Opinion
C.A. No. N15C-04-029 JRJ
03-25-2019
HACAH BOROS, as Administrix of the Estate of JONATHON BOROS; G.B, an Infant under the Age of 14 years, by her guardian HACAH BOROS; N.B, an infant under the age of 14 years, by his Guardian HACAH BOROS; and HACAH BOROS Individually, Plaintiffs, v. Pfizer, Inc.; Pfizer International LLC; Pfizer Pharmaceuticals, Inc.; Teva Pharmaceuticals USA Inc.; Pliva, Inc. a/k/a Sidmark Laboratories, Inc.; and DOES 1 through 10, Defendants.
R. Joseph Hrubiec, Esq., Napoli Shkolnik PLLC, 919 N. Market Street, Suite 1801, Wilmington, DE 19801, W. Steven Berman, Esq. (argued) (pro hac vice), Napoli Shkolnik PLLC, 1 Greentree Centre, Suite 201, 10,000 Lincoln Drive, East Marlton, NJ 08053, Hunter J. Shkolnik, Esq. (pro hac vice), Christopher R. LoPalo, Esq. (pro hac vice), Staesha Rath, Esq. (pro hac vice), Napoli Shkolnik PLLC, 360 Lexington Avenue, 11th Floor, New York, NY 10017, Attorneys for Plaintiffs. William R. Denny, Esq., Jesse L. Noa, Esq., Potter Anderson & Corroon LLP, Hercules Plaza, Sixth Floor, 1313 North Market Street, P.O. Box 951, Wilmington, DE 19899-0951, Jennifer Snyder Heis, Esq. (argued) (pro hac vice), Jeffrey F. Peck, Esq. (pro hac vice), Ulmer & Berne LLP, 600 Vine Street, Suite 2800, Cincinnati, OH 45202-2409, Attorneys for Defendant Teva Pharmaceuticals USA Inc.
OPINION
Upon Teva Pharmaceuticals USA, Inc.'s Motion for Summary Judgment: GRANTED. R. Joseph Hrubiec, Esq., Napoli Shkolnik PLLC, 919 N. Market Street, Suite 1801, Wilmington, DE 19801, W. Steven Berman, Esq. (argued) (pro hac vice), Napoli Shkolnik PLLC, 1 Greentree Centre, Suite 201, 10,000 Lincoln Drive, East Marlton, NJ 08053, Hunter J. Shkolnik, Esq. (pro hac vice), Christopher R. LoPalo, Esq. (pro hac vice), Staesha Rath, Esq. (pro hac vice), Napoli Shkolnik PLLC, 360 Lexington Avenue, 11th Floor, New York, NY 10017, Attorneys for Plaintiffs. William R. Denny, Esq., Jesse L. Noa, Esq., Potter Anderson & Corroon LLP, Hercules Plaza, Sixth Floor, 1313 North Market Street, P.O. Box 951, Wilmington, DE 19899-0951, Jennifer Snyder Heis, Esq. (argued) (pro hac vice), Jeffrey F. Peck, Esq. (pro hac vice), Ulmer & Berne LLP, 600 Vine Street, Suite 2800, Cincinnati, OH 45202-2409, Attorneys for Defendant Teva Pharmaceuticals USA Inc. Jurden, P.J.
I. INTRODUCTION
Plaintiffs assert a failure to warn claim against Defendant, Teva Pharmaceuticals USA Inc. ("Teva"). Plaintiffs allege that Teva should have updated the warnings in the package insert for its generic azithromycin to match the Zithromax warnings, and that Teva's failure to do so proximately caused the death of Jonathon Boros' ("Decedent").
See Boros v. Pfizer, Inc., 2016 WL 3131403, at *1 (Del. Super. 2016) ("Although Plaintiffs assert seven causes of action against [Teva], the core of the claims is the same - [Teva] failed to adequately warn Decedent of the safety issues regarding the azithromycin that he ingested.").
Zithromax is the brand name of azithromycin. Op. Br., E-File 62306689, at 1.
