Archive for March, 2007

Two Doctors Found Liable In Lawsuit Over Fatal Ulcer

Friday, March 30th, 2007

A jury has awarded $1.2 million to the family of a woman who allegedly died as a result of two doctors’ failure to diagnose a perforated stomach ulcer in 2002.

The jury found that Cape Radiology group’s Dr. W.J. Stoecker and Dr. James D. Meritt of Essex were both liable for Ruthie Lacey’s death, according to Lacey’s family’s attorney, David Zevan.

The Negligent Treatment

Lacey died at 57 years old on April 7, 2002 after an emergency surgery to treat a perforated ulcer. The surgery, performed at Missouri Southern Healthcare in Dexter, Mo., did not happen until two days after Lacey first visited the hospital complaining of extreme stomach pain, said Zevan.

A perforated ulcer is an ulcer that has eaten through the stomach wall allowing food and stomach acids to enter the abdominal cavity. It typically requires immediate surgery.

According to Zevan, after seeing Lacey on April 5, 2002, he sent her to Missouri Southern Healthcare to get a CT scan along with instructions for him to be notified when the scan was complete.

Dr. Stoecker, at Cape Radiology, read the scan remotely and missed the ulcer that was visible on the scan results, Zevan said.

Meritt failed to follow up on the test, and he sent Lacey home, said Zevan. She came back the next day still in severe pain, and this time the correct diagnosis was made and she went in for surgery, said Zevan.

“Had the proper diagnosis been made and communicated, she had at least an 80 percent chance of survival,” said Zevan. “Because it had gone over 24 hours, there was no chance of saving her.”

The Award

According to Zevan, the suit had originally named Cape Radiology and the hospital as defendants along with the two doctors, but the facilities were dropped from the suit. The doctors made the mistakes, not Cape Radiology or the hospital, he said.

The jury awarded Lacey’s daughter, Susan Coleman $1.2 million — $0.6 million for past damages and $0.6 million for future damages – mainly for the loss of companionship. Each doctor was found equally liable. The suit did not seek punitive damages.

Man May Sue Insurance Handler For Delay

Friday, March 30th, 2007

 An injured carpenter can sue a company handling worker compensation claims for the state for tying his case up for years and delaying his payments, the state Supreme Court ruled Thursday.The decision reverses a ruling by the 4th District Court of Appeals, which found in 2006 the Worker’s Compensation Act barred Christopher Aslakson from filing a claim alleging bad faith in the compensation process. The Supreme Court ruled the act doesn’t apply in such a situation.

Aslakson’s attorney, Daniel Arndt, called the decision great news for Wisconsin workers whose employers don’t carry compensation insurance and have to turn to the state for benefits.

“This will have widespread implications across the state in that those workers will have to be treated with respect,” Arndt said.

According to the Supreme Court decision, Aslakson of Red Wing, Minn., was hurt in a fall while he was working on a pole barn for Ken Donais Construction in 1998.

The company didn’t have worker’s compensation insurance, so Aslakson filed a claim with the state’s Uninsured Employers Fund in January 2000. The fund provides compensation to workers who suffer injuries for which their employers are liable.

The state Department of Workforce Development had hired Gallagher Bassett Services to handle claims on the fund.

Gallagher Bassett first denied Aslakson’s claims, then ordered him to undergo an independent medical exam. The tests showed he was disabled and entitled to compensation benefits.

Despite Aslakson’s repeated requests, Gallagher Bassett hadn’t paid him anything as of September 2001, more than a year after he underwent the exam.

That November, an administrative law judge ordered Aslakson receive $100,000. Gallagher Bassett gave him $4,000, refused to pay more and launched a legal challenge.

The Labor Industry and Review Commission and a Dane County judge upheld the award. Gallagher Bassett finally paid the balance after an appeals court affirmed the award in September 2003.

Aslakson filed a lawsuit in circuit court, alleging Gallagher Bassett had no basis to deny his claims or make its legal challenges. Gallagher Bassett moved to dismiss the lawsuit, contending the Worker’s Compensation Act governed the lawsuit and those statutes don’t allow bad faith claims.

The case eventually ended up with the state Supreme Court, which said the Worker’s Compensation Act didn’t apply in a bad faith claim separate from the initial injury and reinstated the lawsuit.

