When Is Your Doctor Not Your Doctor?

Modern understanding of medical malpractice is based upon the presence of a physician-patient relationship. This specific relationship gives rise to a special duty on the part of the physician, the breach of which is one of the requirements for finding professional negligence. See, e.g., Wilson v. Athens-Limestone Hospital, 894 So.2d 630, 633 (Ala. 2004); Conley v. State, 141 S.W.3d 591, 597 (Tenn. 2004); Bessenyei v. Raiti, 266 F. Supp. 2d 408, 411 (D. Md. 2003). Although this consensual relationship is often discussed and thought of in terms of an express contract ' that the relationship is created when professional medical services are 'offered' voluntarily and those services are 'accepted' voluntarily by another ' most courts have held that the creation of the relationship need not satisfy the formalities of a contract. Stutes v. Samuelson, 180 S.W.3d 750, 753 (Tex. Ct. App. 2005). The creation of this relationship may be either express or implied. 'The implied contractual relationship may arise from facts and circumstances indicating there was a mutual intention to contract. The consent of the physician, whether express or implied, is absolutely necessary to the creation of the relationship.' Id.

'No Breach of Duty'

Given this understanding of the physician-patient relationship, it is unsurprising that many defendants in medical malpractice lawsuits assume the presence of the relationship ' and therefore a duty ' and begin defense of their case by asserting that there was no breach of this duty. In the past, when disputes over this duty arose, they came about in a fairly familiar medical malpractice context. For instance, a plaintiff patient would often assert that he and a defendant consulting or screening physician had entered into a consensual physician-patient relationship.

More recently, however, the plaintiffs' bar has begun moving the fight over the physician-patient relationship out of the more traditional medical malpractice context and into that of clinical trials litigation. The confluence of three characteristics of clinical trials litigation favorable to the plaintiffs' bar makes this shift a savvy move. First, the number of clinical trials ' and therefore participants therein ' is increasing exponentially. In 1995, the Center for Drug Evaluation and Research's Bioresearch Monitoring Information System recorded that 16,898 Investigational New Drug studies began. Ten years later, 25,642 Investigational New Drug studies were started (http://www.accessdata.fda.gov/scripts/cder/bmis/). This growth may be attributed to the fact that clinical trials are prerequisites to the development of new pharmaceuticals and medical devices, regardless of whether those drugs and devices ultimately make it to the consumer market.

Second, litigation arising out of clinical trials has been limited and sporadic despite increasing numbers of trials. The dearth of reported case law permits aggressive plaintiffs' attorneys to leverage the legal emptiness to suggest to a defendant that most cases settle (and should). If no settlement occurs, this absence presents these same attorneys with the opportunity to test and mold the developing law favorably.

Third, and perhaps most importantly, the structural underpinnings of clinical trials ' which typically include a physician and a person receiving treatment or a placebo ' initially appear analogous to, and therefore seem to lend themselves to, a medical malpractice-type analysis.

The Players in a Clinical Trial

In order to fully appreciate the implications of the imposition of a physician-patient relationship on a clinical trial action, all of the major potential players in a clinical trial should be identified: the sponsor, the investigator, the institutional review board (IRB), and the trial site.

The sponsor is effectively the driving force behind the clinical trial, and therefore takes the macro or global view of the entirety of the project. 21 C.F.R. ' 56.102(j). In this capacity, the sponsor selects qualified investigators, provides them with data, ensures proper monitoring of the investigations and makes sure that the investigations are in accordance with the parameters of the investigational plan. The sponsor also enhances communication between the investigators, the participants, and itself, and, if necessary, communicates adverse events to the Food and Drug Administration. 21 C.F.R. ' 312.50.

If the sponsor is in charge of the big picture, the investigators are responsible for the minutia of the actual research. These individuals, usually physicians, are charged with protecting the participants (in large part by obtaining informed consent) and administering the drug or device under investigation. 21 C.F.R.
' 56.102(h); 21 C.F.R. ' 312.60. The investigators also effect on-the-ground compliance with the plan and applicable federal regulations. 21 C.F.R. ' 312.60. Investigators are those most likely to have interactions with individual participants.

