When the product is the problem, the manufacturer must answer for it.

A device or drug case is three cases at once: an engineering or pharmacology case about the product, a regulatory case about what the manufacturer told the FDA and the medical profession, and a medical case about what the product did to the patient.

Powell Law Offices prepares all three. The firm has resolved claims arising from surgical mesh implanted to treat incontinence, from an over-the-counter weight-loss product that caused a heart attack in a woman with no cardiac history, and from the medical negligence that often accompanies a defective product.

Theories of liability under Florida law

• Strict liability. A manufacturer that places a defective, unreasonably dangerous product into the stream of commerce is liable for the injuries it causes, without proof of negligence.
• Design defect. Florida applies the consumer-expectations test: a product is defectively designed if it fails to perform as safely as an ordinary consumer would expect when used as intended or in a reasonably foreseeable way.
• Manufacturing defect. The product left the factory different from, and more dangerous than, its intended design—a contaminated lot, a flawed weld, a mislabeled dose.
• Failure to warn. The manufacturer knew or should have known of a risk and failed to give adequate warning. For prescription drugs and devices the warning runs to the prescribing physician under the learned intermediary doctrine, which makes the content of the label and the manufacturer's communications with doctors central evidence.
• Negligence and breach of warranty. Careless testing, manufacturing or marketing, and products that do not conform to the manufacturer's representations.

Medical devices, drugs and federal preemption

Whether a claim can be brought at all often depends on how the product reached the market. Devices approved through the FDA's rigorous premarket approval process enjoy broad protection from state-law claims, with a narrow exception for claims that parallel federal requirements. Devices cleared through the far more common 510(k) process, on the basis of similarity to an earlier device, do not enjoy that protection. Claims against the makers of brand-name drugs for inadequate warnings are generally permitted; claims against generic manufacturers are largely barred because federal law requires their labels to match the brand. Identifying the regulatory pathway is the first task in any device or drug case, and it is done before the client is told whether a claim is viable.

Products the firm evaluates

• Surgical mesh and bladder slings used for hernia repair, pelvic organ prolapse and incontinence
• Orthopedic implants—hips, knees, spinal hardware—that fail, corrode or shed metal debris
• Cardiac devices, pumps, filters and leads
• Prescription medications with undisclosed or understated risks
• Over-the-counter products, supplements and weight-loss preparations
• Recalled and contaminated products

Many device and drug injuries are consolidated in federal multidistrict litigation, where thousands of similar claims are managed together. The firm evaluates whether a client is better served in the consolidated proceeding or in an individual Florida action, and explains the difference plainly.

Who may be responsible

The manufacturer is the usual defendant, but component makers, distributors, sales representatives who attend surgeries, and compounding pharmacies may share responsibility. When a physician implanted or prescribed the product without proper evaluation, or failed to recognize and treat the complication, a medical negligence claim may proceed alongside the product claim—subject to Florida's separate presuit requirements for malpractice, which the firm handles routinely.

Preserve the product

The single most important step a patient can take is to keep the product. If a device is being removed, ask the surgeon and the hospital in writing to preserve the explanted device and its packaging rather than discarding it or returning it to the manufacturer. Keep medication bottles, lot numbers, receipts and instructions. Photograph everything. The firm sends preservation demands to the hospital and the manufacturer as soon as it is retained.

Deadlines

A Florida product liability action must generally be brought within four years from when the injury and its connection to the product were, or should have been, discovered; a claim pursued on a negligence theory that arose after March 24, 2023 may be subject to the two-year period that now applies to negligence. Florida also has a statute of repose that generally bars product claims brought more than twelve years after the product was delivered to its first purchaser, with exceptions for latent injuries, products warranted for a longer life and concealment by the manufacturer. Because these periods interact and the discovery date is often contested, the firm treats the earliest plausible date as the deadline.