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FDA Warns PPIs May Cause Severe Diarrheal Infection

Thu, 09 Feb 2012 00:00:00 -0800

Patients who take proton pump inhibitors (PPIs) may be at a higher risk of developing a serious condition called Clostridium difficile–associated diarrhea (CDAD). The danger prompted the U.S. Food & Drug Administration (FDA) to issue a Drug Safety Communication yesterday, and announce that it was working with the makers of PPIs to add information about their association with CDAD to the drug's labels.

CDAD is a type of diarrhea that does not improved. It is caused by Clostridium difficile (C. diff), a bacteria often spread in hospitals, which can be passed from person-to-¬person on contaminated equipment and on the hands of doctors, nurses, other healthcare providers and visitors. The condition can be treated with antibiotics, but often the most severe cases of C. diff infection require surgery.

In its Drug Safety Communication, the FDA advised healthcare providers to

Consider a CDAD diagnosis for PPI users with diarrhea that does not improve.
Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Report adverse events involving PPIs to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

Patients should seek care immediately if they develop diarrhea that does not improve.

PPIs are sold as both prescription and over-the-counter (OTC) medications. Prescription PPIs (Dexilant, Nexium, Prevacid, Prilosec, Protonix, Vimovo and Zegerid) are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs (Prilosec OTC, Prevacid 24hr and Zegerid OTC) are used to treat frequent heartburn.

Why Did Merck Pull Propecia Website?

Thu, 09 Feb 2012 00:00:00 -0800

As of February 8, Merck & Co.'s website for Propecia (finasteride 1mg), a prescription drug for male pattern baldness, is no longer available to the public. Now, some in the legal community are speculating that Merck may have pulled www.propecia.com because of the growing controversy - and litigation - over Propecia's sexual side effects.

At last count, 53 lawsuits have been filed throughout the country by men who claim 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. While Merck's label for Propecia in Europe has warned for several years now that sexual side effects may persist after men stop using the drug, warnings on the U.S. label indicate they are only temporary.

Last Spring, a study published in the Journal of Sexual Medicine found that at men who take finasteride may develop an ongoing loss of libido and orgasm, even after they go off the medication. The study looked at 71 men who reported such side effects. The average duration of persistent sexual side effects was 40 months after they stopped taking finasteride. About 20 percent of the men still had side effects more than six years after stopping finasteride.

At least one plaintiff's attorney believes that the growing litigation over Propecia prompted Merck to pull its Propecia website earlier this month.

“One reason for Merck’s abrupt action might have something to do with the fact that a growing number of lawsuits are being filed against the company,” the attorney told the Baltimore edition of the Examiner.

It's also possible that Merck took the website down because it will be adding new warnings to the Propecia label. Revise warnings would likely prompt more men to file Propecia lawsuits, once they made the connection between their sexual problems and use of the drug.

Pfizer Seeks MDL for Zoloft Birth Defect Lawsuits

Wed, 08 Feb 2012 00:00:00 -0800

A multidistrict litigation (MDL) could be on the horizon for dozens of Zoloft birth defect lawsuits currently pending in federal courts around the country. Pfizer Inc., the maker of the popular selective serotonin reuptake inhibitor (SSRI) antidepressant, is seeking to have the Zoloft birth defect litigation centralized in an MDL in U.S. District Court, Southern District of New York, asserting that its proximity to three international al airports would make it convenient for plaintiffs. Pfizer’s headquarters are also located there.

According to its motion, Pfizer is named as a defendant in 59 Zoloft birth defect lawsuits pending in federal courts in Pennsylvania, New York, Illinois, Mississippi, Missouri and Ohio. All of the lawsuits allege that a mother's use of Zoloft in pregnancy can cause a child to be born with birth defects. In its motion, Pfizer also suggested that, as an alternative, the Northern District of Mississippi, the Southern District of Mississippi, or the Northern District of Ohio could also be suitable for the proposed Zoloft birth defect MDL.

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 31st in Washington, D.C. If the Panel grants Pfizer's motion, the Zoloft birth defect lawsuits would be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.

Zoloft is approved by the U.S. Food & Drug Administration (FDA) to treat major depression (MDD), social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, premenstrual dysphonic disorder (PMDD), and obsessive-compulsive disorder (OCD) in adults and OCD in 6 to 17 year olds. Zoloft was approved in 1991, and by 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the U.S.

A growing number of studies have linked Zoloft use in pregnancy with serious birth defects, including persistent pulmonary hypertension in newborns (PPHN), heart defects, lung defects, abdominal defects, cranial defects and other malformations.

Long-Term Health Concerns Continue to Mount for Metal-on-Metal Hip Implants

Wed, 08 Feb 2012 00:00:00 -0800

The news just keeps getting worse for recipients of metal-on-metal hip replacement devices, including those with DePuy Orthopaedics' recalled ASR Hip Resurfacing System and ASR Acetabular System, as well people implanted with an all-metal version of the company's Pinnacle Hip Implant system. Mounting evidence continues to indicate that patients with metal-on-metal hip implants face not only a high threat of early failures, but the risk of sustaining long-term health problems, even if they have defective devices removed.

"This is a serious problem in the USA," said Mathias Bostrom, an orthopedic surgeon at the Hospital for Special Surgery in New York City. "Some implants have a worse record than others, but almost all the metal-on-metal implants have issues."

According to a report in USA Today, Bostrom was attending the American Academy of Orthopaedic Surgeons in San Francisco, where the issues surrounding metal-on-metal hip implants is a hot topic of discussion.

The research discussed at the conference linking metal-on-metal hip implants to serious health problems includes:

A study out of the Netherlands which found that 202 of 614 (32%) metal-hip implant recipients had suffered adverse reactions in soft tissue.
An English study which 24% of metal-on-metal hip implant patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had revision, and disease progression "was confirmed in all cases of re-revision," the authors wrote.
An orthopedic surgeon from the Hospital for Special Surgery reported that a study he participated in found that 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

Concerns have been growing for some time that metal-on-metal hip implants could pose long-term health risks. Last year, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. This shedding of metal debris could cause tissue damage, premature device failure, the need for revision surgery, and even long-term health problems, including heart and nervous system damage.

