More Metal Hip Implant Troubles for Beleaguered Johnson & Johnson

Despite the fact that Johnson & Johnson is a well-known name in most households, they are currently laboring under yet another hit to their once squeaky-clean image. While most of us associate J & J with such things as baby products, the company is in fact one of the foremost manufacturers of medical devices. The first sign of trouble occurred when the DePuy (a subsidiary of J & J) ASR metal-on-metal hip implant was recalled in 2010 amidst a flurry of reports that the device was defective and responsible for literally thousands of injuries to recipients of the device. At present, some estimate that as many as 10,000 lawsuits have been filed since the recall of the ASR, the first of which is currently being tried in California.

Recalls and Lawsuits Plague Johnson & Johnson

Another all-metal hip implant manufactured by DePuy, the Pinnacle, while not yet recalled has had its own share of problems, leaving J & J to deal with yet another round of litigation.   Very recently yet another Johnson and Johnson hip implant, the Adept, was recalled from the overseas market, reportedly due to the high rate of failure. As if all these recalls and lawsuits over J & J and DePuy’s line of all-metal hip implants were not enough, on February 22, 2013, Johnson & Johnson was notified that the Justice Department and United States Attorney’s Office were looking into potentially suspect practices related to the marketing of DePuy’s metal hip implants.

The First ASR Trial Ongoing

The first ASR trial concerns Loren Kransky, a retired male, who suffered extremely serious side effects from the ASR all-metal hip implant. Although attorneys for Johnson & Johnson are arguing that Kransky’s health issues were due to a history of smoking as well as other pre-existing conditions, Kransky claims he suffered heavy metal poisoning as a result of the all-metal DePuy hip implant. Strong evidence in the case lends credence to the claims by Kransky that DePuy placed the ASR on the market despite being aware of specific safety hazards related to the all-metal implant.

Johnson & Johnson’s Public Image Tarnished

With over two dozen products recalled by Johnson & Johnson in the past few years, Johnson & Johnson’s public image has suffered not to mention their bank account. At the time the ASR was recalled, DePuy claimed it was recalling the implant due to a failure rate of approximately 12%. Bloomberg reports those numbers as being as high as 40%. Although there is currently no database in the United States which tracks hip implants, it is believed that as many as 90,000 ASR hip devices were implanted and recalled.    

The Pinnacle hip implant, although still being marketed, has been buffeted with lawsuits as well from those who claim they were harmed by the implant, whether from metal poisoning or inflammation, tissue death and bone loss leading to total implant failure. When the all-metal hip implants first appeared, they were believed to last from 10-20 years—considerably longer than their ceramic and polyethylene counterparts. Research shows, however, that one in eight patients implanted with an ASR will require revision surgery within five years of their original implant.

Legal Implications for Johnson & Johnson

The Adept recall is unlikely to have the same level of financial impact on Johnson & Johnson as the ongoing lawsuits for the ASR which have already racked up over $900 million dollars in legal fees and settlement fees. It is estimated there are less than 10,000 Adept hip devices implanted in patients overseas, meaning the liability will be much less for J & J. Johnson & Johnson is expected to take a much tougher stance when dealing with Pinnacle lawsuits as compared to the ASR settlements. Even so, surgeons are hesitant to recommend a Pinnacle implant considering the number of patients claiming they were harmed by the device.  Despite the recalls and lawsuits, Johnson & Johnson remains the largest manufacturer in the health care industry. The outcome of the Kransky trial will likely be a predictor of how the future cases will go, so plaintiffs and their attorneys are following the trial with interest.

Following the First DePuy ASR Trial

Kransky v. DePuy—the first ASR metal-on-metal hip implant trial-began on January 25^th in Los Angeles County. Loren Kransky received an ASR hip implant in 2007 and due to severe adverse health effects underwent revision surgery in 2012. Revision surgery is widely considered to be riskier than the original surgery and has a longer recovery time as well. At this time there are over 10,000 lawsuits from recipients of the ASR. On the first morning of the trial Co-Counsel Michael Kelly walked the jury through the original ASR design, the lack of testing prior to marketing and the extreme levels of harm suffered by the Plaintiff as a result.

Risks of the ASR

Kelly referenced documents which clearly reflected DePuy’s knowledge of the potential risks of the ASR—and their lack of action or further studies regarding the implant. Graham Isaac, a DePuy scientist sent an e-mail to other employees which in essence stated that under certain conditions the ASR is susceptible to extreme metal ion levels. Isaac stated in the e-mail “The concern, it has the potential to seriously affect our business.” In other words, while there was concern that the defective product could affect the financial bottom line, there was no evidence of concern for the people who would be receiving the implants.

