Bartlett v. Mut. Pharm. Co. Inc.

• Decision Date: 12 July 2010
• Docket Number: Civil No. 08-cv-358-JL
• Citation: 2010 DNH 112,731 F.Supp.2d 135
• Parties: Karen L. BARTLETT v. MUTUAL PHARMACEUTICAL COMPANY, INC.
• Court: U.S. District Court — District of New Hampshire

731 F.Supp.2d 135

2010 DNH 112

Karen L. BARTLETT

v.MUTUAL PHARMACEUTICAL COMPANY, INC.

Civil No. 08-cv-358-JL.

United States District Court,

D. New Hampshire.

July 12, 2010.

Bryan Ballew, Keith M. Jensen, Patrick J. O'Neal, Jensen Belew & Gonzalez PLLC, Fort Worth, TX, Christine M. Craig, Timothy P. Beaupre, Shaheen & Gordon, Dover, NH, for Karen L. Bartlett.

OPINION & ORDER

JOSEPH N. LAPLANTE, District Judge.

The question in this case is whether a manufacturer may be held liable for injuries caused by a prescription drug. Plaintiff Karen Bartlett, who took the generic drug Sulindac and suffered severe side effects, brought suit against the drug's manufacturer, Mutual Pharmaceutical Company, asserting state-law claims of strict products liability, negligence, and fraud. She alleges, in particular, that Sulindac is an unreasonably dangerous product and that Mutual should have strengthened the drug's safety warning in light of information reported in the medical literature. This court has jurisdiction under 28 U.S.C. § 1332(a)(1) (diversity), because Bartlett is a New Hampshire citizen and Mutual is located in Pennsylvania. Earlier in the case, this court denied Mutual's motion for judgment on the pleadings, see Fed.R.Civ.P. 12(c), rejecting the argument that Bartlett's claims were pre-empted by federal law. See Bartlett v. Mut. Pharm. Co., 659 F.Supp.2d 279 (D.N.H.2009).

Both parties have now moved for summary judgment. See Fed.R.Civ.P. 56. After hearing oral argument, this court grants each motion in part. To the extent that Bartlett's claims are based on Mutual's alleged failure to warn of safety risks, Mutual is entitled to summary judgment because Bartlett cannot prove that conduct caused her injuries. Her doctor, who is the person Mutual had a duty to warn, prescribed Sulindac without reading or relying upon its warning label. Thus, no matter what the label said, it would not have affected the doctor's decision to prescribe the drug or otherwise prevented Bartlett's injuries. But to the extent that her claims are based not on the alleged failure to warn, but on the theory that Sulindac is an unreasonably dangerous product, they present a genuine dispute of material fact that must be resolved at trial. Finally, Bartlett is entitled to summary judgment on some of Mutual's affirmative defenses.

I. Applicable legal standard

Summary judgment is appropriate where "the pleadings, the discoveryand disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c)(2). An issue is "genuine" if it could reasonably be resolved in either party's favor at trial, and "material" if it could sway the outcome under applicable law. Mulvihill v. Top-Flite Golf Co., 335 F.3d 15, 19 (1st Cir.2003). In making this determination, the "court must scrutinize the record in the light most flattering to the party opposing the motion, indulging all reasonable inferences in that party's favor." Id. On cross-motions for summary judgment, this standard is applied to each party's motion separately. See, e.g., Am. Home Assurance Co. v. AGM Marine Contractors, Inc., 467 F.3d 810, 812 (1st Cir.2006).

II. Background ¹

In December 2004, Bartlett sought medical treatment for pain in her right shoulder. Her doctor, Tahsin Ergin, prescribed a non-steroidal anti-inflammatory drug ("NSAID") called Clinoril. Bartlett took the prescription to a pharmacy in Plaistow, New Hampshire, which filled it with Sulindac, a generic version of the drug, manufactured by Mutual. Within weeks, she went to a local emergency room complaining of skin blisters, a fever, eye irritation, and other symptoms. She was soon diagnosed with Stevens-Johnson syndrome ("SJS") progressing to toxic epidermal necrolysis ("TEN"), a serious and potentially fatal condition characterized by necrosis of the skin and mucous membranes. See Dorland's Illustrated Medical Dictionary 1872 (31st ed.2007). She spent about three months in the hospital recovering, two of them in a medically induced coma, and emerged with permanent injuries, including blindness.

