Factual Background

​After the patient in this case was diagnosed with prostate cancer, he consulted with the defendant radiation oncologist and proceeded with a treatment of hormone therapy and radiation. The treatment specifically included administering the drug Amifostine to protect the bladder and rectum from radiation-induced inflammation. The patient was later diagnosed with Stevens-Johnson syndrome, a disease involving skin irritation and blisters, which causes the top layer of skin to die and shed. Shortly after that, he died from pneumonia. (Op. at 4).

The patient’s estate and his family then filed wrongful death and survival actions against the doctor and his medical group in the Circuit Court for Prince George’s County. They brought an informed consent action, alleging that the doctor failed to disclose material risks of administering the radiation therapy, as well as the drug, before obtaining the patient’s consent. (Id. at 5).

The defense moved in limine to exclude a package insert from the drug in reference to the FDA not approving it for prostate cancer. Afterward, the court granted the motion. (Id. at 14).

The jury then found for the defense, finding that a reasonable person, having been informed of the material risks of Amifostine, would not have refused treatment. (Id. at 15).

However, the Court of Special Appeals reversed. (Id. at 16–17). Consequently, the defendants appealed. (Id. at 2-3).

Court of Appeals

​The elements of an informed consent cause of action generally include the duty to disclose to the patient material information that a physician knows or ought to know would be significant to a reasonable person in the patient’s position in deciding whether or not to submit to a particular medical treatment or procedure; breach of that duty by failing to make an adequate disclosure; and that the violation was the proximate cause of the patient’s injuries. (Id. at 18).

The information specifically includes the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. (Id. at 19). The risks the doctor must disclose are material. (Id).

Negligence, however, is a different claim from informed consent. Evidence that a medical procedure or treatment is not for a patient is relevant in a negligence case but is not applicable in an informed consent action. (Id. at 21-22).

FDA Insert & Informed Consent

An issue in this case concerned the admissibility of evidence regarding the package insert for Amifostine and its off-label use. (Id. at 33). The plaintiff attempted to introduce the package insert itself and also testimony through its expert witness, a pharmacist, that the insert cautioned against use in older patients. (Id. at 33-34). The plaintiff also attempted to introduce that the defendant doctor did not inform him of the insert’s caution. (Id. at 34).

The CA held that whether a treatment is appropriate is relevant and admissible evidence in a negligence cause of action, but not in an informed consent case. (Id. at 36). The package insert’s warning against use in older patients may have supported a negligence claim. (Id.).

The plaintiff also attempted to introduce evidence at trial through the pharmacist’s testimony and the defendant that the FDA had approved Amifostine in ovarian cancer and head and neck cancer cases, but not for prostate cancer. (Id. at 37-38). The CA again concluded that this evidence was relevant to negligence but not informed consent. (Id. at 40).

Information about off-label use does not provide the patient with any information about the treatment itself or the likelihood or severity of any risks. Therefore, it cannot be considered material information for an informed consent claim. (Id. at 42).

The CA reversed the CSA and affirmed the trial court. (Id. at 43).

Commentary By Baltimore Medical Malpractice Lawyer Mark Kopec on FDA Insert & Informed Consent

​Similar to the court’s holding discussed in Part 1, the evidence in this part was not relevant to an informed consent claim. The lack of FDA approval did not go to one of the elements of information that a physician must disclose. In addition, cautioning against use in older patients did not include the specific details needed to fit into an informed consent disclosure.

Either of these pieces of evidence could be relevant in a given case. A plaintiff would have to relate them to specifics that demonstrate the probability of success of the treatment or the risk of unfortunate consequences.

Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.

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Factual Background

​The patient in this case was diagnosed with prostate cancer. He then consulted with the defendant radiation oncologist and proceeded with a treatment of hormone therapy and radiation. The treatment included the doctor’s administration of the drug Amifostine. This drug was supposed to protect the bladder and rectum from radiation inflammation. The patient was later diagnosed with Stevens-Johnson syndrome. This syndrome is a disease involving skin irritation and blisters, which causes the top layer of skin to die and shed. Shortly after that, he died from pneumonia. (Op. at 4).

The patient’s estate and his family filed wrongful death and survival actions against the doctor and his medical group in the Circuit Court for Prince George’s County. They brought an informed consent action, alleging that the doctor failed to disclose material risks of administering the radiation therapy, as well as the drug, before obtaining the patient’s consent. (Id. at 5).

