Archive for April, 2007

FDA Alert: Shelhigh Implantable Medical Devices Seized

Friday, April 20th, 2007

This week, the U.S. Food and Drug Administration announced it would be seizing a number of implantable medical devices—including surgical patches, pediatric heart valves, and annuloplasty rings—from Shelhigh, Inc. due to the company’s bad manufacturing practices. These practices have risked the safety and efficacy of the devices, and the FDA is urging doctors to monitor Shelhigh medical device patients for possible malfunctions and infection.

Seized Products

The following Shelhigh products are part of the seizure:

  • Pericardial Patch
  • NR900A tricuspid valve
  • Internal Mammary Artery
  • BioConduit stentless valve
  • No-react Pericardial Patch, PneumoPledgets, VascuPatch, Tissue Repair Patch/UroPatch, EnCuff Patch, Stentless Valve Conduit, Dura Shield
  • Pulmonic Valve Conduit No-React Treated
  • MitroFast Mitral Valve Repair System
  • Gold perforated patches
  • BioRing (annuloplasty ring)
  • Pre Curved Aortic Patch (Open)
  • BioMitral tricuspid valve
  • NR2000 SemiStented aortic tricuspid valve
  • Injectable Pulmonic Valve System

Stack Of Sheetrock Fell Off Dolly, Injuring Worker’s Leg

Friday, April 20th, 2007

On April 21, 2004, plaintiff Nancy Gans, a 50-year-old operating engineer, was operating a temporary elevator lift at a construction site as workers were loading a stack of sheetrock into the lift. The sheetrock was supplied and delivered by Alta Building Material Corp., Anaheim, which was being transported on a dolly that manufactured by Roll Rite Corp., Hayward. Gans was holding open the door to the lift so that her co-workers could transport the sheetrock when the load fell on her.Gans sued Roll Rite on a products liability theory, claiming design defect, and Alta Building Material, for negligently packaging the sheetrock. Plaintiff’s counsel alleged that the caster wheel on the dolly had a design defect that caused the sheetrock to slide off of the dolly. The dolly would have been able to support the load had it not been for the defective caster wheel that Roll Rite installed on it. Plaintiff’s counsel contended that the wheel was not designed with enough strength, according to the plaintiff’s metallurgy expert.Plaintiff’s counsel further alleged that Alta Building Material negligently packed the sheetrock, prior to shipping it to the job site, and it failed to comply with ANSI or CAL OSHA standards.Defense counsel argued that Gans was liable for the collision because she had placed herself in harms way when she was holding the door open for her co-workers. Counsel further argued that the caster wheel was not defective and that the sheet rock packaging met with the custom and practice of the industry.

Gans was taken to the hospital where she was diagnosed with severe bruising along her left leg that eventually led to excision that required skin grafting. Plaintiff’s counsel claimed that Gans also sustained a frozen knee, post-traumatic stress disorder and lymphedema. Plaintiff’s counsel presented $67,000 in past medical bills and suggested that Gans would require an unspecified amount in damages for future medical treatment and ongoing assistance and services.

Plaintiff’s counsel also argued that Gans would never be able to work in any capacity for the remainder of her life. She sought $160,000 in past lost wages and $1 million in future lost wages.

Defense counsel contested the extent of Gans’ injuries, arguing that she would eventually be able to work in a different field. The defense also contested that she had suffered from traumatically induced lymphedema, referencing a court-ordered lymphedema test that contradicted plaintiff counsel’s assertions that she had contracted the disease.

A second mediation at JAMS before Michael Ornstill yielded a $1,961,000 settlement between all of the involved parties whereby Roll Rite agreed to pay Gans $647,130 and Alta Building Material agreed to pay $1,313,870.

Father Files Lawsuit In Son’s Death

Friday, April 20th, 2007

The father of a 13-year-old boy who was killed last month in a traffic accident south of Hesperus has filed a wrongful-death lawsuit against the driver of a pickup who crashed into a parked car, killing three teens.

The lawsuit was filed earlier this month by Raymond Millich Sr., the father of Raymond Millich Jr.

