Charfoos & Christensen Legal Blog

ANOTHER REPUBLICAN VICTORY

2011-12-14T11:33:00.000-08:00

In a major decision from the United States Supreme Court, American consumers are now denied the right to sue generic drug manufacturers for failing to warn of known dangers to human health caused by generic drugs.

In a five-four split, the five Republican Justices decided the case of Pliva, Inc. v Gladys Mensing and Julie Demahy on June 23, 2011 in favor of the drug companies. This decision relating to generic drugs affects 75% of all prescription drugs dispensed in this country as that is the percentage which are generic, as opposed to brand named drugs. In her descent, Justice Soto Mayor properly complains that this decision by the Republican majority on the U.S. Supreme Court ". . .effectively re-writes our decision in Wyeth v Levine (2009), which holds that Federal Law does not preempt failure-to-warn claims against brand-name drug manufacturers".

As a result of the Pliva decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happen stance of whether our pharmacists fill a prescription with a brand name or a generic drug.

As a result of this new United States Supreme Court decision extending preemption (federal powers as being superior to those of the state), residents in the other 49 states are now denied access to American Courts, as Michiganians have been denied access to the courts since Gov. Engler passed statewide legislation, later affirmed by the Republican majority in the Michigan Supreme Court. These immunities favoring pharmaceutical companies over citizens are ironically coming from the Republicans who always claim their disdain for federal power over state's rights.

Each time the clients of Charfoos & Christensen, P.C. vote to support Republican candidates, they can expect those candidates will diminish their rights to sue, and diminish their rights to hold wrongdoers responsible for cleaning up the messes they cause. Where money is concerned, corporate responsibilities go out the window and the consumers lose again. Each time we vote for elected officials, we make choices that affect the type of society we, our friends and family live in.

The EPA & chemicals in the US

2011-12-14T11:20:00.000-08:00

The Environmental Proection Agency has tested just 200 of the 80,000 chemicals registered in the United States. The total number banned: five. ~The Washngton Post

DISPOSING OF PRESCRIPTION DRUGS

2011-12-14T08:07:00.000-08:00

If you want to dispose of unused medications you should follow these suggestions:

• DO NOT FLUSH unused medications and DO NOT POUR them down a sink or drain.
• When discarding unused medications in your trash:
 Pour them into a sealable plastic bag. If medication is a solid (pill, liquid capsule, etc.), ass water to dissolve it.
 Add kitty litter, sawdust, coffee grounds (or any material that mixes with the medication to make it less appealing to pets and children to eat) in a bag.
 Seal the plastic bag and put it in the trash.
 Remove all and destroy ALL personal information (prescription label) from all medication containers before recycling them or throwing them away.

For more information go to www.smarxtdisposal.net

Brain Damaged Baby

2011-07-18T11:36:00.000-07:00

BABY ROE vs. OBSTETRICIAN AND HOSPITAL

(MEDICAL MALPRACTICE-BIRTH INJURY CASE)

J. Douglas Peters, Ann Mandt and local counsel negotiated a 2.5 million ($2,500,000) Dollar settlement against the defendant doctor and defendant hospital in this case involving failure of labor to progress, an unsuccessful attempt at delivery using a vacuum extractor for 13 pulls, and a failure to timely deliver the fetus in the face of fetal distress. This case was not litigated in Michigan.

Mother, a 34 year-old gravida-1 at 40 weeks gestation with good clinical dating and ultrasound, presented herself to the hospital at the onset of contractions at about 5:30 p.m. There was no bleeding or rupture of the membranes. Mother's pre-natal course was uncomplicated. She was rubella negative, blood type A+ and her alphafeto-protein had been normal. An infectious disease workup was negative and the mother did not use cigarettes or alcohol during her pregnancy.

