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Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D. Mark R. Wick, M.D.

Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

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Page 1: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Medicolegal Issues in Anatomic Pathology

Medicolegal Issues in Anatomic Pathology

Mark R. Wick, M.D.Mark R. Wick, M.D.Mark R. Wick, M.D.Mark R. Wick, M.D.

Page 2: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Malpractice Claims: NecessitiesMalpractice Claims: Necessities

NegligenceNegligence:: Defined by “expert” testimony as Defined by “expert” testimony as medical practice that breaches the national or medical practice that breaches the national or regional standard of care. This is defined as regional standard of care. This is defined as the behavior expected of “prudent, careful, & the behavior expected of “prudent, careful, & informed” physician.informed” physician.

InjuryInjury:: Must be objectively documented and Must be objectively documented and judged to be the direct consequence of the judged to be the direct consequence of the negligent professional action.negligent professional action.

NegligenceNegligence:: Defined by “expert” testimony as Defined by “expert” testimony as medical practice that breaches the national or medical practice that breaches the national or regional standard of care. This is defined as regional standard of care. This is defined as the behavior expected of “prudent, careful, & the behavior expected of “prudent, careful, & informed” physician.informed” physician.

InjuryInjury:: Must be objectively documented and Must be objectively documented and judged to be the direct consequence of the judged to be the direct consequence of the negligent professional action.negligent professional action.

Page 3: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Items of Interest Regarding Medical Malpractice Lawsuits

Items of Interest Regarding Medical Malpractice Lawsuits

Some states have an institutional cap for damages that is Some states have an institutional cap for damages that is much much lessless than the cap for individual practitioners ( than the cap for individual practitioners (e.g.,e.g., in Virginia the MC cap is ~$100K, whereas the MD cap is in Virginia the MC cap is ~$100K, whereas the MD cap is $1.6 million)$1.6 million)

Selected states allow the plaintiff to file a separate civil Selected states allow the plaintiff to file a separate civil action against the action against the personal assetspersonal assets of the physician if there of the physician if there is a malpractice judgment against the doctor (double is a malpractice judgment against the doctor (double jeopardy)jeopardy)

The plaintiff’s lawyer is working on a contingency basis– The plaintiff’s lawyer is working on a contingency basis– up to 33% of the monetary award to the plaintiff goes to up to 33% of the monetary award to the plaintiff goes to the attorneythe attorney

Some states have an institutional cap for damages that is Some states have an institutional cap for damages that is much much lessless than the cap for individual practitioners ( than the cap for individual practitioners (e.g.,e.g., in Virginia the MC cap is ~$100K, whereas the MD cap is in Virginia the MC cap is ~$100K, whereas the MD cap is $1.6 million)$1.6 million)

Selected states allow the plaintiff to file a separate civil Selected states allow the plaintiff to file a separate civil action against the action against the personal assetspersonal assets of the physician if there of the physician if there is a malpractice judgment against the doctor (double is a malpractice judgment against the doctor (double jeopardy)jeopardy)

The plaintiff’s lawyer is working on a contingency basis– The plaintiff’s lawyer is working on a contingency basis– up to 33% of the monetary award to the plaintiff goes to up to 33% of the monetary award to the plaintiff goes to the attorneythe attorney

Page 4: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Lawsuits Against PathologistsLawsuits Against Pathologists

How likely is it that current practitioners in pathology How likely is it that current practitioners in pathology will be sued during their careers?will be sued during their careers? Largely dependent upon geographic locale of practice– both Largely dependent upon geographic locale of practice– both

coasts, Florida, Texas, Illinois, and selected other coasts, Florida, Texas, Illinois, and selected other cities/counties are “hotbeds” of plaintiff attorney activitycities/counties are “hotbeds” of plaintiff attorney activity

Subspecialty practice area is also important– Subspecialty practice area is also important– dermatopathology, cytopathology, & hematopathology are dermatopathology, cytopathology, & hematopathology are high-profile with regard to lawsuits against pathologistshigh-profile with regard to lawsuits against pathologists

Most pathologists now in practice will have at least one suit Most pathologists now in practice will have at least one suit filed against them during their careersfiled against them during their careers

How likely is it that current practitioners in pathology How likely is it that current practitioners in pathology will be sued during their careers?will be sued during their careers? Largely dependent upon geographic locale of practice– both Largely dependent upon geographic locale of practice– both

coasts, Florida, Texas, Illinois, and selected other coasts, Florida, Texas, Illinois, and selected other cities/counties are “hotbeds” of plaintiff attorney activitycities/counties are “hotbeds” of plaintiff attorney activity

Subspecialty practice area is also important– Subspecialty practice area is also important– dermatopathology, cytopathology, & hematopathology are dermatopathology, cytopathology, & hematopathology are high-profile with regard to lawsuits against pathologistshigh-profile with regard to lawsuits against pathologists

Most pathologists now in practice will have at least one suit Most pathologists now in practice will have at least one suit filed against them during their careersfiled against them during their careers

Page 5: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Lawsuits Against PathologistsLawsuits Against Pathologists

Clinically “significant” diagnostic error rate in Clinically “significant” diagnostic error rate in surgical pathology & cytopathology ranges from surgical pathology & cytopathology ranges from 0.25% to ~6% in the published literature0.25% to ~6% in the published literature

Factors contributing to this situation include a Factors contributing to this situation include a paucity of “hard” diagnostic criteria for many paucity of “hard” diagnostic criteria for many conditions, some variation in individual visual conditions, some variation in individual visual perception and decision-making, and incomplete or perception and decision-making, and incomplete or misleading clinical informationmisleading clinical information

Despite those realities, the American public & the Despite those realities, the American public & the plaintiff’s bar expect a “zero error standard”plaintiff’s bar expect a “zero error standard”

Clinically “significant” diagnostic error rate in Clinically “significant” diagnostic error rate in surgical pathology & cytopathology ranges from surgical pathology & cytopathology ranges from 0.25% to ~6% in the published literature0.25% to ~6% in the published literature

Factors contributing to this situation include a Factors contributing to this situation include a paucity of “hard” diagnostic criteria for many paucity of “hard” diagnostic criteria for many conditions, some variation in individual visual conditions, some variation in individual visual perception and decision-making, and incomplete or perception and decision-making, and incomplete or misleading clinical informationmisleading clinical information

Despite those realities, the American public & the Despite those realities, the American public & the plaintiff’s bar expect a “zero error standard”plaintiff’s bar expect a “zero error standard”

Page 6: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Surgical Pathology Claims Against the Doctors’ Company– 1998-2003

[Troxel DB: Am J Surg Pathol 2004; 28: 1092-1095]

Surgical Pathology Claims Against the Doctors’ Company– 1998-2003

[Troxel DB: Am J Surg Pathol 2004; 28: 1092-1095]

SpecimenSpecimen TypeType % Claims% Claims %FN%FN %FP%FP Total Claims (%)Total Claims (%)

Breast BxBreast Bx 4242 4848 5252 15.515.5MelanomaMelanoma 4444 9595 55 1616LymphomaLymphoma 1414 5757 4343 55FNA, Misc.FNA, Misc. 1010 4040 6060 3.53.5FNA, BreastFNA, Breast 55 4040 6060 22Gastric biopsyGastric biopsy 1212 4242 5858 4.54.5Prostate biopsyProstate biopsy 99 6767 3333 33Lung biopsyLung biopsy 1212 4242 5858 4.54.5GYN pathologyGYN pathology 3131 7474 1616 11.511.5Sarcoma pathologySarcoma pathology 1515 8080 2020 5.55.5Bladder pathologyBladder pathology 55 100100 00 22CystsCysts 33 100100 00 11MiscellaneousMiscellaneous 4848 6565 1919 26*26*______________________________________________________________________________________________________________________________________________________________________________________________

* Included cases involving failure to diagnose metastatic carcinoma (especially in lymph nodes), suits * Included cases involving failure to diagnose metastatic carcinoma (especially in lymph nodes), suits against primary pathologists for mistakes made by their consultants (“vicarious liability”), failure against primary pathologists for mistakes made by their consultants (“vicarious liability”), failure to solicit consultation or perform special diagnostic studies, frozen section misdiagnoses, and to solicit consultation or perform special diagnostic studies, frozen section misdiagnoses, and actions resulting from specimen misidentification, processing, or mistakes in written or verbal actions resulting from specimen misidentification, processing, or mistakes in written or verbal reportingreporting

SpecimenSpecimen TypeType % Claims% Claims %FN%FN %FP%FP Total Claims (%)Total Claims (%)

Breast BxBreast Bx 4242 4848 5252 15.515.5MelanomaMelanoma 4444 9595 55 1616LymphomaLymphoma 1414 5757 4343 55FNA, Misc.FNA, Misc. 1010 4040 6060 3.53.5FNA, BreastFNA, Breast 55 4040 6060 22Gastric biopsyGastric biopsy 1212 4242 5858 4.54.5Prostate biopsyProstate biopsy 99 6767 3333 33Lung biopsyLung biopsy 1212 4242 5858 4.54.5GYN pathologyGYN pathology 3131 7474 1616 11.511.5Sarcoma pathologySarcoma pathology 1515 8080 2020 5.55.5Bladder pathologyBladder pathology 55 100100 00 22CystsCysts 33 100100 00 11MiscellaneousMiscellaneous 4848 6565 1919 26*26*______________________________________________________________________________________________________________________________________________________________________________________________

* Included cases involving failure to diagnose metastatic carcinoma (especially in lymph nodes), suits * Included cases involving failure to diagnose metastatic carcinoma (especially in lymph nodes), suits against primary pathologists for mistakes made by their consultants (“vicarious liability”), failure against primary pathologists for mistakes made by their consultants (“vicarious liability”), failure to solicit consultation or perform special diagnostic studies, frozen section misdiagnoses, and to solicit consultation or perform special diagnostic studies, frozen section misdiagnoses, and actions resulting from specimen misidentification, processing, or mistakes in written or verbal actions resulting from specimen misidentification, processing, or mistakes in written or verbal reportingreporting

Page 7: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Changes in Claims Against Pathologists from 1995 to 2003– Data from The Doctors’ Company

Increased spectrum of claims, with regard to Increased spectrum of claims, with regard to organ systems and diagnosesorgan systems and diagnoses

Slight decrease in FNA-related claimsSlight decrease in FNA-related claims Slight increase in melanoma-related claimsSlight increase in melanoma-related claims NewNew areas of litigation– soft tissue pathology, areas of litigation– soft tissue pathology,

GYN pathology, bladder pathology, GYN pathology, bladder pathology, pulmonary pathologypulmonary pathology

Increased spectrum of claims, with regard to Increased spectrum of claims, with regard to organ systems and diagnosesorgan systems and diagnoses

Slight decrease in FNA-related claimsSlight decrease in FNA-related claims Slight increase in melanoma-related claimsSlight increase in melanoma-related claims NewNew areas of litigation– soft tissue pathology, areas of litigation– soft tissue pathology,

GYN pathology, bladder pathology, GYN pathology, bladder pathology, pulmonary pathologypulmonary pathology

Page 8: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Why are Pathologists Being Increasingly Targeted in Malpractice Suits?

