ASR trial begins amid controversy over uncovered court documents

The first lawsuit for the DePuy Articular Surface Replacement (ASR) System in the United States got underway on Jan. 25 in Los Angeles.

The plaintiff, former North Dakota prison guard Loren Kransky, sought a hip replacement in 2007 to relieve arthritic pain, which physicians carried out with the DePuy ASR implant. He has since had the implant removed, according to media reports about the trial.

The ASR prosthesis was recalled in August 2010 after the National Joint Registry for England and Wales reported 12% to 13% of patients’ hips treated with the prosthesis would require revision within 5 years.

“DePuy acted in the best interests of patients in deciding to voluntarily recall the ASR Hip System and in creating a program to work with patients and their health insurers to address medical costs directly associated with the recall,” Mindy Tinsley, director of worldwide communications at DePuy Synthes Joint Reconstruction, told Orthopedics Today.

During a pretrial hearing on Dec. 3, 2012, Paul Voorhorst, MS, MBA, director of worldwide biostatistics and data management at DePuy Orthopaedics, stated that a 2011 internal investigation conducted by Johnson & Johnson, DePuy’s parent company, revealed 37% of ASR XL hips were estimated to fail within about 5 years. These projections for survivorship of the implants were reportedly never released, according to court documents from the pretrial hearing.

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Commenting on the estimate, Tinsley told Orthopedics Today, “At all times the company was looking out for patient interests by analyzing data on the ASR Hip System. The internal analysis referenced was based on a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information.”

To date, more than 10,000 lawsuits for failed ASR implants have been filed in state and federal courts regarding the DePuy ASR product. Approximately 93,000 patients worldwide were treated with these prostheses. One-third of the patients are located in the United States.

A Johnson & Johnson press release dated Jan. 24, 2013, stated the company set aside $922 million in 2012 to handle the ASR lawsuits and recalls.

“In the [United States], thousands of payments have been made to ASR patients for testing and treatment and other out of pocket expenses,” Tinsley stated. “We encourage ASR patients to contact the help line at 888-627-2677 to have their questions answered and to submit claims for reimbursement.”

“DePuy believes the evidence to be presented at trial will show the company acted appropriately and responsibly,” she added.

Reference:
www.documentcloud.org/documents/560445-testimony-on-artificial-hips.html.

The first lawsuit for the DePuy Articular Surface Replacement (ASR) System in the United States got underway on Jan. 25 in Los Angeles.

The plaintiff, former North Dakota prison guard Loren Kransky, sought a hip replacement in 2007 to relieve arthritic pain, which physicians carried out with the DePuy ASR implant. He has since had the implant removed, according to media reports about the trial.

The ASR prosthesis was recalled in August 2010 after the National Joint Registry for England and Wales reported 12% to 13% of patients’ hips treated with the prosthesis would require revision within 5 years.

“DePuy acted in the best interests of patients in deciding to voluntarily recall the ASR Hip System and in creating a program to work with patients and their health insurers to address medical costs directly associated with the recall,” Mindy Tinsley, director of worldwide communications at DePuy Synthes Joint Reconstruction, told Orthopedics Today.

During a pretrial hearing on Dec. 3, 2012, Paul Voorhorst, MS, MBA, director of worldwide biostatistics and data management at DePuy Orthopaedics, stated that a 2011 internal investigation conducted by Johnson & Johnson, DePuy’s parent company, revealed 37% of ASR XL hips were estimated to fail within about 5 years. These projections for survivorship of the implants were reportedly never released, according to court documents from the pretrial hearing.

orthomind

Commenting on the estimate, Tinsley told Orthopedics Today, “At all times the company was looking out for patient interests by analyzing data on the ASR Hip System. The internal analysis referenced was based on a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information.”

To date, more than 10,000 lawsuits for failed ASR implants have been filed in state and federal courts regarding the DePuy ASR product. Approximately 93,000 patients worldwide were treated with these prostheses. One-third of the patients are located in the United States.

A Johnson & Johnson press release dated Jan. 24, 2013, stated the company set aside $922 million in 2012 to handle the ASR lawsuits and recalls.

“In the [United States], thousands of payments have been made to ASR patients for testing and treatment and other out of pocket expenses,” Tinsley stated. “We encourage ASR patients to contact the help line at 888-627-2677 to have their questions answered and to submit claims for reimbursement.”

“DePuy believes the evidence to be presented at trial will show the company acted appropriately and responsibly,” she added.

Reference:
www.documentcloud.org/documents/560445-testimony-on-artificial-hips.html.