The three-page complaint accuses Eugene Chavez of negligence and his company, TRC Companies Inc., of wanton and willful conduct. It notes that TRC instructed Chavez to drive straight from Oregon to New Mexico, changing off with one other person to sleep and drive.

The lawsuit seeks damages in excess of $100,000.

TRC - an engineering, consulting and construction-management firm - reported $401.2 million in gross revenue for the fiscal year ending in June 2006, according to news release posted on its Web site.

Durango lawyer Jim Casey, who represents Millich, has also sent a notice of intent to sue to La Plata County. A notice of intent is the first step in filing a lawsuit against a governmental body.

A La Plata County Sheriff’s vehicle was parked partially in the road, facing the wrong way, where the accident occurred, Casey said. If the deputy breached his duty and contributed to the accident, the notice of intent will preserve Millich’s ability to sue the county, Casey said.

And on Wednesday, Durango lawyer Joel Fry, who represents Octabino Romero and Samuel Romero, two survivors of the accident, sent a notice of claim to the county - preserving their right to sue.

Samuel Romero, 11, sustained numerous injuries and is recovering in La Plata County, Fry said. Octabino Romero suffered slight injuries, and he may seek claims resulting from seeing a loved one injured.

Fry said he and his clients believe some responsibility for the accident rests with Deputy Jacob Yeager, who parked in the highway where the accident occurred, but the bulk of responsibility rests with Chavez and his company.

The accident occurred at 11:50 p.m. March 17 on Colorado Highway 140, less then two miles south of Hesperus.

Chavez, driving a 1999 Ford F-550, was southbound when he veered off the right side of the road striking an Isuzu Trooper parked in a private driveway near the highway.

Deputy Yeager was parked in the southbound lane, facing north, with emergency lights activated, investigating suspicious activity.

According to an affidavit filed in District Court, Chavez was trying to avoid the deputy’s vehicle that was facing him on the road. District Attorney Craig Westberg and La Plata County Sheriff Duke Schirard said Yeager parked where protocol allows, and he did nothing wrong.

The District Attorney’s Office has charged Chavez with six misdemeanors, including three counts of careless driving causing death and three counts of careless driving causing bodily injury.

According to the Colorado State Patrol, Chavez failed to slow down and caused the accident when he left the roadway. The State Patrol calculated Chavez’s speed at 55 to 60 mph in a 60 mph zone.

Inside the Isuzu Trooper were Larry Romero, 18; Carly Martin, 16; Millich Jr., 13; and Romero, 11. Everyone in the Trooper was killed except for Samuel Romero, who has been released from a hospital in Denver and is recovering from his injuries.

Study Finds Anemia Patients Over-treated In Some Centers

Thursday, April 19th, 2007

Anemia patients getting treatment at large, for-profit kidney dialysis chains are often over-treated with epoetin—an anemia drug sold as Epogen and Procrit—increasing their risk of suffering potentially life-threatening side effects, a new study finds.

Researchers compared the method of treatment received at for-profit and nonprofit dialysis centers for almost 160,000 patients nationwide and found a significant variation.

On average, hospital-based centers administered about 16,188 doses of Epogen a week compared to the 20,838 doses at for-profit chains—nearly 3,300 more doses per week.

“Basically what we found in the area of anemia management is there are wide differences in practice,” said Mae Thamer, lead researcher.

Epogen Side Effect Concerns

The vast differences in anemia treatment poses a serious problem to patients: Recent studies have found that Epogen, Procrit, and similar anemia drugs increase the risk of life-threatening side effects including blood clots, stroke, hear attack, and death.

So why do some dialysis chains over-treat their patients? Researchers say it may be because Epogen is one of very few drugs used to treat end-stage kidney disease that is covered by Medicare, thus resulting in more profit for these centers. In fact, about a quarter of their profits might actually be coming from Epogen and similar anemia drugs, states an editorial that accompanies the study in the Journal of the American Medical Association.

