Rowland v. Novartis Pharm. Corp.

34 F.Supp.3d 556

Karen ROWLAND, Plaintiff

v.NOVARTIS PHARMACEUTICALS CORP., Defendant.

George Machen and Stacy Machen, Plaintiffs

v.Novartis Pharmaceuticals Corp., Defendant.

Michelle Pratt Orr, Plaintiff

v.Novartis Pharmaceuticals Corp., Defendant.

Civil Action Nos. 2:12–cv–01474

2:12–cv–01476

2:12–cv–01715.

United States District Court, W.D. Pennsylvania.

Signed July 28, 2014.

John J. Vecchione, Valad & Vecchione, PLLC, Fairfax, VA, Daniel E. Krauth, Joseph F. Butcher, Samantha Quinn, Zimmer Kunz P.L.L.C., Pittsburgh, PA, Daniel A. Osborn, Osborn Law, P.C., New York, NY, David K. Lietz, Washington, DC, for Plaintiff, Karen Rowland.

Constantine J. Passodelis, Jeffrey Cohen, Michael R. Lettrich, Meyer, Darragh, Buckler, Bebenek & Eck, P.L.L.C., Pittsburgh, PA, Ethan D. Stein, Diane E. Lifton, Gibbons P.C., New York, NY, Neil S. Bromberg, Donald W. Fowler, Robert E. Johnston, Katharine Ruth Latimer, Hollingsworth LLP, Joe Gregory Hollingsworth, Spriggs & Hollingsworth, Washington, DC, Jacqueline Mecchella Bushwack, Rivkin Radler, LLP, Uniondale, NY, for Defendant.

OPINION

MARK R. HORNAK, District Judge.

Plaintiffs Karen Rowland (“Ms. Rowland”), George Machen (“Mr. Machen”), Stacy Machen (“Mrs. Machen”), and Michelle Pratt Orr (“Mrs. Orr”) bring strict liability, negligence, and breach of warranty claims against the Defendant, Novartis Pharmaceuticals Corporation (“NPC”), alleging that they or their spouse 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, manufactured, and marketed by NPC and used for the purpose of managing metastatic bone cancer. Pending before the Court are NPC's Motions for Summary Judgment, which were originally filed as part of multi-district pre-trial proceedings in the Middle District of Tennessee.¹

The Court has considered the Plaintiffs' Complaints, ECF 2:12–cv–01474–MRH, No. 1, ECF 2:12–cv–01476–MRH, No. 1, and ECF 2:12–cv–01715–MRH, No. 1, Defendant's Motions for Summary Judgment, (originally filed in M.D. Tenn., MDL No. 3:06–MD–1760, Case No. 3:08–cv–00131, at ECF No. 24; Case No. 3:10–cv–00830, at ECF No. 31; Case No. 3:07–cv–00472, at ECF No. 29), and Briefs in Support, (originally filed in M.D. Tenn., MDL No. 3:06–MD–1760, Case No. 3:08–cv–00131, at ECF No. 25; Case No. 3:10–cv–00830, at ECF No. 32; Case No. 3:07–cv–00472, at ECF No. 30), Defendant's Statements of Material Facts, (ECF Nos. 35, 37, and 39), and Plaintiffs' Responses in Opposition, (originally filed in M.D. Tenn., MDL No. 3:06–MD–1760, Case No. 3:08–cv–00131, at ECF No. 37; Case No. 3:10–cv–00830, at ECF No. 41; Case No. 3:07–cv–00472, at ECF No. 38), Plaintiffs' Responses to the Motions for Summary Judgment, (originally filed in M.D. Tenn., MDL No. 3:06–MD–1760, Case No. 3:08–cv–00131, at ECF No. 35; Case No. 3:10–cv–00830, at ECF No. 39; Case No. 3:07–cv–00472, at ECF No. 39), Defendant's Reply Briefs, (originally filed in M.D. Tenn., MDL No. 3:06–MD–1760, Case No. 3:08–cv–00131, at ECF No. 47; Case No. 3:10–cv–00830, at ECF No. 51; Case No. 3:07–cv–00472, at ECF No. 43), Plaintiffs' Supplemental Response, ECF No. 45, and Defendant's Replies, ECF Nos. 48–50.² For the reasons that follow, the Court will grant in part and deny in part the Motions for Summary Judgment.