Why are Pathologists Being Increasingly Targeted in Malpractice Suits?

We are, partially, victims of our own success, through efforts We are, partially, victims of our own success, through efforts of the CAP & ASCP to increase our public visibilityof the CAP & ASCP to increase our public visibility

““Because we are out there”… the plaintiff’s bar is always Because we are out there”… the plaintiff’s bar is always looking to extend its sphere of operations (beyond OB, looking to extend its sphere of operations (beyond OB, Anesthesia, ER Medicine, etc.)Anesthesia, ER Medicine, etc.)

The media and other physicians increasingly tell patients that The media and other physicians increasingly tell patients that we provide the “final answer” in their cases, and often we provide the “final answer” in their cases, and often misrepresent the strengths and weaknesses of pathologic tests misrepresent the strengths and weaknesses of pathologic tests & procedures& procedures ( (e.g., e.g., in Pap smear cases– c.f. A footnote in “A in Pap smear cases– c.f. A footnote in “A Case of Need” by Michael Crichton -Case of Need” by Michael Crichton -“The Papp [sic] smear is “The Papp [sic] smear is the most accurate diagnostic test in all of medicine”)the most accurate diagnostic test in all of medicine”)

We are, partially, victims of our own success, through efforts We are, partially, victims of our own success, through efforts of the CAP & ASCP to increase our public visibilityof the CAP & ASCP to increase our public visibility

““Because we are out there”… the plaintiff’s bar is always Because we are out there”… the plaintiff’s bar is always looking to extend its sphere of operations (beyond OB, looking to extend its sphere of operations (beyond OB, Anesthesia, ER Medicine, etc.)Anesthesia, ER Medicine, etc.)

The media and other physicians increasingly tell patients that The media and other physicians increasingly tell patients that we provide the “final answer” in their cases, and often we provide the “final answer” in their cases, and often misrepresent the strengths and weaknesses of pathologic tests misrepresent the strengths and weaknesses of pathologic tests & procedures& procedures ( (e.g., e.g., in Pap smear cases– c.f. A footnote in “A in Pap smear cases– c.f. A footnote in “A Case of Need” by Michael Crichton -Case of Need” by Michael Crichton -“The Papp [sic] smear is “The Papp [sic] smear is the most accurate diagnostic test in all of medicine”)the most accurate diagnostic test in all of medicine”)

Page 9: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

How Do Suits Against Pathologists Usually Happen?

How Do Suits Against Pathologists Usually Happen?

There is a “lag period”--- usually the biological evolution of the case over time, There is a “lag period”--- usually the biological evolution of the case over time, or referral of the patient and his/her pathologic specimens to other centers or referral of the patient and his/her pathologic specimens to other centers occasions a change in diagnosis and incites the filing of a suit after legal occasions a change in diagnosis and incites the filing of a suit after legal consultationconsultation

The initial pathologist is usually blind-sided; there is rarely a continuous train of The initial pathologist is usually blind-sided; there is rarely a continuous train of information which culminates in the lawsuitinformation which culminates in the lawsuit

Sometimes the only “fault” of the pathologist is being the person on the signout Sometimes the only “fault” of the pathologist is being the person on the signout schedule when a “systems” mistake occurs; schedule when a “systems” mistake occurs; e.g.,e.g., the mislabeling or mixup of a the mislabeling or mixup of a specimenspecimen

The pathologist and/or the hospital is served with a written “bill of complaint” The pathologist and/or the hospital is served with a written “bill of complaint” from the court, usually necessitating personal delivery from a law enforcement from the court, usually necessitating personal delivery from a law enforcement officerofficer

The bill of complaint details the alleged act(s) of malpractice and the supposed The bill of complaint details the alleged act(s) of malpractice and the supposed consequences to the patient (consequences to the patient (i.e., i.e., the damages)the damages)

There is a “lag period”--- usually the biological evolution of the case over time, There is a “lag period”--- usually the biological evolution of the case over time, or referral of the patient and his/her pathologic specimens to other centers or referral of the patient and his/her pathologic specimens to other centers occasions a change in diagnosis and incites the filing of a suit after legal occasions a change in diagnosis and incites the filing of a suit after legal consultationconsultation

The initial pathologist is usually blind-sided; there is rarely a continuous train of The initial pathologist is usually blind-sided; there is rarely a continuous train of information which culminates in the lawsuitinformation which culminates in the lawsuit

Sometimes the only “fault” of the pathologist is being the person on the signout Sometimes the only “fault” of the pathologist is being the person on the signout schedule when a “systems” mistake occurs; schedule when a “systems” mistake occurs; e.g.,e.g., the mislabeling or mixup of a the mislabeling or mixup of a specimenspecimen

The pathologist and/or the hospital is served with a written “bill of complaint” The pathologist and/or the hospital is served with a written “bill of complaint” from the court, usually necessitating personal delivery from a law enforcement from the court, usually necessitating personal delivery from a law enforcement officerofficer

The bill of complaint details the alleged act(s) of malpractice and the supposed The bill of complaint details the alleged act(s) of malpractice and the supposed consequences to the patient (consequences to the patient (i.e., i.e., the damages)the damages)

Page 10: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Consultation with Risk ManagersConsultation with Risk Managers

Virtually all medical centers and medical schools have Virtually all medical centers and medical schools have departments of risk management; these should be departments of risk management; these should be contacted contacted immediatelyimmediately if it is thought that a particular case if it is thought that a particular case is at risk for a lawsuit. RM personnel would much rather is at risk for a lawsuit. RM personnel would much rather deal with many cases that “never go anywhere” than with deal with many cases that “never go anywhere” than with problems they know about only after the filing of a bill of problems they know about only after the filing of a bill of complaintcomplaint

Conversations, meetings, and correspondence with RM Conversations, meetings, and correspondence with RM personnel are typically regarded as privileged under the personnel are typically regarded as privileged under the law, and the contents thereof are not “discoverable” by law, and the contents thereof are not “discoverable” by plaintiff’s attorneysplaintiff’s attorneys

Cases with serious procedural irregularities, major changes Cases with serious procedural irregularities, major changes in diagnosis, or anything inciting anger by the patient (or in diagnosis, or anything inciting anger by the patient (or their family) should be referred to risk managementtheir family) should be referred to risk management immediatelyimmediately

As a general rule, pathologists should As a general rule, pathologists should nevernever speak to speak to plaintiffs directly after a suit has been threatened or filed, plaintiffs directly after a suit has been threatened or filed, or should do so or should do so onlyonly after consulting RM regarding known after consulting RM regarding known case-related problemscase-related problems

Virtually all medical centers and medical schools have Virtually all medical centers and medical schools have departments of risk management; these should be departments of risk management; these should be contacted contacted immediatelyimmediately if it is thought that a particular case if it is thought that a particular case is at risk for a lawsuit. RM personnel would much rather is at risk for a lawsuit. RM personnel would much rather deal with many cases that “never go anywhere” than with deal with many cases that “never go anywhere” than with problems they know about only after the filing of a bill of problems they know about only after the filing of a bill of complaintcomplaint

Conversations, meetings, and correspondence with RM Conversations, meetings, and correspondence with RM personnel are typically regarded as privileged under the personnel are typically regarded as privileged under the law, and the contents thereof are not “discoverable” by law, and the contents thereof are not “discoverable” by plaintiff’s attorneysplaintiff’s attorneys

Cases with serious procedural irregularities, major changes Cases with serious procedural irregularities, major changes in diagnosis, or anything inciting anger by the patient (or in diagnosis, or anything inciting anger by the patient (or their family) should be referred to risk managementtheir family) should be referred to risk management immediatelyimmediately

As a general rule, pathologists should As a general rule, pathologists should nevernever speak to speak to plaintiffs directly after a suit has been threatened or filed, plaintiffs directly after a suit has been threatened or filed, or should do so or should do so onlyonly after consulting RM regarding known after consulting RM regarding known case-related problemscase-related problems

Staying Out ofTrouble-101

Page 11: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

What Should be Done After Receiving a Bill of Complaint (BOC)?

What Should be Done After Receiving a Bill of Complaint (BOC)?