Problems with all-metal hip implants have also led to a growing number of lawsuits against the makers of such devices. At last count, DePuy had been named in more than 3,500 U.S. lawsuits over the recalled ASR devices. At least 900 complaints have been filed against the all-metal version of its Pinnacle hip replacement device, with plaintiffs claiming it is similar in design to the ASR implants and should have been recalled as well.

Long-Term Health Concerns Continue to Mount for Metal-on-Metal Hip Implants

Wed, 08 Feb 2012 00:00:00 -0800

The research discussed at the conference linking metal-on-metal hip implants to serious health problems includes:

A study out of the Netherlands which found that 202 of 614 (32%) metal-hip implant recipients had suffered adverse reactions in soft tissue.
An English study which 24% of metal-on-metal hip implant patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had revision, and disease progression "was confirmed in all cases of re-revision," the authors wrote.
An orthopedic surgeon from the Hospital for Special Surgery reported that a study he participated in found that 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

Lousiana Couple Claims Pfizer Failed to Warn on Zoloft Birth Defects

Tue, 07 Feb 2012 00:00:00 -0800

Pfizer has been named in another Zoloft birth defect lawsuit, this time by a couple in Louisiana. Terry and Nelda Rolling claim Nelda's use of Zoloft during pregnancy caused their child to be born with a congenital birth defect.

Zoloft, known as selective serotonin reuptake inhibitors (SSRI) antidepressant, is approved by the U.S. Food & Drug Administration (FDA) to treat major depression (MDD), social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, premenstrual dysphonic disorder (PMDD), and obsessive-compulsive disorder (OCD) in adults and OCD in 6 to 17 year olds. Zoloft was approved in 1991, and by 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the U.S.

A number of studies have linked SSRI antidepressants, including Zoloft, to birth defects. In July 2006, the FDA warned that women who use the antidepressant Zoloft after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), following the publication of a study in the New England Journal of Medicine that examined the risk of birth defects with Zoloft and similar antidepressants.

The Rollings' complaint accuses Pfizer of failing to adequately warn of the drug’s risks, and of concealing, suppressing, and failing to disclose dangers. They allege Pfizer knew as early as 1996 that Zoloft could cause a variety of problems in children exposed to the antidepressant before birth. Evidence that Zoloft could harm a developing fetus continued to mount between 2002 and 2006. By 2007, due to the publication of a study in the New England Journal of Medicine, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken during pregnancy, the lawsuit claims.

The Rollings joins dozens of other families who are suing Pfizer over alleged Zoloft birth defects. According to the company's own count, at least 59 such lawsuits are currently pending in federal courts throughout the U.S.

Study Cites Problem with Tibial Component Used with Zimmer NexGen Knee

Tue, 07 Feb 2012 00:00:00 -0800

This week, a study will be presented at the American Academy of Orthopaedic Surgeons meeting highlighting a possible problem with the Zimmer NexGen Knee Replacement when it is used with a specific tibial component. According to a report from Dow Jones Newswires, the problem caused failures in some Zimmer NexGen Knee Replacement patients who received that component.

The study was performed by researchers at the Mayo Clinic. According to an abstract obtained by Dow Jones, a total of 1,373 people who Zimmer NexGen knee with the specific type of tibial component were included in the study. All of them had undergone total knee replacement at a single center between 2000 and 2011. Failures occurred in 3.9% of cases for various reasons.

According to the study, half of the failures seen were the result of the implant coming loose from the surrounding bone. Of those cases, 80% were the result of isolated debonding, where the implant comes loose from cement. A similar debonding problem wasn't seen among other implants used at the center.

While the Dow Jones Newswires report did not specify the tibial component cited in the study, a Zimmer spokesperson said that the component represents 1.2% of Zimmer's tibial sales.

Could Cancer Be a Possible Metal-on-Metal Hip Implant Side Effect?

Mon, 06 Feb 2012 00:00:00 -0800

A study that could be unveiled next month in Britain is likely to raise more concerns about the safety of metal-on-metal hip implant devices. According to a report from The Telegraph, the study, conducted by researchers at the University of Bristol, reportedly found evidence linking all-metal hip implants to an increased risk of cancer.

According to The Telegraph, the study involved 72 patients with metal-on-metal hip implants, and found that 17 had sustained genetic damage to cells of the bladder. Atypical cells could be a precursor to cancer, and even more alarming, at least three patients did actually developed full-blown cancer. The study hasn't been published yet, but could be presented next month at the annual British Hip Society conference.

The Bristol University metal-on-metal hip implant study was launched after British regulators warned patients there undergo annual checks, including scans and blood tests if doctors find symptoms that suggest their hips are shedding unsafe levels of metal debris. For several years now, concern has been building that the wearing of metal debris could allow toxic metal shards to make their way into the blood stream, and cause inflammation that destroys tissue and bone.

The concerns have U.S. regulators worried as well. Last year, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.

Several specific models of metal-on-metal hip implants have also raised safety concerns in the U.S. and abroad. For example, in August 2010, DePuy Orthopaedics issued a worldwide recall of its ASR Hip Resurfacing System and the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Recently, a new study - also conducted in Britain - found up to a 50 percent failure rate at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure. Among those implanted with the more limited resurfacing treatment, one in four products failed within the same period, according to the study.

In the U.S., DePuy, a division of Johnson & Johnson, faces more than 3,500 product liability lawsuits over the ASR hip implants. The company faces another 900 over an all-metal version of its Pinnacle hip implant, as well.

