Quick Answer: Courts evaluate safer alternative designs in device defect claims by analyzing whether a feasible, cost-effective design existed at the time of manufacture that would have reduced injury risk without undermining the device’s intended function.

When a consumer product or medical device causes injury, one of the most important questions in a device defect lawsuit is whether the harm could have been avoided through a safer alternative design. Courts use this concept to determine whether a product was unreasonably dangerous at the time it was sold—and whether the manufacturer should be held liable.

Understanding how safer alternative designs are evaluated helps explain why some device defect claims succeed while others fail.

A safer alternative design is a practical, feasible product design that would have reduced or eliminated the risk of injury without destroying the product’s usefulness or making it prohibitively expensive.

In device defect claims, plaintiffs are often required to show that:

1. A safer design existed at the time of manufacture
2. The alternative design was technologically feasible
3. The alternative would have reduced or prevented the injury
4. The alternative would not have undermined the product’s core function

This requirement is especially common in design defect cases involving complex products and medical devices.

Most courts evaluate device defect claims using a risk–utility analysis, which weighs:

• The product’s benefits
• The severity and likelihood of harm
• The feasibility of safer designs
• The cost of implementing design changes

If a manufacturer could have adopted a safer design at reasonable cost and chose not to, that decision can strongly support a finding of defectiveness.

In many jurisdictions, failure to prove a safer alternative design can be fatal to a design defect claim, even when injuries are severe.

Courts examine whether the alternative design was scientifically and technologically achievable at the time the product entered the market.

Important considerations include:

• Existing patents or prototypes
• Industry standards or competing products
• Prior versions of the same product
• Engineering literature available at the time

A design does not need to have been widely adopted, but it must be realistically achievable, not hypothetical.

The proposed alternative must meaningfully reduce the specific risk that caused the injury.

Courts look for evidence showing:

• How the alternative design would function differently
• Whether it would prevent the failure mode that occurred
• Whether it introduces new safety risks

If the alternative merely shifts risk rather than reducing it, courts may reject it.

Manufacturers are not required to create a risk-free product, but they are expected to avoid unreasonable dangers.

Courts analyze whether the alternative design:

• Preserves the product’s intended function
• Maintains acceptable performance levels
• Avoids fundamentally changing the product’s purpose

For medical devices, this often involves balancing safety improvements against clinical effectiveness.

Cost alone does not excuse unsafe design, but courts consider whether the alternative design would have:

• Dramatically increased production costs
• Made the product inaccessible to its intended users
• Eliminated the product’s commercial viability

Minor or moderate cost increases are rarely persuasive defenses if the safety benefits are substantial.

Regulatory compliance does not automatically shield manufacturers from liability, but it plays a role in evaluating alternative designs.

Courts consider:

• Whether the product met minimum regulatory requirements
• Whether safer designs exceeded regulatory baselines
• Whether regulations lagged behind known safety risks

A product can be legally defective even if it complied with existing regulations.

Safer alternative design claims almost always rely on expert witnesses, including:

• Biomedical engineers
• Mechanical engineers
• Human factors specialists
• Medical experts (for medical devices)

Experts help courts understand:

• How the product failed
• Why the alternative design would work
• Whether the alternative was realistically available

Weak or speculative expert testimony is a common reason these claims fail.

Manufacturers often argue that:

• The alternative design was not feasible at the time
• The alternative would impair performance
• The alternative introduces different risks
• The alternative was only developed after the product was sold

Courts carefully scrutinize these claims, especially when internal company documents show prior knowledge of safer options.

Some jurisdictions allow design defect claims under a consumer expectations test, which focuses on whether the product performed as an ordinary consumer would expect.

However, for complex devices (especially medical devices) courts frequently require proof of a safer alternative design due to the technical nature of the product.

Safer alternative design analysis sits at the heart of modern product liability law. It forces courts to answer a practical question: Was this injury an unavoidable risk, or the result of a preventable design choice?

When plaintiffs can show that a manufacturer ignored a feasible, safer design, liability becomes far more likely.

In device defect claims, proving a safer alternative design is often the difference between winning and losing. Courts evaluate feasibility, effectiveness, cost, performance impact, and expert support to determine whether a product was unreasonably dangerous.

Understanding this framework helps injured consumers (and manufacturers) see how responsibility is assigned when product design choices cause harm.