Also known as: medical standards · standard of care · medical standard of care
Written by attorneys — see sources below.
A benchmark of conduct measuring whether a person has grossly deviated from the standard of care a reasonable person would observe in the actor's situation.
Marcus Mitchell, a bus dispatcher, received a report that the driver had nearly fallen asleep after a double shift and that icy conditions were forecast. Mitchell directed the driver to proceed anyway to avoid overtime costs. When the bus later crashed and killed a passenger, the standard of care supplied the measure of whether Mitchell's decision constituted a gross deviation from reasonable care.
Miguel Mendoza, a surgeon, knew a patient faced a substantial risk of stroke if a particular diagnostic step was omitted yet failed to perceive the risk during the procedure. The patient suffered permanent harm. The standard of care determined whether Mendoza's failure to perceive the risk amounted to negligence under the Model Penal Code definition.
Mohan Malhotra, a seventeen-year-old apprentice mechanic, performed a high-speed test drive on a state highway to verify repairs. He caused a multi-car collision that injured another motorist. The modern trend that holds a minor performing an adult activity to the ordinary reasonable-person standard of care was applied.
Miranda Morales operated an abortion clinic in a state that imposed detailed requirements on facilities and physician qualifications. The state defended the rules as necessary to maintain medical standards and protect patient health. The court weighed those interests against the woman's privacy right when deciding whether the regulations could stand.
In March 1970, Jane Roe, a single woman residing in Dallas County, Texas, instituted a federal action against the District Attorney of the county. She sought a declaratory judgment that the Texas criminal abortion statutes were unconstitutional on their face. She also sought an injunction restraining enforcement of the statutes. Roe alleged that she was unmarried and pregnant. She wished to terminate her pregnancy by an abortion performed by a competent licensed physician under safe clinical conditions. She was unable to obtain a legal abortion in Texas because her life did not appear to be threatened by continuation of the pregnancy. She could not afford to travel to another jurisdiction to secure a legal abortion. James Hubert Hallford, a licensed physician, sought and was granted leave to intervene in Roe's action. In his complaint he alleged that he had been arrested previously for violations of the Texas abortion statutes. Two such prosecutions were pending against him in the Criminal District Court of Dallas County. He described conditions of patients who came to him seeking abortions. He claimed that for many cases he was unable to determine whether they fell within or outside the exception recognized by Article 1196 of the Texas Penal Code. John and Mary Doe, a married couple, filed a companion complaint also naming the District Attorney as defendant. The Does alleged that they were a childless couple. Mrs. Doe was suffering from a neural-chemical disorder. Her physician had advised her to avoid pregnancy until her condition materially improved. She had discontinued use of birth control pills pursuant to medical advice. If she should become pregnant she would want to terminate the pregnancy by an abortion performed by a competent licensed physician under safe clinical conditions. The two actions were consolidated and heard together by a duly convened three-judge district court for the Northern District of Texas. Upon the filing of affidavits, motions were made for dismissal and for summary judgment. The court held that Roe and members of her class and Dr. Hallford had standing to sue and presented justiciable controversies. The Does had failed to allege facts sufficient to state a present controversy and did not have standing. It concluded that the Texas criminal abortion statutes were void on their face. The court dismissed the Does' complaint while denying injunctive relief. The plaintiffs Roe and Doe and the intervenor Hallford appealed to the Supreme Court from that part of the District Court's judgment denying the injunction. The defendant District Attorney cross-appealed from the grant of declaratory relief. Both sides also took protective appeals to the United States Court of Appeals for the Fifth Circuit. That court ordered the appeals held in abeyance pending decision by the Supreme Court.
View caseMaurice Marshall's mother had taken DES during pregnancy, and he later developed cancer. Because the specific manufacturer could not be identified, the court applied market-share liability. The medical standard of care for prescribing and warning about the drug supplied the underlying duty that each manufacturer was alleged to have breached.
