Contraceptive Injection Mix-Up Leads to Unwanted Birth, $10 Million Verdict
By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services (2004-2013)
California Hospital Medical Center
Mihir Desai, Esq.
News: A patient requested a contraceptive shot from a Federally Qualified Health Center (FQHC) but mistakenly received a flu shot instead, resulting in the unwanted birth of a child with a congenital disorder. For three months, the FQHC failed to inform the patient staff administered the incorrect shot; by then, she was already pregnant.
The patient filed a malpractice suit, alleging the center negligently failed to follow the accepted standard of contraceptive care by administering the incorrect shot and subsequently failing to inform her of the mix-up on a timely basis. The court agreed, awarding the patient more than $10 million, including special damages related to the child’s neurological disorder despite the patient seeking the shot to avoid pregnancy rather than to specifically prevent giving birth to a child with birth defects.
Background: In 2011, a patient sought contraception from an FQHC. The patient and provider selected Depo-Provera, an injectable contraceptive administered every 11 to 13 weeks. The patient received regular Depo-Provera injections at the FQHC from December 2009 until July 2011. On Sept. 30, 2011, the patient visited the FQHC for a scheduled Depo-Provera injection, but a medical assistant mistakenly administered a flu vaccine instead. The FQHC did not inform the patient of its mistake until December 2011, when she sought an appointment for her next injection. At that time, the FQHC administered a pregnancy test, which was positive.
The patient’s child was born Aug. 2, 2012. Shortly after birth, the child developed clinical seizure activity and remained hospitalized until Aug. 12, 2012. Testing revealed perisylvian polymicrogyria (PMG), a congenital defect resulting in permanent disabilities, including severe speech and language difficulties, impairment in fine and gross motor skills, a decrease in self-help and adaptive abilities, recurrent seizures, and cognitive and academic impairment. There is no family history of similar disabilities or other congenital defects.
The patient filed a lawsuit against the United States (the proper defendant for an action against an FQHC), alleging a multitude of deviations from the applicable standard of care. The patient alleged the medical assistant failed to confirm why the patient was there, failed to document consent to the flu vaccine or a change in the orders, and failed to advise the patient of the side effects of a flu shot and/or the consequences of skipping a Depo-Provera injection. Thus, the patient did not know she was given the wrong injection, and the FQHC negligently failed to inform the patient she was given the incorrect shot for three months. Due to the FQHC’s negligence, the patient gave birth to a child who suffered from a neurological disorder.
Following a bench trial on liability, the court ruled the FQHC was negligent in providing care that ultimately led to the child’s birth with disabilities. Following a bench trial on damages, the court awarded the patient $10.04 million, consisting of $42,294.81 in past special damages for pregnancy-related expenses, $7.5 million for the child’s “future special damages for extraordinary medical, educational, and similar expenses attributable to her conditions,” and $2.5 million in general damages for mental anguish and emotional stress of the parents.
The United States appealed solely the extraordinary damages, contending it was inappropriate to extend liability to the effects of the child’s neurological disorder. The Washington Supreme Court affirmed the lower court’s decision, holding that as a matter of Washington law, damages for negligent reproductive healthcare may include extraordinary costs associated with raising a child with birth defects, even if the plaintiff did not seek contraception to prevent conceiving a child later born with birth defects. The court noted extraordinary damages are permissible as a matter of law, and the child’s congenital defect did not automatically sever the proximate causation from the government’s negligence to the damages.
What this means to you: There are two principal ramifications arising from this decision that relate to a healthcare provider’s failure to adhere to the accepted standard of contraceptive care. First, a patient’s reason for seeking reproductive healthcare does not limit the scope of a negligent provider’s liability as a matter of state law. More specifically, extraordinary damages associated with a child’s congenital defect may be recovered where the plaintiff did not seek care for the specific purpose of preventing the birth of a child with such defects. Legally, a congenital defect effectively may be deemed “foreseeable” in cases of negligent reproductive healthcare. A defect does not automatically sever the chain of causation as a matter of law. If any reproductive healthcare provider in Washington breaches their duty to follow the accepted standard of care, then damages proximately caused by the provider’s negligence may be recovered. Because of this decision, where negligent contraceptive care results in the birth of a child with a congenital defect, the provider may be liable for damages relating to the child’s condition. Furthermore, such liability does not require proof the child was at a known, heightened risk for developing congenital defects or that the patient sought contraception for the specific purpose of preventing the birth of a child with congenital defects.
As the lower court in this case ruled, the risk that any child could be born with a birth defect is neither highly extraordinary nor improbable. The rationale, in part, was supported by expert testimony, which indicated if a medical provider errs in the administration of contraception, an unintended pregnancy is a foreseeable consequence and that any pregnancy carries a 2% to 3% chance of birth defects. Providers should be aware that, subject to the specific facts of a case, a court may presume a reproductive healthcare provider could foresee any latent or unknown disease or defect, whether idiopathic, that is suffered by a patient’s unborn child in negligence cases. Additionally, in such cases, providers would be liable for all damages proximately caused by their negligence, including extraordinary damages stemming from a child’s birth defects.
Second, the terminology used and categorization of claims for negligent reproductive healthcare does not determine the scope of a provider’s duty or potential liability. Most states recognize at least some variant of medical malpractice claims for negligent reproductive care. Many courts adopted terminology dividing such claims into three mutually exclusive categories: “wrongful pregnancy” or “wrongful conception” as an action brought by the parents of a healthy, but unplanned, child against a physician who negligently performed a sterilization or abortion; “wrongful birth” as a claim brought by parents of a child born with birth defects; and “wrongful life” as a claim filed by the child suffering from such birth defects. However, the terminology is neither universally nor uniformly employed. For example, among jurisdictions that use the terminology of “wrongful pregnancy/birth/life,” the definitions of these terms vary considerably. In fact, some jurisdictions have rejected such terminology altogether. Jurisdictions following the latter approach simply refer to any claim for negligent reproductive care as “medical malpractice.” In Washington, this area of law was governed by three previous opinions, which individually or collectively did not establish a uniform terminology but nonetheless did not eschew the “wrongful pregnancy/birth/life” terminology. Regardless, the decision in this case is not confined to any one of these categories; rather, the decision broadly encompasses any case of negligent reproductive care, and extraordinary damages for costs associated with raising a child with birth defects are awardable whether the claims are brought by parents (e.g., wrongful pregnancy/birth) or children (e.g., wrongful life). Reproductive healthcare providers should be aware the scope of their liability for extraordinary damages will not be limited depending on which terminology is used or which claims are asserted against them; therefore, any negligent reproductive care is subject to such damages.
A third consideration in this case involves the negligent act. The medical assistant was either not properly trained in the basics of medication administration or was trained but was not evaluated for competency in following said training or demonstrated at-risk behavior in not following the training. The FQHC holds liability in all three scenarios. In this case, the immediate response that must be taken by the FQHC or any organization is to ensure no other patients who received care from this individual were harmed and ensure the employee was removed from duty until a thorough investigation was completed and remediation or termination followed. The event required immediate disclosure to the patient, federal and state regulatory agencies, and possibly any accreditation body involved with the FQHC. A delay in disclosure to the patient indicated the organization is not monitoring or supervising its employees’ performance or the processes and procedures that they provide.
- Decided Aug. 18, 2022, in the Supreme Court of the State of Washington, Case Number 100526-1.
There are two principal ramifications arising from this decision that relate to a healthcare provider’s failure to adhere to the accepted standard of contraceptive care. First, a patient’s reason for seeking reproductive healthcare does not limit the scope of a negligent provider’s liability as a matter of state law.
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