Niedner v. Ortho-McNeil Pharm., Inc.

• Court: Appeals Court of Massachusetts
• Writing for the Court: BLAKE, J.
• Citation: Niedner v. Ortho-McNeil Pharm., Inc., 90 Mass. App. Ct. 306, 58 N.E.3d 1080 (Mass. App. 2016)
• Decision Date: 21 September 2016
• Docket Number: No. 15–P–1272.,15–P–1272.
• Parties: Leslie NIEDNER, administratrix, v. ORTHO–McNEIL PHARMACEUTICAL, INC., & others.

90 Mass.App.Ct. 306

58 N.E.3d 1080

Leslie NIEDNER, administratrix,¹

v.ORTHO–McNEIL PHARMACEUTICAL, INC., & others.²

No. 15–P–1272.

Appeals Court of Massachusetts, Suffolk.

Argued May 5, 2016.

Decided Sept. 21, 2016.

Roopal P. Luhana, of New York, for the plaintiff.

Susan M. Sharko, of New Jersey, for Ortho–McNeil Pharmaceutical, Inc., and others.

Present: CYPHER, BLAKE, & HENRY, JJ.

BLAKE, J.

Adrianna Duffy was a seventeen year old college student when she collapsed in her dormitory room and died of a pulmonary embolism. Duffy's mother, Leslie Niedner, as administratrix of Duffy's estate, filed a complaint against the defendants, Ortho–McNeil Pharmaceutical, Inc.; Johnson & Johnson; and Johnson & Johnson Pharmaceutical Research and Development, LLC (collectively, J & J), alleging multiple causes of action relating to J & J's birth control product, Ortho Evra.³ Following a hearing on J & J's motion for summary judgment, a judge of the Superior Court allowed the motion and ordered the dismissal of the complaint in its entirety. We affirm.

Background. The following undisputed facts are taken from the summary judgment record. Sara M. Nelson of the Massachusetts General Hospital Chelsea Healthcare Clinic was Duffy's pediatrician from about October of 2004, until her death in 2009. In July, 2008, Duffy, accompanied by Niedner, met with Nelson to discuss birth control options. Nelson recommended and prescribed an oral birth control pill. The prescription was filled in July, August, and September of 2008. Duffy also used condoms when she was sexually active. At some point thereafter, Duffy discontinued her use of oral birth control pills.

In June, 2009, Duffy decided that she needed a backup birth control method, again, in addition to condoms. She and Niedner met with Nelson on June 23, 2009, to discuss Duffy's options. Duffy asked Nelson about the Ortho Evra patch (patch), as she wanted an easy and simple method of birth control. The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.

Nelson prescribed the patch for Duffy at that meeting. As she had when she prescribed oral birth control pills, Nelson informed Duffy and Niedner of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots.⁴ When the prescription was filled by Walgreens pharmacy (pharmacy), the package included an insert prepared by J & J (the manufacturer), as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots. Approximately three months after Duffy began using the patch, she died from a massive bilateral pulmonary embolus.

On October 29, 2010, Niedner filed her first amended complaint alleging that Duffy's use of the patch had caused her death, and that J & J was liable for breach of warranty (under theories of design defect, failure to warn, and manufacturing defect), breach of express warranty, negligence, fraudulent concealment, conscious pain and suffering, and violating the consumer protection act, G.L. c. 93A.⁵ The complaint centers on Niedner's failure to warn claim, which is based on her allegation that she and Duffy were not told that the risk of suffering a blood clot is significantly increased with use of the patch as compared to an oral contraceptive. Put another way, Niedner's complaint is focused on the comparative risk of developing blood clots, not the risk of developing blood clots in and of itself. J & J moved for summary judgment, arguing that the risks of using the patch, including the increased risk of blood clots, were adequately disclosed, and that Niedner's remaining causes of action fail as a matter of law for lack of evidence. The judge agreed and allowed the motion. After judgment entered, this appeal followed. Additional facts will be set forth as necessary.

