Wheeler v. Novartis Pharm. Corp.

944 F.Supp.2d 1344

Michael WHEELER, Individually, and in his capacity as Personal Representative for the Estate of Paula Wheeler, Plaintiff,

v.NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.

No. CV 111–211.

United States District Court,

S.D. Georgia,

Augusta Division.

May 15, 2013.

John A. Girardi, Girardi Keese, Los Angeles, CA, Joseph W. Watkins, Watkins, Lourie, Roll & Chance, PC, Atlanta, GA, for Plaintiff.

Anthony L. Cochran, Chilivis, Cochran, Larkins & Bever, LLP, Atlanta, GA, Kirby T. Griffis, Hollingsworth, LLP, Washington, DC, for Defendant.

ORDER

J. RANDAL HALL, District Judge.

Presently pending before the Court is Defendant's motion for summary judgment. (Doc. no. 28.) For the following reasons, this motion is GRANTED.

I. BACKGROUND

A. Zometa and Osteonecrosis of the Jaw

Zometa is a bisphosphonate medication prescribed to patients with hypercalcemia of malignancy, multiple myeloma, or certain kinds of cancer that have metastasized to the bones. (Doc. no. 28, Ex. 5.) Zometa may reduce skeletal events that can result from these advanced cancers. ( Id.) In 2002, the United States Food and Drug Administration (“FDA”) approved Zometa as a safe and effective treatment for osteolytic bone metastases of breast cancer. ( Id., Ex. 6.) Zometa remains an FDA approved drug, with labeling also approved by the FDA. ( Id., Ex. 14.)

Osteonecrosis of the jaw (“ONJ”) occurs when jaw bone becomes necrotic, or dies. ( Id., Ex. 16 at 4; Ex. 17 at 5.) In December 2002, Defendant received its first report that a patient who received bisphosphonate therapy had developed ONJ. ( Id., Ex. 19.) Within fifteen days of receiving the first ONJ report, Defendant submitted it to the FDA. ( See id., Ex. 20.) The alleged risk of ONJ resulting from bisphosphonate therapy was unknown prior to August 2003. ( Id., Ex. 21 at 5.) In September 2003, Dr. Robert Marx published the first case reports describing ONJ in Aredia and Zometa patients. ( Id., Ex. 22.)

On September 26, 2003, Defendant informed the FDA of its voluntary decision to revise the “Adverse Reactions” section of its Zometa labeling. ( Id., Ex. 23.) The revised label would provide that “[c]ases of osteonecrosis (primarily of the jaws) have been reported since market introduction.” ( Id., Ex. 23.) In February 2004, Defendant amended the Zometa label to read that “[t]he majority of the reported [ONJ] cases are in cancer patients attendant to a dental procedure” and advised that “[a]lthough causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged.” ( Id., Ex. 25.) In September 2004, Defendant again revised the Zometa label to include the following:

[ONJ] has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of the reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis.

A dental examination with appropriate preventative 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 who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. 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.( Id., Ex. 26.) This revision was approved by the FDA. ( Id., Ex. 27.)

Shortly after this revision, Defendant sent a “Dear Doctor” letter to thousands of physicians, including Dr. Mark Keaton, alerting them to the change in the Zometa label. ( Id., Exs. 28, 29.) In May 2005, Defendant also distributed a “Dear Dentist” letter to general practice dentists, oral surgeons, and specialists in periodontics and prosthodontics, to include Dr. Julian Murphey and Dr. Samuel D'Arco. ( Id., Exs. 30, 31.)

In September 2007, the Zometa label contained the following language under “Warnings and Precautions”:

[ONJ] has be en reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zometa. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, local trauma including poorly fitted dentures). Many reports of ONJ involved patients with signs of local infection including osteomyelitis.

Cancer patients should maintain good oral hygiene and should have a dental examination with preventative dentistry prior to treatment with bisphosphonates.

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. 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.

( Id., Ex. 32.)