Expert Testimony

The plaintiffs designated a pharmacist as an expert witness in drug therapy as it applies to oncology. (Id. at 5-6).

In a de bene esse deposition, the pharmacist then testified that the doctor should not have used Amifostine in a patient getting radiation for prostate cancer. He also supported his opinion by testifying that the FDA had not approved it for prostate cancer, and warned against it in older patients. (Id. at 6-7).

The circuit court excluded the pharmacist’s de bene esse testimony. The court found that the pharmacist was not a medical doctor and did not address informed consent standards. (Id. at 9).

The plaintiffs then proffered:

The pharmacist would testify to, inter alia, the risk factors associated with Amifostine; that Amifostine has only benefited patients suffering from head & neck cancer, and kidney cancer; that the efficacy of Amifostine in treating prostate cancer was unknown; that the package insert cautions against use in older patients; that there are no other known alternatives to Amifostine, and that the Food and Drug Administration did not approve Amifostine for the treatment of prostate cancer. (Id. at 10-11).

The judge excluded the pharmacist from testifying at trial. (Id. at 11). The jury found for the defense. It specifically determined that a reasonable person, having been informed of the material risks of Amifostine, would not have refused treatment. (Id. at 15).

The Court of Special Appeals reversed. (Id. at 16–17). The defendants then appealed. (Id. at 2-3).

Court of Appeals on Informed Consent Expert Testimony

The elements of an informed consent cause of action generally include the duty to disclose to the patient material information that a physician knows or ought to know would be significant to a reasonable person in the patient’s position in deciding whether or not to submit to a particular medical treatment or procedure; breach of that duty by failing to make an adequate disclosure; and that the violation was the proximate cause of the patient’s injuries. (Id. at 18).

The information includes the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. (Id. at 19). The doctor must disclose material risks. (Id).

Negligence is a different claim from informed consent. Evidence that a medical procedure or treatment is not for a patient is relevant in a negligence case but is not applicable in an informed consent action. (Id. at 21-22).

The CA held that expert testimony is necessary to assist the trier of fact in understanding the severity and likelihood of the risk, so that the trier of fact may assess the material risks of the proposed treatment. (Id. at 24).

The pharmacist may have qualified to testify about the material risks of administering Amifostine. Still, he did not render such an opinion in his de bene esse deposition or in the proffer of his trial testimony. (Id. at 26).

The pharmacist did not address the severity or likelihood of the risks of administering Amifostine; instead, he opined only on the existence of risk. (Id. at 31).

Therefore, the trial judge did not abuse his discretion in excluding the testimony. (Id. at 32-22).

The CA reversed the CSA and affirmed the trial court. (Id. at 43).

Commentary By Baltimore Medical Malpractice Lawyer Mark Kopec on Informed Consent Expert Testimony

​Informed consent claims are not nearly as prevalent as negligence-based claims in medical malpractice cases. When a plaintiff pursues an informed consent claim, they must closely examine the elements they must meet.

In this case, the plaintiff submitted testimony that sounded in negligence. The deposition and proffer did not satisfy the elements of an informed consent claim.

This decision and others specifically provide the roadmap and checklist for a plaintiff seeking to put on an informed consent claim successfully.

Another point to emphasize in informed consent cases is that it is an objective standard. The jury does not have to accept the plaintiff’s testimony that they would not have pursued the treatment if the doctor had provided all of the information. The jury makes its own determination.

We get calls from plaintiffs who have experienced significant side effects from treatments and then claim the doctor did not disclose those effects. In many instances, however, the entire picture reveals that the treatment was so critical to the patient’s ability to regain health that it would be unlikely that a jury would find the risk of side effects was not worth it.

Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.

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Procedural Background

The plaintiff filed a complaint in the Circuit Court for Baltimore County against a doctor, his practice group, and also a hospital, alleging placement of an unnecessary stent in the LAD artery. The claims were for medical malpractice and fraud. (Op. at 1). The circuit court granted the defendants’ motion for summary judgment on the fraud claims for lack of evidence and on the medical malpractice claims based on the statute of limitations. (Id. at 1-2). Afterward, the plaintiff appealed. (Id. at 2).

Factual Background

Before encountering the defendants, the plaintiff had experienced chest pain, shortness of breath, and chest tightness. He went to the cardiac cath lab, which revealed 95% stenosis in the LAD artery. Accordingly, the doctor placed a stent. (Id.).

