TIMOTHY S. BLACK, District Judge.
This civil case is presently before the Court on the Motion of Defendants, ALZA
This case concerns the death of 51 year-old Cornell Phillips. At the time of his death, Phillips was using a fentanyl patch manufactured by Defendant ALZA and distributed by Defendant Sandoz. Fentanyl patches are prescription pain patches designed to deliver fentanyl through a user's skin.
The patches Phillips wore at the time of his death contain fentanyl gel in a reservoir between a layer of impermeable polyester backing and a semi-permeable layer of ethyl-acetate vinyl ("EVA") film. (Doc. 21-1). The semi-permeable layer is placed on the patient's skin, and, following application, patches are intended to continuously deliver the requisite dose of fentanyl to the patient's bloodstream over a 72-hour period. (Id.) However, Plaintiff alleges that the reservoir design fentanyl patches Phillips wore at the time of his death were known by Defendants to leak as a result of seal integrity defects. (Doc. 1). Further, Plaintiff alleges that, despite proper use, non-leaking reservoir design fentanyl patches were known to "produce levels of fentanyl in patients above the intended and designed level." (Doc. 1).
Before his death, Phillips suffered from chronic pain due to several medical conditions, including chronic intestinal pain and osteoarthritis. (Doc. 32). In 2006, Phillips developed a malignant tumor in his nasopharynx
In June 2006, Phillips was referred to Dr. E. Ronald Hale after being diagnosed with nasopharyngeal cancer. During the course of treatment, Dr. Hale prescribed Phillips a 25 micrograms per hour ("mcg/hr") fentanyl patch for pain on approximately July 25, 2006. (Id.) In August 2006, Dr. Hale increased the dose of the fentanyl patch to 50 mcg/hr by instructing Phillips to use two 25 mcg/hr patches simultaneously. (Id.) Phillips' dosage was thereafter increased to 75 mcg/hr, and later increased again to 100 mcg/hr. (Id.) According to Dr. Hale, on or about October 22, 2006, Phillips' hematology doctor, Dr. Abuerreish, increased the dosage to 125 mcg/hr. (Id.)
On November 6, 2006, Phillips was taken to the Miami Valley Hospital after calling 911. (Doc. 42). He died later that afternoon after attempts to revive him failed. Following his death, Phillips was examined by the Montgomery County, Ohio coroner's office. (Doc. 21-4). Toxicology tests revealed that Phillips had a postmortem fentanyl blood level of 13 ng/mL, well
Plaintiff, William Miller, administrator of Phillips' estate, filed this wrongful death action asserting statutory product liability causes of action, including: (1) a manufacturing defect claim pursuant to O.R.C. § 2307.74; (2) a marketing defect claim pursuant to O.R.C. § 2307.76; (3) a design defect claim pursuant to O.R.C. § 2307.75; and (4) a failure to conform to representations claim pursuant to O.R.C. § 2307.77. (Doc. 1). Plaintiff also sets forth claims of negligence, negligent misrepresentation, breach of the implied warranty of fitness, breach of express warranty and a claim titled "deliberate, intentional, reckless and/or malicious conduct." (Id.) In addition to compensatory damages, Plaintiff's prays for punitive damages.
A motion for summary judgment should be granted if the evidence submitted to the Court demonstrates that there is no genuine issue as to any material fact and that the movant is entitled to summary judgment as a matter of law. Fed.R.Civ.P. 56; see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
"Summary judgment is only appropriate `if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.'" Keweenaw Bay Indian Comm. v. Rising, 477 F.3d 881, 886 (6th Cir.2007) (quoting Fed.R.Civ.P. 56(c)). "Weighing of the evidence or making credibility determinations are prohibited at summary judgment— rather, all facts must be viewed in the light most favorable to the non-moving party." Id.
Once "a motion for summary judgment is properly made and supported, an opposing party may not rely merely on allegations or denials in its own pleading; rather, its response must—by affidavits or as otherwise provided in this rule—set out specific facts showing a genuine issue for trial." Fed.R.Civ.P. 56(e)(2).
