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Bee v. Novartis Pharms. Corp.

United States District Court, E.D. New York

May 9, 2014

BRIAN BEE & DONNA BEE, Plaintiffs,
v.
NOVARTIS PHARMACEUTICALS CORP., Defendant

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For Plaintiffs: John Julian, Vecchione of Valad and Vecchione, Fairfax, VA.

For Defendant: Robert E. Johnston, Donald McMinn, and James Sullivan of Hollingsworth LLP, Washington, D.C.; David Richman of Rivkin Radler LLP Uniondale, NY.

OPINION

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MEMORANDUM AND ORDER

JOSEPH F. BIANCO, United States 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.)

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 bisphosphonate 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.)

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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. Plaintiff's 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.[11] (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. Arcati 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 plaintiff's teeth had he known that plaintiff was taking Zometa. (Def. 56.1 ¶ 119.)

After examining plaintiff's 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 plaintiff's 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 plaintiff's exposed bone likely was attributable to bisphosphonate use. (Def. 56.1 ¶ 49; Pls. 56.1 ¶ 49.)[12]

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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 plaintiff's exposed bone was due to the bisphosphonates; when Dr. Samuel saw the exposed bone in plaintiff's 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 plaintiff's 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 debridement.[13] (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 sequestrum on plaintiff's 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 osteonecrosis." (Def. 56.1 ¶ 56; Pls. 56.1 ¶ 56.) Approximately a week later, Dr. Arcati observed plaintiff's 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 Aredia--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 bisphosphonate--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,

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however, that the main ingredient in Zometa, zoledronic 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.)[14] 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 Aredia 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.)[15]

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.)[16] 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

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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 osteonecrosis 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 osteonecrosis 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 osteonecrosis 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 bisphosphonates were being considered as a potential preventative treatment for osteonecrosis. (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; Pls. 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, coagulopathies, infection, pre-existing 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,

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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 osteonecrosis 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 ( i.e., 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 ...


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