Wednesday, March 10, 2010

Federal Investigation Substantiates Mismanagement at Indiana VA Hospital

Full Article at: Federal Report Sheds Light On VA Hospital Concerns

By Brien McElhatten

Story Published: Mar 9, 2010 at 10:24 PM EST

FORT WAYNE, Ind. (Indiana's NewsCenter) - A federal investigation substantiates reports of resource mismanagement at the VA hospital.

The 17-page document released on March 2nd, highlights problem areas with the VA Northern Indiana Health Care System. The report traced complaints of "persistent instrumentation problems with operating room sets and peel packages; ongoing reusable medical equipment issues; supply processing and distribution stocking and dating of supplies; pharmacy stocking of operating rooms, post anesthesia care unit, endoscopy unit medications and management issues."

The investigation, conducted by the VA Office of Inspector general, substantiated some, but not all of the complaints made by staff members. It found that surgical instrument sets were returning improperly from a VA sterilizing facility in Marion. Some tools were marked with water spots, while tool packages occasionally contained the wrong tools or missing instruments. Investigators discovered that several technicians were unable to identify basic pieces that make up those kits.

Hospital Assistant Director Helen Rhodes says the employees were new at the time of the investigation, and that pictures of the tools and properly assembled tool kits have been issued to them to prevent recurrences.

In addition to improperly packaged tool sets, instruments like endoscopes occasionally returned from sterilization covered in water spots, prompting dozens of surgeries to be postponed in the summer of 2009."

WOODING v. U.S., No. 07-4695, Federal Tort

Full Article at: Leagle, Inc.
WOODING v. U.S.

HENRY L. WOODING; PHOEBE G. WOODING, his wife,
v.
UNITED STATES OF AMERICA
Henry L. Wooding, Appellant.

No. 07-4695.

United States Court of Appeals, Third Circuit.

Submitted Pursuant to Third Circuit LAR 34.1(a) February 26, 2010.

Opinion Filed: March 9, 2010.

Before: CHAGARES, STAPLETON and LOURIE,[ 1 ] Circuit Judges.
NOT PRECEDENTIAL
OPINION OF THE COURT

STAPLETON, Circuit Judge.

Appellant Henry Wooding filed this civil action against the United States under the the Federal Tort Claims Act ("FTCA"), 28 U.S.C. § 2671, et seq., alleging that he was injured during a surgical procedure at the Department of Veterans Affairs Medical Center in Pittsburgh, Pennsylvania. Wooding appeals the order of the District Court granting summary judgment to the United States.

Because we write only for the benefit of the parties, we assume familiarity with the facts of this civil action and the proceedings in the District Court. We will affirm essentially for the reasons stated by the District Court.
I.

In 2001, Wooding was referred to the orthopedic clinic at the Veterans Affairs Medical Center in Pittsburgh, Pennsylvania. There, he was treated by Dr. Peter Dirksmeier, an orthopedic surgeon. At all times relevant to this lawsuit, Dr. Dirksmeier was an orthopedic spinal surgery fellow at the University of Pittsburgh Medical Center.[ 2 ] As part of his medical treatment, Wooding and Dr. Dirksmeier discussed the possibility of surgery, including the risks and benefits of undergoing spinal surgery. Wooding claims that he inquired about Dr. Dirksmeier's level of experience when he and Dr. Dirksmeier were discussing the possibility of surgery. According to Wooding, Dr. Dirksmeier's answers gave him the impression that he had significant experience perform ing surgery. Wooding also alleges that Dr. Dirksm eier did not inform him that he had only recently completed his residency. Wooding claims he would not have allowed Dr. Dirksmeier to operate on him, if he had been aware of his actual level of experience.

In July 2001, Wooding underwent surgery. He alleges that, during the surgery, "a surgical bite was taken, which punctured the dura . . . resulting in the flow of cerebrospinal fluid." [A 11] As a result of the surgery, Wooding claims that he experienced a loss of feeling from the chest to the feet and extreme pain in his neck and shoulders, among other injuries. In 2003, Wooding filed an administrative claim, claiming that he had been injured as a result of medical negligence and seeking $1,500,000 in damages. Two years later, he wrote a letter requesting that his claim be amended to add an informed consent claim and increase the damages sought to $2,500,000. The United States denied his claim, and Wooding filed this civil action.