Meet with the attorney representing your hospital or Meet with the attorney representing your hospital or organization, as well as yourself, after sending them the organization, as well as yourself, after sending them the BOC to studyBOC to study

Your lawyer(s) will gather information about the case Your lawyer(s) will gather information about the case from you and others, to prepare a written document from you and others, to prepare a written document called a “response”– this is your protestation of called a “response”– this is your protestation of innocence of the charges made and is filed with the court innocence of the charges made and is filed with the court and the plaintiff’s attorneyand the plaintiff’s attorney

NEVERNEVER speak or correspond in any way with the speak or correspond in any way with the plaintiff’s counsel after the process has begun, except in plaintiff’s counsel after the process has begun, except in the presence of your attorney(s)the presence of your attorney(s)

Meet with the attorney representing your hospital or Meet with the attorney representing your hospital or organization, as well as yourself, after sending them the organization, as well as yourself, after sending them the BOC to studyBOC to study

Your lawyer(s) will gather information about the case Your lawyer(s) will gather information about the case from you and others, to prepare a written document from you and others, to prepare a written document called a “response”– this is your protestation of called a “response”– this is your protestation of innocence of the charges made and is filed with the court innocence of the charges made and is filed with the court and the plaintiff’s attorneyand the plaintiff’s attorney

NEVERNEVER speak or correspond in any way with the speak or correspond in any way with the plaintiff’s counsel after the process has begun, except in plaintiff’s counsel after the process has begun, except in the presence of your attorney(s)the presence of your attorney(s)

Page 12: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Things to NEVER Do If You are Afraid of a Lawsuit or Have Already Been Sued

Regarding a Specific Case

Things to NEVER Do If You are Afraid of a Lawsuit or Have Already Been Sued

Regarding a Specific Case

NEVER talk to other people who have been named in the suit about NEVER talk to other people who have been named in the suit about

any details of the case, & any details of the case, & certainlycertainly never attempt to influence never attempt to influence their remembrance of details or events;their remembrance of details or events;

NEVER try to alter or discard records, slides, or any other tangible NEVER try to alter or discard records, slides, or any other tangible evidence;evidence;

NEVER speak or correspond directly with the patients, their family NEVER speak or correspond directly with the patients, their family members, or their attorneys about the case;members, or their attorneys about the case;

NEVER try to deflect your own potential culpability by blaming NEVER try to deflect your own potential culpability by blaming others (“passing the poisoned buck”)– it is unprofessional and others (“passing the poisoned buck”)– it is unprofessional and hasn’t a prayer of working…hasn’t a prayer of working…

NEVER talk to other people who have been named in the suit about NEVER talk to other people who have been named in the suit about

any details of the case, & any details of the case, & certainlycertainly never attempt to influence never attempt to influence their remembrance of details or events;their remembrance of details or events;

NEVER try to alter or discard records, slides, or any other tangible NEVER try to alter or discard records, slides, or any other tangible evidence;evidence;

NEVER speak or correspond directly with the patients, their family NEVER speak or correspond directly with the patients, their family members, or their attorneys about the case;members, or their attorneys about the case;

NEVER try to deflect your own potential culpability by blaming NEVER try to deflect your own potential culpability by blaming others (“passing the poisoned buck”)– it is unprofessional and others (“passing the poisoned buck”)– it is unprofessional and hasn’t a prayer of working…hasn’t a prayer of working…

Page 13: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

“Life On the Cheap”---Attorneys Trying to Get Something for Nothing

Lawyers will sometimes attempt to bully their way into getting free Lawyers will sometimes attempt to bully their way into getting free information by trying to talk with housestaff who are attached to an information by trying to talk with housestaff who are attached to an attending physician being sued, attending physician being sued, oror they will co-name the resident(s) and they will co-name the resident(s) and try to talk with them first (free, of course…);try to talk with them first (free, of course…);

““Treating physicians” (attending doctors involved in the case but not Treating physicians” (attending doctors involved in the case but not being sued) will be contacted for a deposition by the plaintiff’s being sued) will be contacted for a deposition by the plaintiff’s attorney, regarding the defendants’ actions;attorney, regarding the defendants’ actions;

ALLALL physicians being asked legal questions about a case in which they physicians being asked legal questions about a case in which they are involved should have their own attorneys present; are involved should have their own attorneys present; if they are not if they are not named in the suit, they have the right to ask for reimbursement for their named in the suit, they have the right to ask for reimbursement for their time & efforts, and should do so.time & efforts, and should do so.

Lawyers will sometimes attempt to bully their way into getting free Lawyers will sometimes attempt to bully their way into getting free information by trying to talk with housestaff who are attached to an information by trying to talk with housestaff who are attached to an attending physician being sued, attending physician being sued, oror they will co-name the resident(s) and they will co-name the resident(s) and try to talk with them first (free, of course…);try to talk with them first (free, of course…);

““Treating physicians” (attending doctors involved in the case but not Treating physicians” (attending doctors involved in the case but not being sued) will be contacted for a deposition by the plaintiff’s being sued) will be contacted for a deposition by the plaintiff’s attorney, regarding the defendants’ actions;attorney, regarding the defendants’ actions;

ALLALL physicians being asked legal questions about a case in which they physicians being asked legal questions about a case in which they are involved should have their own attorneys present; are involved should have their own attorneys present; if they are not if they are not named in the suit, they have the right to ask for reimbursement for their named in the suit, they have the right to ask for reimbursement for their time & efforts, and should do so.time & efforts, and should do so.

Page 14: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

The Medical “Expert” or “Authority”—CAUTION!The Medical “Expert” or “Authority”—CAUTION!

The meaning of “expert” or “authority” (or The meaning of “expert” or “authority” (or “authorit“authoritativeative”) is ”) is veryvery different in the law and in different in the law and in common medical parlancecommon medical parlance

In a legal context, all of these terms imply In a legal context, all of these terms imply infallibility– therefore, infallibility– therefore, each wordeach word in a textbook or in a textbook or treatise that is deemed “authoritative” is, by treatise that is deemed “authoritative” is, by definition, unassailably correct definition, unassailably correct

The word “scholarly” is much preferred in verbal or The word “scholarly” is much preferred in verbal or written discourse about medical opinions and written discourse about medical opinions and publications– it carries no such hidden meaningpublications– it carries no such hidden meaning

The meaning of “expert” or “authority” (or The meaning of “expert” or “authority” (or “authorit“authoritativeative”) is ”) is veryvery different in the law and in different in the law and in common medical parlancecommon medical parlance

In a legal context, all of these terms imply In a legal context, all of these terms imply infallibility– therefore, infallibility– therefore, each wordeach word in a textbook or in a textbook or treatise that is deemed “authoritative” is, by treatise that is deemed “authoritative” is, by definition, unassailably correct definition, unassailably correct

The word “scholarly” is much preferred in verbal or The word “scholarly” is much preferred in verbal or written discourse about medical opinions and written discourse about medical opinions and publications– it carries no such hidden meaningpublications– it carries no such hidden meaning

Page 15: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Malpractice Suits– Not Scarlet LettersMalpractice Suits– Not Scarlet Letters

Physicians who are sued, and who have Physicians who are sued, and who have not committed wrongful acts out of true not committed wrongful acts out of true negligence or personal impairment (negligence or personal impairment (e.g.,e.g., substance abuse) should substance abuse) should notnot take the take the action personally if at all possible– it is action personally if at all possible– it is a a businessbusiness proposition for attorneys and proposition for attorneys and nothing morenothing more

Personal counseling by a psychiatrist or Personal counseling by a psychiatrist or psychologist is a good idea to work psychologist is a good idea to work through these concepts and avoid self-through these concepts and avoid self-recriminationrecrimination

Physicians who are sued, and who have Physicians who are sued, and who have not committed wrongful acts out of true not committed wrongful acts out of true negligence or personal impairment (negligence or personal impairment (e.g.,e.g., substance abuse) should substance abuse) should notnot take the take the action personally if at all possible– it is action personally if at all possible– it is a a businessbusiness proposition for attorneys and proposition for attorneys and nothing morenothing more

Personal counseling by a psychiatrist or Personal counseling by a psychiatrist or psychologist is a good idea to work psychologist is a good idea to work through these concepts and avoid self-through these concepts and avoid self-recriminationrecrimination

MM

Page 16: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Specific Topics & Subspecialty Areas in Pathology Malpractice

Specific Topics & Subspecialty Areas in Pathology Malpractice

Page 17: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

ELEMENTS OF HISTOLOGICAL TISSUE PROCESSING THAT CAN RESULT IN LEGAL

CLAIMS OF “NEGLIGENCE”

ELEMENTS OF HISTOLOGICAL TISSUE PROCESSING THAT CAN RESULT IN LEGAL

CLAIMS OF “NEGLIGENCE”

Errors in:Errors in: Prosection and fixation of the specimen by the pathologist Prosection and fixation of the specimen by the pathologist

(or mixup of specimens by persons unknown before receipt in (or mixup of specimens by persons unknown before receipt in the pathology laboratory)the pathology laboratory)

Automated tissue processingAutomated tissue processing Paraffin embeddingParaffin embedding Microtomy & slide preparationMicrotomy & slide preparation Histochemical stainingHistochemical staining CoverslippingCoverslipping InterpretationInterpretation

Errors in:Errors in: Prosection and fixation of the specimen by the pathologist Prosection and fixation of the specimen by the pathologist

(or mixup of specimens by persons unknown before receipt in (or mixup of specimens by persons unknown before receipt in the pathology laboratory)the pathology laboratory)

Automated tissue processingAutomated tissue processing Paraffin embeddingParaffin embedding Microtomy & slide preparationMicrotomy & slide preparation Histochemical stainingHistochemical staining CoverslippingCoverslipping InterpretationInterpretation

Page 18: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

SOURCES OF TISSUE “FLOATERS” IN MICROSCOPIC SECTIONS THAT CAN RESULT IN

MISTAKES IN DIAGNOSIS

SOURCES OF TISSUE “FLOATERS” IN MICROSCOPIC SECTIONS THAT CAN RESULT IN

MISTAKES IN DIAGNOSIS

““Cutting board” floaters (flawed prosection Cutting board” floaters (flawed prosection technique in the gross room)technique in the gross room)

Automated tissue processor mishaps Automated tissue processor mishaps (transplantation of small tissue fragments (transplantation of small tissue fragments

from one specimen to another via instrument from one specimen to another via instrument solutions)solutions)

Embedding room mistakesEmbedding room mistakes Poor water bath techniquePoor water bath technique

““Cutting board” floaters (flawed prosection Cutting board” floaters (flawed prosection technique in the gross room)technique in the gross room)

Automated tissue processor mishaps Automated tissue processor mishaps (transplantation of small tissue fragments (transplantation of small tissue fragments

from one specimen to another via instrument from one specimen to another via instrument solutions)solutions)

Embedding room mistakesEmbedding room mistakes Poor water bath techniquePoor water bath technique

Page 19: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative CaseIllustrative Case: Tissue Processing Mistakes : Tissue Processing Mistakes as Sources of a Lawsuitas Sources of a Lawsuit

____________________________________________________________________________________

Illustrative CaseIllustrative Case: Tissue Processing Mistakes : Tissue Processing Mistakes as Sources of a Lawsuitas Sources of a Lawsuit

____________________________________________________________________________________

A 53 year old woman complained of persistent dyspepsia A 53 year old woman complained of persistent dyspepsia and was subjected to a gastroesophagoduodenoscopy. and was subjected to a gastroesophagoduodenoscopy. The gastroenterologist saw only “mild gastritis,” but The gastroenterologist saw only “mild gastritis,” but obtained several biopsies. These were unexpectedly read obtained several biopsies. These were unexpectedly read as showing enteric-type adenocarcinoma, and a partial as showing enteric-type adenocarcinoma, and a partial gastrectomy was subsequently performed. There was no gastrectomy was subsequently performed. There was no evidence of malignancy in the resection specimen, despite evidence of malignancy in the resection specimen, despite the fact that the entire mucosal surface was blocked for the fact that the entire mucosal surface was blocked for microscopic examination.microscopic examination.

