Refused Care Coverage and Minor Refusal
Kimberly Wynkoop, OMIC Legal Counsel
Digest, Winter 2013
As the lead article addresses, there are situations where patients refuse care, their vision is adversely affected, and then they sue their ophthalmologist for failing to treat them. Rest assured that OMIC’s policy provides coverage for such allegations. OMIC promises to defend ophthalmologists and pay damages because of claims that result from injury to a patient because of a “professional services incident” arising from “direct patient treatment.” The policy defines direct patient treatment as the provision of health care services to a patient, including making diagnoses, providing medical or surgical treatment, prescribing or dispensing drugs or medical supplies or devices, rendering opinions to a patient, giving advice to a patient, or referring a patient to, or consulting about a patient with, another physician or health care provider. A professional services incident is any act, error, or omission, that is neither intended nor expected in the provision of, or the failure to provide, direct patient treatment. Coverage for omissions and failure to provide direct patient treatment is an important component of your professional liability coverage, as failure to treat can be the alleged breach of duty that triggers a negligence claim.
Minor refusal of care
Adult patients have the legal right to refuse recommended care as long as they have decision-making capacity. Minor patients, on the other hand, lacking the necessary experience, knowledge, and maturity, are generally considered incompetent to make their own decisions and are not granted the legal authority to consent to or refuse care. Legal decision-making authority is generally achieved only when an individual reaches the age of majority, 18 years of age (or after high school graduation if later) in all but four states. There are two traditional categories of exceptions to the age of majority requirement for consent: individual status and medical service. Minor patients whose status indicates that they function as adults are granted the right to consent to or refuse treatment. Such status exceptions, which vary by state, include marriage, being a parent of a child, active duty with the Armed Forces, and court ordered emancipation. Another status exception, recognized in California, is self-sufficiency: when a minor is 15 years of age or older, lives away from home, and manages his or her own financial affairs. Service exceptions occur when minors seek specific treatment for certain medical conditions, such as pregnancy, mental health problems, alcohol or drug dependency, or infectious diseases. The rationale for such exceptions is that minors will be more likely to seek treatment for sensitive health issues if they are not required to notify their parents.
Mature minor doctrine
While courts and legislators have struggled with the issue of when to permit minors to legally consent to medical treatment, they have had even more difficulty when the medical decision-making at issue is refused care. Cases often involving refused care have led to the development of the third exception to the majority requirement for consent, the “mature minor” doctrine. This doctrine recognizes that some minors are mature enough to evaluate treatment options and make their own decisions. Courts look at individual circumstances and factors including the minor’s age, behavior, education, competence, and knowledge. They must weigh the state’s rights and responsibilities to preserve the life of a minor and maintain the ethical integrity of the medical profession, the minor’s rights to autonomy and privacy (and, in some cases, religious freedom), and, if the parents’ wishes conflict with the child’s, the rights of the parents to make decisions for their children. The doctrine lacks clear principles for application, however, and varies from state to state (with many states having not addressed the issue yet and at least one state, Georgia, specifically refusing to apply the doctrine). For example, in Illinois, a mature minor can refuse medical treatment unless such refusal would threaten the child’s health or welfare, while Virginia (by legislation) permits a minor 14 years or older to refuse, with parental acquiescence, medical treatment even for a life-threatening disease. Not all state laws are clear on consent and refusal of care and physicians often have to make decisions before getting a court order or legal determination. Therefore, even if minors have the authority to consent to treatment, it is prudent, with the patient’s permission, to involve the parents in the discussion. Likewise, in cases where minors do not legally have decision-making authority (e.g., for most ophthalmic treatment), it is recommended that ophthalmologists obtain minor assent in addition to parental consent for or refusal of treatment. Insureds are encouraged to seek risk management advice on refusal of care through OMIC’s confidential risk management hotline at 800. 562.6642, option 4, or by email at riskmanagement@omic.com.
Liability and Coverage for Contaminated-Product Claims
Kimberly Wynkoop, OMIC Legal Counsel
Digest, Fall 2012
The plethora of meningitis cases due to contaminated steroid injections has put compounding pharmacies under the microscope. Physicians are also being scrutinized for their part in prescribing and administering the tainted drugs. This article will look at ophthalmologists’ potential liability and the coverage OMIC’s policy provides should an OMIC insured be sued for prescription or use of contaminated compounded products.
