24/7 | Se habla español Call 516.741.5252

Legal Issues Surrounding Defective Medical Devices

Legal Issues Surrounding Defective Medical Devices

Find defective medical device claims and the products liability lawsuits that support them

Faulty surgical instruments, flawed implants, substandard pacemakers, and imperfect prosthetics are examples of dangerous or defective medical devices that can cause people damage, and in extreme situations, occasionally death.

The U.S. Food and Drug Administration (FDA) monitors medical device performance in patients and responds appropriately when defects arise.

Yet, it’s fairly impractical for anyone to preempt defective medical equipment design and manufacturing, and regulators usually only learn about a device maker’s deceptive marketing practices only after serious injuries occur.

High-risk medical devices are now at the focus of many products liability lawsuits where plaintiffs claim manufacturers and health care providers harmed the public by placing dangerous medical products in consumer markets.

These victims further allege medical equipment producers escaped complying with FDA pre-marketing regulatory rules by exploiting loopholes in federal regulation.

It’s Marc Grossman’s mission to hold individuals conducting business in the medical industry accountable for the damages they cause innocent patients.

The lawyers at Sanders Phillips Grossman are products liability specialist, and they want to help victims redress defective medical device harms and return to patients to healthier positions, just as they were in before the careless injuries took place.   

Discover Some Defective Medical Devices

Defective medical devices are not just instruments to support body functionality or corporal aesthetics; they are also tools, machines, technologies, and chemicals used for diagnosing, curing, treating or preventing adverse medical conditions in humans.

Take a peek at some defective medical devices listed below and learn why the FDA recalled them:

  • Implants such as hip replacements and silicone breasts have significant failure rates and may expose patients to leakage or metal poisoning injuries.
  • Catheters treat diseases, aid physicians in surgeries and transport fluids or drugs to blood vessels; but, defective catheter tips split or separate during application and infiltrate patient bloodstreams, causing blood clots and embolisms, and sometimes, sudden death.
  • Machines and Imaging Tools may occasionally fail during service; some lawsuits allege surgical robot arms malfunctioned and caused organ and tissue piercing or produced infections and electrical burns; defective x-ray and imaging machines also expose patients to radiation harm.
  • Defibrillators or pacemakers are apt to malfunction when designed or manufactured incorrectly; faulty devices regularly fail to send proper electrical shocks to regulate abnormal heart rhythms, which can lead to death.
  • Surgical Mesh is absorbent/non-absorbable synthetic material or animal tissue used for reinforcing surgical areas, commonly in hernias. Design flaws have led to mesh malfunctions producing reoccurrence, bleeding, blockages and obstructions.
  • Drug-Coated Stents lodge permanently in arteries or blood vessels and releases chemicals to unblock abnormal cell growth and prevent scarring. The FDA has stents on its radar after records of infections, blood clotting, and internal bleeding emerged shortly the following approval.

Escaping FDA Pre-Marketing Regulatory Compliance

Medical device manufacturers and their lawyers found certain loopholes in the law for accelerating their products into healthcare communities; in the US, medical devices can avoid extensive scientific and regulatory FDA examination through 510(k) application.

Under FDA 510(k) process, devices enter healthcare exchanges without pre-market approval (PMA) and scrutiny (i) if manufacturers claim their products are “substantially equivalent” to other devices approved by the Agency prior; or (ii) if they assert other companies marketed the same product before 1976.

An FDA 510(k) submission merely compares and contrasts products with predicate devices and clarifies why any discrepancies between the two should not affect function. After receiving FDA 510(k) applications, the Agency has one to three months decide if devices are alike and ready for distribution.

Unfortunately for manufacturers, the law asserts all medical supply companies hold duties to discover every known danger in their consumer products and make sure the items are safe before delivering them to market. Obviously, no PMA means manufactures never performed scientific assessments to assure devices are harmless and practical for public use.

Marc Grossman at Sanders Phillips Grossman asserts a company’s 510(k) submission is evidence of negligence per se because juries can infer a PMA omission “speaks for itself.”

How Products Liability Applies to Defective Medical Devices

Dangerous or defective medical devices give rise to causes of action in products liability when poorly designed or manufactured instruments break down or when the devices harm individuals during or after surgery or hospital visits.

Modernly, products liability lawsuits require plaintiffs to prove their medical device was defective or inherently dangerous and caused damages.

Problematic products injure thousands of patients each year though most victims discover their harm only years after leaving their doctor’s care.

Procuring Defects

Marc Grossman at Sanders Phillips Grossman is an authority in identifying the nature and origin of defects or failures in three product domains:

  • Design Defects—properly manufactured medical devices that possess unreasonably dangerous designs that produce serious injuries. These instruments typically fail after years of use.
  • Manufacturing Defects—devices that manufacture design correctly but build incorrectly or let become damaged before use. The fault may exist at any stage in the foreseeable causation link between factory fabrication, distribution and healthcare facility application.
  • Marketing Defects—failure to give direction to a medical device’s safe and proper use or failure to offer accurate and adequate warnings about the product’s known risks. Manufacturers, physicians, healthcare providers, device distributors and salespeople are common defendants named in these products liability lawsuits.

Typical Products Liability Defendants

Plaintiffs can hold accountable any individual found in the chain of foreseeable causation for contributing to medical device harm (from manufacturers to consumers):

  • Manufacturers: Corporations make tremendous profits from designing, fabricating and marketing medical devices. Victims should look at these large companies first when searching for defendants responsible for their injuries.
  • Physicians: Doctors may fail to warn patients about a device’s potential danger or omit to give adequate instructions on how to use medical devices properly.
  • Healthcare Providers: Hospitals, clinics or any medical facility or business that joined in the chain of distribution in medical device delivery to consumers may be liable for injuries.
  • Salespeople: Vendors are agents of medical device manufacturers who meet with healthcare providers to promote product use. The law may hold salespeople liable for selling harmful devices if they provoke sales by making false or negligent misrepresentations about the medical instrument’s dangers.
  • Third-Party Testing: Some companies contract independent research labs to assess their medical devices. These laboratories are liable to consumers if their data negligently proves a medical device is harmless.

Product Liability Damages

The second element of products liability claims requires plaintiffs to show damages needing compensation to make victims whole again.

  • General Damages: Pain and suffering or physical or emotional harm stemming naturally from injuries.
  • Special Damages: Indemnification for out-of-pocket expenses, including restitution for medical expenses, lost wages, recovery treatments and rehabilitation.
  • Punitive Damages: The courts may award punitive damages if plaintiffs prove other parties learned of medical device dangers but deliberately concealed them or show defendants recklessly delayed in recalling their flawed devices.

Medical Device Recalls

Medical device suppliers frequently issue product recalls after FDA approval.

The federal Agency maintains a website that discloses information about medical device recalls when evidence shows certain products may provoke serious public health complications or patient death.

Plaintiffs can nonetheless file product liability lawsuits after sustaining injury regardless of whether a recall exists.

Marc Grossman at Sanders Phillips Grossman keeps current on FDA medical device safety publications and manages its own products liability database on defective medical device legal proceedings, which you can browse through by clicking HERE.

ATTORNEY ADVERTISING. Past results do not guarantee future outcome.