Bock v. Novartis Pharmaceuticals Corp.

137 F. Supp. 3d 802, 2015 U.S. Dist. LEXIS 136920, 2015 WL 5842097
CourtDistrict Court, W.D. Pennsylvania
DecidedOctober 7, 2015
DocketCivil Action No. 2:10-cv-1338
StatusPublished
Cited by2 cases

This text of 137 F. Supp. 3d 802 (Bock v. Novartis Pharmaceuticals Corp.) is published on Counsel Stack Legal Research, covering District Court, W.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bock v. Novartis Pharmaceuticals Corp., 137 F. Supp. 3d 802, 2015 U.S. Dist. LEXIS 136920, 2015 WL 5842097 (W.D. Pa. 2015).

Opinion

OPINION

MARK R. HORNAK, District Judge.

Plaintiffs Bruce and Bonnie Bock, as personal representatives of the estate of William M. Bock (“Bock”), filed this ease against the Defendant, Novartis Pharmaceuticals Corporation (“Novartis”), alleging that Bock developed a painful and permanently disfiguring condition commonly known as osteonecrosis of the jaw (“ONJ”) as a result of using Zometa, a prescription medication designed and manufactured by Novartis for the purpose of managing metastatic bone cancer. Pending before the Court is Novartis’ Motion for Summary Judgment (ECF No. 25) aimed at the remaining Counts II and III of the Complaint. This Court has jurisdiction pursuant to 28 U.S.C. § 1382. For the reasons which follow, Defendant’s motion is granted.

I. BACKGROUND

This pharmaceutical products liability lawsuit involves two prescription drugs manufactured by Novartis: Aredia and Zometa. Both drugs have been approved by the Food and Drug Administration (“FDA”) for the treatment and management of metastatic diseases of the bone such as hypercalcemia of malignancy, multiple myeloma, and bone metastases of certain types of cancer. Defendant’s Statement of Undisputed Facts (“DSUF”), ECF No. 27, ¶¶ 1-5.1! However, both drugs are also associated, with an enhanced risk of ONJ. Id. ¶¶7~13. Plaintiffs allege that Novartis failed to adequately and properly warn Bock and his medical providers of that risk. Compl., ECF No. 1, ¶¶41-45.2

A. Background Concerning Zometa and ONJ

The FDA initially approved Zometa for the treatment of hypercalcemia of malignancy in August 2001. DSUF ¶ 2. In September 2003, a published letter reported cases of ONJ in patients using Aredia and Zometa. Id. ¶ 7. On Septeniber 26, 2003, Novartis informed the' FDA that it was revising the labeling’on Aredia and Zome-ta to include the following language in the package inserts:

Cases of osteonecrosis (primarily of the jaws) have been reported since market introduction. Osteonecrosis of the jaws has other well documented multiple risk factors. It is not possible to determine if these events are related to Zometa® or other bisphosphonates, to concomitant drugs or other therapies (e.g. chemotherapy, radiotherapy," corticosteroid), to patient’s underlying disease, or to other co-mórbid risk factors (e,g. anemia, infection, pre-existing oral disease).

Id. ¶ 8.

In September 2004, NPC revised the labels on Aredia and Zometa again to include the following language in the “Precautions” section of the labels:

Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bis-[804]*804phosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of 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 bisphospho-nates 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 baséd on individual benefit/risk assessment.

Id. ¶ 10. Novartis sent a “Dear Doctor” letter to oncologists and oral surgeons on September 24, 2004, informing them of the new warnings in the Aredia and Zometa prescribing information concerning ONJ and dental surgery. Id. ¶ 11. Both of Bock’s treating physicians, Dr. Mohammed Islam and Dr. Mounzer Agha, were on the mailing list for the Novartis “Dear Doctor” letter. Id. ¶ 28.

On or about May 5, 2005, Novartis sent another mailing to dentists informing them of the language concerning ONJ in the package inserts for Aredia and Zometa. Id. ¶ 13. That letter contained a recommendation that cancer patients:

• receive a dental examination prior to initiating therapy with intravenous bis-phosphonates (Aredia® and Zometa®); and
• avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. Clinical judgment by the treating physician should guide the management plan of each patient based on individual bene-fít/risk assessment.

Id.

B. Bock’s Medical History

Bock was diagnosed with anemia, leu-copenia, and hypercalcemia in August 2005. DSUF ¶ 15. Bock’s oncologist, Dr. Islam, initially prescribed Aredia (or a non-Novartis generic) to address the hy-percalcemia. Id. Dr. Islam testified that it was his general practice as an oncologist to familiarize himself with prescription medications by reading the prescribing information accompanying the medicine. Deposition of Dr. Mohammed Islam (“Islam Depo.”), ECF No. 27-17, at 63-64. He stated that he believed he had reviewed the package insert for Aredia prior to prescribing it for Bock, but that he couldn’t specifically remember doing so. Id: at 64. With respect to the risk of ONJ associated with Aredia, Dr. Islam testified as follows:

Q: In 2005 were you aware that osteo-necrosis of the jaw was a potential side effect of Aredia?
A: Yes.
Q: And was that something you discussed with patients?
A: If I recollect, I’m sure I did.
Q: It was your general practice to discuss it with patients?
A: That’s correct.
Q: That was true in 2005?
A: Absolutely. Yes.
Q: Given that it was your general practice, do you believe that you would have discussed it with Mr. Bock?
[805]*805A: Yes.

Id. at 63.

On August 27, 2005, a CT scan revealed compression fractures and multilevel degenerative changes in Bock’s spine. DSUF ¶ 19. On September 7, 2005, Dr. Islam diagnosed Bock with multiple myelo-ma following a bone marrow aspirate and biopsy. ¶20. At that time, Dr. Islam switched Bock from Aredia to Zometa because he believed Zometa had a shorter infusion time and was more, effective at preventing skeletal complications. Islam Depo., EOF No. 27-17 at 66.

In September 2005, Bock’s treatment shifted to a hematologist, Dr. Agha. DSUF ¶25. Dr. Agha elected to continue Bock on Zometa based on the multiple fractures in Bock’s spine. Id. ¶¶ 32-33. Dr.

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Bluebook (online)
137 F. Supp. 3d 802, 2015 U.S. Dist. LEXIS 136920, 2015 WL 5842097, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bock-v-novartis-pharmaceuticals-corp-pawd-2015.