Injured by recalled DePuy ASR and Pinnacle Hips? Metallosis, pain and suffering, hip replacement? Read More Here >>
Injured by recalled Stryker Rejuvenate and ABG II Hips? Metallosis, pain and suffering, hip replacement?Read More Here >>
Injured by Metal on Metal Hips, Biomet M2A Magnum, Smith and Nephew, Wright Conserve? Metallosis, pain and suffering, hip replacement? Read More Here >>
Injured by Trans Vaginal Mesh complications following Pelvic Organ Prolapse and Urinary Incontinence surgery? Pain and suffering, redo surgery, urinary incontinence? Read More Here >>
Injured by Mirena IUD complications? Mirena uterus perforation and uterus imbedment requiring surgery? We can help, Read More Here >>
Injured by Actos Bladder Cancer? We can help, Read More Here >>
Injured by Pradaxa Hemorrhage or Stroke?We can help, Read More Here >>
Injured by NuvaRing Deep Vein Thrombosis, Pulmonary Embolism, Stroke? We can help, Read More Here >>
Injured by Januvia/Byetta/Victoza Pancreatic Cancer?We can help, Read More Here >>
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Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

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The first federal bellwether trial against Johnson & Johnson’s DePuy subsidiary for its allegedly defective Pinnacle Hip Implant has been underway for the past 3 weeks in Dallas, Texas.

DePuy ASR Metallosis Injury AttorneyThe U.S. District Court for the Northern District of Texas oversaw jury selection on September 2 and over the past three weeks there has been a parade of company executives, paid doctor consultants and defense experts subjected to withering cross examination by the plaintiffs team of lawyers.

DePuy Orthopedics Inc., is facing the first bellwether trial over allegations that the Pinnacle metal-on-metal hip was defectively designed and caused metallosis. According to the plaintiff Kathleen Herlihy-Paoli, the cobalt-and-chromium alloy caused an infection that resulted in the artificial hips to be removed.

Testimony: J&J Knew As Early as 2001 of Pinnacle Problems

According to court testimony, Johnson & Johnson knew as early as 2001 the metal-on-metal version of its Pinnacle artificial hips might generate debris that could cause metal poisoning.

A doctor who consulted with J&J’s DePuy unit on the Pinnacle hip made the company aware in February 2001 that the device would require extensive testing of implant patients to see whether they had metal debris in their bloodstreams.

In an internal memo, DePuy officials said Dr. Thomas Schmalzried warned the potential release of metal ions was a “major issue for metal-on-metal hips.” Schmalzried had said the extent of the metal-hip patient’s tissue damage was “alarming and concerning.” DePuy officials said in the e-mails that they planned to tell colleagues to “keep quiet for now” about the case Schmalzried highlighted.

Smoking Gun Internal Documents

Internal files from 2012 showed DePuy officials found the metal Pinnacle hips had a 15 percent failure rate after five years of use. Company officials had expected a failure rate of 5 percent over that time period. The company failed to warn patients and doctors or the FDA. No recall has been issued for DePuy Pinnacle line of metal on metal

The Hits Keep Coming for Johnson and Johnson (J&J)

Johnson & Johnson set aside $2.5 billion last year to settle claims that 8,000 of its DePuy ASR hips were defective. The pharmaceutical and medical device giant company  is now exposed to allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.

DePuy ASR SettlementThe J&J’s $2.5 billion settlement of ASR claims, only addressed the ASR line of hips. Here the plaintiffs claimed that its ASR hip devices caused premature hip implant failure, dislocations, pain and required surgical removal because of metallosis.

Metallosis Caused by ASR Implants

In many cases, chromium and cobalt debris from the metal-on-metal grinding between the cup and the ball components of the ASR hips caused local muscle and tissue death and increased Cobalt and Chromium blood levels.

According to medical experts the long term side effects of heavy metal poisoning is unclear, with some stating that it can cause bladder and kidney cancer many years down the road.

DePuy ASR Recall August 2010

J&J, the world’s largest health-care company, issued a worldwide recall of 93,000 ASR hip implants in August 2010, saying 12 percent failed within five years.

But, according to internal J&J documents unearthed during litigation, 37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia was 44 percent within seven years.

