Horne v. Novartis Pharmaceuticals Corp.

Decision Date25 March 2008
Docket NumberCivil Case No. 3:06cv368.
CourtU.S. District Court — Western District of North Carolina
PartiesHeather Michelle HORNE, Administratrix of the Estate of Zachary Clifton Home, Deceased, Plaintiff, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.

G. Rick Digiorgio, Leila Hirayama Watson, Cory, Watson, Crowder & Degaris, P.C., Birmingham, AL, Marcus E. Hayes, Sr., Thomas H. Ainsworth, III, Crumley & Associates, P.C., Charlotte, NC, for Plaintiff.

Peter George Pappas, Nexsen, Pruet, Adams, & Kleemeier, PLLC, Greensboro, NC, Russell Thomas Burke, Susan P. McWilliams, Nexsen, Pruet, Jacobs & Pollard, LLC, Columbia, SC, for Defendant.



THIS MATTER is before the Court on the Defendant's Motion to Dismiss [Doc. 10] and the Plaintiffs Objections [Doc. 27] to the Memorandum and Recommendation [Doc. 26] of Magistrate Judge Carl Horn, III, filed on January 8, 2007, 2007 WL 5030723.

Pursuant to 28 U.S.C. § 636(b) and the standing Orders of Designation of this Court, the Defendant's Motion to Dismiss [Doc. 10] was referred to the Magistrate Judge for disposition or for a recommendation of disposition, as may be appropriate. On January 8, 2007, the Magistrate Judge entered a Memorandum and Recommendation [Doc. 26], recommending that the Defendant's Motion to Dismiss [Doc. 10] be granted. The Plaintiff filed timely Objections [Doc. 27] to the Magistrate Judge's Recommendation [Doc. 26] on January 18, 2007, and the Defendant filed a Response [Doc. 28] to those Objections on February 5, 2007.

For the reasons set forth below, the Plaintiffs Objections [Doc. 27] to the Magistrate Judge's Recommendation [Doc. 26] are OVERRULED IN PART, and the Magistrate Judge's Recommendation [Doc. 26] is ADOPTED IN PART to the extent that the Magistrate Judge has recommended the dismissal of the Plaintiffs failure to warn and inadequate labeling claims on the basis of conflict preemption. However, to the extent that the Magistrate Judge recommended dismissal of the Plaintiffs claims which are not premised on a failure to warn or inadequate labeling on the basis of conflict preemption, the Magistrate Judge's Recommendation [Doc. 26] is REJECTED IN PART. The Court has independently reviewed the Plaintiffs remaining claims and, for the reasons stated herein, concludes that the Defendant's Motion to Dismiss [Doc. 10] should be GRANTED IN PART with respect to the Plaintiffs claims of negligent labeling, packaging, promotion, marketing, and advertising; her claim of failure to warn; her claim for wantonness; and her claim of fraud, misrepresentation and suppression. The Motion to Dismiss [Doc. 10] is DENIED IN PART with respect to the Plaintiffs negligence claim related to the design, manufacture, research and development, testing, processing, distribution, and sale of Lotensin HCT® and her claim of breach of implied warranty of merchantability.


Taking the allegations as set forth in the Plaintiffs Complaint as true, the following are the relevant facts for the purpose of the present motion. The Plaintiff1 is a long-time sufferer of hypertension. [Complaint, Doc. 1-3 at ¶ 7]. For years, her doctor treated her with Lotensin HCT®, which is manufactured by the Defendant. [Id. at ¶¶ 6,7]. Lotensin HCT® is a brand name used by the Defendant to market and distribute benazepril, which is an angiotensin-converting-enzyme inhibitor ("ACE inhibitor"). [Id. at ¶ 6]. The Plaintiff became pregnant in October 2003. [Id. at ¶ 7]. She continued to be prescribed and to use Lotensin HCT® until December 16, 2003, when she was seven weeks and four days pregnant. [Id. at ¶ 8]. At that point, Plaintiffs doctor changed her prescription to Aldomet (methyldopa). [Id. at ¶ 9], From that point forward, until she gave birth to her son Zachary on July 9, 2004, the Plaintiff took Aldomet to treat her hypertension. [Id.]. Zachary was born with several heart defects and unilateral kidney defects. [Id. at ¶ 11]. He died on July 28, 2004 at age nineteen days as a result of these heart and kidney defects. [Id. at ¶ 12].

