MEDICAL DEVICE RECALLS


Product Liability Lawyer reviewing medical device recalls and filing lawsuits for injured plaintiffs nationwide
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Medical Device Recall Lawyer

investigating recalled medical devices & instruments

Each year, there are millions of medical device units involved in Class I medical device recalls, initiated by the U.S. Food and Drug Administration (FDA). Many of these devices are put to market under a pre-approval process and not properly tested before they eventually cause injuries to American consumers and recipients. All too often, defective medical devices are recalled only after they cause serious health problems to patients and face lawsuits for producing, marketing and distributing dangerous products to the public.

According to a recent Stericycle recall report, medical device recalls are increasing and becoming more common—one of the bigger defect trend is defective device software. Medical device recalls in the United States jumped over 100 percent and surpassed 200 million units in the early part of 2018. More units were recalled in the 2018 first quarter than were recalled all of 2017. Defective device software represented 78 out of 343 total recalls. Common device recalls involve mislabeling, out-of-spec production, and quality issues.

The FDA and product safety advocates have urged medical device manufacturers to improve their quality assurance through better pre-market testing and post-market management of recalls and defects. Medical institutions and doctors should establish a parallel process for monitoring manufacturers’ release of devices and software updates.

The United States FDA may initiate a “recall” when a device manufacturer takes a correction or removal action to address a problem with a medical device that is deemed hazardous or violates FDA law. Recalls most often occur when a medical device is defective, or poses health risks.

With medical devices, a recall usually does not mean that you can return the product to the company. In implanted devices, for example—knees, hips, shoulders, abdominal mesh—the situation is more complex and may involve implant replacements and revision surgeries. When an implanted device has the potential to fail unexpectedly, companies may recommend that patients remove the device.

Recalls can lead to the following types of actions:

  • Inspecting the device for problems
  • Repairing the device
  • Adjusting settings on the device
  • Re-labeling the device
  • Destroying the device
  • Notifying patients of a problem
  • Monitoring patients for health issues

Many of the medical devices on the market may be inadequately tested, and victims and attorneys have the right to file claims against negligent companies. When a company injures patients with defective medical devices, lawsuits may be necessary to restore financial losses and other damages incurred.

Joe Lyon is a highly-rated Ohio medical device lawyer who has successfully represented individuals throughout the country in complex product liability litigation. The Lyon Firm works with medical specialists and engineers to determine the root cause of medical device failures. 

Types of Medical Device Recalls

Recalls are classified into three categories by the FDA to indicate the relative degree of hazard presented by the medical device. The classes are described as such:

  • Class I—there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.
  • Class II—the use of the device may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences is remote.
  • Class III—the use of the medical device is not likely to cause adverse health consequences.

Types of medical devices recalled in the last few years include:

Complications Caused by Recalled Medical Devices

The FDA maintains a database that records thousands of adverse event reports associated with medical devices. Some patients may face greater health risks than others, though device implants almost always carry some level of complication risk. Common injuries and complications of defective medical devices include:

  • Severe Infection
  • Revision Surgery
  • Chronic Pain
  • Bone Fracture
  • Metallosis
  • Allergic reaction
  • Nerve Damage
  • Formation of cysts or pseudo-tumors
  • Perforation of organs
  • Device Migration
  • Erosion of material
  • Auto Immune Disorders
  • Unwanted Pregnancies
  • Wrongful Death

FDA Device Recalls

Although the U.S. Food and Drug Administration (FDA) is charged with ensuring medical devices are properly tested, device recalls have shown that defects are increasingly common. Medical Device manufacturers have been successful in their lobby to relax FDA approval provisions, and many devices are released without proper testing.

Due to loopholes in the FDA approval process for new medical devices, each year dozens of defective medical products injure American patients. As a victim, you may take legal action, hire a Cleveland medical device lawyer, and force medical device companies to claim responsibility and compensate for any injury caused. It is critical to make a product liability claim in a timely manner, because the Statutes of Limitations for injured clients can affect your case.

