Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant financial and reputational damage, and, most importantly, can harm patient safety. A proactive approach to product liability prevention is crucial.

Product liability cases hinge on three fundamental questions:

1. What allegedly caused the injury?
2. When did the company know about any problems?
3. And what did the company do about it?

A robust prevention strategy addresses each of these questions head-on, prioritizing patient safety at every step.

Read the Signs – What Did You Know?

Identifying potential problems early is paramount for protecting patients. Ignoring warning signs can lead to devastating consequences. Key indicators include:

• Increased customer complaints

• Reports from healthcare professionals or consumers about unexpected product performance

• Internal reports of manufacturing or marketing issues

• Adverse event reports submitted to the FDA

• Regulatory actions like 483 observations or warning letters

Failing to acknowledge and address these signals can significantly increase your liability and endanger patients.

Carefully Monitor All Communications – When Did You Know It?

Vigilance is key to ensuring patient safety. Don't just acknowledge potential problems – thoroughly investigate all credible complaints and data suggesting issues. Companies that act swiftly and decisively are more likely to avoid regulatory repercussions and achieve better litigation outcomes, sometimes even avoiding lawsuits altogether. Conversely, ignoring warning signs and failing to address problems leads to more adverse patient outcomes, increased regulatory scrutiny and penalties, and significantly poorer litigation results.

Act Quickly and Decisively – What Did You Do About It?

Delaying action on known problems, or worse, attempting to conceal them, even unintentionally, compounds legal issues and endangers patients. Negative verdicts often stem from documents and testimony revealing a lack of integrity in addressing product concerns. Any attempt to delay responding to negative outcomes documented internally will be difficult to justify to regulators, law enforcement, and juries. Timely communication with patients, when required, is crucial for their safety.

What to Do: A Proactive Strategy is Your Best Defense

Developing a comprehensive product liability prevention strategy before a crisis occurs is the most effective way to minimize patient harm and protect your company. As expert product liability litigator David Graham, an exceptionally experienced FDA attorney who has tried multiple product liability cases, notes, "A proactive approach to product liability prevention is not just good practice, it's essential for survival in the FDA-regulated landscape. Knowing your product, monitoring all communications, and acting decisively are the cornerstones of a successful defense."

Gardner Law specializes in developing tailored product liability prevention programs. Our team can help you identify vulnerabilities, implement robust monitoring systems, and create clear protocols for responding to potential problems. Contact us today for a consultation and safeguard your business and the patients who rely on your products.