham Corp., 240 F.R.D. 179, 194 (E.D.Pa.2007). As noted in Blain, Some states require no warning, see Robak v. Abbott Labs., 797 F.Supp. 475, 476 (D.Md.1992), while others have varying levels of requirements for adequate warning of an off-label use. Miles Labs., Inc. v. Superior Court, 133 Cal.App.3d 587, 184 Cal.Rptr. 98 (1982) (manufacturer liable for failure to warn of risks of off-label uses of its product if the manufacturer knew or should have known of the off-label use and that use accounted for a significant portion of the manufacturer’s sales of the drug); Peterson v. Parke Davis & Co., 705 P.2d 1001, 1003 (Colo.Ct.App.1985); Reeder v. Hammond, 125 Mich.App. 223, 336 N.W.2d 3, 5-6 (1983) (intervening negligence of a physician precludes the manufacturer’s liability for failure to warn of risks of off-label use). Id. at 194-95. Cases from other federal courts applying state law have expressly found that a pharmaceutical manufacturer had a duty to warn of risks associated with off-label use. See, e.g., McNeil v. Wyeth, 462 F.3d 364, 370-71 (5th Cir.2006) (under Texas law, plaintiffs can pursue failure to warn action despite off-label use of drug); Knipe v. SmithKline Beecham, 583 F.Supp.2d 602, 628-29 (E.D.Pa.2008) (con-eluding, under New Jersey law, that manufacturer owed duty to warn of dangers associated with off-label uses of drugs where manufacture knows or should have known of danger of side effects); Southern v. Pfizer, Inc., 471 F.Supp.2d 1207, 1218 (N.D.Ala.2006) (recognizing, under Alabama law, that drug’s manufacturer owed duty to warn about potential dangers of using prescription drug for an off-label to patient’s prescribing physician by drug’s manufacturer.); Woodbury v. Janssen Pharm., Inc., Civ. A. No. 93-7118, 1997 WL 201571, at *9 (N.D.Ill. Apr. 10, 1997) (recognizing, under Illinois law, that pharmaceutical manufacturer has duty to warn of any dangers associated with off-label use of product if such dangers were reasonably known). As a general rule, under New York law, “[t]he manufacturer’s duty is to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist.” Martin v. Hacker, 83 N.Y.2d 1, 8, 607 N.Y.S.2d 598, 628 N.E.2d 1308 (1993). The “warning must be commensurate with the risk involved in the ordinary use of the product.” Id. at 11, 607 N.Y.S.2d 598, 628 N.E.2d 1308 (citation and internal quotation marks omitted). Further, to avoid liability, drug manufacturers have a two-fold “continuing obligation,” as well. Baker v. St. Agnes Hosp., 70 A.D.2d 400, 421 N.Y.S.2d 81, 85 (1979); see also Glucksman v. Halsey Drug Co., 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1990). First, they “must keep abreast of knowledge of [their] products as gained through research, adverse reaction reports, scientific literature and other available methods. Second, and equally important, [they] must take such steps as are reasonably necessary to bring that knowledge to the attention of the medical profession.” 421 N.Y.S.2d at 85 (citations omitted). In addition, “off-label drug usage is not unlawful, and the FDA’s drug approval process generally contemplates that approved drugs will be used in off-label ways.” United States v. Caronia, 703 F.3d 149, 166 (2d Cir.2012). Synthesizing such principles, a patient prescribed an off-label use of a drug may be a reasonably foreseeable user of the product, such that a manufacturer has a duty to warn of all known adverse effects associated with such use. Novartis cites to no New York case law (and the Court could not find any) holding that a pharmaceutical company is not required to warn of the dangers of off-label uses of its drugs, despite having information of such dangers. In Sita, a medical device case cited by Novartis, the warning at issue stated that nearly all of the components of the medical device were intended for specific uses “only.” 43 F.Supp.2d at 259-60. Intended use and approved use are distinct, however, and there is no evidence that Novartis expressly stated that its drugs should only be used for FDA approved purposes. Moreover, the Second Circuit also has recognized, in dictum, that “[p]hysicians and pharmaceutical manufacturers can be held liable for off-label drug use through medical malpractice and negligence theories of liability.” Caronia, 703 F.3d at 168 n. 11 (citing Boyle v. Revici, 961 F.2d 1060 (2d Cir.1992); Sita v. Danek Med. Inc., 43 F.Supp.2d 245 (E.D.N.Y.1999); Retkwa v. Orentreich, 154 Misc.2d 164, 584 N.Y.S.2d 710 (N.Y.Sup.Ct.1992)). Therefore, under New York law, the Court finds that a drug manufacturer can have a duty to warn even in