A 53 year old woman complained of persistent dyspepsia A 53 year old woman complained of persistent dyspepsia and was subjected to a gastroesophagoduodenoscopy. and was subjected to a gastroesophagoduodenoscopy. The gastroenterologist saw only “mild gastritis,” but The gastroenterologist saw only “mild gastritis,” but obtained several biopsies. These were unexpectedly read obtained several biopsies. These were unexpectedly read as showing enteric-type adenocarcinoma, and a partial as showing enteric-type adenocarcinoma, and a partial gastrectomy was subsequently performed. There was no gastrectomy was subsequently performed. There was no evidence of malignancy in the resection specimen, despite evidence of malignancy in the resection specimen, despite the fact that the entire mucosal surface was blocked for the fact that the entire mucosal surface was blocked for microscopic examination.microscopic examination.

Page 20: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

“Floaters” in Surgical Pathology: Potential Sources of Lawsuits

Biopsies from gastric biopsy specimen, taken from clinical “mild gastritis”Biopsies from gastric biopsy specimen, taken from clinical “mild gastritis”

Blood group Ag immunostains done after negative gastrectomy procedureBlood group Ag immunostains done after negative gastrectomy procedure

Biopsies from gastric biopsy specimen, taken from clinical “mild gastritis”Biopsies from gastric biopsy specimen, taken from clinical “mild gastritis”

Blood group Ag immunostains done after negative gastrectomy procedureBlood group Ag immunostains done after negative gastrectomy procedure

BGABGB

Page 21: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: Tissue Sampling Issues as the Source of a Lawsuit

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Illustrative Case: Tissue Sampling Issues as the Source of a Lawsuit

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A 46 year old woman had a needle core breast biopsy in 1995 for a A 46 year old woman had a needle core breast biopsy in 1995 for a self-detected lesion in the right breast. It was interpreted as showing self-detected lesion in the right breast. It was interpreted as showing fibrocystic changes only, and because the mammographer did not fibrocystic changes only, and because the mammographer did not have a high level of suspicion for malignancy, nothing further was have a high level of suspicion for malignancy, nothing further was done. In 1997, the patient presented with right supraclavicular done. In 1997, the patient presented with right supraclavicular lymphadenopathy, and a lymph node biopsy showed metastatic lymphadenopathy, and a lymph node biopsy showed metastatic breast carcinoma (GCDFP-15+/ERP+). The lesion in the right breast carcinoma (GCDFP-15+/ERP+). The lesion in the right breast was now larger and radiographically atypical, and excision of breast was now larger and radiographically atypical, and excision of it showed invasive ductal carcinoma. When recuts of the 1995 it showed invasive ductal carcinoma. When recuts of the 1995 biopsy were prepared for referral of the patient to another medical biopsy were prepared for referral of the patient to another medical center, a focus of invasive carcinoma was seen that had not been center, a focus of invasive carcinoma was seen that had not been represented in the original set of slides.represented in the original set of slides.

A 46 year old woman had a needle core breast biopsy in 1995 for a A 46 year old woman had a needle core breast biopsy in 1995 for a self-detected lesion in the right breast. It was interpreted as showing self-detected lesion in the right breast. It was interpreted as showing fibrocystic changes only, and because the mammographer did not fibrocystic changes only, and because the mammographer did not have a high level of suspicion for malignancy, nothing further was have a high level of suspicion for malignancy, nothing further was done. In 1997, the patient presented with right supraclavicular done. In 1997, the patient presented with right supraclavicular lymphadenopathy, and a lymph node biopsy showed metastatic lymphadenopathy, and a lymph node biopsy showed metastatic breast carcinoma (GCDFP-15+/ERP+). The lesion in the right breast carcinoma (GCDFP-15+/ERP+). The lesion in the right breast was now larger and radiographically atypical, and excision of breast was now larger and radiographically atypical, and excision of it showed invasive ductal carcinoma. When recuts of the 1995 it showed invasive ductal carcinoma. When recuts of the 1995 biopsy were prepared for referral of the patient to another medical biopsy were prepared for referral of the patient to another medical center, a focus of invasive carcinoma was seen that had not been center, a focus of invasive carcinoma was seen that had not been represented in the original set of slides.represented in the original set of slides.

Page 22: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Sampling Errors in Preparation of Histologic Slides

Sampling Errors in Preparation of Histologic Slides

Sampling errors in histology can be limited by good laboratory Sampling errors in histology can be limited by good laboratory technique, but theytechnique, but they cannotcannot be eliminated entirely be eliminated entirely

RecommendationsRecommendations:: Ask histotechnologists to mount Ask histotechnologists to mount severalseveral tissue cuts from small tissue cuts from small

biopsies on biopsies on eacheach slide, and obtain at least 3 levels of each tissue slide, and obtain at least 3 levels of each tissue blockblock

Instruct histotechnologists to be sure to “face into” blocks Instruct histotechnologists to be sure to “face into” blocks appropriatelyappropriately

AlwaysAlways have pathologists review any recuts that are prepared on have pathologists review any recuts that are prepared on cases being sent away to other institutions, and compare them cases being sent away to other institutions, and compare them with the original sectionswith the original sections

Sampling errors in histology can be limited by good laboratory Sampling errors in histology can be limited by good laboratory technique, but theytechnique, but they cannotcannot be eliminated entirely be eliminated entirely

RecommendationsRecommendations:: Ask histotechnologists to mount Ask histotechnologists to mount severalseveral tissue cuts from small tissue cuts from small

biopsies on biopsies on eacheach slide, and obtain at least 3 levels of each tissue slide, and obtain at least 3 levels of each tissue blockblock

Instruct histotechnologists to be sure to “face into” blocks Instruct histotechnologists to be sure to “face into” blocks appropriatelyappropriately

AlwaysAlways have pathologists review any recuts that are prepared on have pathologists review any recuts that are prepared on cases being sent away to other institutions, and compare them cases being sent away to other institutions, and compare them with the original sectionswith the original sections

Page 23: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Education of Histotechnologists on Medicolegal Matters

Plaintiffs’ attorneys are becoming increasingly aware Plaintiffs’ attorneys are becoming increasingly aware of the details of tissue processing and slide preparation of the details of tissue processing and slide preparation in the histology laboratoryin the histology laboratory

The anonymity of the technologist no longer protects The anonymity of the technologist no longer protects him or her from being the target of a lawsuit, alone or him or her from being the target of a lawsuit, alone or as a “representative” of the medical centeras a “representative” of the medical center

Educational efforts should therefore be directed at Educational efforts should therefore be directed at histotechnologists in regard to their liability and histotechnologists in regard to their liability and counter-measures to minimize mistakes and document counter-measures to minimize mistakes and document ongoing quality assurance programs in the laboratoryongoing quality assurance programs in the laboratory

Plaintiffs’ attorneys are becoming increasingly aware Plaintiffs’ attorneys are becoming increasingly aware of the details of tissue processing and slide preparation of the details of tissue processing and slide preparation in the histology laboratoryin the histology laboratory

The anonymity of the technologist no longer protects The anonymity of the technologist no longer protects him or her from being the target of a lawsuit, alone or him or her from being the target of a lawsuit, alone or as a “representative” of the medical centeras a “representative” of the medical center

Educational efforts should therefore be directed at Educational efforts should therefore be directed at histotechnologists in regard to their liability and histotechnologists in regard to their liability and counter-measures to minimize mistakes and document counter-measures to minimize mistakes and document ongoing quality assurance programs in the laboratoryongoing quality assurance programs in the laboratory

Page 24: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

HematopathologyHematopathology

Cases concerning failure to diagnose Cases concerning failure to diagnose lymphoma principally concern the confusion lymphoma principally concern the confusion of follicular lymphoma with lymphoid of follicular lymphoma with lymphoid hyperplasia, and failure to recognize hyperplasia, and failure to recognize extranodalextranodal lymphomas lymphomas

Confusion between lymphoma/leukemia and Confusion between lymphoma/leukemia and EBV or other viral infections and reactive EBV or other viral infections and reactive hematolymphoproliferations is also a pitfall hematolymphoproliferations is also a pitfall in this area in this area

A high index of suspicion is essential in these A high index of suspicion is essential in these instances; immunophenotyping and at-least-instances; immunophenotyping and at-least-internal consultation (with documentation internal consultation (with documentation thereof in the report) are strongly thereof in the report) are strongly recommendedrecommended

Cases concerning failure to diagnose Cases concerning failure to diagnose lymphoma principally concern the confusion lymphoma principally concern the confusion of follicular lymphoma with lymphoid of follicular lymphoma with lymphoid hyperplasia, and failure to recognize hyperplasia, and failure to recognize extranodalextranodal lymphomas lymphomas