Higher Rate of Bleeding, Death Halts Plavix Study

Mon, 06 Feb 2012 00:00:00 -0800

After patients in a stroke prevention study on Plavix-aspirin therapy suffered a higher-than-expected number of bleeding events compared to subjects taking aspirin alone, that arm of the study was shut down. According to a press release from the American Heart Association, patients in the study treated with the Plavix-aspirin combo also suffered a higher death rate compared to those on aspirin only. The study was presented last week at the American Heart Association’s International Stroke Conference 2012,

According to the study, 6.5% of patients on Plavix-aspirin therapy combination experienced a bleeding event, versus 3.3% of those on aspirin alone. The death rate among people in the combo therapy group was 5.8% versus 4.1% in the aspirin-only group.

The study, "Secondary Prevention of Small Subcortical Strokes," or SPS3, was being conducted by the National Institute of Neurological Disorders and Stroke (NINDS). The Plavix-Aspirin arm involved 3,000 patients. The aim of the clinical trial was determine if Plavix-aspirin therapy could prevent recurring strokes in people who had recently suffered "subcortical" strokes. According to the Journal, such strokes, though usually mild, can reoccur and damage the brain over time, predisposing sufferers to dementia.

In addition to the higher bleeding and death rates, the Plavix-aspirin arm of the study was unable to demonstrate that combo therapy provided any additional benefit in preventing strokes.

Medtronic Infuse Shareholder Lawsuit Witness Must Testify, Judge Says

Fri, 03 Feb 2012 00:00:00 -0800

A former Medtronic Inc. employee won't be able to avoid testifying in a shareholder lawsuit involving the device maker's alleged illegal promotion of off-label uses for its Infuse bone graft product. Yesterday, a federal judge in Minnesota ordered the unnamed witness to testify and turn over a key Infuse document, ruling that he had waived his 5th Amendment protections.

In August 2009, the Minneapolis Firefighters’ Relief Association and other institutional investors alleged in an amended complaint that Medtronic had deliberately promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses. The lawsuit sought class action status on behalf of holders of the company's stock who purchased or acquired their shares between November 2006 and November 2008 and suffered financial losses.

Yesterday, U.S. District Judge Paul Magnuson affirmed a magistrate judge's order for the confidential witness, known in court filings as CW2. In doing so, Judge Magnuson said the decision to sign a declaration in support of one of Medtronic's earlier court filings disqualified him from such protection.

“Given the conclusion that CW2 testified as to the subject matter of the document in question in his declaration, Chief Magistrate Judge Boylan’s conclusion that he waived any Fifth Amendment privilege as to that document is indisputedly correct,” Magnuson said.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery, however, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complications.

Medtronic is facing a mountain of legal trouble over Infuse, including several product liability lawsuits claiming it caused serious complications in patients. Over the summer, The Spine Journal raised serious questions about the validity of the research that was used to gain FDA approval of Infuse. In November, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer.

In addition to lawsuits, the U.S. Justice Department, the U.S. Senate Finance Committee and the California attorney general are all investigating Infuse.

Settlements Reported in 20,000 Avandia Heart Attack Lawwsuits

Thu, 02 Feb 2012 00:00:00 -0800

GlaxoSmithKline has reportedly agreed to settle more than 20,000 Avandia heart attack lawsuits, according to a report from Bloomberg News. The agreement to settle the Avandia lawsuits was reached in court-ordered mediation and comes just months after Glaxo said it would pay $3 billion to settle U.S. criminal and civil probes into whether it illegally marketed Avandia and other medications.

Since November 2007, Avandia's U.S. label has included a black box warning detailing its association with heart attacks. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increase in the risk of cardiovascular disease. Since 2007, more evidence of Avandia's heart risks has accumulated. Last year, the U.S. Food & Drug Administration (FDA) placed severe restrictions on sales of Avandia, after determining its heart risks outweighed its benefits.

The controversy surrounding Avandia sparked thousands of product liability lawsuits. Previously, Glaxo had agreed to pay over $700 million to settle over 15,000 patient claims that Avandia caused heart attacks and strokes. In November, U.S. District Judge Cynthia Rufe appointed a mediator to preside over settlement negotiations for an unspecified number of Avandia cases that were consolidated before her in Philadelphia, and imposed a deadline for settling 75 percent of cases. More than 2,500 cases are pending before Judge Rufe, Bloomberg said, while others have been filed in state courts around the country.

Now, a plaintiffs' attorney involved in that litigation has told Bloomberg that Glaxo has reached an agreement to settle 20,000 Avandia lawsuits. However, it is still unclear if enough cases have been settled to meet the deadline. If Judge Rufe's directive isn't been met by the deadline, she's promised to start scheduling cases for trial.

In a statement emailed to Bloomberg yesterday, a Glaxo spokesperson said the most-recent settlements of Avandia patients’ suits “are covered by existing provisions and those payments will be funded through existing cash resources.”

Cancer, Other Safety Worries Point to Dim Future for Medtronic Infuse

Thu, 02 Feb 2012 00:00:00 -0800

Medtronic Inc.'s sales of its Infuse (rhBMP-2) product have taken a hit in recent months, thanks to concerns that the bone growth protein may be associated with cancer and other serious side effects. Now one analyst is raising doubts as to whether Medtronic can salvage Infuse and convince doctors to start to start using it again.

"Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Caroline Corner, an analyst with investment bank MLV & Co, told MedCityNews.com. “But doctors in general are definitely shying away from using Infuse (most of the time).”

Medtronic's Infuse sales are certainly showing evidence of this. According to a press release issued by the company in November, its core spinal revenue declined by 3 percent in the second quarter compared to last year. At the same time, the biologics portion of Medtronic’s spine business declined by 4 percent, thanks to a drop in Infuse sales. Medtronic blamed the decline on the June 2011 publication of articles in The Spine Journal, which called the safety of Infuse into questions. According to the journal, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic's latest Infuse hit came in November, when Dr. Eugene Carragee - also the author of the damning article in The Spine Journal - presented an analysis of another Medtronic-study in which he raised serious concerns about a cancer risk posed by rhBMP-2. That analysis involved a Medtronic trial for its Amplify product, which contains a higher dose of rhBMP-2. Though both the research team and Medtronic were aware of data linking the product to cancer and informed the U.S. Food & Drug Administration (FDA), the clinical trial results were never made public, Carragee said.

