Articles Tagged with Boston defective medical device lawyer

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

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

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

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.surgery1

“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

NBC Nightly News recently aired a report that has raised significant questions regarding the safety of a medical device known as an IVC filter. Specifically, the Recovery IVC filters made by BARD have been connected to at least 300 adverse events, including 27 deaths.chestxray

The report was just the first in a series the station plans to air in the coming days on these medical devices, which are implanted in thousands of Americans to reduce the risk of blood clots. It’s a 1.5-inch piece of metal that is inserted into the vena cava, a major vein, and has the ability to block blood clots from traveling to the heart or the lungs, where they have the potential to be fatal.

Journalists disclosed a 2004 confidential study commissioned by the maker of the product, C.R. Bard, in which it reveals this particular product had a higher rate of injury and fatalities when compared to those who used competitor product. These devices appear to be perforating, migrating, breaking or, in some cases, actually causing clogs rather than preventing clots. Despite this, Bard, a multinational product manufacturer, did not recall its product.

Despite the fact that researchers who conducted the study clearly stated further investigation of this matter was “urgently warranted.” Continue reading