METAL ON METAL HIP IMPLANTS


Ohio product liability attorney and Dayton Medical Device Lawyer investigates defective medical products for injured plaintiffs nationwide
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Hip replacement surgeries are intended to relieve chronic pain and increase range of movement by fixing or replacing damaged bone or cartilage in the hip joint. Originally hip implants were made of ceramic or a hard plastic. These devices had a large degree of success and are still used as replacements.

Metal-on-metal hip implants emerged in the mid-1990s as the next generation of hip replacement technology. Indeed, thousands of individuals have led happier lives with reduced pain and suffering due to the work of these medical device companies.

Unfortunately, thousands of other individuals have had their conditions made worse by the technology that was designed to fix their problems, which has led to dozens of recalls on numerous models of hip implant and billions of dollars in settlement claims on behalf of patients.

Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio product liability attorney with a broad range of experience on Medical Device Injury, product liability, and class action claims.


Hip Implant Failure


Hip implants are categorized under the FDA 510K approval process, which is significantly less rigorous than other FDA approval processes. The 510K process allows companies to submit new products without submitting safety and efficacy testing data as long as they can prove that their product is significantly similar to a product already on the market.

This system saves medical device companies money and get products to market more quickly, which has made it the predominant system for medical device approvals.

Unfortunately, once a product is on the market it often takes numerous cases of device failure or severe side effects for companies to address the issues or recall their product.

This is certainly the case for metal-on-metal hip implants. Traditional hip implants had relatively low failure rates, often between 3%-5%. By comparison, some of the more notorious metal-on-metal implants, like the DePuy ASR fail in up to 49% of patients after 6 years according to the British Hip Society.

The British Medical Journal published an article in 2012 that explained that the metal-on-metal failure epidemic was not a small or unforeseen issue. They blamed the process for approving medical devices as “[unable] to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally”

After seven years, average failure rates are 11.8% for resurfacing and 13.6% for metal-on-metal total hip replacement, although failure rates vary with the brand used. Failure rates for hip implants made of other materials ranges from 3.3%-4.9%. Metal-on-metal devices have been implanted into over a million patients in the US.

Cobalt-chromium implants have been found to release metal ions, which can get into local tissue causing harmful reactions that destroy muscle and bone. These reactions leave some patients with long term disabilities– a condition known as metallosis. The ions can also get into the bloodstream spreading to the lymph nodes, spleen, liver, and kidneys before being excreted in urine.


Metallosis Toxicity


There are a number of risks associated with metal-on-metal hip implants. Patients have reported various problems years after their initial surgery. Progressive pain is common, as is the issue of metallosis. The BHR implant, for example, is made of cobalt and chromium, and the levels of these metals in the blood can become dangerously elevated.

Metal-on-metal resurfacing releases large amounts of very small particles and metal ions. The long-term biological consequences of the exposure to Co-Cr particles and ions remain largely unknown, but there may be a toxic reaction to an excess of metal debris or a hypersensitivity reaction to a normal amount of metal debris.

Other patients who receive metal-on-metal resurfacing present with various symptoms and soft-tissue masses or pseudo-tumors. It is estimated that approximately 1 percent of patients who have a metal-on-metal resurfacing develop a pseudo-tumor within five years.


Metal-on-Metal Hip Injury


Metal-on-metal hip implants were developed to be more durable than traditional implants. Hip resurfacing techniques were introduced in the 1970s with the aim of minimizing the risk of dislocation, but the method was discarded after showing a high rate of failure. Results have improved over the years, however, there are still a number of reports of serious complications with this type of implant.

In a recent lawsuit, a Texas jury ordered Johnson & Johnson, and its DePuy subsidiary, to pay about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants. Lawyers argued that the Pinnacle hips were defectively designed, and that the companies failed to warn the public about their risks.


Hip Implant Recalls


Due to the consistency and severity of complaints to the FDA regarding metal-on-metal implants, the FDA required five producers of all-metal implants to conduct intensive long-term studies on the effects of their implants. The U.S. does not maintain an orthopedic registry that follows patient outcomes, unlike countries such as Britain and Australia.

The lack of available data on outcomes puts responsibility on patients and lawyers, to litigate against medical device companies in order to force recalls.
Companies who have issued recalls include:

•    DePuy
•    Smith & Nephew
•    Stryker
•    Zimmer-Biomet


Recalled Models:

•    Biomet M2a Magnum
•    DePuy ASR XL
•    Depuy Pinnacle
•    Smith & Nephew Birmingham System (BHR)
•    Wright Hip Implants
•    Stryker Accolade 2
•    Stryker Citation
•    Stryker LFIT V40
•    Stryker Meridian
•    Stryker ABG Rejuvenate
•    Stryker Trident Hemispherical Cup System
•    Zimmer M/L Stem Kinectiv Hip


Symptoms of a Failed Hip Replacement


Hip implants are an increasingly popular means of improving a quality of life for many aging individuals. However, joint replacements, particularly metal-on-metal hip implants, can be defective and cause more harm in patients than good. Metal-on-metal hip implants are manufactured and marketed to relieve the pain and immobility associated with bad hips.