Confusion between lymphoma/leukemia and Confusion between lymphoma/leukemia and EBV or other viral infections and reactive EBV or other viral infections and reactive hematolymphoproliferations is also a pitfall hematolymphoproliferations is also a pitfall in this area in this area

A high index of suspicion is essential in these A high index of suspicion is essential in these instances; immunophenotyping and at-least-instances; immunophenotyping and at-least-internal consultation (with documentation internal consultation (with documentation thereof in the report) are strongly thereof in the report) are strongly recommendedrecommended

EBV

“LIP”

Page 25: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: Misdiagnosis of Non-Hodgkin’s Lymphoma

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Illustrative Case: Misdiagnosis of Non-Hodgkin’s Lymphoma

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A 41 year old man presented with rapidly-worsening abdominal pain A 41 year old man presented with rapidly-worsening abdominal pain and was found by abdominal MRI scan to have a thickened bowel and was found by abdominal MRI scan to have a thickened bowel segment at the ileocecal junction. He underwent laparotomy and segment at the ileocecal junction. He underwent laparotomy and resection of the intestine. Because of the presence of transmural resection of the intestine. Because of the presence of transmural chronic inflammation and fibrosis in the bowel wall, a diagnosis of chronic inflammation and fibrosis in the bowel wall, a diagnosis of Crohn’s disease was made. Despite treatment with steroids, the Crohn’s disease was made. Despite treatment with steroids, the patient had recurrent abdominal pain & weight loss and was found 9 patient had recurrent abdominal pain & weight loss and was found 9 months later to have a huge retroperitoneal mass. A biopsy months later to have a huge retroperitoneal mass. A biopsy established the diagnosis of large-cell lymphoma, and retrospective established the diagnosis of large-cell lymphoma, and retrospective review of the original bowel resection disclosed tumor in that review of the original bowel resection disclosed tumor in that specimen as well. The patient died 3 months later.specimen as well. The patient died 3 months later.

A 41 year old man presented with rapidly-worsening abdominal pain A 41 year old man presented with rapidly-worsening abdominal pain and was found by abdominal MRI scan to have a thickened bowel and was found by abdominal MRI scan to have a thickened bowel segment at the ileocecal junction. He underwent laparotomy and segment at the ileocecal junction. He underwent laparotomy and resection of the intestine. Because of the presence of transmural resection of the intestine. Because of the presence of transmural chronic inflammation and fibrosis in the bowel wall, a diagnosis of chronic inflammation and fibrosis in the bowel wall, a diagnosis of Crohn’s disease was made. Despite treatment with steroids, the Crohn’s disease was made. Despite treatment with steroids, the patient had recurrent abdominal pain & weight loss and was found 9 patient had recurrent abdominal pain & weight loss and was found 9 months later to have a huge retroperitoneal mass. A biopsy months later to have a huge retroperitoneal mass. A biopsy established the diagnosis of large-cell lymphoma, and retrospective established the diagnosis of large-cell lymphoma, and retrospective review of the original bowel resection disclosed tumor in that review of the original bowel resection disclosed tumor in that specimen as well. The patient died 3 months later.specimen as well. The patient died 3 months later.

Page 26: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

CD20

Resection specimen of ileocecal mass– gross & microscopic images

Page 27: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Where Do Immunostains Stand in Malpractice Actions?

Up until 1999, pathologists were “in limbo” in Up until 1999, pathologists were “in limbo” in regard to IHC, because stains were not certified by regard to IHC, because stains were not certified by the FDA for clinical use, and yet they were “state the FDA for clinical use, and yet they were “state of the art” in actual practiceof the art” in actual practice

Now, IHC is indeed considered a necessity of Now, IHC is indeed considered a necessity of “standard of practice;” it most often enters “standard of practice;” it most often enters medicolegal considerations where a lymphoma is medicolegal considerations where a lymphoma is misdiagnosed as another form of undifferentiated misdiagnosed as another form of undifferentiated tumor & the wrong treatment is given tumor & the wrong treatment is given subsequentlysubsequently

Up until 1999, pathologists were “in limbo” in Up until 1999, pathologists were “in limbo” in regard to IHC, because stains were not certified by regard to IHC, because stains were not certified by the FDA for clinical use, and yet they were “state the FDA for clinical use, and yet they were “state of the art” in actual practiceof the art” in actual practice

Now, IHC is indeed considered a necessity of Now, IHC is indeed considered a necessity of “standard of practice;” it most often enters “standard of practice;” it most often enters medicolegal considerations where a lymphoma is medicolegal considerations where a lymphoma is misdiagnosed as another form of undifferentiated misdiagnosed as another form of undifferentiated tumor & the wrong treatment is given tumor & the wrong treatment is given subsequentlysubsequently

Page 28: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

DermatopathologyDermatopathology

The principal area of liability is that of The principal area of liability is that of missed melanoma diagnosis; however, missed melanoma diagnosis; however, suits have also been filed for suits have also been filed for overoverdiagnosis diagnosis of nevi as forms of melanoma;of nevi as forms of melanoma;

Another source of medicolegal action in Another source of medicolegal action in dermatopathology is the underdiagnosis of dermatopathology is the underdiagnosis of squamous cell carcinoma or basal cell squamous cell carcinoma or basal cell carcinoma, with subsequent complications carcinoma, with subsequent complications from local tumor growthfrom local tumor growth

The principal area of liability is that of The principal area of liability is that of missed melanoma diagnosis; however, missed melanoma diagnosis; however, suits have also been filed for suits have also been filed for overoverdiagnosis diagnosis of nevi as forms of melanoma;of nevi as forms of melanoma;

Another source of medicolegal action in Another source of medicolegal action in dermatopathology is the underdiagnosis of dermatopathology is the underdiagnosis of squamous cell carcinoma or basal cell squamous cell carcinoma or basal cell carcinoma, with subsequent complications carcinoma, with subsequent complications from local tumor growthfrom local tumor growth

Page 29: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

“Spitzoid” Melanoma

Page 30: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Pagetoid Spitz Nevus

Page 31: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Desmoplastic Melanoma Misinterpreted as Scar

Page 32: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Squamous Carcinoma Misinterpreted asPseudoepitheliomatous Hyperplasia

Page 33: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: Misdiagnosis of Malignant Melanoma

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Illustrative Case: Misdiagnosis of Malignant Melanoma

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A 35 year old woman had a 4 cm. irregularly pigmented lesion in the A 35 year old woman had a 4 cm. irregularly pigmented lesion in the skin of the left leg, for which she consulted a dermatologist. He took skin of the left leg, for which she consulted a dermatologist. He took a 3 mm. punch biopsy from the periphery of the mass, which was a 3 mm. punch biopsy from the periphery of the mass, which was interpreted pathologically as showing a compound nevus. The interpreted pathologically as showing a compound nevus. The patient was told she had a benign process and that it need not be patient was told she had a benign process and that it need not be excised. When the mass enlarged and began to bleed 11 months excised. When the mass enlarged and began to bleed 11 months later, the patient saw another dermatologist who immediately did a later, the patient saw another dermatologist who immediately did a complete excision. That specimen showed an obvious melanoma in complete excision. That specimen showed an obvious melanoma in vertical growth, with a Breslow depth of 4.1 mm., associated with a vertical growth, with a Breslow depth of 4.1 mm., associated with a compound nevus. The woman subsequently manifested metastases compound nevus. The woman subsequently manifested metastases in the brain and died 2 years later. The pathologist was sued but the in the brain and died 2 years later. The pathologist was sued but the first dermatologist was not.first dermatologist was not.

A 35 year old woman had a 4 cm. irregularly pigmented lesion in the A 35 year old woman had a 4 cm. irregularly pigmented lesion in the skin of the left leg, for which she consulted a dermatologist. He took skin of the left leg, for which she consulted a dermatologist. He took a 3 mm. punch biopsy from the periphery of the mass, which was a 3 mm. punch biopsy from the periphery of the mass, which was interpreted pathologically as showing a compound nevus. The interpreted pathologically as showing a compound nevus. The patient was told she had a benign process and that it need not be patient was told she had a benign process and that it need not be excised. When the mass enlarged and began to bleed 11 months excised. When the mass enlarged and began to bleed 11 months later, the patient saw another dermatologist who immediately did a later, the patient saw another dermatologist who immediately did a complete excision. That specimen showed an obvious melanoma in complete excision. That specimen showed an obvious melanoma in vertical growth, with a Breslow depth of 4.1 mm., associated with a vertical growth, with a Breslow depth of 4.1 mm., associated with a compound nevus. The woman subsequently manifested metastases compound nevus. The woman subsequently manifested metastases in the brain and died 2 years later. The pathologist was sued but the in the brain and died 2 years later. The pathologist was sued but the first dermatologist was not.first dermatologist was not.