However, the plaintiff continued to experience shortness of breath. His cardiologist recommended another cardiac catheterization, and this time it was with the defendants. (Id. at 3). The plaintiff testified that during the procedure, the doctor advised him that the stenosis was 70% and that he needed another stent to avoid a complete blockage. The doctor placed another stent in the LAD artery. (Id. at 4).

Afterward, the plaintiff read a news story that the doctor may have been performing unnecessary stent procedures, he brought this lawsuit for fraud. (Id. at 5). The plaintiff included a certificate of qualified expert stating that the doctor had implanted the stent without sufficient evidence to justify it. (Id. at 6).

The plaintiff contended that the evidence of fraud against the doctor included the expert’s testimony that the stenosis was only 20-40%. (Id. at 6-7). The plaintiff also argued that the hospital committed fraud by concealing the doctor’s actions. (Id. at 7).

Court of Special Appeals on Fraud in Medical Malpractice

The CSA said the issue was the knowledge element of the fraud: whether the doctor knew his statement was false or was recklessly indifferent to the truth. (Id. at 11). The CSA held that there was no evidence that the doctor knew his estimate of 70% stenosis was incorrect. At most, there was negligence or gross negligence. (Id. at 12).

The CSA also noted that the expert witness had not testified about the number at which a doctor should consider a stent, nor what margin of error there is when making a stenosis assessment by eyesight. (Id. at 16-17).

The CSA also noted that the defense introduced evidence that doctors can vary in their readings of stenosis by up to 20%. The plaintiff acknowledged the existence of variability but did not concede the presence of a 20% difference in this case. (Id. at 17 n. 9). 

The CSA upheld the summary judgments. (Id. at 21).

Commentary by the Baltimore Medical Malpractice Lawyer on Fraud in Medical Malpractice

In this case, the distinction between negligence and fraud was of paramount importance. The defense’s argument that reasonable doctors can vary by 20% in their estimate of stenosis, coupled with the plaintiff’s own expert varying 20% in his reading of the stenosis, from 20 to 40%, significantly impacted the strength of the fraud case.

By the time the court in this case held the summary judgment hearing, the doctor had already had his license revoked for unnecessary stents. The hospital had already settled other litigation for $37 million for unnecessary stents by that doctor. This situation raises the question of whether there was other fraud evidence available that could’ve significantly bolstered this plaintiff’s fraud case.

Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.

Factual Background

The plaintiffs had previously brought a birth injury case on behalf of their son against the mother’s OB/GYN and practice group for failure to obtain informed consent for treatment during pregnancy. As a result, the mother had a placental abruption, which caused their son to have cerebral palsy. (Op. at 2). The plaintiffs then obtained a judgment against the defendants for over $5 million, which the defendants paid. (Id. at 2-4).

After the trial, the minor died. The decedent’s parents then filed wrongful death claims in a new lawsuit in the Circuit Court of Baltimore County. The defense moved to dismiss the case, and the circuit court granted the motion. (Id. at 4-5). The Court of Special Appeals then reversed. The defense appealed. (Id. at 7-9). 

Court of Appeals on Wrongful Act in Wrongful Death Claims

Maryland’s wrongful death statute allows the maintenance of an action “against a person whose wrongful act causes the death of another.” Cts. & Jud. Proc. § 3–902(a). “Wrongful act” is defined as “an act, neglect, or default including a felonious act which would have entitled the party injured to maintain an action and recover damages if death had not ensued.” Cts. & Jud. Proc. § 3–901(e). The primary beneficiaries of a wrongful death action are the spouse, parent, and child of the decedent. Cts. & Jud. Proc. § 3 904(a)(1). However, relatives by blood or marriage who substantially relied upon the decedent are also eligible claimants. Cts. & Jud. Proc. § 3-904(b).

Where the decedent is a spouse, minor child, parent of a minor child, or an unmarried child that is not a minor, the wrongful death statute provides damages for “pecuniary losses,” if any, in addition to damages for “mental anguish, emotional pain and suffering, loss of society, companionship, comfort, protection, marital care, parental care, filial care, attention, advice, counsel, training, guidance, or education where applicable. . . .” Cts. & Jud. Proc. § 3–904(c)-(d). (Op. at 10-11).

