FDA Recalls Sterilmed Device Over Concerns Of Possible Lethal Coronary Side Effects

The U.S. Food and Drug Administration (FDA) announced in January of 2018 that Sterilmed’s Agilis steerable introducer sheath (Agilis device) must be recalled due to grave safety concerns. Sterilmed is a subsidiary of the enormous medical device manufacturing company Johnson & Johnson. Sterilmed’s business involves “repurposing” used medical devices and creating new medical devices. Johnson & Johnson claims that Sterilmed conserves approximately 171,000 pounds of carbon dioxide emissions and prevents 281,000 pounds of medical waste from winding up in landfills across the U.S. Additionally, consumers save roughly $8.6 million through Sterilmed’s reprocessing procedure. While financial savings and environmental impact is laudable, Sterilmed has endangered the lives of thousands of people due to their defective Agilis steerable introducer sheath.

Parker Waichman LLP is a nationwide law firm dedicated to the idea that justice is the right of every individual residing in the U.S.

Accordingly, Parker Waichman LLP’s Agilis Defective medical device lawyers aggressively pursue financial compensation for all of their clients who suffered a severe side effect that led to further illness or complications or the families who had loved ones die from complications attributable to Sterilmed’s defective medical device.

Parker Waichman LLP’s defective medical device lawyers are no strangers to holding large medical device companies responsible for producing, marketing, and selling defective medical products. Parker Waichman LLP has recovered more than $2 billion for their clients. The firm’s demonstrable track record of success underscores Parker Waichman LLP’s passion for delivering high-quality legal services for plaintiffs injured by the negligence, recklessness, or intentional act of individuals, corporate entities, and municipalities across the United States.

FDA Class I Recall of Sterilmed’s Agilis Device

A Class I recall is the most urgent level of a recall issued by the FDA. When the FDA issues a Class I recall, the FDA is indicating that medical product in question poses a significant threat of serious bodily injury or death due to the defective medical product. In accordance with its standards, the FDA issued a Class I recall for the Agilis device on January 2, 2018.

The FDA recalled the Agilis device due to a potentially lethal valve problem. The FDA narrowed down the possible defective products to dates of manufacture and distribution on from January 1, 2017, to May 5, 2017. Each of these reprocessed devices has a hemostatic valve that prevents blood from flowing backward while the introducer sheath guides a cardiac catheter into proper position in the patient. The most efficient path of insertion proceeds from the left side of the heart into the right side of the heart through the tissue that divides the two heart chambers. It is during this process which surgeons noted that the valves began to fail.

Each Agilis device uses a sheath valve to stop the backflow of blood. The valves on the defective devices fail when the seals on the sheath hub do not operate correctly. The cap to the hub of the Agilis device can dislodge as a result of the backflow of blood. Air gets into the line and consequently into the patient’s circulatory system when the cap pops off. Alternatively, the failing cap can result in a pressure drop that permits air to enter the circulatory system.

Air that infiltrates the circulatory system is called an air embolism. Air embolisms are potentially deadly medical conditions that require immediate medical intervention. If caught in time, air embolisms can be treated successfully and without complication. Left untreated, the patient could suffer serious medical problems that could cause death if the medical intervention was significantly delayed.

Signs a Patient has an Air Embolism

The cardiac surgeon might not be aware of air entering the circulatory system even if the cap of the Agilis device dislodges. That is because air embolism patients could be asymptomatic at first or have symptoms that mimic more common medical conditions such as other cardiac events like a heart attack, pulmonary events, and neurological problems. However, in patients that are conscious, the most common symptoms of an air embolism are:

• Dizziness,
• Disorientation,
• Vertigo,
• Shortness of breath,
• Rapid breathing,
• A persistent cough,
• Nausea,
• Headaches,
• Seizures,
• Slipping in and out of consciousness,
• Chest pain emanating from below the sternum,
• Blurry vision,
• Anxiety,
• Agitation,
• Speech problems,
• Feeling of despair, and
• Lack of coordination or poor coordination.

Diagnosis of an air embolism can be tricky. Some radiological tests might reveal a large air bubble, but most will not show up. Diagnosis usually comes down to understanding the patient’s history of medical procedures. A history of recent cardiac catheterization should alert the treating physician to the possibility that an air embolism is the cause of the patient’s distress.

Treatment of Air Embolism

Treatment will depend on the physical state of the patient. If unconscious, the doctors will put the patient on 100% pure oxygen and open a dedicated airway with intubation. Administering 100% oxygen is important because the oxygen will dilute the nitrogen present in the gas bubble, thereby shrinking the air embolism.

Doctors will lay a patient in a particular manner so that the bubble moves to a safer location. Also, certain massage techniques can move the embolism to safer locations within the body. However, one the most successful treatments for air embolisms is hyperbaric oxygen therapy. This treatment helps the body absorb the air bubble into the muscles and eventually be discarded through natural processes. There are instances when emergency surgery is warranted. However, the procedure is very risky and might be seen as a last resort.

The Duty of Medical Device Manufacturers

Every medical device manufacturer, such as Johnson & Johnson, must design and manufacture medical products safely, while ensuring a level of effectiveness. Medical device companies also bear the responsibility to market their products accurately and provide warnings to their customers regarding all potential side effects. A necessary component of the duty to warn is to issue recalls or to comply with FDA recalls ensuring the safety of the public. Public safety is significantly more critical than Sterilmed’s or Johnson & Johnson’s bottom line or stock price.

Holding a medical manufacturer liable for damages is a complicated legal matter requiring the most knowledgeable and experienced medical device defect lawyers in practice. Winning a products liability case, especially involving a medical device manufacturer with the resources of Johnson & Johnson takes more than proving someone suffered an injury or died. A successful products liability case involves expert testimony that conclusively proves that the device maker had a design defect, manufacturing defect, or failed to warn about a dangerous condition that the device might cause.

The Time to File a Claim for Damages is Limited

You and your loved ones should recognize that time is of the essence when filing a claim against a medical manufacturer for damages relating to a defective medical device. Each state has its statute of limitations, which can range from as little as two years to as many as four years. Understanding the implications of the relevant statute of limitations is vital to filing a successful claim. Put simply, missing that deadline means you cannot recover any damages because the running of the statute of limitations is an absolute legal bar to recovery.

Parker Waichman LLP is the Medical Device Defect Lawyers You Can Trust

The medical device defect lawyers with Parker Waichman LLP pride themselves on relentlessly pursuing damages for their clients. Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) or use our contact form to speak with us about your Agilis device claim.

A National Law Firm With Offices In:
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation