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Articles Posted in Hip Implant Failure

Thousands of lawsuits have been filed against manufacturers of metal-on-metal hip implants, alleging that claimants suffered painful, debilitating complications from the devices. DePuy’s ASR and Pinnacle models are the focus of most lawsuits, with DePuy’s costs estimated at around $4 billion and growing. The cases involving the two models were recently consolidated into separate multidistrict litigation (MDL) cases. Thousands more remain in pending status. If you experienced severe pain or medical complications after receiving a metal-on-metal hip implant, contact a Boston injury lawyer today.

Complications Associated with Metal Hip Implants

Hip replacement surgery is one of the greatest medical innovations in decades. Millions of people have been able to improve their quality of life as a result. Unfortunately, as with all medical procedures and devices, hip implants come with risks. But some of these risks may be the result of defective design and failure to warn physicians and patients of associated complications. Risks include:

  • Blood clots
  • Metallosis
  • Infection
  • Bone fracture
  • Death

Metallosis

One of the main concerns with metal-on-metal hip implants is the debris that may be released into the body when metal components rub against one another. When this occurs, a condition called metallosis can result. This dangerous condition is caused by a buildup of metal debris in the body’s soft tissue. The effects of metallosis can be quite dangerous, resulting in death of the surrounding tissue and potential blood poisoning. If cobalt, titanium, or chromium ions are released into the bloodstream, toxicity, inflammation, and even cancer can result. Metallosis can also cause:

  • Failure of the implant
  • Joint pain
  • Tissue death
  • Bone deterioration
  • Blood poisoning
  • Toxicity
  • Formation of pseudotumors or cysts
  • The need for revision surgery.

Nearly 35 percent of retrieved hip implants have notable corrosion and other types of damage. Bone fractures, joint dislocations, improperly positioned components, infection, defective stem designs, and poor cementing techniques may contribute to the loosening of stem components and the need for a revision surgery. Unfortunately, revision surgery is a difficult, painful, and longer process than the initial hip replacement. Thigh and / or knee pain are usually the first indicators of a complication with a hip replacement. If you are experiencing any complications after receiving a hip replacement, contact your health care provider immediately.

DePuy Settlements Top $4 Billion

Plaintiffs in both MDL cases and pending cases allege that the medical devices had design defects and that DePuy knew about the risks but failed to adequately warn physicians and patients. In 2013, DePuy and its parent company Johnson & Johnson, agreed to a settlement in cases involving people injured by the manufacturer’s ASR models. At that time, the company set aside approximately $4 billion to settle the claims. Last year, the manufacturer agreed to an additional settlement of $420 million. If a defective or dangerous medical device has caused you harm, contact a MA defective medical device law firm today. Continue reading

Following a rash of serious medical complications allegedly caused by defective artificial hip implants, DePuy Orthopedics has been ordered to pay more than $1 billion. A federal jury in Dallas found the company, a subsidiary of Johnson & Johnson, negligent in its failure to adequately warn physicians and patients about the risks associated with their product’s defective design.

At least six patients had to undergo revision surgery to replace the defective implants with a properly-functioning implant and / or to repair damage to the tissue and bone. The Dallas jury awarded more than $30 million in damages to the six patients and more than $1 billion in punitive damages. The jury made the following ruling:

  • J&J and DePuy were negligent in their design of the implant
  • They failed to warn patients and doctors about known risks
  • They failed to recall the product when defects were discovered
  • They intentionally misrepresented the effectiveness of the product to both doctors and patients

If you have been harmed due to a DePuy hip implant, contact a Boston defective medical product attorney today.

Johnson & Johnson Appeals the Verdict

Following the verdict, Johnson & Johnson and DePuy announced that they will appeal the decision, denying any wrongdoing. “We have no greater responsibility than to the patients who use our products, and our goal is to create medical innovations that help people live more active and comfortable lives,” said DePuy spokeswoman Mindy Tinsley. “DePuy acted appropriately and responsibly in the design and testing of ULTAMET Metal-on-Metal, and the product is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain.”

