Legal Perspectives on Adverse Effects in Medical Technology

Ella McCain

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Legal Perspectives on Adverse Effects in Medical Technology

Medical technology has undoubtedly revolutionized healthcare, offering innovative solutions to improve patient outcomes. However, the rapid pace of development and deployment of medical devices has also given rise to concerns and, in some cases, legal challenges. 

Several medical technology companies find themselves embroiled in lawsuits due to the alleged adverse effects of their devices. 

In this article, we will explore some notable cases and shed light on the challenges faced by both patients and the companies in question.

Bard Access Systems

One prominent example is Bard Access Systems, a company specializing in vascular access devices. Lawsuits have been filed against Bard Access Systems, claiming that certain catheters and vascular access devices manufactured by the company have led to severe complications. 

Notably, the Bard PowerPort has recently come under scrutiny, as reported by TorHoerman Law. Individuals with the implanted device claim that its faulty design increases the risk of organ damage, infections, and blood clots. 

A functional port catheter is a medically implanted device facilitating easy access to veins to deliver medications, such as chemotherapy. Implanted beneath the skin by a physician, the device features a small reservoir for medication injection. The catheter, typically composed of silicone or polyurethane, resides within the vein.

Patients using the Bard PowerPort have experienced an increase in injection flow, leading to pressure against the plastic tubing. Consequently, the barium sulfate tubing fractures, forming a space for bacteria to accumulate within the tiny crack. 

Over time, this pressure releases plastic fragments into the bloodstream. This can potentially result in abnormal heart rhythms, blood clots, punctures in the heart, pulmonary embolisms, and life-threatening ruptured blood vessels.

In response to these allegations, affected individuals and their families have pursued legal action through the Bard Power Port lawsuit. As of February 2024, there are 99 active lawsuits awaiting resolution in Arizona multidistrict litigation 3081 under Judge David G. Campbell. According to Drugwatch, legal professionals anticipate a growing number of individuals filing cases. 

Johnson & Johnson and Ethicon

Another high-profile case involves Johnson & Johnson and its subsidiary Ethicon. The company faced numerous lawsuits related to its transvaginal mesh devices. 

Designed for pelvic organ prolapse and stress urinary incontinence, these mesh implants are linked to complications, including chronic pain, infections, and mesh erosion. The legal battles have spotlighted the need for stringent testing and regulatory oversight in the medical device industry.

Complications arising from transvaginal mesh devices include chronic pain, which can significantly impact a person’s quality of life. Infections are another concern, posing potential risks to overall health. Mesh erosion, where the mesh erodes through the vaginal wall, can lead to discomfort and further complications. Additionally, the risk of punctures or damage to surrounding organs, such as the bladder or bowel, is a serious issue. 

These complications highlight the need for thorough testing and transparent communication regarding the potential risks associated with medical devices like transvaginal mesh implants.

As a result, over 100,000 women have filed lawsuits against various companies, and Johnson & Johnson bears a significant portion of these claims. Recently, according to Reuters, the U.S. Supreme Court upheld a $302 million judgment against Johnson & Johnson. The lawsuit, brought by the state of California, alleged that the company concealed the risks of its pelvic mesh products.

The court’s decision marks a substantial victory for those individuals who have experienced harm due to these medical devices.

Bayer and Essure Controversy

The Bayer and Essure controversy unfolded as the permanent birth control implant faced widespread criticism and legal challenges. Women who underwent the Essure procedure reported severe side effects ranging from chronic pain to unintended pregnancies, prompting a surge in lawsuits against Bayer. Injuries claimed by women included not only physical pain but also debilitating autoimmune conditions.

Between the FDA’s approval of Essure in 2002 and January 2018, the agency received a staggering 26,272 adverse event reports related to the device. Lawsuits alleged that Essure, instead of functioning as intended, exhibited defects such as migration from the fallopian tubes, organ perforation, device breakage, and corrosion. 

These defects caused severe and lasting injuries, with many women experiencing chronic pain and inflammation from persistent metal fragments after multiple surgeries.

Thousands of American women took legal action against Bayer, asserting that Essure had caused devastating side effects and irreversibly altered their lives. The lawsuits argued that Bayer neglected to report severe side effects such as broken devices and perforated organs, as noted by Forbes. This failure extended to both the U.S. Food and Drug Administration and the general public.

In a significant development, in August 2020, Bayer announced a $1.6 billion settlement, resolving almost 90% of the nearly 39,000 Essure-related claims. While Bayer had ceased selling Essure in 2018, the controversy persisted as the company did not issue a recall for the device. 

DePuy Synthes and Hip Implants

DePuy Synthes, a subsidiary of Johnson & Johnson, encountered legal challenges due to issues with its hip implants. Patients reported problems such as metallosis, implant dislocation, and premature device failure. Lawsuits alleged inadequate warnings about potential risks associated with the hip implants, leading DePuy Synthes to address fallout through settlements and legal proceedings.

Despite the initial optimism surrounding DePuy’s metal-on-metal technology in hip implants, issues arose, and many implants failed within a few years. Plaintiffs in these lawsuits claimed that DePuy hip replacements caused failures, tissue death, and the release of metal ions into the bloodstream.

As of 2024, the DePuy Pinnacle hip implant multidistrict litigation remains technically open, but there are no remaining active lawsuits. At its peak, this litigation involved a substantial caseload, with 10,581 cases, as reported by Drugwatch. 

Settlements and verdicts associated with these hip implants totaled around $6.2 billion. This sum reflects the substantial impact on individuals who faced complications from DePuy hip implants.

In conclusion, as medical technology continues to advance, the industry must learn from past mistakes and prioritize patient safety. 

The lawsuits against companies like Bard Access Systems, Johnson & Johnson, and Bayer serve as cautionary tales. They emphasize the imperative for the medical technology sector to uphold the highest standards of testing, transparency, and accountability.

Only through a collective commitment to ethical practices can the industry regain and maintain the trust of patients and healthcare professionals alike.

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