Last year, the FDA declined to approve Amplify because of its association with cancer. But, the findings have important implications for Infuse, as doctors often administer that product significantly above the recommended dosages when it is used in off-label procedures. Many times, those doses exceed the amount of rhBMP-2 found in a dose of Amplify, Carragee said.

Medtronic is, of course, desperate to save its once-promising Infuse product, and has gone so far as commission Yale University to conduct a review of its clinical trial data. But Corner doubts even a total vindication of Infuse would be enough to get sales back on track.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will they (doctors) go back to it, I don’t think so,” she said.

Fracking Water Contamination Lawsuits Mount

Wed, 01 Feb 2012 00:00:00 -0800

Since August 2009, nearly two dozen lawsuits have been filed throughout the country by property owners who claim natural gas drilling via hydraulic fracturing (fracking) has contaminated water supplies. According to a report from Bloomberg News, the lawsuits name some of the biggest frackers in the industry as defendants, including Cabot Oil & Gas Corp., Chesapeake Energy Corp. and Southwest Energy Company.

Perhaps the most famous lawsuit filed so far was brought in Pennsylvania, by residents of the small village of Dimock. State regulators blamed Cabot’s fracking for methane contamination of water sources, and in one case, causing a water well to explode in August 2009. The U.S. Environmental Protection Agency (EPA) has started providing fresh water to four Dimock families, plans to test water at 60 homes to assess whether residents have been exposed to hazardous substances. A trial is scheduled to get underway in Scranton federal court in April, and the 23 Dimock families involved in the lawsuit have asked the court to classify fracturing as inherently dangerous, a designation that may make it easier to win damages, Bloomberg said.

Cabot denies its fracking caused the contamination. However, in an agreement with the state, Cabot established a $4.1 million fund that the 19 families with polluted wells could draw from

Several families in Susquehanna County, Pennsylvania have sued Southwest Energy, claiming drilling activities fouled their water wells. In December, Chesapeake settled a lawsuit by paying $15,000 to two Texas landowners who claimed the company polluted their well,

Plaintiffs in these lawsuits will have to prove that chemicals from natural gas wells reached groundwater, or that fracking allowed naturally occurring methane to migrate into water wells. Earlier this year, their cases got boost when the EPA linked pollution in some Pavillion, Wyoming water wells to fracking being performed by EnCana Corp. It was the first time that fracking was linked to water pollution, but EnCana is disputing the agency's findings.

According to Bloomberg, attorneys are closely watching the case to see if it proves to be the first instance that fracking itself, not just general drilling activities, created a problem. Any finding on the Pavillion situation that “demonstrates that fracking has or may have negative health effects will be beneficial to the plaintiff’s bar and would increase the number of lawsuits filed,” one lawyer told Bloomberg News.

Older Women Face Hip Fracture Risk from PPIs

Wed, 01 Feb 2012 00:00:00 -0800

Post-menopausal women, especially if they smoke, might want to think twice about taking a proton pump inhibitor (PPI) to relieve heartburn. According to a new study in the British Medical Journal (BMJ), post-menopausal women who take PPIs like Nexium, Prilosec and Prevacid for two years or more increase their risk of sustaining a hip fracture by 35 percent.

The study also found that women who took the PPIs for six to eight years were 50 percent more likely to suffer a broken hip. Postmenopausal women with history of smoking who took PPIs for longer than two years had more than a 50 percent chance of sustaining a hip fracture. The researchers suggest that the inhibition of calcium absorption from smoking may act with PPIs to increase fracture risk.

The risk of hip fracture returned to normal two years after women stopped taking proton pump inhibitors, the researchers said.

The study, conducted by researchers from Massachusetts General Hospital, involved data on nearly 80,000 U.S. women enrolled in the Nurses Health Study between the ages of 33 and 55. A total of 893 hip fractures were recorded during the time period the women were followed. According to the research team conducting the study, the use of PPIs among the women followed increased nearly 3-fold from 2000 to 2008 among the women in the study, from 6.7% to 18.9%.

The BMJ study is just the latest to point to an association between PPIs and fractures. In May 2010, the U.S. Food & Drug Administration (FDA) announced new information on fractures was being added to the labels of prescription PPIs after a review of several epidemiological studies reported an increased risk of fractures of the hip, wrist, and spine with PPI use.

Metal-on-Metal Hip Implants May Pose Risk of

Mon, 30 Jan 2012 00:00:00 -0800

Fears are rising in Britain that all-metal hip implants, including DePuy Orthopaedic's recalled ASR Hip Replacement devices, could be causing more harm to patients than previously thought. According to a report from the Sunday Telegraph, advisors to the Medicines and Healthcare products Regulatory Agency (MHRA) are growing increasingly concerned that microscopic metal particles shed by the devices could cause "systemic toxicity” in the body.

For now, the MHRA continues to advise that people fitted with metal-on-metal hip implants should undergo annual check-ups for five years following surgery. It also said that those experiencing pain should be given tests to check the levels of cobalt and chromium in their blood, and an MRI or ultrasound scan to check for soft tissue reactions. That advice was issued in 2010, amid concerns that shedding of toxic metal shards could make their way into the blood stream, and cause inflammation that destroys tissue and bone.

According to the Sunday Telegraph, advisors to the MHRA are now concerned the metal shedding could slowly poison nervous system, heart and lungs. There are also concerns that increased cobalt and chromium levels in the blood could be toxic to kidneys and, in the case of pregnant women, be passed on to the unborn child.