DePuy’s Counterclaims

DePuy and Johnson & Johnson maintain that Mr. Kransky had an infection—unrelated to the ASR implant—and that the infection was the only reason for the revision surgery. The attorney for DePuy and Johnson & Johnson stated that the cobalt and chromium in the ASR were not responsible for Mr. Kransky’s problems. He further stated that the ASR was thoroughly tested and researched and that Mr. Kransky’s illnesses and adverse medical conditions were due to a history of smoking as well as kidney and heart disease and diabetes.

Safety Improvements Not Implemented

Kransky’s attorney then introduced an e-mail from bioengineer Chris Hunt regarding the health hazards of the ASR as well as introducing a deposition by Mr. Flett regarding Project ALPHA. ALPHA was the code name for a re-design of the ASR which would make certain changes which would increase the safety of the implant. One letter was introduced which stated “a small improvement to geometry could represent a large improvement for many patients.” Removing the groove on the ASR cup would greatly reduce the friction experienced by ASR recipients to approximately three times less than the original design yet these simple design changes were not implemented, presumably because of financial considerations.  Plaintiff’s attorney also introduced an exhibit which clearly showed that the DePuy ASR failed its own safety test and rather than make alterations to the device DePuy simply altered the test. 

Metal Ion Backlash

In the early days of the trial, a DePuy marketing executive, Randall Kilburn, testified regarding a marketing team meeting in July of 2007 in Chicago. During this meeting a Power Point presentation was show with a title of “What Scares us the Most in the Year Ahead?” Of the nine items listed, “Metal ion backlash” was number one.  Kilburn was asked if he was aware of the fact that surgeons were complaining about excessive ion debris shedding from the ASR. Kilburn answered, “When it was malpositioned, yes.”  During the second week of the trial jurors heard that a 2011 internal DePuy study showed that 35.8% of ASR hips failed within four and a half years, requiring revision surgery for the recipient.

Testimony from Kransky’s Daughter

Despite the claims of Johnson & Johnson and DePuy regarding other causes of his illnesses, Kransky’s daughter, Jennifer Flynn gave a moving description of her father as a once self-sufficient man whose health deteriorated rapidly after receiving a DePuyASR hip implant. Within three years of the implant, Flynn stated, her father needed help bathing and using the bathroom and was soon in a wheelchair, living in a nursing home with round-the-clock medical attention. When her father initially complained of a metallic taste in his mouth Flynn’s first reaction was that he was being poisoned. In response to DePuy’s defense that Kransky’s other illnesses were the direct cause of the implant failure Dr. Robert Harrison testified that the cobalt and chromium ions released into Kransky’s body and bloodstream were the cause of the failure of the implant.

Harrison further stated that Kransky’s normal white blood cell count and lack of fever during his surgery clearly showed that it was not an infection nor underlying health problems which necessitated the revision surgery rather the toxic metals. Graham Isaac, the engineer for DePuy was asked whether he considered 50 plus micrograms of cobalt to be a safe level he answered “that would be high.” According to the California Poison Control any level of cobalt above 7 micrograms per liter are considered harmful—Mr. Kransky’s levels were 53.6 on September 1, 2011—almost eight times the “acceptable” level.

Managing Perceptions

Further into the trial, Plaintiff’s counsel introduced an e-mail message dated May 2, 2008 from Paul Berman, head of DePuy Marketing Department. The e-mail stated that while a cup redesign would ultimately be required, the “short-term action is to manage perceptions.”  This same e-mail detailed the multiple safety concerns regarding the ASR and noted that as an employee of Johnson & Johnson & DePuy he did not feel comfortable with marketing the ASR.

Testimony of Plaintiff During Fourth Week

The Kransky v. DePuy trial is currently in its fourth week and on February 19^th Loren Kransky testified that he dreaded the revision surgery he had a year ago, however he was in constant pain, unable to walk and believed he was being systematically poisoned from the chromium and cobalt ions shearing away from the ASR metal hip implant. Kransky-who had undergone 25 prior surgical procedures-believed the revision surgery could kill him. Kransky stated “I’m going to die either way. One would be slow and one would be fast. I took the lesser of two evils.” During cross examination of Kransky, J & J attorney, Michael Zellers suggested that a fall Kransky allegedly took prior to having the ASR implanted suggested balance problems caused by Kransky’s other medical conditions. It is expected that this trial may well set the tone for the thousands to follow. The MDL consolidated Federal trials are set to begin in May, 2013 and July, 2013.