The primary function of the IRB, as its name suggests, is review. This group is designated by the sponsor to initiate and periodically review the research and its parameters. 21 C.F.R. ' 56.102(g). More specifically, the IRB is required to follow written procedures for conducting the reviews, for determining which projects need more review, and for ensuring that changes in already-approved research are subject to review. 21 C.F.R. ' 56.108(a). Like all of the entities involved in a clinical trial, the IRB should be concerned with the protection of the trial participants, and in its capacity as a reviewer, the IRB must determine what information should be included in the informed consent. 21 C.F.R. ' 56.109(b)-(c).

Finally, clinical trial sites are the physical locations at which the research is conducted. These entities, often hospitals or other medical facilities, are primarily responsible for the actions of their employees, which can include IRBs or investigators.

As noted above, investigators, by virtue of their medical expertise, are most likely to be singled out from the clinical trial team as being liable in medical malpractice to trial participants. But because the roles of those who conduct clinical trials tend to be fluid, and because an entity can wear several hats during the course of a clinical trial (see Lenahan, infra), it is possible for an investigator/sponsor to be sued for medical malpractice and to have her duties as sponsor construed in favor of finding a physician-patient relationship.

The Changing Face of Medical Malpractice in the Context of Clinical Trials

Courts in some early clinical trial decisions ruled that investigators who were physicians had no physician-patient relationship with trial participants, and therefore were not subject to liability. In Payette v. Rockefeller, 220 A.D.2d 69 (1996), for instance, the court found that a university ' ostensibly a sponsor ' could not be held liable for medical malpractice for harm a participant sustained during a clinical trial, even when university doctors had consistently monitored the participant. The court reasoned that since the participant had never asked for diagnosis or treatment of a medical condition and was a volunteer in the clinical trial of a diet study, she was not seeking medical treatment and therefore was not a patient. Id. at 72-73.

The latest pronouncements on the physician-patient relationship in the clinical trial context are decidedly less defense-friendly. While no published cases have actually found against an investigator in a clinical trials medical malpractice suit, the two most recent cases suggest that, at a minimum, a duty based on the physician-patient privilege may exist even in the context of a clinical trial.

The case of Lenahan v. University of Chicago, 808 N.E.2d 1078, 348 Ill. App. 3d 155 (2004) was the first indication of this change in thinking. Decedent, diagnosed with non-Hodgkin's lymphoma, received chemotherapy/radiation treatment, followed by high-dose chemotherapy alone, followed by a different high-dose chemotherapy combined with stem cell transplants. The doctor who recommended the last treatment also advised decedent to participate in an early-stage clinical trial referred to as Protocol 8558. The decedent enrolled in Protocol 8558, and died during the course of treatment. Among other claims, the plaintiff maintained that the defendant investigator/sponsor directing the research, who was a physician, was liable for medical malpractice. The plaintiff alleged that because the defendant investigator/sponsor provided services to the decedent, conducted laboratory tests, and reviewed test results, the defendant investigator/sponsor and decedent had a physician-patient relationship. Specifically, plaintiff pleaded that the doctor was the sponsor and principal investigator of Protocol 8558, and that he personally designed and/or devised all aspects of Protocol 8558, including eligibility criteria, pretreatment evaluation and the treatment plan (including the timing, choice and dosages of the chemotherapy drugs to be administered, stem cells to be reinfused and co-stimulated T-cells to be reinfused into each patient).

The medical malpractice claim was dismissed by the trial court, but, on appeal, the court determined that the allegations relating to the provision of services, the use of laboratory tests, the direction of other investigators, and the review of test results were sufficient to withstand a motion to dismiss for failure to state a claim. The defendant investigator/sponsor argued no physician-patient relationship could exist because he had never personally met with decedent. The court found this argument unavailing, and analogized the case before it to one in which a physician consults and takes an active advisory role in a patient's care, and thereby becomes the patient's doctor. Despite the fact that the investigator/sponsor's actions were mandated by his dual role, the court nonetheless raised the possibility that he could be liable for medical negligence.

