Friday, August 21, 2009

Evidence-based medicine in court: if you don't know what evidence-based medicine is, read on. Chances are it will soon play a part in one of your case

Evidence-based medicine in court: if you don't know what evidence-based medicine is, read on. Chances are it will soon play a part in one of your cases.

Author: Peters, J. Douglas
Geographic Code: 1USA
Date: Jul 1, 2002
Words: 3428
Publication: Trial
ISSN: 0041-2538

Seven years ago, Alan Trach went to see his dentist for pain in his jaw. The dentist prescribed the antibiotic Amoxil, and Trach took the prescription to Thrift Drug to be filled. The pharmacist's assistant on duty mistakenly filled the prescription with Doxepin, an antidepressant.

After taking the Doxepin at the dosage the dentist had prescribed for Amoxil, Trach began to experience strange sensations, including shakiness, confusion, nausea, and headaches. He also had difficulty walking and talking. The next day, Trach began having vision problems in his right eye.

Trach had taken 23 of the 40 pills prescribed when he learned that he had been given the wrong medicine and had been taking it in an amount that was four times the maximum daily dosage. He suffers permanent neurological injury and glaucoma as a result of the overdose.

At trial in a lawsuit against the pharmacy and others, Trach's medical expert, John Shane, admitted that there were no references in the medical literature showing that overdoses of Doxepin could cause brain and eye injury. For obvious reasons, no one had given overdoses of Doxepin to human subjects in an empirical study.

Instead, Shane extrapolated from the elements of anatomy, physiology, and biochemistry, testifying that Doxepin interferes with the transmission of the neurotransmitter acetylcholine, causing an anticholinergic effect (the blocking of impulses through the parasympathetic nerves). Shane also testified that Trach's symptoms were consistent with the adverse reactions identified in the manufacturer's package insert for Doxepin and in the Physicians Desk Reference (PDR). The jury found for Trach, and the defendants appealed.

Pennsylvania Superior Court Judge Phyllis Beck reversed the judgment and ordered a new trial on damages (liability had been conceded). (1) She found that it was "impossible to infer from the PDR that the scientific community generally accepts the proposition that an overdose of Doxepin can cause glaucoma."

The judge noted that "the absence of medical literature or published studies relating the effects of an overdose should not in itself bar the testimony. However, in the absence of systematic studies, the trial court must examine the methodology underlying the expert's testimony." Accepting the testimony of the defense experts, Beck found that Shane's methodology was "flawed and not generally accepted."

Experts who practice in fields that have traditionally involved both art and science--including doctors, lawyers, and educators--and who offer opinion testimony must be prepared to back it up with scientific proof. Expert opinions that are based on logic or fundamental laws of science, like Shane's, are increasingly disallowed by post-Daubert courts acting as gatekeepers. (2)

Consequently, plaintiffs are being cut off at the pass; juries never even get to consider the value of their experts' testimony. Instead, courts are increasingly allowing expert testimony that merely parrots epidemiologic studies, even poorly designed ones. The substance of this testimony is generally referred to as "evidence-based medicine," and it is supplanting the traditional battle of the experts in litigation.

Coined by researchers in the early 1990s, (3) the term "evidence-based medicine" describes a clinical strategy that uses current research findings as the basis for medical treatment decisions. It has been defined as the "conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients." (4)

Medical professionals, who have traditionally had wide latitude in making clinical decisions, are increasingly turning to this accumulated "best evidence," which narrows the choice of treatments to established norms. (5) Rooted in epidemiology, evidence-based medicine can be used to make decisions regarding a patient's diagnosis, prognosis, or ongoing care. (6)

Developments in clinical research over the last 40 years have led to this paradigm shift. In 1960, the randomized clinical trial was a rarity. Today, no drug can enter the market without a clinical demonstration of its safety and efficacy. Similar trials are increasingly being applied to surgical therapies and diagnostic tests. In essence, these studies have become the basis for the practice of medicine--evidence-based medicine.

Many courts view evidence-based medicine as a "science" that can establish medical standards of care--called clinical practice guidelines (CPGs)--and resolve causation questions. Honestly developed evidence-based medicine and clinical practice guidelines can be a boon to health care and help ensure just outcomes in civil litigation. But when these guidelines have been corrupted, either directly or as a result of manipulated medical studies, they can be used to gain unjust results. (7)

Evidentiary guidelines

American courts often have struggled with the problems of accepting or rejecting evidence produced by emerging technologies (for example, DNA analysis, fingerprints, and lie detectors). These struggles have produced a string of decisions guiding and empowering judges in making evidentiary decisions. How evidence-based medicine and CPGs will fare in light of these decisions remains to be seen, but we can make some predictions.

Frye v. United States held that evidence is admissible only if it is sufficiently established to have gained general acceptance in the pertinent field. (8) The general acceptance standard would be irrelevant to a court that looks to evidence-based medicine as the criterion for accepting or rejecting expert testimony. If an expert's opinion could not be supported by empirical evidence and study replicability, it is foreseeable that mere expert opinion alone will not suffice.

United States v. Barker held that trial judges had the right and responsibility to determine "whether or not to allow the jury to consider a proffered expert's opinions ... [and whether the opinion] will most likely assist the trier of fact in arriving at the truth." (9) This case clearly empowered judges, in their role as gatekeepers, to exclude expert opinion testimony. As evidence-based medicine gains acceptance in the courts, judges probably will exclude opinion testimony that lacks statistical/ epidemiological foundation. Unfortunately, much of the medical-expert opinion testimony offered today does not have epidemiological support.

