The U.S. Food and Drug Administration is responsible for regulating products and activities that impact public health. Its protections include regulating manufacturers of several industries, including food, drugs, medical devices, tobacco, cosmetics, medical devices, radiation-emitting products, and biologics. These manufacturers are subject to tremendous scrutiny, and product liability claims can be successful if they prove that your company did not precisely follow any of the many regulations that apply.
While it may seem obvious that a successful product liability claim against your company can negatively impact your business’s reputation and, ultimately, your revenue, even an unsuccessful claim can do damage to consumers’ opinions of what you manufacture. There are, however, ways FDA-regulated manufacturers can proactively prevent potential claims of product liability. Through a multi-faceted approach, you can develop and implement strategies and practices that help to protect your customers and your business.
Why Should I Take a Proactive Approach to Product Liability Claims?
Protecting your customers and your business is the most compelling reason to adopt a proactive approach to prevent product liability. To protect your company and prioritize consumer safety, rigorous quality control and regulatory compliance must be emphasized by everyone in your organization. This will significantly reduce the risk of product liability claims and their associated repercussions. In addition to prioritizing quality control, consistent and transparent communication with your company’s staff and the public is critical to preventing product liability issues, along with continuous monitoring of changes to the regulatory landscape.
By taking a proactive approach to product liability claims, you create consistency in your procedures and processes, which provides clarity for your workforce and may reduce the risk of violations under additional regulatory requirements from the U.S. Department of Labor’s Occupational Safety and Health Administration. You need to have in place timely audits of processes, complete inspections to ensure compliance with regulations, and strict protocols to test both the success and failure of audits, as well as areas for improvement in terms of compliance. All of this is part of a quality management system that helps to keep defective products from reaching customers and protects your company’s reputation.
In addition to a quality management system to reduce risk, transparency in your communications with all stakeholders is integral to avoid product liability claims. Your products should have clear and accurate labels with simple yet comprehensive instructions for use. By emphasizing proper use instructions, companies can minimize the risk of product misuse by customers, which also protects them from potential liability claims.
What Makes a Product Liability Case Against My Company Successful?
If someone brings an action against your business due to a product defect, improper instruction, or other product liability cause, there are three basic elements to consider:
- What does the party allege caused their injury?
- When did you (i.e., your company) know about the problem that allegedly resulted in the injury?
- What did you do about the problem once you knew about it?
Keeping the safety of your consumers in mind can make a significant difference in the event of a legal action, when reviewing the results of an internal audit, developing plans for a new product, or taking any steps that impact the manufacture or delivery of your products. To paraphrase an old adage, preventing the problem is much simpler than trying to defend against its results.
Evidence in a Successful Product Liability Case
The other party will be required to produce a plausible causal relationship between your product and their injury, and these claims can become quite complex when there are other factors at issue. While expert testimony and medical records likely will be a part of their case in chief, you will want to be able to defend against their claims based on the foreseeability of the harm and any improper use of your product. If the other party is even partially at fault, you will be able to weaken their argument and, therefore, strengthen your defense against it.
What Your Company Did With Knowledge Is Critical in a Product Liability Case
When it comes to what you knew, when you knew it, and what you did about it, proactive protocols and swift action upon notice of an issue are crucial to your defense. Acknowledging issues is, of course, important, but what you do with that knowledge is truly critical. Pursue all concerns, act quickly, and document your actions to best protect your company from liability.
What Can I Do to Be Proactive Against Product Liability Claims?
In addition to investigating all potential issues, one of the best proactive steps you can take to protect your company and its customers is to have a strategy ready to deploy before any such concerns arise. Train your employees on the strategy so there is a shared understanding company-wide about the management of concerns, best practices for manufacturing, and all governmental requirements that apply to your manufacturing and delivery process. When employees are properly trained on an effective strategy, you can decrease the time required for your company to adjust and correct any errors.
Your proactive approach does not stop after you have done what you can in the manufacturing and delivery process. Setting up processes to monitor consumer complaints and reports of adverse events can help identify potential issues before they become larger problems. Investigate quickly and consistently, and follow established processes for remedying any substantiated concerns.
Once you implement effective processes based on a well-socialized strategy, you must maintain awareness of changing requirements and adjust your strategies accordingly. Monitor industry best practices and governmental agency requirements and guidelines for changes that apply to your manufacturing and delivery processes. If changes necessitate a product recall, timeliness and transparent communication will again be crucial in protecting your company and its consumers.
Contact an Attorney to Help with Your Case Today
Developing a strong strategy and accompanying procedures is crucial to preventing product liability problems and safeguarding your consumers from potential injuries. Ongoing maintenance of your processes and protocols is important to consider throughout the life of your business. The products liability team at Fee, Smith & Sharp LLP is here to help, so contact us today.
