Rader v. Teva Parenteral Medicine, Inc. et al
Filing
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ORDER Denying 34 Motion for Summary Judgment and Granting in Part and Denying in Part 41 Counter-Motion for Summary Judgment. Signed by Judge James C. Mahan on 6/20/11. (Copies have been distributed pursuant to the NEF - ASB)
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UNITED STATES DISTRICT COURT
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DISTRICT OF NEVADA
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CHARLES ANTHONY RADER, JR.,
et al.,
2:10-CV-818 JCM (RJJ)
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Plaintiffs,
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v.
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TEVA PARENTAL MEDICINES,
INC., et al.,
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Defendants.
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ORDER
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Presently before the court is defendants Teva Parenteral Medicine, Inc., Sicor
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Pharmaceuticals, Inc., Sicor, Inc., Baxter Healthcare Corporation, and McKesson Medical-Surgical,
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Inc.’s (hereinafter “products defendants”) motion for summary judgment. (Doc. #34). Plaintiff
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Charles Anthony Rader, Jr. filed an opposition (doc. #40) and a counter-motion for summary
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judgment (doc. #41). Products defendants filed a reply in support of their motion and in opposition
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to plaintiff’s motion. (Doc. #46).
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This case stems from plaintiff’s allegation that he was injured when he received a letter from
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the Southern Nevada Health District notifying him that because he was given an injection of the
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generic drug Propofol at the Endoscopy Center of Southern Nevada, he had been “placed at risk for
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possible exposure to bloodborne pathogens.” (Doc. #1-1 Exhibit 1). Plaintiff tested negative for
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Hepatitis C, Hepatitis B, and HIV, but filed the instant class-action1 on behalf of similarly situated
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James C. Mahan
U.S. District Judge
Plaintiff’s motion to certify class (doc. #26) was filed September 27, 2010, but the parties
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individuals seeking “reimbursement of the cost of the Propofol procedure” and of “subsequent
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testing provoked by the ensuing hepatitis outbreak.” (Doc. #40).
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The complaint (doc. #1-1) alleges claims for relief against the products defendants for (1)
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strict product liability, (2) breach of implied warranty of fitness for a particular purpose, (3)
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negligence, (4) violations of the Nevada Deceptive Trade Practices Act, and (5) punitive damages.
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Plaintiff asserts that products defendants manufactured, sold and distributed the vials of Propofol
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that were being reused by the endoscopy center. (Doc. #40).
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Products Defendants’ Motion For Summary Judgment
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Summary judgment is appropriate when, viewing the facts in the light most favorable to the
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nonmoving party, there is no genuine issue of material fact which would preclude summary
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judgment as a matter of law. Bagdadi v. Nazar, 84 F.3d 1194, 1197 (9th Cir. 1996); Federal Rule
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of Civil Procedure 56(c); Matsushita Elec. Indus. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986);
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T.W. Elec. Serv., Inc. v. Pacific Elec. Contractors Assn., 809 F.2d 626, 630 (9th Cir.1987). The
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purpose of summary judgment is to “pierce the pleadings and assess the proof in order to see whether
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there is a genuine need for trial.” Matsushita Elec., 475 U.S. at 586; International Union of
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Bricklayers v. Martin Jaska, Inc., 752 F.2d 1401, 1405 (9th Cir.1985).
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The moving party bears the burden of informing the court of the basis for its motion, together
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with evidence demonstrating the absence of any genuine issue of material fact. Celotex Corp.v.
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Catrett, 477 U.S. 317, 323 (1986). Once the moving party has satisfied its burden, it is entitled to
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summary judgment if the non-moving party fails to present, by affidavits, depositions, answer to
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interrogatories, or admissions on file, "specific facts showing that there is a genuine issue for trial."
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Celotex Corp., 477 U.S. 317, 324; Fed. R. Civ. P. 56(c).
