Redcastle family sue American firm 26.11.07

A BABY girl from Redcastle who survived major surgery for a rare heart defect died due to medical misadventure, an inquest in Carndonagh has found. Molly Markey of Ballyratten, was born with Type I Truncus Arteriosis in May 2005. She successfully underwent surgery on July 6 that year at the Royal Victoria Hospital in Belfast to implant a porcine pulmonary valve made by US company, Shelhigh Inc. The court heard that Shelhigh Inc., has been under investigation by the American Food and Drugs Administration (FDA) since 2000. It also heard that Molly’s implanted valve was manufactured "in a cesspool".
	In a case lasting more than five hours on Friday, the court was told that baby Molly was discharged from the Royal Hospital on July 22, 2005, with her surgeons and cardiologist happy the operation was a complete success. A check-up three months later, in October, confirmed the ongoing success of the surgery. However, Molly became very ill
on November 9, 2005 and died just an hour later at home in her mother's arms. She had suffered a large ventricular aneurysm - a ballooning of a blood vessel in the ventricle. An autopsy undertaken by consultant histopathologist Dr. Michael McDermott at Our Lady's Hospital for Sick Children, Dublin, found there was a live micro-bacterial infection within Molly's implanted valve. He said the infection "most likely" developed because the valve was not sterile at the time of implantation. Dr. McDermott told the court that as a pathologist and not a cardiologist, he was unable to definitively conclude that the micro-bacterial infection had directly caused Molly's death.

However, the family's three-person legal team, led by Raymond Bradley of Malcolmson Law, Dublin, told Carn Coronor's Court that Molly's valve was "adulterated and putrid and was manufactured in a cesspool and wasn't fit to be implanted into humans". In June of this year, the FDA seized all Shelhigh devices and the

company has been forbidden to distribute again until all its manufacturing methods, facilities and controls are in compliance with the regulations. It emerged during the inquest that the European Union continues to certify the Shelhigh porcine valves although it appears the device has not been used in the Republic since 2001. Molly's parents, who are expecting another child, are now pursuing a civil action in the US against Shelhigh Inc. Speaking afterwards, the couple said they were happy with the verdict of medical misadventure. Maria Markey said: "The evidence shows that my daughter Molly's valve was contaminated which tragically led to her death. "I think it speaks volumes that the jury said they were happy that Shelhigh valves were not being used in the Republic and that their use in Northern Ireland should be seriously re-examined." The Irish Medicines Board (IMB) came in for severe criticism during the inquest after it was revealed that following Molly's death, they investigated the wrong batch of valves. The IMB only issued a Medical Device Safety Notice about Shelhigh implantable devices in May of this year.

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