Marseille: PIP breast implants founder Jean-Claude Mas jailed

It was one of the biggest trials in French legal history.  The boss of a French company which distributed defective breast implants around the world has been sentenced to four years in prison for fraud.

Jean-Claude MAS, the founder of the PIP company, was also fined 75,000 euros (£63,000) by a court in Marseille.

The company’s sale of faulty implants caused a global health scare with an estimated 300,000 women in 65 countries affected.

The company used sub-standard silicone gel, causing many implants to rupture.

Four other former PIP executives were also convicted and given lesser sentences.

About 300,000 women in 65 countries are believed to have received PIP implants.  Europe was a major market but more than half went to Latin America.  They were not sold in the United States.  42,000 British, 30,000 French, 25,000 Brazilian, 15,000 Colombian and 16,000 Venezuelan women received PIP implants.

With more than 5,000 women registered as plaintiffs in the case, the trial was considered one of the biggest in French legal history.

The health scare came to public attention in 2011 when the French government recommended that women have PIP implants removed due to an abnormally high rupture rate.

There was confusion as British health authorities said there was no need for routine removal – though they later agreed to replace the implants to put women’s minds at rest.

The issue of whether the sub-standard silicone used in the implants posed any danger was not resolved by the trial, AFP news agency notes.

MAS, 74, showed no sign of emotion as sentence was passed. His defence lawyer, Yves Haddad, said he planned to appeal.

He and the others had all admitted to fraud.

PIP’s director-general was sentenced to three years in prison, two of which were suspended.

The company’s head of quality control received two years, one of them suspended, and the head of research and development was sentenced to 18 months, suspended.

Throughout the trial, MAS had denied the silicone used was harmful while all but one of the other defendants said they had not been aware of the risks.

When an implant ruptures, the silicone gel filling can leak into the body. Some women will not notice anything at all, and there is no evidence of an increased cancer risk.

However, it can result in the formation of scar tissue that can change the shape and feel of the breast. The gel can be an irritant, causing pain and inflammation. It can also be more difficult to remove an implant once it has ruptured.

France’s Health Products Agency (ANSM) has to date registered more than 7,500 implant ruptures and 3,000 cases of undesirable effects, mainly inflammations, among the 30,000 women using PIP products in France.

In a report released in June, the ANSM noted: “Taking into account the known under-reporting of medical device incidents, the number of women actually explanted may be greater than the number of cases reported to the agency.”

Isabelle Traeger, who received a PIP implant and attended the trial, said earlier that four years would be too little for what Mas had done.

“They explained what was in them [the implants],” she told Reuters news agency.

“Inflammable substances, substances to make your car work, and that at a certain point they said to the engineer who made them, ‘How did you make them?  How did you mix together these substances?’  And he said, ‘You use your best guess’.

“And then they asked him, ‘Could you repeat what you just said?’.  ‘You use your best guess’.  Which explains why there were women in the room who had been much more seriously affected, as well as others who actually are coping quite well.

“Can you imagine? It’s a matter of chance.  A dollop more, a bit more, a bit less.  And he’ll get four years for that?  For what is put in your body using one’s best guess.  We don’t even give horses their food according to a ‘best guess’.”


Minnesota: Doctor’s killer ‘hostile’ over mother’s medical treatment

Minneapolis MN:  The 30-year-old lawyer suspected of killing prominent Orono, MN, physician Dr. Stephen LARSON, 74, had expressed hostility toward LARSON because of how he believed the doctor had treated his mother in an undisclosed medical situation, police said Monday.

Ted C. HOFFSTROM of St. Anthony MN, confronted Orono police outside the 74-year-old OBGYN doctor’s home with a semi-automatic handgun Friday night. “Diligent attempts to negotiate” with HOFFSTROM failed and he was shot and killed, authorities said.   Dr LARSON was then found dead inside the house, shot with the gun HOFFSTROM had wielded, ballistics tests would show.