Judith Sindell and Maureen Rogers filed separate lawsuits in California against several pharmaceutical companies that manufactured diethylstilbestrol, commonly known as DES. The complaints stated that the plaintiffs' mothers had taken DES during pregnancy to prevent miscarriage, and that the plaintiffs later developed cancerous and precancerous conditions as a result. Sindell alleged exposure led to a malignant bladder tumor requiring surgery and ongoing adenosis necessitating frequent monitoring. Rogers' allegations were substantially similar. DES was first developed in 1938 and received FDA approval in 1941 for use in preventing miscarriages. Manufacturers produced the drug in multiple forms and strengths under many trade names, but all followed an identical formula set forth in the United States Pharmacopoeia. In 1971 the FDA ordered companies to stop marketing DES for miscarriage prevention after studies linked it to adenocarcinoma in the daughters of women who had used the drug. Hundreds of companies had manufactured DES between 1941 and 1971. Because of the long latency period between ingestion and the appearance of injuries, and because pharmacists often filled prescriptions with whatever brand was in stock, the plaintiffs could not determine which company had produced the particular DES their mothers received. The trial court sustained demurrers filed by the defendants, including Abbott Laboratories, Eli Lilly and Company, E.R. Squibb & Sons, the Upjohn Company, and Rexall Drug Company, on the basis that the plaintiffs had not identified the manufacturer of the injurious product. The actions were consolidated for appeal to the Supreme Court of California. Sindell sought compensatory damages of one million dollars and punitive damages of ten million dollars on her own behalf, along with class-wide equitable relief requiring the defendants to warn physicians and establish free clinics for screening. The complaints further alleged that the defendants had continued to market DES without adequate testing or warnings even after they knew or should have known of its carcinogenic properties.
View caseMelanie Morris received a pacemaker that allegedly failed because of a manufacturing defect. She sued under state tort law claiming the device did not meet the applicable medical standard. The manufacturer argued federal MDA requirements preempted the state claim because it would impose a different standard on the device.
In 1976, Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in response to concerns over defective devices such as the Dalkon Shield intrauterine contraceptive. The amendments established a regulatory framework classifying devices into three classes based on risk, with Class III devices like pacemakers requiring premarket approval unless they qualified for an exemption. In October 1982, Medtronic, Inc. notified the FDA that its Model 4011 pacemaker lead was substantially equivalent to pre-1976 devices, and the FDA cleared it for marketing under the §510(k) process. In 1982, Lora Lohr underwent surgery in Florida to receive a Medtronic pacemaker equipped with the Model 4011 lead. Five years later, on December 30, 1990, the device failed, allegedly causing a complete heart block that required emergency surgery; her physician attributed the failure to a defect in the lead. Lohr and her husband subsequently filed suit in Florida state court in 1993, asserting claims for negligent design, negligent manufacture, failure to warn, and strict liability based on an unreasonably dangerous product. Medtronic removed the action to the United States District Court for the Middle District of Florida. The district court initially denied Medtronic's motion for summary judgment but later dismissed the entire complaint after the Eleventh Circuit's decision in a related case, concluding that the claims were preempted by the MDA. On appeal, the Court of Appeals for the Eleventh Circuit affirmed in part and reversed in part, holding that the design defect claims were not preempted while the manufacturing and failure-to-warn claims were preempted by general federal regulations. The Lohrs and Medtronic both petitioned for certiorari, and the Supreme Court granted review to address the conflict among the circuits regarding the preemptive scope of the MDA's preemption provision. The case was argued on April 23, 1996, and decided on June 26, 1996.
View caseThe hospital must disclose the physician as a witness who will present expert opinion testimony. Disclosure is required whenever the testimony rests on specialized medical knowledge rather than day-to-day factual observations, even if the witness is an employee.
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The disclosure must identify the witness, state the specific medical subject matter of the expected testimony, and provide a summary of the facts and opinions the witness will offer. A bare reference to standard of care and causation is insufficient.
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Yes. Contention interrogatories that seek a party's application of law to fact are permitted. The court may manage timing but cannot sustain an objection based solely on the opinion or contention character of the response.
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Yes. Even non-retained treating physicians must be disclosed with both the subject matter of their expert evidence and a summary of the facts and opinions they will present.
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…are unpersuasive. As noted above, a State may properly assert important interests in safeguarding health, in maintaining medical standards, and in protecting potential life. At some point in pregnancy, these respective interests become sufficiently compelling to sustain regulation of the factors that govern the abortion…