Wooding's complaint included two counts, but only Count One is at issue in this appeal.[ 3 ] In Count One, Wooding alleged a cause of action under the doctrine of informed consent, claiming that he would not have consented to the surgery if he had been accurately informed of Dr. Dirksmeier's experience and the risks of the surgery. However, Wooding subsequently renounced any claim based on a failure to inform him of the risks of the surgery in his response to a government motion for partial summary judgment. The District Court then allowed Wooding to proceed with Count One solely on a theory of misrepresentation.

Before the bench trial, the United States moved for summary judgment on the misrepresentation claim, arguing that summary judgment was appropriate because Wooding had not produced a medical expert who would testify that Wooding's injuries were proximately caused by Dr. Dirksmeier's alleged lack of experience performing surgeries. The District Court granted the Government's motion, concluding that expert testimony was required to establish that Wooding's injuries were caused by Dr. Dirksmeier's alleged inexperience, not by the surgery itself. Wooding filed a timely appeal of that order.
II.

Under Pennsylvania law, a plaintiff alleging intentional misrepresentation must show "1) a representation, 2) which is material to the transaction at hand, 3) made falsely, with knowledge of its falsity or recklessness as to whether it is true or false, 4) with the intent of misleading another into relying on it, 5) justifiable reliance on the misrepresentation, and 6) resulting injury proximately caused by the reliance." Porreco v. Porreco, 811 A.2d 566, 570 (Pa. 2002); Bortz v. Noon, 729 A.2d 555, 560 (Pa. 1999).[ 4 ] The Supreme Court of Pennsylvania has recognized the potential viability of a claim of intentional misrepresentation in a case where a doctor misrepresents his qualifications to a patient. See Duttry v. Patterson, 771 A.2d 1255, 1259 (Pa. 2001).[ 5 ]

Here, Wooding alleged that Dr. Dirksmeier and the Veterans Affairs Medical Center misrepresented Dr. Dirksmeier's level of experience and gave Wooding the impression that he had more experience perform ing surgeries than he actually had. Accordingly, to make out a claim for intentional misrepresentation, Wooding was required to show that his injuries were proximately caused by his reliance on Dr. Dirksmeier's alleged misrepresentations. See Bortz v. Noon, 729 A.2d at 560. Thus, in this case, Wooding must show that his injuries were caused by Dr. Dirksmeier's alleged lack of experience, and not simply a result of the surgery. This requires expert testimony, because the causal link is not obvious to a lay person. Cf. Quinby v. Plumsteadville Family Practice, Inc., 907 A.2d 1061, 1070-71 (Pa. 2006) (recognizing that a plaintiff must produce a medical expert to testify as to causation in "all but the most self-evident medical malpractice actions"). Wooding concedes that the expert he has retained will only testify that the injuries were caused by the surgery, not by Dr. Dirksmeier's alleged lack of experience. Accordingly, the District Court correctly granted summary judgment on his misrepresentation claim.

On appeal, Wooding argues that expert testimony on the issue of whether Dr. Dirksmeier's alleged inexperience caused his injuries is unnecessary. Instead, he contends that he is only required to show that he would not have consented to an operation performed by Dr. Dirksmeier, if he were aware of his actual level of experience. Essentially, he is making an argument under the doctrine of informed consent. The Supreme Court of Pennsylvania foreclosed this possibility in Duttry, when it held that a doctor's misrepresentations about his experience was irrelevant to an informed consent claim. See 771 A.2d at 1259. Therefore, Wooding's argument fails, and the grant of summary judgment was appropriate.

Because we affirm the District Court's decision, we need not address the Government's alternative argument that Wooding's amendment to his claim was untimely or Wooding's request that we provide guidance on the type of damages that are available in this civil action.
III.

For these reasons, we will affirm the order of the District Court.WOODING v. U.S.

HENRY L. WOODING; PHOEBE G. WOODING, his wife,
v.
UNITED STATES OF AMERICA
Henry L. Wooding, Appellant.

No. 07-4695.

United States Court of Appeals, Third Circuit.