Having managed the pleading requirements, the next challenge for the plaintiffs' bar was to survive summary judgment, and they found a case to do just that. Plaintiff's decedent in Clermont-Lundy v. Zimbalist, No. 4950/03, 2005 WL 3309753, at *1 (N.Y. Sup. Oct. 5, 2005), was first diagnosed with Crohn's Disease by his gastroenterologist. After several years of continuing gastrointestinal problems, the gastroenterologist ordered a CT scan, which revealed findings consistent with Crohn's Disease as well as a lesion on the decedent's liver. Shortly thereafter, the gastroenterologist referred decedent to the defendant investigator so that decedent could be evaluated for inclusion in a clinical trial of a Crohn's Disease medication. The defendant evaluated decedent, agreed with the finding of Crohn's Disease, and recommended surgery. Decedent declined.

After participating in the clinical trial for several months, decedent was again admitted to the hospital with gastrointestinal and abdominal pain. Although the exact manner is unclear, decedent was admitted with the defendant as his attending physician. During this hospitalization, a CT scan revealed an impacted bowel and lesions on the liver that the defendant believed could be malignant. Decedent was discharged, however, and only a month later, during an office visit characterized as a follow-up to the clinical trial, did the defendant inform decedent that he required surgery. The defendant did not see decedent again. Decedent was diagnosed with metastatic cancer of the colon and liver, and died 9 days after diagnosis.

Before trial, the defendant moved for summary judgment, arguing that he and decedent did not have a physician-patient relationship be-cause the defendant's sole duty to decedent was to monitor the effects of the drug being tested. The trial court denied the defendant's motion, finding that plaintiff had raised an issue of material fact as to whether a physician-patient relationship existed that was sufficient to defeat a motion for summary judgment. The court found that the physician's following actions raised an issue regarding the existence of the relationship: 1) evaluating a referred patient with a diagnosed disease for inclusion in a clinical trial of a drug or device that would treat that disease; 2) monitoring the patient closely (including the taking of blood samples) during the clinical trial; 3) acting as the patient's attending physician during a clinical-trial related hospitalization; 4) seeing the patient in a 'follow-up' to hospitalization and removal from the clinical trial; and 5) recommending a course of treatment to the patient outside of the clinical trial. While the defendant's decision to act as decedent's attending physician during a hospital admission and to see the patient for a follow up to that admission seems outside his duties as a clinical trial investigator, the other factors are arguably part and parcel of the investigator's duties. Further, if the hospitalization and follow-up visit were seen as necessary for data collection for clinical trial dropouts, these acts might also fall within the duties of a good investigator.

Conclusion

These two decisions highlight both the relative ease with which courts may be persuaded to hear a claim for medical malpractice arising out of a clinical trial and the problems inherent in making the leap of logic from the context of medical malpractice to the context of clinical trials. At first glance, the similarities between these contexts seem sufficient to support the imposition of a medical malpractice veneer onto a clinical trial framework: both arise in medical settings, both involve a physician offering treatment, and both have laypersons receiving the physician's treatment. While these similarities are superficially appealing, the current caselaw demonstrates the problems with succumbing to this appeal. While medical settings provide the background in either case, the medical setting of a clinical trial, by virtue of its experimental purpose, contains more risk for the participant.

In addition, although an investigator is a physician, an investigator has duties incumbent upon her that she may not avoid. These duties may lead to the judicial finding of a physician-patient relationship, even if the investigator did not desire or intend to enter into such a relationship. This pitfall may be further exacerbated if the investigator also acts as sponsor or takes on another role that imposes even greater duties. The average physician, on the other hand, in the absence of the investigator's duties, has much greater discretion in how and if a physician-patient relationship is created. The differences between a typical medical malpractice setting and a clinical trial setting are likely substantial enough to warrant the defense bar's careful consideration of these exploratory medical-malpractice claims in future clinical trials litigation.

The burgeoning number of clinical trials and the relative paucity of reported decisions have opened the door for extension of medical malpractice theories into the clinical trials arena. The incursion has begun slowly, with plaintiffs trying to establish the mere possibility of the existence of a physician-patient relationship in this context. Even at this early stage, however, the problems posed by the potential adoption of this theory are evident. Although the physician-patient relationship is a relatively unlikely source of friction in day-to-day practice of medical malpractice defense, it may be more contentious as it spreads to new areas of law.

Anna A. Sumner is an attorney practicing in the Atlanta offices of Alston & Bird LLP.

