KOSCIUSKO COUNTY — A North Vernon man has filed a six-count complaint against Zimmer Inc., doing business as Zimmer Biomet, Warsaw, for a defect in a shoulder implant/prosthesis. This is the second lawsuit against the company in less than a month.
The suit, filed in Kosciusko Circuit Court Feb. 14, states Oct. 28, 2013, Andrew L. Eder underwent a right total shoulder replacement surgery at Columbus Regional Hospital, Columbus. Dr. Larry Olsen, who performed the surgery, used a Zimmer Trabecular Metal Shoulder System. The complaint alleges following the initial surgery Eder suffered pain, loss of range of motion and loosening of the components.
On Nov. 16, 2017, at the advice of his doctor, he underwent a revision surgery of that same shoulder at Orthoindy Hospital by Dr. Jeffery J. Soldias. Following that surgery, Eder suffered and continues to suffer damages, including disfigurement, pain, suffering, mental anguish, loss of earning capacity and medical expenses.
Eder allegedly has suffered sustained and incurred, and in reasonable medical probability, will continue to suffer, sustain and incur: physical pain, mental suffering, physical impairment, physical disfigurement, reasonable and necessary medical bills, loss of earnings/earning capacity.
He is seeking compensatory damages in an amount above the minimum jurisdictional limits of the court, pre-judgement and post judgement interest according to Indiana law, punitive damages and a trial by jury.
The first count states the components of the implant may have contained a manufacturing defect and may have deviated, in its construction or quality, from the specifications or planned output. The design defects noted are: the use of the implant was unreasonably dangerous for its intended purpose because it had a high propensity to become loose; it was defective in that it had a high propensity for poor bone ingrowth and/or fixation; it was marketed in such a way to mislead consumers regarding its safety and efficacy and it was inadequately tested.
Marketing defects also noted in the case allege: the defects included an inherent risk in the intended or reasonably foreseeable use of the component due to the poor bone ingrowth and/or fixation, inherent risk in the use of the component that it would become loose; inadequate warnings along with: the warnings were not placed in a location to reasonably be expected to catch the surgeon’s attention and the warnings failed to inform the surgeon of the nature of the dangers. The suit alleges the manufacturer knew or reasonably foresaw, or should have known, the risks and they failed to warn the surgeon, failed to instruct the surgeon how to safely use the implant.
Documents noted had the company timely and reasonably warned of material facts regarding the safety and efficacy, proper warnings would have been headed and no health care professional would have used the shoulder system and no consumer would have purchased and/or used the system.
Count two further states the defendants owed the plaintiff a duty to exercise reasonable care in the design, formulation, teasing, manufacture, marketing, sale and distribution of the product, including a duty to ensure the product did not pose a significant risk of bodily injury. A breach of duties by the defendants are noted that include design, manufacturing and testing of the product.
The third count focuses on the advertising of the product that represented the quality to health care professional, the Food and Drug Administration and others in such a way to induce the purpose or use and making an express warranty it would conform to the representation. Allegedly the company represented such facts or promised the system was safe and effective for use, and/or it was safe and effective to replace the plaintiff’s shoulder, it would provide long term fixation and support biological ingrowth.
Count four alleges the system was not fit for the ordinary purposes because the components prematurely loosened under normal use, the plaintiff or his physicians could not have discovered the breached warranty and realized its danger, and the company was notified of the breach of the implied warranty within a reasonable time after it was discovered.
The fifth count alleges the company had reason to know the purpose for which it was required, knew the plaintiff was relying on the company’s skill judgement or knowledge to select or furnish a suitable product, the product was not reasonably fit for the purpose it was required, and other statements previously made in the other counts.
The final count adds to the previously stated allegations the character of the incident that made the basis of the lawsuit was such it would not ordinarily occur without negligence, and Zimmer was in control of the components and is the negligent party.