The U.S Food and Drug Administration (FDA) urges patients who receive metal-on-metal hip implants to pay close attention to changes in their general health including new or worsening symptoms outside their hip. The signs of a failing hip replacement are potentially dangerous if left untreated. Some of the warning signs include:

•    Severe joint pain
•    Bone fracture around the implant
•    Inability to walk
•    Implant failure, dislocation or loosening
•    Dead tissue/bones around the implant
•    Infection
•    Formation of cysts or pseudo-tumors
•    Metallosis
•    Allergic reaction to metallic debris
•    Cobalt or chromium poisoning
•    Nerve damage
•    Rashes


Risk of Metallosis


In addition, metal particles from implants may cause certain adverse reaction. A 2012 study published in the British Medical Journal warned that the metal-on-metal components of hip replacements could rub against each other and result in metal particles released into the surrounding tissue and blood stream.

The particles could cause metal alkalosis (metallosis).  It was not until after the release of this study that the Stryker recall of the Rejuvenate and ABG II systems occurred, citing the need to study the risks of their own products.


Stryker Recall Litigation


More than 20,000 Rejuvenate and ABG II implants were sold before a Stryker recall was issued in July 2012, when it was determined that the modular neck stem components pose a substantial risk of fretting, corroding, and ultimately failing.

In September, 2016, the Australian Therapeutic Goods Administration warned in a hazard alert that the modular components used in Stryker’s Accolade hip replacements have higher-than-expected rates of failures. It has been identified that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have high incidences of taper lock failures.

Australian health officials have identified seven models using the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm, which may cause issues for patients. An entire line of Stryker’s products with similar specifications has also been included in the hazard alert. The affected Stryker femoral heads are used in various models.

Stryker has settled thousands of cases, however, problems continue to surface. Patients are encouraged to seek possible medical and legal representation.


DePuy ASR XL Litigation


In response to numerous complaints from orthopedic surgeons and patients, as well as  new clinical data showing an increased rate of revision surgery associated with DePuy ASR XL Acetabular hip implant systems, DePuy Orthopedics voluntarily recalled all of its ASR XL Acetabular hip replacement devices, as announced by the company in August 2010.

According to Dr. Joshua J. Jacobs from the Rush University Medical Center, “Most major medical centers have seen issues with this device. [The Depuy recall] does not come as a surprise.”

Since the Depuy ASR recall, other metal on metal hip implants by a variety of manufactures have been implicated in lawsuits due to the defective design, failure to warn, and breach of warranties. Patients at the highest risk are female recipients and those who received ASR head sizes below 50 mm in diameter.

Johnson & Johnson, the parent company for DePuy, officially announced a $4B settlement in the ASR case, which amounted to an average plaintiff settlement of $300,000.


Wright Hip Implants


Recipients of hip implant replacement systems like the Wright Profemur, Wright Dynasty and Wright Lineage models hope to reform their physical health and improve their quality of life.

However, when Wright hip implants allegedly cause injuries like metallosis, infection, tissue and nerve damage and requires painful revision surgery, plaintiffs can contact an experienced medical device lawyer and file product liability lawsuits.

The Lyon Firm takes medical device injury claims seriously and has had success engaging large medical device companies in implant defect claims to recover settlements and compensation to help pay for medical costs, pain and suffering, lost wages, future medical expenses and other damages.

We work with industry experts to hold negligent device companies accountable for defective hip products and to ensure that the consumer is protected in the future.

The Wright Medical Conserve Hip Resurfacing System is a metal-on-metal (cobalt-chromium alloy) hip replacement device, that has concerned safety experts for years. Metal on Metal hip implants can present health issues that other hip systems do not, including the risk of metal poisoning, or metallosis in patients.

The Wright Medical Lineage hip and Wright Dynasty hip replacement devices are also available in metal on metal versions, though not exclusively and they can present their own safety issues.

Implanting surgeons and patients have reported the need for revision surgery after infection, device loosening, fracture, implant ineffectiveness, tissue and nerve damage, and chronic pain. Revision surgeries carry an added risk to patients, and can cause additional long-term pain.

