Robotic Surgery Malpractice: da Vinci Surgical System

There is a new type of medical malpractice case that has started to hit the courts.  Due to the recent upswing in robotic-assisted surgery, we are seeing more and more lawsuits over serious injuries caused by da Vinci robotic surgeries.  The da Vinci is a futuristic piece of technology that some hospitals are pushing on their doctors.  The manufacturer, Intuitive Surgical, touts the device as a surgical tool for smaller incisions and quicker recovery times.  Unfortunately, there are problems.

The first problem is the technology itself.  Evidence collected so far indicates that there may be problems with the design or manufacture of the robot.  During some surgeries, patients have been seriously burned by electrical current that jumped from the machine to the patient.  In one case, a young woman who was scheduled for what should have been a routine hysterectomy had burns to her intestines and an artery, and she died within two weeks of the surgery.  Other cases have seen broken surgical blades.

The second problem is training–this is a sophisticated piece of equipment.  To doctors using it, it may feel like a video game, but the equipment and software are complex.  This is not like learning to pass eight levels of Super Mario Bros.  Hospitals are anxious for their doctors to use the equipment so that they can advertise their cutting-edge technological expertise.  The manufacturer provides a small degree of training, but in light of the number of mistakes made by doctors during surgery, that training is clearly insufficient.

The da Vinci is used for any number of surgeries–most often hysterectomies, bladder surgeries and throat surgeries.  Though cases are being filed, these are untested waters.  Lawyers and clients must decide whether to bring a product defect case against the manufacturer (for failure to warn, design defect, or manufacturing defect), or a medical malpractice case against the surgeon or hospital, or both.  Expert testimony in each type of case (product liability and medical malpractice) is extensive.  To do both at the same will require experts in the underlying surgery, and perhaps others like computer programmers,software engineers and mechanical engineers.

Defective Metal-On-Metal Hip Implants: Lawsuit Status

Metal-on-metal hip implants have been getting a lot of publicity, lately.  Now, a few plaintiffs who have been injured because of defective Biomet metal-on-metal hip implants have requested that their cases be combined with others to form multidistrict litigation.  Multidistrict litigation is best explained by comparing it to a class action lawsuit.

What is Multidistrict Litigation (MDL)?

Multidistrict litigation, like a class action, is a bunch of cases combined together.  In both situations, all discovery and court proceedings are combined for efficiency.  Unlike a class action, though, the MDL has cases which are easily separated from the MDL–each case will have the opportunity to go to trial on its own (either as part of the federal MDL bellwether trials, or by being sent back to its home court).  The MDL, if it is created, will combine every federal Biomet metal-on-metal hip implant case into one court before one judge.  The plaintiffs have requested either New York or California.  Wherever they go, the judge will conduct discovery and case management, and will then have the opportunity to encourage hip implant settlements.  Judges wield a lot of influence in cases like this, and the odds of a hip implant settlement are high.

What is the Next Step in the MDL Process?

The defendants in the case will have the opportunity to oppose consolidation, or to request that if consolidation occurs, that the cases get sent to another jurisdiction.  Likewise, other parties in other Biomet cases will have the opportunity to weigh in.

Who Manufactures Defective Metal-On-Metal Hip Implants?

There are several manufacturers of defective metal-on-metal hip implants, including Johnson & Johnson (through DePuy), Biomet, Stryker, Zimmer and Smith & Nephew.  Johnson & Johnson recently issued a voluntary recall on several of its metal-on-metal hip implant devices.  These products can cause inflammation, pain, infection, blood poisoning (metallosis) and may require additional surgeries to remove the defective implants and replace them with safer implants.

Contact a Metal-On-Metal Hip Implant Lawyer

If you believe that your metal hip implant is causing pain, inflammation, or will require a revision surgery, contact our product liability lawyers at 443.850.4426, or online for a free consultation.  We can help you to determine if a metal hip implant is the cause of your injuries, and whether a lawsuit is the best course of action for you.

GlaxoSmithKline Settles Drug Cases for $3 Billion

This is only $1 billion.

That’s right–$3 billion, with a ‘B.’  The money isn’t going to consumers, however.  Not directly, anyway.   This isn’t a civil lawsuit by regular people, but rather the Department of Justice’s probe into GlaxoSmithKline’s inappropriate actions regarding ten of its drugs, including the antidepressant drugs Wellbutrin and Paxil.  The DOJ argued that GSK promoted those, and other drugs, for uses unapproved by the FDA.  Much of the money will go to medical assistance programs who paid money for these drugs.  

