Articles Posted in Defective Medical Device

Published on:

According to a recent news article from NASDAQ, Medtronic has begun to voluntarily recall all unused units of their StrataMR product lines.  StrataMR is a line of adjustable valves and shunts that patients and doctors have been complaining about lately.  These complaints range from minor issues to potentially deadly adverse events.  One person has died, but the company has yet to determine the exact cause of the death.xray

The medical devices are used to treat a medical condition known as hydrocephalus, which involves the buildup of fluid on a patient’s brain.  If this fluid is allowed to build up, it presses against the inner layer of skull known as the dura, and this creates a tremendous amount of pressure.  If untreated, this can result in permanent brain injury or even death. Continue reading

Published on:

Lawsuits against Atrium Medical Corp. for its C-QUR hernia mesh product alleging these devices were not safe for use by humans. hands

One of the most recent cases is one filed in Florida Middle District Court in Orlando just this past month. In his filing, which alleges negligent manufacturing and strict product liability, plaintiff alleges he underwent surgery in April 2013 to repair multiple hernias. His surgeon used the C-QUR product. Subsequently, plaintiff alleges, he suffered injury.

Although the recent Florida Record article reporting the filing does not offer specific details on the man’s injury, we can make the inference based on previous claims, the type of liability asserted here and also what we know about the company’s history.  Continue reading

Published on:

When you go into a hospital on the day of your surgery, you have likely met with your surgeon and discussed the risk and benefits of the benefits of whatever procedure you are scheduled to have that day, assuming you are not brought into the emergency room and rushed into an operating room.  You are likely confident that surgeon has the skill and experience to do his or her job properly, and while this is very likely true, if your surgeon is unknowingly using a defectively-designed medical device, the chance of a complication may be exceedingly high.

surgeonIn a case from the Washington State Supreme Court, a surgeon who had used a defendant’s surgical assist robot on numerous occasions spoke to the patient about his intention to use the relatively new device to operate on the patient’s prostate cancer. The doctor obtained informed consent from the patient, who was considered severely obese at the time of his surgery.   Continue reading

Published on:

Hernia mesh manufacturer Atrium Medical Corp. will face multi-district litigation (MDL) in a federal New Hampshire court, after a  judicial panel surgeryagreed to centralize all federally-filed claims against the company for its C-QUR product. More than a dozen claims are pending at this juncture.

Atrium’s C-QUR hernia mesh was produced for use in reinforcing the abdominal wall as a permanent solution after hernia surgery. The company has said its unique Omega-3 coating lowers the risk of adhesions to internal organ tissue – which had been a major problem with other hernia mesh devices. However, plaintiffs in these pending lawsuits say the polypopylene patches were negligently designed and the company fraudulently convinced doctors the product was safe when executives and scientists with the firm knew it wasn’t.

Specifically, plaintiffs allege the netting of the product is “biologically incompatible” to be used with human tissue. This resulted in an unreasonable risk of serious medical complications, including infections.  Continue reading

Published on:

A subsidiary of product manufacturing behemoth Johnson & Johnson is facing a product liability lawsuit for allegedly selling defective breast implants to unsuspecting women, causing them to suffer health woes such as muscle pain and nausea. The defective implants are reportedly made of a silicone base, and leakage has resulted in a host of problems for patients. woman

Bloomberg reports the subsidiary, Mentor Worldwide, is accused of negligence for its alleged failure to carry out proper studies of its implants. In particular, plaintiff alleges the company refused to explore potential health risks, as it was required by federal regulation agencies to do. The lawsuit, filed in a state court in California, alleges that leaks occur as a result of normal use, and the silicone in the products cause serious injury when it seeps out of the device and into the body.

You may recall that the U.S. Food & Drug Administration had forbidden any companies from selling silicone-based breast implants for nearly 15 years, beginning in 1992. The devices were shown to cause cancer and Rheumatoid arthritis. Initially, a $4 billion settlement was reached to cover all those claims, but that deal eventually fell apart and several firms filed for bankruptcy. The blanket ban on breast implants was lifted in 2006 and today, there are still only three companies – Mentor Worldwide included – that are permitted to sell silicone-based breast implants. Last year, the total market for breast implants nationally topped nearly $640 million. According to the American Society of Plastic Surgeons, about 8 in 10 women undergoing breast implant procedure choose to have the silicone-based product. Continue reading

Published on:

