HADCORP News Sept 9 2008: Doctor sanctioned for okaying large breast implants (Canada)

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----- Forwarded Message ----From: "humanadjuvantdisease@..." <humanadjuvantdisease@...>Also in this edition:

Family's fight for son who died after plastic surgery (Ireland)

Jury gives widow $5.1 million (USA)

Medtronic device focus of lawsuit (USA)

Molecular Breast Imaging Found to Provide More Conclusive Results Than Breast MRI (USA)

Glaxo Loses Another Paxil Preemption Case (USA)

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HADCORP NEWS: September 7, 2008

Doctor sanctioned for okaying large breast implants

CJAD

Montreal, Quebec, Canada

Fri, 2008-08-22 06:29.

Deschamps

A Quebec doctor has been sanctioned by her peers for giving a patient unrealistically large breast implants.

Dr. Elise Bernier admits she erred in judgment in agreeing to the woman's wish for enormous breasts.

Although she had never before worked with large implants, she used the 800 cc size - larger even that what the patient had asked for. Complications ensued, the implants had to be removed and one of the woman's breasts is now deformed.

Dr. Bernier has been suspended from practice for 8 weeks and has promised to never again implant anything larger than 400 ccs.

Family's fight for son who died after plastic surgery

Herald. ie

Dublin, Ireland

NATIONAL NEWS HOME

By Conor Feehan

Saturday August 30 2008

THE family of a young Dublin man have said they will continue their long battle in a bid to discover how he died.

Pierre Christian Lawlor (33) is believed to have died after plastic surgery in Colombia in 2007.

This week, his family have succeeded in getting vital surgical and post mortem documents from Bogota in order to proceed with their quest to find out exactly why their son and brother died.

However, the family have used endless resources to get the documents and are now bidding to translate the medical documents from Colombia word by word.

It's believed father-of-one Pierre died following the cosmetic surgery in September 2007. Tragically, the striking looking tiler had somehow believed he was ugly, and he feared his young wife Galeano (23), from Venezuela, would leave him for someone else.

He paid €3,500 to have liposuction and surgery to his face and neck during a trip to Bogota.

But Pierre, from Stepaside, died following the surgery, leading to an open verdict in the inquest into his death in the Dublin County Coroner's Court.

His wife , who met Pierre over the internet, told the Coroner's Court that she believes he took cocaine and drank at an Irish bar the day before he died.

She was at his side when he died on September 3 last year after a heart attack.

He had travelled to the Colombian capital with his wife and baby Zachary for surgery at the Centro Columblade Cirujin Plastica.

State Pathologist Professor Marie Cassidy, who carried out an autopsy, said drugs may have contributed to his death but he may have suffered strain from lengthy surgery.

Coroner Kieran Geraghty said Pierre had died from cardiac arrest due to prolonged surgical procedure.

He warned people should "avoid unnecessary surgery" but returned the open verdict at the inquest as no clinical notes "were available".

However, an affidavit by MacGuill, the solicitor for the dead man's parents, Tom and Margaret Lawlor, said they had since received the notes and records with the assistance of the Department of Foreign Affairs.

This week the Lawlor's were granted leave by the High Court to seek to quash the open verdict in the inquest and seek a new inquest that would take the new evidence into account.

"We are delighted that we have the documents we feel are crucial to the case, but our next challenge is getting them all translated by experts and then reviewed by medical people here to determine the information in them," said Pierre's sister Claudine.

Mr Justice Gilligan adjourned the proceedings until the beginning of the new law term in October, and the Lawlor family hope to have a date for a hearing early next year.

- Conor Feehan

MEDICAL DEVICE NEWS

Jury gives widow $5.1 million

Spouse died after elective surgery

Louisville Courier-Journal

Louisville, KY, USA

BY JASON RILEY

SEPTEMBER 5, 2008

The wife of a fort, Ky., man who died in 2003 after surgery at Jewish Hospital that was supposed to alleviate his Parkinson's disease has been awarded more than $5 million in damages by a Jefferson Circuit Court jury.

