Kondos & Kondos Has Been Serving The People of Texas since 1984

Vehicle Accidents

Automobile Accidents

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 Each year in the United States hundreds of thousands of people are injured in automobile accidents through no fault of their own. 


Kondos & Kondos Law Offices  is devoted to providing the highest legal representation to those who have been injured in automobile accidents. 


A primary goal of our office is to achieve a just and favorable settlement for our clients.


All of our attorneys have extensive experience and training in this area. The attorneys have all worked hard to obtain the necessary legal and medical knowledge that is essential in providing the best representation for those who have been injured.

If you are involved in an automobile accident, the following information may prove valuable:


The first thing you must do if you are involved in an automobile collision is stop. Obviously, call an ambulance if anyone is injured. Check each person involved in the collision to see if they have been injured. Call the police.

If possible you and the other driver must exchange information. You will want the other drivers name, address, phone number(s), drivers license number, insurance carrier, policy number and agents name and telephone number. You should also provide the same information to the other driver.


If there are any witnesses you should try to obtain their names, addresses and phone numbers before they leave. Also, if possible take photographs of the damage to your vehicle.


It is important to cooperate fully with the police when they arrive. If the police do not come to the scene of the accident, report the collision to the nearest police station as soon as possible. For any injury, no matter how slight you think it might be, you need to have a medical professional examine you. If your injuries persist you need to see a qualified medical professional for assistance and treatment. Your health comes first. 


Oftentimes injuries sustained in automobile accidents do not become symptomatic for hours or even days after the accident. It is essential to get medical documentation of these injuries as soon as they become apparent.


Future Considerations


If there are any witnesses you should try to obtain their names, addresses and phone numbers before they leave. Also, if possible take photographs of the damage to your vehicle.


If you have been injured document all of your losses. These losses can include your medical bills, reasonable transportation costs related to the injuries, future medical treatment, lost wages, future loss of earnings, the effect on your family, and the effect on your life. Oftentimes, if you have experienced a serious injury, it will be necessary to retain the services of experts to prove these damages. This will require the representation of an experienced attorney. If you have been injured because of the negligence of another driver, then contact an experienced Texas Auto Accident Attorney for a free consultation.


Results


Kondos &  Kondos has been active in the representation of motor vehicle accident victims for over thirty (30) years. We have helped thousands of people recover compensation for the injuries and property damage they suffered in the motor vehicle accidents.


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If you or a loved one have been injured as a result of a car accident, please contact Kondos & Kondos today.

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Motorcycle Accidents

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Daniel Kondos has been a motorcycle rider for over forty (40) years. He knows what kind of help riders need when they have been injured.

In the unfortunate event you are involved in a motorcycle accident, you should gather the following information:


  1. Obtain the name and address of the operator of the other vehicle.
  2. Obtain the drivers license number of the operator of the other vehicle.
  3. Write down the license plate number of the other vehicle. The operator of the vehicle may not be the owner. The license plate number will aid in obtaining the owners information.
  4. Obtain the other drivers insurance information.
  5. Take photographs of the other vehicle and the scene of the accident, including skid marks on the roadway. If a camera is not available, take pictures of your motorcycle as soon as possible. Also, photograph any signs of physical injury, such as bruising, cuts, road rash, etc.
  6. Obtain the names, addresses and telephone numbers of all witnesses.
  7. If the police arrive at the scene, ask the police officer whether he or she intends to file a report. If a report is going to be completed, ask when and where it will be available. Regardless of whether a report is prepared, it is a good idea to take down the officers name and badge number.
  8. It is important to determine whether your motorcycle is repairable and at what cost. Take your motorcycle to a repair shop of your choice and obtain and estimate. The place where you service your motorcycle is probably the best place to obtain an estimate. However, you should always obtain at least two estimates. Your insurance company or the other drivers insurance company may recommend a repair shop. You are not obligated to use their recommended facility, but usually it is okay to obtain an estimate from them.
  9. Motorcyclists tend to be very safe drivers. It is the other driver you have to look out for. However, if an accident does occur, by obtaining the information referenced above, you will have gone a long way in protecting your rights to recover for your injuries.


