Archive for February, 2008

Patient Claims Unread Pap Smears Delayed Diagnosis Of Cancer

Monday, February 25th, 2008

In June 2000, plaintiff Sheryle Trainer, a 51-year-old schoolteacher, underwent an annual gynecological examination that was performed by gynecologist Dr. Claudia Ravins. A Pap smear was performed, and the sample was sent to a processing facility, Bio-Reference Laboratories Inc. Although the lab reported the Pap smear as “within normal limits,” it also reported the presence of an incomplete specimen that had “no endocervical component in a menopausal patient.” Ravins did not read the Pap smear and had a “nurse” file it. Trainer was not informed that an incomplete Pap smear had been reported, and she was not offered a repeat Pap smear.On March 17, 2001, Trainer returned to Ravins for an exam and Pap smear. Ravins performed a pelvic exam and reported normal findings. A Pap smear was performed, and the sample was sent to Bio-Reference Laboratories. The report stated, “within normal limits,” but it also stated that there was inflammation and/or infection present. Ravins did not read this report either, and it was put in Trainer’s file.

About four weeks later, Trainer hemorrhaged vaginally. She made an appointment with Ravins, and a biopsy was taken from the hemorrhaging mass. Pathology returned with a 5- by 6-centimeter mass that obliterated the cervix. Further tests revealed that Trainer was suffering stage-IIIB cervical cancer. She underwent numerous rounds of chemotherapy, internal radiation and external radiation. The cancer went into remission, but it returned in June 2002, thus resulting in a total pelvic exenteration.

Trainer sued Ravins and Bio-Reference Laboratories. Trainer alleged that Ravins failed to read the Pap smears’ results, that Ravins failed to perform proper pelvic examinations, that Bio-Reference Laboratories’ staff misread the Pap smears, and that the defendants’ failures constituted medical malpractice.

Plaintiff’s counsel noted that Ravins admitted that she did not read the Pap smear reports because they had been filed by a “nurse” who would presumably have read them.

The gynecological surgeon who performed the exenteration testified that a Pap smear dramatically decreases the need for total a pelvic exenteration because it provides an early detection of cervical cancer.

Trainer’s expert gynecologist opined that Ravins departed from the standards of good and acceptable medical practice in her pelvic exams of Trainer and that the mass should have been palpated on pelvic examination. He contended that the lack of endocervical tissue in June 2000 was significant and that further testing, such as a repeat Pap smear, was warranted. He also contended that stage-I cervical cancer was present at the time of the June 2000 exams with a mass the size of a marble.

Trainer’s expert gynecologists also opined that Ravins failed to perform proper and adequate pelvic exams in 2000 and 2001. They contended that the lab report from March 2001 required immediate investigation because inflammation is a warning sign of cervical cancer.

Trainer’s expert pathologist opined that Bio-Reference Laboratories misread the slides from 2000 and 2001. In 2000, the pathologist claimed, a high-grade intra-epithelial lesion was present but not reported to Ravins. Ravins claimed that if she was aware of this lesion, she would have ordered follow-up work.

The expert pathologist also claimed that, in 2001, invasive squamous cell carcinoma was present in the slide but not reported. Ravins claimed that had she been aware of this, she would have done further testing.

The defense’s expert gynecologist opined that Ravins’ care and treatment of Trainer was appropriate. He contended that the lab reports were within normal limits. Based on these, he claimed that no further testing was required.

Plaintiff’s counsel noted that at the close of their examination of Ravins, she admitted responsibility as to the delayed diagnosis of Trainer’s cervical cancer. However, the next day she testified differently. Ravins admitted that the endocervical cancer is where cancer originates and that inflammation is a warning sign of cervical cancer.

During the trial, Trainer and Bio-Reference Laboratories agreed to a $2.5 million settlement. The matter proceeded against Ravins.

Trainer was diagnosed with stage-IIIB cervical cancer in April 2001. The cancer was treated via chemotherapy as well as internal and external radiation. The cancer went into remission but returned a year later, in June 2002. At that time, Trainer’s only option for treatment was a total pelvic exenteration, which removed her bladder, rectum, colon, anus and vagina. She required three surgeries and now requires an ileostomy and colostomy for her urinary and bowel needs. Both bags are permanent and require hourly draining.

Trainer’s expert oncologist opined that, based on the size of the mass when it was detected in April 2001, it had to be present in June 2000 and certainly in March 2001. He contended that if the mass had been detected in June 2000, only a radical hysterectomy would have been required to treat the cancer, given that it was in an earlier stage.

Trainer sought recovery of damages for her past and future pain and suffering.