Herlihy-Paoli Severe Metallosis

According to Herlihy-Paoli, aged 58, she two Pinnacle hips in 2009 and began to complain of pain from the devices. Blood tests before the 2011 removal surgeries found the “implants had released dangerous levels of cobalt and chromium into her bloodstream. Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal.”

Once surgeons removed Herlihy-Paoli’s left hip, they “discovered the implant had turned black with metallosis.”

J&J Quits the Metal on Metal Hip Business

J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

J&J had advertised the metal-on-metal implants, as a design that would last 20 years and offer greater range of motion.

The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 11-cv-3590, U.S. District Court; Northern District of Texas (Dallas).

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Recently Shirley Boynton from California filed a product liability lawsuit against Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary claiming that she almost died from uncontrollable hemorrhaging after using the new anticoagulant medication Xarelto.

xarelto side effect attorneyThe complaint was filed in the U.S. District Court for the Eastern District of New York. Boynton alleges that she suffered permanent injuries as a result inadequate Xarelto hemorrhage warnings provided to patients and doctors.

Xarelto: Dangerous and Defective Allegations

There are several Xarelto lawsuits filed against Bayer and Johnson & Johnson, alleging that the drug is unreasonably dangerous and defective. According to the plaintiffs the drug manufacturers intentionally misled doctors about the Xarelto’s risks when compared to warfarin, the older and more established blood thinner.

What is Xarelto?

Xarelto (Rivaroxaban) is a new class of anticoagulants, known as “direct thrombin inhibitors.” Xarelto is a factor Xa inhibitor indicated for the prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation) and to treat and reduce the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE) by thinning the blood.

Xarelto: Blockbuster Drug

FDA approved Xarelto to prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery. Xarelto was a result of a joint development by Bayer and Johnson & Johnson’s Janssen subsidiary. Xarelto have achieved blockbuster status with more than $1 billion in annual sales.

Xarelto: Aggressive Direct to Consumer Marketing

Bayer and Johnson & Johnson have aggressively touted Xarelto as a superior alternative to Coumadin (warfarin), which has been the standard anticoagulation therapy for the past 60 years.

Xarelto: Bleeding Concerns

Bayer and Johnson & Johnson heavily promoted that Xarelto is easier to use than warfarin, since patients do not require regular monitoring during treatment. According to many lawsuits the Xarelto warnings fail to adequately disclose the risk of uncontrollable bleeding due to the lack of an antidote.

Warfarin, which can be quickly reversed if bleeding occurs, with Vitamin K and fresh frozen plasma. Unfortunately, Xarelto has no reversal agent to prevent the blood thinning effects of the drug, leaving doctors unable to control bleeding should that occur.

Xarelto: Push for Increased Use

Despite growing safety concerns over Xarelto, Johnson & Johnson and Bayer, said that they still plan to seek expanded FDA approvals that would allow them to market the blood thinner among a wider population of patients, including those with acute coronary syndrome (ACS).

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Boston Scientific was crushed in its vaginal mesh debacle, when a Texas state jury ordered the device manufacturer to pay $73 million to a woman who developed chronic pain and injury from the company’s vaginal mesh implant. This was the first award against the device maker over its incontinence slings.

vaginal mesh injury lawyer-thumbEarlier this week, the Dallas jury found Boston Scientific liable for Martha Salazar’s personal injuries, they found that the company’s Obtryx sling was defectively designed and that the company acted with gross negligence in the sale and marketing of the products. The Texas jury awarded her about $23 million in compensatory damages and $50 million in punitive damages in a two week trial.

Boston Scientific Exposed to Over 20,000 Lawsuits

Boston Scientific had won the first two cases to reach trial over the Obtryx sling in a Massachusetts state court, where the company is based. The mesh and sling manufacturer is exposed to more than 20,000 lawsuits nationwide with similar allegations that its vaginal mesh implants and slings, erode within the body. These devices are commonly used to treat pelvic organ prolapse and urinary incontinence in women. It is estimated that approximately a million women yearly undergo these types of operation.

According to Salazar’s attorney, David Mathews, “this woman was seeking help with minor urine leakage and wound up with a catastrophic, life-altering injury that required four major surgeries. “It’s a tragedy that these slings are still on the market.”

