Mitchell v. Wyeth Pharm., Inc., 356 F. Supp. 3d 634 (2018)

Dec. 17, 2018 · United States District Court for the Western District of Texas · No. 1:16-CV-574-DAE

356 F. Supp. 3d 634

Allistair MITCHELL, Individually and as Personal Representative of the Estate of Klaus Jurgen Glaser, Deceased, Plaintiff,
v.
WYETH PHARMACEUTICALS, INC., a Subsidiary of Pfizer, Inc., and Teva Pharmaceuticals USA, Inc., Defendant.

No. 1:16-CV-574-DAE

United States District Court, W.D. Texas, Austin Division.

Signed December 17, 2018

Jack Edward Urquhart, Craig D. Henderson, Kathryn Snapka, The Snapka Law Firm, Corpus Christi, TX, for Plaintiff.

Carla Rose Karp, Glenn S. Kerner, Jenna C. Newmark, Pro Hac Vice, Nilda M. Isidro, Kate D. Seib, Pro Hac Vice, Goodwin Procter LLP, New York, NY, Michael A. Walsh, Clark Hill Strasburger, Dallas, TX, for Defendant.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT (DKT. # 97)

David Alan Ezra, Senior United States Distict Judge Before the Court is a Motion for Summary Judgment filed by remaining Defendant Teva Pharmaceuticals¹ ("Defendant" or "Teva") on May 31, 2018. (Dkt. # 97.) Plaintiff Allistair Mitchell ("Plaintiff" or "Mitchell") filed a Response on June 21, 2018. (Dkt. # 112.) Defendant filed its Reply on July 9, 2018. (Dkt. # 118.) On December 12, 2018, the Court held a hearing on the motion. At the hearing, Jack Urquhart, Esq. represented Mitchell and Carla Rose Karp, Esq., and Michael A. Walsh, Esq., represented Teva. The motion is fully briefed and ripe for review.

BACKGROUND

Allistair Mitchell, the surviving spouse of Klaus Jurgen Glaser ("Glaser"), brought this action individually and as a personal representative of Mr. Glaser's estate against Wyeth Pharmaceuticals ("Wyeth") and Teva. It is alleged that Mr. Glaser died from complications caused by being prescribed and taking amiodarone for non-life-threatening atrial fibrillation. (Dkt. # 1 at ¶¶ 3-5.) Mitchell contends that the failure to provide the Medication Guide, in violation of the FDA labeling requirement, was a breach of both a federal regulatory duty to warn and a state common law duty to warn. (Dkt. # 82 at 1.)

Federal law requires that a Medication Guide be issued along with amiodarone. See 21 C.F.R. 208.24(b). A Medication Guide is a handout that explains drug safety information in terms the average person would understand. Id. Mr. Glaser filled his amiodarone prescription at a Walmart Pharmacy in Odessa, Texas. (Dkt. # 97 at 11.) The prescription was filled with amiodarone tablets that were manufactured and shipped by Teva. (Id. ) Plaintiff's uncontroverted testimony at her deposition is that she accompanied Mr. Glaser to Walmart and that they did not receive a Medication Guide. (See Dkt. ## 112 at 1; 97 at 11.) Defendant's response is that their deposition witnesses provided uncontradicted and uncontested testimony that Teva "shipped each bottle of amiodarone to distributors with accompanying Medication Guides in accordance with FDA regulations and, in further compliance with its duty, also provided a phone number that distributers and pharmacies could call to obtain additional Medication Guides." (Dkt. # 97 at 1.)

PROCEDURAL HISTORY

Plaintiff's original complaint was filed with this Court on May 13, 2016, against Wyeth and Teva. (Id. ) The original complaint made claims under Texas state law for failure to adequately warn of the risks of generic amiodarone, fraudulent marketing or promotion of amiodarone for an "off-label" use, and failure to provide a Medication Guide to the pharmacy for ultimate distribution to Mr. Glaser, as well as wrongful death and survival action. (Id. ) Plaintiff alleged that Mr. Glaser developed pulmonary fibrosis and pulmonary toxicity as a result of his ingestion of amiodarone, and that he died on October 11, 2015, allegedly due to these complications. (Id. ¶¶ 3, 4.) Wyeth and Teva both moved to dismiss the original complaint. (Dkt. ## 13, 32.) Magistrate Judge Lane issued a Report and Recommendation that all of the claims be dismissed except the claim that Teva "failed to comply with [its] obligation to supply distributors with the FDA-required Medication Guides," and the derivative Wrongful Death and Survival Action claims. (Dkt. # 73.) Teva filed a partial objection on December 30, 2016. (Dkt. # 68.) Judge Yeakel adopted Judge Lane's Report and Recommendation on February 9, 2017, dismissing Plaintiff's Negligence and Gross Negligence, Strict Liability, Breach of Express Warranty, and Fraud claims that were premised on alleged off-label marketing. (Dkt. # 75.) The Court permitted only the Negligent Failure to Provide a Medication Guide, Wrongful Death, and Survival Action claims to proceed as pleaded. (Id. ) The Court dismissed the Fraudulent Off-Label Promotion claim without prejudice. (Id. )