Gallagher Bassett’s attorney, David Piehler, said he disagreed with the court’s interpretation. He plans to fight the case in circuit court, perhaps by arguing the state’s sovereign immunity — a concept in which government is protected from lawsuits unless it agrees to be sued — extends to the company because it was a state agent.

“We believe the claim was handled in good faith,” he said.

Infected Breast Implant Blamed For Woman’s Death

Friday, March 30th, 2007

On Jan. 23, 2003, plaintiff’s decedent Nancy Ocepa, 63, a secretary, was administered injections that were directed to her saline-filled breast implants.At about 11:30 a.m. on Jan. 25, 2003, Ocepa presented to the emergency room of New Island Hospital, in Bethpage. An internist, Dr. Tharun Shetty, noted that Ocepa was confused and suffering a fever, diarrhea and a rash. Ocepa was referred to an infectious-diseases expert, Dr. Brijesh Goyal, who determined that Ocepa was probably suffering toxic shock syndrome. Goyal noted that Ocepa’s right breast was discolored, swollen and tender, and he opined that the condition probably stemmed from an infection of an implant’s tissue-expanding compartment. Goyal determined that a surgeon would have to address the implant’s possible removal.Later that day, at about 5 p.m., a surgeon was requested. However, the surgeon never arrived, and no consultation ever occurred.

Later that evening, Ocepa’s organs began to fail. She was attached to a respirator, and Shetty administered dopamine, which was intended to maintain Ocepa’s blood pressure.

The next day, a surgeon removed the tissue-expanding compartment of Ocepa’s right breast implant. However, Ocepa’s condition continued to deteriorate. She never left the hospital, and she died Feb. 13, 2003.

One of Ocepa’s sons, Steven Ocepa, acting individually and as administrator of his mother’s estate, sued Goyal; Shetty; Shetty’s practice group, Island Primary Medical Care Associates PC; New Island Hospital; the facility that provided his mother’s breast implants, Long Island Plastic Surgical, P.C.; and several other doctors that were involved in his mother’s care, plastic surgeon Dr. Khawaja Hassan, plastic surgeon Dr. Gene Lee and Dr. Anil Manheseshwari. The plaintiffs alleged that Goyal, Shetty and the hospital’s staff failed to promptly obtain the consultation, that their failures constituted medical malpractice and that Island Primary Medical Care Associates was vicariously liable for Shetty’s actions. The plaintiffs further alleged that Hassan, Lee, Manheseshwari and Long Island Plastic Surgical’s staff failed to properly manage Nancy Ocepa’s breast implants and that their actions constituted medical malpractice.

The plaintiffs subsequently discontinued their claims against Goyal, Hassan, Lee, Manheseshwari and Long Island Plastic Surgical. The matter proceeded to a trial against Shetty, his practice group and New Island Hospital.

Plaintiffs’ counsel claimed that Ocepa’s death stemmed from an infection of her right breast implant’s tissue expander. He contended that Shetty should have promptly ordered and obtained the consultation. He also contended that accepted medical standards established that the infected tissue expander should have been removed by 8 p.m., Jan. 25. He claimed that the tissue expander’s prompt removal would have prevented the infection’s spread and that, as such, Ocepa probably would have survived.

After the conclusion of plaintiffs’ counsel’s case, Judge Anthony Parga directed a verdict that established that New Island Hospital was not liable. The matter proceeded against Shetty and his practice.

Shetty contended that Ocepa’s treatment plan did not require an immediate consultation.

Shetty’s counsel also contended that the surgery’s pathology report and postsurgical cultures indicated that the tissue expander was not infected. He claimed that Ocepa’s toxic shock syndrome was caused by cellulitis, which is an acute inflammation of the skin’s connective tissue. Thus, he argued that the tissue expander’s prompt removal would not have prevented Ocepa’s death. The plaintiffs’ infectious-diseases expert acknowledged that cellulitis can cause toxic shock syndrome, but he opined that the condition was caused by an infected tissue expander.