Before the Court is Teva's "Motion for Summary Judgment on the Issue of Proximate Cause." It is undisputed that the Decedent's prescribing physician, Dr. Krumeich, did not review Teva's package insert before prescribing the Decedent azithromycin. The issue is whether Dr. Krumeich's failure to review Teva's package insert prevents the Plaintiffs from establishing that Teva's failure to update the warnings was the proximate cause of the Decedent's death. If Plaintiffs cannot establish proximate cause, then they cannot establish a prima facie case against Teva and Teva is entitled to summary judgment. For the reasons set forth below, Teva's "Motion for Summary Judgment on the Issue of Proximate Cause" is GRANTED.
Defs.' Mot. Summ. J., E-File 62306689.
Dr. Krumeich prescribed Zithromax to the Decedent, but the pharmacy filled the Decedent's prescription with Teva's generic azithromycin. See Compl., E-File 57018818, ¶¶ 71, 73-74.
II. BACKGROUND
On April 2, 2013, the Decedent was prescribed Zithromax for streptococcal pharyngitis. That same day, the Decedent dropped his prescription off at his pharmacy and the pharmacy filled it with Teva's generic azithromycin. Sometime after picking up the filled prescription, the Decedent ingested the generic azithromycin. On April 3, 2013, the Decedent collapsed in his home and was taken to the hospital. An EKG showed the Decedent had a prolonged QT interval. The prolonged QT interval led to an arrhythmia, and after efforts to resuscitate him were unsuccessful, the Decedent was pronounced dead at 11:36 a.m. on April 3, 2013.
Op. Br. at 4; Compl. ¶¶ 71, 74.
Op. Br. at 4; Resp. Br., E-File 62408953, at 4.
Op. Br. at 4; Compl. ¶ 75.
Resp. Br. at 4; Compl. ¶ 78.
Resp. Br. at 4; Compl. ¶¶ 78-80.
On February 19, 2013, prior to the Decedent taking Teva's generic azithromycin, the Food and Drug Administration ("FDA") approved an update to Zithromax's labeling, which contained stronger warnings about QT interval prolongation. On February 28, 2013, an FDA approval letter ("FDA Letter") requested that Teva revise the package insert for its generic azithromycin "to be in accordance with" Zithromax's updated labeling. On March 12, 2013, the FDA issued a Drug Safety Communication ("FDA Communication") stating azithromycin drug labels were being updated "to strengthen the Warnings and Precautions section with information related to the risk of QT interval prolongation . . . ."
Defs.' Transmittal Aff. in Support of Reply Br. ("Reply Br. Aff."), E-File 62470685, Ex. 4.
Id.
Defs.' Transmittal Aff. in Support of Mot. Summ. J. ("Mot. Summ. J. Aff."), E-File 62306689, Ex. 4.
A month after the Decedent's death, on May 9, 2013, Teva submitted a revision of its package insert to the FDA's Office of Generic Drugs. The revision updated the "CLINICAL PHARMACOLOGY" and "WARNINGS" sections of the package insert to match the language in Zithromax's updated labeling. Teva stated in its revision that the updated package insert would be implemented May 12, 2013. On June 27, 2013, the FDA notified Teva that Teva's "supplemental new drug applications" were approved. Teva's failure to update the package insert until after the Decedent's death is the basis for Plaintiffs' failure to warn claim.
Reply Br. Aff., Ex. 4.
Id.
Id.
Reply Br. Aff., Ex. 5.
The parties do not dispute that Dr. Krumeich does not recall ever reviewing a package insert for Teva's generic azithromycin or for any other Teva produced drug. Dr. Krumeich has never spoken to or had any written communications with any Teva representative. Dr. Krumeich has never heard of Teva. Dr. Krumeich does not recall hearing about the FDA Communication stating the azithromycin drug labels were being updated.
Op. Br. at 5; Reply Br. Aff., Ex. 1, at 59:18-24.
Op. Br. at 5; Reply Br. Aff., Ex. 1, at 63:16-24.
Op. Br. at 5; Reply Br. Aff., Ex. 1, at 63:25, 64:1.
Reply Br. Aff., Ex. 1, at 58:1-13.
III. PARTIES' CONTENTIONS
Teva argues it is entitled to summary judgment because: (1) under the Learned Intermediary Doctrine ("LID"), it only had the duty to warn Dr. Krumeich about the known risks of its generic azithromycin; (2) Dr. Krumeich never reviewed Teva's package insert which contained the warnings at issue; and (3) Plaintiffs cannot establish that the warnings in the package insert were the proximate cause of the Decedent's death because Dr. Krumeich never reviewed the package insert.