Future Considerations


If you have been injured document all of your losses. These losses can include all your riding gear, helmet and goggles in addition to your medical bills, reasonable transportation costs related to the injuries, future medical treatment, lost wages, future loss of earnings, the effect on your family, and the effect on your life. 

Oftentimes, if you have experienced a serious injury, it will be necessary to retain the services of experts to prove these damages. This will require the representation of an experienced attorney. If you have been severely injured because of the negligence of another driver, then please feel free to contact our office for a free consultation with an experienced Texas Motorcycle Accident Attorney.


Results


Kondos &  Kondos has been active in the representation of motor vehicle accident victims for over thirty (30) years. We have helped thousands of people recover compensation for the injuries and property damage they suffered in the motor vehicle accidents.


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If you or a loved one have been injured as a result of a Motorcycle accident, please contact 

Kondos & Kondos today

Pedestrian Accidents

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Accidents involving pedestrians can cause serious bodily injury, large medical bills, and even death of loved ones. There are a number of common contributing factors involved in pedestrian accidents. 


However, the most common contributing factor is negligence. 

According to a National Highway Traffic Association and Insurance Institute for Highway Safety report, a pedestrian is injured on average every 8 minutes in the United States. 


Common injuries suffered include, but are not limited to :fractured bones, traumatic brain injuries, and spinal cord injuries.


When cars collide with pedestrians, there is high potential for serious injury. Pedestrian/motor vehicle accidents are a serious problem throughout the world. The United States has a particular problem with pedestrian deaths and injuries. About 5,000 pedestrians are killed and another 64,000 are injured in motor vehicle accidents every year in this country.

The following represents pedestrian accident statistics for the United States according to the National Highway Traffic Association and the Insurance Institute for Highway Safety.


  • Pedestrian fatalities account for 11 percent of motor vehicle fatalities.
  • Over 180,000 pedestrians have been killed in motor vehicle accidents between 1975 and 2005.
  • Pedestrians comprise the second largest category of motor vehicle accident deaths following occupant deaths.
  • On average, a pedestrian is injured in a traffic accident every 8 minutes.
  • On average, a pedestrian is killed in a traffic accident every 111 minutes.
  • In 2005 a total of 4,881 pedestrian were killed in motor vehicle accidents.
  • In 2005, the per capita pedestrian death rate was 1.6 per 100,000 people.

There are numerous common factors that contribute to pedestrian accidents. Negligence is one of the most common factors. Motorists have a responsibility to adhere to the laws of the road and drive in a safe and observant manner at all times. Pedestrians are killed every day due to a driver’s negligence.


Some common negligent practices by motorists include:


  • Inattentive or preoccupied drivers are potentially very dangerous for pedestrians.
  • A driver’s failure to observe posted speed limits can add to the severity in a pedestrian/motor vehicle accident.
  • A driver’s failure to yield the right of way to pedestrians at marked cross walks can increase the chance of being involved in a pedestrian/motor vehicle accident.
  • A driver’s disregard for traffic control devices can also increase the chance of being involved in a motor/vehicle accident.                                             Kondos & Kondos has been active in the representation of motor vehicle accident victims for over thirty (30) years. We have helped thousands of people recover compensation for the injuries and property damage they suffered in the motor vehicle accidents.      

If you or a family member have been injured as a result of pedestrians accident, please contact

Kondos & Kondos today.

Trucking Accidents

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Each year in the United States thousands of people are injured in accidents involving large trucks.


Kondos &  Kondos is devoted to providing the highest legal representation to those who have been injured in Texas Trucking Accidents. 

A primary goal of our office is to achieve a just and favorable settlement for our clients.

