Seufert v. Merck Sharp & Dohme Corp.
| Decision Date | 11 May 2016 |
| Docket Number | Matthews: 15cv2190,Gaines: 14cv0056,Elosegui: 15cv198,Deihl: 15cv1435,Blazer: 15cv1149,McDaniel: 13cv3191,Gibson: 15cv1340,Case No.: 13cv2169 AJB (MDD),Lara: 13cv2928,Seufert: 13cv2169,Marble: 14cv0611,Stovall: 14cv1612,Heindl: 14cv1973,Copel: 15cv1884 |
| Citation | 187 F.Supp.3d 1163 |
| Court | U.S. District Court — Southern District of California |
| Parties | Teresa Seufert, Plaintiff, v. Merck Sharp & Dohme Corp., et al., Lara v. Merck Sharpe & Dohme Corp., et al., (13cv2928) McDaniel v. Merck Sharpe & Dohme Corp., et al., (13cv3191) Gaines v. Amylin Pharmaceuticals, LLC, et al., (14cv0056) Marble v. Merck Sharpe & Dohme Corp., et al., (14cv0611) Stovall v. Amylin Pharmaceuticals, LLC, et al., (14cv1612) Heindl v. Merck & Co., Inc., et al., (14cv1973) Blazer v. Amylin Pharmaceuticals, LLC, et al., (15cv1149) Gisbon v. Bristol-Myers Squibb Co., et al., (15cv1340) Deihl v. Merck Sharpe & Dohme Corp., et al., (15cv1435) Copeland v. Bristol-Meyers Squibb Co., et al., (15cv1884) Mathews v. Merck Sharp & Dohme Corp. et al., (15cv2190), Defendants. |
Nicholas Joseph Drakulich, Robert J. Drakulich, The Drakulich Firm APLC, San Diego, CA, for Plaintiff.
Donald F. Zimmer, Jr., King & Spalding LLP, San Francisco, CA, Cameron J. Hoyler, King and Spalding LLP, Los Angeles, CA, for Defendants.
Donald F. Zimmer, Jr., King & Spalding LLP, San Francisco, CA, Cameron J. Hoyler, King and Spalding LLP, Los Angeles, CA, for Defendants.
ORDER GRANTING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT
On February 27, 2014, the FDA published the following in the New England Journal of Medicine :
, and postmarketing reports of pancreatitis and pancreatic cancer in patients taking certain antidiabetic medications have been of concern to both agencies.... Within the past year, the FDA and the EMA independently undertook comprehensive evaluations of a safety signal arising from postmarketing reports of pancreatitis and pancreatic cancer in patients using incretin-based drugs. These investigations, now complete, included examination of data from a 2013 research report revealing a possible pancreatic safety signal .... Thus, the FDA and the EMA have explored multiple streams of data pertaining to a pancreatic safety signal associated with incretin-based drugs. Both agencies agree that a causal association between incretin-based drugs and pancreatitis and pancreatic cancer as expressed recently in the scientific literature and the media are inconsistent with the current data .... The FDA and the EMA believe that the current knowledge is adequately reflected in the product information and labeling.1
The publication, titled "Pancreatic Safety of Incretin-Based Drugs—FDA and EMA2 Assessment," was prompted by claims that incretin mimetics commonly used to treat type 2 diabetes
cause or increase the risk of pancreatic cancer. Plaintiffs raise the same claims in this litigation, alleging Defendants failed to warn of pancreatic cancer risk in product labeling. However, in addition to the FDA's published assessment of pancreatic safety, the FDA has examined incretin mimetics and pancreatic cancer risk on several occasions. Following each review, the FDA has concluded that evidence of a causal relationship between incretin mimetics and pancreatic cancer is indeterminate, unsupported by current data, and inconclusive. In light of these findings, clear evidence exists that the FDA would have rejected a reference to pancreatic cancer in incretin mimetic labeling. Thus, it would have been impossible for Defendants to provide the warning Plaintiffs seek, and Plaintiffs' claims are preempted under Wyeth v. Levine , 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).
Before the Court is defendants AstraZeneca Pharmaceuticals LP and Bristol-Myers Squibb Company's ("Defendants") motion for summary judgment. (Doc. No. 119.) Plaintiffs3 are individuals who consumed the prescription drugs Onglyza and or Kombiglyze XR ("Kombigylze") for the treatment of type 2 diabetes
.4 Defendants currently or formerly marketed the drugs, which are both dipeptidyl peptidase-4 (DPP-4) inhibitors approved by the FDA for the treatment of type 2 diabetes.