Modern understanding of medical malpractice is based upon the presence of a physician-patient relationship. This specific relationship gives rise to a special duty on the part of the physician, the breach of which is one of the requirements for finding professional negligence. See, e.g., Wilson v. Athens-Limestone Hospital , 894 So.2d 630, 633 (Ala. 2004); Conley v. State , 141 S.W.3d 591, 597 (Tenn. 2004); Bessenyei v. Raiti , 266 F. Supp. 2d 408, 411 (D. Md. 2003). Although this consensual relationship is often discussed and thought of in terms of an express contract ' that the relationship is created when professional medical services are 'offered' voluntarily and those services are 'accepted' voluntarily by another ' most courts have held that the creation of the relationship need not satisfy the formalities of a contract. Stutes v. Samuelson , 180 S.W.3d 750, 753 (Tex. Ct. App. 2005). The creation of this relationship may be either express or implied. 'The implied contractual relationship may arise from facts and circumstances indicating there was a mutual intention to contract. The consent of the physician, whether express or implied, is absolutely necessary to the creation of the relationship.' Id.

'No Breach of Duty'

Given this understanding of the physician-patient relationship, it is unsurprising that many defendants in medical malpractice lawsuits assume the presence of the relationship ' and therefore a duty ' and begin defense of their case by asserting that there was no breach of this duty. In the past, when disputes over this duty arose, they came about in a fairly familiar medical malpractice context. For instance, a plaintiff patient would often assert that he and a defendant consulting or screening physician had entered into a consensual physician-patient relationship.

More recently, however, the plaintiffs' bar has begun moving the fight over the physician-patient relationship out of the more traditional medical malpractice context and into that of clinical trials litigation. The confluence of three characteristics of clinical trials litigation favorable to the plaintiffs' bar makes this shift a savvy move. First, the number of clinical trials ' and therefore participants therein ' is increasing exponentially. In 1995, the Center for Drug Evaluation and Research's Bioresearch Monitoring Information System recorded that 16,898 Investigational New Drug studies began. Ten years later, 25,642 Investigational New Drug studies were started (http://www.accessdata.fda.gov/scripts/cder/bmis/). This growth may be attributed to the fact that clinical trials are prerequisites to the development of new pharmaceuticals and medical devices, regardless of whether those drugs and devices ultimately make it to the consumer market.

Second, litigation arising out of clinical trials has been limited and sporadic despite increasing numbers of trials. The dearth of reported case law permits aggressive plaintiffs' attorneys to leverage the legal emptiness to suggest to a defendant that most cases settle (and should). If no settlement occurs, this absence presents these same attorneys with the opportunity to test and mold the developing law favorably.

Third, and perhaps most importantly, the structural underpinnings of clinical trials ' which typically include a physician and a person receiving treatment or a placebo ' initially appear analogous to, and therefore seem to lend themselves to, a medical malpractice-type analysis.

The Players in a Clinical Trial

In order to fully appreciate the implications of the imposition of a physician-patient relationship on a clinical trial action, all of the major potential players in a clinical trial should be identified: the sponsor, the investigator, the institutional review board (IRB), and the trial site.

The sponsor is effectively the driving force behind the clinical trial, and therefore takes the macro or global view of the entirety of the project. 21 C.F.R. ' 56.102(j). In this capacity, the sponsor selects qualified investigators, provides them with data, ensures proper monitoring of the investigations and makes sure that the investigations are in accordance with the parameters of the investigational plan. The sponsor also enhances communication between the investigators, the participants, and itself, and, if necessary, communicates adverse events to the Food and Drug Administration. 21 C.F.R. ' 312.50.

If the sponsor is in charge of the big picture, the investigators are responsible for the minutia of the actual research. These individuals, usually physicians, are charged with protecting the participants (in large part by obtaining informed consent) and administering the drug or device under investigation. 21 C.F.R.
' 56.102(h); 21 C.F.R. ' 312.60. The investigators also effect on-the-ground compliance with the plan and applicable federal regulations. 21 C.F.R. ' 312.60. Investigators are those most likely to have interactions with individual participants.