Through experience, we have developed a thorough understanding of the Federal and State laws governing the trucking industry. The Federal Motor Carrier Safety Regulations place substantial restrictions on all aspects of trucking, from the hours drivers are allowed to operate their trucks, to the mandatory documentation concerning all aspects of each driver's trip. This documentation can be valuable to show violations of the hours of service rules.

It is critical to hire a competent

 Texas Trucking Attorney as soon as possible following a trucking wreck. The trucking companies and their lawyers will oftentimes be at the scene of an accident within hours of the wreck. It is essential that the victim or their family also obtain counsel in order to preserve evidence that would not be ordinarily preserved unless the trucking company received proper notification from the victim's attorney.

If you have been injured document all of your losses. These losses can include your medical bills, reasonable transportation costs related to the injuries, future medical treatment, lost wages, future loss of earnings, the effect on your family, and the effect on your life. Oftentimes, if you have experienced a serious injury, it will be necessary to retain the services of experts to prove these damages. This will require the representation of an experienced attorney. If you have been injured because of the negligence of a truck driver, then please feel free to contact an experienced Texas Truck Crash Attorney.


Results


Kondos & Kondos has been active in the representation of motor vehicle accident victims for over thirty (30) years. We have helped thousands of people recover compensation for the injuries and property damage they suffered in the motor vehicle accidents.


Contact Us

If you or a loved one have been injured as a result of a truck accident, please contact Kondos & Kondos today.

Malpractice

Medical Malpractice

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Medical malpractice can result in severe injuries to patients. We have all heard of cases where the incorrect limb is amputated. This is not a typical medical malpractice case. Ordinarily medical malpractice cases involve very complicated techniques or procedures.

In Texas it is necessary for the victim of medical malpractice to hire an expert witness to review the individual's medical records and form an opinion as to the existing standard of care and, most importantly, whether a medical professional violated the pertinent standard of care. Oftentimes it is also necessary to obtain an opinion from a separate expert to form an opinion that the alleged negligence of the medical professional resulted in the specific injuries. Due to the nature of the testimony required (i.e. testifying against other medical professionals), these experts routinely charge an exorbitant amount for their time. In a typical medical malpractice case, it is not unusual for the plaintiff's attorney to spend over $50,000 on expert witness reports and testimony.

Medical professionals and their insurance companies are well aware of the high cost in pursuing a medical malpractice claim and therefore, they are reluctant to settle such claims prior to the filing of a lawsuit. This policy has resulted in only the most serious claims being pursued. We are happy to discuss your claims over the phone.


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If you or a loved one has been severely injured because of the negligence of a medical professional, please contact Kondos & Kondos today.

Wrongful Death

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If someone is killed and the fault lies with another party, wrongful death damages may be recovered by the victim's family. 

Examples would be a personal injury that results in death or a fatality caused by drunk driving or a defective product.

There have also been more unusual cases of deaths caused by another party. 

Families in this situation not only must deal with the emotional stress that comes with losing a loved one, but often financial burdens as well. These are the damages a suit aims to recover and a task that a competent wrongful death lawyer must be up for.


Eligible Damages


Survivors of the victim may be eligible for many different wrongful death damages in a claim. Once fault on the part of another has been determined, they may be eligible for the following:


  • Compensation for medical and funeral expenses
  • Pain and suffering
  • Punitive damages
  • Compensatory damages  

Filing A Claim


In most cases, a claim for wrongful death damages can only be filed by close family members of the deceased. In Texas, the parents, the children and the spouse of the deceased may file a wrongful death claim. Keep in mind, however, that laws vary from state to state so speaking with a qualified personal injury lawyer is advisable. The state laws regarding wrongful death tend to vary by the following factors:


 A child may seek compensation in relation to a parent's death even if he or she is over the age of 18. 


In Texas, the deceased's siblings and grandparents are not allowed to file a wrongful death claim.

 

 Texas holds a strict statute of limitations when it comes to personal injury cases, including wrongful death.


