Dallas Fort Worth Injury Lawyer Blog

DePuy ASR metal on metal hip implant recipients in states with a 2 year Statute of Limitations, may lose their rights to file a lawsuit if they do not file their lawsuit before August 23, 2012. J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S., saying more than 12 percent of the devices failed within five years. Over 6,000 lawsuits in federal and state courts describe patients in pain and immobilized by joint dislocations, infections and bone fractures.

What is Statute of Limitations?

Every state has a law called the statute of limitations (SOL) that sets a limited time period in which a lawsuit can be filed. The reason for this law is that the courts want to have a finite time for folks to bring claims and not have an unending litigation time period. If a person with a legal claim fails to have a lawsuit filed within this time period, then their claim can be forever lost.

Why is the SOL for Most DePuy ASR Hips August 2012?

In the United States, the majority of states use a two year time period for the SOL. The remainder of states have a 1 to 6 year time period for the SOL.

Individual states use different rules to calculate when these time periods start running and when it is determined too late to bring a lawsuit.

The official DePuy Recall Notice was issued on August 24, 2010. The two year period from that Recall Notice will expire on August 23, 2012. Therefore lawsuits for folks who claim that they were injured by DePuy ASR hips must be filed in those states with a 2 year statute of limitations or it may be too late for those patients to make a claim.

States With a 2 Year Statute of Limitations

Arizona, Alabama, Alaska, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, and West Virginia.

Exceptions to the Statute of Limitations

Many states have what is called a “Discovery Rule” which means that the Statute of Limitations does not start until a person would reasonably know that they might have a liability claim. But because of the widespread publicity and the FDA warnings, most experts believe that the statute of limitations began to run in August 2010.

Take Home Message

If you or a loved one has had a DePuy ASR metal on metal hip implanted, please seek legal advice and file your DePuy claim as soon as possible, to preserve your legal rights.

Folks with a DePuy ASR Hip Implant should have a detailed review of their case done immediately because once the statute of limitations has run there is no way to reopen or restart it.

According to a Danish report, some women using hormonal contraceptives other than birth control pills have an increased risk for serious blood clots.

These alternate hormone-releasing birth control methods include skin patches, implants and vaginal rings. According to the researchers, to reduce the risk, women who use these should consider switching to safer birth control pills.

Nuvaring Blood Clot Risks

Deep vein thrombosis is a blood clot that typically originates in the legs and can travel to the lungs, where it becomes a pulmonary embolism, which can be deadly.

Study Findings

The transdermal patch and vaginal ring have at least a sixfold increased risk of venous thrombosis as combined pills with desogestrel or drospirenone, a risk which is about twice the risk among women using second-generation pills with levonorgestrel.

According to the researchers, women should be informed about these risks in order to be able to choose the most appropriate hormonal contraceptive product, there are hormonal contraceptive alternatives which confer less or no risk of venous thrombosis.

The findings were published May 10 in the online edition of the BMJ.

Women who used a vaginal ring had a 6.5 times higher risk. There was no reduction in risk with the long-term use of a patch or vaginal ring.

To reduce the number of women who develop clots from these riskier birth control methods, the authors advised that more women choose the safer birth control pills.

Take Home Message

Combined oral contraceptives with levonorgestrel or norgestimate confer half the risk of venous thrombosis than oral contraceptives containing desogestrel, gestodene, or drospirenone.

Progestogen only pills do not confer an increased risk of venous thrombosis

Women who use combined contraceptive transdermal patches are at an increased risk of venous thrombosis about eight times that of non-users of hormonal contraception.

Vaginal rings increased the risk of venous thrombosis 6.5 times compared with non-use of hormonal contraception.

The risk of venous thrombosis was not significantly increased with use of subcutaneous implants or the levonorgestrel intrauterine system compared with non-use of hormonal contraception.

Nuvaring almost 7 times the risk of venous thrombo-embolism, so tell me again, why is the Nuvaring still on the market?

Medtronic faces an increasing number of product liability and personal injury lawsuit. Most recently, a Louisiana man, filed a lawsuit alleging that the company’s Infuse bone graft caused unwanted bone growth along his spinal cord, which worsened his back pain following a lumbar fusion.

The plaintiff, Martin Gavin alleges that Medtronic concealed information about the risk of complications from the Medtronic Infuse bone graft.

What is Medtronic Infuse?

Infuse, also known as bone morphogenetic protein-2, is a powerful bioengineered agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient's own bone to create a fusion between two vertebrae. As a result, it is highly popular with spine surgeons.