Page 34: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Cautionary Notes to Avoid Dermatopathology MisstepsCautionary Notes to Avoid

Dermatopathology Missteps

If clinical information indicates that a melanocytic lesion If clinical information indicates that a melanocytic lesion is larger than a biopsy in hand would suggest, make a is larger than a biopsy in hand would suggest, make a disclamatory statement in the report which indicates the disclamatory statement in the report which indicates the possibility of sampling error and suggests that excision possibility of sampling error and suggests that excision would be prudent;would be prudent;

If the biology of a melanocytic lesion cannot be If the biology of a melanocytic lesion cannot be determined with certainty, determined with certainty, do not try to do sodo not try to do so!;!;

If a keratinocytic proliferation has been only superficially If a keratinocytic proliferation has been only superficially sampled, avoid a definitive interpretation; the term sampled, avoid a definitive interpretation; the term “atypical squamous proliferation” is a good alternative“atypical squamous proliferation” is a good alternative

If clinical information indicates that a melanocytic lesion If clinical information indicates that a melanocytic lesion is larger than a biopsy in hand would suggest, make a is larger than a biopsy in hand would suggest, make a disclamatory statement in the report which indicates the disclamatory statement in the report which indicates the possibility of sampling error and suggests that excision possibility of sampling error and suggests that excision would be prudent;would be prudent;

If the biology of a melanocytic lesion cannot be If the biology of a melanocytic lesion cannot be determined with certainty, determined with certainty, do not try to do sodo not try to do so!;!;

If a keratinocytic proliferation has been only superficially If a keratinocytic proliferation has been only superficially sampled, avoid a definitive interpretation; the term sampled, avoid a definitive interpretation; the term “atypical squamous proliferation” is a good alternative“atypical squamous proliferation” is a good alternative

Page 35: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Breast Biopsies-- Substrates for Malpractice Actions

Breast Biopsies-- Substrates for Malpractice Actions

Sources of legal claims pertaining Sources of legal claims pertaining to breast biopsies:to breast biopsies: Failure to ink margins and Failure to ink margins and

corresponding inability to corresponding inability to comment on themcomment on them

Failure to provide information Failure to provide information on tumor grade, type, size, on tumor grade, type, size, vascular invasion, surgical vascular invasion, surgical margins, hormone receptor margins, hormone receptor status, and associated status, and associated microscopic findings in the microscopic findings in the excised breast tissueexcised breast tissue

Failure to distinguish in the Failure to distinguish in the report between in-situ and report between in-situ and invasive carcinomainvasive carcinoma

Sources of legal claims pertaining Sources of legal claims pertaining to breast biopsies:to breast biopsies: Failure to ink margins and Failure to ink margins and

corresponding inability to corresponding inability to comment on themcomment on them

Failure to provide information Failure to provide information on tumor grade, type, size, on tumor grade, type, size, vascular invasion, surgical vascular invasion, surgical margins, hormone receptor margins, hormone receptor status, and associated status, and associated microscopic findings in the microscopic findings in the excised breast tissueexcised breast tissue

Failure to distinguish in the Failure to distinguish in the report between in-situ and report between in-situ and invasive carcinomainvasive carcinoma

ERP

Page 36: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Synoptic Reporting Forms in Surgical Pathology: Keeping the Wolf from the Door

Synoptic Reporting Forms in Surgical Pathology: Keeping the Wolf from the Door

Breast J 2001 Jul-Aug;7(4):271-274

Synoptic/Checklist Reporting of Breast Biopsies: Has the Time Come?Leong ASY.

Narrative descriptive reporting has been the traditional format employed in surgical pathology for almost as long as its inception as a specialty. While the descriptive prose has served us well in the past, its accuracy and readability is variable. Descriptions of color, shape, and texture are often subjective. Surgical pathologists are trained observers, but there are inherent differences in reporting style, and descriptive prowess depends on language skills and vocabulary. These differences are reflected in reports generated by pathologists in the same laboratory and may even be more evident in reports from different laboratories and across nations using the English language. The reproducibility of morphologic descriptions is thus a matter of some concern.

Breast J 2001 Jul-Aug;7(4):271-274

Synoptic/Checklist Reporting of Breast Biopsies: Has the Time Come?Leong ASY.

Narrative descriptive reporting has been the traditional format employed in surgical pathology for almost as long as its inception as a specialty. While the descriptive prose has served us well in the past, its accuracy and readability is variable. Descriptions of color, shape, and texture are often subjective. Surgical pathologists are trained observers, but there are inherent differences in reporting style, and descriptive prowess depends on language skills and vocabulary. These differences are reflected in reports generated by pathologists in the same laboratory and may even be more evident in reports from different laboratories and across nations using the English language. The reproducibility of morphologic descriptions is thus a matter of some concern.

Page 37: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

FNA Misdiagnoses & Malpractice Suits

FNA Misdiagnoses & Malpractice Suits

The most common site of lesions for which The most common site of lesions for which FNA misdiagnosis results in lawsuits is the FNA misdiagnosis results in lawsuits is the breast-- this is because surgeons will often breast-- this is because surgeons will often perform definitive surgery based perform definitive surgery based principally on the FNA result and may principally on the FNA result and may ignore other data;ignore other data;

Sparsely-cellular specimens should Sparsely-cellular specimens should notnot be be interpreted with certainty, because of the interpreted with certainty, because of the high rate of false-negative error that high rate of false-negative error that attends them;attends them;

The most common source of false-The most common source of false-positivity is positivity is cellular fibroadenomacellular fibroadenoma; ; hence, if that lesion is in the clinical DDx, hence, if that lesion is in the clinical DDx, the pathologist should be cautious in the pathologist should be cautious in making a diagnosis of CAmaking a diagnosis of CA

The most common site of lesions for which The most common site of lesions for which FNA misdiagnosis results in lawsuits is the FNA misdiagnosis results in lawsuits is the breast-- this is because surgeons will often breast-- this is because surgeons will often perform definitive surgery based perform definitive surgery based principally on the FNA result and may principally on the FNA result and may ignore other data;ignore other data;

Sparsely-cellular specimens should Sparsely-cellular specimens should notnot be be interpreted with certainty, because of the interpreted with certainty, because of the high rate of false-negative error that high rate of false-negative error that attends them;attends them;

The most common source of false-The most common source of false-positivity is positivity is cellular fibroadenomacellular fibroadenoma; ; hence, if that lesion is in the clinical DDx, hence, if that lesion is in the clinical DDx, the pathologist should be cautious in the pathologist should be cautious in making a diagnosis of CAmaking a diagnosis of CA

Page 38: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: FNA Misdiagnosis of Breast Carcinoma

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Illustrative Case: FNA Misdiagnosis of Breast Carcinoma

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A 37 year old woman palpated a mass in the left breast on self-A 37 year old woman palpated a mass in the left breast on self-examination, which was confirmed by her internist. examination, which was confirmed by her internist. Mammographic examination yielded indeterminate results Mammographic examination yielded indeterminate results with respect to the probable malignancy of the lesion, and a with respect to the probable malignancy of the lesion, and a consulting surgeon likewise was unsure whether the lesion was consulting surgeon likewise was unsure whether the lesion was carcinomatous or not. An FNA was performed, and a carcinomatous or not. An FNA was performed, and a diagnosis of adenocarcinoma was rendered by the pathologist. diagnosis of adenocarcinoma was rendered by the pathologist. Based on that information, the surgeon proceeded directly to a Based on that information, the surgeon proceeded directly to a simple mastectomy (the woman had small breasts). Surgical simple mastectomy (the woman had small breasts). Surgical pathologic examination of the lesion showed that it was a pathologic examination of the lesion showed that it was a cellular fibroadenoma. There was no evidence of cellular fibroadenoma. There was no evidence of in-situin-situ or or invasive malignancy in the excised breast.invasive malignancy in the excised breast.

A 37 year old woman palpated a mass in the left breast on self-A 37 year old woman palpated a mass in the left breast on self-examination, which was confirmed by her internist. examination, which was confirmed by her internist. Mammographic examination yielded indeterminate results Mammographic examination yielded indeterminate results with respect to the probable malignancy of the lesion, and a with respect to the probable malignancy of the lesion, and a consulting surgeon likewise was unsure whether the lesion was consulting surgeon likewise was unsure whether the lesion was carcinomatous or not. An FNA was performed, and a carcinomatous or not. An FNA was performed, and a diagnosis of adenocarcinoma was rendered by the pathologist. diagnosis of adenocarcinoma was rendered by the pathologist. Based on that information, the surgeon proceeded directly to a Based on that information, the surgeon proceeded directly to a simple mastectomy (the woman had small breasts). Surgical simple mastectomy (the woman had small breasts). Surgical pathologic examination of the lesion showed that it was a pathologic examination of the lesion showed that it was a cellular fibroadenoma. There was no evidence of cellular fibroadenoma. There was no evidence of in-situin-situ or or invasive malignancy in the excised breast.invasive malignancy in the excised breast.

Page 39: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Fine needle aspiration biopsy of left breast mass

Page 40: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Excision of left breast mass

Page 41: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Cautionary Notes Regarding FNA of the Breast

Cautionary Notes Regarding FNA of the Breast

Avoid overinterpretation of sparsely cellular specimens;Avoid overinterpretation of sparsely cellular specimens; ALWAYSALWAYS seek information on results of physical seek information on results of physical

examination and mammography, before a final examination and mammography, before a final cytologic diagnosis is made (the “triple test”);cytologic diagnosis is made (the “triple test”);

If there are doubts as to the finality of a diagnosis of If there are doubts as to the finality of a diagnosis of carcinoma in the FNA, advise the surgeon to perform a carcinoma in the FNA, advise the surgeon to perform a frozen section of the lesion before a definite surgical frozen section of the lesion before a definite surgical approach is takenapproach is taken

Avoid overinterpretation of sparsely cellular specimens;Avoid overinterpretation of sparsely cellular specimens; ALWAYSALWAYS seek information on results of physical seek information on results of physical

examination and mammography, before a final examination and mammography, before a final cytologic diagnosis is made (the “triple test”);cytologic diagnosis is made (the “triple test”);

If there are doubts as to the finality of a diagnosis of If there are doubts as to the finality of a diagnosis of carcinoma in the FNA, advise the surgeon to perform a carcinoma in the FNA, advise the surgeon to perform a frozen section of the lesion before a definite surgical frozen section of the lesion before a definite surgical approach is takenapproach is taken

Page 42: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: FNA Misdiagnosis of Sarcoma

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Illustrative Case: FNA Misdiagnosis of Sarcoma

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A 24 year old man had a painless mass in the right A 24 year old man had a painless mass in the right Achilles tendon, which had enlarged slowly over a 6 Achilles tendon, which had enlarged slowly over a 6 month period. He consulted an orthopedist, who month period. He consulted an orthopedist, who performed a fine needle aspiration biopsy on the performed a fine needle aspiration biopsy on the lesion. It was interpreted as showing “pigmented lesion. It was interpreted as showing “pigmented villonodular tenosynovitis,” and no further therapy villonodular tenosynovitis,” and no further therapy was recommended. Eight months later, the mass was recommended. Eight months later, the mass was larger still and it was excised, showing a clear-was larger still and it was excised, showing a clear-cell sarcoma. Three years thereafter, chest cell sarcoma. Three years thereafter, chest radiographs demonstrated pulmonary metastases. radiographs demonstrated pulmonary metastases.

