ALETA A. TRAUGER, District Judge.
Defendants General Electric Company, GE Healthcare AS, and GE Healthcare, Inc. (collectively, "GE") have filed a Motion for Summary Judgment (Docket No. 35). For the reasons stated herein, the motion will be granted, and the plaintiff's claims will be dismissed.
Marye Wahl, a resident of Nashville, Tennessee since 1999, suffers from nephrogenic systemic fibrosis ("NSF"). NSF is a progressive, incurable, and potentially fatal systemic disease that, among other deleterious effects, hardens organs and disfigures the skin. It has only one known cause: use of gadolinium-based contrast agents ("GBCAs"), such as GE's "Omniscan" product.
On May 8, 2006 and November 1, 2006, Wahl underwent Magnetic Resonance Imaging ("MRI") tests at St. Thomas Hospital in Nashville. In connection with those MRI tests, her physicians administered Omniscan as a contrast agent. In February 2007, GE added a "black box" warning to its Omniscan package that warned physicians of the risks of using GBCAs (including Omniscan) on renally impaired patients. The warning was too late to help Wahl.
Unrebutted evidence introduced by the defendants establishes that, from the point that GE first offered Omniscan on the market in 1993, (1) the FDA-required label on each Omniscan package contained a two-year expiration date, and (2) the product was manufactured abroad — either in Ireland or Norway. Accordingly, although the specific containers of Omniscan administered to Wahl in May and November 2006 are unknown, there is no genuine dispute that the product contained a label bearing a two-year expiration date. Therefore, even assuming that the Omniscan administered to Wahl was manufactured on the date of administration — an unrealistically generous assumption — the products expired no later than May 8, 2008 and November 1, 2008, respectively.
For its part, GE does not dispute the following relevant facts: (1) it issued a uniform set of warnings and instructions for the use of Omniscan, which was distributed internationally; (2) the package inserts relevant to this litigation and GE's
Before Wahl filed the instant lawsuit (indeed, before she was even diagnosed with NSF), multiple other plaintiffs injured by GBCAs filed lawsuits against GE and other GBCA manufacturers, generally alleging product defect theories. Many of these lawsuits were consolidated into a Multi-District Litigation ("MDL") proceeding before the United States District Court for the Southern District of Ohio (the "MDL Court").
On October 4, 2010, while Wahl was living in Tennessee, Wahl was diagnosed with NSF by a physician at Vanderbilt Dermatology in Nashville. Wahl apparently continues to receive treatment in Tennessee.
The defendants apparently settled all but a handful of the 900+ lawsuits comprising the MDL. Wahl's case, among a handful of others, was not resolved. Pursuant to an Agreed Order of Transfer Pursuant to 28 U.S.C. § 1404(a), the MDL Court transferred Wahl's lawsuit to this court.
Following transfer, GE moved for summary judgment, arguing that Wahl's
In support of its Motion for Summary Judgment, GE filed a supporting Memorandum of Law (Docket No. 36), a Statement of Undisputed Material Facts (Docket No. 37) (defendants' SUMF), and evidentiary materials, including, inter alia, the Declaration of Danny Healy (Docket No. 35, Ex. C.) Wahl filed a Response in opposition (Docket No. 41), a combined Response to the defendants' SUMF and a Statement of Additional Undisputed Material Facts ("Wahl's SUMF") (Docket No. 40), and evidentiary exhibits (Docket Nos. 45 (Exs. A-H), 46 (Ex. I), 47 (Exs. J-N)).
On October 18, 2013, the court heard oral argument on the motion. (See Docket No. 62, Transcript of Proceedings.) The court stated on the record that it would apply Tennessee choice of law rules in making its choice of law analysis. The court ordered the parties to file supplemental briefs as to whether, under Tennessee choice of law rules, Tennessee law or New Jersey law should apply to Wahl's claims. The parties accordingly filed supplemental briefs. (Docket Nos. 64(GE) and 65 (Wahl).)