Vaginal Mesh and Bladder Sling MDL Update

U.S. District Judge Joseph Goodwin is overseeing coordinated discovery and a series of bellwether trials involving seven different manufacturers, which have all be centralized in the Southern District of West Virginia as part of multidistrict litigation.

There are about 60,000 mesh/sling lawsuits in the MDL, with 12,000 Boston Scientific, 9,500 Bard Avaulta, 19,300 Ethicon, 18,000 American Medical Systems (AMS), 1,600 Coloplast, 250 Cook Medical and 66 Neomedic mesh lawsuits.

As part of the coordinated management of the litigation, there are early trial dates set, known as “bellwether” case. The outcome of these trials are only binding on the claims that go before a jury, and they may facilitate vaginal mesh settlement negotiations with the manufacturers.

FDA Warning and Investigation

The U.S. Food and Drug Administration demanded that Boston Scientific, Johnson & Johnson and other vaginal-implant makers in 2012 to study rates of organ damage and complications linked to the products.

Global Settlement in the Works

Boston Scientific and other makers of vaginal inserts are considering settling the lawsuits over the devices. Endo and Coloplast have agreed to settle a majority of their mesh lawsuits. Earlier this year, Coloplast paid $16 million to settle some claims related to its vaginal mesh implants. In May, Endo ponied up $830 million to settle 20,000 claims over vaginal mesh products sold by its American Medical Systems unit.

Gross Negligence

Juries in New Jersey and West Virginia over the past year have ruled that J&J and Bard implants caused women’s injuries and ordered the companies to pay a total of more than $13 million in damages. This verdict comes on the heels of Johnson & Johnson’s unfavorable ruling for its vaginal mesh product. Last week, a West Virginia federal jury ordered the company’s Ethicon unit to fork over $3.27 million to a woman who said the manufacturer’s Gynecare TVT Obturator implant caused pelvic pain and injury.

In Salazar’s case, the Dallas jury found that Boston Scientific’s sling suffered from a faulty design. The panel also found company officials failed to properly warn patients and doctor’s about the insert’s health risks. Jurors said Boston Scientific’s handling of the slings amounted to gross negligence, which Mathews said allowed the jury to award punitive-damages.

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There are at least 27 Cook Celect IVC filter or Cook Gunther Tulip IVC filter lawsuits filed nationally in different U.S. District Courts. The plaintiffs have similar allegations that the medical devices were defectively designed and caused patients to be injured after receiving the filters.

Bard IVC FILTER Injury AttorneyWhat is the Cook Celect?

Cook Medical manufactures the Celect Vena Cava Filter. It was approved in 2008 under the FDA 510(k) approval process. This process is a short cut to getting approval for medical devices.

Manufacturers of new devices do not have to present new safety studies so long as the device is similar to another device on the market. Cook introduced the Celect as an improved version of the Günther Tulip IVC filter, which was approved in the 1990s.

The filters are designed to reduce the risk of pulmonary embolism (blood clot in the lung) following a deep vein thrombosis or blood clot in the legs.

Cook Celect IVC Filter Litigation

Recently many IVC filter lawsuits have been filed against Cook Medical, and the U.S. Judicial Panel on Multidistrict Litigation (JPML) is reviewing the federal cases for coordinated pretrial proceedings. If approved, then the lawsuits will be centralized before one judge as part of an MDL, or multidistrict litigation.

Inferior vena cava filters (IVC), are implantable medical devices used in patients who are at high risk of pulmonary embolism. The devices are used when anticoagulant medication is contraindicated, usually because of bleeding problems.

The metallic devices are implanted in the inferior vena cava, with a number of struts that extend out to trap blood clots before they can travel up to the lung. Some IVC filters are associated with metallic failure, where the struts break off, causing perforation of major blood vessels, strokes and deadly bleeding if the struts puncture blood vessels.

Medical Adverse Studies

According to a study published in the Cardiovascular Interventional Radiology in April 2012, 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal caval wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.

A study published in the JAMA Internal Medicine in March 2013 demonstrated that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

Benefits of MDL

The establishment of multidistrict litigation for all Cook IVC filter lawsuits is designed to reduce discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and courts.

