Dallas Fort Worth Injury Lawyer Blog

The plaintiff lost the trial of a Levaquin lawsuit. The man suffered two ruptured Achilles tendons after taking the popular antibiotic.

The jury determined that the drug maker failed to adequately warn consumers and doctors of the risk of tendon damage from side effects of Levaquin.

A Minneapolis jury ruled that Johnson & Johnson failed to provide sufficient warnings about the risk of Levaquin tendon ruptures, but found that the company was not responsible for injuries suffered by the 78 year old plaintiff.

Clifford Straka could not prove that his injuries were caused by the antibiotic.

According to the lawsuit, Straka’s doctor had been unaware of the risk of tendon ruptures when she prescribed Levaquin because there was not adequate label warning.

Although there has been information about the potential risk of tendon damage on the drug’s label since it was first approved by the FDA in 1996, Straka alleged that those warnings were insufficient and that the drug maker actively attempted to downplay the risk for years.

FDA Black Box Warning

In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication.

3,700 Lawsuits Still Pending

Straka is one of more than 3,700 people who are pursuing a lawsuit over tendon damage from Levaquin. All of the federal cases have been consolidated as part of an MDL, or multidistrict litigation, which is centralized in U.S. District Court for the District of Minnesota.

This trial was considered a “bellwether”, as the parties were using the results to gauge how juries are likely to respond to similar evidence in other cases and possibly help the parties reach a Levaquin settlement agreement.

This is the third straight trial win for Johnson & Johnson and the fourth to go to trial.

In December 2010, the first trial ended in a $1.8 million award for the plaintiff, including punitive damages to punish the drug maker for their conduct.

The drug maker successfully defended the second trial, which ended in June 2011, and the third trial, which ended in October.

The first two trials were held in federal court. The third trial was held in New Jersey state court, where about 1,900 of the cases are currently pending.

According to a Johnson & Johnson lawyer, J&J properly warned of the risks of its antibiotic Levaquin and shouldn’t be held liable for tendon injuries sustained by a 78-year-old man.

Clifford Straka, tore two Achilles tendons after taking the drug for pneumonia, sued J&J and its Ortho-McNeil Pharmaceutical unit in 2008. Straka said his doctor wasn’t aware when she prescribed the drug that Levaquin was linked to an increased risk of tendon damage in elderly patients.

Johnson & Johnson denies liability

Johnson & Johnson, has denied any failure to warn and contended that Straka needed Levaquin to treat the pneumonia.

According to Johnson & Johnson, “The label from day one in 1996 was adequate.” “The information was out there and available to the doctors and everyone else.”

Levaquin Lawsuits

The lawsuit is the third federal case to go to trial in Minnesota alleging J&J and its unit, now known as Janssen Pharmaceuticals, downplayed the risks of the antibiotic to boost sales.

J&J lost the first, a jury verdict for $1.8 million in 2010, and won the second last year. The company also won the first state case in October, when a New Jersey jury rejected the claims of two plaintiffs.

Levaquin Tendon Ruptures

J&J is facing more than 3,700 claims involving Levaquin in state and federal courts.

FDA Warning

In 2008, the U.S. Food and Drug Administration required all makers of antibiotics in Levaquin’s class, called fluoroquinolones, to increase warnings about tendon ruptures.

The jury of 7 women and 5 men have begun deliberating.

The case is Straka v. Johnson & Johnson (JNJ), 08-05742, combined for trial in In re Levaquin Products Liability Litigation, 08- md-01943, U.S. District Court, District of Minnesota (Minneapolis).

A Children’s Motrin product liability lawsuit has been allowed to move forward. The plaintiffs allege that Johnson & Johnson failed to warn about the risk of serious and potentially deadly skin problems from Motrin.

U.S. Magistrate Judge Maria Valdez rejected a motion to dismiss by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.

The complaint alleges that McNeil failed to properly warn consumers that side effects Motrin may included a risk of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) reactions.

The lawsuit was brought on behalf of two minor children and their parents. The children were diagnosed with SJS and TEN in 2009 after taking Children’s Motrin to treat fevers.

According to McNeil, SJS and TEN side effects were so rare that it did not need to warn consumers about them. Valdez rejected that argument, saying it was not a defense against a failure to warn.

SJS and TEN often result in the need for treatment in a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases. The condition can cause organ damage, disfigurement through skin loss, and blindness.

The Motrin skin problems are listed as a potential side effect on prescription-strength ibuprofen, but the lower-dose over-the-counter versions marketed as Motrin and Children’s Motrin do not warn that the drug could cause Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.

In addition, over-the-counter Motrin labels in some other countries do carry such warnings.

Last year, the drug maker was crushed by a Los Angeles jury that awarded more than $48 million to a man diagnosed with SJS after taking Motrin as a teen.

In May, a Philadelphia jury awarded $10 million in a Children’s Motrin lawsuit brought by the family of Brianna Maya, a 12-year-old girl who has been left blinded in one eye and suffered burns over 84% of her body after taking the drug in 2000.

In that case, the jury also ruled that Johnson & Johnson was negligent in failing to provide proper warnings about the risk of SJS and TEN from Children’s Motrin on the medication’s label.

Read more here and visit my website for further information.

Product liability lawsuits against generic drugs are facing a tough uphill battle, which usually ends in dismissal, as exemplified by the Fosamax update below.

U.S. District Judge Joel A. Pisano, has dismissed claims against Watson Pharmaceuticals, the manufacturer of generic versions of the popular osteoporosis drug. Plaintiffs had alleged that their generic version of Fosamax caused femur fractures to develop suddenly, with little or no trauma at all.

Following a court order on January 17, Watson Pharmaceuticals has been dismissed as a defendant in several Fosamax lawsuits. These were filed by plaintiffs who suffered an atypical femur fracture after taking generic versions of the drug.

Pliva v. Mensing

The order comes as a result of a recent Supreme Court decision in Pliva v. Mensing, which allows generic drug makers to be shielded from liability for failure to warn about harmful or even deadly side effects of medications they make, since FDA regulations require that their products must carry the same warnings as the name-brand versions.

The complaints against Watson raised similar allegations to those that have also been filed against Merck, the manufacturer of the name brand version of the medication.

In these cases, plaintiffs allege that the drug makers failed to adequately research the side effects of Fosamax or provide adequate warnings to consumers of the medical community.

FDA Warnings for Fosamax

In October 2010, the FDA required new warnings about the risk of bone fractures from Fosamax and other similar bisphosphonate medications.

Merck and generic Fosamax makers now warn consumers that they should seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete Fosamax thigh bone fracture.

All federal Fosamax lawsuits over femur fractures have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before Judge Garrett E. Brown in the U.S. District Court for the District of New Jersey.

Visit my website for further Fosamax femur fracture information

According to St. Jude Medical Inc. its Riata defibrillator leads have a higher failure rate than was disclosed when it stopped selling the product.