Op. Br. at 8.
Id. at 9.
Id.
Plaintiffs argue: (1) there is an issue of fact regarding proximate cause despite Dr. Krumeich's failure to review the package insert; (2) the LID does not apply, and Teva had a duty to warn both Dr. Krumeich and the Decedent because azithromycin is over-promoted and the Decedent is not a lay patient; and (3) Teva could have sent a Dear Doctor Letter ("DDL") to warn Dr. Krumeich.
Resp. Br. at 7.
Id. at 11-16.
Pls.' Supplemental Mem. in Opp'n ("Opp'n Br."), E-File 62959377, at 6.
IV. STANDARD OF REVIEW
Summary judgment is appropriate only where there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. The moving party bears the initial burden of establishing that there is no genuine issue of material fact. The Court must view the record in the light most favorable to the non-moving party. Summary judgment shall not be granted when "it seems desirable to inquire more thoroughly into the facts in order to clarify the application of law to the circumstances." Negligence actions are not ordinarily disposed of on a motion for summary judgment. Unresolved issues of fact about the defendant's negligence, proximate cause, and the parties' respective degrees of negligence usually presents questions of fact for the jury, however, in rare cases summary judgment is appropriate.
Super. Ct. Civ. R. 56(c).
Moore v. Sizemore, 405 A.2d 679, 680-81 (Del. 1979).
Burkhart v. Davies, 602 A.2d 56, 59 (Del. 1991).
Mumford & Miller Concrete, Inc. v. New Castle County, 2007 WL 404771, at *1 (Del. Super. 2007).
Reid v. Hindt, 2005 WL 2143706, at *2 (Del. Super. 2005).
Id.
V. DISCUSSION
In order to recover for a negligence claim, the plaintiff "must allege that defendant owed plaintiff a duty of care; defendant breached that duty; and defendant's breach was the proximate cause of plaintiff's injury."
New Haverford P'ship v. Stroot, 772 A.2d 792, 798 (Del. 2001).
Duty
Teva's duty to warn the Decedent is defined by the LID, which was adopted by the Supreme Court of Delaware in Lacy v. G.D. Searle. The LID "provides an exception to the general rule that the manufacturer of a drug owes a duty to warn the consumer directly concerning the risks associated with the drug." However, under the LID, "a manufacturer of a prescription drug satisfies its duty to provide an appropriate warning about the drug when it gives the patient's physician the necessary information to be disseminated to the patient." The Delaware Supreme Court in Lacy cited the Washington Supreme Court's rationale for the LID in Terhune v. A.H. Robins Co.:
567 A.2d 398 (Del. 1989). The Court in Lacy found that the application of the LID was an "issue of first impression in Delaware" and held that the doctrine applied to failure to warn claims involving a prescription drug manufacturer's duty to warn. See id. at 399-400.
Id. at 399.
Id. (emphasis added).
577 P.2d 975 (Wash. 1978).
Where a product is available only on prescription or through the services of a physician, the physician acts as a 'learned intermediary' between the manufacturer or seller
and patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance on that judgement . . . . Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interests of the patient.
Lacy, 567 A.2d at 400 (quoting Terhune, 577 P.2d at 978).
Dr. Krumeich was the Decedent's prescribing physician and Teva's generic azithromycin is a prescription drug. Thus, in general Teva would satisfy its duty to warn about the known risks of its generic azithromycin by warning Dr. Krumeich, not the Decedent.
However, the Court need not determine whether Teva's failure to update its package insert violated its duty to warn. For the reasons discussed below, the Plaintiffs cannot establish that Teva's alleged out-of-date warnings were the proximate cause of the Decedent's death. Without being able to establish proximate cause, the Plaintiffs cannot establish a prima facie case against Teva and judgment must be entered in favor of Teva as a matter of law.
Proximate Cause
To establish proximate cause, a plaintiff must show that the defendant's negligent act or omission was the cause of the injury where the "[injury] would not have occurred but for" the negligent act or omission. Conversely, the defendant's negligent act or omission "is not a cause of the [injury], if the [injury] would have occurred without it." Dr. Krumeich's failure to review the package insert prevents the Plaintiffs from establishing that the warnings in Teva's package insert proximately caused the Decedent's death.