“This is a tragedy of epic proportions for both families involved, as well as the community of Orono,” Hennepin County Sheriff Rich Stanek said Monday afternoon at a news conference in Minneapolis, Minnesota.  Sheriff Stanek told reporters that HOFFSTROM’s motive is still unclear.  However, HOFFSTROM had allegedly expressed hostility toward LARSON’s family because of how the doctor had treated HOFFSTROM’s delivery when he was born 30 years ago.  It is believed HOFFSTROM blamed Dr LARSON for a birth defect that left him with limited hand mobility.

Just before 21:00 Friday, Orono officers responded to a call about trouble at Dr LARSON’s house on Heritage Lane.  LARSON had been on the phone with someone who heard him answer the door and heard startling noises.  When Dr LARSON didn’t return to the phone, the person he had been talking to called police, Stanek said.  “We know who committed this murder, yet many unanswered questions remain,” Stanek said.  “Orono is a safe community, and there is no threat to the public at this time,” Deputy Chief Chris Fischer said.

Dr LARSON, who founded a medical group in Edina and Burnsville, was a well-known expert on pelvic surgery and a former adjunct professor in the Department of Obstetrics, Gynecology & Women’s Health at the University of Minnesota Medical School.

State records show that Dr LARSON was reprimanded in unrelated instances twice in his 40-year career as a licensed physician, in 1990 and 1996.  He was fined $1,000 in each case, and no corrective action was required.  According to State birth records, Dr LARSON was not the primary doctor at Mr HOFFSTROM’s delivery in 1983.

‘Doesn’t make any sense’

For some who knew Mr HOFFSTROM, his death and suspected involvement in Dr LARSON’s death came as a complete shock.

HOFFSTROM graduated from the University of St. Thomas law school in 2009 and was sworn in to the bar last month.  An online résumé listed brief stints as an intern for state Sen. Chuck Wiger in 2006 and for two Hennepin County District Court judges in 2008.  He also spent his summers for 12 years working at Gross Golf Club in Minneapolis.  He had a virtually spotless record, and a friendly demeanor, friends say.

“He was one of the best guys I’ve ever known,” said Nick Houwman, a high school friend who had seen HOFFSTROM three weeks ago after he was sworn in to the bar on Oct. 25.  “This doesn’t make any sense.”  Another friend, Chris Miller, stayed in touch with HOFFSTROM after they studied journalism at the University of Minnesota.  “That’s not the Ted HOFFSTROM I know,” he said of the shooting, “it’s shocking”.

Work-related violence is not unknown to the nation’s doctors.  An average of five physicians and 20 health care providers die each year in the United States as a result of assaults or other workplace violence, according to U.S. Bureau of Labor Statistics reports dating back to 2003.

That tally, however, does not include killings outside the workplace and would not have counted LARSON’s death.

Police said Ted HOFFSTROM was upset at how he believed Dr Stephen LARSON treated his mother’s medical condition.  He was denied his hospital medical records but according to State birth records, Dr LARSON was not the primary doctor at Mr HOFFSTROM’s delivery in 1983.

New Hampshire: Hepatitis infector gets 39-year jail sentence

A US medical technician who stole painkillers and infected dozens of patients in multiple US states with hepatitis C through tainted syringes has been sentenced to 39 years in prison.

“I don’t blame the families for hating me,” David KWIATKOWSKI said on Monday after hearing about 20 statements from people he infected and their relatives.  “I hate myself.”

KWIATKOWSKI, 34 was a cardiac technologist in 18 hospitals in 7 states before being hired at New Hampshire’s Exeter Hospital in 2011.  He had moved from job to job despite being fired at least four times over allegations of drug use and theft.  Since his arrest last year, 46 people have been diagnosed with the same strain of hepatitis C he carries.

US Attorney John Kacavas said the sentence “ensures that this serial infector no longer is in a position to do harm to innocent and vulnerable people”.

KWIATKOWSKI admitted stealing painkillers and replacing them with saline-filled syringes tainted with his blood.  He pleaded guilty in August to 16 federal drug charges.

Before he was sentenced, KWIATKOWSKI stood and faced his victims, saying he was very sorry and that his crimes were caused by an addiction to painkillers and alcohol.  He told investigators he had been stealing drugs since at least 2003 and swapping syringes since at least 2008.