Riata has an insulation failure rate of 0.63 percent, more than the 0.47 percent disclosed last December, according to a recent warning letter to doctors.

Extractions of Riata leads were linked to two patient deaths and a serious injury. Devices with the flaw, caused when the insulation surrounding the wires is penetrated, may also fail to deliver electric shocks when needed, the company said.

Different Medical Study Failure Results

Other studies showed higher failure rates. An Irish medical center found 15 percent of patients had wires protruding from the insulation when they underwent fluoroscopic screening, an advanced imaging technique. A German study of 357 patients found 8 percent needed surgery after a failure with a Riata lead. Both sets of researchers recommended closer screening for patients.

What are Pacemaker Leads?

Leads are flexible wires threaded through veins to the heart muscle that help defibrillators deliver jolts of electricity to shock hearts back into rhythm.

Recommendations to handle the defective product?

According to St. Jude, the implications of the insulation failures aren’t clear, and they advise doctors to continue routine monitoring of patients with Riata leads.

The wires shouldn’t be automatically replaced, and there is no consensus on treatment even for patients with damaged leads who aren’t suffering electrical malfunctions.

Fluoroscopic screening recommended

Researchers have urged fluoroscopic screening of patients with the Riata leads, since the complications can trigger shocks when they aren’t needed and failure to administer a shock when the heart stops beating properly.

Defibrillator patients are between a shock and a hard place; they need the device to perform when needed, otherwise they die, but they do not like unnecessary shocks, which is extremely painful.

Pfizer, the manufacturer of Zoloft, has filed a motion to consolidate all federal Zoloft birth defect lawsuits. Pfizer requested that they be centralized before one judge for pretrial litigation as part of a multidistrict litigation, or MDL.

On January 18, Pfizer asked the U.S. Judicial Panel on Multidistrict Litigation to create a Zoloft MDL in the U.S. District Court for the Southern District of New York.

Zoloft Birth Defect Lawsuits

A growing number of plaintiffs throughout the country have filed a Zoloft lawsuit against Pfizer, raising similar allegations that use of the antidepressant during pregnancy caused children to be born with a variety of severe birth defects and serious malformations.

New York Federal MDL

According to Pfizer, there are currently at least 59 lawsuits over Zoloft, which involve common claims and questions of fact. Furthermore, according to Pfizer, the Zoloft birth defect litigation should be consolidated to prevent conflicting pretrial rulings, reduce duplicative discovery and to serve the convenience of the parties, the witnesses and the federal court system.

Pfizer has proposed that the federal Zoloft cases should be centralized in New York, near the drug maker’s headquarters, which would provide a central location and easy access to the company’s records and important witnesses.

Pfizer has also offered the Northern and Southern Districts of Mississippi and the Nothern District of Ohio as possible alternate locations.

The majority of the complaints over Zoloft are currently pending in the U.S. District Court for the Eastern District of Pennsylvania, where at least 48 of lawsuits are pending.

Zoloft Indications

Zoloft (sertraline) was released by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety.

By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States. Zoloft belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

Zoloft Birth Defects

Recently, medical research and adverse event reports have suggested that use of Zoloft during pregnancy may increase the risk of serious and potentially life-threatening health problems for babies. These side effects include persistent pulmonary hypertension in newborns (PPHN), heart defects, lung defects, abdominal defects, cranial defects and other malformations.

Studies have suggested that Zoloft may increase the risk of birth defects when used as early as the first trimester of pregnancy, a time when many women do not even know they are pregnant.

The U.S. Judicial Panel on Multidistrict Litigation is expected to hear oral arguments on the motion during a hearing scheduled to occur on May 31, at the E. Barrett Prettyman U.S. Courthouse in Washington, D.C.

Read more here and visit my website for further information.

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A multiple sclerosis drug made by pharmaceutical giant Novartis is under intense investigation after at least 11 patients taking the medicine died.

The drug, Gilenya, was licensed in 2010 in the European Union and by the FDA to treat patients with a severe type of multiple sclerosis.

European Medicines Agency Investigating Gilenya

The deaths raise concerns Gilenya could trigger heart problems after patients take their first dose, according to a recent statement issued by the European Medicines Agency. The agency, which is now investigating the drug, said it isn’t clear if it caused the deaths.

One of the deaths was in the U.S., where a patient died within 24 hours of taking the first dose.

The European agency said it didn’t know where the other 10 deaths occurred, but that they were reported to its drug database, which monitors side effects from medicines in the European Union.

FDA Investigating Gilenya

The U.S. Food and Drug Administration said it also is conducting a data analysis but has not made any definitive conclusions and does not know when its review will be complete.

Scope of the problem

More than 30,000 patients have taken Gilenya worldwide. The European Medicines Agency advised doctors to increase their monitoring of patients after the first dose of the medicine. The agency said the risk of a slow heart rate after the first dose of Gilenya was known when it was approved.

Novartis AG said it was advising doctors of new recommendations on using Gilenya. They include continuous heart monitoring during the first six hours after patients take their first dose and measuring their blood pressure and heart rate every hour. This new guidance applies only to patients taking their first dose, Novartis said in a statement.

Gilenya's Prescribing Warning

Gilenya's prescribing information includes a warning about bradycardia (slow heart rate) and/or atrioventricular conduction block (conduction disorder of the nervous impulse in the heart) in the first hours after starting the drug.

Interacting Medications

Due to the fact that Gilenya has been linked with these problems, the FDA also advises close monitoring of patients on certain medications (class Ia or class III antiarrhythmic drugs, beta-blockers, calcium channel blockers), as well as those with a low heart rate, history of syncope (fainting), sick sinus syndrome, second degree or higher conduction block, ischemic heart disease, or heart failure when they start treatment with Gilenya.

The use of Gilenya has not been studied in these patients, who are at an increased risk of slow heart rate. The patient who died was on a beta-blocker (metoprolol) and a calcium channel blocker (amlodipine) - again, both of which are associated with bradycardia and heart blocks.

Stronger Warning Needed?

Although there are recommendations such as obtaining an electrocardiogram on patients at increased risk for cardiac side effects prior to starting the drug and advising patients about the signs and symptoms of bradycardia, there may need to be a stronger warning about patients on medications that could also cause heart rate problems.

Perhaps people on these kind of medications or with certain heart problems should NOT take Gilenya at all. According the the manufacturer, Novartis, this is the first death within 24 hours of taking the first dose of Gilenya out of the 28,000 patients who have been started on the drug.

As the Band played on, another tale of corporate greed and misdeeds, in the Dark City.

A Stryker Corp. (SYK) unit has pled guilty and will pay a $15 million fine. The medical-device maker was on trial on charges it marketed an unapproved mixture of products for strengthening human bone growth.

The unit, Stryker Biotech, and three Stryker sales representatives were on trial in federal court in Boston on a 13-count criminal indictment claiming conspiracy and wire fraud.

