United States District Court, D. New Jersey
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Nathan Daniel Cromley, Tayjes Matthew Shah, The Miller Firm LLC, Orange, VA, for Plaintiff.
David L. Harris, James A. Long, Monica Nicole Kamison, Lowenstein Sandler PC, Roseland, NJ, for Defendants.
WOLFSON, District Judge.
Plaintiff Ronald Solomon (" Plaintiff" or " Mr. Solomon" ) brings the instant suit against Defendants, Bristol Myers-Squibb Company (" BMS" ), Sanofi-Aventis U.S., L.L.C., Sanofi-Aventis U.S., Inc., and Sanofi-Synthelabo, Inc. (collectively, " Defendants" ), alleging that he suffered injuries as a result of Defendants' design, development, manufacture, testing, packaging, promoting, marketing, distributing, labeling and sale of their prescription drug Plavix, an anti-clotting medication. Plaintiff's Amended Complaint (" Amended Complaint" ) asserts various Texas state and common law claims against Defendants, including Failure-to-Warn, Defective Design, Manufacturing Defect and Negligence. Before the Court is Defendants' motion for summary judgment based upon a number of theories, including the learned intermediary doctrine under Texas law. For the reasons that follow, Defendants' motion for summary judgment is GRANTED and all counts in the Amended Complaint are dismissed.
Plavix is a drug that inhibits blood platelets from forming clots. The drug was initially approved by the United States Food and Drug Administration (" FDA" ) for use as monotherapy, i.e., taken without another drug, in patients with recent heart attack, stroke, or diagnosed peripheral vascular disease (" PVD" ). See Defs. Statement, ¶ 2. Thereafter, the FDA approved Plavix for dual therapy with aspirin, which also contains antiplatelet effects, in the treatment of patients with particular types of acute coronary syndrome (" ACS" ). Id. at ¶ 4.
Taking Plavix is not without risk. Because it functions by inhibiting the formation of blood clots, Plavix increases the risk of bleeding. In that connection, when Plavix entered the market, labeling on Plavix included certain information on that risk. The label provides:
As with other antiplatelet agents, PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, PLAVIX should be discontinued 5 days prior to surgery.
GI Bleeding: PLAVIX prolongs the bleeding time. In CAPRIE , PLAVIX was associated with a rate of gastrointestinal bleeding of 2.0% vs. 2.7% on aspirin. In CURE, the incidence of major gastrointestinal bleeding was 1.3% vs. 0.7% (PLAVIX aspirin vs. placebo aspirin, respectively). PLAVIX should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions should be used with caution in patients taking PLAVIX.
Information for Patients
Patients should be told that it may take them longer than usual to stop bleeding when they take PLAVIX, and that they should report any unusual bleeding to their physician.
* * *
Hemorrhagic: In CAPRIE patients receiving PLAVIX, gastrointestinal hemorrhage occurred at a rate of 2.0%, and required hospitalization in 0.7%. In patients receiving aspirin, the corresponding rates were 2.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for PLAVIX compared to 0.5% for aspirin.
In CURE, PLAVIX use with aspirin was associated with an increase in bleeding compared to placebo with aspirin (see Table 3) . There was an excess in major bleeding in patients receiving PLAVIX plus aspirin compared with placebo plus aspirin, primarily gastrointestinal and at puncture sites. The incidence of intracranial hemorrhage (0.1%), and fatal bleeding (0.2%), was the same in both groups.
See, generally, February 2002 Plavix Labeling.
B. Plaintiff Medical History
Plaintiff has a history of coronary artery disease and vascular related health issues. His first angioplasty to clear coronary arteries occurred in 1997. See Columbia Medical Center of San Angelo Medical Record dated July 21, 1997. Plaintiff has undergone at least seven surgeries to ameliorate his cardiovascular-related issues. In November 2002, Plaintiff suffered a heart attack and he was diagnosed with acute myocardial infraction. See Shannon West Texas Memorial Hospital Discharge Summary. To remediate his condition, Plaintiff's doctors, inter alia, placed two metal stents in his arteries to maintain blood flow to his heart. Id. At that time, the interventionalist cardiologist, Dr. Randy McCullough, prescribed Plaintiff Plavix with aspirin in order " to prevent clots." See Dr. McCullough Dep., T56:5-19. Subsequently, Plaintiff's treating cardiologist, Dr. Gene Sherrod, and his clinical nurse specialist, Kim Coon, continued this prescription until July 2005. See Dr. Sherrod Dep, T125:19-126:7.
In July 2005, Plaintiff began suffering gastrointestinal bleeding. See Dr. Hunt's Examination Report dated August 5, 2005. He was admitted to the hospital for an acute gastrointestinal bleed, and was instructed to stop taking Plavix, but to continue aspirin. See Id. After the discontinuation of Plavix, Plaintiff, for over two months, continued to experience gastrointestinal bleeding and was treated with blood transfusions. See Operative Report dated September 30, 2005. On September 30, 2005, to stop the chronic bleeding, Plaintiff had surgery for bowl resection, gallbladder removal, and hernia repair. Id.
C. Plaintiff's Amended Complaint
Due to the gastrointestinal bleeding allegedly resulting from taking Plavix, Plaintiff brings the instant suit against Defendants asserting product liability related causes of action, under Texas state law, for defective design, manufacturing defect, failure to warn, and negligence.  See Am. Compl., Count I— Count IV. Although these claims are characterized differently, they essentially turn on whether Defendants adequately warned that Plavix carried a risk of bleeding complications. In that regard, Defendants argue that the learned intermediary doctrine precludes Plaintiff from suing them because the doctrine
excuses drug manufacturers from warning Plaintiff, individually, when these manufacturers have properly and adequately warned the prescribing physicians regarding Plavix's risks. It is this issue upon which the Court will focus.
I. Standard of Review
Summary judgment is " proper if there is no genuine issue of material fact and if, viewing the facts in the light most favorable to the non-moving party, the moving party is entitled to judgment as a matter of law." Pearson v. Component Tech. Corp.,247 F.3d 471, 482 n. 1 (3d Cir.2001) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)); accord Fed.R.Civ.P. 56(c). For an issue to be genuine, there must be " a sufficient evidentiary basis on which a reasonable jury could find for the non-moving party." Kaucher v. County of Bucks, 455 F.3d 418, 423 (3d Cir.2006); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). In determining whether a genuine issue of material fact exists, the court must view the facts and all reasonable inferences drawn from those facts in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Curley v. Klem, 298 ...