The MDL motion requests that the Cook IVC filter litigation be transferred to the U.S. District Court for the Southern District of Indiana. Cook Medical’s world headquarters located in that district, and more than 50% of the lawsuits are already filed there.

FDA IVC Filter Warnings

In August 2010, the FDA issued a warning about the risk of IVC filter complications, stressing that they had received more than 900 adverse events, where the filter failed, travelled to other areas of the body and caused severe injuries.

The FDA recommended that doctors remove retrievable IVC filters and urged caution in implanting IVC filters.

Bard IVC Filter Lawsuits

Similar IVC filter injury claims have been filed against C.R. Bard, the manufacturer of the Bard Recovery IVC Filter and Bard G2 IVC Filters. According to plaintiff allegations, Bard knew for years that their IVC filters were prone to fracture, which can cause severe complications, including death, but failed to warn doctors and patients.

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A federal jury in West Virginia today hammered Johnson and Johnson’s Ethicon subsidiary over its transvaginal mesh device. The jury awarded $3.27 million to Jo Huskey over its defective Gynecare TVT Obturator, or TVT-O, transvaginal mesh device. This is one of 33,000 product liability injury lawsuits that claim Johnson & Johnson’s Ethicon Inc unit sold defective transvaginal mesh devices.

Ethicon_Gynecare_Transvaginal_Mesh_LawsuitsFederal Jury Verdict

After a two-week trial, jurors found Ethicon liable for selling defective mesh devices and failing to warn patients and their doctors that they were at risk from serious side effects including pain, erosion, perforation and infection.

2nd Ethicon Bellwether Trial

It was the second bellwether trial in the West Virginia federal court, after the first ended in February with a defense win. Ethicon had been hit with an $11 million verdict in New Jersey state court last year, and in April, a jury in state court in Dallas found that the design of the TVT-O sling implanted in Linda Batiste was flawed and that the 64-year-old deserved $1.2 million in compensatory damages. The TVT-O sling remains on the market.

Huskey, aged 56, was implanted with a Gynecare TVT Obturator, transvaginal mesh device in 2011 to treat stress urinary incontinence. Huskey and her husband alleged that the device led to serious side effects including pelvic pain.

Vaginal Mesh and Bladder Sling MDL Update

U.S. District Judge Joseph Goodwin is overseeing coordinated discovery and a series of bellwether trials involving seven different manufacturers, which have all be centralized in the Southern District of West Virginia as part of multidistrict litigations.

There are about 60,000 mesh/sling lawsuits in the MDL, with 12,000 Boston Scientific, 9,500 Bard Avaulta, 19,300 Ethicon, 18,000 American Medical Systems (AMS), 1,600 Coloplast, 250 Cook Medical and 66 Neomedic mesh lawsuits.

As part of the coordinated management of the litigation, there are early trial dates set, known as “bellwether” case. The outcome of these trials are only binding on the claims that go before a jury, and they may facilitate vaginal mesh settlement negotiations with the manufacturers.

Boston Scientific recently won the first two mesh cases to go to trial against it in Massachusetts state court. Last year, C.R. Bard was hit with a $2 million verdict in the first mesh trial in West Virginia federal court.

In April, Endo International’s American Medical Systems subsidiary became the first major manufacturer to settle its mesh litigation, agreeing to pay $830 million to resolve thousands of these cases.

FDA Response

The U.S. Food and Drug Administration said earlier this year that it was considering proposals to tighten safety standards for transvaginal mesh devices used to treat pelvic organ prolapse. If finalized, the proposals would require manufacturers to submit data proving the devices’ safety and effectiveness before allowing them to be sold.

The case is Huskey v. Ethicon, U.S. District Court for the Southern District of West Virginia, No. 12-5201.

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According to a Massachusetts jury, Boston Scientific’s vaginal-mesh sling was not defectively designed and the company properly warned about its health risks. This verdict marks a second victory for the company in two state trials over the vaginal mesh inserts.

vaginal mesh injury lawyer-thumbJurors in state court in Woburn, Massachusetts, cleared Boston Scientific of any liability for Maria Cardenas’s injuries. Cardenas, had the Boston Scientific’s Obtryx sling implanted to fix urinary incontinence problems. According to Cardenas, the sling caused her pain and she was forced to have it removed surgically.

