On Thursday, the FDA is expected to announce a proposal that could stop manufacturers from selling all-metal hip implants.  The law would require these manufacturers to produce clinical data to prove that these devices are safe and effective in order to continue selling them. 

In the US, an estimated 500,000 patients have received an all-metal hip replacement and many of these devices are failing at high rates - much earlier than the traditional hip replacement that has both plastic and metal components.   Because of the failure of the all-metal hip, patients have had to undergo costly and painful revision surgeries.  Additionally, as a result of the movement of the metal joints, tiny particles of metallic debris have been released into the bodies of some patients.

FDA officials say that this proposal will most likely take a year to be put into effect.  Once finalized, manufacturers will have 90 days to submit the clinical data supporting the safety of their device.

The product liability attorneys at Arias, Ozzello & Gignac are currently investigating claims against Johnson & Johnson and other all-metal hip manufacturers for increased failure rates. If you or someone you know has experienced complications from your metal-on-metal hip replacement, contact our attorneys today for a free consultation. You may be entitled to compensation for your damages.

A 16-month investigation by the US Senate Finance Committee concludes that the medical device maker, Medtronic Inc, paid doctors millions of dollars and edited health journal articles which failed to mention complications from their Infuse bone-grafting device. 

The device was approved in 2002 by the FDA to help patients with a degenerative disease of the lower spine and was used to stimulate spinal bone growth.  However, the device is most often used off-label for repairs to the cervical spinal area.  These off-label uses can come with a host of problems including compression of the airway, nerve damage, difficulty breathing or swallowing, and even death. 

The studies that were manipulated failed to mention these complications and others and wrongly promoted the Infuse device.  Medtronic denies these allegations. 

According to the company, the product has generated approximately $800 million in 2011 and has been use to treat over 500,000 patients. 

The FDA has issued an alert for the Class 1 recall of a ventilation device made by Covidien.  A recall is considered to be Class 1 if the device under consideration would cause serious health problems or death.

The cuffed Shiley tracheostomy tube is a device used during surgical procedures to create an airway in the patient’s windpipe and provide a pathway to remove fluid from the trachea and lungs. The affected tubes were manufactured between October 2009 and June 2012 and are an adult size 8.  Any other styles or sizes of Covidien’s tracheostomy tubes remain unaffected.  The company estimates that there were approximately 330,000 manufactured tubes in this time period.  While all of those are subject to the recall, many of them would have been used and discarded by now. 

There are around 34,000 estimated remaining tubes that they recommend should be replaced as soon as possible and returned to the company.  

There are almost 1,600 lawsuits pending in United States courts against the DePuy Pinnacle metal-on-metal hip system. Doctors estimate that more than 10 percent of patients using these metal hips will experience failure and require an additional surgery within two to three years.

The supposed advantage of this product was its sustainable durability compared to other weaker materials such as ceramic, as they are meant to last up to 15 years. But as the controversy over this product begins to heat up, more and more surgeons are refusing to use them on their patients.

A number of people experienced swelling and pain, limited mobility, and dislocation; the same problems experienced by the individuals who used the DePuy ASR product. Perhaps most concerning, some doctors say, is Metallosis—high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. This can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone.

Government data states that at least 500,000 people have received metal-on-metal hips, and of those patients, 150,000 received the Pinnacle device, and 37,000 received the ASR device. Johnson & Johnson, the owner of both companies, has set aside $3 billion to settle the 3,000 ASR lawsuits.

J&J will not recognize patients’ complaints or pay for revision surgeries, and have hired expert product liability attorneys to defend them on the matter. They continue to support the notion that the device performs better than any other artificial hips.

There has not been an exact number on the failure rate for metal hips, but the British Orthopaedic Association and the British Hip Society stated that almost half of all metal-on-metal hip replacements will fail after six year. When DePuy first recalled their product, they believed the number to be four times less than what is to come.

To products liability attorneys at Arias, Ozzello & Gignac are currently investigating claims against Johnson & Johnson and other all-metal hip manufacturers for increased failure rates. If you or someone you know has experienced complications from your metal-on-metal hip replacement, contact our attorneys today for a free consultation. You may be entitled to compensation for your damages.

Johnson and Johnson (J&J) continued the sale of its Gynecare Prolift transvaginal mesh implant despite a 2007 letter from the Food and Drug Administration directing them to halt sales until the FDA further reviewed the product.  J&J determined that their product was “substantially equivalent” enough to another product it already had on the market, so it simply continued to sell the device despite the FDA’s warning. 

The FDA eventually cleared the device about a year later; however, this does not bode well for J&J who already faces lawsuits regarding their transvaginal mesh implants.  The FDA did not sanction J&J because they later complied with the FDA’s instructions to complete a new application for the device, but many believe this kind of brazen disregard for the FDA’s direct orders indicates the challenge the FDA faces when it comes to enforcing its regulations on major pharmaceutical companies. 

Thousands of women have experienced severe complications from the transvaginal mesh implants including recurrence of prolapse or incontinence, severe pain, erosion of the mesh, and infection. Oftentimes, these complications require women to undergo additional painful and costly surgeries.  California defective device attorneys currently represent women across the United States facing such complications from these transvaginal mesh devices.

The Ti Synex II Vertebral Body Replacement (VBR), a device used in the T1-L5 part of the spine to stabilize a collapsed or damaged spine, was manufactured in June 2007, but was recalled in September 2009 due to serious adverse side effects.

Many patients began experiencing loss of VBR height around six to fifteen months after the implantation, which could potentially lead to other serious health issues, such as neural injury, increased pain, failure of additional fixation, spinal kyphosis if unrecognized, compression fracture, or revision surgery.