Rule 56 requires the court to grant a motion for summary judgment if "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a) (2013). At the summary judgment stage, the moving party bears the initial burden of identifying those parts of the record that demonstrate the absence of any genuine issue of material fact. Moldowan v. City of Warren, 578 F.3d 351,
At this stage, "`the judge's function is not ... to weigh the evidence and determine the truth of the matter, but to determine whether there is a genuine issue for trial.'" Moldowan, 578 F.3d at 374 (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). "In evaluating the evidence, the court must draw all inferences in the light most favorable to the nonmoving party." Moldowan, 578 F.3d at 374 (citing Matsushita, 475 U.S. at 587, 106 S.Ct. 1348). But "[t]he mere existence of a scintilla of evidence in support of the non-moving party's position will be insufficient," Moldowan, 578 F.3d at 374 (quoting Anderson, 477 U.S. at 252, 106 S.Ct. 2505), and the non-movant's proof must be more than "merely colorable." Anderson, 477 U.S. at 249, 106 S.Ct. 2505. An issue of fact is "genuine" only if the record taken as a whole could lead a rational trier of fact to find for the non-moving party. Moldowan, 578 F.3d at 374 (citing Matsushita, 475 U.S. at 587, 106 S.Ct. 1348).
The procedural posture of this case places this court in an atypical position with respect to applying choice of law rules. Typically, when a defendant transfers a case to another district under 28 U.S.C. § 1404, the Erie doctrine requires the transferee court to apply the choice of law rules of the transferor state. Van Dusen v. Barrack, 376 U.S. 612, 637-39, 84 S.Ct. 805, 11 L.Ed.2d 945 (1964). In a case filed originally in one judicial district (the Middle District of Tennessee, for example) and subsequently transferred to another jurisdiction (the Southern District of Ohio, for example), the choice of law analysis is relatively straightforward: the Ohio court (the "transferee" court) applies the choice of law rules of Tennessee (the "transferor" court). However, where, as here, an MDL Court provides for direct filing of foreign cases pursuant to J.P.M.L. R. 7.2(a), the parties skip a step, leading to potentially confounding implications: because the foreign cases were filed directly in the MDL Court, the MDL Court is not (at least officially) acting as a "transferee" of a case transferred from another judicial district. Indeed, formally speaking, this court is the "transferee" of Wahl's case, which was filed directly in Ohio.
If this court applied Van Dusen mechanically, the court would be obligated to apply the choice of law rules of Ohio to this case, even though, as both parties acknowledge, this case has absolutely no legal or factual connection to Ohio, other than the procedural reality that CMO No. 3 permitted Wahl to file her case directly in the MDL Court in Ohio.
On the other hand, a handful of district courts, generally with little or no analysis, have applied the choice of law rules of the MDL court.
In Tennessee, "actions for or on account of personal injury ... from the manufacture, construction, design, formula, preparation, assembly, testing, service, warning, instruction, marketing, packaging or labeling of any product" are "product liability actions" subject to the TPLA. See Tenn.Code Ann. § 29-28-102(6). The TPLA has a unique statute of repose, under which all product liability actions "must be brought within ten (10) years from the date on which the product was first purchased for use or consumption, or within one (1) year after the expiration date of the anticipated life of the product, whichever is the shorter." Penley v. Honda Motor Co., Ltd., 31 S.W.3d 181, 183 (Tenn.2000) (quoting Tenn.Code Ann. § 29-28-103); see also Montgomery v. Wyeth, 580 F.3d 455, 456, 456 n. 1 (6th Cir.2009). The "anticipated life" of the product is "determined by the expiration date placed on the product by the manufacturer when required by law but shall not commence until the date the product was first purchased for use or consumption." Tenn.Code Ann. § 29-28-102(1). Thus, under the TPLA, a product liability action must be brought within one year of the expiration date for products that are required, by law, to bear such a date. See Montgomery, 580 F.3d at 463 (affirming district court's dismissal of plaintiff's claims under the TPLA statute of repose, where the plaintiff filed her lawsuit more than one year after the expiration date on the product). Although the statute of repose can extinguish claims before they accrue, the Tennessee Supreme Court and the Sixth Circuit have repeatedly upheld the statute's constitutionality and its application. See Montgomery, 580 F.3d at 463 (listing cases); Penley, 31 S.W.3d at 184.
Here, if Tennessee substantive law applies, the burden would be on GE to
By contrast, the parties agree that New Jersey has no statute of repose applicable to Wahl's claims. (See Docket No. 62, Transcript of Oral Argument, at 22:15-21.) Therefore, if New Jersey substantive law applies, Wahl's claim will proceed.
Because the court is faced with a potentially dispositive conflict of laws, the court must conduct a choice of law analysis.