The purpose of our court system is to reach just outcomes, not necessarily to determine the scientific truth of every underlying issue. We hope judges will recognize this and allow opinion testimony when there is consensual, if not statistical, support for it, especially when the subject of the testimony has not yet been subjected to epidemiological study. If judges, on the other hand, disallow all expert opinion testimony lacking epidemiological proof, many parties in both civil and criminal cases will be severely restricted in the evidence they can offer to support their positions.

In Daubert v. Merrell Dow Pharmaceuticals, Inc., the U.S. Supreme Court inched closer to creating an objective standard for weighing expert testimony: It determined that the trial judge, acting as gatekeeper, is responsible for insuring that an expert's testimony rests on a reliable foundation and is relevant to the task at hand. (10) The question is, does a "reliable foundation" require epidemiological proof?

If the answer to that question is yes, consider the impact of General Electric Co. v. Joiner. (11) In that case, the Supreme Court affirmed a trial judge's decision to exclude evidence, based on animal studies, that supported the plaintiff's claim that PCBs cause cancer. This presents a problem for plaintiffs in similar cases. Because medical ethics and the Geneva Convention limit human experimentation, many epidemiological studies on humans are not possible.

In Kumho Tire Co. v. Carmichael, the Supreme Court said that a trial judge has broad discretion in applying Daubert standards for assessing the admissibility of expert evidence. (12) Because plaintiffs in civil cases and prosecutors in criminal cases bear the burden of proof, they are the most likely to be adversely affected by the convergence of evidence-based medicine, CPGs, and the high bar of admissibility implicit in Daubert. That decision, coupled with Kumho Tire, puts science--and the judges who judge it--in the position to replace juries in weighing expert testimony.

In Weisgram v. Marley Co., the Supreme Court held that federal appellate courts can direct a district court to enter judgment notwithstanding the verdict against a winning plaintiff if the reviewing court finds that testimony admitted at the trial level is unreliable and inadmissible under Daubert. (13)

To date, evidence-based medicine has been used most to resolve questions of causation rather than standards of care. As more CPGs are developed, however, opinion testimony as to both causation and standard of care will be subject to Daubert or Frye challenges based on evidence-based medicine and CPGs. (14)

Lawyers and judges will increasingly discover that this new "science" may determine ultimate questions of fact. The down side of this trend is illustrated by recent examples of how epidemiological studies can be manipulated to produce certain findings.

After years of litigation, the science supporting claims that silicone-gel breast implants cause connective tissue and other systemic diseases was undercut by the findings of a so-called science panel appointed by U.S. District Judge Sam Pointer under Federal Rule of Evidence 706. Although the panel did no research on its own, it reviewed "scientific/epidemiologic and other studies," the vast majority of which were funded by defendants. It determined that the plaintiffs lacked "scientific" proof that silicone-gel breast implants caused disease.

Looking at how this "peer-reviewed scientific evidence" on silicone was developed, published, and evaluated highlights a major problem with evidence-based medicine and nonjury "science panels."

When the first breast implant cases emerged, Dow Chemical--the parent of Merrell Dow and Dow Corning and a party in the Daubert litigation--hired a number of academic and physician medical consultants. Many of them were also on the editorial boards of peer-reviewed medical journals and would ultimately determine which articles submitted by silicone researchers would be published.

The company also retained epidemiologists at some of the most prestigious universities in the country and commissioned studies that critics assert were designed, in part, by Dow and were structured to find results that would exculpate rather than implicate silicone gel and the implant manufacturers. Using the results of these studies, the company put together a packet of "scientific" research supporting the defendants' position.

This packet was delivered to the editorial offices of every major U.S. newspaper. It is not surprising that a glut of editorials appeared declaring that silicone-gel breast implants were safe and that the plaintiffs' claims were based on "junk" science.

This "Dow science" also served as the key reference for Judge Pointer's science panel. It determined the panel's findings, which were, not surprisingly, adverse to the claimants. After this, the litigation of individual breast implant cases collapsed.

Another example of how evidence-based medicine could affect the outcome of litigation involves the publication of misleading research in the Journal of the American Medical Association. The journal's editor, Catherine DeAngelis, published the results of a six-month study of the popular arthritis drug Celebrex. This study showed that Celebrex caused fewer gastrointestinal problems than comparable medications. Later, DeAngelis learned that the study had actually lasted a year and that the complete data pointed to a very different result.

U.S. News & World Report reported:

The editors from the other major medical journals shared DeAngelis's anger
and frustration. In a joint editorial published this week, the heads of 12
international journals ... warn that pharmaceutical companies have gained
too much control over both medical research and the publication of
experimental results. Clinical investigators are often excluded from study
design and data interpretation ... and in some cases unfavorable results
are intentionally buried to avoid public dissemination. In an effort to win
back some control over the scientific process, the editors declared a
radical change in policy.... "We will not review or publish articles based
on studies that are conducted under conditions that allow the sponsor [drug
company] to have sole control of the data or to withhold publication." (15)

The same article quotes Harold Sox, editor of the Annals of Internal Medicine: "In the worst cases, the drug firms design the trial [study], explain to physicians how to carry it out, analyze the study, do not let the researchers see all of the data, and then control the publication."

Dow Chemical also designed and funded the early epidemiological studies establishing that Dioxin did not cause cancer in veterans exposed to Agent Orange. After Congress created the Agent Orange Compensation Fund, which in effect relieved Dow Chemical of any liability, the company stopped funding "scientific research" in this area.

Independent studies were then published showing that Dioxin is a human carcinogen. These studies turned the science of Dioxin 180 degrees. Today, the Environmental Protection Agency lists Dioxin as a human carcinogen.

The silicone-gel breast implant litigation, the Celebrex drug study, and the Dioxin studies illustrate the greatest danger of evidence-based medicine. Where the financial stakes are high, major corporations--more so than individual litigants--have the resources to design, define, and fund science that supports their case. These case illustrations show how the rich and powerful can manipulate evidence-based medicine to subvert both the civil and criminal justice systems.

