Fort Worth Personal Injury Lawyer

Nuvaring Pulmonary Embolism Can Be Deadly

Shezad Malik MD JD — Tue, 15 May 2012 15:48:39 GMT

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?

Originally posted at InjuryBoard by Shezad Malik MD JD

Medtronic Infuse Bone Graft Side Effects Joke Is On You

Shezad Malik MD JD — Mon, 14 May 2012 15:49:00 GMT

Remember the old Chinese proverb, fool me once...

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.

Originally posted at InjuryBoard by Shezad Malik MD JD

Metal-on-Metal Hip Replacements Corrode Faster

Shezad Malik MD JD — Sun, 13 May 2012 15:52:00 GMT

Can the fact that metal on metal hips may corrode faster than hips made from traditional materials, be the casue of their early failure?

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?

Originally posted at InjuryBoard by Shezad Malik MD JD

DePuy Pinnacle Lawsuit: New Federal Court Orders

Shezad Malik MD JD — Sat, 12 May 2012 16:05:00 GMT

The federal consolidation of the DePuy Pinnacle hip litigation is being to move. 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.

Originally posted at InjuryBoard by Shezad Malik MD JD

DePuy Hip Replacement Lawsuits Filed Reaches 6000

Shezad Malik MD JD — Mon, 07 May 2012 21:21:27 GMT

According to Judge David Katz, overseeing the consolidated cases, there are more than 6,000 lawsuits filed against Johnson & Johnson over its defective DePuy ASR hip replacements.

The federal multidistrict litigation (MDL) is consolidated in the U.S. District Court for the Northern District of Ohio, which includes about 4,200 suits. 2,000 cases are filed in state courts, including California, Nevada, Maryland, Florida, Wisconsin and Utah.

The lawsuits are just a fraction of the 93,000 patients who were implanted with DePuy Orthopaedics ASR hip replacement systems between 2005 and mid-2010. DePuy issued a global recall in August of 2010, primarily because of early failure rates.

Experts question why there are not more lawsuits filed and attribute it mainly to a lack of knowledge among the victims and their families and a general lack of interest on part of the implanting orthopedic doctors, who are concerned about possible medical malpractice lawsuits.

What is DePuy ASR Hip-Replacement Bellwether trials?

A bellwether trial is the first trial in the MDL and a sample case that can set precedent for the other cases that follow. If the plaintiffs win the first rounds of bellwether trials convincingly and with good jury verdicts, that will send the message to DePuy. DePuy will then be more inclined to issue a global settlement and pave the way to giving victims the much deserved monetary compensation.

The first federal trial could be as soon as March or April 2013. The first DePuy hips case to be tried in state court is scheduled for December 3, 2012, in Las Vegas, Nevada. A second state case has been scheduled for January 2013 in Maryland state court.

Originally posted at InjuryBoard by Shezad Malik MD JD

Medtronic Infuse Bone Graft System Linked to Serious Risks

Shezad Malik MD JD — Sun, 06 May 2012 21:23:00 GMT

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.

Originally posted at InjuryBoard by Shezad Malik MD JD

The Problem with Biomet M2a Magnum Hips

Shezad Malik MD JD — Fri, 04 May 2012 21:28:00 GMT

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.

Originally posted at InjuryBoard by Shezad Malik MD JD

Bard BellWether Trials Over Vaginal Mesh Injuries

Shezad Malik MD JD — Thu, 03 May 2012 21:45:33 GMT

C.R. Bard Inc. will face its first federal-court trial in 2013 over claims that the company’s vaginal-mesh implants injured women. U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 Bard Avaulta mesh federal cases. The plaintiffs are alleging that Bard’s Avaulta device caused pelvic organ damage.

The West Virgina court is overseeing the MDL consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.

Bard and Johnson and Johnson on the hook

Bard, based in Murray Hill, New Jersey, and a unit of New Brunswick, New Jersey-based J&J also face litigation in U.S. state courts over their mesh products.

Scope of the Vaginal Mesh Problem

More than 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse, or to deal with incontinence.

FDA Mesh Warning

A U.S. Food and Drug Administration report in August 2011 found that vaginal-mesh products should be classified as posing a high risk to patients based on a review of side-effect reports submitted to regulators from January 2008 to December 2010.

FDA Demands More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ), to study rates of organ damage and complications linked to the vaginal-mesh implants.

According to regulators, the companies must conduct three years of studies on the devices’ safety and effectiveness.

New Jersey Mesh Lawsuits

Some mesh lawsuits are pending in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee is coordinating discovery in those cases.

Higbee has set a Nov. 5 trial for the first case against J&J’s Ethicon unit over claims that its Gynecare Prolift vaginal-mesh insert harmed women.

West Virginia Federal MDL

In February, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before Goodwin. The federal court is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp. (BSX) and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-MD-02187, U.S. District Court, Southern District of West Virginia (Charleston).

