Articles Posted in Defective Medical Device

Johnson & Johnson is keeping mum on a report by Bloomberg News that the medical device giant has agreed to pay more than $4 billion to settle thousands of lawsuits over its recalled defective hip implants.

Bloomberg reported that it had confirmation of the deal from three people very close to the negotiations. If true, it would be the largest settlement of claims for a medical device in United States history, dwarfing the old record by some $3 billion.

According to Bloomberg, the settlement will resolve some 7,500 lawsuits in federal and state courts. That would average out to some $300,000 per claimant – and it would be open-ended, which means it would not bar patients whose hips may fail in the future from seeking compensation from J&J.
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Florida Defective ProductsShould artificial hip and knee replacements in the United States come with a warranty? Consumer Union, the policy arm of Consumer Reports, thinks so, and is calling for the defective medical devices to be dealt with in much the same way that defective automobiles are dealt with in the United States.

According to Consumer Reports, nearly 20 percent of hip replacements and 10 percent of knee replacements require revision surgery. This often has to be done because the product is defective. Consumer Union posits the question: if an automobile manufacturer must pay to have a defective part repaired, why not the manufacturers of defective hip and knee replacements?
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The medical device injury attorneys at Farah & Farah in Jacksonville have been following the allegations of Intuitive Surgical Inc. – a manufacturer of surgical robots that were used in 367,000 U.S. operations last year. The manufacturer allegedly failed to adequately train doctors in the use of its Da Vinci robotic system in a rush to get it out on the market.

Bloomberg News
reports that 10 lawsuits have been filed against Intuitive Surgical Inc. stemming from injuries sustained during robotic-assisted surgery. Majority of those suits claim that the company’s lack of an adequate training regimen on the device led to those injuries.

A lawsuit filed at Washington state court suggests that the plaintiff’s attorney introduced emails, in which Intuitive salesmen were aggressively seeking to cut back the number of doctors’ training procedures required by hospitals. According to Bloomberg, one email detailed how a manager told a sales team not to “let proctoring and credentialing get in the way” of meeting sales goals. Another email described how a clinical sales manager congratulated a salesman who had talked a hospital into reducing the number of training procedures they required.
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The U.S. Food and Drug Administration (FDA) is proposing tighter regulations on emergency defibrillators. The agency has been inundated with reports of failures of the devices – some 45,000 over the past seven years – and is submitting proposals that would require manufacturers to provide proof that their devices are safe and effective before they are allowed on to the market.

There has been a great uptick in the number of automated emergency defibrillators in public venues. They are commonly seen at gyms, airports, restaurants, and shopping malls.

The deputy director of the FDA’s center for devices and radiological health told Reuters there were 88 recalls of defibrillators from 2005 to 2012. The deputy director would not speculate how many deaths may have been prevented if the medical devices had not been defective, but stated that there have been enough reports of failure for the FDA to take action on the matter.
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The attorneys at Farah & Farah have been following the first trial concerning DePuy’s defective ASR XL hip from beginning to end. Recently, we have learned that the attorney for the man who claims he was injured by the defective hip replacement has asked the jury for $5.3 million in compensatory damages and up to $179 million in punitive damages.

During his closing arguments, the plaintiff’s attorney argued that DePuy, the unit of medical device giant Johnson & Johnson that designed and manufactured the hip, knew that it was defective, but marketed the device anyway because the company’s core philosophy emphasized profit over safety. He claimed J&J did not adequately test the device before it began to sell the hip replacement in 2005 and he claims that metal ions released by the faulty device poisoned his client and made him ill.

According to Bloomberg News, the attorney told the jury that it should impose high punitive damages to send the company a “solid message.”
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The Jacksonville hip replacement defect attorneys at Farah & Farah have been following the news on metal-on-metal hip implants very closely. Now, the U.S. Food and Drug Administration (FDA) is proposing taking a big step toward keeping these defective devices from reaching the market.

According to Med Page Today, the FDA recently issued a “proposed order” that would require hip replacement manufacturers to show valid scientific evidence that their products are safe before they can be put on the market. Amazingly, scientific tests on many defective hip implants were never thoroughly completed, because the manufacturers only had to show “substantial equivalency” to a previous FDA-approved device to get their products onto the market.
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Florida Defective Rialta DefibrillatorAn article published by The Wall Street Journal (WSJ) is claiming that St. Jude, manufacturer of recalled Riata defibrillator leads, knew about problems with the defective product long before it sent a warning letter to doctors in 2010.

The Riata leads were ultimately pulled from the market last year after it was found that they could cause defibrillators to send unnecessary shocks to the heart or fail to deliver life saving jolts to normalize heart rhythms.
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Jacksonville Defective Hip ImplantA study published in the July edition of Orthopedics found that more than three-fourths of all the metal-on-metal hip implants failed within two years of being implanted. Amazingly, researchers found that 98 percent of patients surveyed required revision surgery within three years of originally receiving the implant.

According to Drugwatch.com, this is the first study that has pinpointed with any kind of accuracy the causes of metal-on-metal hip replacement failures. Researcher looked at data from 80 patients who needed revision surgery and came to the conclusion that the most common failures could be attributed to aseptic acetabular loosening, pseudotumor formation, metal hypersensitivity reactions, and component seizing.
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The U.S. Food and Drug Administration (FDA) has proposed rules that would require most medical devices to carry unique identifiers. According to the agency, the rule will make it easier to track adverse event reports, will boost recall efforts, and will improve patient safety.

The final rule will require many medical devices to carry two codes. One would be an alphanumeric code that identifies the device model. The other code would be a product identifier that contains specific product information such as serial numbers, batch or lot numbers, expiration dates, and other data.

The system is called the Unique Identifier System or UDI.

The FDA has been criticized for moving too slowly on product recalls. The Government Accountability Office (GAO) released a report last year that faulted the FDA for not having a comprehensive recall strategy. The report went on to say that the agency had consistently failed to efficiently regulate the medical device industry.
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Florida Defective Hip Replacement TrialThe first trial date has been set for one of the many lawsuits brought against Johnson & Johnson subsidiary DePuy Orthopaedics, Inc. concerning its recalled ASR hip implants. The trial, which is set to begin December 3 in a Las Vegas, Nevada state court, will involve three Nevada plaintiffs who had their hip-replacement devices removed and replaced, according to Dailymarkets.com.

So far, only ten plaintiffs have received the go ahead to be excluded from the federal multidistrict litigation (MDL) and have their trials in state courts. Three are in Nevada, three are in Maryland, one is in Wisconsin, and another in Utah. Two are in Florida.

This is considered a victory for attorneys representing these clients because slow moving MDL’s can be ponderous and tend to work in favor of large corporations.
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