Unresolved questions

Because much medical research consists of case reports or small case studies with a limited number of patients, quality data outcomes are sparse. Treatments for some conditions or diseases have no empirical proof of efficacy or safety. Regardless, these treatments may be recognized by a particular medical specialty as the standard of care.

What happens in a world where CPGs become the accepted standards of care? In a case where treatment for a specific condition or disease is not supported by empirically tested data outcomes, is there no admissible standard of care? Does it also mean that insurance will not cover the treatments because there is no proof of medical efficacy?

Courts typically do not have the luxury of holding their decisions in abeyance until a body of research develops. Although there may be expert opinions and animal studies, will the absence of human population epidemiological studies prevent claimants from proving their cases? Indeed, would a proliferation of evidence-based medicine prevent courts from resolving a significant number of disputes? Would this shift favor criminal and civil wrongdoers?

In a civil case, verdicts are determined by the "great weight of the evidence." This is often defined as 51 percent. Yet in science, a finding is not deemed reliable unless it is proven to have at least 95 percent reliability. Does this mean that the civil proof requirement will de facto shift from 51 percent to 95 percent? And would such a standard, if adopted, deny access to the courts and prevent the courts from performing their duties to resolve disputes and maintain order? At least in criminal cases, where the burden Of proof is "beyond a reasonable doubt," a 95 percent standard may be acceptable.

Whether CPGs will be admissible as standards of care in the absence of expert testimony has not yet been determined. CPGs and other published standards can be used to cross-examine or serve as a foundation for expert testimony in civil cases. If CPGs are adopted by federal agencies and used as standards of care and treatment for Medicare and Medicaid patients, they may constitute admissible "public records" under Federal Rule of Evidence 803(8).

The largest single source of CPGs is the National Guideline Clearinghouse, which currently contains 988 clinical practice guideline summaries. Panels of physicians preparing the CPGs evaluate and grade the great mass of scientific studies on a given subject. Guidelines based on powerful evidence receive the highest grades.

Some of the grading scales refer to levels of evidence. Level I evidence is usually the most powerful and is derived from randomized controlled trials. Level III evidence is based on studies that provide limited information about the relationship between a treatment and an outcome. This category includes descriptive studies--such as case reports and case series--and expert opinion that is often based on clinical experience.

Practice points

As evidence-based medicine continues to emerge, trial lawyers should expect motions in limine and Daubert challenges to a broad range of experts and components of their testimony. (16) AS a result, litigators will face increasing costs as these challenges cause bifurcation and may increase the time it takes before the case comes to trial. Proponents claim that when the trial does arrive, it is shorter because many of the disputed science issues have already been resolved.

Before one of your experts is deposed, make sure he or she has human studies, preferably case-controlled ones, that support the proffered opinions. Tangential human or animal studies may not be sufficient to support the testimony.

In anticipation of motions in limine and Daubert challenges, when you are drafting interrogatories, consider asking, "Do you intend to file a motion in limine or make a Daubert challenge to Dr. Smith or any of the components of his opinion?" If the answer is yes, you can prepare for this before trial. If there is no answer, or if it's no, and the opposing party challenges your expert at trial, in most courts the failure to give you notice will empower you to substitute experts or adjourn for more time.

Trial lawyers will have to learn how study design and power variables are analyzed. Until each study carries a grade with it, lawyers will have to evaluate them on their own. Some factors to consider include whether a study is published in a peer-reviewed, as opposed to a nonpeer-reviewed, journal; whether the number of subjects in a study is 10 or 10,000; and whether a study is funded by industry defendants or by a respected and independent organization like the National Institutes of Health.

Evidence-based medicine and CPGs are not all bad or all good for civil plaintiffs. Because plaintiff attorneys frequently have trouble mustering medical expertise to support their clients' claims, CPGs can help provide the necessary proof of standards of care.

Applying evidence-based medicine to causation issues will probably help defendants more than plaintiffs. Because it has not addressed causation questions in many human subjects, plaintiffs, who bear the burden of proof, may be unable to establish causation for lack of empirical data.

The best advice, as always, is be prepared. Read up on evidence-based medicine and its progeny, CPGs. They are probably here to stay, so we'll just have to learn to work with them.


(1.) Trach v. Fellin, Nos. 01921EDA00, 01949EDA00 (Pa. Super. Ct. Jan. 18, 2002).

(2.) See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).

(3.) Sharon Staus, Evidence-Based Medicine: A Commentary on Common Criticisms, 163 CAN. MED. ASS'N J. 837-41 (2000).

(4.) Consensus Statement, Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine, 268 JAMA 2420-25 (1992).

(5.) Arnold J. Rosoff, Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. HEALTH POLITICS & L. 327-68 (2002).

(6.) Epidemiology is the emerging "science" of studying factors that influence the distribution, occurrence, and prevention of health-related events--like disease, injury, and pharmacological effects--in human populations.

(7.) Concerned that plaintiffs could use clinical practice guidelines to their advantage, defense interests--including the insurance industry--have worked to pass statutes limiting their use to defendants in civil litigation. These efforts were initially successful in Maine and Minnesota, but pro-defense laws in those states have since been repealed. 24 ME. REV. STAT. ANN. tit. 24 [section] 2971 (1993); MINN. STAT. [section] 62J-34 (1995).

(8.) 293 F. 1013, 1014 (D.C. Cir. 1923).

(9.) 553 F.2d 1013, 1024 (6th Cir. 1977) (quoting Holmgren v. Massey-Ferguson, Inc., 516 F.2d 856 (8th Cir. 1975)).

(10.) Daubert, 509 U.S. 579, 594-95.

(11.) 522 U.S. 136 (1997).

