DePuy ASR


Ohio Medical Device Lawyer investigates defective hip implant systems for injured plaintiffs nationwide
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The U.S. Food and Drug Administration (FDA) has recalled several hip replacement products manufactured by Johnson & Johnson’s DePuy Orthopedics over the last 15 years. The DePuy recalls cover a variety of products, including the ASR , were recalled due to alleged faulty performance that lead to hundreds of revision surgeries for patients.

Over four million Americans have had a hip implant surgery, typically when diagnosed with serious hip osteoarthritis. Hip replacement systems are an effective way to increase the quality of life in many patients. However, thousands of recipients of defective devices have been injured, and deserve compensation for their pain and suffering.

Medical device companies have a duty to ensure their products are safe to protect consumers. This is not always the case with thousands of revision surgeries performed each year due to faulty hip implants.

Joe Lyon is a highly-rated Ohio product liability lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims, including the Depuy hip lawsuit.  


DePuy Recalls ASR Hip


In 2010, DePuy recalled a component for the ASR Hip System, intended to provide increased patient mobility and reduced pain. The company recalled the product because of continual patient complaints.

DePuy recalled the ASR Hip Resurfacing System and ASR XL Acetabular System after studies surfaced concluding the Depuy ASR hip implants had high failure rates. Plaintiffs and medical device attorneys have alleged that DePuy delayed the recall, and knew of the product’s limitations long before.

Depuy eventually recalled the hip implants after hundreds of complaints and injury reports. The FDA received many reports of hip implant complications and investigated the matter. As early as 2007, surgeons and medical experts warned DePuy that its hip implant products were failing at a very high rate.

Tens of thousands of patients have been implanted with the Depuy ASR hip replacement system.

The litigation surrounding Depuy hip replacement products, and other metal-on-metal hip implants stems from a medical device design that is allegedly prone to failure. Statistics from the National Joint Registry of England and Wales showed 13 percent of hip implant patients who received Depuy Acetabular implants needed revision surgery within five years, far shorter than the average rate of 15 years for other alternative implants.

In recall statements, DePuy said that it would cover the medical costs related to their hip products, including revision surgeries. However, these claims are complex for each consumer and there may be a necessity to contact a product liability lawyer.

The Lyon Firm is experienced in engaging medical device companies following device injury and failure. Compensation is likely and settlements can help pay for medical costs and other damages.


Depuy Hip Complications


Metal-on-metal hip replacements, including the Depuy ASR model, have been linked to serious complications. When metal hip components rub against one another after implantation, they may release metal fragments that can lead to metallosis toxicity. The DePuy ASR hip implants have been recalled, and are subject of thousands of lawsuits.

A patient implanted with a DePuy metal-on-metal hip replacement can have up to 100 times the normal levels of chromium and cobalt in their bloodstream. DePuy patients may also experience infection of the tissue, as well as an allergic reaction. Excessive levels of metals in the blood have been linked to heart, kidney, and liver damage.


DePuy Hip Recall Lawsuit


Metal on metal hip replacement systems have been an area of concern among medical experts and consumer safety attorneys nationwide for many years. Thousands of injuries have been reported, and the products are still on the market for the most part.

The accelerated wear may cause metal debris to shave off and become embedded in the soft tissue within the hip joint. Many defective hip implants have required revision surgery, a good basis for personal injury and product liability lawsuits.

DePuy leads the top six medical device manufacturers of joint implants with over 270 recalls since 2003. Of these recalls, up to 477 different devices or components were recalled.

Four of the recalls were classified as a Class I recall, deemed dangerous enough that that could seriously harm patients. DePuy has recalled components and devices for the following reasons:

•    Possible Fracturing—implant components may crack or fracture during normal activities. These require a need for a revision procedure.
•    Sizing Issues—screw sizes that came with the implant did not match the size of the other components.
•    Mislabeled Components—implanted femur components may have been incorrectly labeled Left or Right.
•    Metal Debris—implanted anchors may have had metal debris inside, causing potentially dangerous complications.
•    Assembly Difficulties—Device defects made it difficult for surgeons to seat the polyethylene insert, acting like cartilage for the implant.
•    Incomplete Seal—incomplete seal may result in loosening of an implant, requiring revision surgery.


Defective Hip Injury


Lawsuits have been filed against DePuy in relation to the premature failing of hip implants, and a potential lack of safety oversight by the medical device company. When complications arise, and hip implants fail, revision surgery is common and often very painful.

Revision surgery can be more complicated than the original implanting surgery because of scar tissue build-up, bone or tissue damage, or resulting infection. Revision surgeries raise the risk of further complications for patients. Other patient issues common for recipients of defective hip devices include the following:

•    Persistent pain
•    Bone Loss or fracture
•    Infection
•    Decreased range of motion
•    Tissue Damage
•    Nerve Damage
•    Metallosis
•    Revision Surgery


DePuy Pinnacle Lawsuits


In 2019, Johnson & Johnson agreed to pay around $1 billion to resolve the majority of pending metal-on-metal Depuy hip lawsuits. Plaintiffs and victims claimed the company sold a defective product, and may have been aware of the health risks their products presented.

With the agreement, J&J settled hip implant defect cases in which surgeons has to remove or replace Depuy Pinnacle devices due to chronic pain, infection, tissue damage or metallosis.

The total Depuy hip settlement includes an earlier amount of $400 million. However, there are still thousands of other hip implant lawsuits, filed by patients who suffered injuries or required revision surgery.

The FDA recalled metal-on-metal DePuy hip implants in 2010 due to device failures, metallosis, inflammation, infection, pain, and the need for revision surgery. In 2012 DePuy stopped selling Pinnacle hip implants with a defective metal component.

J&J pulled Pinnacle’s metal-on-metal version after the U.S. Food and Drug Administration strengthened regulations covering such devices.

Product liability and personal injury lawsuits have been filed against Johnson & Johnson in relation to failing Depuy Pinnacle hip implants. Plaintiffs have alleged a potential lack of safety oversight and clinical testing by the company.

Johnson & Johnson announced the massive settlement a month after the company agreed to pay $120 million in deceptive marketing claims about Depuy hips implant durability. The company claimed said over 99 percent of the metal-on-metal hips would last three years. European health regulators, in an independent study said the actual rate was about 7 percent.

In a U.S. Securities and Exchange Commission report, before the prior settlements, J&J noted the company still faced a total of 10,500 Depuy Pinnacle lawsuits. The company didn’t specify how much it had already spent litigation costs. Further legal action is likely for injured plaintiffs.


Defective Hip Settlements


According to court documents, DePuy was aware that its hip implants had safety issues before the official recall. Failure rates in some reported studies were almost 40 percent. But DePuy repeatedly touted the new technology, and sold the products to the public.

Finally, in March 2010, after legal pressure began to mount and investigations questioned the safety of metal-on-metal hip implants, Johnson & Johnson acknowledged that ASR products had an unacceptable failure rate.

If you or a loved one has been implanted with a defective DePuy ASR hip product since 2003, you may be eligible to receive compensation for the following:

  • Medical costs related to revision surgery
  • Medical costs related to a new hip replacement
  • Costs associated with lost wages, recovery, rehab, or physical therapy
  • Compensation for the loss of a job, or loss of future wages
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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

Your Right to Safety

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Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products 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 accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer

Our Victories

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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