 Families have two years to file a claim after the date of death.  Once this time has expired, a claim or charges cannot be filed against the responsible party.


Anyone who files a claim for wrongful death damages from the responsible party must have valid proof of certain elements and present their case to the court. In most cases, they either need to prove that the responsible party did or did not act in a certain way, thus causing the instance that resulted in the death of their loved one. Because these cases can be very complex, the best way to determine if you have a legitimate claim is to speak with a knowledgeable attorney to evaluate your case and discuss your legal rights.   


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A wrongful death lawsuit is often stressful and emotional for survivors of the deceased. If you have lost a loved one due to the neglect of another party, please contact

Kondos & Kondos today.

Catastrophic Injuries

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A catastrophic injury can leave a person suffering from permanent disabilities for the rest of their life. Catastrophic injuries are any injuries that have serious, long-term effects on the victim. If compensation is not received for catastrophic injuries, the physical, emotional and financial strains can be devastating.

Catastrophic injuries can be caused by any number of different circumstances, and the results of the catastrophic injury can last for weeks, months, or even years. Some of the most common catastrophic injuries include:


  • Back Injuries
  • Neck Injuries
  • Brain Injuries
  • Burns
  • Organ Damage
  • Paralysis
  • Paraplegia
  • Quadriplegia

When a victim suffers a catastrophic injury, the impact can be enormous. Not only can a catastrophic injury prevent a person from gaining any substantial income, it can prevent them from enjoying their life, and it can cause their family huge amounts of stress. Catastrophic injuries to the brain can even change a person's personality, make remembering things difficult, and prevent them from recognizing their most loved family members.


  • Lost Wages
  • Loss of Enjoyment of Life
  • Mental Anguish
  • Pain
  • Suffering
  • Lost Future Wages
  • Permanent Disability
  • Medical Bills


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If you believe that you or a loved one has suffered a catastrophic injury as a result of another person's negligence,, please contact

Kondos & Kondos today.

Additional areas

Insurance Bad Faith

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Within the context of insurance claims, the term “bad faith” is often used by individuals and attorneys to refer generally to almost any improper act or omission alleged to have been committed by the insurance company relating to the processing, adjustment or settlement practices of the insurer.

While coverage disputes often arise regarding the application of a specific policy provision, an insurance company has a duty to act in good faith when making a coverage decision. If your claim was wrongfully denied, it is important that you consult with a qualified and experienced Texas insurance attorney to assess and determine whether a reasonable basis for denial existed under the insurance policy.

If your insurance company has misrepresented the coverage available under the insurance policy or otherwise unreasonably delayed, denied or underpaid your insurance claim, you may have a valid claim involving bad faith allegations against your insurance company, which may entitle you or your business to extra-contractual damages beyond the actual damages covered by the insurance policy.


Combating Insurer Bad Faith


While some insurance claims are fully paid in a timely manner, other people’s claims languish for months or even years without resolution. Unfortunately, many policyholders find themselves in the position of fighting a large insurance company alone while the insurer employs various methods aimed at delaying coverage decisions or intentionally confusing the relevant issues of a particular claim. When this happens, an aggressive and knowledgeable Texas insurance attorney can help you combat your insurance company as well as uncover evidence supporting allegations demonstrating the insurance company’s failure to conduct a reasonable and independent investigation. 

Our practice areas for bad faith insurance litigation include:


  • Coverage Disputes
  • Deceptive Trade Practice Violations
  • Insurance Code Violations   


Failure To Investigate Claims


To avoid liability of valid claims, insurance companies may rely on biased experts retained by the insurance company to provide analysis and opinions which relate directly to the question of coverage. Failure by the insurance company’s expert to conduct an independent investigation into the cause of loss will undoubtedly hinder the policyholder’s ability to obtain money owed under the policy. These insurance company experts often have a long history of providing reports to insurance companies which are then relied upon by the carrier to communicate its denial of the insured’s claim. If the insurance company’s reliance on these expert reports is not reasonable, you may be entitled to obtain damages due to bad faith on behalf of the insurance company.