(12.) 526 U.S. 137, 152-53 (1999).

(13.) 528 U.S. 440, 454-56 (2000).

(14.) Two state courts rejected the application of Daubert to standard-of-care issues in medical malpractice cases. Gilkey v. Schweitzer, 983 P.2d 869, 872 (Mont. 1999); Reese v. Stroh, 907 P.2d 282, 306-08 (Wash. 1995). In two other states, appellate courts determined that trial judges had abused their discretion in excluding expert testimony on causation under Daubert. Williams v. Hedican, 561 N.W.2d 817, 827-32 (Iowa 1997); Bunting v. Jamieson, 984 P.2d 467, 474 (Wyo. 1999). An equal number of decisions from state appellate courts have reached contrary conclusions on both of these issues.

(15.) Stacey Schultz, True, False, Whatever, U.S. NEWS & WORLD RER, Sept. 17, 2001, at 72.

(16.) Some of the problems touched on in this article are more specifically addressed in Martha K. Wivell, When Can Science Go to Court? TRIAL, Mar. 2001, at 27; Stuart Ollanik, Defeating Daubert Challenges in Auto Defect Cases, TRIAL, Sept. 2001, at 28; Ira H. Leesfield & Mark A. Sylvester, Admissibility of Expert Testimony: Whats Next? TRIAL, Dec. 2000, at 64.

J. Douglas Peters is a shareholder with Charfoos and Christensen in Detroit and an adjunct associate professor at the Wayne State University School of Medicine.
COPYRIGHT 2002 American Association for Justice
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

Thursday, August 20, 2009

Causes of Laparoscopic Injuries: A Survey

Author: Aiello, Michelle; Peters, J. Douglas
Date: May 1, 2000
Words: 3715
Publication: Trial
ISSN: 0041-2538

Mae Dukes was a 37-year-old mother of two and a Flint, Michigan, deputy sheriff when she entered Hurley Hospital in late 1995 to have her gallbladder removed. Rather than undergo a traditional open operation with its longer hospital stay and convalescence, she opted for a laparoscopic procedure.

A surgeon inserted into her abdomen a needle through which carbon dioxide gas was passed to create an area in the cavity for him to work. He removed the needle and inserted a trocar--a hollow metal tube. Then, he inserted a sophisticated lighted tool, a laparoscope, into the trocar. The laparoscope permits a magnified view of the abdominal cavity to be projected on video monitors. Through small incisions, other trocars were then placed into her abdomen. The surgeon inserted surgical instruments into these in order to remove the gallbladder.

With his light, the surgeon viewed the interior of Dukes's abdomen, where he saw "a little blood," which he assumed was probably from the initial trocar insertion.

Dukes's blood pressure had dropped to 105/52. The anesthesiologist did not tell the surgeon this and did not ask if there was any bleeding. Dukes's pressure dropped further to 85/50, and her heart rate rose to 120 beats per minute.

At this point, the anesthesiologist assumed Mae Dukes was suffering a pulmonary embolism. He told the surgeon to step away from the table so the patient could be repositioned. During the next 10 minutes as the anesthesiologist searched for emboli, Dukes bled to death. Early in the procedure, during the insertion of the first trocar, the surgeon had severed her iliac artery.

An analysis of Dukes's and other cases involving similar surgical procedures and a review of the medical literature demonstrate the types of injuries that can occur during these procedures and the causes of the injuries.

Laparoscopes, endoscopes, and arthroscopes are names given to tools used by a variety of surgical subspecialties, including orthopedics, gastroenterology, cardiology, and gynecology. Generically, diagnostic and surgical interventions employing these tools, inserted through small incisions and holes, are referred to as minimally invasive surgery.

Laparoscopic surgery specifically refers to the performance of intra-abdominal surgery through small ports inserted through the abdominal wall while visualizing the surgery with a camera. The hand-operated tools can be fitted with lighting, viewing, reaming, drilling, cutting, burning, clipping, gripping, vacuuming, and other tool ends.

Until the mid-1980s, laparoscopy was predominantly used to perform diagnostic procedures or to perform sterilizations.(1) The first reported appellate case involving laparoscopy was a failed tubal ligation in 1974.(2) In that year, nine appellate laparoscopy cases involving failed tubal surgery were brought and lost by plaintiffs. Today, the tables have turned.

Erich Muhe performed the first laparoscopic cholecystectomy in 1986, in Germany.(3) In 1989, the first laparoscopic vaginal hysterectomy was performed. Today, only 11 years later, the public assumes that most laparoscopic technology and applications are safe. This may be a mistake.

When assessing the safety and efficacy of laparoscopic diagnostic and surgical procedures, the following factors should be considered:

* the "newness" of the procedure, as well as the potential use of alternative technologies such as ultrasound or medications, as competing diagnostic and treatment modalities;

* the paucity of large clinical studies regarding the safety and efficacy of many current laparoscopic applications; and

* the lack of a national reporting mechanism for laparoscopy-associated morbidity and mortality, and the tendency of published data to come from researchers rather than practitioners. For this reason, the published studies imply lower morbidity and mortality than probably occurs "in the field."

Laparoscopic v. open surgery

Some of the rationales offered in support of laparoscopy and other forms of minimally invasive surgeries (MIS) include shorter stays in the hospital and shorter convalescence periods, earlier diagnoses, shorter operation times, improved cosmetic results, less pain, fewer complications, and lower costs.

Whether these rationales apply and support choosing laparoscopy depends on the presentation of the patient and the procedure involved (for example, laparoscopic hernia repair, laparoscopic vaginal hysterectomy, laparoscopic appendectomy). Knowing the procedure-specific data in the peer-reviewed medical literature is important in assessing the adequacy of the patient's informed consent as to whether an MIS or open surgical option is selected.