Submitted Pursuant to Third Circuit LAR 34.1(a) February 26, 2010.

Opinion Filed: March 9, 2010.

Before: CHAGARES, STAPLETON and LOURIE,[ 1 ] Circuit Judges.
NOT PRECEDENTIAL
OPINION OF THE COURT

STAPLETON, Circuit Judge.

Appellant Henry Wooding filed this civil action against the United States under the the Federal Tort Claims Act ("FTCA"), 28 U.S.C. § 2671, et seq., alleging that he was injured during a surgical procedure at the Department of Veterans Affairs Medical Center in Pittsburgh, Pennsylvania. Wooding appeals the order of the District Court granting summary judgment to the United States.

Because we write only for the benefit of the parties, we assume familiarity with the facts of this civil action and the proceedings in the District Court. We will affirm essentially for the reasons stated by the District Court.
I.

In 2001, Wooding was referred to the orthopedic clinic at the Veterans Affairs Medical Center in Pittsburgh, Pennsylvania. There, he was treated by Dr. Peter Dirksmeier, an orthopedic surgeon. At all times relevant to this lawsuit, Dr. Dirksmeier was an orthopedic spinal surgery fellow at the University of Pittsburgh Medical Center.[ 2 ] As part of his medical treatment, Wooding and Dr. Dirksmeier discussed the possibility of surgery, including the risks and benefits of undergoing spinal surgery. Wooding claims that he inquired about Dr. Dirksmeier's level of experience when he and Dr. Dirksmeier were discussing the possibility of surgery. According to Wooding, Dr. Dirksmeier's answers gave him the impression that he had significant experience perform ing surgery. Wooding also alleges that Dr. Dirksm eier did not inform him that he had only recently completed his residency. Wooding claims he would not have allowed Dr. Dirksmeier to operate on him, if he had been aware of his actual level of experience.

In July 2001, Wooding underwent surgery. He alleges that, during the surgery, "a surgical bite was taken, which punctured the dura . . . resulting in the flow of cerebrospinal fluid." [A 11] As a result of the surgery, Wooding claims that he experienced a loss of feeling from the chest to the feet and extreme pain in his neck and shoulders, among other injuries. In 2003, Wooding filed an administrative claim, claiming that he had been injured as a result of medical negligence and seeking $1,500,000 in damages. Two years later, he wrote a letter requesting that his claim be amended to add an informed consent claim and increase the damages sought to $2,500,000. The United States denied his claim, and Wooding filed this civil action.

Wooding's complaint included two counts, but only Count One is at issue in this appeal.[ 3 ] In Count One, Wooding alleged a cause of action under the doctrine of informed consent, claiming that he would not have consented to the surgery if he had been accurately informed of Dr. Dirksmeier's experience and the risks of the surgery. However, Wooding subsequently renounced any claim based on a failure to inform him of the risks of the surgery in his response to a government motion for partial summary judgment. The District Court then allowed Wooding to proceed with Count One solely on a theory of misrepresentation.

Before the bench trial, the United States moved for summary judgment on the misrepresentation claim, arguing that summary judgment was appropriate because Wooding had not produced a medical expert who would testify that Wooding's injuries were proximately caused by Dr. Dirksmeier's alleged lack of experience performing surgeries. The District Court granted the Government's motion, concluding that expert testimony was required to establish that Wooding's injuries were caused by Dr. Dirksmeier's alleged inexperience, not by the surgery itself. Wooding filed a timely appeal of that order.
II.

Under Pennsylvania law, a plaintiff alleging intentional misrepresentation must show "1) a representation, 2) which is material to the transaction at hand, 3) made falsely, with knowledge of its falsity or recklessness as to whether it is true or false, 4) with the intent of misleading another into relying on it, 5) justifiable reliance on the misrepresentation, and 6) resulting injury proximately caused by the reliance." Porreco v. Porreco, 811 A.2d 566, 570 (Pa. 2002); Bortz v. Noon, 729 A.2d 555, 560 (Pa. 1999).[ 4 ] The Supreme Court of Pennsylvania has recognized the potential viability of a claim of intentional misrepresentation in a case where a doctor misrepresents his qualifications to a patient. See Duttry v. Patterson, 771 A.2d 1255, 1259 (Pa. 2001).[ 5 ]