Transvaginal Mesh and Sling Defects

Several thousand cases against Boston Scientific and other manufacturers including Johnson & Johnson and C.R. Bard Inc. have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia, for pretrial information exchanges. Many cases have been filed in state courts in Delaware, New Jersey, Massachusetts, Missouri and California.

Manufacturers of transvaginal mesh and bladder sling products are exposed to product liability lawsuits that allege that design defects caused them to suffer severe and painful complications after receiving the mesh for repair of pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Juries in New Jersey and West Virginia over the past year have found that J&J’s and Bard’s implants caused women’s injuries and ordered the companies to pay a total of more than $13 million in damages.

The U.S. Food and Drug Administration ordered Boston Scientific, J&J and more than 30 other vaginal-implant makers in 2012 to study rates of organ damage and complications linked to the products.

Endo International Plc (ENDP) agreed this year to pay $830 million to resolve about 20,000 suits alleging its vaginal-mesh inserts eroded in some women and left them incontinent and in pain.

Mesh and Sling MDL Update

U.S. District Judge Joseph Goodwin is overseeing coordinated discovery and a series of bellwether trials involving seven different manufacturers, which have all be centralized in the Southern District of West Virginia as part of multidistrict litigations.

There are about 60,000 mesh/sling lawsuits in the MDL, with 12,000 Boston Scientific, 9,500 Bard Avaulta, 19,300 Ethicon, 18,000 American Medical Systems (AMS), 1,600 Coloplast, 250 Cook Medical and 66 Neomedic mesh lawsuits.

As part of the coordinated management of the litigation, there are early trial dates set, known as “bellwether” case. The outcome of these trials are only binding on the claims that go before a jury, and they may facilitate vaginal mesh settlement negotiations with the manufacturers.

Judge Goodwin has consolidated five different Boston Scientific Pinnacle mesh lawsuits for one trial date, which is currently scheduled to begin on October 14. A second bellwether trial involving 11 different Boston Scientific Obtryx Sling lawsuits is scheduled to begin on November 3.

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xarelto side effects attorneyCommon problem with Anticoagulants

Unfortunately, like all anticoagulants, Xarelto has an internal bleeding risk for which there is currently no effective antidote. Thousands of adverse event reports regarding bleeding side effects, including reports of deadly complications, have been filed with the FDA over this blockbuster medication.

What is Xarelto?

Xarelto is the generic name for the drug Rivaroxaban, a blood thinner. It is a “direct thrombin inhibitor” that blocks the formation of thrombin, a blood clotting factor. Xarelto is prescribed to patients at risk for blood clot formation, deep vwin thrombosis, pulmonary embolism and stroke. Xarelto blocks the production of a protein called Factor Xa, involved in the formation of thrombin.

Xarelto vs Coumadin

Xarelto is touted as a better alternative to an older blood thinner called warfarin (Coumadin). Warfarin had been the standard anti-coagulant therapy prescribed for the past 60 years. Warfarin requires frequent blood tests and monitoring of diet to be safe and effective. The dosage of the drug is adjusted to keep the patient blood thinning level in a narrow range.

The FDA approved Pradaxa, the first of the direct thrombin inhibitor in 2010. Pradaxa was heavily marketed to both patients and doctors: main selling point was that did not require the close monitoring blood thinning levels in patients.

Xarelto was released in 2011 as a Pradaxa competitor. In the U.S. market Xarelto sales have achieved blockbuster status, the number one sales position among blood thinners. Global sales estimates for the drug in 2013 are $1.3 billion.

Eliquis (apixaban) is jointly manufactured by Pfizer and Bristol-Myers Squibb (BMS), and approved for prevention of strokes among patients with atrial fibrillation. It was introduced in 2012, as the third member of a new generation of blood thinners.

Fatal Xarelto Side Effects

The key difference between warfarin and the new generation of anticoagulants is that warfarin had an effective reversal agent to stop a bleeding event: vitamin K. Xarelto and other newer anticoagulants do not have any reversal agent or antidote.

In 2012, there had been 2081 total serious adverse event reports (151 involving fatal events) sent to the FDA regarding Xarelto bleeding side effects.

