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Chulani Sterling
3 years ago
Medical Device Defect Attorneys Parker Waichman LLP Pursuing Claims Involving Defective Johnson & Johnson Heart Device The huge conglomerate organization known as Johnson & Johnson suffered another setback with one of their medical devices. The U.S. Food and Drug Administration (FDA) issued a Class I recall for Johnson & Johnson’s Sterimed Reprocessed Agilis Steerable […]
The huge conglomerate organization known as Johnson & Johnson suffered another setback with one of their medical devices. The U.S. Food and Drug Administration (FDA) issued a Class I recall for Johnson & Johnson’s Sterimed Reprocessed Agilis Steerable Introducer Sheath. A Class I recall is the most severe and urgent level of recall used by the FDA. When the FDA issues a Class I recall for any medical device, the FDA is warning consumers that use of the device that is the subject of the Class I recall could cause substantial bodily harm, severe illness, or death.
The Sterimed Reprocessed Agilis Steerable Introducer Sheath is a valuable tool if appropriately designed. This tool assists cardiologists insert a cardiac catheter in the heart that helps them determine the heart health of the patient and how your heart is working at the time. However, a valve problem resulting from either a defective design or a flawed manufacturing process could cause potentially the patient to develop a life-threatening condition.
Parker Waichman LLP is a national plaintiffs’ law firm whose medical device defect attorneys possess a tremendous track record for tenaciously and successfully pursuing damages on behalf of their clients who fell victim to Johnson & Johnson and other large medical device manufacturers. Parker Waichman’s medical device defect attorneys thrive on holding huge companies that are worth billions of dollars like Johnson & Johnson liable for the injuries they cause to people just like you who were injured by the faulty Sterimed Reprocessed Agilis Steerable Introducer Sheath.
As mentioned above, the FDA initiated a Class I recall for the Sterimed Reprocessed Agilis Steerable Introducer Sheath, or “the Sheath” for short, on June 12, 2017. The FDA announced the recall in early January of 2018. The FDA determined that the Class I recall is necessary because of the threat the defective Sheath presented to those on whom doctors used the device during cardiac catheterization. The Sheath is a tool designed to help cardiologists insert the catheter into place in the heart. The catheter must be placed in various areas of the heart. The Sheath defect that developed presents a severe health risk.
The FDA notice of recall indicated that Johnson & Johnson narrowed down the defective Sheaths to a few lots. The FDA identified the products numbers as STJ408309, STJ408310, and STJG408324. The FDA warned that all lots of Sheaths bearing those product numbers are defective. The FDA stated that only 112 individual devices are subject to recall. The FDA recommended that physicians monitor their patients carefully who had a catheter inserted with a Sheath subject to the recall.
According to the FDA’s safety bulletin and notice of recall, the Sheath had a hemostatic valve. The valve prevents blood from flowing backward when the valve works correctly. A defective seal within the valve caused the problem with the valve. The seal did not close correctly because of insufficient glue holding the cap firmly to the hub during the reprocessing procedure. The FDA noted that too much glue added to the cap would prevent the seal from correctly operating.
The failure of a seal to work during catheterization insertion is dangerous and presents two equally threatening situations. The first is that blood could leak through the piece of the Sheath called the “hub” which could force the cap to fall off of the Sheath. Secondly, the broken seal can permit air to enter the circulatory system. This is called an “air embolism.” Air embolisms occur when air pressure changes and, as a result, air gets inside the veins or arteries.
An air embolism could create a medical emergency if it is severe enough. A small air embolism may not cause any symptoms at all. However, an acute air embolism can cause symptoms such as:
Developing an air embolism requires severe medical intervention and treatment. Once the physician diagnoses you with an air embolism, your doctor will instruct you to sit up straight to prevent the air bubble from traveling into your heart or lungs. Next, the physician will order you to undergo surgery to remove the embolism. In some instances, the patient may be stable enough to be placed in a hyperbaric chamber. The chamber is a pressurized steel room that is flooded with 100% oxygen. Breathing in the pure oxygen may shrink the bubble so that the patient’s bloodstream can absorb it. Failure of either therapeutic intervention or delay in providing medical care could cause irreversible damage or be fatal. Fortunately, if this happens during a cardiac catheterization, the patient is already monitored closely by a cardiologist and a team of healthcare professionals.
Cardiac catheterization is a medical method that allows cardiologists to use an X-ray to magnify defects in the arteries, veins, and chambers of the patient’s heart. The catheter is a tube that doctors insert into the veins or arteries that follow those blood vessels into the heart. The doctor will run a dye through the catheter to create a contrast when X-rayed. The doctor will be able to determine if the patient is suffering from clogged arteries or veins, valve problems, or arrhythmias. Cardiologists consider cardiac catheterizations to be a very safe procedure. There are potential risks, as with any medical procedure. However, those risks are amplified when doctors use defective equipment.
A medical device defect lawyer from Parker Waichman LLP is ready to advise you if you have a claim. Each case is different. However, if you had a cardiac catheterization and suffered adverse health issues, then you could be eligible for financial compensation. A Parker Waichman medical device defect attorney has the knowledge, ability, skill, and motivation to investigate your claim thoroughly and put you in the best position possible to receive a financial award.
What distinguishes Parker Waichman from other so-called “plaintiffs law firms” is Parker Waichman’s unmatched resources coupled with a deep-rooted desire to hold accountable those who have injured others. Additionally, Parker Waichman’s attorneys have taken big pharmaceutical companies like Johnson & Johnson head-on with tremendous results. They believe that people should go to see their doctor and have medical tests performed so they can be cured, and not be exposed to harmful “reprocessed” medical devices like the Sheath.
Have you or your family member sustained an adverse medical event because of a defective Sheath or another medical device or medication? If so, your time to file a claim is limited. Most states impose a three-year (3) statute of limitations on products liability claims. Some states have longer statutes of limitations on defective products. Your Parker Waichman medical device defect lawyer will be able to educate you about the relevant statute of limitations and take every appropriate step to make sure they protect your rights.
Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) or use our contact form to schedule a free, no-obligation consultation. We pride ourselves on fighting for our clients and making those who are responsible for their injuries pay.