cases involving off-label use. Thus, to determine whether defendant had a duty to warn, the Court must first consider whether the potential development of ONJ was a foreseeable, or reasonably foreseeable, risk to Novartis for those patients who might take its drugs. See Liriano, 92 N.Y.2d at 237, 677 N.Y.S.2d 764, 700 N.E.2d 303 (noting that a manufacturer’s duty to warn is triggered where the company knew or should have known of “latent dangers resulting from foreseeable uses of its product” or “of the danger of unintended uses ... provided these uses [were] reasonably foreseeable”). On reviewing the evidence in the record, the Court concludes that plaintiffs have raised genuine issues of material fact that preclude summary judgment as to whether defendant knew or should have known (and when) about the risk of developing ONJ upon taking the aforementioned medications. Specifically, plaintiffs point to a 1981 study involving rats showing a connection between bisphosphonates and ONJ, which, according to the testimony of Jonathan Green, the head of Zometa preclinical studies, allegedly was in defendant’s possession as early as 1986. (See Pls. Opp’n at 22; see also id. Vecchione Decl. Ex. 22, Dep. of Jonathan Green (“Green Dep.”) at 125-27). Plaintiffs also reference multiple cases of ONJ allegedly reported during Aredia and Zometa’s clinical trials, which date back to 1991. (Pls. Opp’n at 22; see also id. Vecchione Decl. Ex. 19, Email and Attachments of Annmarie Petraglia, Jan. 27, 2005 (“Petraglia Doc.”).) Novartis disputes this evidence, asserting that the first case of bisphosphonate-induced ONJ was not reported to it until December 6, 2002. (See Def. Summ. J. Mot. at 13 (citing Def. 56.1 ¶ 79).) Thus, when Bee first began his Aredia therapy (in August 1997), defendant had no notice “of a single case of ONJ in bisphosphonate users, and no published data existed that rendered ONJ a ‘knowable’ risk.” (Id. (citing Def. 56.1 ¶¶ 79, 81-82, 99).) Defendant notes that plaintiffs’ expert, Dr. Suzanne Parisian (“Dr. Parisian”), has testified to the same, stating that she “agrees that, prior to approval of Aredia and Zometa, no published study indicated necrosis of the jaw in bisphosphonate users.” (Id. (citing Def. 56.1 ¶ 100 Ex. 91, Dep. of Dr. Suzanne Parisian (“Parisian Dep.”) at 209).) Defendant does not explicitly address plaintiffs’ evidence claiming a link, as early as the 1980s, between bisphospho-nates treatment and the development of ONJ, or the presence of ONJ in Novartis’s early 1990s Aredia clinical trials. Instead, Novartis simply states that “plaintiffs have no evidence that [Novartis] knew or should have known about a possible risk of ONJ prior to September 2003.” (Def. Summ. J. Mot. at 12.) On reviewing the parties’ arguments and supporting evidence, it is clear that the question of what was foreseeable to Novartis, and when, is a disputed issue of material fact in this ease. The parties have presented evidence that shows more than unsupported speculation or conclusory assertions, on both sides, as to whether Novartis knew, or should have known, of the risk of developing ONJ while taking Are-dia and/or Zometa during the period relevant to this dispute. The fact that such drugs were possibly prescribed to cancer patients more often than not, or that such drugs might be used in on-or-off label capacity during the pre-warning phase does not weaken the medical evidence to which plaintiff directs the Court’s attention, which (if credited) largely shows a correlation between bisphosphonate usage and the development of ONJ. This evidence does not affirmatively show that the correlation between these drugs and developing ONJ was exclusively dependent on a patient’s cancer status or, for that matter, the drugs’ use in an intended or off-label context. Summary judgment is only appropriate where the moving party (Novartis) can show that there is “no genuine dispute as to any material fact” and that the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a); see Gallo v. Prudential Residential Servs., L.P., 22 F.3d 1219, 1223 (2d Cir.1994) (noting that moving party bears burden of proving there is no genuine issue of material fact). Novartis has not carried that burden here. 2. Adequacy of the Warnings Although Novartis’s main position is that it had no duty to warn in light of Bee’s off-label usage of the medications, Novartis also argues that it fulfilled its obligation to adequately warn physicians of any danger or risk posed by Aredia and/or Zometa. (See Def. Summ. J. Mot. at 12-19.) In support of its argument, defendant