On March 6, 2017, Plaintiff filed the now-operative First Amended Complaint, which contains one count for Negligence based on Teva's alleged failure to provide a Medication Guide (Count I) under both state and federal law, and derivative counts for Wrongful Death (Count II) and Survival (Count III).² (Dkt. # 82.) Plaintiff's First Amended Complaint does not allege any inadequacy in the warnings provided by Teva in the package insert or professional labeling, nor does Plaintiff allege that Mr. Glaser's prescribing physicians did not meet their duty of informed consent, or that the Walmart pharmacy failed to fulfill its duties under state law. The First Amended Complaint focuses solely on the allegation that Mr. Glaser did not receive an FDA-mandated Medication Guide when he picked up his one Teva prescription from the Walmart pharmacy. (Dkt. # 82.) On May 31, 2018, Teva filed the instant Motion for Summary Judgment. (Dkt. # 97.) On June 1, 2018, Teva filed a Motion to Exclude Expert Report and Testimony, and immediately filed a Corrected Motion. (Dkt. ## 100, 101.) On June 18, 2018, Mitchell filed her Response to the Motion to Exclude, (Dkt. # 104), and on July 9, 2018, Teva filed their Reply. (Dkt. # 117.) On June 21, 2018, Mitchell filed her Response to Teva's Motion for Summary Judgment, (Dkt. # 112), and on July 9, 2018, Teva filed their Reply. (Dkt. # 118.) On November 30, 2018, Magistrate Judge Lane denied Teva's Motion to Exclude. (Dkt. # 129.)

LEGAL STANDARD

A movant is entitled to summary judgment upon showing that "there is no genuine dispute as to any material fact." Fed. R. Civ. P. 56(a) ; see also Meadaa v. K.A.P. Enters., L.L.C., 756 F.3d 875, 880 (5th Cir. 2014). A dispute is only genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

The moving party bears the initial burden of demonstrating the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). If the moving party meets this burden, the nonmoving party must come forward with specific facts that establish the existence of a genuine issue for trial. Distribuidora Mari Jose, S.A. de C.V. v. Transmaritime, Inc., 738 F.3d 703, 706 (5th Cir. 2013) (quoting Allen v. Rapides Parish Sch. Bd., 204 F.3d 619, 621 (5th Cir. 2000) ). "Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no 'genuine issue for trial.' " Hillman v. Loga, 697 F.3d 299, 302 (5th Cir. 2012) (quoting Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) ).

In deciding whether a fact issue has been created, the court must draw all reasonable inferences in favor of the nonmoving party, and it "may not make credibility determinations or weigh the evidence." Tiblier v. Dlabal, 743 F.3d 1004, 1007 (5th Cir. 2014) (quoting Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000) ). However, "[u]nsubstantiated assertions, improbable inferences, and unsupported speculation are not sufficient to defeat a motion for summary judgment." United States v. Renda Marine, Inc., 667 F.3d 651, 655 (5th Cir. 2012) (quoting Brown v. City of Hous., 337 F.3d 539, 541 (5th Cir. 2003) ).

DISCUSSION

Teva, the moving party, contends first that Plaintiff has failed to prove a genuine issue of material fact, and second that Plaintiff lacks standing to bring the claim at all.³ Teva relies on another case decided in the Western District, Priest v. Sandoz, which dealt with a similar claim relating to amiodarone. See 2017 WL 7172504 (Dec. 28, 2017). In her Response, Plaintiff contends that her uncontroverted testimony that she and her husband failed to receive a Medication Guide presents such a genuine issue of fact. (Dkt. ## 112 at 1; 112-1.) In its Reply, Defendant maintains that the deposition testimony produced by its witnesses shows its compliance with its obligations under 21 C.F.R. § 208.24(b) and that Plaintiff's argument calls for an "expansive interpretation" of § 208.24(b) that disregards the plain language of the statute. (Dkt. # 118 at 1.) Thus, Defendant argues that there is no issue of material fact. (Id. at 2-7.)

21 C.F.R. § 208.24(b) requires that the manufacturer of a drug product for which a Medication Guide is required provide either (1) "Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers" or (2) "the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers." 21 § C.F.R. 208.24(d) then requires that a distributor, packer, or an authorized dispenser provide the Medication Guide to each patient who fills a prescription for that drug product.

