STRYKER SHOULDER IMPLANT DEFECT


Ohio product liability attorney investigates defective shoulder implants for injured plaintiffs nationwide
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In December, 2016, Stryker Corporation officials sent a warning notice to orthopedic surgeons using the ReUnion TSA shoulder replacement system. According to the warning, Stryker acknowledged the device may fail during surgery. Shoulder replacement system failures may compromise the implant’s effectiveness and the patient’s health.

Stryker stated the reason for recall was that the Reunion TSA Peg Alignment Sound may break during surgery. The Peg Alignment Sound is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA prior to final implantation.

In response, the U.S. Food and Drug Administration (FDA) issued a January, 2017 recall notice for the Reunion TSA Peg Alignment Sound device. The device is manufactured by Howmedica Osteonics Corp., a subsidiary of Stryker Corporation.

This is a Class 2 recall, which the FDA issues when a product may cause “temporary or medically reversible adverse health consequences.” A Class 2 recall is the second-most serious recall classification measured by the FDA.

Anybody with a Stryker ReUnion Total Shoulder Arthroplasty (TSA) System should contact their doctor if there are symptoms of failure. Defective implant issues may require extensive and painful revision surgery.

Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio medical device lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.  


Stryker’s ReUnion TSA Device


This is not the first recall for the ReUnion replacement device. In 2007, Stryker recalled its shoulder prosthesis, the ReUnion Fracture Stem Humeral Component, because the plasma spray component was known to delaminate from the proximal portion of the humeral stem. Again in 2015, Stryker recalled the ReUnion model.

Stryker’s ReUnion Total Shoulder Arthroplasty (TSA) System was designed to address common arthritic disorders affecting the shoulder as well as various fractures of the proximal humerus.

In most cases involving both the humeral head and the glenoid, a total shoulder arthroplasty may be performed. However, occasional complications and post-operative issues may harm a patient’s quality of life, in contrast to the original intention to improve issues with movement and discomfort.


Complications of Shoulder Implants


The U.S. Food and Drug Administration (FDA) has warned in the past that certain patients with defective implants may experience the following side effects:

•    Severe pain
•    Inflammation
•    Implant failure
•    Adverse tissue reactions
•    Joint instability
•    Infection
•    Nerve damage


Stryker Implant Recalls


Stryker is one of the largest orthopedic and device companies in the world. Stryker Corp. has around $9 billion in annual revenue. Its hip, knee, shoulder and bone products are used by millions worldwide. Unfortunately, thousands of patients have received recalled Stryker products. Some of Stryker’s recalls for medical devices include:

•    In recent years, the FDA warned Stryker that components of their Scorpio and Duracon knee implants were not conforming to manufacturing standards.
•    In July, 2012, Stryker Orthopaedics recalled the Rejuvenate and the ABG II modular-neck hip stems.
•    In 2013, Stryker recalled the Accolade modular system. In 2014, the company settled thousands of lawsuits for over $1 billion.


Stryker Forearm Implant Devices Recalled


Five additional medical devices manufactured by Stryker Howmedica Osteonics—the same company which produced the TSA system implants—were recalled in June, 2016. The five Stryker implant devices recalled include the following:

•    Recon radial implant
•    rHead lateral stem
•    Sigmoid Notch radial plate
•    uHead ulnar implant
•    Radio-Capitellum


According to the U.S. Food and Drug Administration Stryker recalled nearly 17,000 arm implant devices in August, 2015 because their packaging could have been compromised during transportation


Failing Stryker Shoulder Implant Devices


Patients who have received a Stryker Total Shoulder Arthroplasty system should consult with their implanting surgeon, especially if they experience uncommon pain, or other post-operative complications.

The FDA approval process for new medical devices has long been too lenient. As a result, many of Stryker’s products like TSA shoulder systems allegedly injure American consumers. Injured patients and experienced attorneys are forcing large medical device companies like Stryker to claim responsibility for the damaging products they continue to market and distribute.

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Questions about Defective Medical Device Litigation

What is a Defective Medical Device Lawsuit?

When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.

How is a Product 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.

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 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.


 

What are consumer product safety regulations?

Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.

Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:

  • The Food and Drug Administration (FDA)
  • The National Highway Traffic Safety Administration (NHTSA;)
  • The Consumer Product Safety Commission (CPSC)

The listed government agencies, however, 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.

Why should I hire The Lyon Firm?

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 Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device 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 personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world

FAULTY MEDICAL DEVICES

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The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law. 

IN RE: DEPUY ASR

METAL ON METAL HIP IMPLANTS

Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.

IN RE: BIOMET MSA MAGNUM

METAL ON METAL HIP IMPLANTS

Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.

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