Discussion. 1. Standard of review. “We review a grant of summary judgment de novo to determine ‘whether, viewing the evidence in the light most favorable to the nonmoving party, all material facts have been established and the moving party is entitled to a judgment as a matter of law.’ ” Juliano v. Simpson, 461 Mass. 527, 529–530, 962 N.E.2d 175 (2012), quoting from Augat, Inc. v. Liberty Mut. Ins. Co., 410 Mass. 117, 120, 571 N.E.2d 357 (1991). See Mass.R.Civ.P. 56(c), as amended, 436 Mass. 1404 (2002). “The moving party bears the burden of affirmatively demonstrating the absence of a triable issue.” Lev v. Beverly Enterprises–Mass., Inc., 457 Mass. 234, 237, 929 N.E.2d 303 (2010). “Conclusory statements, general denials, and factual allegations not based on personal knowledge [are] insufficient to avoid summary judgment.” Madsen v. Erwin, 395 Mass. 715, 721, 481 N.E.2d 1160 (1985), quoting from Olympic Jr., Inc. v. David Crystal, Inc., 463 F.2d 1141, 1146 (3d Cir.1972).

2. Duty to warn. Ordinarily, a manufacturer of a product with known dangers has a duty to warn consumers who will foreseeably come in contact with, and be endangered by, the product of those dangers. H.P. Hood & Sons v. Ford Motor Co., 370 Mass. 69, 75, 345 N.E.2d 683 (1976). When communication with a consumer is unreasonable, however, the “manufacturer may be absolved from blame because of a justified reliance upon ... a middleman.” MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 135, 475 N.E.2d 65 (1985), quoting from Carter v. Yardley & Co., 319 Mass. 92, 99, 64 N.E.2d 693 (1946). Under this “learned intermediary rule,” a drug manufacturer's duty to warn is generally discharged by providing physicians with an adequate warning about any risks associated with its prescription drug products. Id. at 136, 475 N.E.2d 65 quoting from McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 386–387, 528 P.2d 522 (1974) (“the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, [although] the manufacturer is directly liable to the patient for a breach of such duty”). “The rationale underlying the prescription drug rule is that the prescribing physician, as the ‘learned intermediary’ standing between the manufacturer and consumer/patient, is generally in the best position to evaluate the potential risks and benefits of ingesting a certain drug and to advise the patient accordingly.” Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir.1992) (applying Massachusetts law).

In MacDonald, the Supreme Judicial Court created a narrow exception to the learned intermediary rule, holding that a manufacturer of oral contraceptives was “not justified in relying on warnings to the medical profession to satisfy its common law duty to warn,” but also had a duty to directly warn the consumer about the risks of taking birth control. Id. at 138, 475 N.E.2d 65. The court noted several factors that set birth control pills apart from other prescription drugs, such as “the heightened participation of patients in decisions relating to use of ‘the pill’; ... the limited participation of the physician,” and that less medical supervision is provided as compared with other prescription drugs. Ibid. The court also found significant that Federal regulations require that manufacturers of oral contraceptives warn consumers directly of their risks. Ibid. Because the patch is a hormonal birth control product, like the birth control pills at issue in MacDonald, the court's holding in that case controls here. Accordingly, J & J had a duty to directly warn Duffy of the risks associated with use of the patch.

3. Adequacy of the warning. The box containing the patches purchased by Duffy contained an insert entitled “DETAILED PATIENT LABELING.” The insert explains how to use the patch and the risks associated with its use, and informs consumers that they should consult their physician to discuss the information contained in the insert. Both Duffy and Niedner read the insert for the patches Duffy purchased. Neither Duffy, nor Niedner, consulted Nelson concerning the patch after she prescribed it. The relevant portions of the insert, as reviewed by Duffy and Niedner, are as follows:

“DESCRIPTION

“The contraceptive patch ORTHO EVRA ® is a thin, beige, plastic patch that sticks to the skin. The sticky part of the patch contains the following hormones: norelgestromin (progestin) and ethinyl estradiol (estrogen). These hormones are absorbed continuously through the skin and into the bloodstream. On average, the amount of estrogen delivered through the skin produces estrogen exposure that is higher than the exposure when taking a birth control pill containing 35 micrograms of estrogen ” (emphasis supplied)....

“INTRODUCTION

“Any woman who considers using the contraceptive patch ORTHO EVRA ® should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any serious side effects. It will tell you how to use the contraceptive patch properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health care professional. You should discuss the information provided in this leaflet with him or her, both when you first start using the contraceptive patch ORTHO EVRA ® and during your revisits....

“OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA ®

“Hormones from ORTHO EVRA ® get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA ® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the

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