With respect to choice of law issues, Tennessee has adopted the "most significant relationship" approach of the Restatement (Second) of Conflict of Laws (the "Restatement"). Montgomery, 580 F.3d at 459 (citing Hataway v. McKinley, 830 S.W.2d 53, 59 (Tenn.1992)). "Under this approach, `the law of the state where the injury occurred will be applied unless some other state has a more significant relationship to the litigation.'" Id. (quoting Hataway, 830 S.W.2d at 59). "Tennessee adopted this position `because generally the law of the state where the injury occurred will have the most significant relationship to the litigation.'" Id. (quoting Hataway, 830 S.W.2d at 59). "Thus, the most significant relationship `provides a "default" rule whereby trial courts can apply the law of the place where the injury occurred when each state has an almost equal relationship to the litigation.'" Id.
Contacts a court should consider when assessing a state's relationship to the litigation include: "(a) the place where the injury occurred[;] (b) the place where the conduct causing the injury occurred[;] (c) the domicile, residence, nationality, place of incorporation and place of business of the parties[;] and (d) the place where the relationship, if any, between the parties is centered." Hataway, 830 S.W.2d at 59.
Wahl suffered her injury in Tennessee, where she has resided since 1999 — a time period encompassing all of the acts relevant to this litigation. Therefore, the first factor favors the application of Tennessee law. For reasons explained herein, this is a crucial factor in a pharmaceutical products liability case.
The conduct causing Wahl's injury occurred in multiple jurisdictions. The product itself was manufactured abroad. GE is headquartered and made labeling decisions in New Jersey. Wahl's physicians, to whom GE would have a duty to warn under the learned intermediary doctrine (see Harden v. Danek Med., Inc., 985 S.W.2d 449, 451 (Tenn.Ct.App.1998)), received and utilized the Omniscan at issue in Tennessee. Wahl was prescribed, bought, ingested, and was injured by Omniscan in Tennessee. Therefore, the court rejects Wahl's argument that all of the relevant conduct causing Wahl's injuries occurred in New Jersey. See Jones v. Brush Wellman, Inc., No. 1:00 CV 0777, 2000 WL 33727733, at *4 (N.D.Ohio Sept. 13, 2000) ("[T]he majority of courts hold that a failure to warn occurs at the place where the plaintiffs could reasonably have been warned regardless of where the decision not to warn took place. Plaintiffs in this case encountered and were exposed to defendant's products in Tennessee. Therefore, any failure to warn which might have proximately caused plaintiffs' injuries occurred in Tennessee."); Byers v. Lincoln Elec. Co., 607 F.Supp.2d 840, 848 (N.D.Ohio 2009) (analyzing Ohio law) ("[A] defendant's alleged conduct of failure to warn occurred where the plaintiff used the product with the allegedly defective warning."); see also Yocham v. Novartis Pharms. Corp., 736 F.Supp.2d 875, 882 (D.N.J.2010) ("In addition to the injury having occurred in Texas, the conduct causing injury in a prescription drug products liability case, including failure to warn and warranty cases, occurs primarily where the injured party was prescribed and ingested the drug.") Furthermore, the Restatement advises that, where conduct causing an injury may have occurred in multiple states, the law of the place of injury should control:
Restatement, § 146, cmt. e.
The parties are domiciled in different states: Wahl is a Tennessee resident, and GE has a principal place of business in New Jersey. Therefore, the third factor is essentially a wash.
As to the fourth factor, the parties' relationship, to the extent they had one, was centered in Tennessee, where Wahl was prescribed, bought, ingested, and was injured by Omniscan.
Taken collectively and in context, these Restatement factors on balance favor the application of Tennessee substantive law to Wahl's claims. Aside from In re Bendectin, which presented unique circumstances not present here, it appears that the Sixth Circuit, courts within this circuit, and courts in other circuits addressing analogous circumstances, have uniformly concluded that the law of the plaintiff's place of injury applies, particularly where the place of injury is the same as the plaintiff's domicile. For example, in Montgomery v. Wyeth, the Sixth Circuit affirmed the district court's (reluctant) conclusion that the TPLA statute of repose barred a plaintiff's pharmaceutical product liability claims. See generally, 580 F.3d 455. The Sixth Circuit concluded that Tennessee "has the most significant relationship to the parties and the occurrence at issue," because "Tennessee is where [the plaintiff] sustained her injury, Tennessee is her place of domicile and residence, Tennessee is where she intended to and did use almost all of her Pondimin tablets, and Tennessee is the state where she was diagnosed and treated for injury." Id. at 460.