The primary function of the IRB, as its name suggests, is review. This group is designated by the sponsor to initiate and periodically review the research and its parameters. 21 C.F.R. ' 56.102(g). More specifically, the IRB is required to follow written procedures for conducting the reviews, for determining which projects need more review, and for ensuring that changes in already-approved research are subject to review. 21 C.F.R. ' 56.108(a). Like all of the entities involved in a clinical trial, the IRB should be concerned with the protection of the trial participants, and in its capacity as a reviewer, the IRB must determine what information should be included in the informed consent. 21 C.F.R. ' 56.109(b)-(c).

Finally, clinical trial sites are the physical locations at which the research is conducted. These entities, often hospitals or other medical facilities, are primarily responsible for the actions of their employees, which can include IRBs or investigators.

As noted above, investigators, by virtue of their medical expertise, are most likely to be singled out from the clinical trial team as being liable in medical malpractice to trial participants. But because the roles of those who conduct clinical trials tend to be fluid, and because an entity can wear several hats during the course of a clinical trial (see Lenahan, infra), it is possible for an investigator/sponsor to be sued for medical malpractice and to have her duties as sponsor construed in favor of finding a physician-patient relationship.

The Changing Face of Medical Malpractice in the Context of Clinical Trials

Courts in some early clinical trial decisions ruled that investigators who were physicians had no physician-patient relationship with trial participants, and therefore were not subject to liability. In Payette v. Rockefeller , 220 A.D.2d 69 (1996), for instance, the court found that a university ' ostensibly a sponsor ' could not be held liable for medical malpractice for harm a participant sustained during a clinical trial, even when university doctors had consistently monitored the participant. The court reasoned that since the participant had never asked for diagnosis or treatment of a medical condition and was a volunteer in the clinical trial of a diet study, she was not seeking medical treatment and therefore was not a patient. Id. at 72-73.

The latest pronouncements on the physician-patient relationship in the clinical trial context are decidedly less defense-friendly. While no published cases have actually found against an investigator in a clinical trials medical malpractice suit, the two most recent cases suggest that, at a minimum, a duty based on the physician-patient privilege may exist even in the context of a clinical trial.

The case of Lenahan v. University of Chicago , 808 N.E.2d 1078, 348 Ill. App. 3d 155 (2004) was the first indication of this change in thinking. Decedent, diagnosed with non-Hodgkin's lymphoma, received chemotherapy/radiation treatment, followed by high-dose chemotherapy alone, followed by a different high-dose chemotherapy combined with stem cell transplants. The doctor who recommended the last treatment also advised decedent to participate in an early-stage clinical trial referred to as Protocol 8558. The decedent enrolled in Protocol 8558, and died during the course of treatment. Among other claims, the plaintiff maintained that the defendant investigator/sponsor directing the research, who was a physician, was liable for medical malpractice. The plaintiff alleged that because the defendant investigator/sponsor provided services to the decedent, conducted laboratory tests, and reviewed test results, the defendant investigator/sponsor and decedent had a physician-patient relationship. Specifically, plaintiff pleaded that the doctor was the sponsor and principal investigator of Protocol 8558, and that he personally designed and/or devised all aspects of Protocol 8558, including eligibility criteria, pretreatment evaluation and the treatment plan (including the timing, choice and dosages of the chemotherapy drugs to be administered, stem cells to be reinfused and co-stimulated T-cells to be reinfused into each patient).

The medical malpractice claim was dismissed by the trial court, but, on appeal, the court determined that the allegations relating to the provision of services, the use of laboratory tests, the direction of other investigators, and the review of test results were sufficient to withstand a motion to dismiss for failure to state a claim. The defendant investigator/sponsor argued no physician-patient relationship could exist because he had never personally met with decedent. The court found this argument unavailing, and analogized the case before it to one in which a physician consults and takes an active advisory role in a patient's care, and thereby becomes the patient's doctor. Despite the fact that the investigator/sponsor's actions were mandated by his dual role, the court nonetheless raised the possibility that he could be liable for medical negligence.