There are also concerns that the recalled DePuy ASR hip implants might be failing at a much higher rate than thought, the Sunday Telegraph said. In August 2010, DePuy Orthopaedics, a division of Johnson & Johnson, issued a worldwide recall of its ASR Hip Resurfacing System and the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. But a new study conducted in Britain found up to a 50 percent failure rate at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure. Among those implanted with the more limited resurfacing treatment, one in four products failed within the same period, according to the study.

Costa Concordia Passengers Offered $14,460 Each

Fri, 27 Jan 2012 00:00:00 -0800

Trying to head off legal action, the operator of the doomed Costa Concordia cruise ship has made a compensation offer to passengers who were uninjured after the vessel hit a rock on January 13th and ran aground. According to The Wall Street Journal, the offer of $14,460 per passenger would cover compensation for lost baggage and psychological trauma. Costa Concordia passengers who escaped the disaster relatively unscathed would also be reimbursed for their cruise fare, travel costs, and any medical expenses incurred after the grounding.

To be eligible for the deal, each passenger who accepts it would have to surrender their right to take any further legal action against Costa Crociere SpA, or its parent, Miami-based Carnival Corp.

According to the Journal, the proposed settlement agreement was negotiated between Costa Crociere and several Italian consumer groups. The offer does not extend to crew members, passengers who were hurt, or families of those who died as a result of Costa Concordia disaster. Those claims will be handled separately.

At least one Italian consumer group that was not involved in the settlement negotiations, however, is warning passengers that the offer may not be fair. According to Reuters report, Carlo Rienzi, president of Codacons, said Costa Corciere's offer was insufficient and urged passengers to see a doctor to check whether they had suffered psychological trauma.

Earlier this month, Codacons announced its own plan to file a lawsuit in Miami, where Carnival Corp. is headquartered. The lawsuit, which would seek class action status, would ask for at least $160,000 per passenger.

Johnson & Johnson Sets Aside Funds for DePuy ASR Hip Implant Settlements

Thu, 26 Jan 2012 00:00:00 -0800

It looks like Johnson & Johnsons may be getting ready to settle some of the lawsuits filed over its DePuy Orthopaedics unit's recalled ASR hip implants. According to its earnings statement for the fourth quarter of 2011, Johnson & Johnson has taken a quarterly charges of more than $3 billion, mostly related to the DePuy ASR Hip Implant recall.

Among other things, the charge will allow Johnson & Johnson to set aside money for patients and lawyers involved in product liability litigation sparked by the worldwide DePuy ASR Hip Implant recall issued in 2010, The New York Times said. Of the total, $800 million was set aside to cover the medical costs of the recall.

According to a Reuters report, Morningstar analyst Damien Conover predicted that "J&J is getting ready to offer some settlements" to people injured by the defective hip implants. Roughly 93,000 ASR Hip Implants were placed in patients before they were recalled.

That charge, along with others taken in relation to recent recalls of over-the-counter drugs made by its McNeil Consumer Healthcare division and other issues, weighed on Johnson & Johnson's bottom line. In its fourth quarter earnings statement, Johnson & Johnson said the company earned $218 million in the quarter compared with the $1.9 billion it earned just a year earlier.

"The hip recalls worry me because their eventual costs are unknown," said Jeff Jonas, an analyst at Gabelli & Company, according to The New York Times.

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Novartis Agrees to Settle Drug Rep Overtime Lawsuit

Thu, 26 Jan 2012 00:00:00 -0800

After six years of litigation, Novartis Pharmaceuticals Corp. has agreed to pay $99 million to settle a class action lawsuit brought on behalf of pharmaceutical sales reps who allegedly were illegally denied overtime pay for working more than 40 hours per week. The deal has been tentatively approved by U.S. District Judge Paul Crotty in Manhattan. However, the Novartis overtime settlement is still subject to final approval, and a fairness hearing has been scheduled for May 31.

The lawsuit is one of several filed in recent years by pharmaceutical sales reps, including those working for GlaxoSmithKline, Johnson & Johnson, Bristol-Myers Squibb Co. and a unit of Merck & Co. It has long been standard practice for drug makers to avoid paying overtime for pharmaceutical sales representatives by classifying them as commissioned outside sales people, or administrative personnel, both categories that are exempt from the Fair Labor Standards Act's (FLSA) overtime requirements.

The Novartis sales rep had argued in their lawsuit that they did not qualify as outside sales reps. The lawsuit was originally filed in 2006, but a New York trial judge had agreed with Novartis' contention that the sales representatives did fall under FLSA overtime exceptions for outside salespeople and administrative workers. But in July 2010, the Second Circuit Court of Appeals overturned that ruling. The lawsuit moved forward last year, after the U.S. Supreme Court refused to hear Novartis' appeal of the Second Circuit ruling.

According to a Reuters report, the sales reps impacted by the proposed Novartis settlement worked for the drug maker between 2002 and 2007, and from Jan. 25, 2009, to the present. Payouts will vary based on length of employment and compensation, and on how many plaintiffs choose to take part in the settlement

The U.S. Supreme Court is soon to take up another drug sales rep overtime case, this time involving some 90,000 current and former sales representative for GlaxoSmithKline. The Ninth Circuit Court of Appeals has already ruled that the Glaxo reps are exempt from FLSA overtime requirements.

Congressional Hearings Sought for Transvaginal Mesh, Lap-Band Devices

Mon, 23 Jan 2012 00:00:00 -0800

U.S. Rep. Harry Waxman of California and three other Democrats on the House Energy and Commerce Committee have asked the Republican who control the committee to hold hearings on the safety of transvaginal mesh, as well as Allergan's Lap-Band surgical weight loss device. The four Democratic lawmakers are making the request for the second time since last October, after Republicans failed to schedule any hearings on the safety of transvaginal mesh products and the Lap-Band device.

"The committee should hold hearings to examine whether FDA (Food & Drug Administration) device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Waxman and his colleagues wrote in their latest letter. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”

According to Waxman's letter the FDA approved the “Lap-Band” device for obese patients. It is designed to reduce the size of the stomach and cause patients to eat less and lose weight. Allergan is seeking to have the FDA expand its approval for use in children as young as 14, despite concerns among some physicians that the procedure is too drastic or “extreme” for a young person’s developing body.