  1. Safety Alert—this is a more serious recall which requires the responsible company to issue a notification to device users if its use poses a risk of substantial harm. If the use of the device causes probable adverse health consequences or death, a safety alert is issued.
  2. Device Enhancement—device enhancements are meant to improve the performance or quality of a device. An enhancement is not necessarily intended to remedy a violation or defect, however, the FDA may closely monitor the reasons for the change.
  3. Inappropriate Labeling—quite often a medical device will be produced with labels that are considered false or misleading. If it fails to display adequate directions for proper use, the device could be recalled for inappropriate labeling.
  4. Non-compliance with FDA Regulations—if a manufacturer or distributor fails to comply with FDA law, and if an incorrect move is taken toward correcting or removing a marketed device, a recall is likely.
  5. Failure to Meet Specifications—misrepresentation of a medical device is considered a crime. If a device fails to meet a represented specification or doesn’t perform as represented and lacks qualities it is said to possess, this constitutes a recall.
  6. Correction—Corrections are actions taken by a company producing and marketing medical devices to deal with a dangerous product without physically removing the device. This may include modification, repair, relabeling, adjustment or inspection (including patient monitoring).
  7. Market Withdrawal—Withdrawals, in most cases, involve no FDA violation, but the device is withdrawn for repair, equipment adjustments and normal stock rotation.
  8. Routine Servicing—this may include replacing parts at the culmination of their normal life expectancy. Manufacturers and distributors may need to execute calibration, replace batteries, and respond to normal wear of a product.
  9. Stock Recovery—Recoveries usually involve correcting and removing any device that is yet to be marketed or one that is still under the direct control of the manufacturer. A device could still be found on the manufacturer’s premises without having been released or among units involved in a removal or corrective action.

Medical Device Malfunction

The majority of the recalls—over 90 percent—were due to manufacturing defects. With the device recalls also come related adverse events and injuries associated with defective devices. Several devices on the market can be high risk if they malfunction, and it is estimated that only a few percent of all adverse events get reported.

A Medical Device Safety Action Plan from the U.S. Food and Drug Administration (FDA) aims to reduce the requirements to report adverse events, which would potentially put more pressure on device manufacturers and create a safer medical environment. The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health describes how the safety agency will improve safety, better detect safety risks, and keep doctors and patients better informed. The goals include:

  • Establishing a more robust medical device patient safety net
  • Exploring regulatory options to streamline and modernize timely implementation of post-market mitigations
  • Spurring innovation toward safer medical devices
  • Advancing medical device cybersecurity

Medical Device Recalls Lawsuits

Due to safety pitfalls in the FDA approval process for new medical devices, many defective products injure American consumers each year. As a result, injured patients and experienced product liability attorneys are forcing medical device companies to claim responsibility and compensate the many victims.

Modern medicine can save lives, and new technology has the potential to improve the quality of life for millions of patients with various conditions. However, when medical device manufacturers design, produce and distribute dangerous and defective products, they may be liable for serious and permanent injury caused by a product defect. Lawsuits and class action settlements throughout the country have demonstrated that medical device companies are responsible for injuries, and plaintiffs have been rightly compensated for pain and suffering, lost wages, medical expenses and other damages.

Surgeons and patients rely on the expert and ethical manufacturing of medical device products. But perhaps the medical community needs to take a closer look at the risk-reward ratio between common medical devices and the possible complications that are known with certain products.

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ABOUT THE LYON FIRM

Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

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Medical Device Litigation
Why are these cases important?

Many medical device recall cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove faulty devices and change designs and warnings as a result of litigation.

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Questions about Medical Device Litigation

Who is liable for medical device injuries?

Medical device lawsuits often contain causes of action for strict liability, negligence, and breach of warranty. Strict liability applies to different factors than negligence-based claims.

In negligence cases, the actions of the defendant are the focus. In strict liability claims, the focus is on the condition of a product at the time it left the manufacturer. If a product is determined to be defective, the company is liable for any foreseeable injuries that are in-part caused by the defective condition of the product.

How is a Medical Device Defined as Defective?
Ohio Definition of Defective

A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:

(1)  Manufacturing/ Construction Defect:

These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).

As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.

(2) Defective design and/or formulation:

Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.

Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)

(3) Failure to warn or inadequate warning or instruction associated with the product:

All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.

Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.

(4) Misrepresentation:

The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.

The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.

why do medical devices fail?

The most common reasons are a lack of quality control, poor design, poor materials and poor safety check procedures. 

How do you prove design defects?

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a product:  (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation.

BenefitsThe following factors are considered under Ohio law when determining the benefits associated with product design: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c)

Defenses for Defective Design(1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).

EXAMPLES:

what is a device malfunction?

A malfunction is when a medical device fails to perform as intended or to meet specifications. 

What is a manufacturing defect?
  • A manufacturing defect is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.

    Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design.

    The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care.  Ohio Revised Code 2307.74.


    Manufacturing Defect Examples:

What is a failure to warn lawsuit?

In determining whether a product is defective due to inadequate warning or instruction, evidence must be presented to prove:

  • The manufacturer knew, or in the exercise of reasonable care, should have known about a risk
  • A reasonable manufacturer would have provided a warning of the risk
  • The manufacturer failed to provide the warning
  • The person was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.

Defenses to Failure to Warn Claims(1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).

Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.


 

Consumer Safety Lawsuits
Watch our Video About the Legal Process

Defective medical devices on the market present safety and health hazards for adults and children. Cheap and defective products may pose severe health risks. The manufacturers of medical devices have a duty to foresee potential injury and properly design and test products before they are released.

Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in illness and injury can lead to lawsuits filed by plaintiffs and a product liability lawyer.

medical device recalls

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