Defendants move for summary judgment on all claims asserted by Plaintiff. With regard to Plaintiff's product liability claims, Defendants assert: (A) that Plaintiff's failure to warn/inadequate warning claims must fail because the prescribing doctor unequivocally testified that he would have still prescribed the fentanyl patch despite the warnings advocated by Plaintiff, and because Plaintiff have no proper expert testimony regarding the adequacy of the warnings; (B) Plaintiff's design defect claim must fail because an allegedly leaking patch is not a design defect, and, regardless, Ohio law shields drug manufacturers from design defect claims if they warn of the dangerous aspect of the drug; (C) Plaintiff's manufacturing defect claim must fail because there is no evidence, either direct or circumstantial, sufficient to show that any patch used by Phillips actually leaked; and (D) Plaintiff's failure to conform to representations claim must fail because Plaintiff does not identify representations to which the patches failed to conform.
Defendants also move for summary judgment on Plaintiff's claims of negligence, negligent misrepresentation, breach of warranty claims, claims alleging misrepresentations
Plaintiff's failure to warn claim is premised on the assertion that Defendants failed to warn of the risk of overdose "by leaking or otherwise[.]" (Doc. 1). Defendants challenge Plaintiff's failure to warn claim, arguing that: (1) there is no genuine issue of fact regarding the lack of causation because Dr. Hale would have prescribed despite the warnings advocated by Plaintiff; and (2) Plaintiff's proposed warnings experts are not physicians and cannot testify regarding the adequacy of prescription drug warnings.
Pursuant to O.R.C. § 2307.76, inadequate warnings or instructions render a product defective if:
To prove a "failure to warn" claim, plaintiffs must prove: "(1) a duty to warn against reasonably foreseeable risks; (2) breach of this duty; and (3) an injury that is proximately caused by the breach." Graham v. Am. Cyanamid Co., 350 F.3d 496, 514 (6th Cir.2003).
With regard to prescription drugs, a manufacturer's duty is discharged "if the manufacturer adequately warns the patient's doctor of those risks." Id. (citing O.R.C. § 2307.76(C)). Further, "[w]hen a plaintiff alleges that the warning given to a prescribing physician is inadequate, the plaintiff must prove his claim through expert medical testimony." Id.
Initially, the Court finds it necessary to identify the warnings Plaintiff argues should have been given to fully, properly and adequately warn of foreseeable risks. In this regard, Plaintiff cites the opinions of: (1) James C. Morrison (Doc. 46-34), a purported expert in FDA drug regulations and labeling; and (2) the declaration of Dr. Kenneth R. Laughery (Doc. 46-35), a Ph.D. in psychology and a certified human factors professional. (Doc. 34).
James Morrison's report accompanying his declaration essentially proposes two warning deficiencies: (1) a failure to warn that all patches need to be checked by the end user for leaking seals;
(Doc. 44).
Dr. Laughery expressed two similar opinions regarding the inadequacy of the Package Insert warnings or complete failure to warn, opining that the Package Insert (Doc. 21-1) failed to address the following:
(Doc. 46-35). In addressing the "hazard of high levels of fentanyl," Dr. Laughery testified:
(Doc. 34) (Emphasis added).
Finally, Plaintiff's expert, Dr. Prausnitz, testified that he ruled out a number of potential explanations for the high fentanyl levels found in decedent's blood postmortem, including the possibility that such level was the normal level achieved by normal use of a non-defective patch by Phillips. (Doc. 51-1). Specifically:
(Id.) Dr. Prausnitz's ultimate opinion was that a leaking fentanyl patch is the most likely explanation for the high level of fentanyl found postmortem. (Id.)
With these advocated necessary warnings, the Court will address Defendants' arguments regarding Plaintiff's failure to warn claims.