Plaintiffs’ counsel claimed that Ocepa suffered an infection of her right breast implant’s tissue expander. He contended that the infection led to Ocepa’s development of toxic shock syndrome, which was diagnosed Jan. 25, 2003. Some of Ocepa’s organs failed, and she required the assistance of a respirator. The next day, she underwent surgical removal of her right breast implant’s tissue expander. However, the surgery did not improve her condition. On Jan. 28, 2003, she began a daily course of dialysis. She subsequently developed adult respiratory distress syndrome and began to lose consciousness. She underwent blood transfusions, but she could not recover. She died Feb. 13, 2003, at age 63. She was survived by four adult children.

Ocepa’s estate sought recovery of wrongful-death damages that included $1.2 million for Ocepa’s pain and suffering. Ocepa’s children presented derivative claims. Each sought recovery of $150,000 for his or her pecuniary loss.

The jury found that Shetty and his practice were liable for Ocepa’s death. The plaintiffs were awarded a total of $2.2 million.

Ketek Receives New Labeling After Cases Of Liver Failure Reported

Thursday, March 29th, 2007

On February 12, 2007 the Food and Drug Administration (FDA) announced that the antibiotic Ketek, manufactured by Sanofi-Aventis, had new labeling and warnings after it was found last year that three patients experienced severe liver problems.

The crisis first came to light in an article that appeared in the Annals of Internal Medicine entitled: “Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review.” The report found that within days of receiving Ketek (the brand name of the drug “telithromycin”), each patient suffered from symptoms associated with severe hepatitis including jaundice and liver failure. One recovered, one required a liver transplant, and one ultimately died of liver damage.

The authors of the study also noted that the FDA’s own Adverse Event Reporting System had mention of ten other cases where both Ketek and liver problems were present, suggesting that there may have been examples of this connection beforehand. However, the study and these three cases were the only investigation into a possible link between the two.

In light of these findings, the FDA along with Sanofi-Aventis narrowed its approved uses to the treatment of community-acquired pneumonia. Ketek is no longer approved for bronchitis or sinusitis due to the risk of serious liver injury. The included warning also states that those afflicted with myasthenia gravis, a muscular disease, should not be prescribed Ketek.

Further, the new labeling has added stronger warnings about the risk of liver injury, vision problems, and loss of consciousness for those taking Ketek.

In a Question and Answer section on the FDA website, the agency noted that those taking Ketek should continue to do so until instructed to stop by their physician. However, patients who experience fainting, blurred vision, or notice their skin turning yellow should seek immediate medical attention. Those with myasthenia gravis should stop taking Ketek.

Despite the new labeling, many are questioning why Ketek was approved for use in the first place. The drug was rejected by the FDA in 2001 and 2003 but was ultimately approved in 2004, apparently despite the objections of several FDA scientists.

FDA Tightens Rules On Conflicts Of Interest

Thursday, March 29th, 2007

According to the new rules announced for the Food and Drug Administration’s advisory committee, expert advisers to the U.S. government who receive money from a drug or device maker will now be prohibited from voting on whether to approve that company’s products.

When doctors receive more than $50,000 from a company, or a competitor of a company, whose product is of topic, will no longer be allowed to serve on the committees.  Although those who received less than that amount in the previous year can still join a committee and participate in its discussions.

A “significant number” of current advisers to the agency will be affected by the new policy, Randall Lutter, its acting deputy commissioner said.

These new rules are among the first major changes made by Dr. Andrew von Eschenbach since confirmed late last year as the commissioner of the Food and Drug Administration.

Advisory boards recommend drugs for approval and, in some instances, removal from the U.S. market, and their votes can have a very monumental influence on drug companies’ stock prices and profits.

“The $50,000 threshold is something that we think strikes an appropriate balance” between getting smart advisers and reassuring the public that the advisers’ counsel is not tainted, Lutter said.

The new rules were initiated to respond to an increasing number of critics who contend that drug and device makers have unfairly impacted the agency’s approval process by monetarily compensating those who serve on its advisory panels.

In one widely known example, 10 of the 32 advisers who voted in 2005 to allow the painkiller Bextra to remain on the market, and to let the painkiller Vioxx to return to the market despite all of the safety worries associated with the drug, had received money from the makers of the drugs.

Under the new rules, their votes would not have counted, and the committee would have voted to keep both drugs off the market, consequently saving lives.