Plaintiffs allege Defendants failed to warn that Onglyza and Kombiglyze cause or create an increased risk of pancreatic cancer
. Defendants assert that Plaintiffs' failure-to-warn claims are conflict preempted because it would be impossible to reference pancreatic cancer in drug labeling and comply with federal regulations. Defendants moved to dismiss Plaintiffs' claims as preempted in April 2014. (Doc. No. 34.) The Court denied the motion, finding conflict preemption appropriately analyzed after discovery. (Doc. No. 51.) In February 2016, pursuant to a jointly agreed upon briefing scheduling, Defendants moved for summary judgment. Plaintiffs filed an opposition on March 10, 2016, (Doc. No. 125), and Defendants filed a reply on April 1, 2016, (Doc. No. 126). The Court heard oral argument on April 18, 2016. (See Doc. No. 130.)
Although the parties contest the significance of the following events, the following facts are undisputed. Ongylza obtained FDA approval on July 31, 2009, and Kombiglyze obtained FDA approval on November 5, 2010. (Doc. Nos. 119-5 at 26–33; 119-5 at 34–39.) Both drugs contain the active ingredient saxagliptin, which regulates insulin
production. (Doc. Nos. 119-1 at 12; 119-3 at 3.) The FDA has reviewed DDP-4 inhibitors such as Onglyza and Kombiglyze under the broader class of incretin mimetics or incretin-based therapies. (Doc. No. 119-3 at 2–3); (see also Doc. No. 119-5 at 61) ("Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync, saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni) and linagliptin (Tradjenta, Jentadueto).").5
As evident from the record, the FDA first considered the pancreatic safety of incretin mimetics in 2009 when it reviewed adverse event reports6 of pancreatic cancer
associated with the use of incretin mimetics. (Doc. No. 119-5 at 48–59.) Following this review, the FDA concluded that a causal association between incretin mimetics and pancreatic cancer was indeterminate. (Id. at 56) ( ). The FDA did not make any labeling recommendations regarding pancreatic cancer following this review. (Id. )
In April 2012, the FDA received a citizen petition7 requesting the FDA withdraw an incretin mimetic called Victoza from the market. (Doc. No. 119-4 at 2.) Along with health implications not relevant to this litigation, the citizen petition cited adverse event data as suggesting an increased risk of pancreatic cancer
in patients taking Victoza. (Id. at 27) ("The Petition states that Victoza increases the risk of pancreatic cancer
and cites [Adverse Event Reporting System] data to support this finding."). Before responding to the citizen petition, the FDA issued a drug safety communication in March 2013 regarding pancreatic cancer risk and incretin mimetics. (Doc. No. 119-5 at 61) ("FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes"). The safety communication was prompted by findings from academic researchers suggesting an increased risk of pre-cancerous cellular changes in type 2 diabetic patients taking incretin mimetics. (Id. ) The FDA vowed to obtain and evaluate available data, and communicate its conclusions and recommendations when its review was complete or there was additional information to report. (Id. ) The FDA also stated that it had not reached a new conclusion regarding whether incretin mimetics cause pancreatic cancer, and advised health care professionals to continue following the prescribing recommendations in drug labeling. (Id. )
In June of the same year, the FDA participated in the National Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute's Workshop on Pancreatitis-Diabetes-Pancreatic Cancer. (Id. at 65–66; 69–70.) An FDA supervisory toxicologist at the workshop commented that incretin-based drugs were not associated with "overt pancreatic toxicity or pancreatic neoplasms
... that would indicate a risk to human safety." (Id. at 65.) The FDA also acknowledged that postmarketing pancreatic toxicology studies provided by various incretin mimetic manufacturers did not "definitively demonstrate [ ] a treatment-related adverse effect on exocrine histology or proliferation." (Id. )
In February 2014, the FDA published its assessment of pancreatic safety in the New England Journal of Medicine ("Assessment"). (Doc. No. 119-3 at 2–5.) Four FDA officials and members of the European Medicines Agency authored the Assessment, which followed an independent and comprehensive review of pancreatic cancer
risk. (Id. at 2.) In the Assessment, the FDA concluded that claims asserting a causal association between incretin mimetics and pancreatic cancer was "inconsistent with the current data" and that current knowledge was "adequately reflected in product information or labeling." (Id. at 4.)8
In March 2014, the FDA formally responded to the 2012 Victoza citizen petition, and declined to withdraw Victoza from the market. (Doc. No. 119-4 at 2–38.) With respect to pancreatic cancer
risk, the FDA concluded that "any suspicion...
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