Sure, this is a huge number.  And, to make matters even more interesting, it is a settlement, meaning that GSK must have figured their actual exposure was higher–probably much higher.  But you know what?  GSK made $27.5 billion dollars on those drugs.  So to lose $3 billion, not even 10%, is barely the cost of doing business.  GlaxoSmithKline is laughing all the way to the bank.  I’d love to see a study about how much money they would have made had they marketed the drugs appropriately, and never had to pay the $3 billion.  Would it be worthwhile for the company to follow the rules?  I suspect not.  Certainly, there are civil pharmaceutical and product liability lawsuits that detract from the profits, as well as legal fees, but by all accounts, GSK is going to do just fine.  It’s a sad day when $3 billion is not an incentive for good behavior.  

For more, see the Bloomberg story.  

The FDA Weighs In On The Dangers Of Metal-On-Metal Hip Implants

Following up on the experience and decisions of the United Kingdom, the FDA seems to agree that they are dangerous, and is poised to recommend new guidelines on medical monitoring of the 500,000+ Americans with metal-on-metal hip implants.  These metal hip implants, once touted for safety and efficacy by the manufacturers, are now known to cause early breakdown, to release metal particles into the body and bloodstream, and to have an overwhelmingly high failure rate (one study suggests 6.2% over five years).  The FDA has received 17,000 reports of metal hip problems, and in 2009 one-third of all total hip replacements were metal in the U.S.  

Sadly, the FDA probably won’t issue a metal hip recall, leaving the medical device to die a natural death as word of the dangers permeates the medical community, and as the manufacturers put those products to pasture.  Any actual recall at this point would be more philosophical–most orthopedic surgeons are well aware of the dangers, and it is unlikely that many of them are implanting these devices.  Manufacturers affected by these studies include Johnson & Johnson, which manufactures metal hip implants through DePuy Orthopaedics.

Monitoring patients is important–not only can the implants fail, requiring painful revision surgeries, but the metal particles can cause metallosis, which is poisoning of the body.  This metal poisoning may be linked to the development of tumors, inflammation, destroyed tissue and even necrosis.  Blood tests may be necessary to determine whether a patient has hip-implant caused metallosis.  

Contact Us

If you have been injured by a Johnson & Johnson metal hip implant, contact our product liability lawyers at 443.850.4426, or online for a free consultation.  We can help you determine what company manufactured your implant, and whether it is the cause of your injuries.   

More Information on Defective Metal-on-Metal Hip Implants

• Yahoo! Finance:  FDA panel sees little use for metal-on-metal hips
• The Lancet:  Metal-On-Metal Hip Replacement Study
• New York Times:  Hip Device Phaseout Followed FDA Data Request

Vaginal Mesh Injury Update

If the news, FDA reports, scientific studies and lawsuits are any indication, just about every type of vaginal mesh is a defective product.  The evidence clearly shows that they are dangerous medical devices. 

What Is Vaginal Mesh?

Vaginal mesh is known by many names:  transvaginal mesh, bladder sling, transvaginal sling, vaginal sling, bladder sling, .  It is a device that is surgically implanted to treat pelvic organ prolapse, a painful and embarrassing condition, and can affect the bladder, urethra, uterus, small bowel and rectum.  Those organs can drop and push against the vaginal wall, particularly when nearby muscles are weakened after childbirth. 

There are many manufacturers, including C.R. Bard (Avaulta) and Johnson & Johnson. 

What Injuries Are Caused By Vaginal Mesh?

Statistically, many women who are treated with vaginal mesh suffer from infection, organ perforation, movement of the mesh into the vagina, pelvic pain, and urinary problems.  These devices, when defective, must be surgically removed and other surgeries may be necessary to repair internal damage. 

Vaginal Mesh Lawsuits

One of the big manufacturers, Johnson & Johnson, recently told the courts that it will stop selling all but one of their vaginal mesh products.  The decision came nine months after the FDA told them to stop marketing Prolift because of “a potential high risk for organ perforation.”  There are over 1,400 lawsuits against Johnson & Johnson.  Most of the lawsuits have been combined in New Jersey state court, and West Virginia federal court.  Women with vaginal mesh cases can either file directly into the New Jersey court, or can file in any federal court (like the U.S. District Court for Maryland), and the case will be moved to West Virginia, temporarily. 

Contact us

If you have received a vaginal mesh or transvaginal sling implant, and if you have medical problems including punctured organs, or required a removal of the mesh, call our product liability lawyers to determine if your case can qualify for a possible vaginal mesh settlement.  You can call us at 443.850.4426, or online for a discussion about your injuries and your chances of recovery.