MASSDEVICE ON CALL — Johnson & Johnson (NYSE:JNJ) could shell out up to $1 billion for lawsuits concerning its subsidiary DePuy Orthopaedics and the metal-on-metal hip implants that were found to shed minute metal particles into a patient’s bloodstream over time.
Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product.
DePuy, which introduced the ASR in the U.S. in 2005 after winning 510(k) clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits.
Analysts at Wells Fargo estimated that JNJ could be on the hook for around $1 billion in liability and other costs for the approximately 1,000 cases that have piled up against Depuy, The Street reported.
JNJ said it hiked its product-liability reserves to $570 million last year and allotted $280 million for medical costs of patients directly affected by the recalled hips.
DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a "higher-than-expected" failure rate in traditional hip replacements, especially in smaller patients or those with weak bones. Lawsuits had already started piling up by June 2010.
CMS technical progress lags, pushes back stage 2 of meaningful use
The Centers for Medicare & Medicaid Services will have to push back the next stage of meaningful use attestation for electronic health record incentives because its computer systems aren’t ready to accept direct data upload from providers, EMR Daily News reported. As a result, CMS has extended meaningful attestation through 2012.
As part of the delay, CMS also announced a pilot program to pave the way for online data transfer, called the Physicians Quality Reporting System-Medicare EHR Incentive Pilot. Providers who join the pilot can submit data through a software vendor or directly from their electronic health record system, if the system is approved by CMS. CMS plans to release its list of approved software vendors in the summer of 2012.
Dept. of Health & Human Services national health IT coordinator Dr. Farzad Mostashari backed the decision to delay the next stage of meaningful use, agreeing that cramming together a program in time to meet the deadline could hurt the program overall, Government Health IT reported.
"The last thing we want to do is provide a disincentive towards attesting for meaningful use in 2011," Mostashari said.
Redefining bleeding during heart surgery
Bleeding in ACS and PCI patients is getting some attention with a new study that seeks to redefine bleeding for use in cardiovascular clinical trials, Heartwire reported. The study argues that bleeding should not be dismissed as a non-issue, even if transfusion is a ready option.
"Our paper is a summary of evidence regarding the importance of bleeding and identification of issues that need to be looked at," said author Dr. Gabriel Steg. "We need to better figure out how to avoid bleeding as much as possible. This includes better management of the access site and more thought when it comes to prescribing antithrombotics. Many patients are currently overdosed with these agents."
Looking for "Lazy Eye"
A handheld scanning device may be able to identify "lazy eye" in children as young as 2, according to ophthalmologists at Children’s Hospital Boston, who tested the device in 202 children.
Lazy eye, or amblyopia, affects 3 to 5 percent of all children and is the leading cause of vision loss in adulthood, researchers said.
"This technology has the potential to give pediatricians the tool they need to quickly and easily identify those kids most in need of a specialist eye exam as soon as they develop a problem," said the study’s senior author, Dr. David Hunter. "As a result, we expect that health insurers and government agencies will embrace this test, which should reduce the cost of care while at the same time improving quality and efficiency, potentially saving vision in hundreds of thousands of children."