Prison Guard Was Not Watching When 40 Inmates Beat Plaintiff

Thursday, April 19th, 2007

On the evening of Feb. 6, 2001, plaintiff Luis Garza, 28, was attacked and severely beaten by about 40 other inmates in the recreation yard of the federal correctional institution in Three Rivers. At the time, only two correctional employees were supervising 300 to 500 inmates scattered throughout the seven-acre recreation yard.Garza sued the United States, alleging violation of the Federal Tort Claims Act, 28 U.S.C. sec. 2671 (FTCA), claiming that the negligence of prison employees proximately caused his injuries. He alleged that the patrol guard on duty was not patrolling the yard, contrary to specific orders, while another employee was staffing the metal detector. Garza alleged that (1) the government failed to free him from harm pursuant to 18 U.S.C. sec. 4042 and the Eighth Amendment of the U.S. Constitution, (2) the guard failed to follow the post order prohibiting large groups from gathering, and (3) the guard failed to follow the “will patrol” order instructing her to patrol the recreation yard.Judge Hilga Tagle dismissed the complaint, finding that Garza’s claims fell within the discretionary exception to the FTCA, thereby shielding the government from liability.

Garza successfully appealed the court’s ruling to the Fifth Circuit, which reversed the dismissal and remanded the case for a full factual determination on the merits because the “will patrol” instruction prescribed a set course of action for the guard. The Fifth Circuit held that the issue in the case was the guard’s failure even to notice the group, rather than her alleged failure to properly assess its size and potential danger.

Garza alleged that specific post orders dictate the duties of a recreation patrol officer, including maintaining accurate accountability of inmates in the recreation yard. Further, patrol officers are instructed that “[i]inmates should not be allowed to gather in large groups.” When the attack on Garza began, the patrol guard was speaking with the employee who was staffing the metal detector, where only one staff member is typically needed. As a consequence, she did not observe the large groups of inmates that were observed by a number of other witnesses. None of the inmates observed the guard in the recreation yard during the time leading up to the violence.

Garza suffered fractures to his skull, jaw and cheek. He underwent surgery to release intracranial pressure and was in a coma for about eight days. He continues to experience pain and suffering, including severe headaches, dizzy spells and hearing loss.

He sought $500,000 for past and future physical pain and mental anguish, disfigurement, physical impairment, loss of enjoyment of life, and past lost earnings and loss of future earning capacity.

Following a bench trial, Judge Hilda O. Tagle found that it was the guard’s responsiblity to be on heightened awareness regarding her patrol and supervisory duties, and she was negligent in the performance of her duties. The court entered judgment for plaintiff in the amount of $350,000.

$950K Settlement In Illinois Jail Death

Thursday, April 19th, 2007

The Cook County Board agreed to pay $950,000 to settle a claim that an inmate’s requests for medical attention were ignored before she died in jail.The county settled the lawsuit on Wednesday without admitting liability in the 2002 death of Marie O’Donnell-Smith at Cook County Jail, court records showed.

O’Donnell-Smith, 38, who had been arrested on a shoplifting charge, collapsed at the jail. According to court documents, she was a heroin addict suffering withdrawal symptoms.

The lawsuit alleged that a nurse at the jail’s health service told O’Donnell-Smith that she would have to crawl to the dispensary. It said two nurses then pulled and pinched her arms and legs while she was on the floor. She was found dead in her cell hours later.

A doctor hired by her family said she would have lived if she received appropriate care. Her vomiting and dehydration from the heroin withdrawal caused irregular heart arrhythmia, which resulted in her heart stopping, the doctor said.

The Cook County Sheriff’s office already agreed to pay $50,000 in the case, bringing the total payment to $1 million.

A message left for Cook County Board President Todd Stroger was not returned Thursday morning.

Family attorney Kevin Golden said one nurse was fired and another was disciplined after the death.

