This article is from the source 'guardian' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.
You can find the current article at its original source at https://www.theguardian.com/australia-news/2017/oct/04/vaginal-mesh-lawsuit-executive-denies-prioritising-johnson-johnson-interests
The article has changed 5 times. There is an RSS feed of changes available.
| Version 1 | Version 2 |
|---|---|
| Vaginal mesh lawsuit: executive denies prioritising Johnson & Johnson interests | Vaginal mesh lawsuit: executive denies prioritising Johnson & Johnson interests |
| (2 days later) | |
| A senior Johnson & Johnson (J&J) executive has denied placing corporate interests ahead of traumatised transvaginal mesh patients when he advised against referring a serious complaint to health regulators. | A senior Johnson & Johnson (J&J) executive has denied placing corporate interests ahead of traumatised transvaginal mesh patients when he advised against referring a serious complaint to health regulators. |
| More than 700 Australian women launched a federal court class action against the medical giant three months ago, alleging their lives were all but destroyed by flaws with J&J-produced medical implants. | More than 700 Australian women launched a federal court class action against the medical giant three months ago, alleging their lives were all but destroyed by flaws with J&J-produced medical implants. |
| The J&J devices, transvaginal mesh and tape, were used to treat pelvic organ prolapse and urinary incontinence – common complications of childbirth. | The J&J devices, transvaginal mesh and tape, were used to treat pelvic organ prolapse and urinary incontinence – common complications of childbirth. |
| But in a large number of cases worldwide, flaws with the meshes left women in debilitating pain. Sexual intercourse was made impossible and many women suffered the breakdown of relationships. | But in a large number of cases worldwide, flaws with the meshes left women in debilitating pain. Sexual intercourse was made impossible and many women suffered the breakdown of relationships. |
| J&J is accused of playing down the risks of the products and, instead, using aggressive marketing on surgeons, focusing on the cheap and easily replicable nature of the surgery. The company is also alleged to have sought to avoid the scrutiny of regulators and suppress unfavourable data. | J&J is accused of playing down the risks of the products and, instead, using aggressive marketing on surgeons, focusing on the cheap and easily replicable nature of the surgery. The company is also alleged to have sought to avoid the scrutiny of regulators and suppress unfavourable data. |
| On Wednesday, a vice-president of medical affairs, Piet Hinoul, was forced to defend the approach taken to one complaint that J&J and its product development arm, Ethicon, became aware of in 2009. | |
| A woman in the UK had suffered two infections related to sinus complications after having the tape implanted in 2002. The first infection occurred 12 months after the implant and the next occurred three years later, the court heard. | A woman in the UK had suffered two infections related to sinus complications after having the tape implanted in 2002. The first infection occurred 12 months after the implant and the next occurred three years later, the court heard. |
| But the court was shown emails in which Hinoul described those complications as a “transitory foreign body response”, a normal reaction that was contemplated in the company’s instructions for use to surgeons. | But the court was shown emails in which Hinoul described those complications as a “transitory foreign body response”, a normal reaction that was contemplated in the company’s instructions for use to surgeons. |
| The company only has an obligation to report adverse reactions if they are not included in a product’s instructions for use. Hinoul recommended against reporting the case to the UK’s medical products regulator. | The company only has an obligation to report adverse reactions if they are not included in a product’s instructions for use. Hinoul recommended against reporting the case to the UK’s medical products regulator. |
| Barrister Tony Bannon SC, who is acting for the 700 women on behalf of Shine Lawyers, accused Hinoul of using “word games” to avoid reporting the case. Bannon said the infections, occurring so long after the initial operation, were obviously not transitory. | Barrister Tony Bannon SC, who is acting for the 700 women on behalf of Shine Lawyers, accused Hinoul of using “word games” to avoid reporting the case. Bannon said the infections, occurring so long after the initial operation, were obviously not transitory. |
| “Do you say you are comfortable in forming a view, when you wrote this email, that an affliction that occurred three years after – three years after – the implantation of this device was the result of a transitory foreign body response? Is that your evidence?” Bannon asked. | “Do you say you are comfortable in forming a view, when you wrote this email, that an affliction that occurred three years after – three years after – the implantation of this device was the result of a transitory foreign body response? Is that your evidence?” Bannon asked. |
| Hinoul said the transitory foreign body response in the patient had become “sustained”. | Hinoul said the transitory foreign body response in the patient had become “sustained”. |
| “I don’t play word games,” Hinoul said. | “I don’t play word games,” Hinoul said. |
| Bannon later pressed Hinoul on the issue: “You were putting the company’s interests ahead of the patient’s interests. Do you agree with that?” | Bannon later pressed Hinoul on the issue: “You were putting the company’s interests ahead of the patient’s interests. Do you agree with that?” |
| Hinoul responded: “Not at all.” | Hinoul responded: “Not at all.” |
| Bannon asked: “Do you agree you took an unreasonable approach to the [instructions for use] in order to protect the company’s interests?” | Bannon asked: “Do you agree you took an unreasonable approach to the [instructions for use] in order to protect the company’s interests?” |
| Hinoul said: “No, certainly not.” | Hinoul said: “No, certainly not.” |
| Later on Wednesday, Hinoul was forced to agree the company knew its products, as a matter of certainty, would not be suitable for some patients. But Hinoul said that was the same for all medical interventions and there was no way of knowing which patients would have adverse reactions to the implants. | Later on Wednesday, Hinoul was forced to agree the company knew its products, as a matter of certainty, would not be suitable for some patients. But Hinoul said that was the same for all medical interventions and there was no way of knowing which patients would have adverse reactions to the implants. |
| “The answer, as I said, is yes, but that is the same as any kind of intervention in medicine … Unfortunately, medicine isn’t perfect and that is the same of surgery,” Hinoul said. “Certain surgeries, unfortunately, go wrong and have complications – we’re not denying that.” | “The answer, as I said, is yes, but that is the same as any kind of intervention in medicine … Unfortunately, medicine isn’t perfect and that is the same of surgery,” Hinoul said. “Certain surgeries, unfortunately, go wrong and have complications – we’re not denying that.” |
| The case continues before Justice Anna Katzmann in the federal court on Wednesday. | The case continues before Justice Anna Katzmann in the federal court on Wednesday. |