Stryker Biotech agreed to plead to one misdemeanor count of misbranding a medical device and prosecutors agreed to drop the case against the Massachusetts-based Stryker Biotech.

Dangerous Product Sold to Surgeons

The U.S. prosecutors said Stryker Biotech made $12.5 million by misbranding and selling the bone growth mixture to surgeons over a two-year period.

The U.S. had charged Stryker Biotech with misbranding and its sales force with conspiring to defraud surgeons into combining the company’s OP-1 and OP-1 Putty with the bone filler Calstrux. Some patients suffered adverse side effects and required more surgery.

“That mixture was never studied clinically,” Assistant U.S. Attorney Susan Winkler told the jury in her opening statement on Jan. 12. “They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.”

No FDA Exemption for the Product

The U.S. Food and Drug Administration allowed the company to supply its products under a narrow, provisional humanitarian exemption. The company had no FDA approval for mixing in Calstrux, which was later pulled from the market, the U.S. says. Stryker Biotech tracked 63 adverse events in more than 10,000 procedures involving the bone mixture.

The case is U.S. v. Stryker Biotech LLC, 09-cr-10330, U.S. District Court, District of Massachusetts (Boston).

The FDA is blasting DePuy Orthopaedics, a subsidiary of Johnson & Johnson, over the selling of artificial knee and hip replacement implants without FDA approval.

The FDA issued a warning letter to DePuy Orthopaedics in December about the regulatory problems, after inspectors visiting a plant in Warsaw, Indiana discovered implants being manufactured there that were never given FDA approval.

The letter, released by the FDA, has forced DePuy to remove 14 different implant components from the market until the issue can be resolved.

DePuy officials told FDA investigators that the components found at the plant were custom devices made for specific patients, and therefore did not have to get premarket approval. The FDA disagreed, saying that none of the devices qualify as custom devices.

According to the FDA, “although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured.” The FDA further stated that “the fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”

Not only should the devices not have been sold, but they were manufactured with poor quality control procedures, the FDA warning letter notes. The letter cites the company for using poor design validation procedures, not having a process in place for handling customer complaints and other regulatory violations.

DePuy Orthopaedics was the focus of a major artificial hip system recall in August 2010 when it pulled 93,000 ASR metal hip implants from the market. The ASR hip recall has triggered more than 3,500 lawsuits against the company.

The federal DePuy ASR litigation has been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Ohio as part of an MDL, or multidistrict litigation.

At the time of the recall, Johnson & Johnson indicated that the DePuy ASR failure rate was about 12%. Some expects have suggested that the actual percentage of people who are likely to experience problems with their implant, including loosening, metal poisoning and possible revision surgery, is going to be substantially higher.

The judge presiding over all federal Bard Avaulta vaginal mesh lawsuits has asked the parties to develop a list of potential bellwether cases. These bellwether cases would be prepared for early trial dates in the multidistrict litigation (MDL).

More than 250 lawsuits over C.R. Bard vaginal mesh filed in federal courts throughout the United States have been consolidated before Judge Goodwin for pretrial litigation as part of an MDL.

Plaintiff and defense lawyers are to identify eight cases each to be considered for early discovery.

Transvaginal Mesh Injuries

The Bard Avaulta vaginal mesh litigation continues to grow against devices for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The surgical mesh products have been linked to a risk of severe complications, including erosion of the mesh into the vagina, recurrence of urinary problems, pain and disfigurement.

The litigation initially only included Bard Avaulta mesh products, and now includes at least 29 other types of vaginal mesh made by C.R. Bard or their subsidiaries, including Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and Align mesh.

Additionally, a number of similar complaints have been filed against Boston Scientific, American Medical Systems (AMS) and a division of Johnson & Johnson, Ethicon/Gynecare.

January MDL Consolidation Hearing

On January 26, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear arguements over whether the vaginal mesh lawsuits involving these other manufacturers should also be centralized as part of three separate MDLs before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia for coordinated handling.

Growing Number of Mesh Lawsuits

Public awareness about the risk of vaginal mesh problems increased following an FDA warning issued in 2011 about an increasing number of adverse event reports associated with the products.

In July 2011, the FDA issued surgical mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

Earlier this month, the FDA mailed a letter to several device makers calling for more post-marketing studies into the rate of complications with vaginal mesh systems, which many believe is the beginning of tighter regulations aimed at protecting women from these serious and debilitating problems.

The FDA is under fire to hold a new hearing to evaluate the safety of Yaz and Yasmin birth control pills, after conflict of interest issues have been raised regarding some of its advisory committee members.

Allegedly several FDA advisory committee members who voted to keep Yaz and Yasmin on the market had worked as consultants for, or received funding from, Bayer, the YAZ Yasmin manufacturer.

Project On Government Oversight Letter

The government watchdog group Project On Government Oversight (POGO) wrote a letter on January 11 to the agency’s commissioner, Margaret Hamburg, requesting that a new hearing be convened.

In December, the committee voted 15 to 11 that the benefits of Yaz, Yasmin and other drospirenone-based birth control pills outweigh the health risks, allowing Bayer to narrowly dodge a Yaz and Yasmin recall.

Subsequently, it has been discovered that at least four of the committee members had financial ties to Bayer.

The number of members who may have had conflicts of interest is the same as the winning margin of the vote to recommend that the FDA keep the drugs on the market.

According to POGO, “We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011. Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded.”

Financial Conflict of Interest

According to POGO, committee members Drs. Paula Hillard, Anne E. Burke, and Elizabeth G. Raymond received research funding or were paid as consultants for Bayer or one of its subsidiaries. Internal Bayer e-mails referred to Hillard as a “huge” Yasmin advocate.

These folks voted to recommend that the FDA allow the birth control pills stay on the market, despite research that suggests an increased risk of blood clots, pulmonary embolism, stroke, gallbladder disease, deep vein thrombosis, heart attack and sudden death associated with side effects of Yaz and Yasmin.

Discovery Documents made public

The documents revealing their connections to Bayer became public as a part of the discovery process in ongoing Yaz lawsuits and Yasmin lawsuits. The lawsuits are part of a federal Yaz MDL, or multidistrict litigation, which has centralized and consolidated claims by thousands of women.

Almost 11,000 women have filed a federal lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the risk of health problems from Yaz, Yasmin and other drosperinone-based birth control pills.

Drospirenone the Culprit?

Drospirenone is a newer type of synethetic progestin that is used in combination oral contraceptives. It was originally introduced by Berlex Laboratories in Yasmin. Berlex was acquired by Bayer Healthcare and an updated version of Yasmin was introduced called Yaz. Recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement.

Generic versions of Yaz and Yasmin are also now available from other manufacturers. Generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah, all of which contain drospirenone.

The FDA released a report in 2011, that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills. They also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing in less than three months after women started to take the pills.