It is generally true that a patient who undergoes laparoscopic diagnosis and surgery will have a shorter stay in the hospital and a more rapid return to work. However, new technologies, especially imaging technologies, can provide an earlier diagnosis than is possible with a laparoscopic examination. Thus, for certain diagnoses, choosing to use a laparoscope may be the error.

In a study published in 1996 of laparoscopic appendectomy versus open appendectomy in men, the findings suggest that the use of laparoscopy should be limited to men with atypical pain of uncertain diagnosis and men who are obese.(4) As this finding suggests, it is imperative that attorneys handling malpractice cases in this field search for articles specific to patient sex, size, and clinical presentation to see if laparoscopic surgery was appropriate for the plaintiff.

When the safety and efficacy of laparoscopic versus abdominal hysterectomy was studied, researchers found that women undergoing laparoscopic hysterectomies spent more time in surgery than those undergoing traditional hysterectomies (160 minutes as opposed to 102 minutes) but had significantly shorter hospital stays (2.4 days as opposed to 4.4 days).

This finding of increased surgery time predicts an increased anesthesia risk. The researchers admit that their results are preliminary (due to the sample size of 10 subjects) and suggest that when performed by experienced laparoscopists, laparoscopic-assisted vaginal hysterectomy is preferable to abdominal hysterectomy for selected patients.(5)

An analysis of malpractice insurance claims provides important data about laparoscopic safety, demographics, complications, and outcomes.

In the 1994 Physician Insurers Association of America Laparoscopic Procedure Study, the most current study available, 31 member companies reported 615 claims for 13 different procedures.(6)

Cholecystectomies--the surgical removal of the gallbladder--had the highest number of reported claims (331). General surgeons, as a specialty, were named in 304 of these claims.

A variety of injuries are associated with the laparoscopic cholecystectomy claims. The most common injury, a lacerated, transected, or punctured common bile duct, accounted for 197 claims. Similar injuries to the hepatic duct accounted for 45 claims, and perforations and lacerations to the bowel constituted 38 claims. Punctures and tears to arteries and veins (32), fistulas (8), equipment burns (7), and a smattering of other injuries round out the 331 total reported claims involving gallbladders.

The remaining 284 claims involved diagnostic laparoscopies, hernia repairs, appendectomies, and various gynecologic procedures. Diagnostic laparoscopic procedures--most commonly gynecologic in nature--comprised 50 percent of these claims. Tubal ligation was the next most prevalent procedure reported, making up another 25 percent. Women were claimants in more than 95 percent of the cases not involving gallbladders, and most of the claimants were under the age of 40.

Not surprisingly, the medical specialty most commonly involved in these claims was obstetrics/gynecology (more than 90 percent of the claims). General surgeons were involved in a smaller number of cases, most involving hernia repair and appendectomy procedures.

Across all of the procedures, the most common injury was perforation of the bowel. In gynecologic claims, ureter laceration was a common injury requiring surgical repair.

A complication in more than 80 percent of all claims was the need for an additional surgical procedure, most often an open procedure to repair the punctured, lacerated, or perforated organ or vessel. This complication is usually not a fruitful subject of litigation, because the surgical consent forms signed by the patient usually advise that this complication may occur and that the patient consents to an open procedure for correction. Where an injury occurs that should not have, or where an injury occurs and is not timely discovered and repaired, litigation is more likely to be successful.

As procedure-specific laparoscopic data develop, there will be increasingly valuable and reliable evidence of the comparative safety and efficacy of laparoscopic versus open surgeries.

Causes of injuries

An analysis of all types of injuries from all types of laparoscopic surgeries shows eight common causes of the injuries reported above:

* inexperience;

* defects in hand-eye coordination;

* ignorance of anatomy;

* equipment and technique failures;

* infection;

* improper patient selection;

* repositioning of patients during surgery; and

* failure to plan for complications.


With the introduction of any new technology, there are learning-curve errors.(7) Laparoscopy, as sophisticated as it is, is still in its infancy, and many physicians are just entering the MIS field.

Adequate training and experience involve a knowledge of basic anatomy and knowledge of the appropriate equipment and techniques. Practitioners should have had a preceptorship with an experienced surgeon; have been supervised by a teaching surgeon; have performed multiple procedures; and know the standards of care applicable to each procedure. Published standards of care identify the indications, contraindications, and applications of laparoscopic technology to specific diagnostic and treatment modalities.(8) At deposition, it is crucial to explore the defendant's training, experience with the procedure, and knowledge of the standard of care for the procedure.

Hand-eye coordination

The operator's hand-eye coordination and the role that habit plays in these procedures require the laparoscopic operator to set up equipment the same way for each procedure. Researchers have explored the concept of hand-eye coordination and paradoxical movement. For example, if the hand of the operator moves the laparoscopic forceps placed in the abdominal cavity in one direction, and the image shown on a video monitor is displayed normally, the image shows the working end of the forceps moving in the opposite direction. This also applies to up and down movements of the instruments.

In another equipment setup, where the instrument and the viewing telescope are directly opposite to the operator's line of sight to the video monitor, a left-to right movement by the operator's hand is seen as a left-to right movement on the video monitor.(9) A consistent equipment setup in the operating room, repetitive habits, and experience offer the best prevention against the types of problems that can result from this reversal of the images.

The potential complications from this paradoxical-movement quandary are obvious. This illustrates the importance of discovering whether the surgeon can repeat by rote his or her equipment setup. Surgeons who use different equipment setups for the same procedure on different patients are at special risk of committing this type of error.


Surprisingly, ignorance of human anatomy is a major contributing cause of complications in MIS. There are many important blood vessels (not counting ducts, organs, and nerves) for the ignorant, unwary, or unlucky operator to hit. Understanding the layers of overlapping anatomy is important because the instruments move through anatomical planes. Asking the defendant to detail what structures lie on top of what structures will frequently show an ignorance of anatomy.