Mother was admitted to labor and delivery and watched overnight. In the early morning her contractions began occurring every 2-5 minutes, were mild in intensity and lasted 50-70 seconds. There was good beat-to-beat variability. At about 8:00 a.m., mother's membranes ruptured spontaneously with clear fluid. Her blood pressure rose to 150/90's. In the first few hours following the rupture of her membranes there was a failure of the labor to progress. The labor was augmented by IV Pitocin and over the course of the next few hours, she dilated to six (6) cm. Mother was noted to have some coupling and poor relaxation on her contraction pattern so her Pitocin was discontinued. Contractions then decreased to about one every five to six minutes lasting approximately 40-80 seconds. They were moderate to strong in intensity. Over the next hour there was no progress so the IV Pitocin was restarted at a lower level. Mother again failed to progress and an internal fetal monitoring probe was placed. At this point mild variable decelerations were noted.

Over the course of the next hour, mother progressed to 8 cm. and then fully dilated at approximately 9:30 p.m. Mother was encouraged to push but her pushing effort was noted to be poor and she had difficulty relaxing her legs.

After approximately an hour and a half of such pushing, mother having made only a small amount of progress, a telephone conversation with the obstetrician was obtained. Shortly thereafter, he arrived at the hospital and explained various options to the mother including the selected choice of a vacuum extractor. After 13 pulls of the vacuum extractor, with two to three pop-offs, the vacuum extractor did bring the head down to bring the head down to crowning. It took several more pushes after that for the mother to push the baby out.

Following the delivery, the baby had APGAR scores of 1, 3 and 3 at 1, 5 in 10 minutes after birth. During the last 20 minutes of the second stage, the fetal heart tones ranged from about 150 to 180 and decelerations appeared. Delivery was finally effectuated at approximately midnight.

Upon delivery, the baby was described as being severely depressed, color was pale blue and there was no respiratory effort and the muscle tones were flaccid. After resuscitation, including intubation, the baby was transferred to a Children's Hospital in a University Center. Neonatal seizures occurred within the first 24 hours. The records showed the baby was hypoxic and acidotic with massive subglial hematomas, all of which resulted in moderate/severe cerebral palsy.

This case was settled prior to trial with a non-disclosure agreement.

J. Douglas Peters & Ann Mandt
(313) 875-8080
www.c2law.com

BEWARE OF PRESCRIPTION DRUGS

2011-07-18T11:35:00.000-07:00

Patients should pay close attention to the drugs their physicians prescribe. Ask you pharmacist to provide you with information about adverse reactions of each drug you are prescribed as well as the synergistic (combined) effects of taking various drugs together. Often, patients are prescribed one set of drugs by one physician and another set by another physician. Make sure that each of your physicians knows what other physicians have prescribed for you.

Make sure the labeling on the prescription specifically identifies the number of pills you are to take each day, as well as the time of day the pills should be taken. An important article appearing in the January 2011 issue of Vanity Fair reports that approximately 200,000 people a year die in America from prescription drugs that are considered "safe". This is three times the number of people who die each year from diabetes, four times the number who die from kidney disease and approximately five times the number of people killed each year in America from automobile accidents.

In 1996, Gov. Engler and the Republican Legislature passed a law in Michigan that gives immunity from suit to any manufacturer whose products are approved by the FDA. This includes all prescription drugs. Former democratic Gov. Jennifer Granholm was unable to change this law because the republicans controlled the State Senate. Now, the republicans control the governorship and the Michigan Supreme Court, so changes in the law are unlikely. For this reason, since patients do not have adequate legal redress, and because of common sense, patients must vigorously look out for their own personal interests by scrutinizing the labels of the drugs they are prescribed as well as reading available information from pharmacists and the internet on the drugs they are prescribed.

After a dozen or so deaths linked to runaway Toyotas, Japanese executives were called to Washington to testify. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions. Caveat emptor (buyer beware).

If a pharmacist mis-fills a prescription, or if a doctor prescribes a medication that is not indicated for your clinical condition, and you sustain an injury, please feel free to call J. Douglas Peters at Charfoos & Christensen, P.C. with your questions.

CHARFOOS & CHRISTENSEN PC
5510 Woodward Ave., Detroit, MI 48202
(313) 875-8080
www.c2law.com

HOW TO AVOID FOOD POISONING

2011-07-18T11:34:00.000-07:00

Although food poisoning can occur in any season, the warm temperatures of
Summer create special risks.