Merck & Co. has agreed that all Propecia lawsuits filed in federal district courts throughout the United States by men who experienced sexual problems after using their hair-loss drug should be consolidated before one judge for pretrial proceedings.

Merck Prefers New Jersey

Merck has suggested that the U.S. Judicial Panel on Multidistrict Litigation should transfer all cases to the U.S. District Court for the District of New Jersey, where 41 of the 53 lawsuits over Propecia have already been filed.

Some plaintiffs proposed that the Propecia MDL be centralized in the U.S. District Court for the Eastern District of New York, or, in the alternative, in the U.S. District Court for the Western District of Washington.

Merck’s attorneys claim that moving the cases to the Eastern District of New York, or the Western District of Washington, would be inefficient because the courts lack familiarity with issues already addressed in a number of the cases.

Judicial Panel on Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation is expected to hear arguments on the consolidation of the lawsuits over Propecia at a hearing scheduled for March 29, 2012 in San Diego, California.

It appears that all parties agree that centralizing the Propecia cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings. However, the MDL panel will have to determine what is the most appropriate transfer jurisdiction.

What is the problem with Propecia?

Propecia (finasteride) is approved for the treatment of male pattern baldness. It is a low-dose version of Proscar, approved in 1992 for the treatment of benign prostatic hyperplasia.

Men who took the hair loss formula say that Merck failed to warn consumers of the risks of long-term erectile dysfunction from Propecia, as well as loss of libido, infertility, anxiety, depression and other problems.

In the United States, Merck has suggested warned that the sexual side effects of Propecia are temporary, indicating that cases observed during clinical trials resolved after users stopped taking the medication.

Merck has different European warning

Merck has been forced to provide additional warnings to men in certain other countries, indicating that post-marketing reports have indicated that some men experience sexual problems that persist.

A Kansas woman is has filed a product liability lawsuit which was allegedly caused by side effects of Cymbalta. Cymbalta is manufactured by Eli Lilly and Co. She developed a dangerous skin reaction, known as Stevens-Johnson syndrome.

Nanci Matos, filed the Cymbalta lawsuit in the U.S. District Court for the District of Kansas on January 6.

Matos alleges that she developed Stevens-Johnson syndrome from Cymbalta, a popular antidepressant and anti-anxiety medication.

Matos began taking Cymbalta in November 2009. By December, she indicates that she started to show signs of a skin reaction and was hospitalized in January 2010.

Stevens-Johnson Syndrome (SJS) is an auto immune reaction that can be caused by some medications. The medical condition is typified skin blisters, severe rash and the skin may separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as toxic epidermal necrolysis (TEN).

Treatment for SJS or TEN typically involves inpatient care at a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases.

Matos’ Stevens-Johnson syndrome lawsuit claims that Eli Lilly failed to adequately warn doctors and patients that Cymbalta side effects could cause dangerous skin reactions.

According to the lawsuit, the FDA asked the company as early as 2007 to investigate potential link between Cymbalta and skin reaction problems, but Eli Lilly allegedly ignored that request and a number of other warnings by experts until September 2011, when the Cymbalta label was updated to include a warning of SJS and other skin reaction side effects.

Matos accuses Eli Lilly of strict liability, negligence, breach of warranty, misrepresentation, fraud and violations of consumer protection laws. She seeks damages for disfigurement, pain, suffering, mental anguish, embarrassment, shame, loss of enjoyment of life, loss of consortium and other injuries.

Topamax can result in serious birth defects such as cleft palate or cleft lip. These occur when parts of the soft and hard palate fail to completely fuse together. The defect can result in a notched lip, or in severe cases, an open groove that extends from the nose to the roof of the mouth. Cleft lip and cleft palate birth defects can also cause problems eating and communicating, and can increase the risk of ear infections.

What is Topamax?

Topamax is an anti-convulsant drug used to treat epileptic seizures. In addition, Topamax is also prescribed to help prevent migraine headaches. The chemical name for Topamax is Topiramate, and its generic name is Topiragen.

Topamax Problems

In 2009, the makers of Topamax were charged by the Department of Justice of promoting the drug to physicians for unapproved purposes. Such promotions are called “off label” since they encourage use of the drug for purposes not listed on the packaging, and not approved by the FDA. The manufacturers of Topamax plead guilty and paid $75.37 million for violating the False Claims Act, as well as $6.14 million in criminal fines.

Topamax Lawsuit

A product liability or defective product claim for Topamax is a type of pharmaceutical claim in which a person is injured as the result of taking a medication. The cleft lip and palate birth defects were not originally listed as side effects of Topamax, prompting the FDA to update the pregnancy warnings.

Topamax Medical Studies

Topamax has been shown by numerous studies to cause serious birth defects, such as cleft lip or cleft palate. Serious malformations may require expensive surgery or speech therapy, which can be costly.

The UK Epilepsy and Pregnancy Register, as well as the North American ARF Pregnancy Registry, noted a higher incidence of oral clefts in children whose mothers took Topamax during pregnancy.

What was Topamax prescribed for?

Topamax is prescribed to treat epileptic seizures, as well as for the prevention of migraines. However, Topamax has been applied for many off-label uses, such as bulimia, post traumatic stress disorder, obesity, and smoking cessation.

When did the FDA issue a new warning for Topamax?

In March 2011, the FDA increased the pregnancy warning for Topamax to Category D, which means there is positive evidence of fetal risk.

The FDA required new warnings in 2011 after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax during the first trimester of pregnancy experienced an oral cleft about 1.4% of the time, compared to a prevalence rate of between 0.33% and 0.55% associated with other epilepsy drugs.

When did the FDA approve Topamax?

Topamax was approved to treat epileptic seizures in 1994. In 2004, the FDA approved is for use in the treatment of migraines.

The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010. In many cases the drug is prescribed for off-label uses.

Is Topamax sold under any other names?

Yes. A generic version of Topamax was approved in 2006, called Topiragen. It is distributed by Mylan Pharmaceuticals.

Who are the manufacturers of Topamax?

Ortho-McNeil Neurologics and Noramco, Inc. discovered Topamax in 1979. Both companies are divisions of Johnson & Johnson.

According to experts, the new blood thinner Pradaxa has been linked to an increased risk of serious life-threatening bleeding. Now many experts are questioning its safety.

PRADAXA LAWSUIT STATUS

Users of Pradaxa who suffered severe internal bleeding, hemorrhages or other problems may be eligible to pursue a Pradaxa lawsuit. Our lawyers are reviewing potential claims for individuals throughout the United States.

MANUFACTURER

Boehringer Ingelheim

PRADAXA OVERVIEW

Pradaxa (dabigatran) was released in October 2010 as an anticoagulant, but received more consumer complaints to the FDA’s MedWatch adverse event reporting system in its first three months on the market than 98.7% of the other drugs.

The drug is meant to be a replacement for warfarin and is supposedly easier to use because it requires less monitoring. Warfarin can be quickly counteracted by doses of Vitamin K when a bleeding problem occurs. There is no such remedy available when Pradaxa side effects cause internal bleeding.

