Articles Posted in Product Liability

Last week, a Los Angeles County jury awarded 8.3 million dollars to retired Montana prison guard Loren Kransky for pain and suffering and medical expenses he suffered from a defective artificial hip implant manufactured by a division of Johnson & Johnson, which has since been recalled. The implant is known as an Articular Surface Replacement or A.S.R., and was manufactured by the company’s Depuy orthopedics unit from 2003 until 2010, when Johnson & Johnson ordered a recall of the product. Mr. Kransky’s lawsuit was the first of approximately 10,000 that Johnson & Johnson is facing, with another trial set to start in Chicago on March 11, 2013, and numerous other cases scheduled for later this year.

The Depuy artificial hip is made of all metal, and the design would cause the cup and ball to rub against each other as the person moved, leading to some splintering of metallic debris, which caused damaged to tissue and bone, severe pain, and in some cases, permanent injuries to patients. The 12 member jury in Mr. Kransky’s case ordered the company to pay him 8 million for pain and suffering, and $338,000 for medical expenses. Defense lawyers for Johnson and Johnson were unable to overcome evidence which showed that the company was told by surgeons that the design of the Depuy implant was flawed. Consultants to the company had recommended slowing sales of the devices, which was ignored, and Johnson also been considering redesigning the implant but decided against this measure due to a costs benefits analysis that unimpressive sales of the implant did not justify the costs of the redesign.

The A.S.R. is part of a group of extensively used hip replacements with an all metal design, which replaced the design which used metal and plastic. Presently, all metal hips are rarely used by surgeons. Traditional hip replacements are expected to last 15 years before a replacement is recommended, and generally, their failure rate is approximately 5% after five years. Jurors in the Kransky case saw an internal memorandum that Johnson knew that 40% of patients who had an A.S.R. would require a second operation within 5 years to have the Depuy implant removed and replaced. The jurors deliberated for a full five days before reaching their verdict. Mr. Kransky’s lawyers had requested that the jury award him between 36 and 144 million, and award punitive damages to punish the company for intentional and egregious conduct. However, jurors declined to award punitive damages, and their verdict, while substantial, was certainly not anywhere close to the amounts requested of them. Mr. Kransky’s case was expedited as he is suffering from terminal cancer and it was unclear if he would survive until the trial.

Thousands of the other cases against Johnson & Johnson have been consolidated into a class action in federal Court in Ohio. If those cases are settled, it may lead to an analysis of how to calculate the remaining plaintiffs’ damages and a basis for a settlement of the remaining cases. Despite dodging a proverbial bullet in the size of the Kransky verdict, Johnson & Johnson has announced that they will appeal and argue that the design of the Depuy implant was not defective. That could lead to a settlement of the Kransky matter in that if Mr. Kransky is that ill, he will probably not survive until the resolution of the appeal, which can take at least several months to a year for a decision in many Appellate Courts.

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In an article written by Barry Meier in the New York Times on October 1, 2011, there has been a significant failure rate of metallic artificial hips of late, which has led to recalls and defective product lawsuits. Across the United States and in Europe as well, numerous patients are looking to have metal on metal artificial hips removed and replaced. The problems stem from small pieces of metallic debris that break off the devices causing tissue damage and loss of muscle surrounding the artificial hip.

It appears that many when patients sought out their original surgeons to complain of substantial pain and muscle problems, they were informed they were fine, (normal diagnostic scans and/or blood tests) which allowed the issues to be exacerbated, with the possibility of lasting tissue damage.

The failure process is generally seen as occurring in the following manner:

1. Metal fragments get released into the body;
2. Scavenger cells try to engulf them and to digest some of the fragments;
3. The metal fragments are broken down into ions, which react with tissues;

4. Ions react chemically with tissue, causing some tissue to die and the possibility of early failure of the hip.

The research at present points to only a small percentage of the 500,000 people who received all metal hips that are now encountering problems. However, since some patients may not report pain, tissue damage could be occurring without them knowing it. The article discusses Dr. Young-Min Kwon, an orthopedic surgeon at Massachusetts General Hospital, who has been treating many patients with failed metallic hips, and who is seeing increasing numbers of patients with failures. Dr. Kwon noted that: “what we are seeing is a complex phenomenon.”

A study in England determined that all metal hips failed 3 times as often as metal hips that contained plastic components as well. The Food and Drug Administration (FDA) reported more than 5,000 complaints about all metal hips in the first six months of 2011. There have been recalls in the Johnson and Johnson Depuy division of artificial hips due to the significant early failure rate. Further, there have been numerous product liability lawsuits, including one mentioned in the article by Cyndi Lafuente, an IRS advisor who found out in 2010 that the artificial hip she received in 2007 was being recalled by Johnson and Johnson.

Often, the problem is not determined by diagnostic examinations or blood tests, which can be normal despite the ongoing tissue damage engendered by the metallic debris turning into ions in the body. The FDA has ordered manufacturers of artificial hips to institute studies to determine how often the metal artificial hips are failing and the effects on patients from that failure. However these studies will not be completed for several years while the failures continue. Interestingly, there have been patients with high level of metallic debris that nevertheless do not have tissue damage, and some patients with tissue damage yet normal metal blood levels.

In Ms. Lafuente’s situation, she was having occasional groin discomfort and excessive subluxing, or partial dislocation, of the hip joint. As is typical in these cases, her physician referred her for an MRI and CAT Scan, which both came back as normal, as did a blood test. She was concerned that metallosis was causing permanent injury to the bone and muscle surrounding her hip joint, and not satisfied with the “wait and see” approach of her physician.

Fortunately for Ms. Lafuente, an Internet search resulted in an informal consultation with Dr. David Langton, an orthopedist in England who recommended that she undergo a hip aspiration. Hip aspiration involves the removal of synovial fluid from the hip joint to determine if there is an infection or other ongoing process. In the U.S., aspiration is not generally performed until radiological and blood tests have been completed, although metallic debris initially accumulates in the synovial fluid rather than the blood. Ms. Lafuente returned to her surgeon, he aspirated her hip, and the results showed that she had a full 10 times the normal amount of metal in the synovial fluid. Based on this significantly high metal count, the surgeon performed hip revision surgery shortly thereafter, and fortunately for Ms. Lafuente, there was no permanent damage to the bone or muscle surrounding the artificial hip. She is still recovering, albeit the process has apparently been slow and arduous. The conclusion from this seems to be that in artificial hip cases, do not simply rely on normal MRI, CAT scan, and blood tests, nor should you accept a surgeon’s “wait and see approach”, especially in cases where the artificial hip has been recalled.

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