Dallas Fort Worth Injury Lawyer Blog

A lawsuit has been filed against AstraZeneca by two Texans who allege that Nexium caused them to suffer bone fracture side effects. The complaint was filed by Mary Mai Nguyen and Tuoc Duong on September 15 in Harris County, Texas against AstraZeneca.

According to the Nexium lawsuit, the defendants failed to adequately research the heart burn medication or warn about the potential risk of Nexium bone problems. Nexium (esomeprazole) is a member of a class of drugs known as proton pump inhibitors (PPIs).

A number of similar bone fracture lawsuits involving Nexium and other proton pump inhibitors have been filed in recent months. Other drugs in the class include Prilosec, Aciphex, Prevacid, Protonix, Vimovo and Zegerid.

In 2010 and in 2011, the FDA warned that there may be an increased risk of bone fractures from Nexium and the other PPI medications. The risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time.

The Texan plaintiffs allege in their Nexium suit that studies as early as 2006 found the PPIs interfere with the body’s ability to absorb calcium, speeding up bone loss and leading to an increased number of bone fractures. According to the complaint, AstraZeneca was aware of the Nexium bone fracture risk, and their “marketing efforts obscured, misrepresented and obfuscated this information.”

The FDA announced in March 2011 that they are requiring new warnings about the risk of bone fractures from Nexium, Prilosec, Protonix, Prevacid, Zegerid, Aciphex and Vimovo, as the heartburn drugs have been associated with a number of hip fractures, wrist fractures, spine fractures and other injuries.

FDA Update: 3/23/2011
FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely.

The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.

In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14 day course of treatment up to 3 times per year. FDA acknowledges that consumers, either on their own, or based on a healthcare professional’s recommendation, may take these products for periods of time that exceed the directions on the OTC label. Healthcare professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label.

The label changes for the proton pump inhibitors (PPIs), come after the agency looked at a number of studies that linked the drugs to increased bone fracture risks. PPIs are designed to fight the symptoms of a number of gastrointestinal ailments by reducing the body’s production of stomach acid.

The new bone fracture warnings affect both other-the-counter and prescription heartburn drugs, including:

Nexium
Prilosec and Prilosec OTC
Prevacid and Prevacid 24HR
Protonix
Zegerid and Zegerid OTC
Aciphex
Vimovo

The types of bone fractures associated with the drugs include

Hip fractures
Wrist fractures
Spine fractures

The new warnings come just days after the results of a study were published in the Archives of Internal Medicine that linked the use of Nexium, Prilosec and other PPIs to a 25% increase in the risk of bone fractures in women. The risks appear to be connected to long-term use of the drugs of a year or more, but FDA has decided to place the bone fracture risk warning even on those drugs which are not recommended for use longer than two weeks at a time.

U.S. Food and Drug Administration (FDA) issued a warning Monday about an increased risk of blood clots in women taking newer forms of birth control pills, such as Yaz or Yasmin.

The FDA did say it "remains concerned" about a potentially higher risk of blood clots in women taking the "fourth generation" pills containing drospirenone, a new type of synthetic progestin. These new pills, marketed as Yaz, Ocella or Yasmin, among other brand names, are very popular.

Venous thrombosis embolism (VTE) are clots that originate in the legs and can travel to the lungs, causing a medical condition known as pulmonary embolism. Symptoms include leg pain, chest pain or sudden shortness of breath.

Preliminary results of an FDA-funded study show a 50 percent increased risk of VTEs in women taking drospirenone-containing pills versus other hormonal contraceptives.
According to the FDA, the risk to any one woman remains small: the risk of a VTE is about six women per 10,000 users for the older contraceptives versus 10 per 10,000 using the newer versions.

The agency also reviewed six other studies on the subject, the results of which were conflicting. Two studies found no difference in risk, while another two found a 1.5-fold to 2-fold increased risk. And two more studies, appearing earlier this year in the BMJ, found double to triple the risk. The FDA issued a similar safety communication at the end of May, after the two BMJ studies came out.