Culver v. Bennett, 588 A.2d 1094, 1097 (Del. 1991) (emphasis added).
Id. (emphasis added).
Since the LID requires a prescription drug manufacturer to warn only the prescribing physician, the "but for" test under the LID is whether additional information would have made a difference to the prescribing physician in a way that could have prevented injury to the plaintiff. Based on the undisputed facts of this case, no additional information contained in the package insert would have made a difference to Dr. Krumeich in a way that could have prevented the Decedent's death. This is because Dr. Krumeich never reviewed the package insert. He never would have seen such information. Thus, Plaintiffs cannot show that Teva's alleged failure to update its package insert was the proximate cause of the Decedent's death.
See Barba v. Boston Sci. Corp., 2015 WL 6336151, at *6 (Del. Super. 2015) (holding an issue of fact regarding proximate cause existed under the LID because a reasonable jury could find that additional information would have altered the doctor's decision to perform the injuring procedure in a way that could have prevented injury to the plaintiff); see also Bock v. Novartis Pharm. Corp., 661 Fed.Appx. 227, 232 (3rd Cir. 2016) (holding "[p]roximate causation may be shown in learned intermediary cases through evidence that, if properly warned, the doctor either would have declined to prescribe a particular drug or would have detailed the known risks to the patient, who would then have declined the medication.").
Despite Dr. Krumeich's failure to review the package insert, the Plaintiffs claim there is a question of fact on the issue of proximate cause. Plaintiffs argue that Teva "cannot hide behind their failure to update its azithromycin package insert by stating Dr. Krumeich never saw it." The Plaintiffs cite to Dr. Krumeich's testimony that if he saw the additional warnings or information in the update, he would have changed his prescribing habits. The Plaintiffs argue that the Court's decision in Barba v. Carlson requires the Court to consider Dr. Krumeich's testimony as evidence of proximate cause despite his failure to review the package insert.
Resp. Br. at 3.
See id. at 9.
2014 WL 1678246 (Del. Super. 2014).
In Barba, a pelvic mesh device implanted in the plaintiff caused various health complications. The plaintiff sued the device manufacturer and asserted several claims. One of the plaintiff's claims was that the manufacturer failed to warn the doctor about the known risks associated with the device. The manufacturer provided the plaintiff's doctor, who had implanted the device, with directions-for-use, training courses, and other educational opportunities. The doctor testified that, while he relied on training courses and video procedures provided by the manufacturer, he failed to review the directions-for-use. The manufacturer moved for summary judgment. In response to the plaintiff's failure to warn claim and in support of its motion for summary judgment, the manufacturer argued: (1) the LID barred the plaintiff's failure to warn claim; and (2) even if the claim was not barred, the plaintiff could not show that the manufacturer's alleged failure to warn proximately caused her injury because the doctor never relied on the warnings in the directions-for-use.
Barba, 2014 WL 1678246, at *1.
Id.
Id.
Id.
Id. at *3.
Id. at *2.
With regard to the first argument, the Court in Barba found that the LID could not bar a failure to warn claim when there is a genuine issue of material fact about the adequacy of the warning. The Court concluded that the plaintiff demonstrated a genuine issue of material fact regarding the adequacy of the warning and moved on to the issue of proximate cause.
Id. at *3.
Id.
The Court found that the doctor's failure to review the directions-for-use did not end the proximate cause analysis. Instead, the proximate cause analysis continued because the doctor relied on "extensive information" from other sources provided by the manufacturer (training courses and video procedures). The Court concluded that the doctors reliance on other sources from the manufacturer kept alive the inquiry into whether additional information would have made a difference to the doctor.
See id. at *4 ("The inquiry in this case does not automatically end simply because the learned intermediary states that he never read certain warnings.") (emphasis added).
Id.
Id.
This case is distinguishable from Barba. Unlike the doctor in Barba who reviewed other sources of information provided by the manufacturer, Dr. Krumeich failed to review the only source of information provided by Teva (the package insert). Dr. Krumeich's testimony concerning what he would have done had he seen the package insert update does not change the undisputed fact that he never reviewed the package insert and never would have seen the update. Dr. Krumeich's failure to review the package insert breaks the causal chain between Teva's alleged failure to update and the Decedent's death.