In the end, the agency removed Bextra from the market anyway, and Vioxx has never returned. But the controversy surrounding that panel’s vote and similar ones ruined the image of the review process and provided new material for critics of the agency to consider.

While there were some conflicts under the old rules that led to total exclusions, like an adviser’s holding $100,000 of stock in the company at issue, the agency could decide to disregard almost any other potential financial conflict, including tens of thousands of dollars in income from a company that might have business before it.

A U.S. congressional committee has begun an investigation into the marketing and regulation of widely used anemia drugs that have recently fostered safety concerns.

The House Committee on Energy and Commerce sent letters to Amgen and to Johnson & Johnson, who market the anemia drugs, requesting information about when they knew of possible risks and how they had promoted the products.

The letters also asked them to suspend any consumer advertising of the drugs and any incentive programs directed towards doctors who prescribe them until after the FDA has had sufficient time to determine whether further safety precautions are necessary.

The products include:  Epogen and Aranesp from Amgen and Procrit from Johnson & Johnson — are all forms of erythropoietin, a protein made by the kidney to spur production of red blood cells. The drugs are mainly used to treat anemia caused by kidney failure or cancer chemotherapy and have combined worldwide sales of roughly $10 billion a year.

A panel is scheduled to meet May 10, 2007 to discuss the safety of the drugs.

Stronger Warnings Put On Anemia Drugs

Thursday, March 29th, 2007

Under pressure from the Food and Drug Administration (FDA), manufacturers of anemia drugs implemented new, sterner black box warnings on bottle labels. The updated labels include a notice warning doctors to monitor patients’ hemoglobin levels.

The drugs, commonly used to treat patients on chemotherapy and kidney transplant patients, are Erythropoiesis-Stimulating Agents (ESAs). They include darbepoetin alfa (Aranesp), and epoetin alfa (Epogen and Procrit). These drugs are synthesized versions of the human protein erythropoietin. Natural Erythropoietin is produced by the kidney and increases the number of blood cells produced.

Study Findings

Recent studies have found that these drugs increase the risk of death resulting from heart attacks, strokes, and blood clots when they are given in doses larger than recommended.

Other studies have linked the drugs with tumor growth in patients with cancer of the brain or neck.

Even when taken at the recommended dosage, the drugs were linked with an increased risk of blood clots in cancer patients not receiving chemotherapy, and in patients who have had orthopedic surgery.

Patients should discuss the risk of using these drugs and the risks involved with blood transfusions with their doctors.

Labeling had also been changed in 1997, 2004 and 2005 to include more safety information. The labels may also be changed later this year in May.

Steven Galson, Director of the FDA’s Center for Drug Evaluation and research, said, “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee meets in May and further revisions to the labeling may occur after that meeting.”

Cop Shot And Killed Paraplegic Man After Car Chase

Thursday, March 29th, 2007

On Aug. 18, 2003, plaintiff Cornelius Ware, 20, who’s paraplegic, was driving on the south side of Chicago when he was pulled over by police in front of his residence.Three of Ware’s family members, who witnessed the traffic stop, claimed that as Ware remained in his vehicle, four police officers approached him. His family claimed that they yelled at the police officers that he was paraplegic, and one of the officers started opening fire on an unarmed Ware, firing six shots at his vehicle. Ware died three weeks later. Police claimed that they found a .38-caliber gun in his car.Ware’s surviving family, on behalf of his estate, sued Anthony Blake, the officer who fired the shots, and the city of Chicago for violating his civil rights, seeking wrongful death damages.

Plaintiff’s counsel argued that Ware wasn’t armed and didn’t provoke the shooting and that police planted the gun in his car. Plaintiff’s forensic pathology expert, Joye Carter, testified that a bullet, which was fired by Blake in front of Ware’s vehicle, went through the back of Ware’s right hand and exited from his thumb. This shattered the bones in Ware’s hand and disabled him from holding a gun, pointing a gun and firing a gun. Carter also testified that the gun that was found in Ware’s car did not have any blood on it, which would have if Ware allegedly fired a gun with a gunshot wound to his hand, and that Ware’s fingerprints were not found on the weapon.