Recently consumer watchdog, the Institution for Safe Medication Practices (ISMP), issued data indicating that Xarelto has more serious adverse events than its competitor Pradaxa.

Xarelto Bleeding

Patients who experience any of the following, should seek medical attention:

  • Blood in the urine
  • Blood in stools
  • Vomiting blood
  • Severe nosebleeds
  • Coughing up blood
  • Stroke
  • Uncontrollable bleeding
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Some bus companies are still underinsured or not insured at all. Federal law says that all bus companies have to be registered with the Federal Motor Carrier Safety administration and carry a DOT number if they are transporting passengers across state lines.

fort_worth_car_accident_attorney2Bus Companies Must Carry Insurance

Bus companies must carry a $1.5 million insurance policy if they carry less than 15 passengers and a $5 million policy if they carry more than 15 passengers.

Tragic Bus Death Case in Kansas

Here are the tragic details of an avoidable bus death case that happened in Kansas last year. Jamie Frecks, 26, was on the Midnight Express party bus for a bachelorette party. The fun occasion turned tragic when the bus back doors flew open. Frecks fell out on to the interstate and was fatally struck by three cars.

A lawsuit was filed against the Midnight Express Party Bus company and their owners.

Tragic Accident was Avoidable

According to the lawsuit, the bus owners removed a wheelchair lift in the bus. The wheelchair lift was a safety barrier between passengers and the rear doors. It is alleged that the defendants did not make any repairs that would have prevented the doors from coming unlatched.

According to the Federal Motor Carrier Safety administration, the bus was not registered with the Department of Transportation and was not carrying the proper insurance. The lawsuit alleges that if the bus had been properly registered and insured, it would have undergone safety inspections to identify problems on the bus.

Settlement Reached

The Frecks family settled one part of their lawsuit with one of the corporate defendants that owned Midnight Express. The  judge ordered damages totaling $6.78 million paid in a second aspect of the case.

The family say they are considering action against the insurance company that issued the bus policy to Midnight Express.

Underinsured Bus Company Shut Down

The U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) has ordered Midnight Express, LLC to immediately cease operations. According to the government agency, the bus company’s owners were operating an unauthorized and unsafe commercial transportation service.

“There is no higher priority than safety,” U.S. Transportation Secretary Ray LaHood said. “Passengers on any commercial van or bus should feel confident they’ve boarded a safe vehicle, one that is properly maintained and operated by a qualified driver. Carriers that cannot meet our safety regulations will not be allowed to operate.”

Take Home Message

When you hire a bus company, make sure you that their DOT number is in good standing and that they have proper insurance as well as a good safety record. You investigate the bus company here by visiting the FMCSA website.

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A Texas woman is the latest to sue Bayer and Johnson & Johnson pharmaceutical companies, claiming that the anticoagulant Xarelto has inadequate warnings about the bleeding risk associated with the drug. Jeanne Jeffcoat filed the lawsuit in the U.S. District Court for the Eastern District of New York, she claimed that Xarelto caused life-threatening bleeding event that left her permanently injured.

xarelto side effects attorneyThere are many defective drug product liability lawsuits filed nationwide over bleeding and hemorrhage side effects of Xarelto.

Xarelto Aggressive Marketing

Plaintiffs are alleging that the drug makers aggressively marketed Xarelto as superior to warfarin without warning about the risk of bleeding and the lack of an antidote to reverse the blood thinning effects of the medication.

Jeffcoat began using Xarelto in March 2012, and 4 months later she suffered a life-threatening bleed that has left her with severe, permanent injuries, and pain and suffering.

What is Xarelto?

Xarelto (Rivaroxaban) is a new type of anticoagulant, known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots, deep vein thrombosis, pulmonary embolism and embolic strokes. The drug was developed by Bayer and Janssen and was approved in 2011.

Xarelto Misleading Marketing Claims

The lawsuit alleges that the companies purposefully mislead the doctors. Plaintiffs claim that the drug makers withheld information from patients and doctors about the lack of an antidote and about the severe bleeding risks with Xarelto.

The companies promoted three medical studies to get Xarelto approved as a stroke preventative for patients with atrial fibrillation, deep vein thrombosis and pulmonary embolism. All of the studies demonstrated an increased risk of serious bleeding events.

