Category Archives: Defective Products

Biomet Hip Recall Update: Exempting Investigational Devices

biomet hip replacementBiomet is now under investigation after Leslie Caccia and his wife Allison, filed cases against the hip implant maker. Leslie and Allison are the lead plaintiffs of the multiple cases filed against Biomet. The couple claimed that the Biomet M2A-Magnum artificial hip that was used on Mr. Caccia failed to function properly.

Due to the premature failure, Mr. Caccia has suffered from metal poisoning. Mr. Caccia underwent multiple surgeries after the failure of his artificial hip. Other lawyers are also investigating complaints about the artificial hips provided by Biomet of other victims in different parts of the United States. The cases are being compiled to further get up to date information about the Biomet hip recall and to strengthen cases against the company.

What is the cause of the complaints?

The Biomet M2A-Magnum Hip is similar to the Stryker Rejuvenate because it utilizes metal on metal hip replacement during surgery. Victims have also stated that they suffered from hip failure, metal poisoning, or metallosis. Victims are affected by metallosis or metal poisoning because of the debris released into the body’s soft tissues due to artificial hip failure. Some experts have already conducted a study concluding that metal on metal hip replacement is commonly associated with hip failure.

Biomet Hip Recall Updates

Recently, the lawyers of Biomet asked Judge Robert L. Miller, the federal judge for all liability claims against Biomet’s product, to drop all of the cases filed against them because of federal preemption. This legal loophole states that implant makers have legal immunity for defects on their products as long as it has the approval of the FDA.

However, Judge Miller denied the motion of Biomet’s lawyers. Judge Miller stated that even though the product has the approval of the FDA, Mr. Caccia used Biomet’s product outside the controlled study of the investigational device exemption. Mr. Caccia’s use had no proper oversight, monitoring, nor record keeping of the FDA. More Biomet hip recall updates are pouring in to further strengthen the case against Biomet.

Moving Forward with the Biomet Hip Recall

There are around 600 cases against Biomet being consolidated in Indiana alone. The cases also included plaintiffs from different parts of the United States. It is anticipated that there would be more cases filed against Biomet in the coming months as more victims come forward. Biomet’s hip replacement system has caused suffering for many victims. If you need legal consultation, you can consult with a law firm that handles the other cases against Biomet.

Medtronic Infuse Lawsuit Update: Results Same as Bone Grafts but Riskier

medtronic infuseInfuse Bone Graft/LT-Cage, a lumbar tapered fusion device manufactured by Medtronic Inc. (MDT), was discovered to be little better than a regular graft and may come with a range of associated health risks which include cancer.

Infuse is now widely established in the health care industry, however it was thought to be linked to adverse events such as male sterility, infections and even cancer. Before a full scale Medtronic infuse lawsuit was launched, a comissioned review of Medtronic’s Infuse took place in 2011.

“Risk Free?”

Early studies regarding Infuse lead to the conclusion that the product was risk-free, however there have been reports of existing financial ties between the researchers and the innovator company. This leads to the question of integrity in the early data and may in fact have prompted the Medtronic infuse lawsuit.

The Krumholz’s Yale University Open Data Access project reviewed data and findings for Infuse, among other products, and published their findings publicly for other researchers.

Infuse vs Bone Grafts

Two research groups submitted their findings on the issue of Infuse being no better than bone grafts. One of the groups (Oregon review) found that the effects, success and risks of both Infuse and bone grafts were highly similar. For the second group (University of York) found that fusion rates with infuse were better after two years, perhaps with more early pain than later pain. The incidence of cancer was definitely present in a small number of people. However, the risk of developing cancer with Infuse use has still not been firmly established.

Medtronic Infuse and Risk of Cancer

As was mentioned, the rates of cancer from Infuse use were low. Medtronic is considering the occurrence of a small increased risk of cancer associated with Infuse as well as the likelihood of improper usage leading to an elevated cancer risk. For instance, the product is not approved for use at the top of the spine since doing so might lead to complications.

Widespread Use of Medtronic Infuse

In earlier days, the use of Infuse was used everywhere. Physicians believed it carried very little adverse effects and recommended it for a wide variety of conditions. However, at present, doctors seem to have established its’ appropriate use thus its’ administration is significantly more limited.

Although there are a few companies like Nuvasive Inc and Johnson & Johnson who have developed similar products, these have yet to be established in the medical field like Infuse has.

Chrysler Issues Voluntary Recall of Over 1.5 Million Jeep Vehicles

chrysler-recallChrysler has issued a voluntary recall of older-model Jeep SUVs, involving more than 1.5 million vehicles. The recall was issued at the end of June, 2013 in response to pressure from the National Highway Traffic Safety Administration.

Reason for Jeep Recall

The older-model Jeep SUVs are being recalled due to an increased risk of a fire occurring in the event that the Jeep is involved in a rear-end collision. Due to harsh edges on the hitch area, the gas tank can be punctured and a fire can ignite during a rear-end accident.

The National Highway Traffic Safety Administration requested the manufacturer to issue the Jeep recall, but it initially declined to do so. Chrysler has now negotiated the recall, resulting in the recall of 1.5 million Jeep SUVs, but omitting 1.2 million other Jeep vehicles.

