Articles Posted in Medical Device Manufacturers

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Breast augmentation is the most prevalent cosmetic procedure in the United States, with estimates ranging that 1 to 3 million women have some type of breast implant. For years, there has been developing research about the possibility of implants increase the risk of certain cancers, but the evidence was considered too slim to create any action towards addressing the problem.

breast implant cancerNow, the FDA has finally issued a safety warning about the risks of using breast implants manufactured by the company Allergan. The warning requested Allergan to recall all of their micro-textured implants in the United States, citing new sufficient evidence showing a link between their products and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This recall will most likely cause a significant increase in breast implant cancer lawsuits, including class action lawsuits for medical monitoring.

The warning is not without precedent, as there have been similar recalls for Allergan breast implants in Canada, Australia, and France within the past year. However, the FDA was hesitant to issue on their own recall due to “insufficient evidence” that indicated a connection between textured implants and the rare lymphoma cancer. Despite this, hundreds of women around the country have been taking Allergan to court based on claims that their breast implants were the cause of their illness.

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Last month, a group of plaintiffs filed a motion requesting that all federal Mirena IUD lawsuits be consolidated into an MDL. The defendant, Bayer, is fighting this motion.

The technical definition of an MDL is a “sort of class action.” Okay, maybe not so technical.

But the nutshell is that this type of coordination allows the cases to be combined before one federal judge for the purpose of common discovery. In this instance, all product liability lawsuits filed against Bayer over the IUD would be transferred to one U.S. District Judge for coordinated handling during the pretrial proceedings.

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In the past few years, orthopedic surgeries to replace failing body parts have become incredibly common. We live active lives, and the damage done to our joints, from high school sports, skiing, running, and other outdoor activities, is correctable using modern technology and science.

Problems With Zimmer Hip Replacements

Zimmer’s Duron Cup hip replacements are one metal-on-metal implant that has been making the news as causing problems for patients. We’ve seen evidence of problems with other metal device manufacturers, including DePuy, Wright, and Stryker.

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New Jersey has rejected Zimmer’s request to consolidate 10 NexGen Flex knee litigation lawsuits in New Jersey.

Typically, the medical device defendant will try to avoid consolidation as Zimmer did in the MDL. Here, they made the opposite argument: centralizing the New Jersey lawsuits would help streamline discovery.

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It is easy to forget what a rarity hip replacement surgery used to be. Today, people with artificial hips are ubiquitous. Direct costs of hip and knee replacements exceed $35 billion in the United States. More than 285,000 hip replacements are performed annually in the United States, and it is projected that this will increase to 4 million patients because of the aging population. Until very recently, hip replacements have been applauded as a wonderful, revolutionary way to get people back on their feet with less or no pain. But with this revolution came medical device makers looking to make as much money, and get as much market share, as possible.

The temptations for hip makers were extraordinary. Hip replacement surgery may be recommended in cases where hip pain limits daily activities, continues while resting (night or day), limits the ability to move or lift the leg, or in cases where pain relief is not provided by physical therapy, walking supports or anti-inflammatory drugs. Hip replacement surgery has a high rate of success, due to improvements in surgical techniques and technology. Total hip arthroplasty (total hip replacement) involves removing the damaged bone and cartilage and replacing it with prosthetic components. These components did not come cheaply, but health insurance companies readily admitted that this was the appropriate treatment for people with compromised hips.

Though many hip replacement surgeries are successful, there is a risk for infection, failure, and other adverse effects. Concerns have been raised in peer-reviewed publications relating to metallosis, the build-up of metal debris in soft tissues or blood. Reports are generally restricted to metal-on-metal devices or those constructed with acetabular polyethylene liner. Metal-on-metal devices often contain cobalt or chromium. Although the occurrence is rare (occurring in approximately 5.3% of patients), it is a serious complication associated with these devices. Metallic debris can occur because of malpositioning of the implant, subluxation, or jamming of the femoral head.

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The C.R. Bard Avaulta vaginal mesh lawsuits allege that mesh surgically implanted to treat pelvic organ prolapse may be defective. As a result, an unbelievable number of women are at risk for internal injuries and urinary problems.