PRADAXA INTERNAL BLEEDING SIDE EFFECTS

In the first year Pradaxa was on the market, there were more than 360 deaths attributed to internal bleeding from Pradaxa and some experts have raised questions as to whether the drug’s pre-approval clinical trials were valid.

Complaints of Pradaxa problems have included hemorrhages, especially among the elderly and those with impaired kidney function. Other reports suggest that the drug has proven ineffective in some cases, leading to deep vein thrombosis and pulmonary embolism due to blood clots Pradaxa failed to treat.

FDA INVESTIGATES

In December 2011, the FDA announced it was launching a safety review of Pradaxa, after only 14 months on the market. The agency will evaluate post-marketing reports of serious bleeding events. The investigation came about a month after the manufacturer announced it was investigating Pradaxa death reports.

LAWSUITS

As a result of the drug makers’ possible failure to adequately warn about the risks associated with their medication, Pradaxa lawyers are evaluating whether users may be entitled to compensation through a product lawsuit.

SSRIs are a widely prescribed class of drugs most often used as antidepressants to treat depression and anxiety disorders. Since September 2005, scientific information has been emerging that certain SSRIs, such as Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), and Zoloft (sertraline), and SNRI antidepressants, such as Effexor (venlafaxine) may cause birth defects.

SSRI Birth Defects

Cardiac (heart)
Neural-Tube (brain and spinal cord) – spina bifida
Cranial (skull) – craniosynostosis
Abdominal Wall - omphalocele
Cleft Lip and/or Palate
Limb - club foot and other limb abnormalities
Anal Atresia (complete or partial closure of the anus)

The FDA also issued an alert in July 2006 warning about the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) to babies born to mothers taking SSRI antidepressants.

What type of Heart Birth Defects?

The FDA issued a Public Health Advisory on December 8, 2005 based on U.S. and Swedish studies showing that exposure to certain antidepressants in the first trimester of pregnancy may be associated with an increased risk of heart birth defects.

Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed, and leads to a condition otherwise known as a "hole in the heart."

Exposure to antidepressants may also cause other types of heart defects, including pulmonary stenosis and atresia, tricuspid atresia, aortic stenosis, hypoplastic left heart and conotruncal defects, such as transposition of the great arteries, double outlet right ventricle and Tetralogy of Fallot.

What is PPHN - Persistent Pulmonary Hypertension?

PPHN is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream.

On July 19, 2006 the FDA issued a Public Health Advisory for SSRIs, including Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), and Zoloft (sertraline) based on a study that suggests there may be additional risks of SSRI medications during pregnancy.

In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.

FDA Pregnancy Warning

All antidepressants, except for one, are currently classified as Category C medications, meaning that animal reproduction studies have indicated an elevated risk of adverse events on the animal fetus and should only be used if the potential benefits outweigh the potential risks.

According to some experts all SSRI and SNRI antidepressants should be classified as Category D medications - “positive evidence of risk-studies in humans” which means fetal risk has been demonstrated.

This is an interesting issue of conflict of interest, impartiality and doing the right thing, as reported by the Wall Street Journal.

Talk about the fox guarding the chicken house! In December, an advisory panel for the U.S. Food & Drug Administration (FDA) voted to recommend by 15-11 margin that the benefits of Yaz, Yasmin and similar pills made with the synthetic progestin, drospirenone, outweighed their risk of dangerous blood clots.

Now it has come to light that three of the FDA advisors who voted with the majority had ties to Bayer AG, the maker of the drugs, that were not disclosed by the agency.

According to a report from The Wall Street Journal, (WSJ) those advisors were:

• The panel's chair, obstetrics professor Julia V. Johnson of the University of Massachusetts Medical School, told the WSJ in an email that she has been an "investigator in four research studies from Bayer or Berlex [a Bayer unit]," including one that involved the use of a drospirenone product in post-menopausal women. In her email, Dr. Johnson said she has "received no funding or grants" for her work.

• Paula Hillard, an obstetrics professor at Stanford University School of Medicine, who Bayer documents said ""enables us to now have another huge ... Yasmin advocate here in Nor Cal—she will be well utilized!" Another Bayer "tactical brief" from 2010 describes a video clip the company planned at the time with Dr. Hillard to deal with the blood clots and other safety issues. She told the WSJ she received $10,000 for her work.

• Anne E. Burke, professor of gynecology and obstetrics at Johns Hopkins Bayview in Baltimore, who declared in published articles that she received research funding from Bayer.

Their ties to Bayer were not revealed by the. According to the WSJ, the panelists' Bayer ties were first disclosed in a joint article by the British medical journal BMJ and Washington Monthly. Details of their work with Bayer also were revealed in documents in the ongoing Yaz and Yasmin litigation in federal court in Illinois.

The fact that the three were allowed to vote at all, however, does raise some ethical questions. Experts acknowledge that significant ties between committee members and drug makers could result in biased recommendations

As mentioned by an expert polled for his opinions on the matter by the WSJ, "Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."

Interestingly it should be noted that one panelist, Dr. Sidney Wolfe of the consumer group Public Citizen, was stripped of his voting rights by the FDA because he had publicly criticized the drugs' safety in newsletters published by the group.

Is it any wonder that the general public has lost faith in its government, particularly when it comes to the governmental watch dog, the FDA? The FDA instead of being the wonder dog, is essentially has become a toothless canine alongside all the other toothless and powerless federal agencies.

Look at the examples of Medtronic Infuse bone graft injuries, the defective DePuy ASR and Pinnacle metal on metal hips, defective Cardiac Pacemaker leads, Transvaginal mesh, the dangerous drugs including Accutane, Fosamax, Plavix, Tylenol, Actos, Nuvaring, SSRI left on the market with inadequate warnings.

Big Pharma putting profits before people.

Read more here and visit our website for more information.

I am providing this timely slip and fall update. Unfortunately many folks get injured by slipping and falling in a Dallas store or businesses every day. Many serious injuries can be avoided if Texas' business owners would simply take the time and invest the money to make their stores safer.

As a Texas supermarket trip and fall attorney, I have represented customers who have been injured in grocery stores, convenience stores, shopping malls and big-box retailers for many years. Consistently, I have found that most of our clients have fallen because the business owner has not dedicated enough resources to customer safety. Some companies spend millions advertising each year but skimp when it comes to keeping customers safe.

Customer safety begins by creating the safest environment reasonably possible. Stores should have adequate lighting, clean and clear places to walk and non-slip surfaces. Many people in the Dallas Fort Worth area walk around in sandals and open-toed shoes. Knowing this, extra precautions should be used by store owners to make sure that anti-slip surfaces and anti-slip wax are used.

In addition, there should be a detailed inspection protocol for store aisles. Depending on the size of the store, employees should be assigned to inspect the floors for dangerous or slippery conditions on a routine basis. We recommend that floors should be observed several times per hour and a checklist form completed after each inspection.