“There’s no excuse for what I’ve done,” he said.  “I know the pain and suffering I have caused.”

The victims spoke angrily and tearfully of the pain that KWIATKOWSKI had inflicted by giving them hepatitis C, a blood-borne virus that can cause liver disease and chronic health problems.  Authorities say the disease played a role in one woman’s death.


Melbourne: Thalidomide victims receive landmark payment

VICTIMS of thalidomide have won an $89 million settlement from the drug’s distributor, but their lawyers say the drug’s manufacturer behaved appallingly in not paying compensation.

More than 100 Australian and New Zealand victims, many of whom were born with missing or shortened limbs, will be compensated under the landmark settlement, announced to the Victorian Supreme Court on Monday.  The $89 million will be paid by the drug’s distributor DIAGEO, with thalidomide’s manufacturer GRUNENTHAL not included in the settlement.

A class action against GRUNENTHAL will no longer proceed.  Lawyers for the victims say GRUNENTHAL’s conduct has been appalling.

“Every single Australian thalidomider was injured by a drug made by GRUNENTHAL in Germany,” lawyer for the victims said.  “Despite that, GRUNENTHAL still will not pay a cent to its Australian and New Zealand victims.

“Fifty years on, GRUNENTHAL will still not `fess up to its shameful behaviour in relation to that drug.”  “The result we have achieved today is a vindication of their courage and it is a vindication of the proposition that right around the world there are people like them who have missed out and whose time has come,” the lawyer said.  A lawyer for the victims said in some ways he regretted that the settlement meant they could take no further action against GRUNENTHAL in this country but voiced hopes it will pay its dues elsewhere in the world.  “We think time is running out on GRUNENTHAL, and before too long its sorry secrets and its embarrassing and shameful conduct in relation to the drug will be exposed,” he said.

The settlement comes after DIAGEO last year reached a multi-million-dollar settlement with prominent thalidomide victim Lynette Rowe, who was born with no limbs, was in court for Monday’s announcement.

The drug was distributed in Australia and New Zealand around 1960 and 1961 by DISTILLERS, which became part of DIAGEO in 1997.

GRUNENTHAL apologised for thalidomide for the first time in August last year.  The settlement is subject to final court approval in February, with victims likely to receive payments as early as March 2014.


London: Surgeon jailed for manslaughter for being ‘too laid back’

Senior surgeon David SELLU, 66, was found guilty of gross negligence manslaughter over the death of father-of-six James Hughes.  SELLU has been jailed for two-and-a-half-years after being criticized for being “far too laid back” as a patient died at his private hospital.  Mr Hughes, also 66, died at the Clementine Churchill Hospital in Harrow, north west London, on February 14, 2010 after falling unexpectedly ill following knee surgery.

His wife, Ann, described the suffering experienced by their family in a victim impact statement read to the court.  She said: “For three years we have struggled to discover and then accept the truth of what happened to Jim.  The world does not stand still but for us we have been subjected to a tortuous purgatory that can only be brought to an end by truth and justice.  Our trust in normal processes, authorities and structures of society was shattered by the inexplicable, callous and deceitful actions of the medical profession entrusted with the most basic responsibility to protect human life.”

Mr Hughes, a retired builder, had a planned left knee replacement on February 5, 2010.  The operation went well but while recovering from surgery he developed abdominal pain and was transferred to the care of SELLU, who had been a doctor for four decades.  He suspected that there had been a rupture in Mr Hughes’ bowel – a potentially life-threatening condition that requires surgery – but the surgeon ignored the urgency that the case demanded.  After being in pain for around 40 hours, Mr Hughes was sent to the operating theatre at 9pm on February 12. But by this point the situation had deteriorated so badly that intensive care specialists had to work to stabilise Mr Hughes before SELLU could operate on his bowel.  Four hours later, at 0100 hours, SELLU was eventually able to operate, but Mr Hughes died the following day.