I. BACKGROUND

A. History of Bisphosphonate–Related Osteonecrosis of the Jaw (“BRONJ”)

These lawsuits involve Zometa, a Food and Drug Administration (“FDA”) approved intravenous bisphosphonate (“IV BP”) prescription drug used to prevent bone destruction that frequently occurs in cancer patients when the disease has metastasized to their bones. Defendant's Statement of Material Facts as to Ms. Rowland (“RSOF”), ECF No. 39, ¶¶ 1–3; Rowland Compl. (“RC”) ¶ 6. The reported clinical value of using IV BPs includes reducing skeletal complications, reducing pain, and improving the patient's quality and duration of life. RSOF at ¶ 51. Plaintiffs allege that they developed ONJ, a permanently disfiguring and painful condition that causes bone necrosis (death) and may result in complete loss of the jaw bone. RC ¶ 1. More specifically, Plaintiffs claim they developed a form of ONJ caused by IV BPs, interchangeably referred to by the parties as bisphosphonate-related ONJ (“BRONJ”), bisphosphonate-induced ONJ (“BIONJ”), or bisphosphonate ONJ (“BONJ”)³ , as a result of their Zometa use. Id.

NPC is a pharmaceutical corporation that produces and distributes Zometa and Aredia, the “first generation” precursor to Zometa. RC ¶¶ 4, 6. The FDA initially approved Zometa in August 2001 for treatment of patients with hypercalcemia of malignancy and then in February 2002 approved it for treatment of patients with multiple myeloma and bone metastases from solid tumors, including breast cancer. RSOF ¶¶ 1–2. NPC received an adverse event report of ONJ from a dentist in Florida in December 2002. Id. ¶ 7. In September 2003, Dr. Robert Marx authored the first published case report addressing ONJ in IV BP users. Id. ¶ 33. On September 26, 2003, NPC informed the FDA that it was revising the Zometa labeling to include the following language in the Adverse Reactions section of the label:

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-morbid risk factors (e.g. anemia, infection, pre-existing oral disease).

Id. ¶ 14. In February 2004, NPC revised the Post–Marketing Experience portion of the Zometa label as follows:

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.

Id. ¶ 20.

In September 2004, NPC revised the Zometa label again to include the following language in the Precautions section of the label and distributed letters to oncologists and oral surgeons reflecting the same:

Osteonecrosis of the jaw (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 reported cases have been associated with dental procedures such as tooth extraction.

Many had signs of local infection including osteomyelitis.⁴

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. ¶ 21. In May 2005, NPC sent a mass-mailing letter to dentists informing recipients of the language change concerning BRONJ in the Zometa label. Id. ¶ 42. It read, in part:

The prescribing information recommends that cancer patients:

• receive a dental examination prior to initiating therapy with intravenous bisphosphonates (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 benefit/risk assessment.

Id. ¶ 43.

In 2009, the American Association of Oral and Maxillofacial Surgeons (“AAOMS”) issued guidelines regarding BRONJ stating the following:

Patients may be considered to have BRONJ if all of the following three characteristics are present:

Current or previous treatment with a bisphosphonate.

Exposed bone in the maxillofacial region that has persisted for more than eight weeks; and

No history of radiation therapy to the jaws.

Id. ¶ 53.

B. Ms. Rowland's Medical History

Ms. Rowland was diagnosed with Stage IV breast cancer in July 2004. Id. ¶ 57. By that time, her cancer had spread to her lymph nodes, left hip, and sacrum. Id. ¶ 59. Her treating hematologist, Dr. John Waas (“Dr. Waas”), prescribed her Zometa, and Ms. Rowland began treatment with the drug in September 2004. Id. ¶¶ 64, 66. As part of routine procedure with chemotherapy patients, Dr. Waas advised her to see a dentist. Deposition of Dr. John Waas (“Waas Dep.”), ECF No. 39–55, other portions filed in M.D. Tenn., MDL No. 3; 06–MD–1760, Case No. 3:08–cv–00131, ECF No. 38–26, at 95–96, 115–16.

In April 2005, while on Zometa, Ms. Rowland had one of her teeth extracted. RSOF ¶ 84. She remained on Zometa until October 2005, when Dr. Waas discontinued her treatment. Id. ¶ 65. Regarding his decision to stop Zometa, Dr. Waas testified as follows:

A: I took her off when she complained of pain.

Q: Can you be more specific in relation to pain?

A: In October of 2005 she was complaining of right jaw pain and that is the last—she did not receive any additional Zometa after that particular complaint, the date is in October of 2004 [sic].

Q: You said that you discontinued it

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