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In the present motion for summary judgment (doc. #34), products defendants contend that
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summary judgment is appropriate on two different grounds; (1) “plaintiff’s claims are preempted by
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federal laws that require the labels and warnings of generic pharmaceuticals such as Propofol to be
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identical to their branded counterparts,” and (2) that since the “United States Food and Drug
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James C. Mahan
U.S. District Judge
stipulated that the responses were not due until May 23, 2011 (doc. #57).
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Administration specifically approved the label and the package insert provided with vials of
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Propofol, the warnings are adequate as a matter of law.”
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A.
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With regards to the products defendants’ first ground for summary judgment, the Ninth
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Circuit has held that federal law does not preempt state law failure-to-warn claims against generic
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manufacturers. Gaeta v. Perrigo Pharmaceuticals Company. 630 F.3d 1225, 2011 WL 198420 (C.A.
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9 (Cal.)), 11 Cal. Daily Op. Serv. 987, 2011 Daily Journal D.A.R. 1269. Therefore, products
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defendants’ first ground allegedly warranting summary judgment fails.
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B.
Federal Preemption
Adequate Warnings As A Matter of Law
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In products defendants’ second ground for summary judgment, they assert that since the label
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and packaging of the generic drug Propofol was approved by the Food and Drug Administration, it
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is adequate as a matter of law. Products defendants contend that since plaintiff’s claims “are
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premised on the theory that the Porpofol vial warnings were inadequate, the current motion is
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dispositive of all claims.” (Doc. #34). The evidence supports a finding that the label and the package
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inserts on the Profopol warned the users that it was intended for “[s]ingle patient use,” that
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“[c]ontamination can cause fever, infection/sepsis, and/or other life-threatening diseases,” and to
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“not use if contamination is suspected.” (Doc. #34 Exhibit B and C). As evidenced by the letter from
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the Food and Drug Administration (doc. #34 Exhibit A), Profopol was approved and found to be
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“safe and effective for sale use as recommended in the submitted labeling.” Thus, as products
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defendants contend, there are no genuine issues with regards to these facts.
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In light of this, products defendants argue that summary judgment is appropriate. They rely
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on this court’s decision in Moretti v. Pilva, Inc., 2010 WL 3385450 (D. Nev. Aug. 20, 2010), where
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it rejected the federal preemption argument, but granted summary judgment because; “(1) the
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labeling (also known as the package insert) for [the generic drug] met the applicable statutory and
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regulatory requirements of being the same as the labeling for the [r]eference [l]isted [d]rug; (2) the
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labeling was approved by the FDA; and (3) the labeling warned [of the risk identified by plaintiffs.]”
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The court agrees with products defendants that all of these elements are seen here, but recognizes
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James C. Mahan
U.S. District Judge
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the subsequent decision of the Ninth Circuit in Gaeta v. Perrigo Pharmaceuticals Company as it
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relates to the facts/allegations of the case now before this court.
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In Gaeta v. Perrigo Pharmaceuticals Company, the court held that despite the approval by
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the FDA and the compliance with the “same as” requirement, it is “clear that generic manufacturers,
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just like their name counterparts, must take specific steps when they learn of new risks associated
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with their products,” and “shall revise their drug labeling to include a warning as soon as there is
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reasonable evidence of an association of a serious hazard with a drug.” Gaeta, 630 F.3d 1231–1232;
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21 C.F.R. § 201.57(e) (2004) (emphasis added)(internal quotations omitted). Further, the court held
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that there are several ways in which a generic manufacturer may amend its labeling or packaging to
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strengthen the warnings; “(1) the CBE process approved by the Supreme Court...; (2) the “prior
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approval” process; and (3) by asking the FDA to send “Dear Doctor” warning letters to health care
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professionals.” Id.
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Here, plaintiff’s complaint is premised upon the allegation that products defendants learned
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of risks associated with the drug, yet failed to “take specific steps” to revise the drug labeling.