The Court notes that Dr. Krumeich testified he did not recall hearing about the FDA Communication, which would have put him on notice that the warnings were being updated. Reply Br. Aff., Ex. 1, at 58:1-13.
Plaintiffs' Arguments Against Application of the LID
The Plaintiffs make two arguments against the application of the LID. First, Plaintiffs argue that an over-promotion of the azithromycin drug precludes the use of the LID. Plaintiffs contend that mere compliance with warning regulations is not enough because an adequate warning may be "eroded or even nullified by over promotion of the drug through a vigorous sales program, or . . . where a doctor may come to rely on information previously provided to them at the time of their training or during a lunch and learn session." The Court finds this argument unpersuasive because Dr. Krumeich testified he did not recall ever interacting with Teva's representatives.
Resp. Br. at 11.
Id. at 12.
Second, Plaintiffs assert that the LID does not apply in this case because the Decedent was a medical professional. The Plaintiffs argue that "[t]he policy behind the learned intermediary doctrine is to discharge a manufacturer of prescription medications of its duty to warn under the belief and assumption that it is properly informed healthcare providers who are in the best position to advise their lay patients." The Plaintiffs maintain that because the Decedent was a medical professional, he was not a lay patient and the LID does not apply to him. However, Plaintiffs do not cite any authority to support this argument. The Court finds Plaintiffs' unsupported argument without merit.
Id. at 14. The Plaintiffs state that at the time of his death, the Decedent, "who already had a bachelor's degree in nursing, and had previously worked as a nurse in The Hospital of Central Connecticut, was pursuing a doctorate degree in nursing with the goal of becoming a family nurse practitioner." Id. at 15.
Id. (emphasis added).
Plaintiffs' Argument that Teva Should Have Sent a Dear Doctor Letter
During the MSJ Hearing, Plaintiffs' counsel argued for the first time the theory that Teva could have, and perhaps, were obligated to issue a Dear Doctor Letter ("DDL") to all physicians about the increased warnings for azithromycin products. Prior to asserting this theory, Plaintiffs only argued their failure to warn claim exclusively under the failure to update theory previously discussed in this opinion. There is no mention of a DDL in the Plaintiffs' Complaint. The Court will not consider Plaintiffs' DDL theory because it was not adequately pled in their Complaint.
Hearing Tr., at 26:7-11.
See generally Compl.
See Wilson v. Urquhart, 2010 WL 2683031, at *1 (Del. Super. 2010) (finding that the "Court cannot reach the merits of Plaintiffs' premises liability arguments, because the Second Amended Complaint in this case has not properly pled claims for premises liability . . . .").
The Plaintiffs contend that the DDL theory was adequately pled because: (1) the Complaint contains repeated references to a defective and inadequate label; and (2) the Complaint is "replete with allegations of failures to warn and disseminate evidence of danger by other means with additional materials . . . ."
Pls.' Supplemental Mem. in Opp'n ("Opp'n Br."), E-File 62959377, at 4.
Pursuant to Superior Court Civil Rule 9(b), allegations of negligence shall be stated with particularity. The purpose of Rule 9(b) is to "ensure that the defendant is notified of the 'acts or omissions by which it is alleged that a duty has been violated in order to enable the preparation of a defense.'"
Super. Ct. Civ. R. 9(b).
Doe 30's Mother v. Bradley, 58 A.3d 429, 443 (Del. 2012) (quoting State Farm Fire & Cas., Co. v. Gen. Elec. Co., 2009 WL 5177156, at *5 (Del. Super. 2009)).
While the Complaint states particular allegations for the failure to update theory, it states only conclusory allegations for other ways in which Teva failed in its duty to warn. Conclusory allegations do not satisfy the particularity requirement of Rule 9(b). Plaintiffs cannot overcome Teva's "Motion for Summary Judgment on the Issue of Proximate Cause" with their belated DDL theory because they failed to plead the DDL theory with particularity.
See, e.g., Compl. ¶ 41 ("Defendant Teva Pharmaceuticals should have adopted, as the package inserts for their own generic azithromcycin products, the verbatim content of the package insert for Zithromax . . . .").