The jury found that Ravins was negligent, but Bio-Reference Laboratories was assigned 10-percent liability. The jury determined that Trainer’s damages totaled $30 million. The offset of Bio-Reference Laboratories’ liability and the addition of the $2.5 million settlement produced a net recovery of $29.5 million.

Sheryle Trainer

$15,000,000 Personal Injury: Past Pain And Suffering

$15,000,000 Personal Injury: Future Pain And Suffering

Defense counsel has moved to set aside the verdict as against the weight of the evidence and excessive as a matter of law.

Suit Says Spinal Disk Maker Falsely Won F.D.A. Approval

Monday, February 25th, 2008

A patient suing the maker of an artificial spinal disk now says the original maker of the device, Spine Solutions, and the investment firm that financed its development misled patients and federal regulators about the disk’s safety and effectiveness.

Earlier this year the patient, Calvin Timberlake, sued Synthes, the disk’s current maker, because he said the device, the Prodisc, had come apart in his back and had to be removed surgically, leaving him in severe pain. On Thursday he added Spine Solutions and the investment firm Viscogliosi Brothers to the suit.

Mr. Timberlake and his lawsuit were mentioned in a January article in The New York Times that reported that many of the doctors who had conducted the clinical research for the Prodisc stood to benefit financially if it won approval from the Food and Drug Adminstration. That approval came in 2006.

The amended lawsuit by Mr. Timberlake claims that the Viscogliosi firm, and the three brothers running it — Marc, John and Anthony — “were under tremendous pressure” to sell Spine Solutions and receive F.D.A. approval for the Prodisc because they needed to repay “embezzled funds” and “prevent financial ruin and likely criminal indictment.”

Synthes, which agreed to acquire Spine Solutions for $350 million in 2003, declined to comment Thursday on Mr. Timberlake’s lawsuit.

Describing the lawsuit as “completely baseless and without merit,” Viscogliosi Brothers said in a statement that it would “aggressively defend themselves” and “take all remedies to defend their reputations and achieve justice.”

According to the lawsuit, in September 2002 the Manhattan district attorney’s office became aware of accusations that the firm’s principals had embezzled money from its investors and began an investigation.

“At no time, even after intense reviews, did any government agency pursue any action against Viscogliosi Brothers,” the firm said, saying all of the judicial and regulatory bodies reviewing the claims had either dismissed them or did not pursue them.

In an earlier interview, Daniel J. Castleman, chief of investigations for the Manhattan district attorney, said, “We examined the allegations and found they lacked prosecutorial merit, as investors recouped their investments and more.”

Mr. Timberlake’s lawsuit also contends that Viscogliosi Brothers “intentionally set up an inherent conflict” in the clinical research by finding surgeons who would invest in Viscogliosi funds that financed the Prodisc and who would serve as researchers.

Doctors at about half of the 17 research centers involved in the study stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year.

The companies behind the Prodisc have previously said the researchers’ financial interests had no impact on findings of the research, which they say have been published in various peer-reviewed medical journals.

In Thursday’s statement, Viscogliosi Brothers said it is “proud of their achievement in this area and with the technology that has given thousands of patients hope and relief from spinal pain.” The Prodisc has undergone two separate assessments by the F.D.A., one for use in the lower back and the other for the neck, the firm added.

In light of Wednesday’s Supreme Court decision that would protect medical device companies from many personal-injury lawsuits if the products were approved by the F.D.A., Jim Cole, the lawyer representing Mr. Timberlake, said his case differed from that one in several ways.

He said the fact that many of the doctors performing the research had a financial interest in the outcome raised questions about the validity of the data supplied to the F.D.A. He also said that the disk had not been manufactured according to the specifications approved by the F.D.A.

High Levels Of Formaldehyde In FEMA Trailers

Monday, February 25th, 2008

Testing in more than 500 FEMA trailers showed unhealthy levels of formaldehyde, a toxic chemical that could cause serious health effects such as respiratory problems and cancer.

FEMA spent more than $850 million on 25,000 trailers and manufactured homes in the wake of Hurricane Katrina to be distributed to victims. At one point, nearly 150,000 families were living in trailers supplied by FEMA.

Higher than New Homes

According to the recent test results, formaldehyde levels in the FEMA trailers ranged between 3 and 590 parts per billion (ppb), with an average of 77 ppb. Formaldehyde levels in new homes average between 10 and 20 ppb.

An official from the Centers for Disease Control and Prevention said that about 30% of the FEMA trailers had high enough levels of the toxic chemical to cause health problems in children, the elderly, and adults with preexisting respiratory ailments.