FDA Approved Infuse for limited use

The FDA approved Infuse in 2002 for use during anterior lumbar fusion surgeries. But as a result of slick and pressured marketing, it has been widely used off-label for a number of other types of spinal surgery, which have been found to increase the risk of severe adverse side effects.

Plaintiffs allege that they were never told that the Infuse was only approved for single-level anterior lumbar fusion, and had ever been adequately tested or approved for the type of spine surgery they underwent.

Medtronic Infuse Off Label Use

Off-label use of the Medtronic Infuse bone graft during procedures other than single-level anterior lumbar fusion have been linked to the growth of bone in those areas, leading to swelling and nerve damage.

FDA 2008 Warning

The FDA issued an alert in 2008, advising doctors not to use the Medtronic Infuse in neck or cervical spinal fusion procedures. The FDA had received numerous adverse event reports, involving potentially fatal complications that included swelling of the neck and respiratory difficulties.

U.S. Department of Justice investigation

The U.S. Department of Justice initiated an investigation focusing on the actions of Medtronic in 2008. The U.S DOJ was particularly interested in investigating whether Medtronic illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.

Other Medtronic Infuse Side Effects

Last year, concerns also emerged that the Medtronic Infuse bone graft may increase the risk of cancer. There have also been concerns that med treated with Medtronic Infuse may face a risk of sterility.

Medtronic Shareholder Suit

Medtronic Inc agreed to pay $85 million to settle a shareholder lawsuit accusing it of making misleading statements concerning Infuse.

The settlement resolves claims that Medtronic failed to reveal that as much as 85.2 percent of Infuse sales depended on so-called "off-label" uses, where doctors sometimes paid by Medtronic would prescribe the product for applications not approved by the U.S. Food and Drug Administration.

Shareholders said Infuse sales and Medtronic's share price fell after the company revealed that the U.S. Department of Justice was probing off-label marketing and the U.S. Senate began its own inquiry.

Scope of Medtronic Infuse Problems

According to Medtronic, Infuse has been implanted into more than 500,000 patients and it is used by more than 2,300 surgeons. Its sales amount to several hundred million dollars a year.

According to new medical research, metal-on-metal hip replacements may corrode faster than traditional types of artificial hip implants, such as those made from plastic or ceramic.

Experts speculate that the corrosion may be linked to an increased risk of local tissue reactions that require revision or removal of the artificial hip implant.

Researchers examined corrosion on the heads of metal-on-metal hip implants, and compared it to the corrosion found on metal-on-polyethylene implants, which have a plastic liner between the metal femoral head and metal acetabular cup. This study is published in the Journal of Arthroplasty,

Study results revealed that metal-on-metal hips showed more corrosion and that rate of corrosion increased over time.

Cobalt and Chromium Heavy Metals

Metal-on-metal hip replacement femoral heads systems are made from cobalt and chromium, which interface within a metal acetabular cup.

Mechanism of Metallosis

As the metal parts of the ball and cup grind against each other, microscopic metal particles are released into the body, which can cause metallosis, or metal blood poisoning.

Local Tissue Reactions

Researchers found that metal-on-metal implants that had been revised after patients experienced local tissue reactions had higher corrosion scores than those without such tissue problems.

FDA Now Investigates

The FDA has scheduled a meeting of its orthopedic devices advisory board to review the safety of metal hip systems for June 27 and 28.

The committee are to review failure rates, testing for metal ion blood poisoning, imaging methods, local and systemic complications, patient risk factors and considerations for follow-up after surgery.

DePuy ASR Recall

In August 2010, a DePuy ASR metal-on-metal hip recall was issued after data suggested that about one out of eight implants failed within five years. More than 93,000 of the DePuy ASR components were sold worldwide before the recall, with about 40,000 implanted in the United States.

More than 6,000 metal on metal hip replacement victims are pursuing a DePuy ASR hip lawsuit against the manufacturer, Johnson and Johnson.

The plaintiffs are alleging that the implant was not adequately researched and that warnings should have been provided about the risk of metal-on-metal hip poisoning.

DePuy Pinnacle Lawsuits

Hundreds of individuals are currently pursuing a DePuy Pinnacle lawsuit, after experiencing problems with the older metal-on-metal hip implant, which has also been linked to a high number of failures.