In their first challenge to Plaintiff's failure to warn claim, Defendants argue that Plaintiff cannot prove causation. Defendants argue that there is no evidence of causation because Dr. Hale "testified that he would have prescribed the fentanyl patches to Phillips even if additional warnings were added to the prescribing information as advocated by Plaintiff." (Doc. 20).
Plaintiff bears the burden of establishing a defect and establishing that such defect proximately caused the claimed injury. See O.R.C. § 2307.73(A)(2). A plaintiff "not only must convince the fact finder that the warning provided is unreasonable, hence inadequate, but he also must establish the existence of proximate cause between the [product] and the fact of the plaintiffs injury." Hisrich v. Volvo Cars of N. Am., Inc., 226 F.3d 445, 450-51 (6th Cir.2000) (citing Seley v. G.D. Searle Co., 67 Ohio St.2d 192, 423 N.E.2d 831, 838 (1981)). "`In analyzing the proximate cause issue as it relates to failure-to-warn cases,' the Ohio Supreme Court `divided proximate causation . . . into two sub-issues: (1) whether lack of adequate warnings contributed to the plaintiff's [use of the product], and (2) whether [use of the product] constitute[d] a proximate cause of the plaintiff's injury.'" Id.
In Ohio, "where no warning is given, or where an inadequate warning is given, a rebuttable presumption arises, beneficial to the plaintiff, that the failure to adequately warn was a proximate cause of the plaintiff's ingestion of the drug." Seley, 67 Ohio St.2d at 200, 423 N.E.2d 831. However, where the evidence demonstrates that "an adequate warning would have made no difference in the physician's decision as to whether to prescribe a drug or as to whether to monitor the patient thereafter, the presumption ... is rebutted, and the required element of proximate cause between the warning and ingestion of the drug is lacking." Id. at 201, 423 N.E.2d 831; see also Wheat v. Pfizer, Inc., 31 F.3d 340, 343 (5th Cir.1994) (stating that plaintiffs asserting a failure to warn claim must "demonstrate that `a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would not have used or prescribed the product'").
Thus, where the treating physician unequivocally testifies that s/he would have prescribed the subject drug despite adequate warnings, judgment as a matter of law is appropriate. See Wheat, 31 F.3d at 343-44; see also Motus v. Pfizer, Inc., 196 F.Supp.2d 984, 997-98 (C.D.Cal.2001) (stating that "most cases do not permit a plaintiff to get past summary judgment where the doctor made unequivocal statements in a pre-trial deposition demonstrating that adequate warnings would not have affected his or her decision to prescribe a drug'"). However, where the evidence does not affirmatively establish that the prescribing physician "would not have behaved differently had he received a different warning[,]" a matter of credibility may exist that is "better made by the finder of fact." Williams v. Lederle Laboratories, 591 F.Supp. 381, 387 (S.D.Ohio 1984).
Here, with regard to the risk of leaking patches, Dr. Hale testified unequivocally that he would have prescribed the patch even if specifically warned that
Even assuming Plaintiff's experts opined that the Phillips' high postmortem fentanyl level was most likely caused by normal use of a non-leaking patch, Dr. Hale testified that he would have prescribed the patch to Phillips despite a warning in that regard. (Doc. 32). Again, both of Plaintiff's purported warnings experts submit that the Package Insert should specifically warn physicians that patients properly using a non-leaking patch "can get levels of fentanyl in the blood that can be an overdose and can be fatal" (Docs. 34, 44, 46-34, 46-35), even though Dr. Prausnitz eliminated that possibility in the case of Phillips. Nevertheless, Dr. Hale testified that he would have prescribed the patch even if warned that "despite normal use of a non-leaking patch a patient could still receive a fatal doses of fentanyl[.]" (Doc. 32).
In Plaintiffs Response to Defendants' Motion, Plaintiff points to particular testimony from Dr. Hale in an attempt to show that Dr. Hale was not so certain in this regard. Such testimony highlighted by Plaintiff addresses a more specific warning than that advanced by Plaintiff's purported warnings experts, i.e., a warning that despite normal use of the patch, a patient can receive four to five times the expected level of fentanyl. Nevertheless, even when asked if he would prescribe the patch to "a patient" if warned "that despite normal use of the patch, a patient could receive a level of fentanyl that was four to five times the [expected] level identified" in the Package Insert, Dr. Hale testified generally that he "may" still prescribe the patch and that he would not "categorically deny using the drug under those conditions." (Id.)