Furthermore, spills should be properly cleaned and dried before customers are permitted access to the scene. Pop-up safety cones, like the Spill Safety Cone, are excellent products that provides a high-quality and cost-effective alternative to the leading high-priced safety cones currently on the market.

The Spill Safety Cone comes in two sizes: 20 inch & 30 inch. We recommend the 30 inch cone as it provides even greater visibility to distracted shoppers. The cone comes in a plastic storage sleeve with mounting hardware included. It is a strong, simple, device that is made of a high-quality, durable materials and can fit seamlessly into existing safety cone programs. Furthermore, since there is a low replacement cost, store owners should be more likely to use them.

We also recommend that any business owner with a large demographic of Spanish- speaking customers also use bilingual markers that have ANSI approved symbols. It is also essential that business owners training their employees how to inspect, clean and maintain the premises is essential to eliminate unnecessary slip and fall injuries.

Our Fort Worth slip and fall injury lawyers are devoted to holding businesses responsible for injuries caused by failing to putting profits over customer safety.

I am providing this important update regarding car safety and car accidents. Since our Fort Worth car accident lawyers have represented injury victims for many years we understand that while some accidents are unavoidable the extent of the injuries often depends on the safety of the cars involved.

Very often, the difference between a safe car and one that fails to meet national standards can mean the difference between simply walking away from an accident or being seriously injured or killed.

The Insurance Institute for Highway Safety (IIHS) is a not-for-profit group financed entirely by the insurance industry. As a Tarrant traffic accident lawyer, we study closely the recently released IIHS 2012 list of Top Safety Picks, with a record breaking 115 passenger vehicles receiving the distinction of being a Top Safety Pick. Utilizing the IIHS study will help drivers make better-informed selections about the cars they drive.

Crash-worthiness is the study of how well a particular car protects its occupants in a crash. The IIHS rates vehicles in four separate tests. High-speed front and side crashes, roll-overs and rear-enders. It also analyzes seat restraints and head rests to determine the probability of sustaining a neck or back injury in a rear-end crash.

For any vehicle to score a Top Safety Pick it has to have good ratings in all four tests. Our Tarrant County car crash lawyers cannot recommend that any of our clients drive mini-cars. Surprisingly there are only four mini-cars that were deemed to be safe enough to be a Top Safety Pick. The Mini Cooper which seems to be very popular on the streets of Dallas did well in front impact crashes but scored poorly in side impact and roll-over tests.

It may not be stylish, but Suburu with the most models receiving 2012 picks while BMW has the least. Honda was the manufacturer deemed to be "most improved" due to increases in roof strength in 2012. To find out how will your car did, click here.

Analysis of data from the Women's Health Initiative, postmenopausal women who were on a statin at study entry had almost a 50% greater risk of diabetes than those who weren't on the cholesterol-lowering drugs, according to a report in the Archives of Internal Medicine.

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Potential Link Found Between Statins and Diabetes

Recent research has suggested a potential link between statins and the development of diabetes, most notably a meta-analysis that found a 9% increased risk of the disease with statin use.

Women's Health Initiative Study

Data was reviewed for 153,840 women, mean age 63, who didn't have diabetes when they were enrolled in the study in 1993. About 7% of them were on statins at that time.

Through follow-up ending in 2005, there were 10,242 cases of new-onset diabetes.

In initial analyses, researchers found that statin use at baseline was associated with an increased risk of diabetes, and that association remained significant in multivariate analyses controlling for age, race, and weight.

The researchers found that statin use was associated with a higher risk of diabetes in women with a body mass index (BMI) under 25 than in those who had a BMI of 30 or higher. They said differences in phenotype, such as weight distribution, may explain the association.

Risk of diabetes also was similarly elevated, by about 50%, for women with and without heart disease, and was similar if women used either high- or low- potency statins.

Take Home Message

This study found that older women who take statins may be at an increased risk for developing type 2 diabetes. Note that the risk was seen with all types of statins.

The researchers said the study was limited by its observational nature, and because individual statin analysis may be confounded by the fact that women may have changed statin type before developing diabetes.

Following the lead of the Federal Court ordered mediation in the Yaz/Yasmin litigation, the Pennsylvania state court judge has entered a similar order.

Judge Moss, who is managing thousands of cases in Philadelphia state court, required mediation in an order published on January 6, 2012. Judge Moss’s order comes just one week after a federal judge entered a similar order.

Both judges appointed Professor Stephen Saltzburg of George Washington School of Law, Washington D.C., to assist in the mediation.

Plaintiffs are hopeful that this is good news for women across the country who have been injured by Yaz, Yasmin and Ocella birth control pills and they are hoping that this mediation paves the way for a global Yaz settlement.

The parties have been ordered to negotiate in good faith, but this does not mean that they will be able to come to an agreement.

See the Order below, click here to review the Philadelphia Mass Tort Docket in re YAZ/YASMIN/OCELLA LITIGATION

IT IS ORDERED THAT IN CONJUNCTION WITH THE HONORABLE DAVID HERNDON'S 12/31/11 CASE MANAGEMENT ORDER #53, THE COURT APPOINTS PROFESSOR STEPHEN SALTZBURG OF GEORGE WASHINGTON SCHOOL OF LAW, WASHINGTON DC, AS SPECIAL MASTER FOR PURPOSES OF MEDIATION, WITH ALL HIS EXPENSES AND FEES TO BE BORNE EQUALLY BY PLTFS AND DEFENSE SIDES. PHILA LIAISON COUNSEL ARE ORDERED TO COORDINATE WITH THE MDL LEADERSHIP TEAMS AND TO PARTICIPATE IN ALL ORGANIZATIONAL MEETINGS WITH PROFESSOR SALTZBURG. PROFESSOR SALTZBURG SHALL CONSIDER AND UTILIZE EVERY REASONABLE MEDIATION OPTION AVAILABLE TO EFFECTUATE SETTLEMENTS IN THIS LITIGATION. EACH PARTY IS ORDERED TO NEGOTIATE IN GOOD FAITH. IT IS FURTHER ORDERED SINCE THE CASE OF BODNAR V. BAYER, #1003-2173, SET FOR A FEBRUARY 2012 TRIAL, NOT BEING SUBJECT TO THE SUPREME COURT OF PA KING'S BENCH PETITION, IS CONTINUED TO MAY 2012 SO THE COURT CAN EVALUATE THE MEDIATION'S PROGRESS AND CHANCES FOR SUCCESS. BY THE COURT ...MOSS,J 1/6/12

Novartis is under the gun over the deadly side effects caused by Tekturna (Aliskiren), its blood pressure pill, the so called "wonder drug."

Recently Tekturna's clinical trials were canceled by Novartis due to a high number of strokes and kidney problems among diabetic test subjects. Tekturna HCT, Valturna, TekAmlo and Amturnide are all variations of Teckturna (Aliskiren).

