FDA Notes Multiple Issues During Inspection of Zimmer Biomet’s Indiana Plant
In a recent article from Mass Device, the authors reveal that a United States Food and Drug Administration inspection of a Zimmer Biomet plant in Warsaw, Indiana did not go so well for the medical device manufacturer. The FDA later published the Form 483 that was sent to the manufacturer, highlighting its findings during the inspection. Specifically, FDA inspectors noted eight observations that needed to be remedied at the Indiana plant. The inspection occurred during the first half of October 2017.
The Form 483 spanned 12 pages. In it, FDA inspectors commented that former inspectors had previously reported some of the problems noted in the October 2017 visit.
The issues noted during the October 2017 plant visit included:
- Failing to use written medical device reporting (MDR) protocols.
- Failing to create and implement procedures for studying and reviewing complaints by a specially designated group (this was also noted in 2015).
- Failing to implement a procedure to make sure equipment is regularly calibrated (this was noted in 2015 as well).
- Failing to properly validate its quality system software for its specified uses per an existing protocol.
- Failing to have procedures in place that allowed for control and monitoring of process parameters for established processes.
- Failing to create packaging for its devices that protected them from being damaged during transit (this was also noted in 2015)
- Failing to have procedures in place that implemented preventive and corrective action for products that did not meet standards (also noted in 2011, 2012, 2013, 2014, and 2015).
In response to the publication, Zimmer Biomet released a statement, saying:
“Like all medical device companies, Zimmer Biomet is subject to periodic FDA inspections. In the fourth quarter of 2017, the FDA completed an inspection of the legacy Zimmer manufacturing site in Warsaw, Indiana. As is often the case, at the conclusion of the inspection, the FDA issued various inspectional observations on Form 483. Zimmer Biomet takes the FDA matters very seriously and has submitted its written response to the Form 483 observations. The company has developed and is executing a remediation plan to address the issues cited by the FDA fully. The company will continue to communicate with the FDA regarding the status of the corrective actions and remediation work. Zimmer Biomet is committed to operating an excellent quality management system across its global manufacturing network. While the company is taking the necessary steps to address certain regulatory compliance gaps, it remains confident in the quality, safety, and efficacy of all of its products.”
In January of 2017, the FDA also sent a Form 483 to Zimmer Biomet, that time laying out 14 observations it made needing correction.
Zimmer Biomet Faces Numerous Legal Claims Regarding its Products
Zimmer Biomet is facing legal claims from many consumers who argue that its products are not safe. For example, the Biomet M2a 38, as well as the M2a Magnum, are two metal-on-metal hip implant devices that have been linked to a number of serious side effects. As the metal parts of the implant rubbed together, metal ions leached into the surrounding tissue and bloodstream. The buildup of these metal ions caused symptoms such as:
- Tissue death
- Heart damage
- Loss of vision
- Increased levels of metal in the blood
Many individuals who received these metal-on-metal hip implants required revision surgeries, as the devices failed much more quickly than other types of hip implants.
Zimmer Biomet is also facing lawsuits that claim injuries were caused by its knee replacement devices and its shoulder implant devices.
What Can Consumers Do if a Defective Product Causes Injuries?
If a product is defective and causes injuries, the manufacturer is typically strictly liable for the damages that result. With strict liability, an injured consumer does not have to prove that the manufacturer was negligent—instead, the consumer must show:
- A product was being used as directed or as anticipated by the manufacturer
- The product was defective
- The consumer was injured
- The defect in the product was the actual cause of the consumer’s injuries
Each of these elements must be proven for a consumer to prevail in a products liability lawsuit—including those that involve medications or medical devices. If one of the elements cannot be substantiated, the claim will likely be dismissed from the court. The consumer would be completely responsible for his financial losses.
There are three types of product defects that may be present in a product:
Design defects occur when a product’s design, or its “blueprints,” is faulty. For example, with metal-on-metal hip implants, the issue is with the design of the implant, because the metal-on-metal design is what caused the severe side effects.
Manufacturing defects occur at some point between the assembly of the product and its arrival to the consumer. Factory errors and damage during shipment are examples of manufacturing defects. For example, if a shipment of EpiPens, which help prevent anaphylactic shock, became overheated on a truck, consumers may be able to file a claim against the manufacturer if the EpiPens were not as effective in life-threatening situations.
Marketing defects are those that stem from a lack of proper warnings or instructions from the manufacturer. For example, if a medical device should not be implanted into patients with certain types of allergies, these patients may be able to file a products defect lawsuit if they are allergic to the material in the device but were not warned about it.
A product may contain just one defect, or it may contain two or three.
Damages in a Hip Implant Product Liability Lawsuit
Depending on the circumstances surrounding the Zimmer metal-on-metal hip implant claim, the damages in a products liability lawsuit may reach hundreds of thousands of dollars or more. Some recent settlements with medical device manufacturers and other pharmaceutical companies have been several million dollars.
Damages may include:
- Medical expenses
- The cost of future medical care
- The expense involved with altering a home, such as installing handrails or wheelchair ramps
- Lost wages
- Loss of consortium
- Pain and suffering
- Emotional distress
- If the consumer died due to his injuries, the cost of funeral and burial expenses might be claimed, as well as an estimate of the deceased’s future earnings
Other damages may also be available, depending on the facts of the claim. So long as the consumer is able to link his injuries to the product’s defect, the consumer should have a strong claim for damages.
It is essential to hire an attorney as soon as possible if you believe that a product has caused your injuries. There are deadlines in place that restrict the time consumers have to file a claim, and if these deadlines are missed, the consumers may forever lose the right to file a lawsuit seeking damages. Deadlines vary from jurisdiction to jurisdiction, so call an attorney in your area today to discuss your legal options.
Call for Your Free Zimmer Biomet Metal-On-Metal Hip Implant Evaluation
If you have been injured, call our Zimmer Biomet metal-on-metal hip implant lawsuit attorneys at Parker Waichman LLP to discuss your legal options. To schedule your free consultation with our excellent legal team, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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