Articles Posted in Hip Implant Failure

Is Negligent Medical Device Testing to Blame for Thousands of Injuries and Deaths?

Seemingly countless injuries involving defective or dangerous medical devices have occurred in recent years, prompting the question—are medical devices being adequately tested for safety? Earlier this month, the Medical Imaging and Technology Alliance (MITA) held a congressional briefing “to discuss how medical device providers are regulated and how standards can be better aligned to ensure patient safety.”

The need for such a briefing may confirm what lawyers, physicians, and the general public have been saying all along—manufacturers’ desire to get medical devices to market supersedes their desire to ensure public safety through proper testing. A Boston personal injury lawyer can help you determine how to proceed if you’ve been injured due to the negligence of a medical device manufacturer.

Medical Device Servicing and Safety Accountability Act

The MITA has proposed new legislation that would make it a requirement for any medical device servicer to “maintain records and make reports as the FDA requires to ensure the safety and effectiveness of serviced devices.” The Medical Device Servicing and Safety Accountability Act would reduce or eliminate the risk of improper servicing and reporting. According to the MITA, “the current regulatory structure for medical device providers could lead to instances of improper servicing.” The quality of servicers varies widely, and improper handling can lead to avoidable injuries, and even death.

In addition to proper servicing, the new bill would prompt any entity performing service on a device to alert the FDA to any issues or “adverse events should they occur.” Further, most medical device servicers agree that “consistent standards for device servicing” would be of benefit to everyone involved. A MA personal injury attorney can help you recover damages if you’ve been injured due to the negligence of a medical device servicer or manufacturer.

Medical Device Testing Facts

The facts below further illustrate the severity of the problem involving improper medical device testing.

  • The vast majority of medical devices receive no testing before going to market.
  • Metal hip implants, surgical mesh, and lap-bands are among the most prominent recalls of medical devices in recent years.
  • According to the Institute of Medicine, medical devices should be tested “at least as rigorously as drugs.”
  • Currently, no national registry for patient medical devices exists that would allow patients to know if they have a dangerous or defective device.
  • In 2017, Endo, a major manufacturer of transvaginal mesh agreed to pay $775 million to settle 22,000 lawsuits.
  • Earlier this year, Mary McGinnis received $68 million after she suffered severe injuries as a result of Bard’s pelvic mesh. The award consisted of $33 million in compensatory damage/$35 million in punitive damages.
  • All-metal hip implants have been involved in countless lawsuits. In 2014, Stryker settled thousands of lawsuits involving its Rejuvenate and ABG II hip implants for $1.43 billion.
  • Power morcellators, commonly used during hysterectomies, may spread uterine cancer cells. So far, Johnson & Johnson has settled nearly two-thirds of the morcellator lawsuits it is facing. Individual settlements ranged from $100,000 to $1 million based on various factors.

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Hip replacements are one of the most common surgeries in the United States today. For years, hip replacement implants were made of plastic or ceramic, but a “longer-lasting, more durable” alternative gained popularity over the past decade. All-metal hip implants were hailed as having a lower failure rate and a reduced need for replacement surgeries. But these claims soon proved to be false.

When the chromium and cobalt components of all-metal hip implants rub together over time, bits of metal debris can be released into the blood stream and surrounding tissue. This debris can lead to inflammation, bone deterioration, tissue damage, and a type of blood poisoning called metallosis.

What is the Statue of Limitations?

In Massachusetts, as in other states, the Statute of Limitations sets a time limit on bringing lawsuits against an individual or entity who has caused you harm. Once that time limit has expired, the injured party can no longer file a claim in MA. The statute of limitations varies based on the type of incident and the circumstances involved. In certain cases, a person may be unaware of an injury for an extended period. Faulty hip implants are a good example of such a situation.

Johnson & Johnson, for example, has argued that the statute of limitations should have begun when they recalled their defective DePuy ASR hip implant in 2010. Given a two-year statute of limitations, patients would have had to file their claims by 2012 in order to recover damages. However, many patients who received DePuy hip implants in 2010 didn’t discover their injury for several years. A Boston defective medical device attorney can help you determine how to proceed if you’ve been injured by a faulty or defective medical product.

The Discovery Rule

Fortunately, MA imposes the discovery rule in certain situations. The “discovery rule” holds that

the statute of limitations does not begin until the claimant knew or should have known that he was injured and that the injury was caused by another’s negligence. As such, an individual who is only now determining that a) she is injured, and b) the injury was caused by DePuy’s negligence, may still be able to file a lawsuit for injuries caused by a hip implant that was recalled in 2010.