As of November 7, 2012, 28 lawsuits in states from Minnesota to Florida had been filed against the New England Compounding Center (“NECC”), the pharmacy that compounded the steroids in the meningitis cases. Not only have the NECC corporate entity and executives been named as defendants, plaintiffs looking for deeper pockets are suing the physicians and clinics who supplied and administered the tainted injections.
Ophthalmologists use compounding pharmacies for a variety of products, including bevacizumab, Brilliant Blue-G (BBG), triamcinolone acetonide, and 5 percent Betadine. Compounded Trypan Blue, BBG, and Avastin have all been implicated in outbreaks of endophthalmitis. While no cases of ophthalmic injury from NECC products have been reported, its compounded betamethasone suspension was recalled due to potential contamination.
If a physician is named in a contaminated-product lawsuit, potential liability will depend on whether the plaintiff alleges product liability or professional liability (“medical malpractice”) and whether the court finds those claims applicable to the physician. Most state’s product liability laws provide for strict liability, which means a defendant can be held responsible without proof of fault. With strict product liability, all people or entities in the distribution chain are potentially liable. However, under some state’s laws, product liability claims against health care providers are not permitted. Product liability claims can also be based on negligence. A finding of negligence requires that the defendant breached a duty owed to the plaintiff, which caused the plaintiff to suffer damages.
There are three types of product liability defects: manufacturing, design, and failure to warn. A manufacturing defect occurs when the product is different than its design due to the manufacturing process. This includes contamination of the product during compounding as occurred at NECC.
A design defect means that the actual intended design of the product makes it unreasonably dangerous. In drug cases this usually means unreasonably severe side effects.
Failure to warn defects, also called marketing defects, occur when a product has improper or insufficient labeling, instructions, safety warnings, or recommendations for use. These marketing omissions can occur at the manufacturer, pharmacist, or provider level and often require a finding of negligence. The prescribing provider and even ancillary staff who instruct the patient on proper use of a drug or device may be liable as “learned intermediaries” between a drug’s manufacturer (or compounder) and the patient.
Medical malpractice, unlike product liability, always requires a finding of negligence. In this case, the breach of duty applies to the provision of medical services to the patient, not the sale of products. Therefore, in order for the court to determine whether product liability or malpractice should apply to a claim, it may attempt to determine if the provider “sold” the product. One way the court could do so is to look at the medical bills. Separate prices for the service (e.g. an injection) and the product (e.g. a steroid) could indicate a sale, whereas a global service charge or non-itemized bill would suggest a service.
If the prescription or administration of the contaminated product is considered a service, the plaintiff must show that the provider was negligent. For instance, did the provider fail to investigate the safety of the product being prescribed? Did the physician not obtain proper informed consent by failing to discuss all of the risks that went along with the use of the product? If the plaintiff can prove the physician breached this duty of care and the patient was harmed, the physician will be liable.
OMIC does not exclude coverage for an ophthalmologist’s prescription or use of compounded drugs or devices. OMIC respects the provider’s prerogative to select the most appropriate drug or device for a particular procedure or treatment for an individual patient even if it is off-label, unapproved, or compounded. OMIC’s policy covers insureds for allegations of medical malpractice based on an ophthalmologist’s direct patient treatment. This includes the prescribing or dispensing of medical supplies, devices, and drugs, including compounded products. However, OMIC’s policy does not cover product liability claims; it expressly excludes claims based on the designing, producing, manufacturing, assembling, distributing, marketing, or selling of any medical device or other product, including the failure to provide warnings or instructions with the product. If ophthalmologists will be reselling or otherwise participating in the distribution of products beyond direct patient treatment, they should secure separate coverage for product liability on a stand-alone basis or as part of a general liability package.
Sources:
American Academy of Ophthalmology, “Deadly Meningitis Outbreak Prompts Lawmakers to Consider Tighter Regulations on Compounding Pharmacies,” Member Alert, November 19, 2012.
Nick Brown, “Meningitis Lawsuits: Product Liability or Medical Malpractice?” The Insurance Journal, October 24, 2012.
Han W. Choi & Jae Hong Lee, “Pharmaceutical Product Liability,” Chapter 55, http://mofo.com.
Sarah Sellers and Wulf H. Utian, “Pharmacy Compounding Primer for Physicians: Prescriber Beware,” Drugs 2012: 72 (16): 2043-2050.
“Compounding Pharmacies – What Every Retina Specialist Needs to Know,” American Society of Retina Specialists Website.