In fact, Dr. Hale testified that his decision to prescribe the patch in any particular circumstance requires a risk/benefit decision based on the circumstances in each particular case.
Dr. Hale did state at one point in his testimony that he would have more closely monitored Phillips in light of a specific warning that "a patient could receive a blood serum level four to five times in excess of the levels identified" in the Package Insert. Nevertheless, Dr. Hale did testify that he was already monitoring Phillips "on a daily basis because [he] was seeing [Phillips] everyday through radiation treatment and would have treated the
Thus, because: Dr. Prausnitz eliminated the possibility that Phillips' high fentanyl level was the normal level achieved by Phillips' use of a non-defective patch; Plaintiff's purported warnings experts do not propose warning that normal use of a non-leaking patch can lead to levels four to five times in excess of the expected blood fentanyl level; Dr. Hale would have prescribed the patches to Phillips even in light of such warnings; Dr. Hale was already monitoring Phillips on a daily basis; and actual levels of fentanyl are "irrelevant" to Dr. Hale's prescribing decisions, the Court finds any alleged uncertainty created by questions regarding a warning that normal use of a non-leaking patch can lead to levels four to five times in excess of the expected blood fentanyl level does not create an issue of fact precluding summary judgment.
In light of the foregoing, Defendants have rebutted any presumption that allegedly inadequate warnings contributed to Phillips' use of the drug, leaving the "required element of proximate cause between the warning and [use] of the drug... lacking." Seley, 67 Ohio St.2d 192, 423 N.E.2d 831. Therefore, Court finds that Defendants are entitled to summary judgment on Plaintiff's failure to warn claims, and Defendants' Motion for Summary Judgment in this regard is
Defendants also challenge Plaintiff's defective design claim. First, Defendants assert that Plaintiff's claim is not a design defect claim because an allegedly leaking patch is a manufacturing defect, not a design defect. Second, Defendants contend that they are protected from liability for alleged design defects pursuant to O.R.C. § 2307.75(D) because they provided adequate warnings regarding the unsafe aspects of the patch. Plaintiff contends that he asserts a defective design claim,
Defendants argue that "Plaintiff has not properly alleged a design defect claim under Ohio law" because any existence of a leaking patch is not intended in the design, and, therefore, injuries resulting from leaking patches must necessarily result from a defect in manufacturing. In making such an argument, Defendants appear to focus on the adequacy of Plaintiff's pleading rather than Plaintiff's actual proof of a design defect.
Pursuant to O.R.C. § 2307.75, "a product is defective in design or formulation if, at the time it left the control of its manufacturer, the foreseeable risks associated with its design or formulation . . . exceeded the benefits associated with that design or formulation[.]" To prevail on a design defect claim, a plaintiff must show that the design risks outweigh the benefits. See Patterson v. Central Mills, Inc., 112 F.Supp.2d 681, 687 (N.D.Ohio 2000) (citing Perkins v. Wilkinson Sword, Inc., 83 Ohio St.3d 507, 700 N.E.2d 1247 (1998)). In making such a determination, O.R.C. § 2307.75(B) sets forth a number of factors to consider in determining the foreseeable risks associated with the design of a product, and O.R.C. § 2307.75(C) sets forth a number of factors to consider in determining the benefits of a particular design.
