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From Products Liability Law Daily, January 31, 2017

Failed contraceptive implant did not give rise to claim under Maine’s Wrongful Birth statute

By Jeffrey H. Brochin, J.D.

The birth of a healthy child was not a legally recognized injury under Maine’s Wrongful Birth statute, and, therefore, the mother could not claim damages against the United States which operated her health care center, nor against the contraceptive device manufacturer when the device applicator failed, the Maine Supreme Judicial Court ruled. The "sterilization procedure" exception to the statute did not apply to the failed implant procedure because contraception was not the permanent sterilization procedure intended by the legislature (Doherty v. Merck & Co., Inc., January 26, 2017, per curiam).

In February 2012, the patient underwent a procedure at a community health center for the implant of a drug-eluting contraceptive rod under her skin with the intention of obtaining protection against pregnancy. In October 2013, a test at the health care center revealed that she was pregnant, and an examination and subsequent ultrasound failed to locate the rod in either of her arms. A nurse later told the patient that the physician believed that the rod was never inserted, and the patient later alleged that the rod applicator had a history of failed insertion attempts when the rod would become stuck in the applicator. In June, 2014 she gave birth to health child following a long and painful delivery. In connection with her pregnancy, the patient suffered nausea, mental and physical pain and suffering, insomnia, swelling, and weight gain. She also incurred expenses and she lost wages as a result of missing work for medical appointments.

Following the birth of her child she received mental health counseling and suffered emotional distress as a result of being unprepared to raise a child as a single mother. She filed suit against the device manufacturer as well as against the United States which operated the health care center. Her complaint asked the federal court to declare Maine’s Wrongful Birth statute unconstitutional, and the United States and the device manufacturer moved to dismiss her complaint. The federal court denied the motions pending the answers to three questions it certified to the Maine Supreme Judicial Court, the first of which queried whether the statute’s protections extended to the device manufacturer. The state high court held that it did, and that the statute’s ‘failed sterilization procedure’ exception did not apply to the case. Accordingly, the patient could not recover any damages on her claims against either the device manufacturer or the United States.

Wrongful birth versus wrongful life. The statute recited as the intent of the legislature that the birth of a normal, healthy child does not constitute a legally recognizable injury and that it is contrary to public policy to award damages for the birth or rearing of a healthy child. The statute further provided that no person may maintain a claim for relief or receive an award for damages based on the claim that the birth and rearing of a healthy child resulted in damages. However, the statute provided an exception for cases based on a failed sterilization procedure resulting in the birth of a healthy child, in which case a person may receive an award of damages for the hospital and medical expenses incurred for the sterilization procedures and pregnancy, the pain and suffering connected with the pregnancy, and the loss of earnings by the mother during pregnancy.

An unambiguous bar. The court noted that the statute was not at all ambiguous in that it barred a specific legal claim regardless of against whom the claim was brought. The patient’s claim against the device manufacturer was precisely the claim barred by the statute’s clear language. Furthermore, her contention that the statutory bar applied to the physician who treated her, but not to the manufacturer, disregarded the statute’s declaration that the birth of a healthy child is not a legally recognizable injury ab initio; therefore, it was not actionable against any defendant. The only exception would exist under the "failed sterilization procedure" exception.

Contraception not a sterilization procedure. The term, "sterilization procedure," was not defined in the statute. However, the patient argued that the exception should apply in her case because the implantable, long-term drug was synonymous with sterilization, and, therefore, the statute should have been interpreted to apply to any long-lasting effortto render a woman infertile. The court disagreed and concluded that the legislature intended "sterilization procedure" to include medical or surgical procedures that alter the body’s anatomy for the purpose of permanently ending the possibility of procreation. The term did not include temporary pharmaceutical intervention in the reproductive process such as the implant the patient sought, nor did it include physical intervention such as an IUD. Those were means of contraception designed to be reversible without permanently altering the body’s reproductive organs, and the legislature explicitly made an exception to the prohibition against recovering damages for the birth of a healthy child only for sterilization.

In sum, the court recognized the distinction between permanent sterilization and reversible contraception and concluded that the statute’s "failed sterilization procedure" exception was not applicable to the facts presented. Accordingly, the court ruled that the patient could not recover any damages on her claims against either the drug device manufacturer or the United States.

The case is No. 2017 ME 19.

Attorneys: Laura H. White (Bergen & Parkinson, LLC) for Kayla Doherty. Daniel J. Mitchell (Bernstein, Shur, Sawyer & Nelson, PA ) for Merck & Co., Inc. Thomas E. Delahanty II, U.S. Attorney's Office, for the United States. Janet T. Mills, Office of the Attorney General, for State of Maine.

Companies: Merck & Co., Inc.

MainStory: TopStory DefensesLiabilityNews MedicalDevicesNews DrugsNews MaineNews

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