Having managed the pleading requirements, the next challenge for the plaintiffs' bar was to survive summary judgment, and they found a case to do just that. Plaintiff's decedent in Clermont-Lundy v. Zimbalist, No. 4950/03, 2005 WL 3309753, at *1 (N.Y. Sup. Oct. 5, 2005), was first diagnosed with Crohn's Disease by his gastroenterologist. After several years of continuing gastrointestinal problems, the gastroenterologist ordered a CT scan, which revealed findings consistent with Crohn's Disease as well as a lesion on the decedent's liver. Shortly thereafter, the gastroenterologist referred decedent to the defendant investigator so that decedent could be evaluated for inclusion in a clinical trial of a Crohn's Disease medication. The defendant evaluated decedent, agreed with the finding of Crohn's Disease, and recommended surgery. Decedent declined.

After participating in the clinical trial for several months, decedent was again admitted to the hospital with gastrointestinal and abdominal pain. Although the exact manner is unclear, decedent was admitted with the defendant as his attending physician. During this hospitalization, a CT scan revealed an impacted bowel and lesions on the liver that the defendant believed could be malignant. Decedent was discharged, however, and only a month later, during an office visit characterized as a follow-up to the clinical trial, did the defendant inform decedent that he required surgery. The defendant did not see decedent again. Decedent was diagnosed with metastatic cancer of the colon and liver, and died 9 days after diagnosis.

Before trial, the defendant moved for summary judgment, arguing that he and decedent did not have a physician-patient relationship be-cause the defendant's sole duty to decedent was to monitor the effects of the drug being tested. The trial court denied the defendant's motion, finding that plaintiff had raised an issue of material fact as to whether a physician-patient relationship existed that was sufficient to defeat a motion for summary judgment. The court found that the physician's following actions raised an issue regarding the existence of the relationship: 1) evaluating a referred patient with a diagnosed disease for inclusion in a clinical trial of a drug or device that would treat that disease; 2) monitoring the patient closely (including the taking of blood samples) during the clinical trial; 3) acting as the patient's attending physician during a clinical-trial related hospitalization; 4) seeing the patient in a 'follow-up' to hospitalization and removal from the clinical trial; and 5) recommending a course of treatment to the patient outside of the clinical trial. While the defendant's decision to act as decedent's attending physician during a hospital admission and to see the patient for a follow up to that admission seems outside his duties as a clinical trial investigator, the other factors are arguably part and parcel of the investigator's duties. Further, if the hospitalization and follow-up visit were seen as necessary for data collection for clinical trial dropouts, these acts might also fall within the duties of a good investigator.

Conclusion

These two decisions highlight both the relative ease with which courts may be persuaded to hear a claim for medical malpractice arising out of a clinical trial and the problems inherent in making the leap of logic from the context of medical malpractice to the context of clinical trials. At first glance, the similarities between these contexts seem sufficient to support the imposition of a medical malpractice veneer onto a clinical trial framework: both arise in medical settings, both involve a physician offering treatment, and both have laypersons receiving the physician's treatment. While these similarities are superficially appealing, the current caselaw demonstrates the problems with succumbing to this appeal. While medical settings provide the background in either case, the medical setting of a clinical trial, by virtue of its experimental purpose, contains more risk for the participant.

In addition, although an investigator is a physician, an investigator has duties incumbent upon her that she may not avoid. These duties may lead to the judicial finding of a physician-patient relationship, even if the investigator did not desire or intend to enter into such a relationship. This pitfall may be further exacerbated if the investigator also acts as sponsor or takes on another role that imposes even greater duties. The average physician, on the other hand, in the absence of the investigator's duties, has much greater discretion in how and if a physician-patient relationship is created. The differences between a typical medical malpractice setting and a clinical trial setting are likely substantial enough to warrant the defense bar's careful consideration of these exploratory medical-malpractice claims in future clinical trials litigation.

The burgeoning number of clinical trials and the relative paucity of reported decisions have opened the door for extension of medical malpractice theories into the clinical trials arena. The incursion has begun slowly, with plaintiffs trying to establish the mere possibility of the existence of a physician-patient relationship in this context. Even at this early stage, however, the problems posed by the potential adoption of this theory are evident. Although the physician-patient relationship is a relatively unlikely source of friction in day-to-day practice of medical malpractice defense, it may be more contentious as it spreads to new areas of law.

Anna A. Sumner is an attorney practicing in the Atlanta offices of Alston & Bird LLP.