Other Metal on Metal Hip Lawsuits

Similar product liability lawsuits have also been filed over problems with Wright Conserve metal hips, BioMet M2A-Magnum metal hips and other metal-on-metal hip replacements manufactured by other companies.

Can thousands of injured hip replacement patients be wrong?

The DePuy Pinnacle MDL that is consolidated in the Northern District of Texas, has had some new orders issued by the court.

Judge James E. Kinkeade, who is overseeing In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation ("MDL No. 2244"), has issued three new orders that will facilitate the discovery phase of the federal DePuy litigation.

DePuy Pinnacle Hip Replacement Lawsuits

The DePuy Pinnacle hip replacement federal lawsuits have been consolidated in the U.S. District Court for the Northern District of Texas, in Dallas, Texas.

New MDL Court Orders

These orders address:
1. the designation of documents, material, or information as confidential;
2. the remand of an action filed by a plaintiff who had a DePuy ASR hip implant device, and
3. the protocol for the production of documents between plaintiffs and defendants.

More than 1,100 MDL DePuy Pinnacle lawsuits

As of March 31, 2012, there are more than 1,100 DePuy Pinnacle lawsuits pending in the consolidated federal litigation in the Northern District of Texas.

DePuy ASR Metal on Metal Lawsuits

Many plaintiffs have also filed lawsuits, these folks have been implanted with metal-on-metal ASR hip replacement systems, also manufactured by DePuy, in In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation ("MDL No. 2197"), which is currently consolidated in the U.S. District Court for the Northern District of Ohio.

The hip replacement lawsuits allege that the ASR hip replacement and the metal-on-metal Pinnacle hip replacement systems were defectively designed.

DePuy ASR Hips Recalled in 2010

Johnson & Johnson recalled the ASR hip implants in August 2010, perhaps under pressure from the FDA. According to experts, those who received either a DePuy ASR hip implant or a Pinnacle metal-on-metal hip system and have experienced hip replacement pain or had to undergo revision surgery may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.

What is Infuse?

The Medtronic Infuse bone graft is a genetically engineered liquid protein that helps the body to grow its own bone. It includes a bioengineered protein manufactured by Wyeth, called bone morphogenetic protein (BMP).

Scope of the Infuse Problem

Medtronic’s Infuse Bone Graft is used in about a quarter of the estimated 432,000 spinal fusions performed in the U.S. annually, according to the New York Times.

The Infuse system involves three steps:

Small collagen sponges are used to absorb in bone morphogenetic protein (known as rhBMP-2), a substance that encourages bone growth. Sponges are then placed in small, hollow metallic cages. The cages are then implanted in the spine between vertebrae to support the spine while new bone grows between the vertebrae.

FDA Approved Infuse only for Anterior Lumbar Surgery

Medtronic’s Infuse Bone Graft system was FDA-approved in 2002 for anterior approach lumbar fusion surgery. Infuse was not, approved for other types of spine surgeries, including lateral or posterior approach lumbar fusion surgeries or for those on the cervical spine.

Medical research has demonstrated that both approved and off-label uses of Infuse Bone Graft system may cause serious and potentially fatal injuries, such as:

Cancer
Infertility/Sterility
Uncontrolled/Ectopic Bone Growth
Airway Swelling and Compression

Questionable Behavior by Medtronic Infuse Manufacturer

Medtronic, maker of Infuse Bone Graft System, should have conducted thorough and competent research into all possible risks of Infuse. But according to the Spine Journal, Medtronic caused the endangerment of patients who received the Infuse system.

The Spine Journal review found that the 13 original Medtronic-funded studies overestimated the usefulness and downplayed the risks of Infuse component rhBMP-2.

The authors of these studies received an estimated $12 million to $16 million each from Medtronic, and their studies frequently revealed absolutely no Infuse complications.

Other studies that weren’t funded by Medtronic have revealed serious and potentially fatal injuries associated with Infuse Bone Graft system.

Medtronic to Pay $85 Million Lawsuit

Medtronic has agreed to settle a shareholder lawsuit for $85 million, regarding accusations that the company made misleading statements about Infuse.

Shareholders claim that Medtronic failed to disclose that 85.2% of Infuse sales depended on off-label uses that are not approved by the FDA.

They allege that Infuse sales began to drop after the U.S. Department of Justice and the U.S. Senate launched investigations into whether Medtronic was illegally promoting off-label uses of Infuse to doctors.

According to attorneys, DePuy ASR hip implants which were recalled by the company in 2010, will start going to trial later this year to help determine liability and damages in more than 6,000 lawsuits.