Fourth Trial Scheduled for September 2017

This trial was the third bellwether trial for thousands of similar lawsuits. Earlier this year, a jury – also in Dallas – awarded more than $500 million in damages to a group who suffered medical complications from DePuy implants. However, the award was later reduced to $154 million. The companies are also appealing the reduced ruling in that case. The first trial, which took place in 2014, was decided in favor of J&J and DePuy. A fourth trial is on the horizon, scheduled for September 2017. If you have been injured due to a DePuy artificial hip implant, or any other type of defective medical product, contact a Boston injury attorney today.

Risks Associated with DePuy Hip Implants

Thousands of lawsuits have been filed against DePuy for medical complications arising from defective hip implants. The most commonly cited complications include:

  • Bone fractures – in many cases the bones surrounding the hip implant have weakened, resulting in fractures
  • Metallosis – this condition occurs when metal fragments release toxins into the body
  • Pseudotumors – the formation of tumor-like deposits have adhered to joints in some patients
  • Necrosis – the death of bone and tissue due to metallosis has been cited in multiple lawsuits
  • Revision surgery – due to defective implants, bone erosion, and tissue damage, thousands of patients have required revision surgery to replace implants and repair damage

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The Stryker Corporation, a multi-billion dollar medical technology and joint replacement manufacturer, is once again making headlines for all the wrong reasons, as their LFIT V40 CoCr Femoral Head is generating reports of catastrophic failures necessitating painful and expensive surgery for some patients who received the implant.  The LFIT V40 device is a hip implant that utilizes a metallic shaft, which attaches to the patient’s femur, leading up to the “head” of the device that attaches to a joint connected to the patient’s hip. The problematic area of the V40 device lies in the head, which has been reported to corrode over the course of its life and eventually weaken to the point where the head may slip out of the joint or snap off completely.

As the metal of the head corrodes, tiny metallic particles (which could be a combination of cobalt, nickel, chromium or titanium) may be released into the patient’s bloodstream, causing a type of blood poisoning known as “metallosis.” Advanced metallosis can result in complete bone and tissue death, leading to severe pain and other medical issues in the affected patient.

Symptoms of metallosis include:

As people age, their joints and bones become weaker after years of wear and tear pile up and compound on one another. Eventually, in many cases, people may need some of the more utilized joints – hips primarily – to be resurfaced or totally replaced when traditional physical therapy can no longer help with pain and soreness.  Medical technology is incredibly advanced in this nation, however, the practice of metal-on-metal hip replacements – replacing hips joints with metallic alloy structures made from a combination of cobalt, nickel, chromium and titanium – is complicated and can lead to severe adverse side effects on one’s health.

The FDA stresses that all hip replacements come with implicit risks, however metal-on-metal hip replacements carry a unique risk – metallosis. Metallosis is essentially blood poisoning that occurs in patients when the metal ball and socket rub against one another through daily use, releasing microscopic bits of metal into the blood stream that can lead to serious medical issues for some patients.  An FDA study from 2012 showed that of all patients that underwent hip replacement surgery with metal-on-metal implants, between 85 and 92% had no need for revision surgery, even seven years after receiving the implants. This shows that most of the time, there isn’t a real problem with hip replacements. But as with anything else, there are always unfortunate cases where things do go wrong.

Signs of metallosis

  • General hypersensitivity that results in skin rashes
  • Cardiomyopathy (heart problems)
  • Sensory changes such as with vision or hearing
  • Depression or other unusual cognitive changes
  • Kidney complications
  • Thyroid issues such as a throbbing, painful neck, weight gain, fatigue or feeling cold constantly

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As we age, it is normal that our bodies begin to deteriorate.  Common areas prone to deterioration are the joints, i.e. knees, hips, etc.  Wear and tear on these parts of the body can cause pain, stiffness, and difficulty walking.   Physicians typically prescribe conservative treatment such as physical therapy, exercise and medications, but often times, joint deterioration requires total replacement or resurfacing.  Hip replacements are one of the most common joint replacements.