Independent Cause of Action

The question on appeal was whether the wrongful death claims were derivative or independent of the decedent’s prior personal injury claim, which was based on the same facts and resulted in a judgment. (Id. at 11). The CA found that the phrase “if death had not ensued” in the definition of wrongful act was ambiguous. (Id. at 14). Legislative history did not answer the issue that was on appeal. (Id. at 17).

Maryland has historically adhered to the minority view that the wrongful death statute created a new and independent cause of action, distinguishable from a decedent’s personal injury action during their lifetime, or a survival action. (Id. at 18). The CA held that the phrase “if death had not ensued” pertains only to the character of the injury and was not intended to be a procedural or jurisdictional prerequisite to a subsequent wrongful death action. (Id. at 29). 

Next, the court rejected res judicata as a bar to the action. (Id. at 29-32). It also rejected the defense’s argument that allowing the wrongful death claims would provide for duplicative damages. The CA observed that the damages recovered in a wrongful death action compensate for losses incurred by a decedent’s beneficiaries only after death ensued, and are distinguishable from damages recovered by a decedent in a personal injury action. (Id. at 33-35).

Commentary by Baltimore Medical Malpractice Lawyer Mark Kopec on Wrongful Act in Wrongful Death Claims

This opinion is a significant one, confirming the independence of wrongful death claims. I do not believe that the phrase “if death had not ensued” is ambiguous. I think the definition of wrongful act merely establishes that the act was a tortious act against the person before they passed away.

It’s important to note that the core damages in a wrongful death case are distinct from those in a personal injury/survival claim. The damages in the personal injury claim focus on the harm to the person directly injured. In contrast, the damages in the wrongful death claims focus on the loss of the person by certain relatives. 

As a practical matter, lawyers on both sides of medical malpractice claims involving injury must consider whether the malpractice could ultimately lead to death. This possibility has potential ramifications, and being aware of these can help lawyers prepare their cases more effectively.

Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.

The plaintiffs brought a medical malpractice lawsuit in the Circuit Court for Baltimore County alleging that the patient had acute appendicitis and that the defendant surgeon performed an appendectomy. In doing so, the doctor failed to completely remove the entire appendix. The patient suffered pain and needed another procedure to remove the appendiceal stump. (Op. at 1).

The plaintiffs also included a claim for breach of contract against the doctor for failing to remove the entire appendix. The circuit court granted the doctor’s motion to dismiss that count. The parties went to trial on the malpractice claims, and the jury returned a defense verdict. The plaintiffs then appealed the dismissal of the contract claim. (Id. at 1, 3).

Court of Special Appeals

The CSA addressed the plaintiffs’ argument that the trial court erred in considering attachments to the doctor’s motion to dismiss. Rather, it should have limited the analysis to the four corners of the complaint. (Id. at 4).

The appellate court treats the trial court’s grant of a motion to dismiss as one for summary judgment when the court considers facts beyond those in the complaint. (Id. at 5). The CSA noted that this can unfairly prejudice a party if they did not have the opportunity to submit materials in addition to the complaint, but that was not the case here. (Id. at 9). 

Maryland courts have a long-standing view that a doctor’s failure to exercise reasonable care is a tort, not a breach of contract. To establish a breach of contract claim, the patient must demonstrate that the doctor made an additional promise or warranty, distinct from the doctor’s agreement to properly perform the procedure. 

The CSA described part of the rationale for this principle:

The argument against imposing contractual liability on the physician is that considering the unpredictability of medical results and the differences in individual patients, it is unlikely that the physician of integrity can, in good faith, promise a particular outcome. (Id. at 16).

The plaintiffs here made no such allegation. (Id. at 11-13). As a result, the trial court correctly determined that the doctor was entitled to judgment as a matter of law. (Id. at 14-15).

Insightful Commentary by Baltimore Medical Malpractice Lawyer Mark Kopec on Breach of Contract

Even though this appellate opinion focused on the breach of contract claim, it is worth briefly discussing the accompanying medical malpractice claim.

Many medical malpractice lawyers would not have brought this malpractice case. The parties can fight over whether it violates the standard of care to leave the stump. However, it does not appear that the patient suffered any permanent injury. In this situation, whether the jury finds that the remaining stump is a recognized risk of the procedure or the jury awards insignificant damages, I do not believe that the prospects for the plaintiffs were good. Accordingly, the defense verdict was not surprising.