Frances Hughes, one of the victim’s daughters, said outside court: “For three years we have all struggled to discover and then accept what happened to dad.  As a family we are grateful that a light has now been shone on the truth. We hope now it is less likely another person will suffer like he did.”

Judge Mr Justice Nicol said SELLU “was simply far too laid back for someone with a suspected perforated bowel”.  He went on: “This was not a single isolated act of negligence.  There were several.  Nor were they committed in the pressured circumstances of an acute NHS hospital where the stress of dealing with very many patients in an emergency condition can be particularly challenging.”

The judge told SELLU that “several failures” in his care meant his “culpability is high” and “that negligence contributed significantly to the death of Mr Hughes”.

Prosecutor Bobbie Cheema QC said: “That death was avoidable.  Had (SELLU) operated the night before or even earlier on February 12, Mr Hughes would have had a very good chance of survival.  Dr SELLU’s care of this patient on this occasion fell very far below an acceptable standard.  There was a series of missed opportunities and serious errors in judgment in the care of this patient and they combined to cause Mr Hughes’ death.  The standard of care was exceptionally bad.”

SELLU, who gave no reaction as he was jailed, was told he will serve half his sentence in custody.

Doctors and nurses “warned” still at work

MELBOURNE:  There are 500 doctors, nurses and other health specialists working in Victorian hospitals and clinics with a black mark on their registration due to addictions, poor performance or conduct risking patient safety.

The group has been allowed to continue treating patients – with those suffering “health” problems having their issues hidden from the public – after medical boards imposed the safety measures through their disciplinary processes.

The extent of restricted health workers can be revealed for the first time by the Herald Sun, with details from the health watchdog showing there are 3000 across Australia working with conditions and undertakings on their registration, due to concerns about their conduct, behaviour and abilities.

With 590,000 registered health professionals working across the country, Australian Health Practitioner Regulation Agency  (AHPRA) spokeswoman Nicole Newton said fewer than half a per cent required limitations on their registration, with doctors accounting for less than one in six.

“The boards take their job seriously and are not willing to take risks with patient safety,” Ms Newton said.

“Restrictions are designed to keep the public safe.

“If there is a serious risk to health and safety, the boards can suspend registration and stop someone working altogether while they investigate.”

But patient advocates and lawyers have ­accused medical boards of being too soft.

Medical Error Action Group spokeswoman Lorraine Long said patients should not have to put their lives in the hands of anyone facing issues serious enough to warrant registration conditions.

“I don’t believe they should be allowed to practise at all while they have any impairment, because they are dealing with human life”, Ms Long said.

“People go to doctors and get looked after by nurses with 100 per cent trust, and a lot of times that trust is not returned.

“If you go to a pediatrician you would want to know if they are under a condition because they are being investigated by police for child abuse, but the public are none the wiser.”

The restrictions cover 14 professions, including doctors, nurses, dentists, pharmacists and psychologists and relate only to serious conduct and behavioural issues, not routine regulation training or qualification processes.

Read more of GRANT McARTHUR’s story in The Australian 3 November 2013 at:

Warned doctors, nurses and health workers still at work


Practitioners repeatedly brought to the attention of Victorian medical boards:

JAILED for 14 years after pleading guilty to negligently infecting 55 women with hepatitis C while treating them at an abortion clinic.

SUSPENDED in 2008 after he paid a female patient $50 for oral sex in his consultation room in 2004. He was also suspended for 15 months in 2001 after the board found he engaged in sexual relationships with two vulnerable patients.  He was reprimanded in 2006 after telling a female patient, “Holy mackerel, you’re small”, during a Pap smear test. He was granted his registration back this year.

REGISTRATION cancelled for one year in July after he was found guilty of serious misconduct for prescribing addictive drugs to heroin-addicted patients, including more than 25,000 Xanax tablets and 9000 Valium.

THE high-profile cosmetic surgeon agreed to surrender her registration after continuing to treat patients during a 10-year legal battle with authorities over claims of botched facial treatments.  She can still practise non-surgical cosmetic procedures.