Teva maintains that it fulfilled its obligations under 21 C.F.R. § 208.24(b) with regard to the amiodarone that Mr. Glaser received, and thus that there is no genuine dispute as to a material fact. (Dkt. # 97 at 7.) The Court agrees.

Two Teva witnesses testified via sealed deposition about Teva's practices and procedures with respect to the shipping of amiodarone and Medication Guides during the relevant time period, 2012-14. (Dkt. ## 97-11; 97-12.) These witnesses stated that Teva provided adequate numbers of Medication Guides and provided a phone number that Walmart could call to obtain additional Guides either in paper form or via link. (Dkt. # 97-11 at 55, 87-88, 171.) Plaintiff argues, in response, that Teva has to take reasonable steps to ensure that their Medication Guides are distributed to patients, and that Teva has failed to do so. (Dkt. # 112 at 7.) At the hearing, Plaintiff argued that Teva has to reasonably ensure that whatever Medication Guide they deliver to the distributor is the Medication Guide that is likely to be provided to the consumer. Plaintiff also argued that Teva's failure to attend hearings in 2006 on the subject and failure to hire external consultants to analyze whether their Medication Guides were reaching consumers shows a dereliction of this duty.

21 C.F.R. § 208.24(b), however, does not require such steps. The plain text of the regulation states that the burden on the manufacturer is as follows:

(a) The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA approval of the Medication Guide before the Medication Guide may be distributed.

(b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this part is responsible for ensuring that Medication Guides are available for distribution to patients by either:

(1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product; or

(2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product.

21 C.F.R. § 208.24(a) - (b). The text, contrary to Plaintiff's contention, does not place a duty upon Teva to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in "sufficient numbers" to distributors, packers, and authorized dispensers. Id. Rather, the duty to distribute Medication Guides to consumers falls on "[e]ach authorized dispenser of a prescription drug product for which a Medication Guide is required." 21 C.F.R. § 208.24(e). The authorized dispenser here, Walmart, is "required ... when the product is dispensed to a patient (or to a patient's agent), [to] provide a Medication Guide directly to each patient (or to the patient's agent)." Id. The regulation does not require that Teva's specific Medication Guide be provided to patients, rather, it requires the manufacturer to provide enough Medication Guides to its distributor or authorized dispenser "to permit" that distributor or authorized dispenser to provide those Medication Guides to patients. 21 C.F.R. § 208.24(b), (c). Nothing in the regulation forbids Walmart from printing their own Medication Guides and providing those to patients. Id. Nothing in the regulation requires Teva to monitor their "distributors, packers, or authorized dispensers" to ensure compliance. Id. The uncontroverted affidavit from Walmart states that Medication Guides are printed at the pharmacy, though it does not state where those Medication Guides come from. (Dkt. # 97-7 at 3.) As stated supra, however, the statute does not prevent Walmart from printing their own Guides rather than relying on Teva's, nor has there been any evidence presented that the Guides printed by Walmart are inadequate.

Teva has introduced uncontroverted evidence that the FDA approved its Medication Guide. (Dkt. # 97-6.) It has also submitted uncontroverted evidence that, from 2012 to 2014, Teva shipped 200 mg amiodarone tablets in 60-count and 250-count bottles. (Dkt. # 97-11 at 55, 61-62.) The 60-count bottles were sent to distributors with two printed Medication Guides attached. (Id. at 87-88, 171.) The 250-count bottles were sent with six printed Medication Guides attached. (Id. at 57.) Mr. Glaser's prescription, per pharmacy records, was filled from a 60-count bottle of amiodarone, and thus would have come from a bottle containing two Medication Guides. (Dkt. # 97 at 6.) The number of Medication Guides per bottle of amiodarone are based on Teva's internal business practices, which are based on pharmacy prescribing practices. (Id. at 155, 202-03, 207.) At the hearing, Defendant noted that Plaintiff has not presented any evidence that these numbers are insufficient. Further, Teva presented uncontroverted deposition testimony that Teva completed compliance documentation to ensure that the Medication Guides were actually affixed to the amiodarone bottles, (Dkt.# 97-12 at 56-57), and that the shipments contained a notice directing pharmacists to provide patients with Medication Guides. (Dkt. # 97-11 at 101-10.)