ALTITUDE Study

During the ALTITUDE clinical trials, Novartis was testing Tekturna and hoping that a positive result could lead to an expansion of its use in the treatment of diabetic hypertension. The results were disastrous. Novartis discovered that Tekturna may actually increase the risk of non-fatal strokes, kidney problems and other health risks.

Health Canada Investigates

As a result of the Tekturna clinical trial findings, a safety review of the potential Tekturna problems was launched in Canada, by their federal regulators, Health Canada. The Novartis anti-hypertensive drug is sold under the brand name Resilez.

What did Novartis do Wrong?

According to experts, Novartis engaged in extraordinary reckless behavior. Novartis was allegedly instructing its sales representatives to engage in "off-label marketing" of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in the diabetic patient population while claiming it had "protective effects" on these patients.

In fact, it was not specifically indicated for use in diabetic patients and actually caused serious adverse health effects.

Novartis' Aggressive Off Label Marketing

Novartis engaged in an aggressive off-label marketing campaign to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide specifically for use in the diabetic patient population, a use for which each of the drugs is not indicated and most importantly not FDA approved.

Novartis Sales Reps Under Fire

Because Tekturna is the only drug on the market that is a Direct Renin Inhibitor, this allowed for Novartis to heavily promote the drug (or one of its combinations) for use in the diabetic patient. Sales representatives voiced concerns about selling these drugs for uses for which they were not indicated. Company managers refused to budge.

In fact, sales representatives were trained to illegally used an unbranded sales aid (approved for a disease state, not a drug) that showed the effect of Renin in a rat kidney in order to sell Tekturna and Valturna to the diabetic patient population. This sales aid was used by Novartis to convince medical prescribers that these drugs had positive health effects for the diabetic patient population.

Novartis trained its sales representatives to make claims that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide would significantly lower blood pressure, protect the heart, protect the kidneys and protect end organs. Flash cards anyone?

Medical Claims Not Supported

Such claims were unsupported by medical science and in fact, contrary to medical data that suggests that the drugs Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide cause an increase in cardiovascular risk, including stroke, renal complications, hyperkalemia and hypotension, especially in the diabetic patient population.

What Novartis Knew or Should Have Known?

During the time that Novartis was actively engaging its sales representatives to use such tactics, it is believed by some that Novartis possessed and still possesses information that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide causes serious health risks, some of which has been released via the ALTITUDE clinical trial.

According to some experts, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide have minimal blood pressure lowering effects and are of little benefit to patients. To the contrary, these drugs can cause more harm than good. Moreover, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide carry serious cardiovascular and renal side-effects when used in combination with an ACE or ARB, a use which is most common.

Novartis Paid Kickbacks?

On December 20, 2011, Novartis temporarily suspended the promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in combination with an ACE inhibitor or ARB.

But prior to its December 20th action, Novartis paid kickbacks in the form of speaker fees and "Lunch and Learns" in order to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population.

More Information

For another great article on the topic, look at Attorney Larry Jones, of Jones Ward's blog.

For more information about Tekturna lawsuits, feel free to contact The Dr Shezad Malik Law Firm or dangerous drug attorney Dr Shezad Malik by clicking here: DrMalik@ShezadMalik.com.

The off label use of Medtronic Infuse(R) bone graft has been associated with severe side effects including in some cases, death.

Medtronic Infuse(R) Bone Graft What is It?

Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. designed and marketed the Infuse(R) Bone Graft device (“Infuse(R)”) for lumbar spine surgery. Infuse(R) is a bio-engineered bone filling material containing a bone morphogenetic protein (“BMP”), and is used as an alternative to grafting a patient’s own bone.

Infuse(R) is a genetically engineered protein -rhBMP to help fuse vertebrae in the lower (lumbar) spine in order to treat degenerative disc disease.

Side Effects including:

Excessive swelling of the neck

Difficulty swallowing, or speaking

Compression of the airway

Medtronic Infuse(R) Off Label Use

Infuse(R) Bone Graft, is only approved for a limited surgical procedure, but Medtronic allegedly illegally promoted it for a number of off-label procedures according to a pending lawsuit filed in the Superior Court of California. Case No.: BC465313

Medtronic Infuse(R) only cleared for Anterior Lumbar Surgeries

Infuse(R) was approved by the Food and Drug Administration (“FDA”) on July 2, 2002, for use only in the lower region of the spine (at levels L4 through S1) to treat degenerative disc disease, and was approved only for anterior surgeries at L4 through S1.

That meant that it was initially approved only to be used by surgeons, when the surgeons placed the cage within the vertebrae in the lumbar region of the back, and only by entrance through the abdomen.

Infuse(R) has never been approved by the FDA for use in other parts of the body or for use in any other type of procedure, and any such uses are “off-label” uses.

The Medtronic California Infuse(R) Lawsuit

The plaintiff alleges that while physicians may use FDA-approved medical devices in any way they see fit, companies are not permitted to promote off-label uses for their medical devices or to pay doctors inducements or kickbacks to promote the off-label uses or to perform procedures using the devices off-label.

FDA Adverse Event Reports

At least 280 reports of adverse events involving Infuse(R) have been made to the FDA. Approximately 75% of those reports involve off-label use.

On July 1, 2008, the FDA issued a Public Health Notification about complications from the off-label use of Infuse(R) in the neck, or cervical, area of the spine. The FDA reported that it had received 38 reports over a four year period through July 1, 2008, of complications from cervical uses of Infuse(R); and, that some reports were of life-threatening and fatal events. Some of the complications were associated with swelling of the neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck, and patients reported difficulty swallowing, breathing and speaking.

Several patients required emergency treatment, including tracheotomies and the insertion of feeding tubes. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, issued July 1, 2008.

Dr Shezad Malik recommends that folks who have been treated with Infuse Bone Graft and experienced side effects outlined above should fill out a MedWatch Form at www.fda.gov and explore their legal rights.

Read more here, visit my website for further information and review my blog.

Medical side effect concerns about Tekturna, a blood pressure drug sold by Novartis, have arisen after clinical trials were canceled due to a high number of strokes and kidney problems among diabetic patients.

Novartis was running a trial of the drug to see if it could be useful in the treatment of diabetic hypertension. The drug maker found that Tekturna may increase the risk of non-fatal strokes, kidney problems and other health risks.

Read the Safety Warning from Novartis here. Direct Healthcare Professional Communication on potential risks of cardiovascular and renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular disease treated with aliskiren (Tekturna®) tablets and aliskiren-containing combination products.

As a result of the findings, a safety review of the potential Takturna problems was launched in December in Canada, where the medication is sold under the brand name Resilez.

The cancellation of the clinical trials was announced in a December 20 press release by Novartis. The trial, known as ALTITUDE, involved 8,609 patients from 36 countries. It was a randomized, double-blind, placebo-controlled study of the drug’s use in patients with diabetes and kidney problems.