Since 2005, the agency has received over 7,000 complaints from trailer residents about fumes and health problems.

Moving Families to Safer Places

FEMA Administrator R. David Paulison said the agency is currently trying to move families out of the toxic trailers.

“The issue is not what it will cost, but how fast we can move people out. We have to be very aggressive about it,” he said

Driver Critically Injured In Support Race Accident

Sunday, February 24th, 2008

A 27-year-old race driver was in critical condition Saturday after he crashed into a concrete barrier during a support race on the V8 Supercar program.

Ashley Cooper was given an emergency tracheotomy on site to help him breathe before being rushed to the hospital, reported The Sunday Times.

Race officials said Cooper, who is married with two young children, suffered from severe head trauma, swelling of the brain and internal injuries following the accident on the 11th lap of the second and final series race of the weekend.

According to the Australian Associated Press, Cooper remains on life support at Royal Adelaide Hospital after the high-speed wreck. His wife Casey has flown from their home to be at his bedside.

Cooper made heavy, side-on contact with a safety barrier at the eighth turn. The initial contact was to the driver’s side of the vehicle before the car veered across the track and hit the opposite wall with the rear-end.

V8 Supercars chief executive Wayne Cattach told The Sunday Times that the Confederation of Australian Motor Sport (CAMS) would “carry out a full and thorough investigation as a matter of course”.

Cattach also said it was doubtful safety issues concerning turn eight, where a number of accidents had happened over the years, were a factor in the serious nature of the crash.

“It’s a fast corner, no question … but it meets all the design requirements of FIA (International Automobile Federation),” said Cattach.

“We have absolute confidence in the way the barriers have been put together.”

It is the second serious accident in less than two years in the V8 support series.

In October 2006, New Zealand driver Mark Porter was killed following an accident during the Bathurst 1000. He was 32.

Cooper, the 2006 V8 Utes rookie of the year, made his Fujitsu series debut in 2007.

Police Officer Killed In Crash Escorting Clinton

Friday, February 22nd, 2008

A police motorcycle officer died after a crash while escorting Hillary Rodham Clinton’s motorcade to a campaign rally.

“We are just heartsick at this loss of life in the line of duty,” Clinton said at the rally.

Dallas police spokesman Sgt. Gil Cerda said he had no details on the crash, which happened shortly after 9 a.m

Study Finds Being Fit Can Lower Stroke Risk

Friday, February 22nd, 2008

Being merely moderately fit - walking briskly half an hour a day - can lower the risk of having a stroke, according to a new study whose findings apply to women as well as men.Much of the previous research on stroke and fitness has been on men and relied on participants to report their physical activity, said Steven Hooker, who heads the University of South Carolina’s Prevention Research Center in Columbia and led the study. About a quarter of those in the new study were women, and everyone had a treadmill test to measure his or her fitness level.

“It seems that benefits we’ve been observing in men for many years … are also observed in women,” Hooker said.

He said even those who were moderately fit had a lower risk of stroke. Most people can reach that fitness range by walking briskly for 30 minutes a day, five times a week, said Hooker, who presented the findings Thursday at the International Stroke Conference in New Orleans.

Stroke is the nation’s third-leading cause of death. It occurs when blood flow to the brain is stopped when a blood vessel is blocked by a clot or bursts. Hooker said physical activity can help prevent blood clots and the buildup of artery-clogging plaque.

For their research, Hooker and his colleagues used data from a study of more than 61,000 adults at the Cooper Aerobics Center in Dallas. After taking a treadmill test, the participants periodically answered health surveys. The latest research divided the group into four levels of fitness and looked at how many of them had strokes, following them an average of 18 years.

Overall, there were 692 strokes in men and 171 in women.

The study found that men in the most fit group had a 40 percent lower risk of stroke than the least fit men. The most fit women had a 43 percent reduction in their risk of stroke compared with women in the least fit group.

For moderate levels of fitness, the risk reduction ranged from 15 to 30 percent for men and 23 to 57 percent in women.

The lower risks held true even when taking into account other risk factors for stroke such as smoking, weight, high blood pressure, diabetes and family history.

Fitness is “a strong predictor of stroke risk all by itself,” Hooker said.

The study’s participants were mostly white, well-educated and middle-income or higher; other populations should be studied, he said. Fitness tests were only done when people entered the study so the researchers didn’t know if their fitness level changed over time.

In its stroke prevention guidelines, the American Stroke Association recommends at least 30 minutes of physical activity of moderate intensity on most days of the week. The new study “is certainly consistent with all of the recommendations that we already have in place,” said Dr. Larry Goldstein, a spokesman for the group and director of the Stroke Center at Duke University.

