Dallas Fort Worth Injury Lawyer Blog

Nuvaring Pulmonary Embolism Can Be Deadly

Sat, 12 May 2012 09:08:30 -0600

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 Infuse Bone Graft Side Effects no Laughing Matter

Wed, 09 May 2012 08:53:20 -0600

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.

Metal-on-Metal Hip Replacements Corrode Faster

Tue, 08 May 2012 19:49:21 -0600

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?

DePuy Pinnacle Lawsuit: New Court Orders

Mon, 07 May 2012 10:30:59 -0600

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.

Medtronic Infuse Bone Graft System Linked to Serious Risks

Sat, 05 May 2012 10:29:10 -0600

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.

DePuy ASR Hip Patients Bellwether Trials in 2012

Fri, 04 May 2012 19:59:41 -0600

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 Problem with Biomet M2a Magnum Hips

Thu, 03 May 2012 11:31:52 -0600

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.

Pradaxa Cerebral Hemorrhage Lawsuit

Wed, 02 May 2012 12:11:59 -0600

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

Bayer pays out $142 M in Yasmin Lawsuit Settlements

Thu, 26 Apr 2012 17:25:26 -0600

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).

DePuy Pinnacle Hip Lawsuit MDL Status Update

Wed, 25 Apr 2012 18:15:55 -0600

Today, in Dallas, Texas, my home town, the attorneys involved in the multi-district consolidated federal DePuy Pinnacle litigation, met with Judge Ed Kinkeade, who is overseeing the MDL Court.

The topics that were discussed included the recent Case Management Order that is to provide a schedule for proceeding with the Pinnacle metal on metal hip lawsuits.

From my vantage point in the "peanut gallery," I counted 6 attorneys from the defense and about 35 plaintiff attorneys and each side made a short presentation on the status of the lawsuits at this time.

The court announced that there were about 1,245 Pinnacle lawsuits on file at this time. Experts believe that number will increase as more victims will require hip revision surgery, over the next few years.

Attention and discussion was given to formulating a standardized short and long form federal petition or lawsuit, an agreed to plaintiff fact sheets (streamlined discovery), confidentiality order, deposition schedules, a protocol for joint production of documents and determining what types of metal on metal hip replacements should be considered a "Pinnacle" lawsuit.

No firm progress had been made regarding these items. The court indicated that it expected that these issues to be resolved within a month, certainly before the next scheduled status update meeting, which is tentatively set for in 6 weeks.

Dallas Texas DePuy Pinnacle MDL

The U.S. Judicial Panel on Multidistrict Litigation centralized pretrial proceedings in the cases before Judge Kinkeade in the in the U.S. District Court for the Northern District of Texas, as part of an MDL, or multidistrict litigation.

DePuy Pinnacle Injuries and Allegations

All of the DePuy Pinnacle lawsuits involve similar claims that the product was negligently designed with defects in the DePuy Pinnacle hip that caused plaintiffs to suffer injuries with their implant within a few years, often resulting in the need for revision surgery.

DePuy ASR Ohio MDL

Johnson & Johnson and DePuy also face over 6,000 lawsuits over their DePuy ASR hip replacement. Those cases are consolidated in a separate MDL, which is pending in the U.S. District Court for the Northern District of Ohio.

Visit the US District Court for the Northern District of Texas and review the case management orders here.

Nuvaring Blood Clots 2012 Update

Sun, 22 Apr 2012 13:07:09 -0600

Approximately 1,000 women across the United States who suffered serious blood clot side effects have filed a Nuvaring lawsuit claim.

What is Nuvaring?

NuvaRing birth control is a third generation contraceptive manufactured by Organon USA. Organon is part of the Schering-Plough Corporation, which is now owned by Merck.

Nuva Ring birth control is a flexible polyethylene ring that contains a combination of the hormones estrogen and etonogestrel which is a synthetic form of the progestin desogestrel. NuvaRing uses a different form of progestin compared to older contraceptives.

NuvaRing birth control was approved by the Federal Drug Administration (FDA) in October 2001. It was first marketed in the United States in July 2002.

How Does Nuva Ring Work?

NuvaRing releases hormones, and the hormones are absorbed through the vaginal wall.

The hormones inhibit a fertilized egg from being implanted. In addition, the cervical mucous becomes thicker which helps prevent sperm from entering the uterus.

Nuvaring Pulmonary Embolism

NuvaRing pulmonary embolism, is a serious side effect reported by women using this third-generation contraceptive.