According to the lawsuit, the companies used the studies’ positive results to promote Xarelto to doctors in their promotional materials, but the “promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns.”

The companies allegedly spent at least $11 million on advertising in medical journals in 2013 alone, making Xarelto the number one pharmaceutical product advertised in professional health journals in the third quarter of 2013 based on pages and money spent.

Xarelto: No Reversal Agent

Xarelto was designed to replace Coumadin (warfarin) for the prevention of stroke in patients with atrial fibrillation. Atrial fibrillation is a common heart rhythm problem that increases the risk of strokes. All blood thinners increase the risk of suffering a bleeding event, but warfarin’s blood thinning side effects can be reversed with vitamin K.

Xarelto has no reversal agent. The lawsuit claims that the FDA had to issue a warning on June 6, 2013, saying that the companies direct to consumer ads were misleading because they minimized the risk of uncontrollable bleeding.

According to the FDA, the companies downplayed the risks and placed them so that they would not catch readers’ attention. Furthermore made misleading claims that there were no dosage adjustments required, when in fact there were.

Xarelto Scope of Bleeding Problems

According to the lawsuit, “In the year leading up to June 30, 2012, there were 1,080 Xarelto-associated ‘Serious Adverse Event’ (‘SAE’) Medwatch Reports filed with the FDA, including at least 65 deaths.”

The lawsuit goes on to allege, “At the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated SAR reports were filed with the FDA in its first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA. Of those reported events, 151 resulted in death, as compared to only 56 deaths associated with warfarin.”

According to the reports, Xarelto bleeding problems result in death in 8% of all cases, which is double the rate of death for warfarin bleeding events.

The Institute for Safe Medication Practices warned that the figures indicated a “strong signal” that there were safety problems with Xarelto and said that the public and scientific community needed to be warned and Xarelto safety needed to be further investigated.

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There are several thousand lawsuits filed by folks both in state and federal courts by patients who took the prescription drug pioglitazone, sold as brand name Actos and later developed bladder cancer. Doctors prescribe Actos to treat patients with Type 2 Diabetes.

Actos_Bladder_Cancer_AttorneyTakeda Actos Bladder Cancer Verdict

On April 7, 2014, a federal jury in Louisiana found Takeda failed to adequately warn about bladder cancer risks of Actos. Jurors also found that executives of Takeda acted with wanton and reckless disregard for patient safety and awarded a total of $9 billion in punitive damages.

Actos Bladder Cancer Link & FDA Warnings

In June 2011, the U.S. Food and Drug Administration announced a drug safety alert warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA released a “Drug Safety Communication,” indicating that based on dose and duration of use, there exists a 40 percent increased risk of developing Actos bladder cancer.

Health authorities in France also suspended the use of Actos due to the risk of developing bladder cancer.

In April 2012, Health Canada, the government drug safety agency for Canada, announced a safety warning on Actos. Diabetes patients prescribed Actos for over a year had two times higher risk of bladder cancer than diabetes patients not taking Actos.

One of the most recent studies on Actos and bladder cancer was published in the British Medical Journal, May 2012 issue.

Researchers studied 115,727 patients and discovered that Actos use increased the risk of bladder cancer by 83 percent. They also noted that the risk increases with long-term use of Actos.

Actos Cancer Side Effects Lawsuits

Manufacturers of prescription drugs have a duty to patients to produce safe products and to warn patients and their doctors of any adverse health effects. The lawsuits filed by Actos patients with bladder cancer allege that Takeda breached both of these duties and Takeda is legally responsible for the harm and must pay damages.

Takeda Knew About Bladder Cancer Risk

The Actos complaints allege that Takeda had studies on laboratory animals showing an increased risk of bladder cancer when the animals were provided the drug. Takeda allegedly failed to disclose these laboratory test results to health regulators.

Actos was released in 1999, and the FDA directed Takeda to undertake a post-marketing study on the safety and effectiveness of Actos. Takeda allegedly delayed initiating the study until 2003 and designed the study as a 10-year trial. Because of this study design, the final results will not be available until after the expiration of Takeda’s exclusive patent on Actos.

Early results published in 2011 did show increased risk of bladder cancer.