The angle of placement of a trocar, whether a trocar tip is conical or pyramidal, and the force of insertion are all technical variables, which, when coupled with anatomical ignorance, offer a potential for great injury.

In many laparoscopic procedures, more than one trocar is inserted. Inserting the first trocar carries the most danger because it is inserted somewhat blindly. For this reason, complications associated with the first trocar insertion are sometimes legally defensible, although the failure to recognize and treat the injuries is not. Injuries caused by second or third trocar insertions are largely indefensible. Visualization through the first trocar should allow for safe insertions of subsequent trocars because the anatomic structures at the insertion sites can be seen in advance.

Equipment and technique failures

Equipment failures may be the result of product defect, but most often the fault lies with improper assembly, maintenance, and use of equipment. Insulated surfaces, for example, should be inspected before each surgery to minimize inadvertent burns. Electrical malfunction is frequently due to poor cable connection or operator error. At deposition, each item of equipment, hookup, and placement must be established. Where relevant, exemplar pieces of equipment should be purchased for use in depositions and as demonstrative evidence.

Technique failure is usually related to the inability to attain an initial inflated abdomen.(10) Injecting the inflating gas above, instead of below, the serous membrane lining the abdominopelvic walls is a common complication, often due to inexperience, improper equipment, or poor patient selection. Testing intraperitoneal placement with fluid in a syringe "is mandatory prior to gas insufflation."(11)

Insufflation is the process of injecting gas via machine (an insufflator) into the intra-abdominal space to create a tent to allow for the safe placement of later trocars, visualization of the operative field, and manipulation of instruments during the procedure. The amount and type of gas used for insufflation should be monitored and recorded. Room air, carbon dioxide, and nitrous oxide are common insufflation gases. Each option has its own risks and benefits.

Deciding whether to use unipolar or bipolar electrogenerators also involves crucial choices. Unipolar electrogenerators develop currents that travel through the entire body before returning to the ground electrodes. This increases the risk of arcing through unintended anatomical structures if that route to the ground electrodes is more direct.

In contrast, a bipolar system develops current only between the jaws of the forceps. This offers greater safety and decreased risk of damage to tissue due to lower voltage.

The operator must also recognize that repairing burns or lacerations is more difficult where they are caused by unipolar current, because unipolar damage is harder to see but usually more extensive than bipolar damage. For this reason, suture repairs of unipolar-caused injuries require taking larger margins to ensure only undamaged tissue is sutured. A suture of dead tissue will fail because dead tissues cannot mend when connected.


Infection is reportedly a rare complication of laparoscopy, even with complicated and lengthy cases.(12) Establishing liability is almost impossible. Because surgery of all types, open or MIS, carries a risk of infection, most surgical infection cases do not make good plaintiff cases.

Patient selection

Patient selection is another crucial variable. Performing minimally invasive surgeries on patients for whom the procedure is not appropriate is common and an invitation to danger. Patients with a previous laparotomy are at increased risk of surgical complication.(13)

Further, because the performance of laparoscopy has profound effects on movement of blood and respiration, emergency, older, or acutely medically impaired patients may not be able to tolerate the procedure well.(14)

Septic peritonitis, multiple previous surgical procedures, diaphragmatic hernia, chronic pulmonary disease, intolerance to proper positioning, and obesity also constitute relative contraindications to laparoscopic surgery complications.(15)

Thin, athletic women who have never been pregnant are at even higher risk of complications than the obese patients because the fibrous tissue deep within their skin is not pliable enough "to facilitate safe trocar insertion."(16)

Absolute contraindications to laparoscopy currently include the presence of shock caused by low blood volume (hypovolemic shock); intestinal obstruction with extensive bowel distention; the presence of a large pelvic or abdominal mass; or severe cardiac decompensation.(17)


The repositioning of the patient after insufflation but before all trocars are placed, or repositioning by the anesthesiologist or surgeon during the surgical procedure, may shift organs and anatomical structures by moving previously safe organs into the way of harm. "Moving the patient ... or even tucking the arm can change the anatomy so much that the planned puncture becomes dangerous."(18)


Complications are predictable. The surgical team must

* be prepared to perform an open procedure for correction;

* have available redundant equipment in the event of equipment failure;

* have proper informed consent forms signed in anticipation of the need for an open procedure;

* be prepared to stop the surgery and exhaustively search for perforations, burns, or other injuries because changes in intra-abdominal anatomy, through repositioning, may obscure an injury; and

* have adequate personnel, blood products, and equipment available to address specific complications.(19)

Discovery tips

Attorneys representing patients or physicians in laparoscopic malpractice cases must thoroughly understand the planes of anatomy, the equipment, and its configuration and placement. They must also understand the repetitive protocols used by a defendant surgeon for insufflation and trocar placements.

If the surgeon cannot repeat at deposition, by rote, each step of insufflation technique, angle of trocar introduction, and so on, it is likely that the surgeon does not follow strict and repetitive protocols, a practice necessary to avoid complications in the patient.

Attorneys must recognize that many laparoscopic procedures are filmed in whole or part. If these films exist, they should be requested at the earliest possible date and carefully reviewed.

During discovery, it is imperative to probe the education, training, and experience of the surgeon and each member of the surgical team. Each piece of equipment used, how each was positioned, and the settings of each must be discovered. The names and duties of each team member, and the number of trocars used and their sizes must also be explored.

Counsel should ask the physician to draw the surgical table, the angle of table position, the position of the patient, and the placement of equipment. If the patient was repositioned, who did it? How many times was it done? When was it done? Were there corresponding changes in vital signs? Was any blood noticeable after the initial trocar insertion? What was the source of the blood? What did the surgeon do to explore its source?