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Specifically, plaintiff alleges not only that products defendants’ drug contained inadequate warnings,
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but that products defendants “had prior knowledge of the risk of infection attendant to dosing
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multiple patients from a single container of...Propofol,” prior knowledge of “actual incidents of
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hepatitis infection in the ambulatory surgical center environment occurring as a result of such
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facilities dosing multiple patients from a single container,” and that they continued to manufacture,
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market, and sell the Propofol to the subject endoscopy clinics “in packaged quantities which they
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knew or should have known were too large to be safely sold to these ambulatory surgical facilities.”
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Id.
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Additionally, plaintiff asserts that products defendants failed to adequately warn of the risks
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of infection associated with dosing multiple patients from a single container, “despite the knowledge
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that the subject endoscopy clinics were likely engaging in precisely that practice due to the
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inordinately large size of Propofol bottles being used at these facilities.” Id. Plaintiff presents
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evidence that products defendants “conducted research and had knowledge that the 10mL vial of
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James C. Mahan
U.S. District Judge
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Propofol was the safer vial for use in endoscopy centers2” and that selling larger vials to such centers
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“would lead to the temptation to multi-dose.3” Specifically, plaintiff argues that “as far back as 1995,
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senior representatives from [products defendants] were aware of the dangers of cross contamination
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caused by multi-dosing or misuses of the designer form of Propofol, Deprivan. See Exhibit 18 and
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19. Additionally, plaintiff presents evidence via the deposition of Al Ponterdolph, that defendant
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Baxter received inquiries from the users of its products regarding “if the 10mL vials were multi-dose
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vials.” Exhibit 24.
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Despite this knowledge and the user inquiries, plaintiff asserts that products defendants
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continued to sell 50 mL vials to endoscopy centers and failed to warn the FDA of the information
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or “request permission to revise their warnings, package inserts, vial design, or marketing materials.”
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Products defendants even concede that there is “recourse available to a generic drug manufacturer
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wishing to change the label,” whereby the manufacturer would simply “furnish adequate supporting
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information to FDA, which would [then] determine whether the labeling for all products should be
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modified.” (Doc. #46).
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As approval by the FDA and compliance with the “same as” requirement do not make the
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labeling adequate as a matter of law, and there are genuine issues of material fact surrounding
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whether products defendants knew or should have known that the dosage sold to the endoscopy
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clinic was of an amount susceptible to multiple dosages resulting in contamination and that multi-
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dosing was in fact occurring, summary judgment is not appropriate based on the products
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defendants’ second ground. Fed. R. Civ. P. 56; Gaeta, 630 F.3d 1231–1232.
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James C. Mahan
U.S. District Judge
In March of 2002, defendant Baxter conducted marketing research which it shared with
Teva, demonstrating that “ideal procedures for the 10mL vial include;...endoscopic procedures,”
such as here, and that the “biggest advantage is that it will result in less wasted Porpofol.” Exhibit
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In May of 2000, Gensia n/k/a defendant Teva submitted a suitability petition to the FDA
requesting approval of a 100mg/10mL vial (Exhibit 20), stating that “a smaller size is safer in that
it may reduce the temptation for dosing multiple patients from a single container thereby reducing
opportunities for microbial contamination,” and that it would “reduce the temptation and the
opportunity for dosing multiple patients form a single drug container.”
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Plaintiff’s Counter-Motion for Summary Judgment
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In plaintiff’s counter-motion (doc. #40), he contends that summary judgment should be
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granted in plaintiff’s favor regarding defendants’ affirmative defense of compliance with federal
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regulations. Additionally, he asserts that all evidence of federal regulations should be precluded, as
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presentation of such evidence would mislead the jury on the law. In asserting this, plaintiff is
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referring to two of his claims for relief, namely (1) strict products liability, and (2) breach of implied
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warranty of fitness for a particular purpose.
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A.
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The central feature of the doctrine of strict products liability is the potential for imposing
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liability “although the seller has exercised all reasonable care...” Shoshone Coca-Cola Bottling Co.