Food poisoning is caused when we eat food or drink that has been contaminated, most commonly by bacteria, but sometimes by viruses and chemicals.

Food poisoning can be caused by forces we can control and forces we cannot control. When shopping, check the "used-by-dates" on products to make sure you are not buying old inventory that might have started to spoil. Especially be careful of pre-ground hamburger, it has lots of surface area which may become contaminated with fecal material from slaughtered cows. If you can buy hamburger that has been freshly ground at the store from chunks of meat, as opposed to being re-ground from tubes of previously ground hamburger, you decrease your chance of food poisoning. Vegetables may be contaminated by fecal material from the fields where the vegetables are grown or from poor sanitation on the part of workers who harvest these vegetables. No matter how fresh and clean your vegetables look, they should be thoroughly washed and drained before use. Buying from a reputable food store increases your chances for safety as most of the large chain stores have strict food purchasing and handling protocols.

Making sure you buy your foods in a careful manner, is only the first step. Food preparation is also a common source of contamination. Unclean cutting boards and other contaminated surface areas will pass bacterial contamination onto foodstuffs that are prepared on those surfaces. Cleaning surfaces prior to food preparation with a mix of water and dish-soap will decontaminate 99% of all surface areas.

Foodstuffs prepared with mayonnaise are especially susceptible to bacterial growth during the summer heat. Refrigeration and rapid consumption of foodstuffs after removal from refrigeration is the best way to avoid a bad summer experience.

Always wash your hands before and after preparing foods. Wash with hot soapy water and use disposable towels for wiping and cleanup wherever possible. Some people suggest using separate cutting boards for preparing raw meat and poultry, and a separate board for vegetables. Wherever possible keep hot foods hot (over 150°F) and cold foods cold (under 40°F).

Trust your senses. If food looks strange or smells bad or otherwise worries you, don't eat it. It is not worth the risk.

The symptoms of food poisoning may vary with the source of the contamination. Most types of food poisoning cause one or more of the following: nausea, vomiting, watery diarrhea, abdominal pain, stomach cramps, fatigue and fever. You should see a doctor or go to an emergency room immediately if you have any of the following symptoms: frequent episodes of vomiting for more than 2 days; vomiting blood; inability to keep fluids down for 24 hours; severe diarrhea for more than 3 days; blood in your bowel movement; extreme pain or severe abdominal cramping; an oral temperature higher than 101.5 F; or, signs of dehydration such as excessive thirst, dry mouth, little or no urination, severe weakness, dizziness or lightheadedness.

If you are a victim of food poisoning, chances are you will not be the only one to get sick as others have probably eaten from the same store, restaurant or picnic. If you suspect a source, check with others who ate the same food at the restaurant or purchased hamburger or other foods from the same grocery store.

Although most cases of food poisoning cause mild symptoms, food poisoning can be life threatening, so when in doubt, it is better to go to the emergency room or see your doctor.

Charfoos & Christensen, P.C. has been handling food poisoning claims for over 35 years. From contaminated mushrooms on pizzas, to contaminated peppers, to contaminated hamburger, our firm has made recoveries against commercial grocers and restaurants. Saving samples of suspected food and gathering the names and phone numbers of other customers who shopped at the same store or ate at the same restaurant is always helpful in proving food poisoning cases.

If you believe you have been a victim of serious food poisoning resulting in hospitalization or a permanent injury, please feel free to call any of the lawyers at Charfoos & Christensen, P.C.