Risk factors for VTE include smoking, being overweight or a family history of blood clots. The FDA statement released Monday noted that studies to date have only looked at pills containing drospirenone and a higher dose of estrogen, not those containing drospirenone and a lower dose of estrogen. FDA advisory committees are scheduled to investigate further into the matter at a December meeting, at which time the full findings of the agency-funded study will be released.

Data Summary
FDA has reviewed six published epidemiologic studies that evaluated the risk of blood clots (venous thromboembolism, VTE) in women using birth control pills containing drospirenone. These studies have conflicting findings. Two were postmarketing studies required by the FDA or European regulatory agencies.1,2 These studies did not report any difference in VTE risk between drospirenone-containing products and products containing levonorgestrel or other progestins. Two publications from 2009, however, reported a 1.5- to 2-fold higher VTE risk in women who use drospirenone-containing contraceptives as compared to the risk in women who use levonorgestrel-containing contraceptives.3,4 More recently, two articles published in 2011 in the British Medical Journal reported a 2- to 3-fold greater risk of blood clots in women using oral contraceptives containing drospirenone rather than levonorgestrel.5,6 As with all epidemiologic studies, there are methodological issues that make interpretation of these conflicting results complex. FDA has not reached a conclusion on the risk for blood clots in women using drospirenone-containing birth control pills, but remains concerned about the potential increased risk.

Initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives. To put this risk into perspective, if the risk of developing a blood clot among women using other hormonal contraceptives is about 6 women in 10 thousand, then the risk of developing a blood clot among women using drospirenone-containing oral contraceptives would be about 10 women in 10 thousand. The full study report of this study, along with the completed FDA review of the results of the study, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December 2011.

FDA notes that the available studies have only examined the risk of VTE in users of contraceptive pills that contain drospirenone and 0.03 mg of ethinyl estradiol (an estrogen) and not other pills that contain drospirenone combined with a lower dose of estrogen (e.g., 0.02 mg ethinyl estradiol). It is unknown at this time whether the reported VTE risk applies to all drospirenone-containing products.

Table 1. Approved Oral Contraceptives containing Drospirenone

Brand name
Generic name
Drospirenone and ethinyl estradiol
Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Ocella
Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Safyral
Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
Syeda
Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Yasmin
Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Zarah
Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Beyaz
Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
Drospirenone and ethinyl estradiol
Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Gianvi
Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Loryna
Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Yaz
Drospirenone 3 mg and ethinyl estradiol 0.02 mg

As a Texas Medical Doctor and DePuy ASR Failure Attorney, I am providing this update and commentary on a recent British database study.

According to a British database, the National Joint Registry for England and Wales, which tracks hip replacement problems, a number of recalled DePuy ASR metal hip implants are failing within six years. Data from the National Joint Registry for England and Wales indicates that 29% of patients who received the DePuy metal-on-metal hip replacement have reported that they failed after only six years of use.

DePuy Orthopaedics, a division of Johnson & Johnson, issued a DePuy ASR hip recall last year, indicating that about 12% to 13% of these hips mail fail within five years. More than 90,000 DePuy ASR XL Acetabular Systems and DePuy ASR Hip Resurfacing Systems were sold worldwide before the metal-on-metal hip implants were recalled in August 2010. About 40,000 of those were sold in the United States.

Johnson & Johnson currently faces more than 1,000 DePuy metal-on-metal hip lawsuits that have been filed by patients whose devices failed or who have suffered metallosis. According to experts, Johnson & Johnson may have to pay out more than $1 billion in liability over the defective hip devices. Earlier this summer, it was reported that Johnson & Johnson has increased its liability fund by $570 million to cover the cost of DePuy ASR settlements.

All hip implants that use metal-on-metal designs appear to have a higher failure rate than other types of artificial hips. A hip implant is supposed to last an average of about 15 years. But, many all-metal hip replacement systems are failing much faster, causing crippling injuries, metal blood poisoning and often requiring revision surgery to have the devices replaced.