Premises Claims and Liability

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Premises liability related accidents can occur at restaurants, supermarkets, ballparks, large sports arenas and sundry other places. Inside buildings, dangerous conditions such as lack of security or security cameras, torn carpeting, abrupt changes in flooring, poor lighting, narrow or poorly maintained stairs, or a wet floor can cause victims injury. 

The owner or operator of a business has a legal duty to maintain the premises in a reasonably safe condition, or at least to warn the public of a dangerous condition that may exist, or that the owner was aware of, or should have been aware of. If this duty is not met, and one is injured on someone else’s property as a result of an owner’s failure to meet proper conditions, then one may have a valid claim against that business owner or operator. Premises liability claims encompass a variety of injuries including but not limited to injuries sustained in elevators, stores, building corridors; injuries sustained outside on private or public land; injuries sustained in resorts; injuries sustained during recreational activities; injuries sustained in swimming pools.

Slips and falls are the most common types of premises injuries, but premises liability lawsuits may also stem from any kind of unsafe or dangerous conditions on the premises, or a defect in construction, or inadequate maintenance of the premises where an injury or accident occurs. Premises liability injuries include injuries sustained from toxic chemical exposure, toxic mold, lead poisoning, defective lighting, failure to warn of hazardous conditions on the property, improperly maintained equipment, dog bites and animal attacks, and the list goes on. If you believe you or a loved one may have a premises liability claim, 

please contact 

Kondos & Kondos today.

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Construction Accidents

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Construction sites are some of the most dangerous places in Texas. Construction workers diligently try to be safe at all times, but the safety challenges of the work itself, actions of others or the location sometimes are just too great and many times lead to construction accidents and injuries that threaten lives, financial futures, and stable homes of the worker.

The causes of construction accidents can vary: slips or trips, falling objects, live electrical wires, explosions, defective equipment, and building collapse. Negligent general contractors, sub-contractors, vendors, and employees can also cause many of these dangers. Construction accidents often cause life-threatening injuries that may require extensive surgery, brain injuries, disfigurement, and other permanent conditions that affect the worker and their family for the rest of their lives.

While workers' compensation covers the employees of the company, worker’s compensation does not extend to non-employees such as contract labor, temporary workers or sub-contractors. Injured construction workers that are not covered by worker’s compensation insurance, have the right to bring a lawsuit against the negligent party that caused the dangerous condition at the work place. The negligent party can include the owner of the property, the general contractor, sub-contractors and equipment manufacturers. These lawsuits can seek money to pay for a wide range of medical services, wage loss, pain, suffering, disfigurement, mental anguish and permanent disabilities.

Due to the extremely complicated nature of construction accidents, including issues like comparative fault, multiple layers of insurance coverage, and other complexities, it is recommended that injured worker consult with an experienced construction injury lawyer as soon as they are hurt to help determine the best course of care and legal action.


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If you or a loved one have been injured as a result of a construction Accidents, please contact

 Kondos & Kondos today. 

Product Defect

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Every year, some of the most devastating injuries are caused by products that fail to work properly, or that were designed or manufactured without due care to the end user. These injuries often leave a person with permanent, disabling injuries, large medical bills and many questions as to what rights they have against a giant corporation. 


At Kondos & Kondos, our attorneys have the requisite experience and expertise to answer any questions you may have regarding a potential claim against a manufacturer.

There are a number of steps you can take if you are injured by a defective product that will assist you in making a successful claim against the manufacturer:


  1. Keep the product and all the original packaging that came with the product whenever possible. Gather up any pieces of the product you can find to preserve them. DO NOT allow the product to be taken away by anyone whenever possible. If you cannot prevent someone from taking the product, get as much information about the person or agency taking the product, where the product will be taken and what will be done with it.
  2. Take photographs and/or video of the product and the injuries it caused. If the product was damaged in some way or a part broke off the product, take photographs of the broken parts.
  3. Get the names and addresses of anyone who saw the incident occur.
  4. Gather the receipts from the purchase of the product.
  5. Contact a qualified attorney with experience in products liability cases.