There are several types of hip implants used in replacement surgery, five currently being available in the United States.  These are, Metal-on-Polyethylene, Ceramic-on-Polyethylene, Metal-on-Metal, Ceramic-on-Ceramic, and Ceramic-on-Metal.  All of these implants have different risks and benefits.  The same implant can also react differently depending on the patient.  The different types of implants refer to the different materials used to make the ball and sockets of the artificial hip.  In metal-on-metal hip implants, both the ball and the socket of the device are made from metal.  Some notable advantages of metal-on-metal hip implants are “bone conservation on the femoral side with possible lower dislocation rates”, better range-of-motion, more normal walking posture, increased activity, and “increased ease of insertion with proximal femoral deformities or retained hardware, and straightforward revision”.

However, there are many risks with these replacement surgeries.  Common adverse effects regardless of the type of implant are hip dislocation, bone fracture, joint infection, local nerve damage, device loosening or breakage, difference in leg lengths, and bone loss.  Even with these potential complications, data from an FDA study performed of patients from Australia and the U.K. shows that 95 percent of patients with any type of total hip replacement have not undergone revision surgery for at least seven years after their initial operation.  Specifically with metal-on-metal implants, over 85 percent of patients have not have a revision for at least seven years after the initial implant.  Interestingly, patients with larger heads, defined as 36mm or larger, had more revisions than those with smaller heads.

Although this is true for this study, there has recently been a massive recall for several different manufacturers of hip implants in the U.S.  Consumer’s Union found that from 2002 to 2013 hip implant recalls six major manufacturers, Biomet, DePuy, Smith & Nephew, Stryker, Wright and Zimmer.  However, these recalls came after the implants had already been used in hundreds of thousands of hip replacement surgeries.  In total, more than 500,000 patients in the United States received metal-on-metal hip implants after they were claimed to be more durable and provide a greater range of motion when compared to older forms of artificial implants.  However, it was later found that the manufacturers’ claims that the implants were more durable were false.  These metal hip replacements began failing rather quickly.  Common symptoms of hip replacement failure are regular and prolonged pain around the groin, hip, or leg, swelling near the hip joint, and difficulty walking.  The key reason these metal-on-metal hip replacements are failing is due to the friction caused by the normal movement of the device.  This friction releases microscopic shavings and metal debris into the tissue around the joint.  Consequently, this can cause metallosis, a build up of metal fragments in the soft tissues of the body, which causes painful and inflamed joints and a high blood-metal count.  Continue reading

Stryker, a company that makes artificial hip implants, has reached a settlement to resolve thousands of products liability lawsuits over the now-recalled medical devices. The deal is expected to cost the manufacturer approximately $1.43 billion.

The agreement covers patients who were implanted with the ABG II Modular-Neck or the Rejuvenate Modular-Neck and had to undergo another procedure to have the hip implant replaced. Both models were recalled in 2012 in the wake of growing patient complaints of corrosion and other problems.

According to the plaintiffs, Stryker sold the faulty implants, which deteriorated in their bodies and caused them illness, swelling, and pain. Their defective medical device lawsuits accused Stryker of negligence for failing to properly test the ABG II and Rejuvenate models before releasing them and not warning doctors and patients about the possible side effects and risks. Some of the devices loosened while in patients, while others released toxic metal into the bloodstream.

With a Monday, January 6, 2014 deadline looming for people looking to avail of a multibillion-dollar DePuy ASR settlement deadline, many of those who were forced to undergo revision surgery to replace their faulty hip implants are rushing to meet the deadline to register their claim. That said, there will be another filing date so even if you aren’t ready just yet, you should still speak with an experienced Boston hip implant defect law firm to find out whether you have grounds for a Massachusetts products liability case.