Las Vegas: Life sentence for largest US hepatitis C outbreak

Former Las Vegas endoscopy clinic owner, Dr Dipak DESAI, 63, has been sentenced to life in prison with the possibility of parole after 18 years, following his criminal convictions in what is believed to be the largest hepatitis C outbreak in the USA.

Clark County District Judge Valerie Adair sentenced DESAI yesterday.  The former state medical board member was found guilty in July of 27 criminal charges, including second-degree murder, in a viral outbreak in 2007 that officials traced to his clinics.  DESAI was convicted in the death of 77-year-old Rodolfo Meana in April 2012, and authorities have since reported the death of a second infected person in the case.  Michael Washington, 73, died on 23 August in Dallas TX of complications from the disease. Prosecutors haven’t decided whether to press additional murder charges, according to the Las Vegas Review-Journal.

DESAI had created a penny-pinching work environment at the Endoscopy Clinic of Southern Nevada, emphasising profits over patient safety and leading to unsafe clinic and injection practices that spread the virus.  The outbreak was believed to be the nation’s largest when it became public in February 2008.

The Southern Nevada Health District notified 63,000 former clinic patients to get tested for potentially fatal blood-borne diseases, including hepatitis and HIV.  Investigators from the Centers for Disease Control and Prevention in Atlanta later determined nine people had contracted hepatitis C at two DESAI clinics.  Authorities later said hepatitis C infections of another 105 patients might have been related.

CSL agrees to settle class action

BLOOD products and vaccines supplier CSL expects that settlement of an antitrust class action in the United States will reduce its fiscal 2014 net profit by $USD39 million ($AUD41.47 million).

CSL on Monday said it had agreed to settle the law suit that was filed by various hospital groups in the US and Puerto Rico and has been going on since 2009.  The settlement, including payment of $USD64 million by CSL, is subject to approval by the US Federal Court.  It is tax deductible in the US.

The settlement agreement dismisses claims against CSL and the Plasma Protein Therapeutics Association.

“If approved, the settlement represents a one-off charge reducing NPAT (net profit after tax) expectations for fiscal 2014 by $USD39 million,” CSL said in a statement to the Australian Securities Exchange.

“This charge takes anticipated NPAT growth for the current financial year to approximately seven per cent, at 2012/2013 exchange rates.”

CSL chief executive Paul Perreault said CSL still rejects any allegation of wrongdoing but had negotiated a settlement to avoid the matter dragging on.

“To pursue the case further would have required several more years of management time and focus as well as substantial additional legal costs with no absolute certainty of the outcome,” he said.

The lawsuit alleged that CSL and a competitor had conspired to restrict output and artificially increase the price for plasma-derived therapies in the US.

Shares in CSL were 40 cents lower at $64.64 at 1025 AEDT.

A CSL Plasma's plasma collection centre

CSL’s profits will take a $39 million hit if a US court approves the settlement of a class action.

7 October 2013

Brisbane: GP suspended for altering patient notes

Queensland-based GP Dr GARY MARTIN, who retrospectively changed his notes to falsely claim that a patient refused to go to hospital – then submitted those notes as evidence in an inquest, has been found to have committed professional misconduct and been suspended from practising medicine for 12 months including six months plus another six if he breached conditions within three years – and banned him from conducting most surgical procedures except under supervision for at least a year.  Dr MARTIN was also found to have committed unsatisfactory professional conduct on four counts after taking too long to refer two patients with skin cancer to a specialist, and both intentionally misled and avoided responding to AHPRA investigators.

Moscow: Body of evidence on doctor’s drug theft

A surgeon who helped himself to drugs he removed from a patient’s stomach faces up to 15 years in prison for theft and possession of illegal substances.  The 32-year-old doctor had been asked to remove containers of heroin from the stomach of a suspected drug mule in the Siberian region of Krasnoyarsk.  A spokesman for Ministry of the Interior said the doctor helped himself to capsules of the drug after removing them from the man’s stomach in a bid to save his life.  After the operation police checked the containers removed from the smuggler’s stomach and searched the doctor.  They found 5g of heroin hidden in the surgeon’s clothing.  A police spokesman said:  “The doctor was intoxicated at the time of detention.”