Symptoms of Hip Implant Failure

If you have received an all-metal hip implant, it may be in your best interest to speak to your doctor about the risks. In the meantime, if you develop any of the following symptoms, seek immediate medical attention.

Signs of metal poisoning may include:

Problems with the nervous system

Difficulty hearing

Skin rash

Vision problems

Heart problems

Behavioral or emotional changes

Thyroid problems

Signs of bone deterioration or tissue damage may include:

  • Swelling around the site
  • Extreme pain
  • Difficulty walking
  • High fever

As many as 93,000 patients may have received DePuy’s ASR hip implant before the device was recalled. Unfortunately, J&J failed to keep adequate records and was unable to notify each person of the recall. As such, the number of lawsuits continues to rise. A MA injury attorney can help you determine how to proceed if you’ve been injured by the negligence of a medical device manufacturer. Continue reading

Every year in the United States, thousands of patients undergo hip replacement surgery to treat severe hip arthritis and other degenerative conditions affecting the hip joint. Hip replacement surgeries are generally a last resort option, after non-surgical treatments have failed to help. These patients are typically in serious pain, and unable to perform basic daily activities. The hip replacement is supposed to help them get their lives back. Unfortunately, that’s not always the outcome.

In addition to relieving pain and improving mobility, hip implants are supposed to last the rest of the patient’s life. Hip replacement surgery is complicated and painful; nobody wants to go through it multiple times. Although hip replacement surgeries have been performed for decades, the hip implants themselves have gone through quite an evolution. In recent years, ceramic and plastic models have been “upgraded” to all-metal devices that were originally hailed for being more durable and providing greater range of motion.

It is common for patients to want the newest model when it comes to surgical implants, and hip implants are no exception. As such, tens of thousands of patients have been implanted with all-metal hip implants in the last decade. But shortly after all-metal hip replacement surgeries skyrocketed, claims of serious complications began flooding in. A MA defective medical products attorney can help you determine how to move forward if you’ve been injured by an all-metal hip implant, or any other medical device.

Complications Linked to All-Metal Hip Implants

All-metal hip implants are designed with a ball and socket, both of which are made of metal. Unfortunately, when the ball and socket rub together, the metal-on-metal contact results in friction that can release metal debris into the patient’s blood stream and surrounding tissue. This metal debris can become toxic in the bloodstream and cause the surrounding tissues to become irritated and inflamed, a condition called Metallosis. If left untreated, Metallosis can be fatal. In addition, these metal particles can cause an immune reaction in the body, leading to soft-tissue damage and bone deterioration around the joint.

If you have an all-metal hip implant, it is in your best interest to visit your doctor regularly for routine evaluations of the implant and your hip joint. If it is determined that your hip implant is causing problems or has failed, you may require a revision surgery to remove and replace the implant. A Boston defective medical products attorney can help you recover damages if you’ve been harmed by any type of medical device.

Symptoms of All-Metal Hip Implant Complications

If you have an all-metal hip implant, seek medical attention if you develop any of the following symptoms:

  • Severe pain in the hip, groin, or leg
  • Difficulty walking
  • Swelling or inflammation around the hip joint
  • Infection
  • Feelings of malaise
  • Nausea
  • Dizziness
  • Headaches
  • Skin rash

The above symptoms may signal a problem with your implant, including loosening of the implant, fracture or deterioration of the surrounding bone, misalignment of the ball and socket, or blood poisoning / tissue inflammation from metal debris. Continue reading

Metal-on-metal hip implants were hailed as a superior alternative to their plastic and ceramic counterparts. Unfortunately, they are increasingly associated with serious medical complications, including the risk of blood poisoning. Read on for more information about metal hip implants and what to do if you’ve been injured by one of these defective medical devices.

Many metal hip implants are made of chromium-cobalt, a carcinogenic substance. When the metal components of the implant grind together through normal wear and tear, particles of chromium and cobalt can be released into the body. If the toxic substances enter the bloodstream, the results can be fatal. In addition to the risk of blood poisoning, the grinding of metal parts may also create metal debris. The shedding of this debris can lead to inflammation, extreme pain, bone deterioration, pseudo-tumors, and the need for revision surgery.

What Hip Implant Models are Dangerous?

Johnson & Johnson is at the center of thousands of lawsuits due to dangerous defects in its DePuy Pinnacle hip replacement devices. Claimants allege that J&J failed to adequately warn patients and physicians about risks with the all-metal implants. Thousands have suffered extreme pain, and many will have life-long complications as a result. J&J agreed to settle a portion of the cases for billions, but more than 8,000 pending lawsuits remain. Read on to learn more about the risk of Pinnacle hip implants and whether you may be eligible to receive compensation. It may not be too late.