Metal-on-metal hip replacements, which use cobalt and chromium, accounted for about one-third of the 250,000 hip replacements performed in the United States in recent years. But, concerns over metal-on-metal hip replacement and metallosis have caused many orthopedic doctors to move away from the devices in recent months. According to the registry, all types of hip implants, including combinations of ceramic, plastic and metal, have only a 4.7 percent failure rate after seven years. Metal-on-metal hip implants have a failure rate of 14 percent.

As the metal hip replacement ball and socket grind against each other, cobalt and chromium metallic particles may be shed into the body, which can result in metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, and local necrosis that may lead to the need for a risky hip revision surgery.

The FDA has requested metal hip manufacturers to provide more data on metallosis and metal on metal hip implants.

30 plaintiffs who have filed a vaginal mesh lawsuit against C.R. Bard, are asking the U.S. Judicial Panel on Multidistrict Litigation (JPML), to include these cases as part of the consolidated federal Bard Avaulta litigation.

In October 2010, the JPML ordered that all federal Bard Avaulta pelvic mesh lawsuits be consolidated before U.S. District Judge Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation for coordinated pretrial proceedings.

This MDL included cases filed by women who received three different types of Bard surgical mesh used for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI): the Bard Avaulta Biosynthetic, Bard Avaulta Plus and Bard Avaulta Solo mesh. These products were sold by C.R. Bard and manufactured by either Bard or subsidiaries of Covidien plc.

These complaints were filed by women who received other Bard pelvic repair products, such as Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex or Align mesh. All of these products were also sold by C.R. Bard and manufactured by either Bard or Covidien subsidiaries.

All of the pelvic repair mesh lawsuits involve similar allegations that the defendants designed and sold defective and dangerous products without providing appropriate warnings or instructions. All of the Bard pelvic mesh products, which are also known as transvaginal mesh, are used to support the bladder and/or uterus organs. The mesh is often used as a sling or support to prevent the organs from prolapsing into the vagina or rectum.

The Bard pelvic slings have been associated with reports of serious and debilitating complications, including erosion of the mesh into the vagina or rectum, infection, movement of the mesh, pelvic pain and injury to nearby organs.

In recent months, a growing number of pelvic mesh lawsuits have been filed against Bard, Covidien and manufacturers of other similar products. Public awareness about the risk of transvaginal mesh problems increased after the FDA issued a warning this summer. The FDA also held an advisory panel meeting earlier this month to determine whether a pelvic mesh recall should be issued.

In July 2011, the FDA issued a statement directed at consumers and the medical community indicating that they have been unable to find any evidence that Bard pelvic mesh or other transvaginal mesh products used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

Plaintiffs argue that all of the Bard pelvic repair products should be included in the same multidistrict litigation (MDL), as they will involve common questions of fact relating to Bard’s and/or Covidien subsidiaries’ research, development, design, testing, manufacturing, selling, marketing and labeling of these products.

According to the motion, attorneys for the various defendants involved in the cases have indicated they support the expansion of the Bard Avaulta litigation to include all Bard pelvic mesh lawsuits.

Consolidation of complex product liability lawsuits into an MDL help reduce duplicative discovery for all parties, eliminate inconsistent pretrial rulings and avoid potentially conflicting deadlines in different courts.

The 29 Bard mesh lawsuits that are not currently included in the MDL are now pending before at least 12 different judges in 3 different federal district courts.

According to the concerned women who are calling our offices; they believe that the FDA and other U.S. regulators have failed them by not requiring extensive testing before allowing Johnson & Johnson (JNJ) and other manufacturers to sell the type of surgical mesh implanted in them, to hold their pelvic organs in place. Now many these callers say that they cannot work, sleep through the night, or have sex with their partners due to endless pain.

There are about 270 lawsuits pending against J&J. In all, about 600 suits have been filed against it and other mesh makers, including C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings.

The U.S. Food and Drug Administration warned on July 13 of a fivefold increase in women suffering pain and injuries after surgeons inserted mesh through vaginal incisions. Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”

In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures.

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The reports don’t always differentiate between transvaginal and abdominal procedures.

The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.

The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.

FDA recommends that health care providers:
• Recognize that in most cases, POP can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

The FDA recommends that patients:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

Last week an advisory panel agreed with FDA staff that the agency should reclassify mesh from moderate risk to high risk of harming patients if it fails, and require more studies to determine if they are safe and effective.