More than a year before these events, an international medical journal published a study of the link between NSAIDs and SJS/TEN. The study revealed that, from 1980 to 1997, Sulindac had 89 reported cases of SJS/TEN in the Food and Drug Administration's ("FDA") adverse event reporting system, more than any other NSAID on the market and all but four drugs of any kind. See Maja Mockenhaupt et al., The Risk of SJS and TEN Associated with NSAIDs: A Multinational Perspective, 30 Journal of Rheumatology 2234-2240 (Oct.2003). Mutual was not aware of that study, however, because it had not been monitoring the medical literature for information about Sulindac's safety risks. Mutual believed that the manufacturer of Clinoril, the brand-name version of the drug, was responsible for such monitoring.

At the time of Bartlett's prescription, Mutual's generic version of Sulindac had the same FDA-approved package insert, or warning label, as Clinoril. The label expressly listed SJS/TEN as potential adverse reactions in its "Adverse Reactions" section. In its "Warnings" section, however, the label did not mention SJS/TEN by name. Rather, it stated as follows:

Hypersensitivity

Rarely, fever and other evidence of hypersensitivity (see ADVERSE REACTIONS) including abnormalities in one or more liver function tests and severe skin reactions have occurred during therapy with sulindac. Fatalities have occurred in these patients. Hepatitis, jaundice, or both, with or without fever,may occur within the first one to three months of therapy. Determination of liver function should be considered whenever a patient on therapy with sulindac develops unexplained fever, rash or other dermatologic reactions or constitutional symptoms. If unexplained fever or other evidence of hypersensitivity occurs, therapy with sulindac should be discontinued.²

Dr. Ergin admitted at his deposition that he never reviewed Mutual's Sulindac label before treating Bartlett and that "nothing about it influenced [his] prescribing of the drug" or what he told Bartlett about it. When asked if he reviewed the identical Clinoril label before treating Bartlett, Dr. Ergin responded "not in detail, no." He then admitted that he never read the part of the Clinoril label that listed SJS/TEN as potential adverse reactions, nor the part that warned of "hypersensitivity" and "severe skin reactions" that have caused fatalities.

Even without reading the warning label, Dr. Ergin knew from his medical background that Sulindac and other NSAIDs carried some risk of causing SJS/TEN. But it was not his usual practice to discuss that risk with patients, and he did not do so with Bartlett. If, however, there had been "strong warnings in place" about "what may well be [a] higher risk of severe reactions like SJS and TEN with Sulindac," Dr. Ergin claims that he likely would have prescribed a different drug for Bartlett that carried less risk of SJS/TEN. He admitted, however, that he still prescribes Sulindac on rare occasions, even after learning of Bartlett's ordeal.

Bartlett brought this suit against Mutual in New Hampshire superior court in January 2008, asserting state-law claims of strict products liability based on failure to warn of safety risks (Count 1), strict products liability based on defective design (Count 2), fraud (Count 3), and negligence based on both failure to warn and defective design (Count 6).³ She alleges, in particular, that Sulindac's safety risks outweigh its medical benefits, making it an unreasonably dangerous product. She also alleges that Mutual should have strengthened Sulindac's safety warning in light of the study mentioned above and other reports in the medical literature about the connection between Sulindac and SJS/TEN.

After removing the case to this court, Mutual moved for judgment on the pleadings, arguing that all of Bartlett's claims were pre-empted by the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., and regulations issued thereunder. Specifically, Mutual argued that federal law prohibits a manufacturer from unilaterally strengthening the safety warning for a generic drug approved by the FDA, because the warning must remain identical to that of the brand-name drug. This court denied the motion, concluding that federal law allows such changes and thus does not pre-empt Bartlett's claims. See Bartlett, 659 F.Supp.2d at 279; accord Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir.2010); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir.2009), petition for cert. filed, 78 U.S.L.W. 3522 (U.S. Feb. 19, 2010) (No. 09-993).

As the case proceeded, the parties engaged in a series of discovery disputes. See, e.g., Bartlett v. Mut. Pharm. Co., 2009 DNH 166 (imposing sanctions against Mutual for the late production of certain FDA filings). With discovery now complete and trial scheduled for August 2010, Mutual has moved for summary judgment on all claims. See Fed.R.Civ.P. 56(b). Bartlett, in turn, has moved for partial summary judgment on various issues, some of which overlap with those raised by Mutual. See Fed.R.Civ.P. 56(a). This court will address each issue in turn, beginning with the key issues on which both parties seek summary judgment (i.e., the adequacy of Sulindac's safety warning and whether its alleged inadequacy caused Bartlett's injuries) and then turning to the other issues that they have raised separately.

III. Adequacy of the safety warning

The first issue, on which both parties seek summary judgment, is whether Mutual's Sulindac label adequately warned doctors of the risk of SJS/TEN. Bartlett has the burden of proving its inadequacy as an essential element of her claims for strict liability (Count 1) and negligence (Count 6) based on failure to warn. See, e.g., Brochu v. Ortho Pharm. Corp., 642 F.2d...