The medical device and pharmaceutical maker, Johnson & Johnson, faces a second set of product liability lawsuits and another potential recall concerning its portfolio of all-metal artificial hips. Two years ago, Johnson & Johnson conducted a $3 billion recall for and faced product liability suits over its ASR all-metal artificial hips. Now its successor, the Pinnacle metal-on-metal hip system is under fire for potential design defects leading to replacements and potential health issues linked to metal in the bloodstream. So far, Johnson & Johnson refuses to recognize patient complaints or pay for the replacement of the hip devices. But, problems with the Pinnacle hip system will soon be addressed in approximately 1,600 related lawsuits pending in courts across the U.S.
Metal-on-metal hip implants were created, marketed and sold to be more durable than hip implants made of other materials, such as ceramic or polyethylene. The intended advantage of a hip implant made of more durable material is that the life of the hip replacement will last longer and hopefully prevent the patient from having to get another replacement. All-metal hip implants were designed to last up to 15 years, but questions surround the benefit of metal-on-metal hip systems as problems with the systems surface and as doctors begin to avoid their use.
Like patients who received the ASR replacement hip, many patients with the Pinnacle system are experiencing problems such as dislocation, limited mobility and pain and swelling. In addition and most importantly, some doctors worry that the deterioration of the all metal implant produces high levels of chromium and cobalt. Excessive levels of metals in the blood stream is referred to as metallosis and can destroy soft tissue, muscle and bone. It can also create neurological, cardiovascular, thyroid and renal problems. Recently, the U.S. Food and Drug Administration warned of the potential problems with the Pinnacle system, and since then, the warning usage of the implant has dropped by at least 6 percent. However, the FDA has not linked metal ions in the blood to health risks.
Product Liability For Defective Hip Replacements
The law requires that a product like an artificial hip meet the ordinary expectations of a consumer. Product liability refers to a manufacturer or seller being held liable for placing a defective product into the hands of a consumer. There are various types of product defects and one of them is a design defect. A product has a design defect when there is a flaw with its intentional design that makes it unreasonably dangerous. It is not clear yet whether the Pinnacle hip system has a design defect, but the issue will likely be vetted in court.
An estimated 150,000 patients have received the Pinnacle device and while Johnson & Johnson set aside billions to settle product liability lawsuits regarding the ASR device, the company is currently fighting complaints about the Pinnacle device. Johnson & Johnson maintains that the Pinnacle system performs better than all other all-metal hip systems. There is no data on the failure rate of the Pinnacle system because Johnson & Johnson has not disclosed the number implanted, and because of the way the FDA records problems with artificial hips. However, an outside panel of medical experts prompted by the FDA has concluded that the risks of the devices currently outweigh the benefits.
If you have a medical device and suspect that it may have a dangerous defect, contact an experienced personal injury attorney to review your legal path to recovery.