J. Douglas Peters
(313) 875-8080
www.c2law.com

Accused Landlord Killer Freddy Young Can't Spend Lotto Money

2011-06-08T07:50:00.000-07:00

Accused Landlord Killer Freddy Young Can't Spend Lotto Money

Medical Malpractice

2011-04-27T06:30:00.001-07:00

Medical malpractice law in Michigan, in 2006, is a complex and highly
regulated area of law as a result of Republican legislatures and Governor
Engler’s attempts to limit the amounts of money that can be recovered, shorten
the statutes of limitations, that is the time within which lawsuits might be brought,
as well as a variety of other changes which make the litigation of these cases
more expensive and complex.
As a result of the Michigan Legislative and Michigan Supreme Court
decisions limiting the rights and recoveries of medical malpractice patients in
Michigan, the public must carefully select an attorney who is experienced in the
specialty field of medical malpractice.
Patients used to have three years from the date of malpractice to file a
suit. That has now been shortened to two years. Although patients can still
recover for past and future medical expenses, health insurers are increasingly
asking to be repaid the health insurance dollars they paid for the malpractice
patient’s care. The Michigan legislature has limited the amount of money that can
be recovered for pain and suffering to $380,000 where the patient, regardless of
the consequences, has an injury that does not involve permanent paralysis,
coma and/or brain damage. Where there is permanent paralysis, coma and/or
brain damage, the maximum amount that can be recovered is $680,000. The law
also provides that if a patient is receiving disability insurance benefits, life
insurance benefits or other benefits from “collateral sources”, the wrongdoing
defendant gets the benefit of the coverage purchased by the patient and these
sums are subtracted from any recovery the patient might make.
Some medical specialties, such as neurosurgery, orthopedics and
obstetrics and gynecology present special medical malpractice litigation
problems. The Michigan Society of Orthopedic Surgeons, the Michigan Society of
Neurosurgery and the Michigan Society of Obstetricians and Gynecologists have
met and agreed that none of their members, regardless of the merits of the case,
will testify against other members of the same specialty. This forces patient
plaintiffs and their attorneys to seek expert testimony from experts outside of the
State of Michigan. This creates a strong disadvantage to the patient plaintiff
because all of the defendant physician’s experts come from hospitals and
universities in the State of Michigan.
The general rules outlining and defining medical malpractice remain the
same, however. In order for a claim to be brought, the patient must show that the
physician deviated from the accepted medical standard of care of that specialty
and that an injury was caused by that deviation that otherwise would not have
happened. Because of the changes in Michigan’s Supreme Court case law and
legislative changes as well, the cost of bringing medical malpractice cases has
doubled or tripled in most instances over the last l0 years. This means that
attorneys practicing in the specialty of medical malpractice litigation may now
reject cases that previously would have been accepted because the amount of
the recovery is less or equal to the amount of money that would have to be spent
to bring the case.
Careful case selection and work-up prior to filing suit is the cornerstone of
a successful medical malpractice case. Attorney Larry Charfoos of Charfoos &
Christensen recovered the first million dollar medical malpractice verdict in 1973.
In the approximate 30 years since that verdict, attorneys with Charfoos &
Christensen have developed and expanded their expertise in the field of medical
malpractice at the trial level, the trial preparation and work-up levels. Charfoos &
Christensen attorneys have authored and co-authored scholarly articles and
books (see Publications) on a multitude of medical malpractice issues causing
the firm to be recognized as the preeminent medical malpractice firm in the State
of Michigan.

orkut blog: Badges on orkut! Can you collect them all?

2011-04-25T11:23:00.000-07:00

orkut blog: Badges on orkut! Can you collect them all?: "You might have noticed something new in orkut. Some of your friends may have little icons on their profile pages, and you may start seeing ..."

COLON CANCER SCREENING

2011-04-20T07:28:00.000-07:00

COLON CANCER SCREENING
Saving your own life can be as easy as getting a colonoscopy screening.
Over 50,000 people died from colon cancer in 2010. Over 100,000 new cases of colon cancer were diagnosed that same year. Fortunately, there is a 90% survival rate when the cancer is treated early. Unfortunately, only 40% of colon cancers are found early.
Everyone 50 years old or over should have a colonoscopy if they haven’t had one yet. Most insurers cover this test.
Although the colonoscopy is painless, the 24 hour prep, although painless too, is not fun. The bowel preparation requires the patient to drink approximately 1 gallon of special liquid that cleans all fecal material from the bowel. This allows the colonoscopist a totally clear view of your bowel.
For people found with 1 or 2 small precancerous polyps, the next follow-up colonoscopy should be in 5 years. 3 years follow up is recommended for people will bigger or multiple polyps. For people with benign polyps or none at all, a colonoscopy is recommended every 10 years thereafter.
If you are 50 yrs old and have not had your first colonoscopy yet, do not put it off any longer. If you wait until you have symptoms, such as rectal bleeding, abdominal distension, or abdominal pain, your chances of recovery may be diminished.
As attorneys’ in the business of suing physicians and hospitals that fail in their obligations to patients, we are also mindful of patients’ obligations to themselves. For this reason we have inserted this little column.