Status of the DePuy ASR Litigation

The DePuy ASR hip implant received FDA approval in 2005, yet merely five years later the device was being recalled due to the excessively high failure rate of the implant. The ASR is an all-metal hip implant which is constructed of cobalt and chromium. When the metal ball rubs against the metal acetabular cup during periods of activity, tiny metal ions are released into the body, becoming lodged in the surrounding tissues or entering into the bloodstream. Although DePuy’s Pinnacle hip implant has suffered some of the same problems, it has not yet been recalled. The ASR was recalled in August of 2010, and lawsuits began flooding in soon after.

The DePuy ASR Hip: Even if You Have No Pain,You Should Consult With an Attorney

The failure rate of the DePuy ASR hip implant system was stated by the company at the time of the August, 2010 recall as being 12%--high for hip implants under any circumstances. A 2011 article in PubMed.gov, however, placed the failure rate of the ASR resurfacing implant at 25% at six years and 48.8% at six years for the ASR total hip replacement system.

Primary Differences between the DePuy ASR and the DePuy Pinnacle Hip Implant

Like many of the metal-on-metal hip implant systems, the DePuy ASR and the DePuy Pinnacle have had their share of problems. The Pinnacle gained FDA approval in 2000, and has not been recalled despite adverse reports of failure and metal toxicity. The ASR was approved in 2005 and spent only five years on the market prior to being recalled in August of 2010.

Miss the Filing Deadline for Your DePuy ASR Hip Case? There May Still Be Hope

Despite the fact that the August, 2010 recall of the DePuy ASR metal-on-metal hip implant caused a significant stir among the medical community, thousands of recipients of the metal implant remained unaware of recall and subsequent warnings. Due to the initial FDA notice which was issued July 17, 2010 and the recall of the implant on August 24, 2010, all those who live in a state which operates under a two-year statute of limitations may have already lost their right to file suit against DePuy and Johnson and Johnson. Over half of the states do operate under that two year SOL, while others extend that time limit to three, four, six or even ten years. A handful of states have a one-year statute of limitations.  If you are the recipient of a DePuy metal hip implant it’s important that you determine your state’s statute of limitations for defective medical products even if you are currently having no problems with your implant.

Although DePuy originally set their metal implant’s failure rate at approximately 5%, they increased that number to 12% at the time of the 2010 recall. Independent studies place the likelihood of a DePuy ASR implant failure much higher—50% at five years following implant surgery and 80% at eight years following implant surgery. Statistically speaking, even those patients who have not yet experienced failure of their hip implant or adverse health effects from metal toxicity will do so in the very near future. It is extremely important that all DePuy ASR implant recipients at least be aware of their options prior to the date the statute of limitations will run.

The DePuy ASR Metal-on-Metal Hip Implant: A Scientific Analysis of its Problems

The last ten years have seen surgical replacement of hip joints with an artificial prosthesis increase significantly. The main reason for this surge in hip replacement surgeries is our aging population. With people living longer, more active lives, degenerating hip joints can put a halt to that activity. From 1997 through 2004, the number of hip replacement surgeries increased nearly 50% and if the trend continues it is estimated that the annual number of hip replacements in the United States will reach 600,000 by 2015.

Factors in Hip Replacement Surgery

Primary reasons for patients undergoing hip replacement surgery include chronic pain, impairment of daily functions and severe arthritis in the hip joint. The most common type of arthritis leading to total hip replacement is osteoarthritis and is generally seen with aging or trauma to the hip joint. In some instances necrosis of the hip can be present, usually caused by a fracture, alcoholism, lupus, or taking steroid drugs such as prednisone. Patients may experience progressively worsening chronic pain which prohibits them from walking, climbing stairs or even getting up from a sitting position.

Types of Hip Implants

There are many different types of hip replacement implant including the metal-on metal, metal-on-polyethylene and metal-on-ceramic as well as the implants which are 100% ceramic or polyethylene. Other than the materials the implant is constructed with, the only other major difference is in how the implant is affixed—it can be cemented to the bone or attached in such a manner that it grows into the patient’s remaining bone. The idea behind the cobalt and chromium metal-on-metal hip implant was to create an implant which would not have to be re-done for fifteen to twenty years—unlike the ceramic and polyethylene hip implants which last approximately 8-12 years.