HADCORP NEWS: September 13, 2008

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Plastic surgeon to pay $75,000 to fired pregnant worker (USA)Vaccine Makers Shielded From Autism Liability Lawsuit (USA)

Fiery tonsil lawsuit goes to court (USA)

Controversy Over Unethical Payment Within Medical Device Industry (USA)

HADCORP NEWS: September 13, 2008

Plastic surgeon to pay $75,000 to fired pregnant worker

Thursday, September 11, 2008

By a Ward, Pittsburgh Post-Gazette

Pittsburgh, PA, USA

A Cranberry plastic surgery office has reached a consent decree with the Equal Employment Opportunity Commission over a lawsuit filed by an employee who claims she was discriminated against because she was pregnant.

Griggle, hired as a secretary at Premier Plastic Surgery in June 2005, filed a discrimination complaint against the center in September 2007. After her supervisors learned she was pregnant, Ms. Griggle said, she was told to "suck in her belly," because if she didn't, she would scare away patients who went to the facility to "look better."

She was fired on Dec. 27, 2005, because, she was told, "she was not a good fit."

According to the lawsuit, when it was time to hire Ms. Griggle's replacement, Dr. Heil, the president of the center, asked if the candidate "had a uterus."

As part of the consent decree, Premier has agreed to pay Ms. Griggle $75,000.

However, the agreement states that Premier Plastic Surgery entered into the consent decree "solely to avoid the time, expense and distraction of litigation."

As part of the settlement, both parties agree that it does not constitute a finding on the merits and "shall not be construed as an admission by defendant of any violation of Title VII."

Premier Plastic Surgery, which agreed to post a notice of the consent decree in its offices for the next three years, agrees to avoid pregnancy discrimination and not to retaliate against anyone, including Ms. Griggle, in the future. Also, officers at Premier must revise their current discrimination, harassment, retaliation and complaint procedures and provide annual anti-discrimination training to managers.

First published on September 11, 2008 at 10:58 am

AUTISM

Vaccine Makers Shielded From Autism Liability Lawsuit

InjuryBoard.com

Tampa, FL, USA

Posted by Jane Akre Wednesday, September 10, 2008 10:09 PM EST

An 11-year-old boy with autism and his family cannot proceed with their case against pharmaceutical companies after a judge ruled that federal law pre-empts state claims against companies if their vaccines are FDA-approved.

, 11, of Texas, was given six vaccines during the first year-and-a-half of his life.

Five of the vaccines contained the mercury-based preservative, thimerosal. ’s parents, and claim the mercury in the vaccines caused ’s autism.

The vaccine makers named in the product liability lawsuit were Aventis Pasteur Inc., Merck & Co. Inc., and Wyeth.

But Philadelphia Common Pleas Judge Arnold L. New granted the companies summary judgment and wrote that the drug makers are shielded from liability by the federal National Childhood Vaccine Injury Act.

22( of the Vaccine Act expressly pre-empts claims of design defects or a failure to warn the public about a vaccine’s dangers.

“Congress clearly intended when it enacted the Vaccine Act to exercise its constitutionally delegated authority to preempt all state design defect claims without case-by-case determination that the side effects are unavoidable," New wrote.

The 1986 National Childhood Vaccine Injury Act was created as a no-fault system by the federal government to provide recovery of damages to people hurt by vaccines and to reduce the potential financial liability of vaccine makers due to injury claims.

The ’s attorney Marc P. Weingarten of Locks Law Firm, had argued that the drug companies were negligent because the public and doctors were kept in the dark about the use of mercury in vaccines.

But Judge New ruled that violating the protection provided by the Vaccine Act might destabilize the supply of child vaccines.

Weingarten said the case is "an extremely important issue to be heard by the courts of Pennsylvania" because of the federal pre-emption issues arising in pharmaceutical and medical device litigation in both state and federal jurisdictions.

Proponents of vaccines argue that major studies have not found a link between the use of thimerosal and neurological injury.

But scientists pointing to the case of Hannah Poling earlier this year, put the industry on notice that pre-existing conditions in children, such as mitochondrial disorder in Hannah, might result in autism after vaccinations.

In March, Gerberding, head of the CDC, appeared with Dr. Sanjay Gupta on CNN and confirmed that vaccines can trigger autism in a subset of vulnerable children. That video is available via YouTube on the web site of Adventures in Autism.

To overcome this federal safety blanket for drug makers, the plaintiff would have to show the pharmaceutical companies engaged in fraud or wrongfully withheld information from the FDA; or failed to exercise due care even though the manufacturer complied with federal laws and regulations.