The FDA recently expressed an even graver concern that the placement of surgical mesh through the vagina to repair pelvic organ prolapse may expose women to greater risks than other available options.

Bard Avaulta mesh lawsuits allege that the defective design of the mesh implant may increase the risk of infection, erosion, and other painful complications. Plaintiffs’ lawyers are bringing lawsuits against C. R. Bard, Inc., which makes and sells Avaulta Plus and Avaulta Solo synthetic surgical mesh tissue supports, and a host of other manufacturers.

These lawsuits are multiplying quickly. But there are a lot of women who are not going to bring a vaginal mesh lawsuit because they perceive a privacy invasion. This is understandable, but it underscores a general misconception about what a claim will entail.

These are national mass tort cases. Frankly, mass torts are rather impersonal and are handled by national lawyers – attorneys you likely will ever meet. Many vaginal mesh lawsuits have already settled for pretty decent sums of money – life-changing for many people. In many ways, it is about filling out some paperwork and waiting and you always have the option of just dropping your case if you don’t like where it is going in terms of your privacy or your need to be involved in the case.

Ultimately, some women will read the preceding paragraph and say “I don’t care, I’m not putting myself out there in any way.” I can’t really argue with this. I’m just trying to provide the full context to potential clients.

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DePuy’s president resigned yesterday. What does this mean for the settlement of the DePuy hip replacement lawsuits?

My question is: who replaces him? If it is someone outside of DePuy, it increases the likelihood the DePuy hip lawsuits settle faster. Why? It is always easier to accept the pain that comes with settling cases when you were not the person on the line making the decisions that caused the problems in the first place. Would a new DePuy president from outside of the company – outside DePuy, not necessarily J&J – be more inclined to pay a reasonable settlement value on the thousands of hip implant cases that are out there? Of course.

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History tells us that it is not the crime but the cover-up that often causes the most damage. In drug and medical device cases, there is usually a Nixonian leitmotif: what did you know and when did you know it with respect to the potential harm caused by the drug.

Last month, another DePuy class action lawsuit was filed. The claim is an interesting cover-up allegation. The class action claims that after the DePuy ASR recall, the company deceived patients by agreeing to make things right and in exchange, getting access to hip recall victims’ medical records. Making things right is relative. DePuy has essentially promised victims nothing in exchange for something, which is the essence of this class action lawsuit.

This byproduct DePuy hip recall lawsuit is probably a sideshow to the core of these hip implant lawsuits. Rummaging through plaintiffs’ medical records while pretending to promise them something in exchange is awful. It is a clear end-run artifice designed to fool plaintiffs into believing they don’t need a lawyer. But the compensation for this inappropriate conduct pales in comparison to the real injuries that stem from the DePuy ASR hip recall. But this class action lawsuit underscores that people are mad and DePuy is not making things any better by not playing it straight with victims.

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We’re just hearing about a May 7, 2010, FDA warning letter to Medtronic over Medtronic’s failure to establish protocols to review customer complaints and to validate device designs. The letter relates to image-guided surgical systems for spinal, cranial, and ENT applications.

This probably isn’t a huge deal and doesn’t imply any particular defects. On the other hand, it’s hard to know about defects if Medtronic isn’t actively looking for them…

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St%20Jude%20Logo-06-22-10%29.gifThe California Watch wrote about questionable ties between a cardiologist, Dr. Michael Burnam, and a medical device company, St. Jude Medical, Inc.

The allegations are that Dr. Burnam convinced St. Jude to give his son a $200,000 a year job in exchange for a lot of new business. St. Jude manufactures defibrillators, and one patient is accusing Burnam of arranging for a completely unnecessary defibrillator implant surgery. That surgery almost cost a patient his life, when the implanting surgeon accidentally stabbed the patient’s heart with the implant.

This kind of quid pro quo is intolerable, particularly to the extent that patients have no idea of the relationship between their physicians and medical device manufacturers. Part of the problem, in this case, is that, as alleged by the patient, the cardiologist deliberately misinformed the implanting surgeon about the patient’s medical history. Had he been properly informed, the surgeon would have realized that the surgery was unnecessary.