Urinary Tract Stress, a Class Action Lawsuit and Transvaginal Mesh Insertion Case

In November 2021, a Class Action suit was filed against defendants Boston Scientific, Inc. and Dr. Arthur Katz, and Dr. Katz. According to the Boston Scientific lawsuit, during the Class Period plaintiffs were made completely aware that the Company’s LOTUS EDGE Aortic Valve system was faulty and/ or false and/ or failed to disclose that: (a) the LOTUS EDGE Aortic Valve system was defective and/ or false and/ or (b) that the Company’s promotion of that product was deceptive and dangerous to consumers. Also as a direct result of defendants’ negligence, and after the suit was filed in Massachusetts General Court, defendants refused to incorporate parts of the complaint into their products and/ or sell the product in the state of Massachusetts. As a result of these actions, plaintiffs seek damages for their injuries and losses, including: pain and suffering, physical impairment, permanent disfigurement, permanent nerve damage, loss of earning capacity, emotional distress, embarrassment, and general damages.

Boston Scientific Lawsuit

During the course of this class action lawsuit, and at several other times throughout the litigation, defendants repeatedly made numerous and inaccurate representations regarding the nature of their products, their efficacy, safety, and related risks. For example, during the discovery process, defendants repeatedly and falsely claimed that their product was “nutritionally designed” and “superior to all prior designs”. In fact, according to the complaint, and contrary to defendants’ claims, none of the ingredients of the LOTUS system are “nutritious”, “essential”, or “essential to a healthy diet” and that the system is not intended to treat any medical condition, except perhaps “the symptoms of high blood pressure”. At one point during the litigation, a defense attorney asked a witness if it was possible that the ingredients of the Boston Scientific System “could be considered as junk food”. In response, another defense attorney stated that “no such thing exists”, and that the “exact same ingredients have been used for decades in thousands of dietary supplements.”

In some instances, after defendants have been found liable and have failed to retain adequate counsel, the plaintiff may seek a verdict in a “lesser-used” class-action lawsuit. Such lawsuits are generally referred to as “puppy class-action lawsuits.” In many instances, plaintiffs will receive either general damages or punitive damages as the result of their lawsuit. However, some plaintiffs will receive nothing because the jury did not believe that they had a sufficiently persuasive case for jury award. The Massachusetts Supreme Judicial Court has repeatedly upheld the principle, “Punitive damages are not allowed as a remedy for fraud or deceit.”

Plaintiffs who obtained class action lawsuit awards in this case brought a claim against defendants for “psychological harm,” “general bodily harm,” “emotional distress,” “physical impairment,” and “psychic pain,” but did not receive monetary damages on account of the defendant’s refusal to retain counsel. On appeal, the District Court for the Massachusetts Court of Appeals affirmed the trial court’s denial of damages based on the defendants’ argument that the phrase” `disability’ is a term that denotes a person’s condition regardless of whether the condition actually is a disability.” That argument was rejected by the Massachusetts Supreme Judicial Court. In its view, because” `disability’ describes a medical condition, rather than an impairment, the word `disability’ itself supports the common-law understanding of the term.”

Plaintiffs now ask the courts to allow them to file a class action lawsuit on behalf of all persons who were injured as a result of defendant B’s refusal to retain counsel and to follow FDA’s policy on warnings about transvaginal mesh products. The FDA, in assessing safety for dietary supplements, considers whether a product poses a health threat even if the consumer is not exposed to directly the product. FDA’s general statements on labels regarding the availability and effectiveness of contraceptive tools and devices apply to dietary supplements. The FDA, in addition to determining safety, bases its regulations on whether the product can reasonably be expected to cause harm or even death. The plaintiffs contend that they have met FDA’s burden of proving that defendants knew about the hazard or did not reasonably believe the product to be safe under the conditions described in the complaint.

A three-judge federal district court in Boston has granted class action status to a case brought by plaintiffs who were among the roughly 80 percent of women who experienced urinary tract stress while using Boston Scientific’s “Specially designed Fax Leakage Dipper” as a transvaginal mesh insert during pregnancy. The women were diagnosed with frequent bladder infections and had to undergo multiple surgeries to remedy their problems. Ultimately, they settled for a settlement which included a substantial financial award but no medical benefits. The women are now pursuing a lawsuit against Boston Scientific and defendants GlaxoSmithKline, the manufacturer of the specially designed leakage device.

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