Venous thrombo embolism events have been linked to NuvaRing. Pulmonary embolism (PE), deep vein thrombosis (DVT), and ischemic strokes are some of the side effects being associated with NuvaRing.

What is a Pulmonary Embolism?

A pulmonary embolism is a sudden blockage in a lung artery. The cause is usually a blood clot in the leg called a deep vein thrombosis that breaks loose and travels through the bloodstream to the lung.

Pulmonary embolism is a serious condition that can cause permanent damage to the affected lung or sudden death in severe cases. 50% of victims who have pulmonary embolism have no symptoms. Typical symptoms include shortness of breath, chest pain or coughing up blood.

What is a Deep Venous Thrombosis?

Venous thrombosis is a blood clot that forms in a vein. This slow or prevent blood flowing through the veins, causing swelling and pain. In most cases, venous thrombosis occurs in the “deep veins” in the legs, thighs or pelvis; this is called a deep vein thrombosis, DVT.

If the blood clot breaks off from the leg, it can travel to other organs; this is called an embolism. If the clot lodges in the lung, it is called pulmonary embolism (PE). PE is a serious medical condition that can cause death.

Victims who have a DVT or PE have a higher risk of developing another blood clot in the future.

Status of Nuvaring Lawsuits

As of April 2012, the NuvaRing litigation has climbed to almost 1,000 individual injury lawsuits filed in state and federal courts throughout the United States. Many more lawsuits are expected to be filed in the upcoming months as the slowing moving litigation begins to heat up, and progesses to the bellwether trial stage.

According to experts, many more severly affected Nuvaring victims are out there waiting to file their claim against Merck.

To date, there have been no reported NuvaRing settlements and the first trials are not expected to begin until early 2013.

All of the lawsuits involve similar allegations that the manufacturer failed to adequately research the side effects of the birth control ring or warn woman that they may face an increased risk of blood clots compared to older birth control pills.

Federal Nuvaring MDL

The majority of NuvaRing personal injury and death claims throughout the United States have been consolidated for pretrial federal proceedings as part of a multidistrict litigation or NuvaRing MDL.

All lawsuits filed in federal courts throughout the U.S. are automatically removed and centralized in the U.S. District Court for the Eastern District of Missouri to avoid different rulings and speed up discovery proceedings. This is known as the Federal MDL.

Some Nuvaring injury cases have been selected for early trial dates, this process is known as “bellwether” trials. Bellwether trials help the plaintiffs and the defense assess how juries are going to respond to the blood clot and alleged lack of warning evidence that will be introduced in the litigation.

State Nuvaring MDL

Some Nuvaring personal injury and death lawsuits have been filed in New Jersey. Merck's corporate headquarters is in New Jersey. The New Jersey NuvaRing litigation has been centralized as a “Mass Tort” in Bergen County.

FDA Aliskiren New Warning and Contraindication

Sat, 21 Apr 2012 10:33:09 -0600

Federal regulators at the Food and Drug Administration (FDA) have issued a warning about the combination of blood pressure medication Aliskiren (Tekturna) with ACE inhibitors and angiotensin receptor blockers (ARBS) in diabetics or kidney patients.

Novartis, the maker of Aliskiren, announced that the TekturnaR labels have been updated in the US, following the FDA's review of the preliminary findings from the ALTITUDE study.

Altitude Study

The ALTITUDE study, found an increased risk of adverse events in patients who were taking the direct renin inhibitor as an add-on to other anti-hypertensive medications such as ARBs and ACE inhibitors.

The FDA said that diabetic patients who mix the drugs are at risk of renal impairment, hypotension, and hyperkalemia.

Novartis, has decided to cease marketing in the US of ValturnaR (aliskiren and valsartan, USP), a single pill combination of aliskiren and the ARB valsartan. Valturna will no longer be marketed after July 2012.

Medications that contain aliskiren include:

Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
Tekturna (aliskiren hemifumarate)
Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
Tekamlo (aliskiren hemifumarate and amlodipine besylate)
Valturna (aliskiren hemifumarate and valsartan).

FDA Medwatch

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm

da Vinci Robot Personal Injury Lawsuits

Fri, 20 Apr 2012 11:55:39 -0600

Wrongful death and personal injury lawsuits are being filed against Intuitive Surgical, Inc., the maker of the da Vinci Robotic system. These lawsuits are alleging that patients are being injured following the use of a da Vinci robot during a hysterectomy and other surgeries.

Recently a case was filed by Gilmore McCalla in the U.S. District Court for the Southern District of New York on April 4, alleging that the death of his daughter, Kimberly McCalla, was caused by problems with the device used during her robotic surgery.

What is the da Vinci Robotic System?