Vehicles Involved and Method Used to Correct Defect

The 1993-1998 models of the Jeep Grand Cherokee and the 2002-2007 models of the Jeep Liberty are the vehicles involved in the recall. Those vehicles that do not have a trailer hitch will have one installed at no cost for the consumer. Jeeps that have aftermarket hitches will be inspected and a new hitch will be installed if the inspector finds dangerous harsh edges. Jeeps that have factory trailer hitches will also be inspected and issues will be resolved if they are detected.

Drop of Some Vehicles during the Jeep Recall

Approximately 1.2 million Jeep Grand Cherokees that were manufactured in the years between 1999 and 2004 have been dropped from the original recall.

However, owners of these vehicles will receive a notice regarding the recall if they have factory hitches. If they have aftermarket trailer hitches, they will be inspected and they may be replaced if problems are detected.

Owners of these vehicles are concerned about why their vehicles were removed from the initial recall. They wonder if their vehicles are actually safe and if it was safe to remove them from the recall. Chrysler has responded by stating that these models were designed in a different manner than the other vehicles that are still part of the recall.

Jury Awards $8.3 Million in First DePuy ASR Verdict

depuy hip replacement recallFirst trial, first award

After a four week trial and six days of deliberation, a Superior Court jury in Los Angeles recently awarded $8.3 million in damages to terminally ill plaintiff, Loren “Bill” Kransky in the first jury verdict to appear for victims of DePuy’s ASR hip replacements.

Kransky’s case, expedited under a California law giving preferential trial status to terminally ill plaintiffs, was against Johnson & Johnson subsidiary DePuy, maker of the ASR XL metal-on-metal hip replacement device.

The plaintiff’s claim was that the artificial hip was defectively designed, causing him to suffer multiple injuries following a hip replacement surgery in 2007. The jury’s verdict was mixed, awarding Kransky $338,136 for payment of medical bills and $8 million for physical and emotional suffering due to the defective hip, but declining to award punitive damages against DePuy.

Kransky’s attorneys had requested punitive damages to the tune of $179 million, but the jury declined, saying that DePuy did not act with fraud or malice in marketing its product.

Testimony and background

During the trial, Kransky testified that, due to the device’s defective design, he experienced constant pain, inability to walk, and metal poisoning from the DePuy hip implant following his 2007 surgery, and had to undergo an additional surgery in February of 2012 to have the device removed.

DePuy sold approximately 93,000 ASR XL hip implants, marketing them as a safe and revolutionary alternative to traditional hip implants. After high failure rates for the device, Johnson & Johnson set aside more than $3 billion to cover costs for a recall of the ASR XL, which was issued by DePuy in 2010 following reports from doctors that the device was shedding metal debris into patients’ bloodstreams.

Numerous studies have now shown that the metal-on-metal design causes the release of metal ions into patients’ blood, potentially creating serious adverse health outcomes such as bone or soft tissue damage, chronic pain, device failure, and/or the need for additional implant surgery.

Potential impact on future lawsuits

Kransky’s was the first case against DePuy to go to trial. There are several more trials involving the DePuy ASR XL, set to begin later this year. Legal experts expect this first result to have a significant impact on the nearly 11,000 additional lawsuits over the device and DePuy’s marketing practices.

So far, DePuy has refused to settle any of the suits, instead offering to pay co-pays and out-of-pocket medical expenses through Broadspire Insurance Adjustment firm. Kransky’s attorney Brian Panish said he believes future verdicts will include awards of punitive damages, and that this victory “is the first day of reckoning for DePuy and Johnson & Johnson.”

Hyundai & Kia Recall 1.8 Million Vehicles Due to Loose Headliner and Defective Switch

hyundai recallThe automobile company known as Hyundai Moto Corp., as well as their Kia Motors affiliate have issued a recall for more than 1.8 million vehicles. Not only did Hyundai recall brake switch units that appear to be faulty, but there is a recall on loose headliners, as well.

Vehicles Included in the Recall

There are a number of cars and SUVs that have hit the list of recent recalls. These automobiles include:

  • 1,059,824 cars and SUVs under Hyundai.
  • 186,000 additional recalled Hyundai Elantra cars.
  • 623,658 additional recalled vehicles under Kia.
  • Vehicles that are model years 2007 through 2011, with the exception of the Elantra vehicles, which were model years 2011 through 2013.

All of the aforementioned recalls could be attributed to faulty brake switches.

The Dangers of Having a Faulty Switch

Not only are defective switches reported as increasing the risk of crashing, but such crashes can potentially be serious enough to result in fatalities.

  • The stop lamp switch, the brake switch in question, results in the brake lights not lighting when engaged.
  • Not only will this switch no longer light when necessary, but it also can prevent a driver of a vehicle from turning the cruise control option off when engaged.
  • The third possible effect of this switch being faulty is that it can also disable the gear that keep a car from automatically switching out of the parked gear. This means that the car can be shifted without having a button or special dial to press, which can be dangerous in a number of situations.

Hyundai and Kia have reported that there have yet to be any crashes associated with this defect, at this point.

Issues with the Elantra

Elantras have also been recalled due to a loose headliner. Owners of these vehicles are now required to apply an adhesive strip that will prevent the headliner from moving out of position if the side curtain airbag is forced to be engaged. Unlike with the faulty brake switch situations, Hyundai has had a single report of an individual suffering a minor injury due to this defect.