Resident Kept Alive despite Do-Not-Resuscitate Order

Wednesday, April 18th, 2007

In 1998, plaintiff’s decedent Madeline Neumann, 92, was a resident at the Joseph L. Morse Geriatric Center in Palm Beach. Neumann was suffering from Alzheimer’s and had been there since 1995. She had signed a living will, which stated that she did not want any extraordinary life saving measures taken in the event of a medical emergency. Neumann fell ill and was tended to by rescue workers who started the process of executing extraordinary life saving measures by intubating her. The family told the nursing home to remove the tube and Neumann died six days later.On behalf of Neumann’s estate, her daughter sued Joseph L. Morse Geriatric Center and her primary care physician, Jaimy Bensimon, for medical malpractice and negligence theories.The parties did not contest that Neumann had a valid living will that provided that she did not want life saving measures.

Plaintiff’s counsel argued that Morse Geriatric failed to note on her chart that Neumann wished to not have extraordinary measures taken. The chart was introduced into evidence at trial.

Barbara C. Malmuth, plaintiff’s expert in nursing home procedures, found fault with Morse Geriatric’s training procedures in regards to living wills. Malmuth said that while the policies Morse Geriatric had in place were sufficient, employees were not trained in the procedures and were often unaware of the them.

Plaintiff’s counsel argued Bensimon did not take steps to make himself aware of Neumann’s wishes.

Morse’s counsel argued that it was reasonable for their workers to have ignored any medical directives. The medical workers needed to evaluate what was wrong with her in order to attempt to comply with her living will. Defense medical expert Lee Fischer opined that the nursing home medical workers responded appropriately to an unanticipated emergency.

Benisimon’s counsel stated that Morse Geriatric did not provide him with a copy of Neumann’s will; therefore he had no knowledge of it.

Plaintiff’s counsel sought damages for Neumann’s pain and suffering during the dying process. To keep Neumann alive she was subject to measures such as the inserting of a catheter and intubation procedures. She regained consciousness, became distraught and attempted to remove tubes from her throat. Hospital staff then placed physical restraints on her. After life saving measures were removed, Neumann lingered for four more days until passing.

The jury found that the Joseph L. Morse Geriatric Center was negligent, but Bensimon was not negligent. It awarded $150,000. Plaintiff’s counsel indicated that this case was to their knowledge Florida’s first “prolonging of life” trial.

Former UCI Liver Patient Wins Appeal On Settlement

Wednesday, April 18th, 2007

The woman who first accused UCI Medical Center of negligence in its liver transplant program will be allowed to continue her lawsuit against the hospital, according to a state appeals court decision filed this week.

Elodie Irvine, 52, alleged in a lawsuit filed four years ago that UCI delayed her liver and kidney transplants, causing her health to deteriorate. She later received transplants at Cedars-Sinai Medical Center in Los Angeles.

She settled her original lawsuit against UCI two years ago for $50,000 – before federal investigators sanctioned UCI’s liver program, a move that prompted the school to close that program. It was eventually revealed that UCI had misled health regulators and the public, incorrectly saying it had a full-time transplant surgeon.

Irvine says her attorney coerced her into settling the 2003 lawsuit, and the appeals court ruled this week that Irvine’s dispute over the settlement was compelling enough to return the case to the courts.

“I’ve gone through so much,” Irvine said Tuesday. “Justice has prevailed.”

A UCI spokesman said the university will pursue more legal action in response to the court’s decision.

“The court specifically did not address the underlying merits, including whether Ms. Irvine has actually entered into a binding settlement,” Tom Vasich said.

Virginia Tech Students And People From All Over The World Grieve And Vent Online

Wednesday, April 18th, 2007

Horrible, real-world happenings are unfolding almost simultaneously in the virtual world, as Virginia Tech students and people from all over the world gather online to grieve and vent.Almost immediately after Monday’s deadly shootings, Virginia Tech students created an “I’m OK” page on Facebook to let one another and their loved ones know that they survived. Other students posted photos and cell phone video on their own sites, or shared it just hours after the shootings with news organizations.

Since Monday, there has been a nonstop flood of postings on the popular Facebook student site, on MySpace and LiveJournal, and on personal blogs - expressing everything from grief to anger to confusion.