“Overview of Medical Product and Drug Product Liability Cases,” Attorneys.com, http://www.attorneys.com/products-liability/overview-of-medical-product-and-drug-product-liability-cases/ (accessed November 8, 2012).
“Pharmaceutical Drug Liability,” Findlaw, http://injury.findlaw.com/product-liability/pharmaceutical-drug-liability.html (accessed November 8, 2012).
“Product Liability Claims Involving Pharmaceutical Drugs,” Nolo Law For All, http://www.nolo.com/legal-encyclopedia/product-liability-claims-pharmaceutical-drugs-30314.html (accessed November 8, 2012).
“Products Liability and Prescription Drugs,” Louisiana Insurance Litigation Blog, Thornhill Law Firm, October 31, 2008, http://www.louisianainsurancelitigation.com/2008/10/products_liability_and_prescri.html.
Injection of Anecortave Acetate into Globe during ARMD Risk Reduction Trial
Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Fall 2012
Allegation
Negligent administration of Anecortave Acetate into globe.
Disposition
Drug manufacturer indemnified OMIC insured and settled claim for $500,000.
Case Summary
A 75-year-old female was diagnosed with wet macular degeneration and treated with photodynamic therapy and intravitreal Kenalog. Subsequently, she developed a massive subretinal hemorrhage secondary to age-related macular edema in the right eye. The left eye also had high-risk macular drusen. A non-OMIC-insured ophthalmologist recommended that the patient participate in an age-related macular degeneration risk reduction trial, as he felt there was no other treatment currently available that would be of benefit to the left eye. An OMIC insured performed eight injections of Anecortave Acetate under the trial protocol.
During the last procedure, the insured applied Xylocaine on a Q-tip to the conjunctival surface superotemporally, approximately 8 mm back from the limbus. Xylocaine was then injected about 8mm posterior to the limbus superotemporally. While waiting for the anesthesia to take effect, he pushed the medication through the cannula to the appropriate mark on the syringe. One additional drop of topical anesthetic was applied and the lid speculum was inserted. The insured marked the spot using calipers on the slightly elevated conjunctiva that was 8 mm posterior to the limbus superotemporally. The insured then used grasping forceps to pinch the slightly elevated conjunctiva and make a small snip in the conjunctiva and tenons capsule. A fair amount of scarring was encountered as he tried to dissect down to the sclera surface. The insured was able to insert a cannula but upon withdrawing the tip he noticed a clear strand of material. The insured suspected it was vitreous and realized at this point that the medication had been injected into the globe. A non-OMIC insured retinologist subsequently performed a vitrectomy to remove the Anecortave with silicone oil tamponade and silicone removal OS along with epiretinal membrane peeling. The macula was stable; however, the prognosis for visual recovery was uncertain. The patient’s visual acuity remained at 20/200 OS despite cataract surgery.
Analysis
The OMIC insured was adamant that he did not deviate from the standard of care during the final trial injection. It was the insured’s opinion that the previous injections were responsible for the scarring. The insured reported to his attorney that he had discovered reports of several other patients who experienced similar complications. As discovery progressed, the drug manufacturer abandoned the treatment as it became apparent that it was not beneficial to patients. Prior to the drug trial, the OMIC-insured had obtained a specific indemnification agreement covering this type of incident. OMIC’s defense attorney approached the manufacturer’s attorney about this agreement; however, the attorney for the manufacturer maintained that there was no indemnification since the proposed claim was for alleged negligence by the OMIC insured. Defense counsel reminded this attorney that the agreement specifically spelled out that the manufacturer would indemnify the OMIC-insured in that context. The attorney for the manufacturer continued to disagree but allowed that the manufacturer, for professional relationship reasons, would indemnify the OMIC insured. The manufacturer recommended that defense counsel submit a formal demand for indemnification. The demand was accepted and the insured was dismissed from the claim. The drug manufacturer settled for $500,000.
Risk Management Principles
The insured and the entity he was working for at the time of this incident were extremely thorough in drafting their agreement with the drug manufacturer prior to participating in the trial. By entering into a legally enforceable indemnification agreement with the drug manufacturer, the insured was able to avoid a large settlement. Ophthalmologists should indeed negotiate such agreements before they become involved in surgical and drug studies. Furthermore, the insured applied good technique throughout the trial and thoroughly documented his approach and technique during each injection. This documentation made it very difficult for the drug manufacturer to allege that the insured’s technique was improper.