Personal injury lawyers say they expect a surge in lawsuits by women because of the dangers of transvaginal mesh for pelvic organ prolapse, POP. POP refers to a condition in which the uterus or bladder bulge, or prolapse, into the vagina.

None of the cases have been tried, and women must prove their claims that mesh makers knew of safety risks and failed to disclose them and that the products were defective. JNJ, Boston Scientific, Bard, and American Medical Systems told the FDA advisory panel that using mesh in transvaginal procedures is safe and effective and serious injuries are rare.

About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year, including more than 70,000 who received vaginal meshes. Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction, a fivefold increase from 2005 to 2007.

Bard, which estimated the global prolapse mesh market at $175 million, saw its own pelvic prolapse business fall about 30 percent in 2010 due to what it called “regulatory delays” on product approvals. J&J is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard. According to experts, the law suits are another high-profile controversy pushing the FDA toward toughening its approval process for devices. As moderate-risk devices, vaginal meshes currently need only show that they are “substantially equivalent” to existing products. A change to a high-risk status would require tests to show efficacy and safety.

As a Texas medical doctor and Actos Bladder Cancer Attorney I am providing this information and commentary. The maker of the world's best-selling diabetes drug is facing many lawsuits as adverse medical research shows that taking the pill for more than a year raises the risk of bladder cancer.

A motion was filed asking for all federal Actos bladder cancer lawsuits to be centralized before one judge for coordinated handling during pretrial proceedings as part of an MDL, or multidistrict litigation.

There are about 12 lawsuits over Actos that have been filed in federal district courts. Experts believe that hundreds of complaints that will likely be filed on behalf of individuals who claim they developed bladder cancer from side effects of Actos.

The motion was filed on August 31 by plaintiffs Glen and Nina Weant, who have petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal Actos lawsuits in the U.S. District Court for the Southern District of Illinois before Judge Murphy. According to the filing, there are at least 12 lawsuits pending in 8 different federal district courts throughout the United States involving individuals who developed bladder cancer after Actos use.

All of the lawsuits involve similar allegations that Takeda Pharmaceuticals, the makers of Actos, failed to adequately research their medication or warn about the increased risk of bladder cancer when Actos is used for long periods of time.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the study conducted by Takeda Pharmaceuticals, indicated that after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

In June, an Actos recall was issued in France after a review of public insurance data identified an increased incidence of bladder cancer with Actos use. The European Union’s European Medicines Agency (EMA) also conducted a review and confirmed the bladder cancer risk, calling for new warnings and a six-month review of every patient on Actos.

Consolidation of the Actos litigation before one judge as part of an MDL is designed to reduce duplicative discovery, avoid contradictory rulings from different judges and to serve the convenience of the court, witnesses and parties. While the pretrial management of the cases in an MDL is often managed similar to how an Actos class action lawsuit would be handled, each claim will still remain an individual lawsuit.

During pretrial proceedings the Court will coordinate discovery and help facilitate a possible Actos settlement agreement. The U.S. Judicial Panel on Multidistrict Litigation is not likely to schedule a hearing on the petition until at least December 1, when they are scheduled to hold a hearing session in Savannah, Georgia.

As a Texas medical doctor and Fosamax femur fracture injury Attorney, I am fielding many calls from concerned plaintiffs regarding their side effects from using Fosamax and similar drugs. We are providing the following update and commentary.

A FDA advisory committee wants the agency to limit the duration of bisphosphonate therapy for treatment of osteoporosis. This year, the FDA required that all bisphosphonates used to prevent or treat osteoporosis warn on their labels that optimal duration of use hasn't been determined. The issue has become concerning to the FDA as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee met to discuss whether emerging reports of adverse events should cause the FDA to change the label to indicate that the drug not be used long term. The medical advisers did not press the issue as strongly as the F.D.A. staff itself did in a 45-page report issued on Wednesday. The staff report said studies “suggest no significant advantage of continuing drug therapy beyond five years.”