Jesse Connolly, a 21-year-old from Lynn, Massachusetts, made a posting Tuesday on the Myspace page of Ross Alameddine, one of the students who died. The pair worked together last summer at an electronics store in their home state.

“If only you were here to read this Ross… You’d know what an imaginative, intelligent, compassionate and most of all hysterically funny human being you were, and how appreciative I am to have spent last summer working with such a great kid,” Connolly wrote. “My every thought is with you and your family.”

Even before names of the victims were officially released, a few students created Facebook memorial pages for some of the dead - though others worried that it was too soon, since family and friends were still being notified.

There are myriad other ways the Internet continues to shape the grieving process.

In addition to using the university’s Web site to communicate with the world, Virginia Tech officials planned to set up a site where families of the victims could post photos.

TechSideline.com, a site for Virginia Tech sports fans, also quickly morphed into a meeting place where students, family and friends could communicate - especially when phones were jammed.

And as a show of support, many students, including scores from other colleges, replaced their Facebook profile photos with a Virginia Tech logo shrouded in a black ribbon.

Patti Jacobs, a junior at Canisius College in Buffalo, New York, was among them. Saddened by the shootings, she went searching for memorial pages on Facebook on Tuesday morning.

Jacobs was alarmed when she also came across several pages that included hateful, sometimes racist remarks toward shooter Cho Seung-Hui, other Asians and his family.

“This is not about just one guy and his problems,” Jacobs wrote. “Yes - he alone is accountable for all the damage and pain caused yesterday - but the reason for this was not his race, his child-rearing by his family or his girlfriend breaking up with him….

“How much of our society is accountable as well?”

Some of the hateful postings were removed, likely after other Facebook users flagged them - a process of communal self-editing used on some sites.

Those kinds of entries are a product of the open nature of the Internet, where rumors and inaccuracies also can linger.

Such was the case for 23-year-old Wayne Chiang, who was mistaken by some as the shooter - partly because his Facebook profile includes references to graduating from Virginia Tech and several photos of him with his gun collection.

At first, Chiang says he “played along with it” on his personal Web page, partly to see how much money he could make, since payment from the ads he places on his site are based on the number of hits the site gets. (He claims he’s going to donate the proceeds to a fund for the shooting victims at his alma mater.)

Chiang decided to post the truth after he received death threats. But many of those who thought he was the shooter had the same question: Why did the killings happen?

“I always knew the Internet was very powerful, just not to this extent,” Chiang, who lives in suburban Washington, D.C., said in a telephone interview.

“People just want to blame it on somebody in order to understand the situation. It’s completely understandable.”

Court Allows Suit Over Police Shooting

Wednesday, April 18th, 2007

A federal appeals court refused to dismiss a lawsuit against a former Louisville police officer Monday, saying he acted in “bad faith” when he fatally shot a 19-year-old man three years ago.McKenzie Mattingly lacked justification to shoot Michael Newby in January 2004 during an undercover drug buy, the 6th U.S. Circuit Court of Appeals in Cincinnati said. The court’s decision upholds a ruling by U.S. District Judge Charles Simpson, who allowed Newby’s family to sue Mattingly.

In a unanimous opinion, a three-judge panel said Mattingly overreacted in shooting Newby as he fled from an undercover drug deal gone bad.

Garry Adams, an attorney for Newby’s estate, said the ruling wasn’t surprising and should allow the case to move toward a trial or settlement.

Messages left Monday for Mattingly’s attorneys were not immediately returned.

Mattingly was charged with murder and later fired, but a jury cleared him of criminal charges after a high-profile trial in September 2004. Mattingly is white and Newby was black, and the shooting set off complaints of police brutality in Louisville’s black community.

Mattingly had argued in court papers that the lawsuit should be thrown out because he shot an armed drug dealer who had threatened him. Police found drugs and a gun on Newby after the shooting.

Newby’s mother, Angela Bouggess, alleges that Mattingly acted negligently. The lawsuit also names Louisville Metro government, saying the city failed to train Mattingly properly.

Bouggess’ suit seeks punitive and compensatory damages “in amounts to be proven at trial.” A trial date has not been set.