EXACTECH RECALL

• OPTETRAK® All-polyethylene PS Tibial Components
• OPTETRAK® CR Tibial Inserts
• OPTETRAK® CR Slope Tibial Inserts
• OPTETRAK® PS Tibial Inserts
• OPTETRAK® HI-FLEX® PS Tibial Inserts
• OPTETRAK Logic®
• OPTETRAK Logic® CR Slope Tibial Inserts
• OPTETRAK Logic® CRC Tibial Inserts
• OPTETRAK Logic® PS Tibial Inserts
• OPTETRAK Logic® PSC Tibial Inserts
• OPTETRAK Logic® CC Tibial Inserts
• TRULIANT® CR Slope Tibial Inserts
• TRULIANT® CRC Tibial Inserts
• TRULIANT® PS Tibial Inserts
• TRULIANT® PSC Tibial Inserts
• VANTAGE® VANTAGE® Fixed-Bearing Liner

After extensive testing, the company confirmed that most inserts manufactured since 2004 were packaged in out-of-specification vacuum bags that are oxygen resistant but do not contain a critical secondary barrier layer that further augments oxygen resistance.

The use of these non-conforming bags may enable increased oxygen diffusion to the insert, resulting in increased oxidation of the material relative to inserts packaged with an additional oxygen barrier. Oxidation can severely degrade the mechanical properties of the device and can lead to accelerated wear debris production, bone loss, and component fracture, all leading to revision surgery.

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

Experience: Joe Lyon is an experienced Defective Medical Device Lawyer. The Lyon Firm has 20 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device and recall lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results: Mr. Lyon has obtained numerous seven and six figure results in medical device cases. He has litigated cases successfully against some of  the largest companies in the world including: Johnson & Johnson, Biomet, Ethicon, Stryker, Coloplast, Smith & Nephew, American Medical Systems, Boston Scientific, Medtronic, Guidant, Bard, & Bayer. 

A medical device is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of medical device product defects. Most jurisdictions have a version of one or more of these cause of actions:

(1)  Manufacturing/ Construction Defect of the medical device:

(2) Defective design and/or formulation of the medical device:

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

(4) Misrepresentation on the Safety or Efficacy of the Medical Device:

(5) Fraud Related to the Safety or Efficacy of the Medical Device

(6) Negligent Distribution or Testing of the Medical Device

• Hernia Mesh
• Breast Implants
• Transvaginal Mesh Implants
• Catheters
• Hip Replacements
• Knee Implants
• Ankle Replacements
• Shoulder Replacements
• Heater Coolers
• Bone Grafts
• Ventilators
• Defibrillators
• IUD
• IVC Filters
• Da Vinci Robot Surgery System
  

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Medical Device Manufacturers

• Atrium Hernia Mesh
• Bard Hernia Mesh
• Bard IVC Filters
• Covidien Hernia Mesh
• Depuy Hip Implants
• Arthrex knee replacement
• Exactech knee replacement
• Exactech ankle replacement
• CareFusion ventilators
• Essure Birth Control System
• Ethicon hernia mesh
• Infuse Bone Grafts
• LivaNova Heater-Coolers
• Stryker Hip Implants
• Smith & Nephew Hip Systems
• Zimmer Biomet Shoulder Systems
• Wright Medical Hip Implants

Defective design medical device 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 (e.g. the metal on metal design, the porosity and stiffness of transvaginal mesh).

For these claims, the FDA Review process is critical on whether a pre-emption defense exists.  For devices that went through the PMA (pre-market approval process), rather than the 510K process, the case must be evaluated very carefully for any parallel claims under state and federal regulations (e.g., failure to warn or failure to disclose adverse events) that can advance the case forward. Without a careful legal analysis, the case may be subject to dismissal even where the medical device design proves to be defective. 

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a medical device:  (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. These factors are considered in most other jurisdictions. 

Benefits: The following factors are considered under Ohio law when determining the benefits associated with a medical device: (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) These factors are considered in most other jurisdictions. 

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).

A manufacturing defect claim arises where the medical device is released from the factory in a manner that deviates from the intended design or specifications. 

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. In defective medical device cases, the manufacturing defect is often related to performance standards (e.g., the metal does not meet the strength specification or has microscopic fractures–these defects require an examination by a qualified metallurgist who can examine the medical device).

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 product liability law.

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.  

All medical device products come with warnings and instructions for use that are provided to the physician. If the company does not provide the physician with all the relevant safety data so that the physician adequately understand the risks and benefits of the product, then the medical device is defective. 

The physician must be in a position to pass the appropriate safety data onto the patient, so the patient can make an informed decision on whether they wish to have the medical device implanted.  Patient informed consent is critical because many devices are designed to be permanent.  

Litigation arises where there is evidence the medical device 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.

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

• The medical device manufacturer knew, or in the exercise of reasonable care, should have known about a risk
• A reasonable medical device manufacturer would have provided a warning of the risk
• The medical device manufacturer failed to provide the warning
• The patient 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.
  

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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”).

Design and manufacturing defects result in medical device product recalls each year in the United States, initiated by federal safety agencies.

• The Food and Drug Administration (FDA)
• The Consumer Product Safety Commission (CPSC)

The foregoing listed government agencies may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product. Only litigation can be utilized to compensate patients injured by a defective medical device.