points to the following evidence: (1) the adverse event report from December 2002 showing a link between the treatment drugs and ONJ, which Novartis asserts was the first such report it received concerning such a risk (see Def. 56.1 ¶ 79; see id. Ex. 72); (2) exhibits showing that once Novartis received the December 2002 adverse event report, it immediately alerted the FDA and promptly put into action steps to implement a label change in 2003 (see Def. Summ. J. Mot. at 13; see also Def. 56.1 ¶¶ 86-93); (3) evidence (including a September 2003 letter to the FDA requesting a revision of the Adverse Reactions section to the Aredia and Zometa labeling (Def. 56.1 Ex. 76), a March 2004 letter confirming the FDA’s acceptance of the proposed Adverse Reactions-labeling change (id. Ex. 82), a letter indicating that Novartis revised its Post-Marketing Experience section of the Zometa label in February 2004 to add additional language concerning the risk of ONJ (id. Ex. 83), a letter indicating that the FDA approved the proposed February 2004 labeling revision (id. ¶ 91), and a “Dear Doctor” letter, sent to more than 17,200 hematologists, urologists, oral surgeons, and oncologists, warning that ONJ had been reported in cancer patients receiving bisphosphonate treatment (id. ¶¶ 92-94; id. Ex. 87)) indicating defendant’s efforts to alert the medical community of the discovered correlation between bisphosphonate treatments and the development of ONJ following the December 2002 alert; (4) evidence showing that the FDA approved defendant’s labels for Aredia and Zometa throughout the time when Bee was undergoing treatment with these drugs (see Def. 56.1 ¶¶ 59-64); and (5) excerpts from plaintiffs’ experts’ testimonies suggesting that Novartis was not in possession of information concerning the risk of ONJ before 2002 or 2003 (see id. ¶ 100). Based on this evidence in the record, defendant contends that it satisfied its duty to warn by issuing adequate warnings — once it had notice of the drugs’ associated risks — to Bee’s prescribing physicians at the time period relevant to this dispute. (See generally Def. Summ. J. Mot. at 12-14.) Plaintiffs argue that defendant’s warnings were inadequate because they were not issued until long after Novartis had notice of the risk of ONJ in patients receiving bisphosphonate treatment with Aredia and Zometa. (See Pis. Opp’n at 21-22.) Plaintiffs again direct the Court’s attention to evidence indicating there were cases of ONJ in Aredia and Zometa’s clinical trials dating back to 1991 (see id. Vechhione Decl. Ex. 19, Petraglia Doc.), and Green’s testimony that, as early as 1986, Novartis possessed a 1981 study showing ONJ in rats exposed to bisphos-phonates (see id. Vecchione Decl. Ex. 22, Green Dep. at 125-27). Plaintiffs also point to evidence showing that defendant has acknowledged that there were at least six incidents of ONJ in its clinical trials (see id. Vecchione Decl. Ex. 20, Series of Emails Addressing Slides). Lastly, plaintiffs note that, at the time Dr. Arcati extracted Bee’s teeth in 2003, there still was no language in the warning label section of the drugs, even though Novartis had knowledge of the risk of ONJ before that time. (Id. at 22.) It is undisputed that Novartis issued no explicit warnings concerning the risk of ONJ until sometime after December 2002. This is about the only point upon which the parties agree concerning the alleged adequacy of Novartis’s warnings. Given the factual dispute (coupled with supporting evidence) between the parties concerning the adequacy of the information provided to the doctors in this case, the Court concludes that this is a question properly left for the jury. Plaintiffs point to evidence indicating that Novartis had knowledge of the dangers of ONJ in patients undergoing bis-phosphonate treatments, like Aredia and Zometa, well before December 2002&emdash;a time when the products’ labels bore no mention of any such risk. Defendant has pointed to evidence countering this, both summarizing the steps it took to warn upon allegedly first learning of the dangers of ONJ, and indicating evidence that supports its position that there was no actual, “knowable” risk of ONJ before December 2002, whether in the medical literature or otherwise. Testimony from plaintiffs doctors raises genuine issues of material fact as to the extent of information concerning Aredia and Zometa that was available at the time relevant to this dispute. In light of these genuine issues of material fact concerning the adequacy of the warnings for Aredia and Zometa during the time when Bee was taking these drugs, the Court concludes that summary judgment cannot be appropriately granted as to this element of the failure to warn claim. 