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J&J Executive Noted ASR Hip High Failure Rates a Year Before U.S. Recall
February 22, 2012
In August 2009, only days after Johnson & Johnson received a letter from the FDA that rejected their metal-on-metal ASR Hip Resurfacing System for U.S. sales, company executive Pamela Plouhar emailed three other top executives to explain the FDA's decision. As reported in The New York Times, Plouhar explained that a chief FDA concern was the ASR Hip Resurfacing System's high failure rate in clinical trials. Plouhar also stated that providing more data to the FDA "might not change its stance and that it might take years to conduct new studies of the hip."
According to Times' medical device columnist Barry Meier, Plouhar's email acknowledgement of the high failure rates is significant because such statements "contrast those made by the company in recent years about the all-metal hip. Before recalling the device amid rising failure rates in 2010, Johnson & Johnson insisted it was safe and maintained that its internal studies refuted complaints by surgeons and regulators abroad that the device was flawed."
For more information on the case and to learn of the legal rights of those suffering from defective all-metal hip implants, visit Depuy Metal Hip Recall.com.