The study found an increase in Tekturna side effects after 18-24 months that included not only strokes and kidney complications, but also caused hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause circulatory problems.

The clinical trial involved the use of Tekturna along with angiontensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). As a result of the bad side effects, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients.

ALTITUDE was cancelled after an independent Data Monitoring Committee (DMC) overseeing the clinical trial became alarmed at the high rate of Tekturna health risks among tests subjects and recommended Novartis pull the plug.

The company has not yet released data from the study, but has told all of the clinical trial’s investigators to remove Tekturna products from their patients’ treatment regimen.

Tekturna (aliskiren) was approved in 2007 for the treatment of high blood pressure. In several countries outside the United States, it is sold under the brand name Rasilez.

In a recent statement released by the Canadian regulatory agency, Health Canada, noted that 329 of the test subjects were from Canada and the agency has expressed concerns over the risks of the clinical trial to its citizens.

Canadian officials say they are looking at available safety data and is considering taking appropriate regulatory action if necessary. The actions could include new label warnings and safety recommendations.

Read more here on Mass Tort Pharmaceutical Litigation and visit our website for more information

The FDA is alarmed about the risk of complications with vaginal mesh used to treat pelvic organ prolapse and stress urinary incontinence. The Federal regulators are ordering manufacturers to conduct new medical studies on the surgical products’ safety.

FDA Notice Letter Sent

The FDA sent a letter to several medical device makers recently calling for the new postmarketing studies on transvaginal mesh. Many experts believe that this is the beginning of tighter regulations designed to protect women from bladder sling problems.

The letter was sent to 33 manufacturers of vaginal mesh products, including Johnson & Johnson, American Medical Systems (AMS), C.R. Bard and Boston Scientific.

Controversial 510(k) Fast-Track Approval Process

The vaginal mesh products have been approved through the FDA’s controversial 510(k) fast-track approval process, which only requires that they be substantially equivalent to a device that has already been approved for sale.

510(k) fast-track approval process means that there were no requirements for clinical studies or tests of safety or effectiveness before the medical devices were implanted in American women.

FDA Mandates New Studies

The FDA will now require 99 new postmarket studies, with 88 of those focused on surgical mesh for pelvic organ prolapse (POP) and 11 targeting single-incision mini-slings used to treat stress urinary incontinence (SUI). Manufacturers will have to submit study plans to the FDA showing how the studies will address the agency’s safety concerns.

Scope of the Problem

An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010.

In summer 2011, the FDA issued a warning about the risks of problems when vaginal mesh products are used. The regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh complications, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infections, pelvic pain and other complications.

A growing number of transvaginal mesh lawsuits have been filed in courts across the country by women who say that vaginal sling manufacturers created defective products and failed to warn doctors or patients adequately about the risk of complications.

Read more here and visit our website for more information

The federal judge overseeing the thousands of Yaz, Yasmin and Ocella venous thrombo-embolism lawsuits, has delayed the first trial scheduled to begin January 9th. The Court ordered the parties to meet with a special mediator in an attempt to negotiate a settlement for the litigation.

The first Yaz trial was involved a plaintiff who suffered a pulmonary embolism after taking the birth control pill.

Judge Herndon issued the order December 31 and determined that the litigation will be better served by delaying the start of the bellwether trial. This trial was designed to help the parties gauge how juries are likely to respond to evidence that will be presented in many of the cases.

Experienced Mediator Appointed
Professor Stephen Saltzburg of George Washington School of Law was appointed to serve as Special Master for purposes of mediating the entire litigation.

Scope of the YAZ Problem
Over 10,500 women have filed a product liability lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the side effects of Yaz, Yasmin and other drosperinone-based birth control pills.

Is Drospirenone the Culprit?
Drospirenone is a new type of synthetic progestin that is used in combination oral contraceptives pills that includes estrogen. Berlex Laboratories originally manufactured Yasmin. Berlex was acquired by Bayer Healthcare, and newer version of Yasmin was manufactured called Yaz.

Recently, Bayer introduced a third version, called Beyaz, which includes a folate supplement. There are several generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

Medical Studies Reveal the Problem
Several medical studies have found that women using Yaz face an increased risk of suffering a blood clot, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT) and sudden death, a condition known as Venous Thrombo- Embolism (VTE).

FDA Now Involved
The FDA recently released a report that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills.

A panel of FDA advisors which met in December called for stricter label warnings on Yaz and Yasmin, but stopped short of recommending a Yaz recall.

All federal Yaz and Yasmin lawsuits have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before Judge Herndon in the U.S. District Court for the Southern District of Illinois.

Read more here on YAZ lawsuits and visit my website for more information

The Judicial Panel on Multidistrict Litigation (JPML) is streamlining litigation for all federal cases alleging injury caused by the diabetes drug ACTOS®. These cases will now be brought under MDL No. 2299.

On the basis of the papers filed and the hearing session held, the JPML found that eleven current actions involve common questions of fact, and that centralization in the Western District of Louisiana will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.

Each of the actions alleges claims arising from the use of Actos, a prescription medication approved by the FDA, for use in the treatment of type 2 diabetes. Plaintiffs allege that individuals who use Actos face an increased risk of developing bladder cancer. Plaintiffs further allege that the defendants concealed their knowledge of this risk and failed to provide adequate warnings to consumers and the health care community.

Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary.

The JPML was persuaded that the Western District of Louisiana is an appropriate transferee district for this litigation.

The eleven cases are transferred to the Western District of Louisiana and assigned to the Honorable Rebecca F. Doherty for coordinated or consolidated pretrial proceedings in that district.

Read more here on the Actos litigation and visit my website for more information.

A New Jersey state court jury was unable to render a verdict in the most recent Accutane product liability trial. The plaintiffs had alleged that the acne medication Accutane caused a teenager to suffer inflammatory bowel disease (IBD) as a result of Accutane side effects.

The Accutane product liability claim, was brought by the parents of Priya Tanna, who was 15 when she started taking the Roche medication to treat her acne.

Roche claimed that there was a 7-step warning process in place before Tanna began taking Accutane, and therefore, they are not liable for the injuries.

As deliberations was drawn out, the jury failed to come to an agreement on the claims, resulting in a hung jury.

This case was one of about 6,000 Accutane lawsuits that are currently pending in New Jersey state court before Judge Carol E. Higbee. All of the complaints involve similar allegations that plaintiffs developed inflammatory bowel disease, Ulcerative Colitis, Crohn’s disease and other severe and chronic debilitating bowel injuries.

Accutane, known generically as isotretinoin, has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne.

Roche stopped the manufacturing of Accutane in June 2009, but a number of generic versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

To date, plaintiffs have been successful in seven out of the first 10 Accutane bowel disease lawsuits that have been presented to a jury.

Read more on Accutane Side Effects and Inflammatory Bowel Disease and visit my website for further information.