Teva also submitted uncontested evidence that all amiodarone shipments from which Mr. Glaser could have filled his prescription included either two or six Medication Guides per bottle of amiodarone that was shipped, and that there was no record of any authorized distributor or individual calling to complain about not receiving adequate numbers of Medication Guides. ((Dkt. ## 97-11 at 63, 97, 127; 97-12 at 29) (Sealed Depo Testimony); Dkt. # 97-2 (Pharmacy Records).) Further, Teva submitted evidence that it provides additional Medication Guides either via paper or via electronic link, if requested. (Dkt. # 97-11 at 127.) Teva has thus provided evidence that every shipment of amiodarone to Walmart from which Mr. Glaser's prescription could have been filled (all shipments to Walmart between 2012 and 2014) was shipped with adequate numbers of Medication Guides. (Dkt. ## 97-11 at 97, 170; 97-12 at 92.) Teva has adequately shown that it provided the Medication Guides to the Walmart where Mr. Glaser filled his prescription, in compliance with federal law. See 21 C.F.R. § 280.24(b).

Teva's argument for summary judgment is on all fours with the one adopted by the Court in Priest v. Sandoz. Priest also concerned the purported failure of a pharmacy to provide a Medication Guide for amiodarone. 2017 WL 7172504 at *10. In Priest, District Judge Yeakel granted summary judgment for the manufacturer based on the Report and Recommendation of Magistrate Judge Lane because the deposition testimony of the decedent's wife "d[id] not raise a material fact issue as to whether [the manufacturer] provided [the pharmacy] with Medication Guides." Id.

Similarly, here, Ms. Mitchell's deposition testimony that neither she nor her husband received a Medication Guide does not create a genuine issue of material fact. Her testimony is probative of whether Mr. Glaser received a Medication Guide from Walmart, "it is not at all probative of whether [Teva] provided the Medication Guides to [Walmart]." Id. Teva has met it's burden to show a lack of genuine issue of material fact, and it is now Mitchell's burden under Rule 56 to cite to specific materials within the record to show that a fact is genuinely in dispute. Mitchell relies on her own deposition testimony, an expert report by Venktesh Ramnath, M.D., a deposition of Venktesh Ramnath, M.D., a deposition of Fernando Boccalandro, M.D., the treating cardiologist, one of Teva's witness' depositions, and an FDA presentation slide. (Dkt. # 112 at 2.) None of these materials contradict Teva's witness' testimony as to the Medication Guide procedures in place for amiodarone. The expert report and depositions of both doctors supports the idea that amiodarone was a "causative factor" in Mr. Glaser's death. (Dkt. ## 97-10; 112-2-4.) The FDA slide, similarly, just presents Teva's duties under federal law, which are not in dispute. (Dkt. # 112-6.) The final deposition testimony relates to Walmart's protocol. (Dkt. # 112-5.) Mitchell points to the idea that the Walmart protocol "did not use (1) Medication Guides supplied by Teva ... nor (2) any electronic provided by Teva [to] produce Medication Guides." (Dkt. # 112 at 7.) However, "[t]hat [Walmart] implemented its own system to provide the required Medication Guides, without more, is not probative of whether [Teva] adequately provided the Medication Guides to [Walmart]." Priest, 2017 WL 7172504 at *11. Nowhere in the record before the Court is there any evidence that Teva failed to comply with its obligation to provide Medication Guides.⁴

Accordingly, Plaintiff has filed to present a genuine issue of material fact, as the uncontroverted evidence shows that Teva provided adequate numbers of amiodarone Medication Guides to Walmart. See id. Walmart's use of its own system to print Medication Guides for the drugs it dispenses does not indicate that it did not receive the Medication Guides from Teva. Id. at 10-11. Mitchell's testimony that she and Mr. Glaser did not receive a Medication Guide from Walmart, similarly, does not indicate that Walmart did not receive the Medication Guides from Teva. Teva is thus entitled to summary judgment on this issue.

CONCLUSION

For the reasons stated, the Court GRANTS Defendant's Motion for Summary Judgment. (Dkt. # 97.) Plaintiff's claims are DISMISSED WITH PREJUDICE and the Clerk's Office is INSTRUCTED to ENTER JUDGMENT and CLOSE the case.

1 The initial Complaint asserted claims against both Teva and another company, Wyeth Pharmaceuticals. Wyeth was dismissed as a defendant by this Court on January 11, 2017. (Dkt. # 70.) Following that dismissal, Plaintiff's First Amended Complaint only asserted claims against Teva. (Dkt. # 82.)

2 Wyeth was dismissed as a defendant, and thus the First Amended Complaint does not contain any claims against them. (Dkt. # 82.)

3 Because the Court can decide the motion on Teva's first contention, it does not reach the second argument regarding standing.

4 Further, there is uncontroverted testimony in the record that Walmart's Standard Operation Procedures include placing printed Medication Guides in the paper prescription bag when providing those prescription bags to customers. (Dkt. # 97-7 at 3.) Mitchell's deposition testimony raises a genuine issue of material fact as to this, but Walmart is not a party to this lawsuit.

IT IS SO ORDERED.