Doctors who were using the Synthes USA device were told to stop implementation immediately following the recall.  Patients who have experienced these kinds of side effects or others should contact a product liability attorney as soon as possible. Synthes USA likely failed to warn its consumers of the detrimental effects, and therefore patients with the VBR device may be eligible for compensation. 

 Stryker Corp. offered $33 million to the United States Department of Justice on May 31 for an expected settlement that will end a probe into marketing practices involving the OtisKnee device.

"We recently entered into discussion with the DOJ regarding the potential settlement of this matter, and on May 31, 2012, we offered $33 million to the DOJ," stated the filing, signed by Curt Hartman, who is serving as Stryker's interim chief executive officer, as well as the company's vice president and chief financial officer.

 The Kalamazoo, Michigan-based company is taking the $33 million charge in the second quarter of 2012, which it expects to reduce its diluted earnings by 9 cents a share. The company will exclude the charge from its adjusted diluted earnings per share. In 2010, the company received a subpoena alleging there had been violations of laws that prohibit marketing medical devices that had not been cleared by the U.S. Food and Drug Administration.

U.S. District Judge Joseph R. Goodwin recently set a February 5 trial date in West Virginia for the C.R. Bard Avaulta vaginal mesh cases. This trial date covers the first of nearly 600 federal cases against Bard for its vaginal mesh implant. Judge Goodwin is also overseeing trials against Johnson & Johnson, American Medical Systems, and Boston Scientific for failures in their comparable mesh implants.

In July 2011, the FDA issued a universal safety warning against these devices for a high risk of adverse side effects. Over 75,000 women a year have these mesh devices implanted and hundreds, if not thousands, suffer immense pain and have to undergo additional surgeries. The FDA has recently ordered all manufacturers of the vaginal mesh to conduct studies based on the high rates of failure, complications, and organ damage.

The medical device attorneys at Arias Ozzello & Gignac are investigating claims against the manufacturers of the vaginal mesh devices. If you or someone you know has a mesh implant and is experiencing severe pain or has undergone corrective or removal surgeries, contact us today for a free consultation. You may be entitled to compensation for your pain, suffering, and other damages.

In June, the FDA will hold a two-day meeting to evaluate the current standards for metal-on-metal hip replacements. Numerous adverse reports regarding the all-metal hip implants have led to growing concern over these devices specifically, as well as the standards for medical device approval in general. The FDA will be seeking the advice of medical experts, scientists, and researchers to possibly establish new requirements for devices before they can be marketed and sold in the United States. This two-day conference will address numerous concerns over the safety of the all-metal hip implants and the standards for medical devices in general.

Growing safety concerns have already led to a recall of almost 100,000 all-metal hip implants. Numerous lawsuits across the United States have been filed against the main manufacturers of these devices, including Johnson & Johnson, DePuy, and Zimmer, because the all-metal hips have been failing at a premature rate and often cause patients to endure excruciating pain and undergo subsequent surgeries.

The hip replacement attorneys at Arias, Ozzello & Gignac are currently investigating claims against the all-metal hip implants. Contact us today if you have been injured as a result of these defective devices. You may be entitled to compensation for your pain and suffering.

Since 1968, more than 600,000 knee replacement surgeries have been performed to help patients with knee joint damage. Knee joints can be rendered useless by injuries, such as those sustained in certain sports or serious falls, and from the effects of arthritis. Knee replacement surgery has become one of the most common surgeries performed in the United States, and the majority of patients are older people, although the surgery is also common for younger people such as athletes who have severe injuries from sports or car accidents. Overall, knee replacements can give a patient back the ability to walk without pain and engage in exercise and healthy activities that contribute to quality of life.

There are several ways a knee replacement device can be implanted, and the Zimmer Nex-Gen CR-flex knee model was one of the more popular choices of orthopedic surgeons due to its relative ease of implantation. The Zimmer NexGen CR-flex knee replacement model, however, proved to have a very high incidence of failure when compared to other knee replacement options.

According to a 2010 report by a respected orthopedic surgeon, the Zimmer NexGen CR-flex device had too high a failure rate to warrant its continued use. The device was advertised to last at least fifteen years with average use, but the Zimmer NexGen CR-flex device had a life of as little as three years in many patients before serious problems developed. While there has been no Zimmer recall by the Food and Drug Administration at this point, the outcry from certain surgical centers to remove the product from the market continues.

According to one study done at the Rush University Medical Center in Chicago, 36 percent of patients who received the Zimmer NexGen CR-flex suffered from a loosening of the device from the femur, the large thigh bone to which the knee replacement is attached. In at least eight percent of these patients, the pain from the loosened knee replacement was so bad that they were convinced that they needed to undergo a second surgery to correct the problem. The second surgery, known as "revision surgery," has a high rate of success when a different device or knee replacement technique is used. However, the pain of multiple knee replacement surgeries is a deterrent to many patients who may choose to suffer with the Zimmer model rather than undergo revision surgery. Most frightening of all, with no recall of Zimmer knee replacements forthcoming, doctors continue to use the Zimmer devices in alarming numbers.

If you have suffered from side effects including pain, loss of mobility, infections, and failure of knee replacement due to the Zimmer NexGen CR-flex device, it is time to take action. First, talk to your doctor about possible options for repairing your knee replacement. Next, contact a professional Zimmer attorney. A professional injury lawyer can guide you through the steps you need to take to file a suit to recover damages for your injuries from Zimmer products, including medical bills, pain and suffering, loss of work time, and other expenses.