J.Douglas Peters
5510 Woodward Ave.
Detroit, MI 48202
(313) 875-8080

Which types of medical malpractice cases are most common in Michigan?

2010-06-18T06:58:00.000-07:00

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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

2009-08-21T10:52:00.000-07:00

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.

Notes

(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.

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Causes of Laparoscopic Injuries: A Survey

2009-08-20T19:05:00.000-07:00

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.

Inexperience

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.

Anatomy

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

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)

Repositioning

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

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.

Notes

(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).

(6). PHYSICIAN INSURERS ASS'N OF AMERICA, LAPAROSCOPIC PROCEDURE STUDY 7 (1994).

(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 http://www.sages.org.

(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).

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

2009-08-06T15:01:00.001-07:00

CERVICAL CANCER

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:

CHARFOOS & CHRISTENSEN, P.C.

5510 Woodward Avenue

Detroit, Michigan 48202

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

Fax: (313) 875-8522

Website: www.c2law.com

E-Mail: lawyers1@c2law.com

How to tell if your child has Cerebral Palsy

2009-08-05T14:18:00.000-07:00

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:

CHARFOOS & CHRISTENSEN, P.C.

5510 Woodward Avenue

Detroit, Michigan 48202

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

Fax: (313) 875-8522

Website: www.c2law.com

E-Mail: lawyers1@c2law.com

Preventing Cerebral Palsy

2009-08-03T14:24:00.000-07:00

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:

CHARFOOS & CHRISTENSEN, P.C.

5510 Woodward Avenue

Detroit, Michigan 48202

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

Fax: (313) 875-8522

Website: www.c2law.com

E-Mail: lawyers1@c2law.com

The Rights of Patients in Nursing Homes

2009-07-28T12:24:00.000-07:00

The decision to utilize a Nursing Home for a loved one is often a difficult one for family members to make. It is important that relatives and the prospective resident are aware of their rights once moved into the home. The following is a printable list of rights that are declared in Michigan Compiled Laws Annotated, 333.20201 (1998)3.

* receive appropriate care regardless of race, religion, color, national origin, sex, age, handicap, marital status, sexual preference, or source of payment.

* to receive treatment for your physical and mental problems.

* to receive complete information about your medical condition and care plan.

* to be free from physical or drug induced restraints which are not required to treat your medical symptoms.

* to refuse treatment and be told of the possible consequences if you refuse.

* to issue instructions about your future medical treatment or to appoint a "patient advocate" to make such decisions for you.

* to receive meals that meet your needs.

* to live in a clean place.

* to meet privately with your spouse.

* to regular, private use of a telephone.

* to privacy during treatment or when attending to your personal needs.

* to see visitors you want to see.

* to participate in social, religious, and community activities.

* to a safe place to keep your valuable possessions.

* to keep and manage your own money.

* to return to your facility following a hospital stay.

* to advance notice before your room or roommate is changed.

* to have information about you kept private.

* to inspect and copy your personal and medical records.

* to be informed of your rights and responsibilities.

* to information from the nursing home on how you can get help to pay for your care.

* to written notice of all services available in the home and their cost.

* to receive a copy of your nursing home’s rules about resident care and conduct.

* to review the most recent state and federal inspection reports of your nursing home and the home’s plan of correction.

* to meet with other residents and residents’ families in the home to discuss nursing home issues.

* to send and receive personal mail unopened the day the nursing home receives it.

* to the same constitutional and civil rights given to all citizens.

If you, a relative or friend have suffered an injury while in a nursing home, or have any questions, please call or visit:

CHARFOOS & CHRISTENSEN, P.C.