The Lyon Firm feels strongly that taking legal action against medical device companies that market and distribute unsafe and defective products improves the lives of consumers and discourages bad corporate practices. Wright Medical has faced numerous lawsuits regarding a hip implant that has allegedly caused injury and required revision surgery.


Wright Medical Lawsuits


In 2015,  a recall was issued for the Profemur modular neck devices manufactured from June 15, 2009 to July 22, 2015. Because MicroPort Orthopedics, Inc. did not acquire Wright Medical Group’s OrthoRecon business until 2013, some of these recalled devices were manufactured by Wright, and they faced legal consequences.

The Profemur complications included fracture, fretting, implant loosening, metallosis and pain, all reported to the FDA’s adverse event database by doctors and patients.

In 2013, Wright medical sold its hip and knee manufacturing division for $290 million, which coincided with reported health problems linked to metal-on-metal hip implants like the Conserve, Dynasty and Profemur hips. Plaintiffs have alleged that Wright hip implant defects occur more frequently than other hip implant systems, and cite certain studies and injury reports.

A 2016 study found high, sooner-than-expected failure rates among 108 Wright Conserve metal-on-metal hips. The hips were implanted in 98 patients – some patients having both hips replaced. Usually, only 1 in 10 hip implants will fail within 15 years of being implanted. But the Conserve hips in the study failed in larger numbers and sooner.

While soreness is to be expected for a few weeks after implantation of the Lineage, Dynasty, Profemur or Conserve, chronic discomfort can be a result of Wright hip implant defects.


Smith & Nephew Hip Recall


In 2015, Smith & Nephew issued a field safety notice which warned consumers of current risks associated with their metal-on-metal hip resurfacing products. Patients have reported serious problems that include infections, fractures, dislocations, metallosis, and pseudo-tumors in the hips.

The company started selling their hip implants in the United States in 2009, many of which were recalled within the next three years after experiencing a higher-than-normal rate of revision surgery.

In the 2012 recall, Smith & Nephew said the metal liner of the replacement hip was “not performing as well” as the company expected, and stated it may lead to premature failure and potential health issues. Smith & Nephew’s chief medical officer said the company was “not satisfied with the clinical results of this component.”

The decision to withdraw a component of its metal-on-metal artificial hip system, followed a high percentage of patient problems. Clinical results showed that 1.6 percent of patients with the system needed revision surgery each year, almost double the safety guideline set by Britain’s National Institute for Health and Clinical Excellence.

Smith & Nephew is a British multinational corporation that develops metal-on-metal hip implants, and other medical equipment. The company manufactures and sells a variety of hip replacement and resurfacing products, some of which have been recalled, injured patients and stimulated lawsuits in the U.S.

In 2012, the U.S. Securities and Exchange Commission (SEC) investigated Smith & Nephew for allegedly paying doctors employed by foreign governments to use the company’s equipment instead of competitors’ products.

In a settlement, Smith & Nephew paid $22 million in fines. In 2012, a New York woman filed a hip implant defect product liability lawsuit against Smith & Nephew. Her attorneys claimed she had suffered instability consistent with anterior dislocation and severe pain, requiring emergency care.

Current personal injury and product liability lawsuits and settlements can compensate victims implanted with defective Smith and Nephew, Zimmer Biomet and Stryker systems. 

Contact a hip implant defect lawyer if you have been implanted with a defective product. Smith & Nephew has said patients who experience symptoms including pseudo-tumors, tissue masses, fluid collections, pain and swelling, buildup of excessive metal particles or metal hypersensitivity, may require revision surgery.


Metal on Metal Hip Risks


If a patient is fitted with a Birmingham Hip Replacement (BHR) System, or metal liners for its R3 acetabular system, the patient is at a risk of needing revision surgery. Those at greater risk of requiring a revision surgery:

•    Females
•    Males aged 65 or greater
•    Patients requiring an implant head size <48mm


Hip Implant Defect Lawsuits


Many defective devices are approved by the U.S. Food and Drug Administration (FDA) each year because the safety agency does not always require studies and clinical trials if the hip replacement is deemed similar to an already existing device. This process hastens the sales process and results in recalled faulty products and preventable injuries for hip implant patients.

Attorneys and victims taking legal action to medical device companies force manufacturers to take responsibility for any defective products they produce and distribute.

If you are experiencing persistent pain, a loss of mobility, inflammation, or instability, you should contact your implanting surgeon and an experienced defective hip replacement lawyer. You may have a claim against the device manufacturer.

The Lyon Firm is taking cases involving hip implants manufactured by Wright Medical, Smith and Nephew, Depuy, Zimmer Biomet and Stryker. Medical device litigation is critical in not only reaching settlements for plaintiffs but for improving consumer safety for America in the future.

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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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