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v. Dolinski, 82 Nev. 439, 441, 420 P.2d 855 (1967). Under Nevada law, “the defectiveness of a
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product is determined solely by the consumer expectation test.” Id. The court’s attention, plaintiff
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states, should therefore be focused “on the buyer’s expectation,” and how the product “performed
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in light of the buyer’s reasonable expectation, not upon what the manufacturer did or did not do.”
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Lenardi v. Ford Motor Company, 683 P.2d 1097 (Wash. 1984).
Strict Products Liability
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Accordingly, plaintiff requests that this court exclude any evidence of the defendants’
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compliance with FDA regulations. In arguing this, plaintiff suggests that this court should follow the
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court in Guadio v. Ford Motor Company, 976 A.2d 524, 543 (Penn. Sup. 2009), when it excluded
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evidence of an automaker’s compliance with Federal Motor Vehicle Safety Standards, because it
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would “mislead the jury’s attention away from their proper inquiry, namely quality and design of the
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product in question.”
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Therefore, plaintiff contends that in a strict liability case, such as this, the focus at trial should
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be on “the expectations of the ultimate consumer” and “the attributes of the product itself, and not
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the conduct of the [p]roducts [d]efendants and whether they complied with industry standards,” i.e.
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the FDA regulations. (Doc. #40). Further, he argues that the question at trial “should be is a 50mL
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vial unsafe for use on a patient in a facility that is solely licensed to conduct endoscopies[,]
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colonoscopies and other similar short procedures and/or whether the warnings were deficient.” Id.
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James C. Mahan
U.S. District Judge
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Products defendants argue that the plaintiff cannot have it both ways; either the “evidence
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about FDA regulations and industry practice must be admitted at trial, or [p]laintiff’s claims must
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be dismissed in their entirety as preempted.” (Doc. #46); See generally FDA Brief. They contend that
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there are several reasons why the evidence is admissible and denial of the cross-motion is necessary.
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With regards to strict products liability, products defendants argue that the evidence is
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relevant to the “threshold question...of whether Propofol was in fact ‘defective’ or ‘unreasonably
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dangerous.’” See e.g., Rivera v. Philip Morris, Inc., 125 Nev. 18, 209 P.3d 271, 275 (2009); Allison
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v. Merck & Co., 110 Nev. 762, 767, 878 P.2d 948, 952 (1994) (both holding that “defective or
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unreasonably dangerous” is an element that must be shown in a strict liability claim). Therefore,
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products defendants assert that they are entitled to defend the claim by presenting evidence that
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would “tend to show that Propofol is safe or that would otherwise tend to show that [p]laintiff cannot
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carry its burden of proving that Propofol was unreasonably dangerous.” (Doc. #46).
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Products defendants rely on the Nevada Supreme Court when it held that evidence of industry
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standards is admissible in products liability cases: “The best way to determine if a defendant should
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have built a safer product is to let the jury hear all the evidence relating to the course of conduct of
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both the industry, and the particular manufacturer.” Robinson v. G.G.C. Inc., 107 Nev. 135, 142, 143,
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808 P.2d 522, 526, 527 (1991). This court agrees with product defendants and the Restatement of
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Torts, that “compliance with product safety regulations is relevant and admissible on the question
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of defectiveness.” See Restatement (Third) of Torts: Products Liability § 4 cmt. e (1998); O’Neill
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v. Novartis Consumer Health, Inc., 147 Cal. App. 4th 1388, 1394, 55 Cal. Rptr. 3d 551, 557 (2007)
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(in a design defect and failure to warn case involving drug products containing
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phenylpropanolamine, the court noted that government standards are relevant and deserve “serious
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consideration.”). However, the court does not find that evidence of compliance is a bar to recovery
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under strict products liability.
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Therefore, the court in not inclined to exclude evidence of products defendants’ compliance
with FDA regulations with regards to plaintiff’s strict liability claim.