Here, Wooding alleged that Dr. Dirksmeier and the Veterans Affairs Medical Center misrepresented Dr. Dirksmeier's level of experience and gave Wooding the impression that he had more experience perform ing surgeries than he actually had. Accordingly, to make out a claim for intentional misrepresentation, Wooding was required to show that his injuries were proximately caused by his reliance on Dr. Dirksmeier's alleged misrepresentations. See Bortz v. Noon, 729 A.2d at 560. Thus, in this case, Wooding must show that his injuries were caused by Dr. Dirksmeier's alleged lack of experience, and not simply a result of the surgery. This requires expert testimony, because the causal link is not obvious to a lay person. Cf. Quinby v. Plumsteadville Family Practice, Inc., 907 A.2d 1061, 1070-71 (Pa. 2006) (recognizing that a plaintiff must produce a medical expert to testify as to causation in "all but the most self-evident medical malpractice actions"). Wooding concedes that the expert he has retained will only testify that the injuries were caused by the surgery, not by Dr. Dirksmeier's alleged lack of experience. Accordingly, the District Court correctly granted summary judgment on his misrepresentation claim.

On appeal, Wooding argues that expert testimony on the issue of whether Dr. Dirksmeier's alleged inexperience caused his injuries is unnecessary. Instead, he contends that he is only required to show that he would not have consented to an operation performed by Dr. Dirksmeier, if he were aware of his actual level of experience. Essentially, he is making an argument under the doctrine of informed consent. The Supreme Court of Pennsylvania foreclosed this possibility in Duttry, when it held that a doctor's misrepresentations about his experience was irrelevant to an informed consent claim. See 771 A.2d at 1259. Therefore, Wooding's argument fails, and the grant of summary judgment was appropriate.

Because we affirm the District Court's decision, we need not address the Government's alternative argument that Wooding's amendment to his claim was untimely or Wooding's request that we provide guidance on the type of damages that are available in this civil action.
III.

For these reasons, we will affirm the order of the District Court.

VAOIG Investigation Patient Information Breach Atlanta-VA

Full Article at: VA investigating security breach of veterans' medical data

By Bob Brewin 03/09/2010

The Veterans Affairs Department's inspector general has launched a criminal investigation into a physician assistant's alleged downloading of veterans' clinical data at its Atlanta medical center, sources have told Nextgov.

The assistant allegedly recorded two sets of patient data on to a personal laptop for research purposes. One set included three years' worth of patient data and another held 18 years of medical information, according to a source familiar with the incident and who asked not to identified.

Roger Baker, VA's chief information officer, commented on an item about the incident that was posted Monday evening on a Nextgov blog that the physician assistant's laptop was never connected to the VA network and any data she recorded on her laptop was "hand entered."

But the source told Nextgov the VA inspector general is investigating whether the assistant used two thumb drives to transfer the data to the laptop.

The department has not disclosed the number of patients involved in the incident, what kind of personal data was copied, or whether it plans to notify the veterans whose records were downloaded."

Brain Scans Show Clear Differences in Veterans Suffering from Gulf War Syndrome

What is clear, he says, is that “our data now clearly show, beyond a shadow of a doubt, that there are brain abnormalities – physiological differences – between ill veterans and normal ones.” And from the new scans, “we can tell the ill veterans from the well veterans. And we can distinguish syndromes one, two and three from each other.”

Full Article at: Brain Scans Depict Gulf War Syndrome Damage

By Janet Raloff, Science News Email Author
March 10, 2010

"Nearly two decades after vets began returning from the Middle East complaining of Gulf War Syndrome, the federal government has yet to formally accept that their vague jumble of symptoms constitutes a legitimate illness. Here, at the Society of Toxicology annual meeting, yesterday, researchers rolled out a host of brain images – various types of magnetic-resonance scans and brain-wave measurements – that they say graphically and unambiguously depict Gulf War Syndrome.

Or syndromes. Because Robert Haley of the University of Texas Southwestern Medical Center in Dallas and the research team he heads have identified three discrete subtypes. Each is characterized by a different suite of symptoms. And the new imaging linked each illness with a distinct – and different – series of abnormalities in the brain.