According to the FDA panel placebo-controlled trials provide data for only five years of therapy, but there is no clinical evidence that bisphosphonates work better after they are used for a long period of time.

Bisphosphonates are prescribed to some 5 million patients annually to prevent or treat osteoporosis and are highly effective at reducing the risk of osteoporotic fractures. The drugs, which include brand-names Actonel, Atelvia, Boniva, and Reclast, have been shown to reduce the risk of breaking a hip by 40% to 50% and fracturing a vertebra by between 40% and 70% by inhibiting bone resorption to prevent loss of bone mass.

In 2010, the FDA required makers of bisphosphonate drugs to add a warning to their labels about an increased risk of atypical femur fractures after an American Society for Bone and Mineral Research task force concluded that the risk is real.

The panel heard from women who were taking bisphosphonates to prevent osteoporosis when suddenly and painfully, they broke their femurs. One woman was on a subway train that screeched to a halt, and as her weight was thrust onto one leg, her femur snapped and she collapsed. Other women had similar stories -- a teacher reaching something in front of her students, a grandmother taking a large step to walk toward her grandchild, a woman walking down a front stoop to pick up the morning newspaper -- and in each case the women collapsed to the ground as their femurs snapped.

The panel was also concerned with the drug's link to deterioration of the jawbone. In 2005, the FDA added a warning on bisphosphonates about osteonecrosis of the jaw, a rare disease in which the bone in the jaw dies. In data presented Friday, an FDA reviewer said the risk for osteonecrosis of the jaw appears more prevalent after four years or more of use.

There are also some data suggesting a link to long-term use of bisphosphonates and esophageal cancer. In 2009, a study in the New England Journal of Medicine used data from FDA's Adverse Event Reporting System to identify and describe 23 patients taking alendronate who were diagnosed with esophageal cancer.

As a Texas Transvaginal Mesh Injury Lawyer and medical doctor, I am providing this update and commentary involving TV Mesh failures.

An FDA advisory panel is currently examining recent complications and failure reports associated with transvaginal mesh systems that are used to repair pelvic organ prolapse, POP.

The FDA’s Obstetrics and Gynecological Devices panel will offer recommendations to protect women from the serious debilitating problems associated with transvaginal use of surgical mesh, which medical evidence suggests may provide no actual benefit over more traditional means of treating pelvic organ prolapse.

The transvaginal mesh products, known as bladder sling or vaginal surgical mesh, are designed to support the bladder and vagina in older women. The products are sold by a number of different companies, including Ethicon, C.R. Bard, American Medical Systems (AMS), Boston Scientific among others. They are made of non-absorbable synthetic material that is permanently implanted using small incisions as an alternative to other methods of treating pelvic organ prolapse.

The FDA issued warnings in July to inform the public and medical community about the growing number of reports involving transvaginal mesh failure after use to repair pelvic organ prolapse, including erosion of the mesh into the vagina, pain, bleeding, organ perforation and recurrence of POP.

According to a report the FDA agency is considering the reclassification of all transvaginal mesh products as Class III medical devices, which would prevent companies from seeking market approval through the agency’s “fast track” 510(k) approval program. The program allows medical devices to be approved without rigorous testing if they are functionally equivalent to existing products.

Johnson & Johnson (JNJ) and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.

Manufacturers including J&J and Endo Pharmaceuticals Holdings Inc. (ENDP) proposed that new versions of the devices require clinical trials before they can be sold and existing implants be tracked for safety.

More than 75,000 women received vaginally implanted meshes last year to strengthen weak pelvic muscles that fail to support internal organs. Patients claiming the meshes led to internal injuries have filed almost 500 lawsuits against two of the manufacturers, New Brunswick, New Jersey-based J&J and C.R. Bard Inc. of Murray Hill, New Jersey.

The FDA is evaluating a U.S. Institute of Medicine report in July urging it to scrap the 510(k) process for moderate-risk devices. The current system allows devices like the mesh implant to enter the market if manufacturers show they are “substantially equivalent” to others already for sale. The IOM said a new process should be devised that provides reasonable assurance of the safety and effectiveness of moderate-risk devices.