Norman Gene Carroll, the brother of former Gov. n Carroll, died Feb. 4, 2003, a week after an elective surgery in which he was supposed to have a deep brain stimulating device inserted.

On Friday, his widow, 73-year-old Retha Carroll, was awarded almost $5.1 million from medical staff involved in the surgery, including $3.5 million for her husband's pain and suffering, $1.5 million for the loss of consortium and about $96,000 in medical expenses.

Jewish Hospital was dismissed from the lawsuit a few years ago.

"She is overjoyed that a jury finally made the health-care providers take responsibility," said Hans Poppe, her attorney. "For five years … everybody said it was somebody else's fault."

Ragland, editor and publisher of Kentucky Trial Court Review, said the pain and suffering award was particularly high given the relatively short amount of time Norman Carroll suffered -- "though it was a horrible way to go."

And the $1.5 million consortium award, which allows claims for loss of companionship of spouses from injury until death -- was the largest for a wife in Kentucky since at least 1997, when Ragland began tracking state jury verdicts.

The previous high, Ragland said, was $1 million in a Boyd County case from 2001 where the husband lived three years after a missed cancer diagnosis. Norman Carroll lived only a week following the surgery.

The lawsuit, filed in 2004, claimed that doctors and nurses who were working on Carroll on Jan. 28, 2003, did not stop the surgery and take appropriate action when he started struggling to breathe.

Poppe said Carroll was awake for the procedure and told his surgeon, Dr. Dante J. Morassutti, and his nurse, Carolyn Lowe, that he was having difficulty breathing.

Five medical personnel testified during the trial that Dr. Atul Barry, an anesthesiologist, was called to the room to decide whether to stop the procedure, Poppe said.

During the two-week trial, Barry denied that he was called to the room, but Morassutti and others claimed Barry was present and said it was safe to continue, Poppe said.

"This was an elective procedure that they could have stopped anytime," said Poppe. "But the procedure didn't stop and he didn't get any better."

Carroll eventually lost consciousness and went into a coma.

His wife took him off life-support about a week later, according to court records.

"Norman should not have died that day and his wife should not have had to make the decision to take him off life-support," Poppe said.

The jury apportioned much of the blame to Barry, who was ordered to pay about $3 million in damages. Morassutti was ordered to pay more than $1 million and Lowe's estate and Medical Center

Anesthesiologists must each pay $509,000.

"We all sympathized and felt for this family," said Ragland, an attorney for Lowe's estate. He declined to discuss specifics of the case or trial.

Attorneys for Barry, Morassutti and Medical Center Anesthesiologists did not immediately return phone calls.

Medtronic device focus of lawsuit

Minneapolis Star Tribune

Minneapolis, MN, USA

The suit alleges that local surgeons took part in illegal marketing of a popular product used in spinal surgery; Medtronic itself is not named.

By CHEN MAY YEE, Star Tribune

Last update: September 4, 2008 - 8:52 PM

Nine Minnesota physicians allegedly received kickbacks and illegally marketed a popular Medtronic product used in spine surgery, according to a federal whistleblower lawsuit recently made public.

The lawsuit, filed last year by two former employees of Medtronic Inc.'s spinal products division, alleges that they and more than 100 other physicians and physician groups nationally received improper payments to buy and promote "Infuse Bone Graft." The suit also states they marketed the product for uses not approved by regulators.

Medtronic, based in Fridley, is not a defendant, though it has been in other lawsuits that made similar kickback allegations, but which were settled out of court or dismissed.

The Minnesota spine surgeons named in the suit are Drs. Garvey, Francis Denis, ph H. Perra, Pinto, Schwender, Ensor Transfeldt and Amir Mehbod of Twin Cities Spine Center, and Polly at the University of Minnesota. A Minnesota neurologist, Dr. Stanley Skinner, is also on the list.