B. Mrs. Wheeler's Medical and Dental History

Plaintiff Michael Wheeler is the personal representative of the Estate of Paula Wheeler, as well as Mrs. Wheeler's husband. ( See Compl.) In October 2007, Mrs. Wheeler was diagnosed with an infiltrating ductal carcinoma in the left breast that had metastasized to the spine. (Doc. no. 28, Ex. 39; Keaton Dep. at 20–21.) In November 2007, Mrs. Wheeler's oncologist, Dr. Keaton, prescribed Zometa, as well as chemotherapy and hormonal therapy. (Keaton Dep. at 24; Doc. no. 28, Ex. 41.) Dr. Keaton specifically prescribed Zometa to reduce the risk of skeletal related events and complications from bone metastasis. (Keaton Dep. at 27,) Mrs. Wheeler received all of her Zometa infusions in Georgia, as well as all of her dental and oral surgery treatment. (Doc. no. 28, Exs. 35–38.)

Dr. Keaton was familiar with Zometa and its various possible side effects well before 2007. (Keaton Dep. at 26.) Dr. Keaton testified that when he prescribed Zometa to Mrs. Wheeler, he discussed its risks and benefits. ( Id. at 26–27.) Dr. Keaton also testified that it was his habit and practice to discuss with patients the risk that Zometa could potentially cause ONJ, as well as that patients should not have anything done by a dentist other than cleanings and fillings without talking to him first. ( Id. at 27, 31.)

On July 14, 2009, Dr. Murphey extracted an erupted tooth and performed a socket graft for Mrs. Wheeler. (Doc. no 28, Ex. 50; Murphey Dep. at 22.) Because Mrs. Wheeler was in pain, she did not fill out a medical history form until she was leaving Dr. Murphey's dental practice that day. ( See Murphey Dep. at 25.) This medical history form indicated that Mrs. Wheeler had “Zometa IV (port) every 6 w[ee]ks.” (Doc. no. 28, Ex. 49; Murphey Dep. at 25.) On July 17, 2009, Dr. Murphey noted boney dehiscence on lingual # 31, and his records note it was due to “traumatic tooth loss [one] month ago.” (Doc. No. 28, Ex. 51; Murphey Dep. at 31–32.) Dr. Murphey also extracted tooth # 30 and the retained root tip of tooth # 13, with socket grafts. ( Id.)

Dr. Murphey testified that on July 20, 2009, Mrs. Wheeler informed him she was taking Zometa. (Murphey Dep. at 33.) In response to this information, Dr. Murphey informed Mrs. Wheeler that Zometa was the potential cause of her jaw problems. ( Id. at 33–36.)

On September 11, 2009, Mrs. Wheeler visited an oral surgeon, Dr. Samuel D'Arco, who noted that Mrs. Wheeler had “[o]steonecrosis of right posterior mandible—possible BRONJ due to long term Zometa and recent [extractions].” (Doc. no. 28, Ex. 54.) Dr. D'Arco also testified that he would have informed Mrs. Wheeler of the potential correlation between Zometa and the bone death in her jaw. (D'Arco Dep. at 30.)

In August 2009, Mrs. Wheeler received her last dose of Zometa. (Doc. no. 28, Ex. 56.) On October 8, 2009, Dr. Keaton instructed Mrs. Wheeler that he was discontinuing administration of Zometa because “she had evidence of osteonecrosis of the jaw and that continuing the Zometa could worsen the condition.” (Keaton Dep. at 32–33.) On July 10, 2010, Mrs. Wheeler passed away due to her metastatic breast cancer. (Doc. no. 28, Ex. 62.)

C. Procedural History

On December 28, 2011, Plaintiff filed suit alleging strict liability, negligent manufacture, failure to warn, breach of express and implied warranty, and loss of consortium for damages associated with Mrs. Wheeler's use of Zometa. (Doc. no. 1.) On January 22, 2013, Defendant filed a motion for summary judgment. (Doc. no. 28.) To date, Plaintiff has failed to respond to the motion for summary judgment.

II. SUMMARY JUDGMENT STANDARD

The Court should grant summary judgment only if “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). Facts are “material” if they could affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The Court must view the facts in the light most favorable to the non-moving party, Matsushita Elec. Indus. Co v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986), and must draw “all justifiable inferences in [its] favor.” U.S. v. Four Parcels, 941 F.2d 1428, 1437 (1991) (internal punctuation and citations omitted).

The moving party has the initial...