According to a recent news article from Give Me Sport, Mark Calaway, the 51-year-old professional wrestler better known as, “The Undertaker,” has already had several medical procedures involving his hip and will soon need a total hip replacement operation.  While many are aware that much of what is shown in the WWE is scripted and the outcome is predetermined, there is no question that these wrestlers are professional athletes. Years of wrestling will most certainly take its toll on the human body.

knifeWhile the Undertaker had not been seen publicly in quite some time, his character was revived in a major way at the end of 2016 and is expected to play a major role in the upcoming months.  It was also around that time that he was seen using crutches to get around, and it become known that had already had one surgical operation on his hip. Continue reading

Published on:

Surgical mesh devices have caused significant problems for patients across the country. Transvaginal mesh and bladder slings have been the primary target of litigation, as patients suffered serious complications and many times were forced to undergo revision surgery. In some cases, people underwent multiple surgeries. Some did not survive. sad

Now, Ethicon, a subsidiary of Johnson & Johnson, is facing a new round of products liability claims for its Physiomesh Open medical device, used for those who have suffered a hernia. The manufacturer marketed the product as a way to help bond the abdominal tissue, without exposure to the polypropylene material of which the product is made. Ethicon used a thick coating on both sides of the Physiomesh in order to protect human tissue, which can be severely damaged by direct contact with polypropylene. The problem, however, is that the mesh fails to properly incorporate into the abdominal wall, meaning it is floating around in the patient’s abdominal cavity. In other cases, the material breaks down and polypropylene does come in direct contact with human tissue, causing serious injuries.

The most recent Physiomesh lawsuit was filed in the U.S. District Court for the Middle District of Florida. In Quinn v. Ethicon and Johnson & Johnson, patient seeks damages in excess of $75,000 from the New Jersey-based company. Although defendants are both based in New Jersey, plaintiff asserts jurisdiction in Florida because the defective product was placed in the stream of commerce in Florida and caused injuries to patient while she resided in Florida.  Continue reading

Published on:

The United States Food and Drug Administration (FDA) is not only charged with the task of regulating pharmaceutical drugs, but also medical devices.  Medical devices can include anything from a tool used by a surgeon, to an artificial knee, to a hybrid implant that slowly releases a medicine over time as a broken leg heals. While there is a lot of regulation of medical devices by the FDA, the regulations allow the medical device manufacturers a bit more leeway than they do in the case of drugs.  There are also certain loopholes in medical device regulation, such as the one that allows a medical device on the market with less testing and data if there is already a similar device on the market.

surgeryFor this reason, the FDA will conduct follow-up investigations in hospitals around the nation to see if these devices are working as planned. This should be easy for them to do since the hospitals are required to promptly report any injury or death that involved a medical device. However, according to a recent news report form Kaiser Health News, the FDA has just found that Massachusetts General Hospital (MGH) in downtown Boston, as well as 11 other hospitals, have failed to promptly make these reports to the FDA and the medical device makers, as required by federal regulations.    Continue reading

Published on:

A recent news article from Fox News looks at a new procedure that allows doctors to perform a total hip replacement with the assistance of a robot.  While we have seen many instances where hospitals across the country are using robots to perform partial knee replacement surgeries, there are only 10 surgeons in the country who are presently certified to use this new technology.

ward1It is a robot in the sense that one might think in that it is self-controlled.  Instead, the system uses an advanced scanner that creates a 3D model of the patient’s knee joint and displays that model on a monitor used during surgery.  The surgeon then uses a robotic surgical instrument to make the cut, and controls the robot using a series of hand control levers.  The surgeon is then able to look at the monitor with the 3D model and see where he or she is cutting. Continue reading

Published on:

We have heard a lot recently about how stem cells can be used to help patients who would typically require the implantation of an artificial joint such as a hip or knee. Using one of these methods, doctors are able to remove bone marrow from the patient and use the stem cells in the bone marrow to attempt to regrow bone tissue and joint material inside the patient.  While this method may work, it is only one method doctors are using with stem cells, but there are others.

surgeryIn a recent news feature form HNGN, doctors are now using stem cells to regrow cartilage in a laboratory and then implant that it into the patient.  Since the cartilage was grown using the patient’s own stem cells, the new cartilage will have the same DNA as the patient.  This should mean that the body will not see the new cartilage as a foreign substance, so there should be no risk of rejection, which is always a major risk in an organ transplant or event the implanting of an artificial joint like a knee or hip. Continue reading