Last month, the consumer advocacy group Public Citizen filed a petition with the FDA calling for a transvaginal mesh recall to be issued to prevent the needless exposure of patients to the risk of the painful and life-altering complications.

As a result of complications and failure following the pelvic organ prolapse repair, a number of women throughout the United States are pursuing a transvaginal mesh lawsuit against the makers of the products, arguing that they failed to properly research the products or warn about the risk of the painful and often disfiguring injuries that can result from the pelvic mesh.

As a Texas medical doctor and Medical Malpractice attorney, I am providing this case law update and commentary.

As part of Texas's tort reform laws, enacted by the Texas legislature in 2003, one of the requirements in order to file a medical malpractice claim, was the furnishing of a medical expert's report within 120 days of filing the lawsuit.The 5th District Court of Appeals says that the legislation serves the state's interest in preventing frivolous medical liability lawsuits and related health care system costs. This medical expert report requirement is also known as the Texas' certificate-of-merit law, and is similar to many other states' medical malpractice reform.

Recently Texas' certificate-of-merit law passed another constitutional challenge after the 5th District Court of Appeals validated the requirement for plaintiffs to file an expert report demonstrating the merits of a medical liability case.

The 5th District Court of Appeals rejected arguments that the legislation amounted to an unconstitutional special law that treated medical liability lawsuits differently from other cases. Further, the court said that the provision subjecting plaintiffs who file a deficient report to financial penalties does not violate the constitutional separation powers.

Trial court judges have discretion to determine the amount of monetary sanctions and to inquire whether plaintiffs made a good-faith effort to pursue a medical malpractice or wrongful death case.

The August 12 opinion states that the expert report requirement "rationally relates to the interest of the state to prevent medical practitioners from defending frivolous claims at a high cost to the health care system."

According to the Texas Medical Association's statistics, since the 2003 law was enacted as part of a liability reform package that included a $250,000 noneconomic damages cap, Texas has seen a 50% drop in medical negligence cases, a 30% reduction in physicians' liability insurance rates and more than 20,000 newly licensed doctors.

Critics of the law state that those changes may have happened anyway because of the increase in Texas' population, which boomed as a result of the oil and gas business and the resulting need for more physicians and that as a function of doctors per capita, Texas is actually less served by the total number of physicians. So the new law is a red herring and an excuse for the insurance companies to be treated as a special interest deemed worthy of protection. Is it any wonder that the shiniest, tallest and the most aesthetically pleasing buildings in Texas are owned by insurance companies? Follow the money trail my friends.

The Texas liability reform package is now being touted as a role model for other states to deny plaintiffs their day in court.

The added expert report requirement means an extra layer of protection for physicians and hospitals. Plaintiffs in medical malpractice claims have to show ahead of discovery that they have a meritorious claim, whereas in any other personal injury claim, for example a car wreck injury case, you can take depositions and exchange discovery to determined what happened. In 2006 the Oklahoma Supreme Court ruled that invalidated the state's certificate-of-merit statute as a special law.

The Legislature's imposition of mandatory sanctions, of the defendant's cost of defense and attorny fees, if the medical expert's report is considered defective, usurps judiciary's powers and places an unfair burden on plaintiffs who make a good-faith effort to pursue a case. The cost of defense and attorney fees can be in thousands of dollars that the plaintiffs will have to pay.

This ruling arises from a wrongful death claim Joshua Hightower's parents filed after their son died from complications of rabies contracted during a kidney transplant at Baylor University Medical Center in 2004. Other patients who received organs from the same donor also died of the disease.

The Hightowers filed two physician expert medical reports supporting their claim that the surgery was risky given the donor's history of drug use and incarceration, and that the hospital and transplant doctors misrepresented the risks involved.

A trial court found the reports deficient and dismissed the case. The appeals court agreed, saying neither report showed "a connection between the donor's alleged high-risk status and the rabies virus. ... Joshua was injured by rabies, a condition of the donor that no one was aware of at the time of the surgery."

The judges said that "expert reports need not demonstrate all of a plaintiff's proof, but they must explain the basis of the expert's statement to link the conclusions to the facts."