Originally posted at InjuryBoard by Shezad Malik MD JD

Bayer pays out $142 M in Yasmin Lawsuit Settlements

Shezad Malik MD JD — Wed, 02 May 2012 21:31:00 GMT

According to Bayer AG, the German pharmaceutical giant has shelled out $142 million so far, in settlements of U.S. lawsuits claiming that its Yaz, Yasmin and Ocella line of birth-control pills caused blood clots.

Bayer, said today in its Stockholders’ Newsletter for the first quarter, that it has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks, deep vein thrombosis, pulmonary embolism and strokes.

The company said it paid $142 million in the settlements, for an average of about $218,000 a case.

According to experts, Bayer's strategy is to avoid the possibility of a large jury award in these clot cases; settlements provide a fixed and determinable amount when it comes to the cost of resolving these cases.

Bayer's Hit could be as high as $2.65 Billion

Bayer’s update comes after financial analysts estimate that the drugmaker may have to pay more than 2 billion euros ($2.65 billion) to resolve all the cases over the contraceptives.

FDA New Warning Label

The U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen blood-clot warnings on their products.

FDA Drospirenone Blood Clot Triple Risk

Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.

The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line.

Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them one of the drugmaker’s biggest-selling drugs.

Federal 11,900 Suits

As of April 18, Bayer faced 11,900 lawsuits over Yaz and Yasmin in the U.S. involving about 14,000 plaintiffs, the company said.

YAZ Gallbladder Cases

Bayer is rejecting women’s claims that the contraceptives damaged their gallbladders or caused them to suffer from gallstones.

Yasmin Bellwether Trials on Hold

The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.

The Judge David R. Herndon, of the U.S. District Court for the Southern District of Illinois, extended a stay for the bellwether process on April 19, delaying all deadlines for the third time this year.

The bellwether process was established in the Yaz MDL to allow the parties to prepare a small group of cases for early trial dates and help gauge how juries are likely to respond to certain evidence that is presented throughout the litigation. Bellwether trials are often scheduled in complex pharmaceutical litigation to help facilitate settlement negotiations.

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).

Originally posted at InjuryBoard by Shezad Malik MD JD

Merck Reports 950 NuvaRing Lawsuits

Shezad Malik MD JD — Sat, 14 Apr 2012 13:50:19 GMT

According to Merck & Co., Inc. form 10-K annual report for the fiscal year 2011, published on February 28th, approximately 950 NuvaRing lawsuits were pending as of Dec. 31st 2011. Beginning in May 2007, a number of complaints were filed in various jurisdictions asserting claims against the Company’s subsidiaries Organon USA, Inc., Organon Pharmaceuticals USA, Inc., Organon International (collectively, “Organon”), and Schering-Plough arising from Organon’s marketing and sale of NuvaRing, a combined hormonal contraceptive vaginal ring.

This information was buried deep in the report, pages 118,119 of a 168 report. The plaintiffs are alleging damages for personal injuries sustained from NuvaRing, including deaths, venous thromboembolism, deep vein thrombosis, pulmonary embolism and strokes.

One of many injuried plaintiffs is our own client, Dawn Kregel, from Denton Texas, who has filed a $10 million lawsuit against the manufacturers of NuvaRing, claiming she suffered a massive deep vein thrombosis shortly after using the birth control device.

Dawn Kregel, a nurse, filed suit against Organon USA Inc., Organon Pharmaceuticals USA Inc., Organon International Inc., Schering-Plough Corp. and Merck & Co. Inc. on Jan. 9 in the Eastern District of Texas, Sherman Division.

Kregel used the NuvaRing, for just over a month in 2010.
She states she was subsequently diagnosed with an extensive whole leg deep vein thrombosis, that required emergency surgery to prevent a massive potentially lethal pulmonary embolism.

Kregel argues that the defendants failed to warn that that the ring product was associated with more thrombotic events than the pill. The defendants are accused of marketing, promoting and advertising that the ring product had a relatively low amount of estrogen in an effort to hide that it had a high level of dangerous third-generation progestin.

What is Nuvaring

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), a vaginal contraceptive ring. NuvaRing is a birth control vaginal ring placed around the cervix, that slowly releases female hormones of estrogen and a 3rd generation progestin, that inhibits ovulation.

NuvaRing was approved by the FDA in October 2001 and it is marketed and sold by subsidiaries of Merck, Organon USA Inc. and Schering-Plough.

FDA Study

In 2011, the FDA published a birth control study revealing that the NuvaRing raised the risk of blood clots including DVT and PE by 56% when compared to older birth control pills.

Approximately 820 cases are or will be pending in a federal multidistrict litigation (MDL 1964) in Missouri and approximately 125 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey.

Plaintiffs Complaints

The plaintiffs contend that Organon and Schering-Plough, among other things, failed to adequately design and manufacture NuvaRing and failed to adequately warn of the alleged increased risk of venous thromboembolism (“VTE”) posed by NuvaRing, and/or downplayed the risk of VTE.

Originally posted at InjuryBoard by Shezad Malik MD JD