The prospects were even worse for the breach of contract claim. The plaintiffs ignored well-established case law in Maryland and other states that required a promise beyond the agreement to do the procedure. The CSA had no trouble distinguishing the cases the plaintiff relied upon because most of them contained the same requirements that the courts in this case relied upon.

You can read other Blog posts in the category of causes of action.

Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.

In part 1, I addressed the issue of when an expert is in a “similar specialty” to that of the defendant doctor under CJP 3-2A-02(c)(2)(ii)(1)(B). In part 2, I then addressed the Court’s ruling on the issue of peremptory challenges.

Facts

Here, I will repeat the basic facts of the case. The plaintiff sued a hospital, an emergency room doctor, a vascular surgeon, and their practice groups. She alleged that as a result of malpractice, she had to undergo a below-the-knee amputation. After a two-week trial, the jury then returned a defense verdict, and the plaintiff appealed. (Op. at 1).

On June 16, 2017, the plaintiff went to the emergency room. Her right foot was numb, pale, and cool. Thereafter, an ultrasound showed an abnormal Ankle-Brachial Index (ABI). After a physical exam, Dr. Lu specifically found no emergent vascular compromise to warrant emergent intervention. However, due to the low ABI, she recommended follow-up with vascular surgery if symptoms continued (Id. at 3-4).

On June 18, the plaintiff then returned to the ER, reporting that the pain was worse and the top of her foot was icy cold. Dr. Bassi admitted the plaintiff. The ER doctor accordingly requested a vascular surgery consultation. The consultation did not occur for two days. (Id. at 5-6).

Informed Consent

The plaintiff asserted an informed consent claim in the Circuit Court for Harford County. She contended that ER Dr. Lu had to offer alternatives to discharge, including an immediate consult with a vascular surgeon and admission to the hospital. (Id. at 20). An informed consent claim is based on a doctor’s duty to provide sufficient information for a patient to decide whether to submit to a particular treatment. Maryland has described this as a duty to reveal: “the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment.” Sard v. Hardy, 281 Md. 432, 439-40 (1977).

Informed Consent Cases

The Appellate Court discussed prior Maryland informed consent cases:

• Sard v. Hardy, 281 Md. 432 (1977): The plaintiff stated an informed consent claim when an obstetrician performed tubal ligation without telling the patient there was a risk of failure, and other sterilization procedures with lower risks of failure were available.
• Reed v. Campagnolo, 332 Md. 226, 241 (1993): when a physician does not propose treatment, there is no informed consent claim.
• McQuitty v. Spangler, 410 Md. 1 (2009): Informed consent claims also apply to treatment plans.

The Appellate Court found that ER Dr. Lu did not recommend a treatment plan she would oversee. She suggested following up with a vascular surgeon or returning to the ER if the plaintiff worsens. A doctor has no duty to disclose alternative treatment options if the doctor has concluded that they are not needed. The Court noted the chaos that could occur by informing the patient that admission was an option and then declining to do it if the patient requested it (Id. at 33-36).

The plaintiff claimed that Dr. Lu should have recommended admission and an immediate consult with a vascular surgeon and that not doing so was a breach of the standard of care. The Appellate Court ruled that this was an ordinary negligence claim, not informed consent (Id. at 40).

Commentary By the Baltimore Medical Malpractice Lawyer

I believe the Appellate Court got the informed consent claim correct. The plaintiff’s informed consent argument would not work in practice. Envisioning the exchange between the doctor and patient is all that is needed to reveal that such a rule would not work:

• Doctor: One of the treatment options is for us to admit you and get you an immediate consultation with a vascular surgeon
• Patient: I’d like that.
• Doctor. You can’t have that.
• Patient: Why?
• Doctor: Because I don’t believe it’s medically needed.
• Patient: But you said it is an option for me, and I want it. If you don’t give it to me, I want to see another doctor.

Accordingly, this rule would be unworkable. The plaintiff’s claim that there should have been an admission and consultation is fully presentable through a traditional negligence claim without imposing impractical requirements on doctors.

In part 4, I will then examine the Appellate Court’s ruling on the standard of care applicable to the vascular surgery practice group, and the status of the case on remand.

Other Case

• Collis v. Mid Atlantic Skin Surgery Institute: In a November 6, 2023 unreported opinion, the Appellate Court of Maryland upheld dismissal of an informed consent claim for failure to plead the elements. Plaintiff did not specifically allege that she suffered from the risk not disclosed or that the harm suffered was a result of lack of informed consent.

Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.