To qualify for this settlement, your revision surgery would need to have taken place by August 31, 2013. Each plaintiff is to get $250,000 plus additional compensation depending on what other costs and damages they incurred. (Reductions, however, will also be factored in if a patient had his/her device for longer than five years.)

According to The New York Times, Johnson & Johnson, of which DePuy is a subsidiary, has put aside over $2.5 billion for these hip implant cases alone. Some 8,000 patients in the US who had to have their all-metal artificial hip implants taken out and replaced are expected to qualify for this deal. That said, there are still thousands of other patients who were also impacted by these faulty Articular Surface Replacement devices and do not qualify.

When implanted medical devices cause injuries to a patient, are improperly labeled or defectively manufactured, or otherwise fail after being implanted, a device manufacturer or the Federal Drug Administration will initiate a recall. Too often though, these recalls come after there have been hundreds of complaints filed by injured patients.

medical-doctor-1314902-m.jpgMost recently, Stryker, a leading medical device manufacturing company that specializes in developing orthopedic, neurotechnology and spine products, has issued a voluntary recall of one of its knee replacement products ShapeMatch Cutting Guides.

What Are ShapeMatch Cutting Guides?

ShapeMatch Cutting Guides are single-use, disposable cutting guides that are intended to be used as surgical instrumentation to assist surgeons in positioning the Stryker Triathlon Knee System. This software is used to guide where surgeons will cut and shape a patient’s bone before implanting the replacement knee device.

About the Recall

In April of 2013, Stryker Orthopedics issued a Level 1 voluntary recall of the Shape Match Cutting Guides, after becoming aware of the potential issues with the software. It was found that the software did not meet surgeon’s pre-operative planning parameters, and some manual edits used in the software did not meet the standards of the FDA. The overall effects these discrepancies in the software resulted in improper cutting of bones, as well as many serious adverse health consequences for patients who had Stryker system knee replacements including poorly-fitting, loose knee implants, knee fractures, chronic pain, and the need for revision surgery.

Your Consumer Rights

Like all knee replacement device manufacturers, Stryker has a legal obligation to properly design, test, and ensure their products are working correctly. They also are responsible for warning the public of any problems with their products, no matter how minor.
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Lisa Lincoln has filed the first federal Stryker ABGII hip lawsuit in the U.S. District Court for the District of Massachusetts. Her complaint comes nearly one year after Stryker recalled its Rejuvenate Modular and ABG II hip implant parts because of possible risks, such as corrosion/fretting of/around the modular-neck stems.

In her hip injury lawsuit, Lincoln claims that her ABG II system implant caused her to develop a number of health issues, including metallosis, and she has been forced to undergo revision surgery. (High cobalt levels in her blood indicate that this condition was caused by the stem and metal neck rubbing together.) She also said that not even two years after she was implanted with the hip replacement parts, she was already experiencing chronic pain and developed a pseudo-tumor on the back of the acetubular cup.

Meantime, her doctors reportedly found fluid accumulation around her hip implant, which are signs of early failure and loosening. Lincoln is suing for products liability, alleging negligence and breach of express and implied warranties. Her husband is seeking damages for loss of consortium.

A California jury ruled on March 8, 2013 that DePuy Orthopaedics knowingly produced and marketed a defective hip replacement device known as the DePuy ASR™ Hip Resurfacing System. The basis of the verdict was that DePuy (a subsidiary of Johnson & Johnson) failed to warn consumers of the dangerous effects that the metal device may have on the body.

During the trial, experts stated that the grinding of the metal apparatus caused dangerous metal toxins to be released into the bodies of patients who were implanted with the device, and caused various medical complications including dislocation, infection, and the need for a second replacement surgery. The jury spoke explicitly of Johnson & Johnson’s responsibility.
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