The Plaintiff alleges that the Lotensin HCT® package insert "failed to give any warning to women of child bearing years or those in their first trimester of pregnancy to avoid using Lotensin HCT®," and that the Defendant "proactively stated that fetal injury does not appear to be associated with use of Lotensin HCT® during the first trimester of pregnancy." [Id. at ¶ 13].

The package insert in question is dated August 2003 and was specifically approved by the FDA for Lotensin HCT®. The package insert contains the following pregnancy categories and warnings and other information:


When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Lotensin HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.


* * *

Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, Lotensin HCT should be discontinued as soon as possible.

The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patient ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE-inhibitor exposure.

These adverse effects do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to ACE inhibitors only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should make every effort to discontinue the use of benazepril as soon as possible.

Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.

* * *

No teratogenic effects were seen when benazepril and hydrochlorothiazide were administered to pregnant rats at a dose ratio of 4:5. On a mg/kg basis, the doses used were up to 167 times the maximum recommended human dose. Similarly, no teratogenic effects were seen when benazepril and hydroclorothiazide were administered to pregnant mice at total doses up to 160 mg/kg/day, with benazepril:hydrochlorothiazide ratios of 15:1. When hydrocholorothiazide was orally administered without benazepril to pregnant mice and rats during their respective periods of major organogenesis, at doses up to 3000 and 1000 mg/kg/day respectively, there was no evidence of harm to the fetus. Similarly, no teratogenic effects of benazepril were seen in studies of pregnant rats, mice, and rabbits; on a mg/kg basis, the doses used in those studies were 300 times (in rats), 90 times (in mice), and more than 3 times (in rabbits) the maximum recommended human dose.

* * *


Pregnancy Categories C (first trimester) and D (second and third trimesters): See WARNINGS, Fetal/Neonatal Morbidity and Mortality.2

[Novartis Lotensin HCT® Package Insert, Doc. 11-2].

Plaintiff specifically alleges in her Complaint that on June 8, 2006, nearly two and a half years after the Plaintiff stopped taking Lotensin HCT® due to her pregnancy,3 the New England Journal of Medicine published the results of a study ("Cooper Study") in which investigators found that infants exposed to ACE inhibitors during the first trimester were found to be at a significant increased risk of birth defects, including malformations of the cardiovascular system. [Complaint, Doc. 1-3 at ¶ 15]. The Cooper Study prompted the FDA to issue a Public Health Advisory, which stated, in pertinent part, as follows:

While the results of this single study do not establish a causal relationship between exposure to the drugs early in pregnancy and birth defects, they are concerning. ACE inhibitors are already known to have risks to the developing infant when used in the last six months of pregnancy. The prescribing information for all ACE inhibitor drugs has long emphasized that women who become pregnant should be taken off ACE inhibitors as soon as possible to avoid exposure of the fetus in the second and third trimesters, which is known to cause fetal abnormalities, especially related to the kidneys and related structures. The findings from this new study ... confirm the importance of this recommendation.

* * *

At this time, based on this one observational study, the FDA does not plan to change the pregnancy categories for ACE inhibitors....

[FDA Public Health Advisory, Angiotensin-Converting Enzyme Inhibitor (ACE Inhibitor) Drugs and Pregnancy, dated June 7, 2006, Doc. 11-3].4

The Plaintiff filed this present action on July 27, 2006 in the General Court of Justice, Superior Court Division, for Mecklenburg County. [Complaint, Doc. 1-3]. The matter was removed to this Court in August 28, 2006. [Notice of Removal, Doc. 1]. In her Complaint, the Plaintiff alleges that "[d]espite knowledge of reported incidents of birth defects associated with first trimester use of ACE Inhibitor blood pressure medicines such...

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