Product Liability
A device meant to restore your health should not be the reason you need surgery again
Patients accept the ordinary risks of surgery. They do not accept an implant that corrodes, migrates or fractures because its maker never adequately warned anyone of the risk.
About defective medical devices claims
Medical device litigation focuses on what the manufacturer knew and when. A device can be defective in its design, for example a metal-on-metal bearing surface that predictably sheds metal ions into surrounding tissue, or in its manufacture, where a single lot deviates from specification. Just as often the defect is a failure to warn: the company had adverse-event data and did not adequately communicate the risk to physicians or patients.
The device failures we investigate include hernia and pelvic mesh that contracts, erodes or adheres to organs; hip and knee implants that loosen, fracture or cause metallosis; surgical staplers and clips that misfire; insulin pumps, infusion pumps and CPAP units that deliver the wrong dose or degrade into the airway; IVC filters that tilt, perforate or migrate; and catheters and ports that fracture and embolize.
These claims can be legally complex because federal regulation of devices interacts with state law, and the analysis differs depending on whether a device went through premarket approval or was cleared through the substantially-equivalent pathway. We evaluate that threshold question early so a client is not left pursuing a theory that cannot survive.
Common injuries
Injuries we see most often in these cases. Every claim is different, and this list is not exhaustive.
- Chronic pain, infection and tissue erosion requiring revision surgery
- Metallosis and bone loss from implant wear debris
- Organ perforation, bowel obstruction and internal bleeding
- Device migration, fracture or embolization to the heart or lungs
- Sepsis and prolonged hospitalization following device failure
- Permanent loss of function, mobility or fertility
Who can be held liable
Responsibility often extends well beyond the most obvious company. We look at every party in the chain.
- The device manufacturer that designed, tested and marketed the product
- A component or materials supplier whose part failed in service
- The distributor or sales representative that promoted an off-label or unsuitable use
- A hospital or surgical center that used a device after a recall or safety notice
- A reprocessor that cleaned and resold a single-use device
Evidence that matters
What we work to preserve and obtain early, because this proof tends to disappear with time.
- Complete medical records, operative reports and implant identification stickers
- Preservation of the explanted device itself after revision surgery
- FDA adverse event (MAUDE) reports, recall notices and safety communications
- The manufacturer’s premarket submission, clinical data and internal risk analyses
- Treating surgeon testimony on what warnings and instructions were provided
Do not wait on the deadline
California generally allows two years to bring a personal injury or product liability claim under Code of Civil Procedure § 335.1, and two years from the date of death in a wrongful death case. Shorter deadlines apply when a government entity is involved, and deadlines can be extended for injured children. Exceptions are fact-specific. Talk to us before you assume anything about your own timeline.
Answers
Defective Medical Devices: common questions
Injured by medical devices? Let us review it at no cost.
A conversation costs you nothing and there is no obligation. No fee unless we recover compensation for you. In some matters a client may still be responsible for case costs and expenses, and we will explain exactly how that works before you decide to hire us.