Defective Medical Device

March 17, 2017

Alleged Breast Implant Defects Causing Illness in Women

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.

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

February 19, 2017

Professional Wrestling’s Undertaker Needs Total Hip Replacement

by Jeffrey S. Glassman

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.

While 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

December 2, 2016

J&J’s Ethicon Faces Physiomesh Lawsuit For Hernia Surgery Complications

by Jeffrey S. Glassman

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.

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

November 28, 2016

A Dozen Hospitals Allegedly Failed to Disclose Medical Device Related Injuries and Deaths

by Jeffrey S. Glassman

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.

For 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

October 16, 2016

A Look at Robotic Knee Replacement Surgery

by Jeffrey S. Glassman

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.

It 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

August 15, 2016

Growing Cartilage in Lab May Take Place of Artificial Joint Devices

by Jeffrey S. Glassman

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.

In 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

July 2, 2016

Report: Boston Scientific to Add New Warnings to Surgical Mesh Devices

by Jeffrey S. Glassman

Boston Scientific Corp. is a named defendant in some 36,000 product liability lawsuits related to its surgical mesh devices, also sometimes referred to as pelvic mesh, pelvic slings or transvaginal mesh. These devices have been touted as a means to repair a host of pelvic disorders in women, but instead, they have proven extremely dangerous.

Now, the company is doing something it probably should have done long ago: Updating its safety warnings.

Of course, it shouldn’t take 35,000 lawsuits to prompt this kind of action from a pharmaceutical manufacturer, but better late than never. The question some people might have, though, is whether the safety warnings will have any impact on their ability to bring a civil lawsuit against the firm. The answer is probably not, so long as the surgery took place before the safety warnings were updated. Each individual case will be different, and there will be a lot of factors to consider, which is why we encourage anyone who suspects they may have suffered injury as a result of these devices to seek immediate legal counsel. Continue reading

April 13, 2016

Zarick v. Intuitive Surgical Inc. – Defective Robotic Surgery Machine Caused Serious Injury Says Plaintiff

by Jeffrey S. Glassman

Robotic surgery nearly killed her. That’s what plaintiff in Zarick v. Intuitive Surgical Inc. alleges in her $300 million product liability lawsuit. Although she survived, she suffered enormous physical pain and suffering and mental and emotional distress. She experienced the horror and agony of her intestines prolapsing through her vagina. She endured a life-threatening second surgery to repair the damage. Her internal injuries were significant, permanent and have all but annihilated her sexual relationship with her husband.

“It forever changed my life for the worse,” she told a reporter in 2013, four years after she had undergone hysterectomy surgery with the assistance of the Da Vinci robotic surgical system.

Her case is the first of many pending against the robotic surgery manufacturer, Intuitive Surgical, Inc. The 44-year-old alleges she underwent the surgery to address bleeding caused by benign cysts. She said she was convinced by her doctor to undergo the procedure because it was minimally invasive and, she was told, one of the safest and most effective ways to treat her condition. Continue reading

January 7, 2016

Mary Meeks v. Hologic, Inc.: Defective Medical Devices

by Jeffrey S. Glassman

Mary Meeks v. Hologic, Inc., a case from the Supreme Court of Mississippi, involved a doctor at a women’s clinic who performed an outpatient diagnostic procedure known as a hysteroscopy as well an endometrial ablation on the plaintiff. During this procedure, her doctor used a Novasure medical device. Hologic is the medical device company that manufactures Novasure.

Two days after having the medical procedure, plaintiff went back to the medical center complaining of vomiting, nausea, and pain in her abdomen. Doctors did an initial test and determined plaintiff had a perforated uterus and the surrounding wall was blanched in a manner consistent with being burned. Continue reading

December 1, 2015

Jury Awards $11 Million to Defective Hip Implant Victim in Bellwether Trial

by Jeffrey S. Glassman

Jurors overseeing the bellwether case involving Wright Medical’s Conserve Plus metal-on-metal hip implant in a federal case in Georgia have decided in favor of plaintiff for $11 million. That award, granted to a retired ski instructor, allows for $1 million in compensatory damages and $10 million in punitive damages.

The former is intended to compensate the victims for actual losses, while the latter is supposed to punish defendant for an egregious violation.

This was an important decision because it was the first trial in a multi-district litigation pending before the Atlanta-based court. There are 440 other cases similar to this one pending before U.S. District Judge Bill Duffey. In addition to those, there are hundreds more pending against the same defendant in a state court in California. Continue reading