However, while the Lap-band is effective, the FDA says it can pose serious risks including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea and vomiting. Several studies have also raised questions about its safety and effectiveness, including one published last week in the Archives of Surgery raised questions about the effectiveness of gastric banding, finding that after six years, nearly 50% of patients had either not lost weight or had needed the device to be removed and that over 40% of patients experienced long-term complications.

Transvaginal mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods. FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Recently, the FDA ordered more than 30 manufacturers of transvaginal mesh products to conduct studies of their safety.

According to the Democrats' letter, an investigation of the transvaginal mesh and Lap-Band issues is vital as Congress considers an overhaul of FDA rules for medical devices.

Costa Concordia Captain Admits Error Caused Cruise Ship Accident, Now Under House Arrest

Wed, 18 Jan 2012 00:00:00 -0800

Italian prosecutors could file charges against Costa Concordia cruise ship captain Francesco Schettino later this week, after a judge ordered him held under house arrest on suspicions of manslaughter and abandoning ship. According to the Associated Press, Schettino faces 12 years in prison on the charge of abandoning ship alone, according to an Associate Press report.

Eleven people are confirmed dead, and 22 are still missing in the Costa Concordia disaster. The massive cruise ship ran aground off the Tuscan coast of Italy last Friday. The vessel was four miles off course when it hit a rock, which tore a 160-foot hole in its hull. The ship began to list and eventually capsized.

Passengers aboard the ship have described chaos in the hour after the Concordia ran aground, with little direction from the ship's senior officers, and crew - including kitchen and entertainment staff - unsure of how to proceed. An SOS from the ship may have been delayed or not sent at all. According to The Wall Street Journal, an Italian official said that the coast guard learned of the ship's troubles after passengers phoned police to complain. The coast guard then contacted the ship's command at about 10:15 p.m., more than a half-hour after the boat hit the rock formation.

According to various media reports, an official order to abandon ship and board life boats did not come until about 10:50 p.m., more than an hour after the Concordia hit the rocks. By that time, the ship was listing severely, rendering many life boats useless.

Yesterday, the recording of a conversation between Schettino, by this time in a life boat while many passengers and crew remained on the Concordia, and an obviously furious Italian Coast Guard Officer was released. In the tape, the officer can be heard ordering Schettino to get back to the Concordia to oversee the evacuation, but the Concordia captain resisted, asserting he was coordinating the evacuation from the life boat.

“What are you coordinating there? Go on board! Coordinate the rescue from aboard the ship. Are you refusing?" the coast guard officer demands, according to a translated transcript.

Schettino complained at one point, "Do you realize it is dark and here we can't see anything?"

Yesterday in court, Schettino, who was detained by Italian authorities on Saturday, admitted his error caused the Concordia to run aground. He also said he brought the ship close to the coast of the Italian island of Giglio to salute a retired captain who lived there.

"I was navigating by sight because I knew the depths well and I had done this maneuver three or four times. But this time I ordered the turn too late and I ended up in water that was too shallow. I don't know why it happened, I was a victim of my instincts," he testified, according to a report from The Guardian.

Schettino, however, disputed accusations that he abandoned the stricken ship, claiming he fell into a lifeboat when the vessel listed violently.

Meanwhile, dive crews today suspended their search of the Concordia after the overturned ship shifted on the rocks where it is resting. There are fears that the ship could rip apart, spilling fuel that would create an ecological disaster. Hopes that any of the missing will be found alive have dimmed.

Costa Concordia Captain's Unauthorized Detour Blamed for Cruise Ship Disaster

Mon, 16 Jan 2012 00:00:00 -0800

Costa Crociere SpA is blaming the captain of the doomed Costa Concordia for running the cruise ship aground off the western coast of Italy last Friday. According to various media reports, the company's chairman and CEO said Monday morning that Costa Concordia captain Francesco Schettino took an unauthorized detour from the ship's route, bringing it close to the shore of the Italian island of Giglio. The ship struck a rock that tore a 160-foot hole in its hull, and caused the vessel to capsize

Six people are known to have died in the Costa Concordia disaster. The number of missing has been revised upwards, from 15 yesterday to 29 today. Divers continue to search the partially submerged ship, hoping to find survivors.

In order to make the unauthorized detour, Schettino would have had to override the automatic commands and enter his own, Costa Crociere chairman and CEO Pier Luigi Foschi said at a news conference today, according to The Wall Street Journal. Under normal circumstances, the ship's computerized navigation system should have immediately detected the route deviation and automatically sounded an alarm on the command bridge of the vessel. But if Schettino had overridden the automatic commands himself, the alarm wouldn't have sounded.

Foschi said company policy requires that captains keep their vessels no closer than 500 meters (547 yards) to the Giglio coast. The Concordia was about 150 meters from the island.

It's not clear why Schettino would have deviated from the approved route. But Reuters is reporting that a head waiter on the Concordia telephoned his father before the accident to say the crew would salute him by blowing the ship's whistle as they passed by Giglio, where both the waiter, Antonello Tievoli, and his father live. An Italian newspaper is reporting that shortly before the collission, the captain called the head waiter to the bridge saying, “Antonello, come see, we are very close to your Giglio.”

The U.K.'s Daily Telegraph is reporting that just prior to the accident, Antonello's sister updated her Facebook status to state: “In a short period of time the Concordia ship will pass very close. "A big greeting to my brother who finally gets to have a holiday on landing in Savona."

Schettino was detained in Italy on Saturday on suspicion of manslaughter and abandoning ship. In the aftermath of the accident, it was reported that the captain had left the Concordia and gone ashore before all 4,200 passengers and crew were evacuated. Prosecutors say he refused to go back on board when requested to do so by the coast guard.