"Our clients categorically deny those allegations," said Lundquist, a Minneapolis attorney for the physicians. "A great number of physicians in the case do not even use Infuse and have not consulted on Infuse but have consulted with Medtronic on other products."

Infuse is one of the best selling products in Medtronic's spinal biologics division, which brought in $815 million of the company's $13.5 billion in revenues last year.

Medtronic declined to disclose sales for Infuse.

"Infuse is a revolutionary and safe product, when used within its current product labeling," said Medtronic spokeswoman beth Thorsgaard. "Medtronic does not promote off-label use."

Growth agent in a cage

Infuse is used to fuse spinal vertebrae. It consists of a sponge soaked in a genetically engineered growth agent that is inserted in a small, metallic cage, which is then implanted between vertebrae to fuse them together. Before its introduction, surgeons used bone taken from patients' hips, which required two surgeries.

The lawsuit cites safety concerns raised at an FDA Advisory Committee about whether Infuse might promote uncontrolled bone growth around the spine if used off-label.

In July the FDA warned surgeons it had received reports of life-threatening complications linked to using Infuse on the cervical spine near the neck.

Since it was approved in 2002, Thorsgaard said, the rate of complaints to the FDA was less than one-tenth of 1 percent of all units sold. The FDA approved Infuse for use in the lower back. However, as with many other devices and drugs, physicians use it for purposes not specifically approved by the FDA. That is not illegal.

However, it is illegal to market or promote a medical product for off-label use, one of accusations in the whistle blower suit.

Not the first time in court

It is the third such suit involving Medtronic's spinal products. In 2006, the company agreed to pay $40 million to settle a previous whistleblower case filed in U.S. District Court in Memphis, Tenn., but without admitting wrongdoing. That suit alleged illegal marketing for Medtronic spine products and sought refunds for the federal government for Medicare and Medicaid payments.

A second lawsuit was filed against Medtronic by Kay Poteet, a former employee of Medtronic's spinal division -- Medtronic Sofamor Danek U.S.A. Inc. -- against Medtronic in U.S. District Court in the Western District of Tennessee. That suit alleged that between 1998 and 2003, illegal kickbacks such as travel junkets, sham consulting and royalty agreements were showered on doctors. However, the government declined to intervene and the suit was dismissed.

Suit targets physicians, groups

The whistleblower suit unsealed recently was also filed by Poteet and another ex-employee, Bobbie Vaden, in 2007 in federal District Court in Massachusetts. This time it targets 120 physicians and physician groups, and 16 medical device distributors, but not Medtronic. The government has again declined to intervene and the case is pending.

The lawsuit alleges the physicians received sham consulting fees, bogus royalty payments, research grants and fellowships, free travel and other gifts to buy and promote Infuse, including off-label uses. These actions, the lawsuit alleges, caused other physicians to submit claims to Medicare that were ineligible for reimbursement, or false claims.

Besides the nine Minnesota physicians, Team Spine Minnesota, a Medtronic distributor in St. Louis Park, is also a defendant.

Poteet worked for Medtronic's spinal unit for eight years until 2003 and was senior manager for travel services. She oversaw a $10 million annual budget for employee and physician travel.

Carr, the Memphis-based attorney for Poteet and Vaden, declined to comment on the case.

Lundquist, who represents 82 of the defendants, declined to say if his clients had indeed received the consulting fees detailed in the lawsuit. The sums ranged from tens of thousands to hundreds of thousands of dollars.

It's a common practice in the device industry for surgeons to contribute to the design of new products, to lecture about them and train other surgeons to use them. Surgeons are compensated at an hourly rate based on what they would make as neurosurgeons and orthopedic surgeons, said Lundquist.

"All payments to our clients are appropriate and based on services rendered," he said.

Molecular Breast Imaging Found to Provide More Conclusive Results Than Breast MRI.

MarketWatch

USA

Last update: 6:09 p.m. EDT Sept. 4, 2008

NEWPORT NEWS, Va., Sept 04, 2008 /PRNewswire via COMTEX/ -- On the heels of the recent press release from the Mayo Clinic regarding molecular breast imaging, researchers from Jefferson University Hospital have released their findings using this new imaging modality at the American Society of Clinical Oncology national meeting.