Oil Magnate Claimed He Was Defamed By Court Brief

Friday, February 22nd, 2008

On Jan. 10, 2005, plaintiff Jose Ramiro Garza Cantu, a Mexican businessman who owns more than 20 companies that provide oil-related services, was named in an amicus brief that was filed in a forfeiture action that was being heard in the U.S. District Court, Eastern District. The brief was filed by Billy Flanigan, and it addressed the court’s decision to restrain funds that were owned by the Petroleum Workers Union of the Republic of Mexico. Flanigan claimed that a 1986 default judgment established that he was entitled to $92 million of the funds. His brief alleged that Cantu and others had committed acts of corruption, money-laundering, murder and racketeering. Flanigan’s claims were initially communicated to a reporter who was employed by Mexico City-based Proceso magazine. The reporter was given a copy of the then-unfiled brief, and the brief’s allegations were widely published by members of the Mexican media.Cantu sued Flanigan. Cantu alleged that he was defamed by Flanigan’s allegations.

Flanigan commenced a counterclaim. He alleged that Cantu attempted to prevent his recovery of the default judgment and that Cantu’s actions constituted intentional interference with a contract. The counterclaim was dismissed.

Cantu’s counsel claimed that Flanigan’s brief included false, defamatory allegations.

Flanigan contended that the brief’s contents were true and that it was protected by judicial privilege.

Cantu claimed that Flanigan’s allegations damaged his business reputation and his personal reputation. He also claimed that the allegations resulted in a loss of goodwill.

Cantu’s counsel presented a Greek businessman, who claimed that Flanigan’s allegations prompted his termination of a $289 million contract that involved his purchase of eight oil vessels that Cantu intended to sell. Two vessels were ultimately sold; another was leased.

Cantu’s counsel also claimed that Cantu was denied a contracted job for which he had submitted the lowest bid. They contended that the denial was another adverse result of Flanigan’s allegations.

Cantu’s expert forensic economist opined that Cantu’s economic losses would total about $38 million. Cantu sought recovery of that amount and noneconomic damages.

Flanigan noted that Cantu was able to sell or lease some of the vessels that would have been sold to the Greek businessman. Thus, he claimed that Cantu mitigated his lost profits.

The jury found that Flanigan’s allegations were false and defamatory. It determined that Cantu’s damages totaled $188 million.

Jose Ramiro Garza Cantu

$38,000,000 Commercial: economic damages

$150,000,000 Commercial: noneconomic damages

Post Trial:

Flanigan moved for judgment notwithstanding the verdict. He also moved for a reduction of the noneconomic damages. The motions were denied.

Two New Studies Confirm Trasylol Risks

Friday, February 22nd, 2008

The heart surgery drug, Trasylol, increases the risk of death and kidney damage in patients, two new studies have confirmed.

Trasylol (aprotinin) is given to patients undergoing coronary artery bypass surgery to control bleeding. The drug entered the U.S. market in 1993, but sales were suspended in November because of the drug’s potential risks.

Study Reveals Long-Term Risks

In a 10,000 patient study, researchers found that patients given Trasylol had a 32% increased risk of death compared with those who were not given any medication and a 27% increased risk compared to those who were given aminocaproic acid, which is also used to control bleeding.

Research showed this heightened risk to continue over the long-term. Dr. Andrew Shaw, a professor at Duke University and lead author of the study, said that the follow-up period was as long as a decade.

Shaw said the study also confirmed Trasylol’s increased kidney risks. “There does appear to be an association between continued use of aprotinin and reduced kidney function,” he said.

Short-Term Risks Too

The second study looked at the data of more than 78,000 bypass surgery patients who were given Trasylol or aminocaproic acid to limit bleeding. The short-term death risk in patients given Trasylol was 64% higher than in patients given aminocaproic acid, the study showed.

Researchers also found that patients in the Trasylol group had an increased need for kidney dialysis.

The study was conducted by physicians at Harvard Medical School and Brigham and Women’s Hospital.

Teen Honor Roll Student Killed In Crash With Tow Truck

Thursday, February 21st, 2008

On Jan. 25, 2002, plaintiff’s decedent Timothy Orefice, 17, a senior in high school, was pulling out of a Saab car dealership, where he worked part-time, onto Route 1 in Guilford when he was broadsided on the passenger side of his vehicle by a tow truck driven by Jason Secondino. Orefice died instantly.Secondino was driving in the course and scope of his employment with Guilford Texaco Inc. GELCO, a General Electric subsidiary leasing company, was owner and lessor of the tow truck. (The crash occurred before lessor liability was eliminated by statute.)