Because of the issues involved, products liability cases are extremely complex and involve issues of a technical nature. Like a medical malpractice claim, products liability claims require expert testimony to prove that the product was indeed defective at the time it was purchased by the consumer. This testimony is provided by chemical or mechanical engineers, human factors experts or others with the knowledge and experience to make the determination. The necessity of this testimony often results in products liability cases costing tens of thousands of dollars. Because of the cost associated with bringing these types of claims, you should contact an experienced Texas Product Liability Attorney with the experience and knowledge necessary to handle these complex cases.


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If you or a family member have been injured as a result of defective product, please contact 

Kondos & Kondos today.

dangerous devices

Depuy Attune Knee System

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Only five years after announcing a $4,400,000,000 settlement to resolve lawsuits involving defective knee and hip replacement systems, DePuy – a subsidiary of Johnson & Johnson - is now facing additional lawsuits over their most recent knee replacement system, the DePuy Attune.


Marketed on release as the most costly and research-intensive medical device in DePuy’s development history, the Attune Knee System has since exhibited questionable results in terms of both the safety and effectiveness of the device. In recent months, dozens of adverse event reports by clinicians and DePuy have been filed with the Food and Drug Administration’s Medical Device Adverse Event Reporting Database. Moreover, a recently published study in the Journal of Knee Surgery noted an unusually-high rate of revisions due to premature failures of the Attune Knee System. The authors further attributed the failures to design features inherent in the device, namely that the tibial portion of the system fails to adequately integrate into the tibial surface of the bone. As a result, the device becomes destabilized and/or loosened, and typically will require additional surgery to resolve.


Thousands of patients have been implanted with the Attune Knee System to date. Symptoms associated with these premature failures include:


  • Loosening of the device
  • Decreased range of movement
  • Infection
  • Bone loss
  • Swelling
  • Persistent pain
  • Instability of the device
  • Surgery to remove and/or replace the device


Contact Us


If you or a loved one have a DePuy Attune Knee System, please contact

 Kondos & Kondos Law Offices today.

Find out more

IVC FILTER

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IVC filters are small metal devices inserted into the inferior vena cava via access to the jugular or femoral vein. 


The umbrella-like filter shape allows the device to catch clots traveling through the bloodstream before they can reach vulnerable organs, preventing complications such as pulmonary embolism.


 The filters are typically used when blood-thinners are contraindicated, and come in two types: permanent and retrievable. To date, the focus of IVC filter litigation has primarily revolved around the poor design and inadequate safety and efficacy profile of the retrievable filter models.


Injuries


  • IVC filter migration
  • IVC filter fracture
  • IVC filter perforation
  • Tilting of the IVC filter
  • The inability to retrieve the IVC filter
  • Pulmonary embolism
  • Compromised respiration
  • Stroke
  • Death


Contact Us


If you or a loved one suffered from symptoms or other serious complication that might be tied to IVC Filter, please contact Kondos & Kondos today. 

TRANSVAGINAL MESH

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Transvaginal slings and meshes are medical devices used to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both SUI and POP occur with advancing age, child birth, and pregnancy; and both are associated with weakened musculature in the pelvic region, resulting in an inability to properly support internal organs. As a result, symptoms arise such as the inability to properly control bladder function, pain, discomfort, and the extrusion of internal organs into and/or from the vaginal entrance. The lifetime risk of undergoing an operation to treat POP or SUI by the age of 80 is estimated to be around 11.8%, and currently there are over 200,000 surgeries performed annually for POP.


The Controversy


Transvaginal mesh was approved for use by the FDA based on the 510(k) approval process, which requires a showing of substantial similarity to previously approved devices. As such, the FDA required little to no safety testing for the approval and marketing of transvaginal mesh. Manufacturers have lauded the use of transvaginal mesh as an alternative method of treating POP and SUI using a minimally invasive procedure, without the need of trimming the vagina or suturing mesh to the vagina.