Plaintiff’s police practices expert, Dennis Waller, testified that Blake violated police practices by shooting an unarmed alleged suspect. Waller also testified that two of the of three officers, who claimed that they did not fire shots upon Ware’s vehicle because the third officer was in their crossfire, violated police practices by standing idly and failing to mobilize themselves to a position where it would render better aim. Waller further testified that police training dictated that officers would have moved in and taken immediate action to secure Ware’s alleged firearm, remove him from his vehicle and call medical emergency personnel.

The defendants denied the allegations. Defense counsel contended that the four officers received a call about a vehicle that was involved in an earlier police chase, which matched Ware’s vehicle and was then spotted and pursued by the four officers. The vehicle ran a stop sign and began driving erratically, and then crossed the center line and drove and stopped adjacent to a curb in front of Ware’s residence, according to the defense.

The officers, who claimed that they did not hear Ware’s family members say that he was paraplegic, approached Ware’s vehicle with their guns drawn and ordered Ware to step out of the vehicle, and he did not obey their orders. Ware then drew his gun with his right hand and aimed the weapon from the driver’s side window, and Blake, who was positioned at the passenger’s side of the vehicle, fired five shots, defense claimed. Ware slumped over to his right side and then aimed his gun out of the driver’s side window, and Blake, who did not have time to reload his firearm, fired a sixth shot. Blake claimed that the fired shots occurred within five to eight seconds. Defense police practices expert Clarence Chapman testified that it was routine protocol for officers to approach vehicles involved in police pursuits with guns drawn, and that the officers did not violate any police practices, as they reacted appropriately when Ware drew his gun. Defense forensic pathologist expert Vincent DiMaio testified that it was possible for an individual to be shot in the hand and still hold and fire a gun.

Ware was taken to a local hospital where he was treated for gunshot wounds to the head, back, thigh and hand. He died from his injuries three weeks later. If the trial proceeded to damages, plaintiff’s counsel would have sought an unspecified amount in Ware’s past pain and suffering.

In a bifurcated trial, the jury found for Ware on liability. Both sides then settled for $5.25 million.

State Farm Settles Katrina Lawsuit Involving Nature Of Damage To US Couple’s Home

Thursday, March 29th, 2007

State Farm Fire and Casualty Co. has reached another settlement with a Mississippi Gulf Coast couple who sued the insurer over damage to their home from Hurricane Katrina.State Farm spokesman Phil Supple told The Associated Press the settlement with Virginia and John Roper Sr. was reached Wednesday, but had no other details and terms were not disclosed.

“We’ve come to an agreement and we’re moving forward,” Supple said late Wednesday. “We’re in a spirit of resolution on these and this is another example.”

Trial in the lawsuit was to begin April 9. The case was to be heard by federal Judge Bernard A. Friedman, a Michigan judge assigned to the lawsuit after Southern Mississippi district judges disqualified themselves because John Roper is a federal judge.

The company recently decided it will no long offer new homeowner policies in Mississippi and has been working with the state to settle claims.

The couple sought more than $75,000 in actual damages and an unspecified amount in punitive damages. They originally filed in Jackson County Circuit Court, but moved the case to federal court where hundreds of Mississippi residents have sued State Farm and other insurers.

Justice Department Medical Malpractice Report Released

Wednesday, March 28th, 2007

The Justice Department has released a report Sundaycontaining data on medical malpractice claims in seven states, including Illinois, Florida, Missouri, Maine, Massachusetts, Nevada and Texas.

Prompted by ongoing debate about the reason for the increased cost of healthcare in the United States, the report describes settlement and payout amounts.

Findings

The report found that about 17 percent of all medical malpractice claims in those states yield payments of $1 million or more.

It also reported that about 95 percent of medical malpractice cases are settled out of court before the trial. Most of these are settled after the lawsuit is filed, said the report.

According to the report the median damages paid in medical malpractice cases has increased 49 percent in the last 10 years.

The report found that 24 percent of injuries resulting in medical malpractice claims occurred in physicians’ offices while 42 percent occurred in inpatient hospital facilities.

In Illinois, about 21 percent of insurance claims in closed malpractice cases result in payouts under $100,000, while nearly 25 percent result in payouts between $500,000 and $999,999, the report found.

Payout Timeframe

According to the report, the states from which they gathered data took an average of 15 to 24 months before medical injuries were reported to insurance companies. It took about 67 months on average in Illinois and Nevada to close.