Men with the same symptoms exhibited similar brain changes, features starkly different from healthy vets their age who had served in the same battalions. (That said, a few vets’ symptoms seemed to encompass more than one syndrome. And in such instances, imaging confirmed their brains showed impairments that extended beyond those associated with a single syndrome.)"

"What’s emerged is evidence to suggest “that there are three major syndromes responsible for Gulf War Illness,” he says. They appear loosely linked to at least three different types of agents to which many troops were exposed: sarin nerve gas, a nerve gas antidote (pyridostigmine bromide) that presented its own risks and military-grade pesticides to prevent illness from sand flies and other noxious pests. But Briggs acknowledges that no one knows for sure which combination of agents or environmental conditions might have conspired to trigger Gulf War illness.

What is clear, he says, is that “our data now clearly show, beyond a shadow of a doubt, that there are brain abnormalities – physiological differences – between ill veterans and normal ones.” And from the new scans, “we can tell the ill veterans from the well veterans. And we can distinguish syndromes one, two and three from each other.”

The new neuroimaging on a subset of 57 Gulf War vets was completed eight months ago. Yesterday’s presentations represent an unveiling of the complex statistical analyses of data gleaned from those functional MRI scans (or fMRIs), brain-wave recordings, and other magnetic resonance tools.

Some testing employed old-style technologies. For instance, about a dozen years ago, Haley’s team performed magnetic resonance spectroscopy, also known as MRS, to study the chemical composition of various regions in the brains of Gulf War vets. And these tests uncovered the first solid indicators that there were physiological abnormalities in men complaining of Gulf War Illness. Such as a perturbation in the ratio of two chemicals active in the brain’s basal ganglia: n-acetyl aspartate (or NAA) and creatine.

Don’t know what that means? I didn’t either. So Briggs explained.

“The basal ganglia is sort of the switching system of the brain. It’s where a lot of communication between the left and right hemispheres occurs.” Because it crosses the midbrain region, he says, “it’s heavily involved in a lot of these decisionmaking and attention/inhibition networks” – processing centers that, if messed up, could explain many symptoms reported by sick vets.

NAA is a biomarker of healthy nerve cells. So any decrease is a bad sign. The concentration of creatine, which comprises the fuel for brain activities, tends to remain constant, Briggs says, so “it’s often used as an internal standard” against which to compare things like NAA.

The Gulf War syndromes are each associated with a roughly 10 percent lower than normal NAA-to-creatine ratio in the left and right basal ganglia, Briggs says – “an indicator of either sick or dead neurons.”

After Haley’s team initially published evidence in the late ‘90s of the diminished NAA-to-creatine ratio in sick vets, two other labs confirmed this characteristic MRS feature in sick Gulf War veterans, Briggs notes. More recently, when one of those labs failed to reconfirm those changes during a followup study, the UT Southwestern team began to wonder whether it had erred the first time it had conducted the pioneering tests. Or whether the sick vets had simply gotten well over the past 10 years.

“Our new follow-up [MRS] tests now show our initial findings were right,” Haley says – “and that the soldiers haven’t gotten better with time.”

Many of scans that his team unveiled here at SOT rely on a technology – fMRI – that was not available in the late ‘90s. So it provides new evidence of what sets sick vets apart.

This technology allows researchers to identify which areas are active as the brain works. Haley’s multi-center team designed a series of fMRI tests that required subjects to look at threatening pictures of a battlefield, or imagine the theme behind two words to come up with a third (“desert” and “humps” might be the clues given to suggest “camel”), or to learn words and recall faces.

In healthy veterans, appropriate parts of the brain lit up as they thought, reasoned, viewed – even experienced extremes of temperature. But in men suffering from Gulf War Illness, Haley says, “a different part would often light up as their brain attempted to work around its damage.”

Affected areas of the brain in each test varied. The thalamus, for example, is involved in attention and inhibition, Briggs explains. “It is activated differently in syndrome two versus controls,” he notes. Not surprisingly, people with that particular syndrome have problems with those traits. The researchers also correlated what combinations of areas in the brain respond in concert during particular tasks. And sometimes, the collection of brain locales that lit up in sick vets differed markedly from those in healthy vets (see images above)."