Complications and Symptoms


  • Mesh erosion and exposure through the vaginal wall
  • Pain
  • Urinary problems
  • Recurrence of prolapse
  • Recurrence of incontinence
  • Infection
  • Pain during sexual intercourse
  • Inability to engage in intercourse
  • Vaginal scarring and/or shrinkage
  • Bladder, bowel, or blood vessel perforation. 


Contact Us


 If you or a loved one have suffered from any side effects from transvaginal mesh please contact 

 Kondos & Kondos today.    


MEDTRONIC INFUSE

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Medtronic’s InFUSE bone graft system is both groundbreaking and unique in many aspects. The FDA approved InFUSE/LT-CAGE in 2002 as a combination device comprised of InFUSE, a collagen sponge used as a carrier for InFUSE, and a spinal cage called the LT-CAGE to hold all three components together


 While the cage and collagen matrix don’t necessarily represent a groundbreaking discovery, the development of InFUSE changed the landscape of spinal surgery.

Arguably more accurately described as a new drug or even biologic, InFUSE is a recombinant human bone morphogenetic protein (rhBMP-2) which stimulates new bone growth by mimicking a protein naturally produced by the human body. To put this in perspective, most, if not all, previous spinal fusions required either harvesting the patient’s own iliac crest bone or the use of cadaver grafts, in order to gather enough BMP to stimulate bone growth and achieve spinal fusion. As both autologous and cadaver bone grafts have their own inherent drawbacks, such as graft rejection or pain at the site of harvesting, Medtronic found themselves in a wide open market once the system was approved by the FDA. Unfortunately for Medtronic, the FDA also implemented a number of very stringent controls on the use and marketing of InFUSE. 


The Controversy 


Since FDA approval of InFUSE, Medtronic has captured the majority share of the spinal fusion market, and has realized billions in profit from sales. However, while some of their sales are certainly a result of developing a new, groundbreaking treatment, recent findings show much more was at work driving those sales.


Perhaps the most egregious actions undertaken by Medtronic are allegations, and findings, that Medtronic not only sponsored many of the studies touting InFUSE for both on- and off-label procedures, but also wrote and published the studies and paid the authors tens of millions of dollars in return. Worse yet, when these studies were critically reviewed by The Spine Journal, which dedicated an entire issue to the topic, unbelievable ethical violations came to light. For example, in 13 studies funded by Medtronic, encompassing over 700 patients, not a single adverse event was reported. In one study at Walter Reed Army Medical Center, the author simply made up data. In another, adverse events previously reported to the FDA during the approval process disappeared when published in a scientific journal. In yet another, Medtronic authored an article and purposefully excluded adverse event data. With such glowing reviews permeating the literature, it’s no wonder surgeons throughout the country began using InFUSE in off-label procedures. These surgeons were denied the full story. 


By reporting perfect or near perfect safety, the original studies might have led others to widespread off-label use of the product with some potentially catastrophic outcomes. Revised estimates of adverse events are: 


 

  1. Posterior lumbar inter body fusion techniques: 25-50% risk of associated adverse events.
  2. Anterior lumbar inter body fusion: 10-15% risk of adverse events.
  3. Anterior cervical fusion: 40% greater risk of adverse events in the acute postoperative period including potentially life-threatening complications.
  4. Posterolateral fusions: equivalent or greater early postoperative risk of morbidity compared with ICBG harvesting for this dosage; 16-20% of rhBMP-2 subjects had adverse back and leg pain events, a probable two to threefold increase in the first three months after surgery over control groups.     