When all-metal implants hit the market, they quickly grew in popularity as a sturdier, more durable device than their plastic or ceramic predecessors. J&J’s first attempt at all-metal implants in the 2000s proved to be a disaster; the company eventually issued a global recall of its ASR model due to the risk of serious complications. Nearly 10,000 lawsuits arose from ASR and earlier models, forcing J&J to settle for $4 billion. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by a hip implant or other medical device.

As mentioned above, there are still more than 8,000 lawsuits pending against J&J for its more recent model, the Pinnacle implant. After recalling its ASR implant, J&J continued to market and sell Pinnacle implants for nearly three years. Plaintiffs in the lawsuits against J&J allege the company is guilty of negligence because it sold defective products, failed to warn patients and physicians of associated risks, willfully concealed those risks from the general public, and acted maliciously. They even allege that J&J committed fraud.

Medical Complications Linked to All-Metal Hip Implants

All-metal implants have high failure rates and can lead to the following medical conditions:

  • Metallosis (a type of blood poisoning)
  • Bone deterioration
  • Tissue death
  • Infection
  • Inflammation
  • Loss of mobility
  • Extreme pain

During earlier trials, lawyers discovered an internal memo in which J&J estimated that approximately 40 percent of patients with an ASR hip replacement device would require a revision surgery in five years or less. Additional documents revealed that J&J was aware of the design defects, and that physicians had warned the company to pull its hip implants off the market. Further evidence showed that J&J decided to discontinue the devices rather than redesign them because they weren’t profitable enough.

Blood tests in patients with all-metal implants have shown high levels of cobalt and chromium. One patient had 85 times the normal amount of cobalt in her system. Chromium and cobalt poisoning can lead to multiple medical problems, and can eventually lead to death. If you are experiencing severe pain, hear popping or grinding noises, suffer from loss of mobility, or notice inflammation in your hip or groin area, contact your physician immediately. These symptoms may indicate a serious problem with your hip implant.  A MA defective medical products attorney can help you recover damages if you have been harmed due to a Pinnacle hip implant. Continue reading

All-metal hip replacements have been in the spotlight recently due to thousands of lawsuits filed against manufacturers of these products. Lawsuits allege the implants are linked to serious medical complications, including metal poisoning and bone deterioration. Plaintiffs in lawsuits against Johnson & Johnson for its DePuy Pinnacle hip replacement claim they suffered from metal poisoning and other complications after the implant shed metal, affecting surrounding tissue. Despite these risks, J&J has not issued a recall for its all-metal hip replacements.

Medical Complications Linked to DePuy Pinnacle Hip Implants

All-metal hip implants pose the risk of several serious medical conditions, including:

  • Severe pain
  • Dislocation
  • Deterioration of surrounding bone
  • Death of surrounding tissue
  • Implant loosening
  • Inflammation and swelling
  • Infection
  • The need for revision surgery
  • Metallosis (a type of metal poisoning)

It was originally believed that all-metal hip replacements would last longer and be more durable than their ceramic or plastic counterparts. However, it appears that the vast majority of complications are linked to the all-metal implants. In fact, many patients report that their all-metal device failed only a few years after being implanted. Research has shown that the issue is likely due to the process of metal shedding that often occurs with these implants. When metal particles are released into the surrounding tissue, high levels of cobalt and chromium may build up in the blood, resulting in a condition called metallosis. This painful, potentially-debilitating condition can lead to death of surrounding tissue, and deterioration of surrounding bone.

Symptoms of a Malfunctioning Hip Implant

According to a report from the National Joint Registry in Great Britain, up to 14 percent of all-metal hip replacements need to be removed within seven years. If you have a hip replacement device, the following symptoms may indicate a malfunction with your implant.

  • Severe pain in the hip, leg or groin
  • Difficulty walking
  • Difficulty standing
  • Swelling at or around the hip joint
  • Popping, squeaking, or grinding sounds
  • Kidney problems
  • Skin rashes
  • Depression
  • Thyroid problems
  • An enlarged heart

In 2011, the FDA issued a warning about the potential dangers of metal debris from all-metal hip replacements. The agency said that high levels of cobalt and chromium in the blood may cause additional illnesses and medical complications, including problems with the heart, thyroid, and nervous system. A Boston defective medical device attorney will help you recover damages if you’ve been injured due to an all-metal hip implant. Continue reading

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


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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