Ultimately, measures aimed at reducing the right to file liability lawsuits against drug and device makers is one tool of the tort reform movement. #

MEDICAL DEVICE NEWS

Fiery tonsil lawsuit goes to court

abc7news.com

San Francisco, CA, USA

Wednesday, September 10, 2008 | 8:33 PM

By Vic Lee

SAN JOSE, CA (KGO) -- It was a sensational story five years ago when it happened - a child goes to the hospital to get his tonsils removed but his breathing tube catches fire. Now the lawsuit filed by his family is finally going to trial.

"My parents told me I was going to get a Popsicle afterwards," eight-year-old said.

That's the last thing remembers before he was anesthesized for a tonsillectomy in April 2003.

The doctor inserted an electro-cauterizing device to remove his tonsils. A breathing tube pushing oxygen and anesthesia was also in his throat.

Suddenly, the breathing tube caught fire.

"And just very quickly fire erupts because 100 percent oxygen is going down the tube into this child's lung," family attorney Joe Carcione Jr. said.

The surgical staff extinguished the fire, but over 40 percent of 's upper airway was burned.

is now 13-years-old and continues to suffer pulmonary problems. He has also developed a new medical condition, which is caused by the lack of oxygen, Carcione said.

San Medical Center, where had the procedure performed, is now closed, but the doctor wrote in his incident report that was deprived of oxygen for only about 15 seconds.

But when he began deposition interviews for the lawsuit, Carcione said he found it was longer.

"We unquestionably found that it was minutes that were involved that this boy was given little or no oxygen," he said.

In the lawsuit, Carcione maintains the medical device that caught fire has a design flaw. The family wants the device taken off the market. But he maker of the device Conmed said in its incident report that the operator's manual warns never to perform electrosurgery, such as the tonsillectomy, where there is an abundance of oxygen.

The doctor's attorney declined to comment, and when ABC7 called the attorney representing Conmed, she responded by asking the judge to stop the media from covering the trial. Conmed's attorney went on to file a motion asking for, not only a gag order to prevent attorneys from talking to the media, but specifically mentioning ABC7.

's father still wonders how a simple tonsillectomy could go so wrong.

"I took my son in to improve his lifestyle and ended up damaging him for life," said.

As for , his tonsils are still there and he is too scared to have them removed.

Controversy Over Unethical Payment Within Medical Device Industry

findingDulcinea

New York, New York, USA

September 09, 2008 4:24 PM by Coakley

Government officials are watching some orthopedic and medical device companies due to concern that they suspect are handing out kickbacks to doctors.

A Unique Industry?

A three-part series in the Minneapolis Star-Tribune is examining the practice of medical device companies paying orthopedic surgeons. Some call the money kickbacks, others consulting payments.

One company’s spokeswoman said the company’s agreements with doctors help improve the devices. “The products we develop and manufacture cannot be invented by trying a new formula in a lab like the pharma industry. They must be designed and produced in close collaboration with the men and women who will use them: the world’s most highly-skilled and innovative doctors and surgeons,” beth Thorsgaard of Medtronic told the Star-Tribune.

But federal agencies and Congress are investigating these practices.

The series tells of one extreme case involving money: an Arkansas doctor pleaded guilty to a criminal charge for receiving illegal payments. Medical device distributors allegedly bought a new computer system for Chan’s office. Another distributor allegedly paid for a nurse’s honeymoon.

Chan is also accused of unnecessarily operating on patients. The Star-Tribune describes a shouting match that occurred after an anesthesiologist asked why Chan was performing spine fusion surgery on an elderly patient “who only had a few weeks to live.”

He pleaded guilty to a single count of “soliciting and receiving kickbacks,” and was sentenced to three years probation, the Star-Tribune reports. He also had to pay fines and $1.5 million for a civil whistleblower lawsuit.

Allegations of accepting kickbacks aren’t unique to American medicine. Earlier this year, Australia’s newspaper The Age reported that U.S. investigators were looking at donations and financial relationships with Australian doctors and hospitals.

Two medical device companies were among the top donors to Royal Melbourne and The Alfred hospitals, The Age said. Doctors at the hospitals allegedly have contracts with companies to use particular brands of devices.

The paper also quoted an unnamed doctor as saying: “These are contracts that are given for exclusive supply without being tendered for in public hospitals. There are instances when the sales reps will actually do the rounds of the hospital and threaten junior staff, like residents, if they see them using other companies’ implants.”

In 1994, French officials charged a dozen doctors with fraud for allegedly accepting kickbacks, according to the medical journal BMJ. The doctors were allegedly overcharging for prosthetic knees, and getting money from the distributor or maker. In that case the government hadn’t yet set a price for the devices, so it was reimbursing doctors for whatever they charged.

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