Identified Risks & Injuries


While we still don’t know the full extent of injuries associated with InFUSE, some of the risks being reported to the FDA include:

  1. Severe inflammation
  2. Severe infections
  3. Massive bone loss
  4. Graft migration
  5. Loss of fixation
  6. Epidural Hematoma
  7. Retrograde ejaculation
  8. Persistent bladder retention
  9. Severe back and/or leg pain
  10. Overgrowth or uncontrolled bone formation (ectopic bone growth)
  11. Male sterility
  12. Cancer

 

In many cases, patients will need revision surgery to correct adverse events associated with InFUSE. Further, it now appears that many of these associated risks may be untreatable.


Contact Us


If you or a loved one have undergone spinal fusion using Medtronic’s InFUSE bone graft, and have experienced any side effects, please contact Kondos & Kondos today.

DePuy Hip Replacement

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Designed by Johnson and Johnson’s subsidiary, the ASR total hip replacement device was released in 2005 after obtaining 510k clearances from the FDA. Such clearance allowed the manufacturer to enter the market without first evaluating the safety and effectiveness of the device on the basis of ‘substantial similarity’ to previously cleared devices.


The purported advantage of the device was two-fold. First, the device used a chromium-cobalt alloy, hypothesized to reduce wear damage and consequently last longer. Second, instead of using traditional adhesive cement, or screws to bind the device to the skeleton, the ASR is covered in a porous metal coating, facilitating natural adhesion via bone growth into the pores. Since its release, 93,000 devices have been installed worldwide.


The Controversy


Since 2005, the ASR device has suffered multiple blows from academic, medical, and government reports; ultimately resulting in DePuy recalling the device in July of 2010[1]. The magnitude of such a catastrophic failure is strongly evidenced by Johnson and Johnson’s most recent financial statement indicating the company had set aside $992 million dollars in anticipation of litigation[2]. These funds will be used to litigate, and settle, claims arising from both the defective nature of the device, as well as potential heavy metal poisoning. 


Evidence of the substandard nature of the ASR device began to surface in 2008, with reports by both the FDA and the British HMRA (the British equivalent to the FDA). In their report, the MHRA detailed evidence of ‘genetic damage in patients with certain metal hip implants,’ including those with the same components as the ASR. In addition, the report cites the potential for systemic immunotoxic effects, local immune effects, and increased levels of metal in serum [3]. In the same year, the FDA reported over 400 complaints from or about patients with the ASR device. Thirteen percent of patients with the ASR device required a second surgery to replace the defective device[4]. 


 

A year later, the Australian Joint Registry investigated metal on metal bearings, concluding that both the Zimmer Durom, and the DePuy ASR exhibited higher than average revision rates. Specifically, the authors pointed out that 41% of the devices exhibited loosening, while noting a pattern of extensive wear markings, corrosion, and some carbide precipitation (which can affect wear and mechanical performance)[5].


Subsequent reports support the conclusion that the ASR is an inferior device. Difficulty installing the device, as well as getting it to adhere to the body, have resulted in unreported data from the UK and Wales Joint registry, suggesting a failure rate requiring revision between 11-13%[6]. There have also been subsequent studies pointing to the danger of having heavy metal particles, which enter the bloodstream after separating from the device during movement, accumulating in the body. Specifically, clinical research has shown that a small percentage of patients with a metal-on-metal device similar to the ASR exhibited adverse reactions to metal debris, requiring revision. These patients further exhibited higher blood levels of Cr and Co ions than asymptomatic patients[7]. Genotoxicity, which can alter the structure or integrity of genetic material in an organism, has also been reported by the British Committee on the Safety of Devices[8]. The danger of this form of toxicity is that it can result in cancer, or if the damage occurs in reproductive cells, inherited disorders in offspring. Finally, as these metal ions are excreted through the kidneys, internal damage can be exacerbated in those with renal failure, or those at risk of renal failure.


Symptoms


  • Unexplained hip pain
  • Difficulty standing or walking
  • Loss of mobility
  • Intense lift-off pain, noted as the most common symptom
  • Behavioral effects associated with heavy metal poisoning

 


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If you or a loved one have a DePuy hip implant, please contact 

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