It is important to understand the anesthesia record. Respirations, blood pressure, and other vital signs noted in the anesthesia chart frequently provide the earliest warning of a problem. The communication between the anesthesiologist and the surgeon must be probed in detail.

As the case of Mae Dukes shows, the surgeon who does not thoroughly explore the origin of a problem and an anesthesiologist who fails to recognize that a dramatic drop in blood pressure and increase in respirations may be due to a bleed can cause death.

Laparoscopy is a relatively new technology, more widely disseminated than the safety and efficacy data might justify. The "popularization" and promotion of laparoscopy to the public may be responsible for the dissemination and use of this technology at a faster rate than the professions can properly train operators. Economic and market share concerns may also motivate some physicians to operate solo before they are ready.

As the "science" of laparoscopy develops and as the various surgical colleges and professional organizations develop standards of practice, including standardized criteria for the education and training of surgeons,(20) it is hoped that laparoscopy will become safer with more frequent and broader applications.

As surgeon training, supervision, standards of practice, and incident analysis more fully define appropriate laparoscopic uses and the limitations of the procedure, we can expect a continued flowering of laparoscopy, a most useful technology, in the hands of experienced surgeons. Hopefully, trial lawyers representing physicians and patients can make a positive contribution to this process.

J. Douglas Peters, a shareholder with Charfoos & Christensen, Detroit, and a principal with Peters & Christensen, Philadelphia, is also an adjunct associate professor, Department of Community Medicine, Wayne State University School of Medicine. Michelle Aiello, a former nurse, is an attorney associate with Charfoos & Christensen.


(1). See Frank Willem Jansen et al., Complications of Laparoscopy: A Prospective Multicentre Observational Study, 104 BRIT. OBSTETRICS & GYNAECOLOGY 595 (1997).

(2). See, e.g., Raitt v. Johns Hopkins Hosp., 322 A.2d 548 (Md. Ct. Spec. App.), rev'd, 336 A.2d 90 (Md. 1975).

(3). Erich Muhe, The First Cholecystectomy Through the Laparoscope, LANGENBECK, ARCHIVES CHIROPRACTY 369 (1986).

(4). Didier Mutter et al., Laparoscopy Not Recommended for Routine Appendectomy in Men: Results of a Prospective Randomized Study, 120 SURGERY 71 (1996). Moberg and Montgomery studied many of the same parameters regarding laparoscopic application to appendicitis. This study also found no significant difference in the length of hospital stays or the complication rate between the two groups. It did find that the post-operative need for pain medication was lower but that the operation time was significantly longer in the laparoscopic group. These authors concluded that the greatest benefits of laparoscopic over open surgery is that it caused less trauma (evidenced by less use of post-operative analgesia) and provided better diagnostic accuracy and a better cosmetic result than the conventional operation. Ann-Cathrin Moberg & Agneta Montgomery, Appendicitis: Laparoscopic Versus Conventional Operation, 7 SURGICAL LAPAROSCOPY & ENDOSCOPY 459 (1997).

(5). Farr Nezhat et al., Laparoscopic Versus Abdominal Hysterectomy, 37 REPRODUCTIVE MED. 247 (1992).


(7). See Paivi Harkki-Siren et al., Major Complications of Laparoscopy: A Follow-Up Finnish Study, 94 OBSTETRICS & GYNECOLOGY 94, 98 (1999);see also Jansen et al., supra note 1, at 599.

(8). For examples of clinical guidelines, see Society of American Gastrointestinal Endoscopic Surgeons Committee on Standards of Practice, Revised Guidelines for the Clinical Application of Laparoscopic Biliary Tract Surgery (1999); Society of American Gastrointestinal Endoscopic Surgeons Committee on Standards of Practice, Revised Guidelines for Diagnostic Laparoscopy (1998); Charles Chapron et al., ESHRE Guidelines for Training, Accreditation, and Monitoring in Gynaecological Endoscopy, 12 HUMAN REPRODUCTION 867 (1997); Guidelines for Diagnostic Laparoscopy, 13 SURGICAL ENDOSCOPY 202 (1999). For an example of training and education criteria, see Society of American Gastrointestinal Endoscopic Surgeons Committee on Credentialing, Revised Guidelines for the Granting of Privileges for Laparoscopic and/or Thoracoscopic General Surgery (1997). Copies of documents from the Society of American Gastrointestinal Endoscopic Surgeons can be obtained on the Internet at

(9). Michael Patkin & Luis Isabel, Ergonomics and Laparoscopic General Surgery, in LAPAROSCOPIC ABDOMINAL SURGERY ch. 8, at 83-88 (John N. Graber et al. eds., 1993).

(10). Edward Beadle, Complications of Laparoscopy, in LAPAROSCOPIC ABDOMINAL SURGERY, supra note 9, at ch. 7.

(11). Mark Pentecost & Earnest Curtis, Laparoscopy, in GYNECOLOGIC SURGERY: ERRORS, SAFEGUARDS, SALVAGE 135 (John H. Ridley ed., 2d ed. 1981).

(12). Beadle, supra note 10, at 78.

(13). Jansen et al., supra note 1, at 599.

(14). Beadle, supra note 10, at 75.

(15). Id. at 77.

(16). Barbara S. Levy, 3 OB-GYN MALPRACTICE PREVENTION, Feb. 1996, at 11.

(17). Beadle, supra note 10, at 76.

(18). Levy, supra note 16.

(19). Beadle, supra note 10, at 81.

(20). See sources cited at note 8. It should be noted that physicians do not always follow clinical guidelines for various reasons. See Michael D. Cabana et al., Why Don't Physicians Follow Clinical Practice Guidelines? A Framework for Improvement, 282 JAMA 1458 (1999).

