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MPs call for criminal inquiry into toxic hip implants – Telegraph.

MPs call for criminal inquiry into toxic hip implants

MPs have called for an inquiry after it emerged that a company sold toxic hip implants used in thousands of operations in Britain despite knowing for at least three years that they were potentially dangerous.

More than 10,000 Britons have been fitted with the metal-on-metal implants
Britons have been fitted with the metal-on-metal implants Photo: Darren Greenwood / Design Pics Inc./Rex Features

By Mark Hughes, Claire Newell, Holly Watt and Peter Dominiczak

9:36AM GMT 01 Feb 2013

The Telegraph has disclosed that Depuy, a subsidiary of Johnson & Johnson, continued to market “metal on metal” hip implants after a leading British surgeon warned in emails to an executive of the manufacturer that patients were suffering.

The company’s own data also allegedly disclosed that a relatively high proportion of the artificial hips, which are supposed to last a lifetime, were failing after two and a half years.

Tests concluded that they were significantly more likely to fail than other models. Depuy continued to market the hips to British patients, hundreds of whom are now having them replaced because they are suspected of causing blood poisoning.

The test results are not thought to have been shared with British regulators or made public.

Andrew Miller, Labour MP for Ellesmere Port and Neston and chair of the Science and Technology Committee, described the Telegraph’sdisclosures as “appalling”.

“If this is proven then it ought to be up to the regulator to contemplate involving the police so there is a criminal inquiry,” Mr Miller said.

“If a company would knowingly do this then where does the buck stop? I think it’s a question of a criminal inquiry rather than a civil one.”

“We need a very tight regulatory regime and what we should be saying to the NHS is to make sure that products that are being bought have been regulated and approved in Britain,” Mr Miller added.

Mr Miller said that all products used in UK operations must be “rigorosly tested to British standards and if there is any doubt they should not be bought”.

David Tredinnick, Tory MP for Bosworth, said: “There should be an investigation and I shall be raising this in the Health Committee and also in the Science and Technology Committee.”

The disclosure over the warnings came in an American court case that is considering whether patients should be compensated for the faulty implants. Documents appear to show that Depuy was repeatedly warned about the impact on British patients.

More than 10,000 Britons have been fitted with the metal-on-metal implants, which are suspected of wearing down and depositing potentially toxic metal into the bloodstream. The product was withdrawn from use in 2010, a number of years after the warnings were made.

The documents raise renewed questions for British regulators. Last year, following a joint investigation with the British Medical Journal, The Daily Telegraph revealed that the health of British patients was being potentially put at risk by European regulators who were prepared to license potentially dangerous medical implants for sale in this country. They included metal-on-metal implants manufactured to the same specifications as the Johnson & Johnson product.

The Depuy ASR hip implant was launched in Britain in 2003. The documents allege that, as early as 2006, Dr David Beverland, an orthopaedic surgeon at Musgrave Park Hospital in Belfast, was reporting problems to Depuy.

Dr Beverland wrote an email to Graham Isaac, an engineer at DePuy, on May 15, 2006 that read: “Hi Graham, this is another patient with similar problems.”

The following year he told the company he would no longer be using the hip implants. In his deposition, Mr Isaac said he was not aware exactly why Dr Beverland had stopped using the product.

In June 2007, the company’s own figures showed that the implants had scored a “survival rate” of 89.9 per cent after two and a half years. Ten per cent is a relatively high failure rate compared to other models.

In March 2008, the company’s marketing team discussed ways of using a different set of data to market the product that claimed a 99 per cent success rate. In an email, a marketing manager describes the new data as a “game changer”, although appears to be aware that it should not be used, adding: “We were told these data cannot be used publicly. Can someone confirm.”

In April 2008, tests by Depuy showed that its ASR product performed poorly against another type of hip replacement known as the BHR and Mr Isaac wrote in an email that the data had the potential “to seriously affect our business”.

He discussed comparisons of metal ion levels between the two products and wrote: “In essence, this shows that under certain conditions, ASR is susceptible to extreme metal — levels of metal ions.”

In August 2008 there was further bad news about Depuy’s product in comparison with another metal-on-metal hip implant. An internal memo reveals: “The overall rate of complaints is eight times higher for the ASR versus the Pinnacle.”

The documents were filed in Los Angeles in a case in which Loren Kransky, 65, is suing Depuy for defective design and failure to warn that his hip implant may be faulty. His surgeon said the claim of a 99.2 per cent success rate was one of the reasons he decided to use the ASR.

Sally Gration, 58, of Stockport, Greater Manchester, who had a Depuy hip implant, said she was furious that the company allowed it to be used when there might be problems. “Having the implant changed my life,” she said. “It became so painful that I became unable to work and lost my job as a nursery teacher.”

A spokesman for Depuy said the company acted in the best interests of patients by voluntarily recalling the ASR and creating a programme to address patient medical costs associated with the recall.

“Depuy believes the evidence will show the company acted appropriately and responsibly,” said the spokesman. “At all times the company was looking out for patient interests by analysing data on the ASR Hip System.”

In court, Alexander Calfo, a lawyer for Johnson & Johnson, said Mr Kransky’s legal team had used “snippets of emails, smidgens of depositions and sound bites of memos” to paint a false picture.

A spokesman for the Medicines and Healthcare products Regulatory Agency said the body is “currently investigating and will consider the need to take further regulatory action once we have more information available”.

“The majority of patients who receive metal on metal hip implants have well functioning hips and are at a low risk of developing any serious problems,” the spokesman added.