Furthermore, the additional policy factors in the Restatement favor the application of Tennessee law. The Tennessee General Assembly passed the TPLA in 1978 in response to a perceived "`crisis' in products liability lawsuits," which it feared was roiling the market for products liability insurance. See Penley, 31 S.W.3d at 187. The legislature believed that "uncertainty as to future liability increased the premiums for product liability insurance, which in turn increased the costs of production and ultimately consumer prices." Id. Thus, "[t]he legislature considered the limitation of future liability to a reasonable and specific period to be one of the most important keys in solving the perceived products liability crisis." Id. Therefore, Tennessee has a strong policy interest in the issues presented here.
Although New Jersey does have some policy interest in this lawsuit, Tennessee's policy interest is greater with respect to Wahl's product liability claims. In Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 917 A.2d 767, 769 (2007), a Michigan resident sued two New Jersey pharmaceutical manufacturers of an anti-acne drug, alleging that the manufacturers had failed to issue adequate warnings concerning the drug's health risks. Michigan law provided that an FDA-approved label would preclude liability for failure to warn, whereas New Jersey law did not. One of the defendants "manufactures, labels, and packages" the product in New Jersey, and the other defendant "markets, sells, and distributes the drug from New Jersey." Id. at 616, 917 A.2d 767. By contrast, the plaintiff had "lived in Michigan all his life," was prescribed the drug in Michigan, filled the prescription in Michigan, used the drug in Michigan, and suffered alleged
Finally, as the defendants point out, a contrary holding could have detrimental implications with respect to "certainty, predictability, and uniformity of result." It would obviously benefit Ms. Wahl personally to apply a more generous statute of repose from another state (based on the place where labeling decisions were made). However, to the extent that other jurisdictions have less generous products liability laws than Tennessee (at least in some respects), a decision on Wahl's favor here would not promote uniformity of results within Tennessee and could work an injustice on future Tennessee products liability plaintiffs in other contexts. For example, if a Tennessee resident sued a Michigan manufacturer that had affixed an FDA-approved label to a drug, the Tennessee resident could not recover because of Michigan's highly restrictive statutory bar. On the other hand, if another resident Tennessee sued a California manufacturer of the same drug, the plaintiff would have a valid cause of action. In both instances, the Tennessee resident's substantive rights would essentially be at the mercy of foreign legislative bodies over which the plaintiff has no control and had no contacts. It would not promote certainty, uniformity, and predictability for Tennessee citizens to be subject to the fortuitous circumstance that the drugs that injured them were labeled or manufactured in a particular foreign jurisdiction. Indeed, holding that New Jersey law governs here would essentially mean that, for any other plaintiff injured by GE's drugs, New Jersey law would trump the laws of the other 49 states and frustrate those state's rights to protect their own citizens and/or to promote particular policy goals in those states.
The plaintiffs' counter-argument is that the Sixth Circuit decision in In re Bendectin requires this court to apply New Jersey law. In In re Bendectin, the district court had conducted MDL proceedings concerning claims by over a thousand plaintiffs, who alleged that their mothers' ingestion during pregnancy of the defendant manufacturer's anti-nausea "morning sickness" drug had caused them to suffer birth defects. 857 F.2d at 293. After being given the option to opt out of a "common issues" trial, most of the plaintiffs consented to the application of Ohio law by agreeing to participate in that trial.
Notwithstanding this holding, the Sixth Circuit, "out of caution," proceeded to analyze the application of Ohio law under the Restatement factors for "plain error."
Having minimized the "place of injury" factor, the Sixth Circuit stated that it viewed "the law of the state of manufacture of the product as being more significant in this type of case than that of the state where an individual plaintiff happens to live." Id. at 305 (emphases added). The court observed that the defendant "distributed a uniform drug internationally," issued "a uniform set of warnings and instructions for use," and was subject to the laws of Ohio and/or the federal government with respect to the labeling, research, and distribution of the drug." Id. Accordingly, the court concluded that "the relationship between the parties is essentially centered in Ohio, where the tortious conduct and the safety of the product are regulated." Id.