Having been involved in many medical malpractice cases, I know first hand of the difficulties in obtaining a medical expert's report that is not conclusory and that adequately addresses the standard of care, the conduct that involves the deviation of the standard of care, the damages that result and the causation ie how the deviations caused the damages.

In other words the doctors who write these reports have to understand complex legal theories and case law in order to write reports that pass muster with the court. Doctors are not lawyers and because of their training they do not understand the legal basis of the claim. They understand the medicine but these reports are not about the medicine but law. You therefore have no medical personnel unless they have a legal background or exposure, being able to write these legal treatises which is basically required to pass the court's muster.

Meanwhile in California...
State public health officials have fined 12 California hospitals for medical errors that hurt or killed patients, according to a report. Three of the hospitals — L.A. County/USC Medical Center, Torrance Memorial Medical Center and Brotman Medical Center — are in Los Angeles County.

The penalties were issued for errors such as leaving foreign objects in patients' bodies during surgery and administrating the wrong medication. They occurred in 2009 and 2010. The fines, which hospitals can appeal, range from $50,000 to $75,000 for each mistake.

"Most of these are preventable medical errors," said Ralph Montano, spokesman for the California Department of Public Health. "Either someone was harmed or killed or likely to be harmed."

So here you have it folks, the rich get richer and the usual poor plaintiffs get the short end of the stick.

As a Texas medical doctor and Fosamax ONJ and femur fracture side effect Attorney, I am fielding many calls from concerned plaintiffs regarding their side effects from using Fosamax and similar drugs. We are providing the following update and commentary.

An FDA advisory panel will meet this week to review the risks associated with long-term use of Fosamax and other bisphosphonate medications. Fosamax and other bisphosphonate medications have been linked to a potential risk of spontaneous femur fractures and osteonecrosis of the jaw (ONJ), which is a rare jaw bone condition.

A panel of medical experts will review whether the FDA should adjust the length of time Fosamax and other similar drugs are used. They may recommend that the medication users should be required to take a “drug holiday” to reduce the risk of the serious and potentially debilitating problems associated with long-term use.

Fosamax is designed to strengthen the bones and reduce the risk of fractures associated with osteoporosis, long-term Fosamax side effects have been linked to decay of the jaw bone and reports of femur fractures. Our law office has been fielding many calls from concerned patients suffering from these side effects.

Osteonecrosis of the jaw, which is known as ONJ or jaw necrosis, can be caused when side effects of Fosamax and other bisphosphonates interrupt the blood supply to the jaw. This can result in the death of the jaw bone. This side effect may result in the need for surgery to remove portions of the jaw.

Long term use of bisphosphonate medications has been linked to an increased risk of bone fractures. A growing number of people have reported suffering spontaneous and unexplained femur fractures on Fosamax. These fracture side effects appear to occur with little or no trauma at all. Side effects of Fosamax may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a sudden femur fracture.

In October 2010, the FDA required new warnings about the risk of thigh fractures from Fosamax and other bisphosphonate medications. During a review of the potential Fosamax side effects, the FDA determined that the risk of fractures of the thigh bone may be connected to long-term use of bisphosphonates.

Merck & Co. currently faces hundreds of Fosamax jaw decay lawsuits and Fosamax bone fracture lawsuits that have been filed by individuals who claim the drug maker failed to adequately warn about the potential side effects.

As a Texas Medical doctor and Fort Worth Personal Attorney, I am providing this commentary regarding the state of traffic in our Great State of Texas, particularly in the Dallas Forth Worth Metroplex.

I was sitting here in my office on a Friday afternoon, before the long holiday weekend for Labor Day, when I browsed this interesting article that I would like to share.

I-35W in Fort Worth is the most stressful road in Texas, and fifth overall on the state's list of 100 most congested roadways. According to the Texas Department of Transportation's 2011 edition of the 100 most congested roadways, I35w Interstate 35W north of downtown Fort Worth is the most stressful road to travel on in Texas during peak congestion periods.