J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S. According to medical experts, more than 12 percent of the devices failed within five years.

According to the allegations raised in lawsuits, filed in federal and state courts, patients are in pain and immobilized by joint dislocations, infections, bone fractures, and a medical condition known as metallosis.

What is Metallosis?

Metallosis occurs when there is metal on metal grinding, which releases metal ions into the hip joint and into the bloodstream. This is a form of heavy metal poisoning.

Patients suing J&J, claim metal debris from the hips, made from a cobalt and chromium alloy, causes tissue death around the joint and may increase metal ions in the bloodstream to harmful levels.

Size of the Litigation group

There are approximately 4,200 federal lawsuits filed and consolidated in the multi-district litigation. According to attorneys, another 2,000 are in state courts, and both sides are negotiating bellwether trials or mini trials, to help resolve whether J&J bears blame and how much each case could be worth.

Cost of DePuy Litigation

The company said in January that it spent about $800 million on the recall in the past two years, while it wouldn’t estimate its product liability costs.

The first trial is scheduled to begin in state court in Las Vegas in mid-December. Another trial is slated for January in state court in Maryland. The first federal trial could be next March or April.

The federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

The Biomet M2a-Magnum hip implant is the latest metal-on-metal hip device to come under scrutiny following reports of a wide range of adverse side effects associated with it.

What is Biomet M2A-Magnum Hip?

The Biomet M2A-Magnum Hip is a metal-on-metal hip replacement system that has been implanted in patients throughout the United States.

According to experts, the Biomet M2A Magnum metal on metal hip implant may be subject to early failure within a few years of surgery.

Many patients who were implanted with the Biomet Magnum hip implant have also reported loosening, dislocation, wear or failure of the implant due to the design of the device.

According to Biomet M2A Magnum hip lawsuits, these problems were known to the device manufacturer, yet they continued to market the implant as safe and effective.

Metal on Metal Hip Metallosis

Patients with a defective Biomet Magnum metal on metal hip implant may face metallosis, a medical condition where metal particles build up in the tissue around the implanted joint.

While typical hip implants consist of components made of metal and plastic, the Biomet Magnum has three all-metal components, a metal femoral head, metal taper insert and metal acetabulum cup.

As the metal parts grind against each other, microscopic metal debris may be released into the hip joint, which causes localized inflammation, loosening and other systemic problems associated with metal hip poisoning.

Metal-on-Metal Hip Replacements Biomet Magnum

In recent years, similar problems have affected many patients with DePuy ASR, DePuy Pinnacle, Wright Profemur and other “metal-on-metal” hip replacement systems.

The Biomet Magnum device includes chromium and cobalt in its composition, and both the femoral head and the acetabular cup contain these metals.

The American Academy of Orthopaedic Surgeons expressed alarm in October 2010 regarding potential problems with metal-on-metal hip replacements.

Its warning, directed to consumers and medical providers, stated that pain continuing for months following implantation might be a symptom of metallosis (metal poisoning).

Biomet Magnum Hip Device Recall?

In May 2011, the Food and Drug Administration (FDA) ordered twenty-one manufacturers of hip implant devices to collect and report data on metals levels in the blood of implant patients as well as the adverse health effects that may be caused by them.

About one-third of all hip replacement surgeries in the United States are performed using metal-on-metal devices, and all are now implicated in the examination of them.

A Tennessee man has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage.

According to the complaint, Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects may be irreversible.

The plaintiff alleges that he was prescribed Pradaxa, and after 2 months of use, he suffered a cerebral hemorrhage, as well as other severe personal injuries which are permanent in nature.

Pradaxa FDA Approval

Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 and is one of a number of new blood thinners that have been touted as a superior alternative to warfarin.

Both warfarin and Pradaxa pose a risk of serious bleeding. But warfarin bleeding can be stopped with the administration of vitamin K or a drug called recombinant factor VIIa. There is currently no practical antidote for Pradaxa bleeding.Pradaxa bleeds cannot be stopped since there is no known reversal antidote for this drug.

Pradaxa 260 Deaths

Last year, Boehringer Ingelheim, acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa.

The Institute for Safe Medicine Practices (ISMP) reported that Pradaxa was associated with a total 856 reports of serious, disabling or fatal injury, including 117 bleeding deaths, in the second quarter of 2011.

FDA Investigates Pradaxa

The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects, while regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

Pradaxa the Hits keep coming