It's also unclear if the ship sent out an SOS after it hit the rocks and began to list. According to The Wall Street Journal, an Italian official said that the coast guard learned of the ship's troubles after passengers phoned police to complain. The coast guard then contacted the ship's command at about 10:15 p.m., more than a half-hour after the boat hit the rock formation.

Schettino denies being too close to the coast and says the rock he hit was not marked on charts.

BMJ Study Find SSRIs During Pregnancy Double Risk of PPHN

Fri, 13 Jan 2012 00:00:00 -0800

A new study published in the British Medical Journal has provided compelling new evidence of a connection between selective serotonin reuptake inhibitors (SSRI) antidepressants and pulmonary hypertension of the newborn (PPHN). The study, conducted by researchers at Sweden's Karolinska Institute, found that babies exposed to SSRI antidepressants in-utero are two times as likely to be born with the life-threatening lung condition compare to those who aren't.

PPHN is caused when arteries leading to the lungs constrict upon birth, blocking blood flow and air to the vital organs. In about 10 percent of cases, it turns out to be fatal. The disorder affects about 1 in 1,000 births.

Some earlier studies have pointed to a connection between SSRI antidepressants - a class of medications that includes Prozac, Paxil, Celexa, Zoloft - and PPHN. In fact, in 2006 the U.S. Food & Drug Administration (FDA) issued a warning about SSRIs and PPHN in 2006, after a New England Journal of Medicine study found that women taking the drugs were six times more likely to deliver babies with PPHN. But last month, the FDA revised that warning, and told doctors to continue treating expectant mothers with SSRIs because the conflicting results different studies made it "premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.

This new study was based on 1.6 million births in Denmark, Finland, Iceland, Norway or Sweden from 1996 to 2007. The researchers took into account other factors, such as obesity, diabetes, or behaviors such as smoking, or the way the baby was delivered, that are known to be associated with the development of PPHN. Of the 30,000 women in the study who took SSRIs while pregnant, nearly 11,000 took the drugs during late pregnancy and about 17,000 took them during early pregnancy. Among the group who took SSRIs during late pregnancy, 33 babies (0.2 percent) were born with PPHN, the researchers found. In the group who took the drugs during early pregnancy, 32 (0.2 percent) PPHN babies were born.

"Infants born to women treated with SSRIs in late pregnancy had a twofold increased risk [of] their infants having persistent pulmonary hypertension," lead researcher Dr. Helle Kieler, head of the Centre for Pharmacoepidemiology at Karolinska University Hospital in Stockholm, wrote.

"The increased risk seemed to be a class effect of SSRIs, as risks for the specific SSRIs were of similar magnitude," she added.

FDA Yaz, Yasmin Advisors Had Relationships with Bayer

Wed, 11 Jan 2012 00:00:00 -0800

Last month, an advisory panel for the U.S. Food & Drug Administration (FDA) voted to recommend by a four vote (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's been learned 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, those advisors were:

•    The panel's chair, obstetrics professor Julia V. Johnson of the University of Massachusetts Medical School, told the Journal 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 had t 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 Journal 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.

While all three backed the safety of Yaz and Yasmin, two did later voted to encourage stronger labeling about blood clot risks. Their ties to Bayer were not revealed by the FDA, which is not permitted to make public information from the financial disclosure it requires the outside experts that serve on its panel to provide. According to The Wall Street Journal, 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 questions. Dr. Stephen Nissen, a cardiologist with the Cleveland Clinic and frequent FDA advisory panel member, acknowledged that significant ties between committee members and drug makers could result in biased recommendations

"Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process," Nissen told the Journal.

It should also 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.

Pradaxa Clinical Trial Analysis Sees Higher Heart Attack Risk

Tue, 10 Jan 2012 00:00:00 -0800

A new study is raising more concerns about Pradaxa. According to researchers from the Cleveland Clinic, people taking Pradaxa may be at a higher risk of suffering heart attacks and chest pain.

The large study used to gain Pradaxa its 2010 approval did hint at a small increased risk of heart attack among people taking the medication, according to The Wall Street Journal. Since then, researchers have been trying to determine if Pradaxa does pose an increased risk.

In conducting this study, the Cleveland Clinic researchers analyzed data from seven Pradaxa clinical trials. All of the studies compared patients taking Pradaxa to those taking other blood thinners or a placebo. The study found that Pradaxa boosted the risk of a heart attack and a condition known as acute coronary syndrome by 33%. ACS encompasses both heart attacks and chest pain. The added risk for any one individual of having a heart attack if on Pradaxa - known as the absolute increased risk - was 0.27 percent.

"For persons with atrial fibrillation, dabigatran has a favorable benefit-risk profile, but for other uses the risk of heart attack has to be taken into account," said lead researcher Dr. Ken Uchino, director of the Vascular Neurology Fellowship Training Program at the Cleveland Clinic.

Physicians Want Pause on Fracking

Tue, 10 Jan 2012 00:00:00 -0800

It's time to put a hold on fracking in the U.S. until its health impacts are better understood, some medical doctors say. The physicians were all attending a conference in Arlington, Virginia that’s the first to examine criteria for studying hydraulic fracturing, a controversial process of natural gas extraction.

"We are leaping before we are looking," said Jerome Paulson, of the Mid-Atlantic Center for Children's Health and the Environment. "Those who are drilling and extracting ... have not done the human health research and ecological studies to assure that the process and chemicals they use are the least hazardous possible.”

Among other things, Paulson called on major natural gas drillers to set up a foundation to fund fracking research. He also advocated for more independent study of fracking public health impacts.

Paulson's group, along with Physicians, Scientists and Engineers for Healthy Energy helped sponsor the conference. According to Reuters, the groups hope to set up a consortium to collect and assess scientific data on the effects of shale development on the public.

Other attendees pushed for a halt of fracking while its public health implications are studied.

"We’ve got to push the pause button, and maybe we’ve got to push the stop button” on fracking, Adam Law, a physician with Weill Cornell Medical College and head of Physicians Scientists and Engineers for Healthy Energy, told Bloomberg News.