A 24 year old man had a painless mass in the right A 24 year old man had a painless mass in the right Achilles tendon, which had enlarged slowly over a 6 Achilles tendon, which had enlarged slowly over a 6 month period. He consulted an orthopedist, who month period. He consulted an orthopedist, who performed a fine needle aspiration biopsy on the performed a fine needle aspiration biopsy on the lesion. It was interpreted as showing “pigmented lesion. It was interpreted as showing “pigmented villonodular tenosynovitis,” and no further therapy villonodular tenosynovitis,” and no further therapy was recommended. Eight months later, the mass was recommended. Eight months later, the mass was larger still and it was excised, showing a clear-was larger still and it was excised, showing a clear-cell sarcoma. Three years thereafter, chest cell sarcoma. Three years thereafter, chest radiographs demonstrated pulmonary metastases. radiographs demonstrated pulmonary metastases.

Page 43: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Fine needle aspiration biopsy of mass in Achilles tendon

Page 44: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Excision of mass in Achilles tendon

Page 45: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Non-FNA, Non-GYN Cytology Specimens & Malpractice SuitsNon-FNA, Non-GYN Cytology Specimens & Malpractice Suits

Exfoliative pulmonary cytology Exfoliative pulmonary cytology specimens are relatively high-risk specimens are relatively high-risk medicolegally, because definitive medicolegally, because definitive surgery may be undertaken based upon surgery may be undertaken based upon them;them;

False-positive results (owing to the False-positive results (owing to the effects of infarcts, granulomas, alveolar effects of infarcts, granulomas, alveolar damage, & other causes) are more damage, & other causes) are more damaging than false-negative findings, damaging than false-negative findings, although the latter are not although the latter are not inconsequential (inconsequential (e.g.,e.g., failure to make a failure to make a timely diagnosis of small-cell carcinoma timely diagnosis of small-cell carcinoma in sputum)in sputum)

Exfoliative pulmonary cytology Exfoliative pulmonary cytology specimens are relatively high-risk specimens are relatively high-risk medicolegally, because definitive medicolegally, because definitive surgery may be undertaken based upon surgery may be undertaken based upon them;them;

False-positive results (owing to the False-positive results (owing to the effects of infarcts, granulomas, alveolar effects of infarcts, granulomas, alveolar damage, & other causes) are more damage, & other causes) are more damaging than false-negative findings, damaging than false-negative findings, although the latter are not although the latter are not inconsequential (inconsequential (e.g.,e.g., failure to make a failure to make a timely diagnosis of small-cell carcinoma timely diagnosis of small-cell carcinoma in sputum)in sputum)

Page 46: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: Cytological Misdiagnosis of Lung Cancer

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Illustrative Case: Cytological Misdiagnosis of Lung Cancer

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A 56 year old man was found to have a cavitary lesion in the A 56 year old man was found to have a cavitary lesion in the mid-left lung field, in a set of screening chest radiographs. mid-left lung field, in a set of screening chest radiographs. He underwent examination of several sputum cytology He underwent examination of several sputum cytology specimens, which were negative for malignancy. specimens, which were negative for malignancy. Subsequently, a bronchoscopy was performed with Subsequently, a bronchoscopy was performed with bronchial brushing and washing. Cytologic specimens from bronchial brushing and washing. Cytologic specimens from those procedures were interpreted as showing non-small-those procedures were interpreted as showing non-small-cell carcinoma. A left pneumonectomy was performed, cell carcinoma. A left pneumonectomy was performed, pathologic examination of which demonstrated only a pathologic examination of which demonstrated only a histoplasmoma with surrounding bronchial atypical histoplasmoma with surrounding bronchial atypical squamous metaplasia. There was no evidence of squamous metaplasia. There was no evidence of in-situin-situ or or invasive malignancy.invasive malignancy.

A 56 year old man was found to have a cavitary lesion in the A 56 year old man was found to have a cavitary lesion in the mid-left lung field, in a set of screening chest radiographs. mid-left lung field, in a set of screening chest radiographs. He underwent examination of several sputum cytology He underwent examination of several sputum cytology specimens, which were negative for malignancy. specimens, which were negative for malignancy. Subsequently, a bronchoscopy was performed with Subsequently, a bronchoscopy was performed with bronchial brushing and washing. Cytologic specimens from bronchial brushing and washing. Cytologic specimens from those procedures were interpreted as showing non-small-those procedures were interpreted as showing non-small-cell carcinoma. A left pneumonectomy was performed, cell carcinoma. A left pneumonectomy was performed, pathologic examination of which demonstrated only a pathologic examination of which demonstrated only a histoplasmoma with surrounding bronchial atypical histoplasmoma with surrounding bronchial atypical squamous metaplasia. There was no evidence of squamous metaplasia. There was no evidence of in-situin-situ or or invasive malignancy.invasive malignancy.

Page 47: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Chest radiograph & bronchial brushing cytology specimen

Page 48: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Resection specimen (upper left-H&E; upper right- GMS; lower- atypicalbronchial epithelial metaplasia)

Page 49: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Intraoperative Followup of Exfoliative Cytologic Diagnosis of Lung Carcinoma

Intraoperative Followup of Exfoliative Cytologic Diagnosis of Lung Carcinoma

When exfoliative cytology is the When exfoliative cytology is the onlyonly source of source of a diagnosis of lung cancer, it is wise to prompt a diagnosis of lung cancer, it is wise to prompt the surgeon to ask for a frozen section on the the surgeon to ask for a frozen section on the lesion before proceeding with a lobectomy (or lesion before proceeding with a lobectomy (or more);more);

Granulomas, infarcts, organizing pneumonias, Granulomas, infarcts, organizing pneumonias, and other benign processes may yield false-and other benign processes may yield false-positive cytologic resultspositive cytologic results

When exfoliative cytology is the When exfoliative cytology is the onlyonly source of source of a diagnosis of lung cancer, it is wise to prompt a diagnosis of lung cancer, it is wise to prompt the surgeon to ask for a frozen section on the the surgeon to ask for a frozen section on the lesion before proceeding with a lobectomy (or lesion before proceeding with a lobectomy (or more);more);

Granulomas, infarcts, organizing pneumonias, Granulomas, infarcts, organizing pneumonias, and other benign processes may yield false-and other benign processes may yield false-positive cytologic resultspositive cytologic results

Page 50: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

The Pap Smear Crisis

In the past 15 years, plaintiffs’ attorneys have discovered Pap smears as a In the past 15 years, plaintiffs’ attorneys have discovered Pap smears as a “growth industry,” ignoring the fact that they are “growth industry,” ignoring the fact that they are screeningscreening tests and tests and notnot intended for definitive diagnosis. The main issue is whether “atypical cells” intended for definitive diagnosis. The main issue is whether “atypical cells” (no matter how scant) have been missed on smears preceding another one (no matter how scant) have been missed on smears preceding another one (or a biopsy) that is diagnostic for SIL or invasive SCC. (or a biopsy) that is diagnostic for SIL or invasive SCC. The situation is The situation is worsened by the growing presence of several unscrupulous plaintiffs’ worsened by the growing presence of several unscrupulous plaintiffs’ “experts” who will testify to virtually anything in this arena.“experts” who will testify to virtually anything in this arena.

In the past 15 years, plaintiffs’ attorneys have discovered Pap smears as a In the past 15 years, plaintiffs’ attorneys have discovered Pap smears as a “growth industry,” ignoring the fact that they are “growth industry,” ignoring the fact that they are screeningscreening tests and tests and notnot intended for definitive diagnosis. The main issue is whether “atypical cells” intended for definitive diagnosis. The main issue is whether “atypical cells” (no matter how scant) have been missed on smears preceding another one (no matter how scant) have been missed on smears preceding another one (or a biopsy) that is diagnostic for SIL or invasive SCC. (or a biopsy) that is diagnostic for SIL or invasive SCC. The situation is The situation is worsened by the growing presence of several unscrupulous plaintiffs’ worsened by the growing presence of several unscrupulous plaintiffs’ “experts” who will testify to virtually anything in this arena.“experts” who will testify to virtually anything in this arena.

Page 51: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Pap Smears: What Are the Facts?Pap Smears: What Are the Facts?

Pap smears are associated with a 70-80% decrease in cervical cancer-associated death rates.

The irreducible false-negative Pap fraction is > 5 %.

“Atypical cells of undetermined significance” is a poorly defined category with poor interobserver and intraobserver reproducibility.

Pap-smear slides should be reviewed legally by "reasonable pathologists" without knowledge of clinical outcome or details of pending litigation.

A 5-10% false-negative rate is an admirable goal; a 15-20% rate is a more feasible standard.

Pap smears are associated with a 70-80% decrease in cervical cancer-associated death rates.

The irreducible false-negative Pap fraction is > 5 %.

“Atypical cells of undetermined significance” is a poorly defined category with poor interobserver and intraobserver reproducibility.

Pap-smear slides should be reviewed legally by "reasonable pathologists" without knowledge of clinical outcome or details of pending litigation.

A 5-10% false-negative rate is an admirable goal; a 15-20% rate is a more feasible standard.