Dr. Brill and her colleagues conducted a multi-center study containing 201 women who required additional imaging after a questionable mammogram. Patients had both breast MRI and molecular breast imaging. The authors concluded, "BSGI (Breast-Specific Gamma Imaging) demonstrates equal sensitivity to breast MRI in the detection of malignant and high-risk breast lesions while reducing the rate of indeterminate findings by 50 percent. BSGI has additional advantages over MRI in that the study generates four to eight images, as compared to up to 1000 images in MRI and can be utilized in all patients including those with ferromagnetic implants or renal insufficiency. In addition, BSGI is conducted at a fraction of the cost per procedure of breast MRI."

The term BSGI has been used to describe molecular breast imaging for the last 5 years. This imaging technology is FDA approved, is currently available in approximately 80 centers across the United States and approximately 50,000 patients have been imaged to date. About Dilon Technologies

Dilon Technologies is bringing innovative new medical imaging products to market. Dilon's cornerstone product, the Dilon 6800, is a high-resolution, small field-of-view gamma camera, optimized to perform Breast-Specific Gamma Imaging (BSGI), a molecular breast imaging procedure which images the metabolic activity of breast lesions through radiotracer uptake. Many leading medical centers around the country are now offering BSGI to their patients, including: Cornell University Medical Center, New York; Washington University Medical Center, Washington, D.C.; and The Rose, Houston. For more information on Dilon Technologies please visit http://www.dilon.com.

SOURCE Dilon Technologies

BIG PHARMA

Glaxo Loses Another Paxil Preemption Case

Newsinferno.com

New York, NY, USA

Date Published: Friday, September 5th, 2008

A federal judge has sided with the family of a teenager who committed suicide while on Paxil, and has ruled that their lawsuit against GlaxoKline can proceed. The ruling rejects the drug maker’s claim that the Food & Drug Administration (FDA) approval of Paxil barred plaintiffs from filing product liability claims. Recently, drug makers have been trying to convince courts that this concept - known as preemption - shields them from such lawsuits.

In September 2004, the Food & Drug Administration (FDA) issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain’s Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters showed an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.

On May 12, 2006, the FDA issued another Paxil suicide warning when results of another study showed that Paxil increased suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.

Critics of Glaxo have charged that the company knew about Paxil’s problems with suicidal behavior long before it ever made them public.

Recently, British authorities concluded a four-year investigation into whether Glaxo failed to inform drug regulators in that country about a link between Paxil and suicidal behavior in children and teens in a timely matter. Criminal charges were not pursued in that case because British laws are unclear on whether companies are obligated to report certain drug data.

In the U.S., Sen. Grassley (R-Iowa) has asked the FDA to probe whether Glaxo knew of Paxil’s suicide risk when it first sought approval for the drug. The Justice Department is also probing the company’s handling of the drug.

Jake Garrison was only 16 years old when he shot himself in September 2002. The teenager had been prescribed Paxil eight months before he took his life. His parents sued Glaxo, claiming the drug maker knew there were risks associated with off-label pediatric use of Paxil and, therefore, had a duty to warn of those risks.

Glaxo had argued that the suit was preempted by FDA regulations which, at the time of Jake’s death, did not call for suicide warnings for pediatric patients on Paxil.

Senior U.S. District Judge L. Buckwalter of the Eastern District of Pennsylvania disagreed with the company. In a 55-page opinion, he wrote that FDA rules allow a drugmaker to “unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug.” Therefore, Judge Buckwalter wrote that jury must decide whether the drug manufacturer “indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling.”

Drug makers have been waging a battle in the courts to win protection from product liability lawsuits. A case pending before the U.S. Supreme Court, Wyeth vs. Levine, seeks just that. The High Court ruled in favor of medical device makers, granting them such a lawsuit shield earlier this year.

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