Thursday, August 6, 2009

Legal Information About Cervical Cancer from Charfoos & Christensen (Detroit Michigan Law Firm)


Cervical cancer, unlike ovarian cancer, can be diagnosed early enough to provide effective treatment. Key facts about cervical cancer include:

  • In the U.S.A. -- 14,500 new cases and 4,900 deaths from cervical cancer are reported each year

  • Worldwide - cervical cancer is second only to breast cancer as most common malignancy in both incidence and mortality

  • 1/4 of cervical cancers in women greater than 60 years

  • Failure-to-diagnose cervical cancer produces 14% of the "failure-to-diagnose" claims for malpractice

Physician errors leading to misdiagnosis of cervical cancer include:

  • The physician's failure to act on an abnormal PAP test result

  • The physician's failure to realize no PAP test report has come back (fell between the cracks)

  • The physician's failure to specify a follow-up interval to the patient

  • Physician or staff failure to document positive or negative PAP test results

Because cervical cancer can be diagnosed at an early stage and because viable treatments exist, a medical-legal investigation by an attorney may be appropriate wherever there has been a failure to diagnose or timely treat cervical cancer.

If you, a relative or friend have a family member suffering from Cervical Cancer and have any questions, please call or visit:


5510 Woodward Avenue

Detroit, Michigan 48202

Phone: (313) 875-8080 or (800) 247-5974

Fax: (313) 875-8522



Wednesday, August 5, 2009

How to tell if your child has Cerebral Palsy

4500 children are diagnosed with cerebral palsy each year in the United States. 5 to 10 percent of those children suffer their injury as a result of doctor or nursing error.

Cerebral palsy is caused by damage to the motor areas of the brain, usually occurring before, during or shortly after birth. Common signs and symptoms in cases caused by doctor or nursing errors include:

* The infant has seizures shortly after birth.

* The child has stiff or spastic leg muscles and to a lesser degree, in the arms
during first years of life.

* The child has difficulty: grasping objects; walking; speaking; holding head up.

* The child has involuntary movements such as uncontrollable writhing, motion of the hands, or drooling.

* The child has mental impairment.

* The child does not develop bowel control.

These conditions are static; that is, they do not improve over time, nor do they become worse.

If you, a relative or friend have a family member suffering from Cerebral Palsy and have any questions, please call or visit:


5510 Woodward Avenue

Detroit, Michigan 48202

Phone: (313) 875-8080 or (800) 247-5974

Fax: (313) 875-8522



Monday, August 3, 2009

Preventing Cerebral Palsy

Approximately 5000 new cases of cerebral palsy are reported each year in the United States. Great controversy surrounds the cause(es) of cerebral palsy. Various authors have suggested that maternal trauma, bacterial infection, viral exposure, oxygen deprivation prior to or during birth, cigarettes, and plethora of unknowns can cause cerebral palsy.

In a great majority of the cases (over 50%) no specific cause for cerebral palsy can be found. It is known that the greatest predictor of cerebral palsy is prematurity (pre-term labor is defined as the appearance of contractions and dilatation before 37 weeks gestation). Maternal trauma during pregnancy as well as bacterial/viral exposures to the fetus inutero are suspected of being significant contributors to cerebral palsy. Great controversy surrounds the percentage of cerebral palsy caused by physician or nurse errors during labor and delivery. Some authors have suggested that there is no proof that oxygen deprivation during labor and delivery can cause cerebral palsy. The great weight of the evidence on this question, however, suggests that up to 5% of cerebral palsy (250 cases a year in the United States) are the result of physician or nurse errors during labor and delivery.

Because some of the mechanisms capable of causing cerebral palsy are known, certain causes of cerebral palsy may be preventable, avoidable or treatable. These include:

1. Jaundice in newborn infants can be treated with photo therapy. Jaundiced infants are exposed to blue lights that break down bio pigments, thus preventing them from building up and threatening disruption of brain chemistry. In rare cases where this treatment is not enough, physicians can correct the condition with a special type of blood transfusion.

2. Rh (blood factors) incompatibility can be identified by a simple blood test routinely performed during early pregnancy on mothers, and if indicated by history, expectant fathers. Blood typing compatibility does not usually cause problems during a woman’s first pregnancy, as the mother’s body does not produce the unwanted antibodies until after the first delivery. There are exceptions to this.

3. Severe trauma during delivery (e.g. high/mid-forceps, vacuum extraction, aggressive manual rotation, excessive fundal pressure, etc.) can cause skull fractures and/or intra ventricular hemorrages in the fetal/newborn brain. These traumas and/or hemorrhages can cause oxygen deprivation or damage to the cerebral cortex of the newborn’s brain, resulting in cerebral palsy.

4. Some evidence exists that oxygen deprivation during labor and delivery, whether the result of neucal cord, protracted labor, etc. can cause damage to the fetal/newborn’s cerebral cortex, resulting in cerebral palsy.

5. Infectious exposures such as rubella or German measles can be prevented if moms are vaccinated against these diseases before becoming pregnant. Regular pre-natal care and good nutrition, although not directly related to the eliminating of cerebral palsy, are always suggested.

6. It is known that cigarette smoking may lead to small babies and premature deliveries and alcohol/drug consumption can lead to Fetal Alcohol Syndrome and other types of brain damage. Accordingly, physicians should advise their patients to avoid these behaviors during pregnancy.

7. The role of environmental exposures is controversial. Because such exposures tend to be multiple and not single, providing causation is very problematic.

If you, a relative or friend have a family member suffering from Cerebral Palsy and have any questions, please call or visit:


5510 Woodward Avenue

Detroit, Michigan 48202

Phone: (313) 875-8080 or (800) 247-5974

Fax: (313) 875-8522