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James C. Mahan
U.S. District Judge
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B.
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To establish an implied warranty that goods will be fit for a particular purpose under a theory
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of strict products liability, “the seller must, at the time of contracting, know of a particular purpose
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for which the goods are required and know that the [consumer] is relying on the seller’s skill or
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judgment to select or furnish suitable goods.” Piotrowski v. Southworth Prods. Corp., 15 F.3d 748,
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752 (8th Cir. 1994). Plaintiff contends that evidence that products defendants’ generic drug Porpofol
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was approved by the FDA should not be admissible, because “proof of compliance with
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governmental standards is no bar to recovery on a breach of warranty theory.” Reid v. Eckerds
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Drugs, Inc., 40 N.C. App. 476, 483, 253 S.E. 2d 344 (1979); Gottdanker v. Cutler Labratories, 182
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Breach of Warranty of Fitness For A Particular Purpose
Cal. App. 2d 602, 6 Cal. Rptr. 320 (1960).
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Plaintiff asserts that such evidence is not only irrelevant to the breach of warranty claim, but
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the affirmative defense of compliance is not permissible. Products defendants rebut this argument
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by relying on Goodman v. Wenco Foods, Inc., 333 N.C. 1, 17, 423 S.E.2d 444, 452 (1992), where
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the court stated that “[p]roof of compliance with government standards is no bar to recovery on a
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breach of warranty theory; although such evidence may be pertinent to the issue of the existence of
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a breach of any warranty, it is not conclusive.” As with the strict liability claim, the court agrees that
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proof of compliance is not a bar to recovery, but is nonetheless admissible evidence.
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In addition to the claims discussed above, products defendants address the relevant nature
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of the evidence of compliance with regards to the remaining claims for relief for (1) violations of the
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Nevada Deceptive Trade Practices Act, and (2) punitive damages. First, they contend that the
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“knowingly” aspect of the alleged misrepresentations necessarily requires the admission of evidence
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of their “understanding of the regulatory framework and its attendant obligations and limitations.”
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See also Nevada Revised Statute § 598.0915 (defining deceptive trade practice).
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Second, with regards to the punitive damages sought, products defendants assert that the
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evidence is relevant in connection with the question of whether the conduct rises to the level of
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“oppression, fraud, or malice.” See Nev. Rev. Stat. § 42.005(1) (defining oppression, fraud, and
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malice). Specifically, whether the products defendants acted with the requisite level of malice needed
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James C. Mahan
U.S. District Judge
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to permit a jury to even consider an award of punitive damages. Cf. Countrywide Home Loans v.
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Thitchener, 129 P.3d 243, 252058 (Nev. 2008). In addition, products defendants argue that the
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evidence is admissible and relevant “to assist the jury (assuming arguendo that a jury finds liability
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and malice) in determining the appropriate level of punitive damages to award.” (Doc. #46).
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The court agrees with products defendants, that since the claims against them involve their
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knowledge, the reasonableness of their actions, and the fraudulent or malicious intent behind their
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actions, evidence of compliance with FDA regulations is admissible.
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Accordingly,
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IT IS HEREBY ORDERED ADJUDGED AND DECREED that defendants Teva Parenteral
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Medicine, Inc., Sicor Pharmaceuticals, Inc., Sicor, Inc., Baxter Healthcare Corporation, and
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McKesson Medical-Surgical, Inc.’s motion for summary judgment (doc. #34) be, and the same
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hereby is, DENIED.
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IT IS FURTHER ORDERED that plaintiff Charles Anthony Rader, Jr.’s counter-motion for
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summary judgment (doc. #41) be, and the same hereby is DENIED in part and GRANTED in part.
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Products defendants may present evidence of compliance with FDA regulations, but such evidence
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does not conclusively bar recovery of plaintiff’s claims.
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DATED June 20, 2011.
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UNITED STATES DISTRICT JUDGE
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James C. Mahan
U.S. District Judge
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