Here, in support of the design defect claim, Plaintiff alleges that the risks of the reservoir design outweighed its benefits, especially considering the availability of alternative, safer designs. (Doc. 1). The Court finds that such allegations sufficiently assert a defective design claim under O.R.C. § 2307.75. See Boroff v. Aha Corp., 685 F.Supp.2d 704 (N.D.Ohio 2010) (holding that allegations "that Duragesic `has been recalled for causing death to users due to an excessive leak of fentanyl, a dangerous narcotic medication, into the skin,' and that this sort of leakage caused the death at issue . . . is enough to give rise to a plausible inference that the foreseeable risks associated with Duragesic's design or formulation outweighed its benefits"). Defendants' contention that the claim in this regard actually alleges a manufacturing defect is without merit, and their Motion in this regard is
Defendants also argue that Plaintiff's defective design claim must fail because they are shielded from such a claim pursuant to O.R.C. § 2307.75(D), which provides that:
A product is "unavoidably unsafe" when "in the state of technical, scientific, and medical knowledge at the time a product in question left the control of its manufacturer, an aspect of that product was incapable of being made safe." O.R.C. § 2307.71(A)(16).
Consistent with the statutory definition of "unavoidably unsafe," in a case preexisting the Ohio Products Liability Act, the Supreme Court of Ohio held that "a product is unavoidably unsafe if, at the time of its distribution, there existed no alternative design which would have as effectively accomplished the same purpose or result with less risk." White v. Wyeth Laboratories, Inc., 40 Ohio St.3d 390, 395, 533 N.E.2d 748 (1988). Further, the court held that "a prescription drug, vaccine, or
Here, the Court finds that the plan language of O.R.C. § 2307.75(D) renders it applicable only to those instances where some aspect of the ethical drug is unavoidably unsafe. Defendants have not asserted that their patch is unavoidably unsafe, and, instead, apparently argue that O.R.C. § 2307.75(D) applies even in instances where an ethical drug is avoidably unsafe.
Wimbush v. Wyeth, 619 F.3d 632, 637 (6th Cir.2010) (citing Frey v. Novartis Pharmaceuticals Corp., 642 F.Supp.2d 787, 794 (S.D.Ohio 2009)).
The Court acknowledges the somewhat ambiguous nature of the language in Wimbush, However, the Court does not read the statement in Wimbush as constituting a holding that the defense set forth in O.R.C. § 2307.75(D) is applicable in cases where the subject prescription drug is avoidably unsafe. First, a reading of Wimbush does not reveal whether the parties even disputed whether the drug at issue was unavoidably unsafe. Id. Further, a review of Frey, 642 F.Supp.2d at 794, which the Sixth Circuit cited in setting forth the aforementioned language, specifically stated that:
(Emphasis added). A review of this language in Frey assists in clarifying the language in Wimbush.
The Court holds that the defense set forth in O.R.C. § 2307.75(D), by its clear language, applies only to instances where the ethical drug at issue is unavoidably unsafe. Because O.R.C. § 2307.75(D) applies only to ethical drugs that are unavoidably unsafe, and because Defendants apparently do not argue that their patch is unavoidably unsafe,
Accordingly, Defendants' Motion with regard to Plaintiff's design defect claim is
Defendants move for summary judgment on Plaintiff's manufacturing defect claim asserting that there is no evidence, either direct or circumstantial, to support Plaintiff's theory that any patch used by Phillips actually leaked and contributed to
Pursuant to O.R.C. § 2307.74, "[a] product is defective in manufacture . . . if, when it left the control of its manufacturer, it deviated in a material way from the design specifications, formula, or performance standards of the manufacturer, or from otherwise identical units manufactured to the same design specifications, formula, or performance standards." As noted above, in proving a products liability claim in Ohio, Plaintiff bears the burden of proving a number of elements, chief among those elements is "that . . . there was, in fact, a defect." Harker v. Black & Decker, 21 F.3d 427 (6th Cir.1994).
The Supreme Court of Ohio has stated that the "existence of a defect" is "but one of the three elements necessary for recovery" for an alleged manufacturing defect; Plaintiff must also prove "the claimed defect was present when the product left the hands of the manufacturer and proximately caused the claimed injuries." State Farm Fire & Casualty Co. v. Chrysler Corp., 37 Ohio St.3d 1, 6-7, 523 N.E.2d 489 (1988). Here, Defendants' arguments regarding Plaintiff's manufacturing defect claim focus solely on the alleged absence of evidence that the patch leaked.