Pamela Orefice, on behalf of her son, sued Secondino, Guilford Texaco and GELCO for vehicular negligence resulting in the death of her son. The trial was bifurcated at the plaintiff’s request.

Plaintiffs’ counsel argued that the Secondino was speeding and inattentive, and his employer was negligent and reckless in its hiring, training and supervision practices.

The plaintiffs’ accident reconstruction expert, testified that Secondino’s speed at the time of the accident was seven to 10 miles over the posted 45-mph speed limit.

The plaintiffs’ truck safety expert, opined that the standard of care for the operator of a commercial motor vehicle required the operator to drive substantially below the posted speed limit at the accident location, because it was immediately beyond an exit ramp from Interstate 95. As a basis for his testimony, the expert drove at the crash location in January 2007 (virtually the same date and time of the crash) in a replica vehicle that was the same year, make and model as the defendant’s vehicle.

Through a series of photographs, the expert showed the shift lever of the truck in each of the five forward speed positions. Comparison of the photos showed that the defendants’ truck was in fifth gear at the time that the police photo was taken, prompting the expert to testify that this corresponded to excessive speed (over 50 mph) and represented a conscious choice by the driver to operate at a high rate of speed.

The expert added that Guilford Texaco failed to check Secondino’s driving background, as well as his criminal and psychiatric background, and that the employer breached the standard of care that governed the hiring, training and supervision of commercial motor vehicle operators, based both on industry standards and standards set forth by the Federal Motor Carrier Safety Administration regulations.

If Guilford Texaco had checked Secondino’s criminal history, it would have found a two-year-old burglary and larceny conviction and a pending case wherein Secondino used a motor vehicle to try to escape from a police officer after a shoplifting incident, argued counsel. The truck safety expert said that a reasonable employer would not have hired under these circumstances.

Counsel introduced evidence about Secondino’s drug treatment program that showed that he missed appointments, refused random drug screens and had questionable urine samples. Dorrity said that Guilford Texaco should have watched Secondino more closely and should have sought information from the treatment program, and that these were red flags. Counsel asserted that Secondino would never have passed the required DOT medical exam, which the employer never required him to take.

Further relying upon photographic evidence, plaintiffs’ counsel argued that the tow truck’s lights were off at the time of the accident, thus explaining why Timothy would pull out in front of Secondino.

The defendants denied the allegations.

Counsel for Secondino and Texaco asserted that Secondino had the right of way and that the decedent pulled out in front of the tow-truck driver. Defense counsel relied upon an eyewitness, who saw the tow truck moments before the crash, who testified that the truck did not appear to be speeding.

The defense accident reconstruction expert said that Secondino was traveling 1mph to 9 mph over the speed limit.

The defendants challenged the causal connection between hiring practices and the crash, particularly since Secondino did not have any prior motor vehicle history at the time that he was hired. During his employment, Secondino had only one minor incident (a dent in a parking lot).

At the end of the liability phase of the trial, the jury found that Secondino was 20 percent negligent ; Guilford Texaco was 70 percent negligent ; and that Timothy was 10 percent comparatively negligent. The jury also found that Secondino and Guilford Texaco were both reckless; that Secondino was liable for statutory double damages under Connecticut General Statutes 14-295, and that Guilford Texaco was liable for common law punitive damages (limited in Connecticut to litigation costs).

The case then proceeded to damages.

Plaintiffs’ counsel argued that Timothy had aspirations of becoming an airline pilot like his father. He was an honor roll student and star baseball player who had been accepted to four colleges. Counsel presented a series of still photos and home video taken throughout Timothy’s life, as well as material such as his college application essay. The plaintiffs’ economist testified to a future lost earning capacity of $2.9 million, which was based on earnings projections by Kit Darby, an expert on the earning capacity of commercial airline pilots.

The parties settled for $18.3 million. On behalf of all defendants, Harleysville Insurance paid $6 million, and on behalf of GELCO, Electric Insurance paid an additional $12.3 million.

Crew Member Missing From Cruise Ship

Thursday, February 21st, 2008

The Coast Guard is searching for a crew member missing from a cruise ship off the east coast of Florida.Coast Guard spokesman Dana Warr says a ship surveillance camera has shown that the 28-year-old Chinese man went overboard from the Celebrity Constellation early Monday. The search is focused near Cape Canaveral.

Crews have searched about 1,500 square miles of ocean since the man was reported missing.

The man’s identity has not been released.