“Several factors influence the decision concerning when to file a medical malpractice claim, including statute of limitations restrictions and the need to ascertain various medical, work-related, and pain and suffering expenses,” the study’s authors said.

Jurors Side With Merck In Vioxx Trial

Wednesday, March 28th, 2007

A state jury Tuesday sided with Vioxx maker Merck & Co. over claims that its once-blockbuster painkiller caused the 2003 deadly heart attack of an obese 52-year-old Illinois woman, concluding her own poor health likely led to her demise.

The Madison County jurors deliberated about six hours over two days before rejecting the request from Patty Schwaller’s widower to hit Merck mightily in the pocketbook for allegedly contributing to his wife’s death and not sufficiently warning that the drug carried potentially dangerous cardiovascular side-effects.

In siding with Merck, the jury concluded that Vioxx was not a “proximate cause” in the death of Patty Schwaller, who had taken the drug for about 20 months before suddenly collapsing and dying in her Granite City home.

An attorney for the Schwallers pledged to appeal.

“Today, at least for the moment, Goliath bested David,” Andy Crouppen said on behalf of Frank Schwaller, who showed no emotion as the verdict was read and left the courthouse without commenting.

Merck, which pulled Vioxx off the market in 2004 after its research showed it increased the risk of heart attacks and strokes, celebrated its 10th victory in 15 cases that have been tried in the mushrooming litigation over Vioxx. It was the first trial in the Midwest and had been conducted in a county known for large awards favoring plaintiffs.

“This was a very tragic event,” Dan Ball, an attorney for Merck, told reporters moments after he mouthed “thank you” several times to jurors in the courtroom. “But the tragedy was not related in any way to Vioxx.”

Merck isn’t out of the woods. The company, based in Whitehouse Station, N.J., has been deluged with more than 27,000 personal injury lawsuits and another 265 potential class-action lawsuits alleging harm from Vioxx. The company has reserved $1.64 billion in its Vioxx legal defense fund and said again Tuesday it plans to fight each lawsuit.

“Plaintiffs have the burden of proving their claims, and we believe these cases are best suited for individual review,” Kenneth Frazier, Merck’s executive vice president and general counsel, said in a news release.

During the monthlong trial peppered by numbingly medical jargon, Merck lawyers insisted that 5-foot-2 Patty Schwaller had several risk factors for heart disease, including her weight that ranged from 250 to 300 pounds, diabetes, high blood pressure and a sedentary lifestyle.

Frank Schwaller’s attorneys pressed that his late wife had no heart attacks, strokes or symptoms of congestive heart disease before her fatal collapse. And the widower alleged that Merck failed to adequately study Vioxx’s possibly harmful side-effects and publicly downplayed worries by outside researchers that the drug could put users at greater risk of heart attacks or strokes.

But jurors concluded Tuesday that while Merck knew or should have known Vioxx may have posed dangers to patients like Patty Schwaller, Vioxx labels in 1999 and 2002 - well before Patty Schwaller’s death - adequately urged caution among Vioxx users with cardiovascular risks including hypertension.

One juror, Jennifer Fourcault of Granite City, told reporters that pinpointing what caused Patty Schwaller’s death was hampered because her body was cremated without an autopsy. Fourcault and other jurors said the case spent too much time generally attacking Merck’s conduct before and after Vioxx’s release and not enough on Patty Schwaller specifically.

“This is about one person,” Fourcault said.

The trial has been closely watched in Madison County, which has gained national notoriety as a place where lawyers from across the country file cases involving everything from asbestos exposure to medical malpractice, hoping for big payouts.

On March 12, jurors in Atlantic City, N.J., found that Vioxx contributed to an Idaho postal worker’s 2001 heart attack, reversing the verdict in the man’s first trial and hitting Merck with a total of $47.5 million in damages. If the verdict and damage amounts are upheld on appeal, it could be the biggest hit to Merck so far.

In New Orleans, a judge has ordered a new trial over what he called a “grossly excessive” $51 million jury award last August to a South Carolina man who used Vioxx.

A New Jersey Supreme Court panel also is considering whether to allow health insurers and union health plans to sue Merck jointly to recover money they paid for Vioxx prescriptions - a lawsuit potentially worth more than $15 billion.