"In manufacturing defect cases, the plaintiff has the burden of proving the existence of the defect." Smitley v. Nissan North America, Inc., No. 2:09-cv-148, 2010 WL 3027915 at *3 (S.D.Ohio Aug. 2, 2010) (citing Bonacker v. H.J. Heinz Co., 111 Ohio App.3d 569, 676 N.E.2d 940, 942 (Ohio App.1996)). In Ohio, defects can be proven by circumstantial evidence. O.R.C. § 2307.73(B).
Defendants essentially argue that summary judgment in their favor is proper because it is just as likely, if not more likely, that Phillips' postmortem fentanyl levels resulted from "variability of inter-individual rates of absorption, distribution, metabolism, and excretion of opioids in general, and fentanyl in particular. Individuals vary with regard to relevant genetic factors, co-administered rugs, and co-morbidities" rather than an allegedly leaking patch. (Doc. 20). To support this position, Defendants not only point to evidence from their own expert, but point to the testimony of Plaintiff's expert, Dr. Prausnitz, who testified in another case
However, a review of Dr. Prausnitz's deposition in this case reveals the opinion that the excessive fentanyl level found in decedent's blood was most probably the result of a leaking patch.
Thus, circumstantial evidence is present to create a genuine issue of material fact on the issue of whether decedent, in fact, used a leaking patch. Because Defendants' Motion is targeted solely at the existence of a leaking patch, and because there is a genuine issue of fact as to whether decedent used a leaking patch, Defendants' Motion in this regard is
Defendants contend that Plaintiff has failed to identify any representations to which the patches failed to conform. In Ohio, "[a] product is defective if it did not conform, when it left the control of its manufacturer, to a representation made by that manufacturer." O.R.C. § 2307.77. Further, "[a] product may be defective because it did not conform to a representation even though its manufacturer did not act fraudulently, recklessly, or negligently in making the representation." Id.
To prevail on this claim, Plaintiff must prove that: (1) Defendant "made a representation as to a material fact concerning the character or quality of the" patch; (2) that the patch failed to conform to Defendants' representation; (3) justifiable reliance on Defendants' representation; and (4) that such reliance directly and proximately caused the alleged injuries. Westfield Ins. Co. v. HULS Am., Inc., 128 Ohio App.3d 270, 295, 714 N.E.2d 934 (Ohio App.1998) (citing Gawloski v. Miller Brewing Co., 96 Ohio App.3d 160, 165, 644 N.E.2d 731 (Ohio App.1994)); Barrett v. Waco Internatl., Inc., 123 Ohio App.3d 1, 702 N.E.2d 1216 (Ohio App. 1997); White v. DePuy, Inc., 129 Ohio App.3d 472, 718 N.E.2d 450 (Ohio App. 1998).
Defendants' Motion argues that Plaintiff failed to identify any representations made by Defendants, and further
Defendants argue that Plaintiff's negligence and negligent misrepresentation claims, along with Plaintiff's claims for breach of the implied warranty of fitness and breach of express warranty, have been abrogated by Ohio's Product Liability Act ("OPLA"). Plaintiff concedes that the claims of negligence and negligent misrepresentation have been abrogated by the OPLA, and, therefore, summary judgment on those claims is proper as a matter of law. See O.R.C. 2307.71(B) (stating that Ohio Revised Code "Sections 2307.71 to 2307.80 of the Revised Code are intended to abrogate all common law product liability claims
Further, common law warranty claims have also been abrogated by the OPLA, and therefore, insofar as Plaintiff asserts warranty claims under the common law, those claims have been abrogated by virtue of O.R.C. § 2307.71(B), and summary judgment in favor of Defendants on such claims is proper as a matter of law. Stratford, 2008 WL 2491965; Donley v. Pinnacle Foods Group, LLC, No. 2:09-cv-540, 2009 WL 5217319, at *4 (S.D.Ohio Dec. 28, 2009).
Here, however, Plaintiff states that the breach of warranty claims are statutory warranty claims under Ohio's codification of the Uniform Commercial Code ("UCC") in O.R.C. Chapter 1302. Plaintiff argues that UCC warranty claims are not abrogated by the OPLA, citing Miles v. Raymond Corp., 612 F.Supp.2d 913, 924-25 (N.D.Ohio 2009). Courts in this District have also determined that UCC warranty claims are not abrogated by virtue of O.R.C. § 2307.71(B). CCB Ohio LLC v. Chemque, Inc., 649 F.Supp.2d 757 (S.D.Ohio 2009) (stating that "Plaintiffs' warranty claims can find a basis grounded in the Uniform Commercial Code and therefore are not claims abrogated by the OPLA"); see also Donley, 2009 WL 5217319 at *4.
Here, Defendant argues that the allegations in the Complaint do not support Plaintiff's contention that the warranty claims are asserted under R.C. Chapter 1302. Defendants point out that the "Complaint makes no reference—expressly
This district has dealt with the failure to specifically state whether warranty claims are asserted under the UCC. In Miles, the court seemingly allowed the UCC claims to stand, only to dismiss them as being time-barred under O.R.C. 1302.98. Miles, 612 F.Supp.2d at 926-27, n. 13. In Donley, however, the court stated:
Donley, 2009 WL 5217319, at *4.
Here, Plaintiff fails to cite any portion of O.R.C. Chapter 1302 in the Complaint (Doc. 1) or in the Response to Defendants' Motion. (Doc. 46). In fact, in Plaintiff's Response, Plaintiff merely asserts in conclusory fashion that the claims are UCC claims, not common law claims.
Accordingly, Defendants' Motion with regard to Plaintiff's negligence, negligent misrepresentation and warranty claims is
Defendants contend that Plaintiff asserts a claim seeking recovery for purported misrepresentations made by
(Doc. 1). In response, Plaintiff argues that no claim is premised on fraudulent statements to the FDA. However, despite Plaintiff's contention that no such claim is asserted, the Complaint, in the Court's view, clearly asserts such a claim.
Claims asserting fraud on the FDA are preempted by the Food, Drug and Cosmetics Act ("FDCA"). See Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 965 (6th Cir.2004) (citing Buckman Co. v. Pls. Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)); see also In re Aredia and Zometa Products Liab. Litig., 352 Fed.Appx. 994 (6th Cir.2009). Here, Plaintiff's tenth cause of action, entitled "Deliberate, Intentional, Reckless, and/or Malicious Conduct," insofar as it is premised on alleged fraudulent withholding of information or making misrepresentations to the FDA, are preempted and are dismissed, with prejudice.
Accordingly, Defendants' Motion in this regard is
Finally, Defendants argue that Plaintiff cannot recover punitive damages in a wrongful death action pursuant to O.R.C. § 2125.02(B), and cite Rubeck v. Huffman, 54 Ohio St.2d 20, 23, 374 N.E.2d 411 (1978), wherein the Supreme Court of Ohio held that "punitive damages are . . . not available in a wrongful death action." See also Estate of Beavers v. Knapp, 175 Ohio App.3d 758, 889 N.E.2d 181 (Ohio App.2008). In response to Defendant's arguments in this regard, Plaintiff "concedes that he is not entitled to punitive damages in this wrongful death case." (Doc. 46).
Accordingly, the Defendants' motion in this regard is
For the foregoing reasons, Defendants' Motion for Summary Judgment is
Defendants' Motion for Summary Judgment is
Here, a review of the pleadings and the evidence presented in the parties' memoranda reveals that Phillips used the patch to relieve pain. The relief of pain is the ordinary purpose for which the patch was to be used, not some particular purpose "peculiar" to Phillips. Therefore, even if Plaintiff appropriately pled and sought relief under O.R.C. § 1302.28, such a claim seemingly has no merit.
