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Growing Concern for Heart Surgery Infections in Pennsylvania

Undergoing heart surgery is a very risky endeavor, however, it is often the only means of saving a persons’ life. While thousands of heart surgeries are performed every year across the country without issue, there are countless instances of complications, infections, and even deaths following heart surgery. Recently, there has been a growing concern over infections following heart surgeries. Specifically, the Center for Disease Control and Prevention (CDC) is concerned with a potentially fatal bacterial infection from a potentially fatal bacteria called Mycobacterium chimaera a species of nontuberculous mycobacterium (NTM) that is quickly becoming associated with a device used during open heart surgeries.  

Concerns from the CDC and other Health Agencies

The Centers for Disease Control and Prevention estimates that each year there are more than 250,000 heart bypass procedures that are performed using a heater-cooler device that assists in the successful completion of bypass operations by keeping a patient’s blood and organs at a specific temperature during the procedure. What the CDC and other health agencies are concerned with is that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices used during their bypass surgeries may have been contaminated during manufacturing and could potentially put their patients at risk for life-threatening infections. As part of their concern, the CDC reported that approximately sixty percent of the 250,000 plus bypass procedures performed every year in the United States utilize these specific devices. Because of the slow-growing nature of this particular species of bacteria, the CDC estimates that approximately 600,000 patients could potentially be infected.

The CDC as well as the Federal Drug Administration have reached out to organizations such as the Society for Healthcare Epidemiology of America to notify and inform the public and health officials of the dangers posed by Non-tuberculous Mycobacterium (NTM) as well as to document the CDC’s need for increased vigilance for NTM infections by health departments, healthcare facilities, and individual healthcare providers.

As of December 2016, Pennsylvania has reported 24 cases of the slow-growing bacteria in Philadelphia hospitals and the area that can cause night sweats, muscle aches, weight loss, fatigue, unexplained fever, and even death. In an article, twelve cases were documented at WellSpan York Hospital, five cases at Penn State Hershey Medical Center, and three cases were noted at Penn Presbyterian Medical Center.  While this is cause for concern, the CDC has estimated that the risk of a patient’s getting the infection is as much as between 1 in 100 and 1 in 1,000 in hospitals where at least one infection has been identified.

While the infection is not contagious, it can result in a potentially life-threatening infection for those who have undergone surgery. A major concern is that the infection can take months or even years to for symptoms to begin to set in.

Can you Sue a Product Manufacturer for Strict Liability in Pennsylvania?

Those who have undergone surgery and have subsequently suffered an injury or infection due to a heater-cooler device such as the 3T model may wonder if they are able to file a suit against a product manufacturer.  While the Pennsylvania Supreme Court has not squarely addressed the issue, other cases in the state as well as on the Federal Circuit may provide insight. Notably, the United States District Court for the Eastern District of Pennsylvania recently issued a memorandum addressing this issue.

In the case of Wagner v. Kimberly-Clark Corporation slip op., No. 16-4209 (E.D. Pa. Dec. 1, 2016), the federal court was presented with a wrongful death claim and survival action stemming from the defendant corporation’s design and manufacture of a feeding tube that resulted in the death of Regina Wagner. The District Court analyzed available case law to determine that it appears that the Pennsylvania Supreme Court would permit a cause of action against medical device manufacturers under a “manufacturing” defect theory of strict liability Wagner, slip op. at 6.

Pennsylvania Law on Product Liability

Pennsylvania recognizes three separate types of claims for strict liability: (1) design defect; (2) manufacturing defect; and (3) failure to warn. Phillips v. A-Best Prods. Co., 665 A.2d 1167, 1170 (Pa. 1995).  Pennsylvania has continually affirmed that Pennsylvania follows the Restatement (Second) of Torts§ 402A in product liability cases. See Tincher v. Omega Flex, Inc., 104 A.3d 328, 415 (Pa. 2014).  Section 402A provides:

1) One who sells any defective product in any condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation and sale of his product, and

(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

While the Pennsylvania Supreme Court has relied on comment k of the Restatement (Second) of Torts which states:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. See Restatement (Second) of Torts § 402A cmt. k.

Comment K has been used by Pennsylvania courts to preclude litigants from filing a claim against a drug manufacturer under strict liability. However, the Pennsylvania Superior Court has applied Comment k to medical devices. In the case of Creazzo v. Medtronic, Inc. the Pennsylvania Superior court applied Comment k to medical devices specifically, “find[ing] no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.” See Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006). However, whether or not a medical product such as the 3T Heater-Cooler is unreasonably dangerous has not been addressed by the Pennsylvania Supreme Court.

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Under Pennsylvania law, “[t)he question of whether a product is unreasonably dangerous is a question of law.” Riley v. Warren Mfa .. Inc., 688 A.2d 221, 224 (Pa. Super. Ct. 1997). In deciding this question, courts apply a risk-utility test. Id. at 224-25. This risk-utility test considers several factors, such as the product’s utility to the public versus its risk of causing injury. Id. at 225. After applying this test to a product liability claim, if a court finds as a matter of law that the product is not unreasonably dangerous then it may dismiss the claim on that basis.

While Pennsylvania law prohibits claims based on a “design” defect or a “failure to warn,” it appears that the law does not prohibit strict liability claims against a medical device and drug manufacturer for “manufacturing” defects, which as the CDC notes may be the cause of these fatal infections.

Contact a Philadelphia Personal Injury Lawyer of The Reiff Law Firm If Someone You Love Developed a Heart Infection

If you have questions or concerns about your risk of developing an infection following a procedure where a 3T Heater-Cooler was used or any other device then contact one of our experienced Philadelphia personal injury attorneys today.  Along with our extensive legal background, we strive to help our clients recover physically, emotionally, and financially in any way that we can and fight so that they can begin the healing process. If you or someone you love has been injured because of a faulty product, design flaw, or malfunction, call our law offices at (215) 709-6940, and speak to a surgical error lawyer for free today.

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