In order to prevail in proving that a Defendant was negligent (and thus, liable for a Plaintiff’s injury), the Plaintiff must prove all of the elements:
2) Breach of Duty
3) Cause in Fact
4) Proximate Cause
In the case of a Transvaginal Mesh suit, Plaintiff must show that Defendant had a duty to individuals to use reasonable care in designing, manufacturing, marketing, labeling, packaging and selling the Pelvic Mesh Products (“products”). Plaintiff must prove that Defendant was negligent in failing to use reasonable care in designing, manufacturing, marketing, labeling, packaging and selling the products. Plaintiff’s allegations of breach of duty could include a Defendant’s failure to design and/or manufacture the products so as to avoid an unreasonable risk of harm to women in whom the products were implanted. Other actions by Defendant that could be alleged as breach of duty include failing to use reasonable care in the testing of the products and failing to use reasonable care in inspecting the products.
In a Transvaginal Mesh complaint, a Plaintiff could allege some of the reasons that a Defendant’s negligence caused the products to be unreasonably dangerous and defective, such as: the use of polypropylene material and/or collagen material in the products and the immune reaction that results from such material, causing adverse reactions and injuries; biomechanical issues with the design of the products, including the propensity of the products to contract or shrink inside the body, that in turn cause surrounding tissue to be inflamed, become fibrotic, and contract, resulting in injury; and the propensity of the collagen products to disintegrate after implantation in the female pelvis, causing pain and other adverse reactions. Furthermore, Plaintiff could allege that Defendant also negligently failed to warn or instruct the Plaintiff and/or her health care providers of subjects including: the rate and manner of mesh erosion or extrusion; the need for corrective or revision surgery to adjust or remove the products; and the warning that complete removal of the products may not be possible and may not result in complete resolution of the complications, including pain. Plaintiff could then demonstrate that as a direct and proximate result of the Defendant’s negligence, the Plaintiff has experienced the following: significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, lost income, and other damages.
Strict Liability – Design Defect: This cause of action alleges the products implanted in the Plaintiff were not reasonably safe for their intended uses and were defective with respect to their design.
Strict Liability – Manufacturing Defect: This cause of action alleges the products implanted in the Plaintiff were not reasonably safe for their intended uses and were defective as a matter of law with respect to their manufacture because they deviated materially from the Defendant’s design and manufacturing specifications in such a manner as to pose unreasonable risks of serious bodily harm to the Plaintiff.
Strict Liability – Failure to Warn: This cause of action alleges the products implanted in the Plaintiff were not reasonably safe for their intended uses and were defective as a matter of law due to their lack of appropriate and necessary warnings. Plaintiff could specifically allege that Defendant did not provide sufficient or adequate warnings regarding subjects relating to: the products’ propensities to contract, retract, and/or shrink inside the body; the products’ propensities for degradation, fragmentation, disintegration and/or creep; the products’ inelasticity preventing proper mating with the pelvic floor and vaginal region; the rate and manner of mesh erosion or extrusion; the risk of chronic inflammation resulting from the products; the risk of chronic infections resulting from the products; the risk of permanent vaginal or pelvic scarring as a result of the products; and the risk of recurrent, intractable pelvic pain and other pain resulting from the products.
Breach of Express Warranty: This cause of action alleges that Defendant made assurances to the general public, hospitals and health care professionals that the products were safe and reasonably fit for its intended purposes. The Plaintiff (individually and/or by and through her physician) reasonably relied upon Defendant’s express warranties and guarantees that the products were safe, merchantable, and reasonably fit for their intended purposes. For this cause of action, Plaintiff could allege Defendant breached these express warranties because the products implanted in her were unreasonably dangerous and defective and not as Defendant had represented. Thus, Defendant’s breach of its express warranties resulted in the implantation of unreasonably dangerous and defective products in Plaintiff’s body, placing her health and safety in jeopardy.
Breach of Implied Warranty: This cause of action alleges that Defendant impliedly warranted that the products were merchantable and were fit for the ordinary purposes for which they were intended. When the products were implanted in the Plaintiff to treat her pelvic organ prolapse and/or stress urinary incontinence, the products were being used for the ordinary purposes for which they were intended. The Plaintiff (individually and/or by and through her physician) relied upon Defendant’s implied warranties of merchantability in consenting to have the products implanted in her. For this cause of action, Plaintiff could allege Defendant breached these implied warranties of merchantability because the products implanted in her were neither merchantable nor suited for their intended uses as warranted. Therefore, Defendant’s breach of its implied warranties resulted in the implantation of unreasonably dangerous and defective products in Plaintiff’s body, placing her health and safety in jeopardy.
Loss of Consortium: In this cause of action, Plaintiff’s spouse alleges that as a direct and proximate result of the injuries sustained by Plaintiff, the spouse has suffered a loss of his wife’s consortium (the right of association with one’s spouse), companionship, society, affection, services and support.