See id. ¶ 64 ("Defendants knew, or in the exercise of reasonable care should have known, that the Drugs were . . . not properly . . . labeled . . . and/or provided with proper warnings . . . ."); id. ¶ 63 ("Defendants did not timely apprise the FDA, the . . . public, nor treating physicians of the defects . . . ."); id. ¶ 72 ("In prescribing either Zithromax and/or azithromycin for [the Decedent] as they did, [the Decedent's] physician foreseeably and reasonably relied upon the information . . . otherwise disseminated by the Defendants . . . ."); id. ¶ 52 ("As a result of Defendants' actions, Decedent and Decedent's physicians were unaware, and could not have reasonably known . . . that Decedent would be exposed to the risks identified in this Complaint."); id. ¶ 48 ("a physician's reliance on the information concerning the properties and effects of a drug or name brand prescription drug product as contained . . . in any other materials disseminated . . . is foreseeable and reasonable . . . ."); id. ¶ 85 ("Zithromax and/or azithromycin products materially failed to conform to those representations made by Defendants in package inserts, and otherwise, concerning the properties and effects of Zithromax and/or azithromycin products . . . ."). The Court notes that these paragraphs are the paragraphs the Plaintiffs cite in support of their argument that the DDL theory was pled.
See Mooney v. Pioneer Nat. Res. Co., 2017 WL 4857133, at *8 (Del. Super. 2017) (finding conclusory allegations did not satisfy Civil Rule 9(b) and identifiable facts must be alleged to satisfy the pleading requirement).
Even assuming arguendo the DDL theory was properly pled, it is pre-empted by federal law. As the Court noted in its decision denying Teva's Motion for Judgment on the Pleadings, federal law preempts a state law failure to warn claim when the claim requires a party to act in violation of a federal law. Under federal law, generic drug manufacturers may not unilaterally send a DDL. The United States Supreme Court in PLIVA, Inc. v. Mensing, held that "if generic drug manufacturers, but not the brand-name manufacturer, sent [DDLs], that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly 'misleading.'" Thus, Teva could not unilaterally send a DDL and Plaintiffs' failure to warn claim under the DDL theory is preempted. The Plaintiffs contend that a claim under the DDL theory is not pre-empted because Teva could have unilaterally sent a DDL that contained the same information as Zithromax's updated labeling. In support of their contention, the Plaintiffs cite the California Court of Appeal's decision in Teva Pharmaceuticals USA, Inc. v. Superior Court which states:
See Boros v. Pfizer, Inc., 2016 WL 3131403, at *3 (Del. Super. 2016) ("Even in the absence of an express pre-emption provision, a state law may be pre-empted 'where it is impossible for a private party to comply with both state and federal requirements.'") (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 617 (2011)).
Id. at 615.
See Opp'n Br. at 8-9.
158 Cal.Rptr.3d 150 (Cal. Ct. App. 2013).
Mensing does not preempt a claim that a generic drug manufacturer failed to send a Dear Doctor letter containing the same information that is on the RLD's approved label.However, this holding runs contrary to the opinions of several federal circuit courts that have interpreted Mensing to prohibit any unilateral DDL, irrespective of the information it contains. Given this, the Court declines to adopt the holding in Teva Pharmaceuticals USA, Inc. v. Superior Court and rejects Plaintiffs' argument on this point.
Id. at 163.
See Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) ("Under federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not whether the proposed warning to be disseminated contains substantially similar information as the label. Because no brand-name manufacturers sent a warning . . . the generic manufacturers were not at liberty to do so.") (emphasis added); In re Darvocet, 756 F.3d 917, 932-33 (6th Cir. 2014) ("In Mensing, the Supreme Court held that generic manufacturers cannot send 'Dear Doctor' Letters unless their brand counterparts do so first . . . ."); Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir. 2013) ("Yet '[b]ecause the duty of sameness prohibits the generic manufacturers from taking such actions unilaterally, they are dependent on brand-names taking the lead.'") (citing Morris, 713 F.3d at 777). --------
VI. CONCLUSION
Viewing the facts in the light most favorable to Plaintiffs, the Court finds Plaintiffs' cannot meet their burden to establish Teva's alleged failure to warn proximately caused the Decedent's death. For the foregoing reasons, Teva's "Motion for Summary Judgment on the Issue of Proximate Cause" is GRANTED.
IT IS SO ORDERED.
/s/_________
Jan R. Jurden, President Judge cc: Prothonotary