3. General Causation In assessing proximate cause, the Court must consider whether a lack of adequate warnings contributed to plaintiffs use of the drugs, and whether plaintiffs use of the drugs constitutes a proximate cause of Bee’s injury. See Golod v. La Roche, 964 F.Supp. 841, 856 (S.D.N.Y.1997) (“A plaintiff suing a prescription drug manufacturer on a failure to warn theory must prove that the failure to warn was a proximate cause of the plaintiffs injury. Thus, the plaintiff must generally demonstrate that had appropriate warnings been given, the treating physicians would not have prescribed or would have discontinued use of the drug.” (internal citations omitted)); see also Lindsay, 637 F.2d at 90-91 (“A plaintiff who seeks recovery for an injurious side effect from a properly manufactured prescription drug must prove that the drug caused her injury and that the manufacturer breached a duty to warn of the possibility that the injurious reaction might occur.”). Because plaintiffs allege that Novartis failed to provide adequate warnings, and further, that this case concerns pharmaceutical drugs, the learned intermediary doctrine applies. As previously set forth, pursuant to this doctrine, “a defendant manufacturer has an obligation to inform the treating physician of the risks of a medical device” so that the physician, acting as the learned intermediary, may properly inform the patient. Henson v. Wright Med. Tech., Inc., No. 12-CV-805, 2013 WL 1296388, at *3 (N.D.N.Y. Mar. 28, 2013) (citing Glucks man, 553 N.Y.S.2d at 726); see also Steinman v. Spinal Concepts, Inc., No. 05-CV-774S, 2011 WL 4442836, at *9 (W.D.N.Y. Sept. 22, 2011) (“It is well settled with respect to prescription drugs and medical devices that a manufacturer’s duty to warn is owed not [to] the patient, but to the treating physician as the ‘learned intermediary.’ ”). Here, there is no dispute that the drugs at issue did not contain warnings or language explicitly addressing the particular risk of ONJ until sometime after December 2002. Defendant argues that Bee would have developed ONJ, even if Novartis had issued different or earlier warnings. The crux of defendant’s argument is twofold: (1) Dr. Samuel still would have prescribed Aredia and/or Zometa to plaintiff, even if different warnings had issued, evidenced by the fact that Dr. Samuel continues to prescribe such drugs to patients today and was prepared to continue administering the drugs to plaintiff, even after being told of another doctor’s opinion that plaintiff had bisphosphonate related ONJ; and (2) Bee would have taken Are-dia and/or Zometa, even with a proper warning, because the drugs were necessary for treating his condition, and he was desperate for a cure. (See Def. Summ. J. Mot. at 14-19.) The Court addresses each of these arguments in turn. a. Whether Plaintiffs Physicians’ Treatment Would Have Differed Because Novartis argues that any duty to warn here only extended to Bee’s prescribing physicians (here, Dr. Samuel), it limits its arguments (that altered warnings would not have made a difference for Bee) to Dr. Samuel. In particular, defendant contends that (1) there is no evidence indicating that Dr. Samuel did not know of the association between bisphosphonates and ONJ during the time when he treated Bee (id. at 16); (2) Dr. Samuel testified that he had intended to continue prescribing Zometa to plaintiff, even after learning of Dr. Ruggiero’s jaw necrosis diagnosis, until he observed exposed bone in plaintiffs mouth (id.)-, (3) Dr. Samuel did not rely on the product labels when deciding whether to prescribe the drugs (evidenced by plaintiffs off-label use of the drugs) (id.); and (4) Dr. Samuel presently prescribes both Aredia and Zometa for the off-label treatment of osteoporosis (id.). In essence, defendant seeks to break the causal link between the warning it issued to Dr. Samuel (via the drugs’ labels), Dr. Samuel’s subsequent administration of the drugs to plaintiff, plaintiffs taking of the drugs, and plaintiffs development of ONJ. It does so by relying on two principles that may act as intervening events and thereby sever causation. The first type of intervening event that might shield Novartis from liability under a failure to warn theory occurs where “[a] treating physician[] [decides] not to inform a patient of a side effect.” Krasnopolsky, 799 F.Supp. at 1346. Thus, if Dr. Samuel had independent knowledge concerning the