Page 52: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Bethesda Terminology: EssentialsBethesda Terminology: Essentials

There is absolutely no There is absolutely no place for the old “Pap” place for the old “Pap” designations in designations in interpreting GYN interpreting GYN cytology;cytology;

The updated Bethesda The updated Bethesda terms, terms, with therapeutic with therapeutic recommendationsrecommendations, are , are advisedadvised

There is absolutely no There is absolutely no place for the old “Pap” place for the old “Pap” designations in designations in interpreting GYN interpreting GYN cytology;cytology;

The updated Bethesda The updated Bethesda terms, terms, with therapeutic with therapeutic recommendationsrecommendations, are , are advisedadvised

Page 53: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Illustrative Case: Pap Smear “Miss” or Not?______________________________________

Illustrative Case: Pap Smear “Miss” or Not?______________________________________

A 36 year old married G2P2 woman had yearly Pap smears A 36 year old married G2P2 woman had yearly Pap smears that were interpreted as showing “reactive epithelial changes” that were interpreted as showing “reactive epithelial changes” from 1995 through 1997. In 1998, she presented with from 1995 through 1997. In 1998, she presented with postcoital spotting and colposcopy showed a small cervical postcoital spotting and colposcopy showed a small cervical lesion at 5:00. Biopsy revealed microinvasive squamous lesion at 5:00. Biopsy revealed microinvasive squamous carcinoma. Review of one 1997 Pap smear showed 2 atypical carcinoma. Review of one 1997 Pap smear showed 2 atypical squamous cells that were felt to be reactive by 2 expert squamous cells that were felt to be reactive by 2 expert witnesses and “ASCUS; cannot rule out a high-grade lesion” witnesses and “ASCUS; cannot rule out a high-grade lesion” by the plaintiff’s expert. The patient had a hysterectomy and by the plaintiff’s expert. The patient had a hysterectomy and sued because she said she had been prevented from expanding sued because she said she had been prevented from expanding her family as she had wished to do.her family as she had wished to do.

A 36 year old married G2P2 woman had yearly Pap smears A 36 year old married G2P2 woman had yearly Pap smears that were interpreted as showing “reactive epithelial changes” that were interpreted as showing “reactive epithelial changes” from 1995 through 1997. In 1998, she presented with from 1995 through 1997. In 1998, she presented with postcoital spotting and colposcopy showed a small cervical postcoital spotting and colposcopy showed a small cervical lesion at 5:00. Biopsy revealed microinvasive squamous lesion at 5:00. Biopsy revealed microinvasive squamous carcinoma. Review of one 1997 Pap smear showed 2 atypical carcinoma. Review of one 1997 Pap smear showed 2 atypical squamous cells that were felt to be reactive by 2 expert squamous cells that were felt to be reactive by 2 expert witnesses and “ASCUS; cannot rule out a high-grade lesion” witnesses and “ASCUS; cannot rule out a high-grade lesion” by the plaintiff’s expert. The patient had a hysterectomy and by the plaintiff’s expert. The patient had a hysterectomy and sued because she said she had been prevented from expanding sued because she said she had been prevented from expanding her family as she had wished to do.her family as she had wished to do.

Page 54: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

1997 Smear

Page 55: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

1998 Conization Specimen

Page 56: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Suggestions Regarding Administration of GYN Cytology

Suggestions Regarding Administration of GYN Cytology

Comply rigidly with all regulations set forth by state governing Comply rigidly with all regulations set forth by state governing agencies, CLIA, CAP, & JCAHO regarding handling of Pap agencies, CLIA, CAP, & JCAHO regarding handling of Pap smears, & keep strict documentation;smears, & keep strict documentation;

Make certain that continuing cytology-related educational Make certain that continuing cytology-related educational activities for cytotechnologists and pathologists meet or exceed activities for cytotechnologists and pathologists meet or exceed recommended guidelines;recommended guidelines;

Make sure that a regular cytopathology-surgical pathology Make sure that a regular cytopathology-surgical pathology correlation conference is held in regard to GYN specimens, and correlation conference is held in regard to GYN specimens, and keep good documentation of such;keep good documentation of such;

DISCARDDISCARD all Pap smears that are older than the period all Pap smears that are older than the period prescribed in the local legal statute of limitationsprescribed in the local legal statute of limitations

Comply rigidly with all regulations set forth by state governing Comply rigidly with all regulations set forth by state governing agencies, CLIA, CAP, & JCAHO regarding handling of Pap agencies, CLIA, CAP, & JCAHO regarding handling of Pap smears, & keep strict documentation;smears, & keep strict documentation;

Make certain that continuing cytology-related educational Make certain that continuing cytology-related educational activities for cytotechnologists and pathologists meet or exceed activities for cytotechnologists and pathologists meet or exceed recommended guidelines;recommended guidelines;

Make sure that a regular cytopathology-surgical pathology Make sure that a regular cytopathology-surgical pathology correlation conference is held in regard to GYN specimens, and correlation conference is held in regard to GYN specimens, and keep good documentation of such;keep good documentation of such;

DISCARDDISCARD all Pap smears that are older than the period all Pap smears that are older than the period prescribed in the local legal statute of limitationsprescribed in the local legal statute of limitations

Page 57: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

What is the “Standard of Care” in Surgical Pathology & Cytopathology?

““Standard of care” is defined as the “practice of a Standard of care” is defined as the “practice of a reasonable, careful, informed, & prudent physician who is reasonable, careful, informed, & prudent physician who is board-certified in his or her specialty”board-certified in his or her specialty”

This description does This description does notnot mandate that one have mandate that one have subsubspecialty board certification to make diagnoses in specialty board certification to make diagnoses in hematopathology, dermatopathology, cytopathology, etc.hematopathology, dermatopathology, cytopathology, etc.

It also does It also does notnot imply that all difficult cases in surgical imply that all difficult cases in surgical pathology or cytopathology must be sent to consultants pathology or cytopathology must be sent to consultants who are outside of one’s own institutionwho are outside of one’s own institution

Showing a case to internal colleagues, and documenting that Showing a case to internal colleagues, and documenting that this has been done and what the consensus diagnostic this has been done and what the consensus diagnostic opinion is, constitutes adherence to the standard of care, opinion is, constitutes adherence to the standard of care, even if the diagnosis proves to be incorrect!even if the diagnosis proves to be incorrect!

““Standard of care” is defined as the “practice of a Standard of care” is defined as the “practice of a reasonable, careful, informed, & prudent physician who is reasonable, careful, informed, & prudent physician who is board-certified in his or her specialty”board-certified in his or her specialty”

This description does This description does notnot mandate that one have mandate that one have subsubspecialty board certification to make diagnoses in specialty board certification to make diagnoses in hematopathology, dermatopathology, cytopathology, etc.hematopathology, dermatopathology, cytopathology, etc.

It also does It also does notnot imply that all difficult cases in surgical imply that all difficult cases in surgical pathology or cytopathology must be sent to consultants pathology or cytopathology must be sent to consultants who are outside of one’s own institutionwho are outside of one’s own institution

Showing a case to internal colleagues, and documenting that Showing a case to internal colleagues, and documenting that this has been done and what the consensus diagnostic this has been done and what the consensus diagnostic opinion is, constitutes adherence to the standard of care, opinion is, constitutes adherence to the standard of care, even if the diagnosis proves to be incorrect!even if the diagnosis proves to be incorrect!

Page 58: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Serving As An “Expert” Witness

Serving As An “Expert” Witness

Page 59: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

General Rules for Expert Testimony

General Rules for Expert Testimony

Keep your testimony factual, and clearly within your area of Keep your testimony factual, and clearly within your area of professional knowledge; there is no place for advocacy or wild professional knowledge; there is no place for advocacy or wild opinion in medicolegal work;opinion in medicolegal work;

Charge reasonably for your time; Charge reasonably for your time; Seriously consider requests to serve as an expert if you are Seriously consider requests to serve as an expert if you are

asked to do so; if you don’t, some unscrupulous person asked to do so; if you don’t, some unscrupulous person may…;may…;

Don’t let yourself be tricked or goaded by attorneys; they Don’t let yourself be tricked or goaded by attorneys; they operate by rules that are completely different than those operate by rules that are completely different than those applying to scientific or medical endeavorsapplying to scientific or medical endeavors

Keep your testimony factual, and clearly within your area of Keep your testimony factual, and clearly within your area of professional knowledge; there is no place for advocacy or wild professional knowledge; there is no place for advocacy or wild opinion in medicolegal work;opinion in medicolegal work;

Charge reasonably for your time; Charge reasonably for your time; Seriously consider requests to serve as an expert if you are Seriously consider requests to serve as an expert if you are

asked to do so; if you don’t, some unscrupulous person asked to do so; if you don’t, some unscrupulous person may…;may…;

Don’t let yourself be tricked or goaded by attorneys; they Don’t let yourself be tricked or goaded by attorneys; they operate by rules that are completely different than those operate by rules that are completely different than those applying to scientific or medical endeavorsapplying to scientific or medical endeavors

Page 60: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D

Contributory Areas of the Law for Pathology Experts

Contributory Areas of the Law for Pathology Experts

Diagnostic accuracy & timeliness;Diagnostic accuracy & timeliness; ““Causation”-- a broad term encompassing the Causation”-- a broad term encompassing the

pathophysiologic basis of disease, etiology, pathophysiologic basis of disease, etiology, epidemiology, and temporal evolution of a epidemiology, and temporal evolution of a pathologic conditionpathologic condition ( (e.g.,e.g., did a delayed diagnosis did a delayed diagnosis of malignancy really of malignancy really causecause metastasis, or did it metastasis, or did it occur before the tumor was first noticed by the occur before the tumor was first noticed by the patient, based on the best evidence in hand?)patient, based on the best evidence in hand?)

Diagnostic accuracy & timeliness;Diagnostic accuracy & timeliness; ““Causation”-- a broad term encompassing the Causation”-- a broad term encompassing the

pathophysiologic basis of disease, etiology, pathophysiologic basis of disease, etiology, epidemiology, and temporal evolution of a epidemiology, and temporal evolution of a pathologic conditionpathologic condition ( (e.g.,e.g., did a delayed diagnosis did a delayed diagnosis of malignancy really of malignancy really causecause metastasis, or did it metastasis, or did it occur before the tumor was first noticed by the occur before the tumor was first noticed by the patient, based on the best evidence in hand?)patient, based on the best evidence in hand?)

Page 61: Medicolegal Issues in Anatomic Pathology Mark R. Wick, M.D