In re Bendectin is distinguishable from this case for multiple reasons. As an initial matter, in contrast to In re Bendectin, the parties vigorously dispute which state's law should apply. Furthermore, In re Bendectin at most could be construed as a "plain error" review of the district court's application of Ohio law, not as an affirmative statement that, upon de novo review, the Sixth Circuit would have reached the same conclusion. Regardless, even taking In re Bendectin's analysis at face value, the circumstances presented there differed from those presented here in several crucial respects. Here, unlike the anti-nausea medication at issue in In re Bendectin, the place of injury is readily ascertainable and is not subject to dispute. Moreover, unlike an anti-nausea medication that presumably could have been ingested anywhere, at any time, Omniscan was administered as part of monitored
Moreover, Bendectin held that the state of "manufacture" was relevant for the choice of law analysis, and the state of manufacture happened to be the same jurisdiction in which labeling decisions were made. Here, the facts are different: the product was manufactured abroad and the labeling decisions were made in New Jersey.
Subsequent to In re Bendectin — notwithstanding the analysis contained therein — many courts, including the Sixth Circuit in Montgomery, have continued to find that the law of the state of injury and/or domicile governs in pharmaceutical product liability actions. See, e.g., Montgomery, 580 F.3d at 461-62 (distinguishing In re Bendectin); Jones, 2000 WL 33727733, at *4 (same); Byers, 607 F.Supp.2d at 847-849 (same); In re Am. Med. Sys., 75 F.3d 1069 (6th Cir.1996) (reversing trial court's grant of class certification, where trial court failed to consider that putative class members' claims would be governed by the laws of their home states — not the state of product manufacture — which would vary substantially); Bowling v. Pfizer, 143 F.R.D. 141, 163 (S.D.Ohio 1992) (limiting In re Bendectin to its facts). Indeed, the plaintiffs have not identified any case in which a court has followed In re Bendectin and concluded that the substantive law of the state of manufacture and/or labeling decisions applied. Whatever continuing viability In re Bendectin has, it does not apply to the circumstances presented here.
On a separate note, the court acknowledges the parties' various submissions regarding positions taken by other plaintiffs and courts in the MDL and/or in other GBCA cases nationwide. In Pennsylvania state court, for example, the parties disputed whether New Jersey law should apply to the issue of punitive damages: the plaintiffs argued against the application of New Jersey law, while the defendants argued for it. The positions of other parties in Pennsylvania prove nothing here: the court denied the motion, the representations cut both ways, and it appears that that court already intended to apply the law of Pennsylvania to the plaintiffs' underlying (non-punitive) claims in the first place. Moreover, under the doctrine of depecage, there is no inconsistency in applying the law of one state to a particular issue (such as compensatory claims) and the law of a different state to another issue (such as punitive damages claims). See Byers, 607 F.Supp.2d at 846 n. 16.
In conducting its choice of law analysis, the court has not relied upon the litigation positions taken by the plaintiffs in other cases. That said, it is notable that the MDL Court (and the parties) in other Omniscan cases appear to have taken for granted what Wahl here disputes: that the law of the place of her injury and domicile — Tennessee — governs her claims.
In sum, the law of Tennessee governs Wahl's claims. The undisputed facts establish that the TPLA statute of repose bars her claims as a matter of law.
On a final note, although it is unavoidable, the court views the result in this case as manifestly unjust. Through no fault of her own, Wahl is left with an essentially incurable degenerative condition for which she has no recourse, because Tennessee extinguished her claims against GE before she could have discovered them. The time period here between the procedures at issue and Wahl's NSF diagnosis was only about four years, which is not a time period that shocks the conscience. This court, as did Judge Collier in Montgomery, 540 F.Supp.2d at 936 and 945, urges the Tennessee General Assembly to revisit the TPLA and its effect on Tennessee citizens injured by pharmaceutical products.
For the reasons stated herein, GE's Motion for Summary Judgment will be granted and Wahl's claims will be dismissed with prejudice.
An appropriate order will enter.
For the reasons set forth in the accompanying Memorandum, the defendants' Motion for Summary Judgment (Docket No. 35) is
It is so
On a separate note, although GE in part relies on a supplemental affidavit introduced in support of the defendants' Reply (see Docket No. 53, Ex. 3, Supplemental Affidavit of Danny Healy), the court finds it appropriate to consider that supplemental affidavit. The Supplemental Affidavit addresses specific (albeit largely speculative) arguments raised in the plaintiffs' Response brief. Furthermore, Wahl has had ample time to cure any conceivable prejudice, including the opportunity to present evidence and argument at the October 18, 2013 hearing on the motion and in post-hearing submissions ordered by the court.