5510 Woodward Avenue

Detroit, Michigan 48202

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

Fax: (313) 875-8522

Website: www.c2law.com

E-Mail: lawyers1@c2law.com

Breast Cancer Facts & Risk Factors

2009-07-27T19:26:00.000-07:00

Cancers of the breast present complex medical and personal issues. With the modern diagnostic techniques of mammography, ultrasound and biopsy, more cancers are being detected at an earlier stage. Because early detection and treatment are believed to provide better survival rates, more women are undergoing breast screening and suspicious lump explorations. In spite of improved diagnostic techniques, however, many physicians still wrongfully believe that they can distinguish the cancerous from non-cancerous lumps "by feel."

Obstetrician-gynecologists are in general agreement that a suspicious lump should not be followed for more than one menstrual period. A lump may be followed for a menstrual period to see if it shrinks or disappears with the passing of the cycle. Where the lump continues beyond the cycle, even though it may prove to be cystic and non-malignant, there is general agreement that such lumps must be aggressively explored and presumed malignant until proven otherwise.

Mammography and ultrasound are useful in identifying the existence and location of lumps (cysts or tumors). However, only a biopsy of the lump can determine whether a lump is cancerous or merely cystic.

GENERAL FACTS:

Most frequent cancer in women, but it also occurs in men.

The odds that a woman will get breast cancer are:
- 1 in 50 by age 50
- 1 in 17 by age 65
- 1 in 8 over a lifetime

Breast cancers constitute 32% of all cancers.

Breast cancers cause 18% of cancer deaths in women in USA annually.

RISK FACTORS:

Factors increasing risk of breast cancer (role of hormones) unclear.

Personal history factors suggesting risk of breast cancer are:
- Nipple discharge
- Trauma
- Fever
- Present or previous cancer lesions in the breast
- A maternal history of breast cancer
- A lump that doesn't go away after a period, or a lump that has pain or increases in size.

In spite of improved technologies, physician failure to diagnose breast cancer is one of the most common claims of medical malpractice faced by obstetricians/gynecologists. The suspicious lump that is "followed too long" (more than two months); the "suspicious lump" that is determined to be cystic and non-cancerous by feel alone (and not biopsied); the "suspicious lump" accompanied by nipple discharge, or pain; or the "suspicious lump" that increases in size, in the face of physician complacency, are all situations, if a cancer is later found, that warrant a medical-legal investigation to determine whether medical malpractice occurred.

Because the medical/scientific literature shows improved chances of survival with early diagnosis and treatment (surgical, chemical and/or radiation) a physician’s failure to aggressively investigate "suspicious lumps" may result in the patient having to undergo more extensive surgery or treatment, or indeed, suffer a loss of life. Because breast cancer is treatable, a physician’s failure to timely diagnose and treat the "suspicious lump" may result in a successful malpractice claim.

In cases were the failure to diagnose breast cancer occurs, the 1995 Physician Insurers Association of America (PIAA) Breast Cancer Study shows that:

The patient discovered the "suspicious lump" in 60% of cases

The most common presenting symptom: painless mass (46.5%)

No suspicious symptoms were reported (16.6%)

No physical finding in 1/5 of cases (21.4%)

80% of the mammograms were negative or equivocal

Most "suspicious lumps" were discovered by the woman during self examination.

The most common reasons for delay in diagnosis were:

The physician was unimpressed by "suspicious lump" (35%)

The patient failed to follow up with the physician after the discovery of symptoms (e.g. "suspicious lump" or nipple discharge)

A falsely negative mammogram (25.8%)

A misread mammogram (27.7%)

The failure of the physician to biopsy (27.7%)

The delay or failure of the physician to request a surgical consult

From the findings of the 1995 PIAA Breast Cancer Study, it is apparent that a significant number of cases involving the failure to diagnose, or a delay in diagnosing breast cancer, are the result of physician error. In any case where there has been a delay or failure to diagnose breast cancer and subsequent treatment provides evidence of spread to the lymph nodes, a medical-legal investigation is warranted. <back