The stretch of I-35W between I-30 and 28th Street north of downtown is the fifth most congested roadway in the state, according to calculations made by the Texas Transportation Institute. And I-35W has the highest score in the state when ranked by the congestion level during rush hours -- tied for first place with U.S. 281 in the San Antonio area.

Also in Tarrant County, Northeast Loop 820 between U.S. 377 and the Northeast Interchange is the 17th most congested roadway. If you want to review the list, click here. The top three most congested roads in Texas are Woodall Rodgers Freeway, LBJ Freeway and Central Expressway in Dallas, followed by I-35 in Austin.

There is an obvious relationship between stressful driving and car accidents. Y'all be safe this holiday weekend, as for me I am going to drive into Dallas as soon as this blog is published.

As a Texas medical doctor and Transvaginal Mesh Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted Transvaginal Mesh medical device. We are providing the following update and commentary. The FDA recommends surgical mesh be reclassified as "High Risk."

FDA Transvaginal Mesh Safety Alert - Transvaginal Mesh Lawsuit and Class Actions being filed across the Nation. Johnson & Johnson, Boston Scientific Corp. (BSX) and other makers of surgical mesh may have to submit added safety data to regulators to keep their products on the market under a Food and Drug Administration staff recommendation.

The transvaginally implanted products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients, according to a FDA report. Patient advocates are demanding a recall of the devices, now classified as moderate risk.

The devices were approved through a streamlined process called 510(k) that is used to evaluate products similar to those already cleared and itself is under an agency review. The U.S. Institute of Medicine cited flaws with surgical mesh in July when it urged the FDA to abandon the process and require makers to prove each product is safe and effective on its own merits.

Mesh products “may expose patients to greater risk” than traditional repairs without mesh, FDA staff said in the documents. The agency received 1,503 reports of complications associated with the material from January 2008 to December 2010 when used for pelvic organ prolapse, the FDA said in a safety warning July 13. The devices were used in 75,000 transvaginal surgeries last year, according to the FDA.

The agency advised patients to be aware of risks including mesh erosion, pain and urinary incontinence, and to have annual check-ups after surgery. The FDA said it has cleared 85 surgical mesh devices to treat pelvic organ prolapse from 1992 and 2010.

Consumer advocacy group Public Citizen, based in Washington, said Aug. 25 that the mesh devices should be recalled and reclassified.

According to FDA data, the devices are used in surgeries to address prolapsed organs and incontinence. About 300,000 women underwent surgical procedures last year to repair prolapsed organs.

As a Transvaginal Mesh Lawyer, our attorneys are reviewing and filing cases across the nation. The FDA recently issued a Transvaginal Mesh Safety Alert because the product, primarily manufactured by Bard, Boston Scientific and Johnson and Johnson, has been shown to cause injuries in female patients.

Bard, Gynecare, AMS (American Medical Systems) and Boston Scientific have the largest market shares of transvaginal mesh products.

C.R. Bard's products include:

Bard Pelvitex
Bard Pelvisoft
Bard Pelvilace or Pelvicol
Bard Utrtex
Bard Uretex TO
Bard Uretex TOO2
Bard Uretex TOO3

Gynecare/Ethicon/Johnson & Johnson products include:

Gynecare Prosima
Gynecare TVT Exact
Gynecare TVT Abbrevo
Gynecare TVT Retropubic System
Gynecare TVT
Gynecare TVT Obturator
Gynecare TVT Secur
Gynecare Gynemesh PS
Gynecare Prolift
Gynecare Prolift+M

AMS products include:

AMS MiniArc Precise Single-Incision Sling
AMS MiniArc Single Incision Sling
AMS Monarc Subfascial Hammock
AMS In-Fast Ultra Transvaginal Sling
AMS BioArc
AMS Sparc Self-Fixating Sling System
AMS Elevate
AMS Perigree
AMS Apogee

Boston Scientific products include:

Boston Scientific Arise
Boston Scientific Pinnacle
Boston Scientific Advantage Fit
Boston Scientific Lynx
Boston Scientific Obtryx
Boston Scientific Prefyx PPS
Boston Scientific Solyx