The da Vinci surgical robot is a medical surgical machine that features four remote controlled arms and a camera, allowing surgeons to operate through a small incision with a joystick-like control.

The device is touted as less invasive surgery and shorter recovery times, but there have been a large number of serious and fatal complications and problems associated with the da Vinci surgical robot.

da Vinci Surgical Robot Background

Intuitive Surgical received clearance from the U.S. Food & Drug Administration (FDA) to market the da Vinci Surgical Robot in 2000.

The robot, which can cost hospitals as much as $2 million, is controlled remotely from a console, while the robot’s arms are placed into the patient for burning away tissue in order to remove the diseased organs.

Da Vinci Lawsuits

The da Vinci surgical robot lawsuits allege that the manufacturer, Intuitive Surgical, failed to adequately research the device or warn patients and the medical community that use of the robot carries a substantial risk of complications and injuries, including burns, tears, dehiscence, bleeding, hematomas, sepsis and fistulas.

The complaints claim that the Da Vinci surgical robot is defective, that relies on use of monopolar energy to cut, burn and cauterize tissue, although safer methods are available that would reduce the risk of complications.

The device also has inadequate insulation for the arms, allowing electrical current to pass into the tissue outside of the operative field. The injuries do not always appear immediately during the actual operation, which can further increase the seriousness of the complications.

Da Vinci Health Benefits?

Both the American College of Obstetricians and Gynecologists and the Kaiser Foundation have raised questions over the widespread adoption of the robot at many hospitals.

In addition to failing to adequately research the device, Intuitive Surgical has allegedly failed to reveal through publications or reports to the FDA the true extent of complications and injuries that have occurred. The complaint also alleges that the company has suppressed reports of complications and performance errors.

Research suggests that hundreds of cases may be necessary before a surgeon becomes proficient at use of the device, Intuitive Surgical only provides hospitals with a two-day course operating on human and pig cadavers, followed by four live cases supervised by a proctor.

Study: Doctors Need 1,600 Robot-Aided Prostate Surgeries to be Competent

Thu, 19 Apr 2012 13:55:07 -0600

According to researchers, doctors who perform robotic-assisted prostate cancer surgery are not skilled enough to able to remove all the cancer cells until they have done the procedure more than 1,600 times.

According to Prasanna Sooriakumaran, lead author and urologist, results from a study suggest the operations using Intuitive Surgical Inc.’s da Vinci robot are being performed too often at community hospitals by surgeons without enough experience.

According to the American Society of Clinical Oncology, more than 90,000 men in the U.S. have their prostate gland removed each year because of cancer.

The surgery is typically by doctors who perform 100 or fewer procedures annually, done mainly with robotic technology introduced in 2000 by Sunnyvale, California- based Intuitive Surgical.

Removing Malignant Cells

According to the study, the surgeons needed to perform more than 1,600 operations before they were able to gauge with at least 90 percent accuracy how much tissue surrounding the tumor they needed to remove to get all the malignant cells.

Leaving stray cancerous cells in the margins, at the edge of the tissue removed during surgery, can lead to recurrences of the disease.

Da Vinci Robotic System

Intuitive Surgical Inc., which manufactures Da Vinci, promotes the robot’s treatment of bladder, colorectal, gynecologic, kidney, prostate and throat cancers, and also marketed for coronary artery disease, endometriosis and obesity.

Da Vinci Lawsuits filed

Lawsuits are being filed, alleging tears and burns to blood vessels, intestines and reproductive organs, complicated by the fact that problems generally aren’t apparent until after surgery, resulting in delayed treatment.

Merck Reports 950 NuvaRing Product Liability Lawsuits

Sat, 14 Apr 2012 12:13:23 -0600

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.

This critical information is buried deep in the financial disclosures, pages 118, 119.

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.

Nuvaring Lawsuit Status

As of December 31, 2011, there were approximately 950 NuvaRing cases. Of these cases, approximately 820 are or will be pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before Judge Rodney Sippel, and approximately 125 are pending in coordinated discovery proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. Four additional cases are pending in various other state courts.

Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties originally selected a pool of more than twenty cases to prepare for trial and that pool has since been narrowed to eight cases from which the first trials in the NuvaRing MDL will be selected.

Pursuant to Judge Martinotti’s order in the New Jersey proceeding, the parties selected ten trial pool cases to be prepared for trial. The parties have completed fact discovery in the originally selected trial pool cases in each jurisdiction and Merck anticipates expert discovery to be
completed in those first trial pool cases by the summer of 2012.

What is Nuvaring

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.