In hydraulic fracturing, fracking fluids are injected into the ground at high pressure to shake loose gas and oil deposits. Studies have shown that fracking fluids often contain some hazardous chemicals, including the carcinogen, benzene, and diesel. Opponents of fracking are concerned that this type of natural gas drilling could lead to pollution of vital drinking water sources. According to Bloomberg, anecdotal evidence has tied fracking to water pollution around the country, including Pennsylvania and Wyoming.

Group Seeks Wingspan Brain Stent Recall

Fri, 06 Jan 2012 00:00:00 -0800

A study finding that patients treated with the Wingspan Brain Stent System are more likely to suffer a stroke or death has prompted Public Citizen to petition the U.S. Food & Drug Administration (FDA) to recall the device. The consumer group has been joined in its petition by a former official from the FDA.

According to Public Citizen's Dr. Sidney Wolf, the Wingspan Stent System "was able to gain marketing approval based on a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone." That's because the system was approved in 2005 under the FDA's Humanitarian Device Exemption program, which allows for clearance without proof that a device is safe or effective. The device was cleared for use in patients who have had one stroke and are at risk for additional strokes.

In September, the New England Journal of Medicine published results from a study funded by the National Institutes of Health that found a 2.5-fold increase in stroke or death with the Wingspan stent system compared to those treated with blood-thinning medications. The study began in November 2008, but ended early last April, due to safety concerns.

“The message from the trial could not be clearer: The risks of this intervention substantially outweigh any potential benefit to patients,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.”

Professor Larry Kessler joined Public Citizen in filing the petition with the FDA.

"With the conclusion of the recent (clinical) trial showing that Wingspan has a much higher complication rate than modern medical management, it is imperative that the FDA take swift and decisive action," said Kessler, former director of the FDA's Center for Device Evaluation and Radiologic Health (CDRH) Office of Surveillance and Biometrics, former director of the CDRH Office of Science and Engineering Laboratories and currently a professor in the University of Washington's School of Public Health.

Mediation Bid Postpones First Yaz, Yasmin Lawsuit Trial

Thu, 05 Jan 2012 00:00:00 -0800

The much anticipated first bellwether trial in the Yaz and Yasmin multidistrict litigation won't be starting next week after all. The trial was postponed, and U.S. District Court Judge David Herndon has ordered both sides to meet with a mediator to discuss possible settlement of Yaz and Yasmin lawsuits.

George Washington law professor Stephen Saltzburg has been appointed special master in the litigation. In an order dated December 31, Judge Herndon directed attorneys for both plaintiffs and defendants to meet with Saltzburg “without delay” to negotiate in good faith. According to FiercePharma, Saltzburg previously handled mediation for more than 20,000 Seroquel product liability lawsuits.

More than 10,000 lawsuits are pending before Judge Herndon in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in the U.S. District Court for the Southern District of Illinois. The lawsuits claim Yaz, Yasmin and similar drugs caused young women to suffer dangerous blood clots and other serious side effects.

Just last month, a panel of advisors for the U.S. Food & Drug Administration (FDA) recommended stronger label warnings for Yaz, Yasmin and similar oral contraceptives regarding their possible association with blood clots. The outside advisors voted 21-5 that current label warnings for Yaz, Yasmin and other pills made with the progestin, drospirenone, are inadequate and need to include clearer information about data that have linked the pills to a higher risk of blood clot

FDA Orders Transvaginal Mesh Studies

Thu, 05 Jan 2012 00:00:00 -0800

As part of its ongoing safety review of transvaginal mesh devices, the U.S. Food & Drug Administration (FDA) has asked 33 manufactures of such products to conduct safety studies assessing their use in procedures to repair pelvic organ proplapse (POP) and stress urinary incontinence (SUI). According to various media reports, Johnson & Johnson, C.R. Bard Inc., Endo Pharmaceuticals Holding Inc., Boston Scientific Corp. and other companies have been sent letters from the FDA requesting the studies. They have 30 days to respond.

"We believe there are certain uses of mesh where we need additional data to help guide the clinical community," William Maisel, deputy director of science for the FDA's device-approval center, told Bloomberg News. "Our goal is to make sure the right women use it at the right time."

In its letters, the FDA asks the manufacturers to collect as much as three years of data on the safety and effectiveness of the implants.

Patient advocates cheered the FDA's action.

"Now these companies are going to have to tell the truth," said Lana Keeton, the Austin, Texas, founder of Truth In Medicine, an advocacy group for mesh patients

Transvaginal products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.

Canadian Victims of Defective Hip Implants Launch Lawsuits

Wed, 04 Jan 2012 00:00:00 -0800

More Canadians are lining up to sue the manufacturers of allegedly defective hip implants that they claim have failed and caused them pain. At least four hip implant class action lawsuits are currently pending in Canada, and over the past five years, a dozen different hip implant recalls have been issued there.

According to a report from CBC.com, most of the problems reported in Canada involve newer versions of hip implants. One plaintiffs' attorney attributed that fact to Health Canada's fairly rudimentary approval process for new medical devices that are merely modifications of older designs. In such cases, new clinical trials are not required, something that may be hurting patients.

"The risk to people has been huge in relation to the benefit, particularly bearing in mind that there were effective products on the market that were working for decades before these new products came out. In this case, newer was not better,” the attorney told CBC.com

One doctor said that patients need to be informed that newer versions of hip implants have not undergone extensive testing. According to CBC.com, Dr. David Urbach, a surgeon with Toronto's University Health Network, suggested telling patients that "we've done all the diligence that's required for testing, but we actually don't know that this will perform well over many years."

Some patients have found that out the hard way. They include Res Desborough of Nova Scotia, who told CBC.com that his hip replacement surgery left him in worse shape after his implant failed. "Now I have some degree of pain and my lifestyle is quite a bit different than it was," Desborough said.

Desborough told CBC.com that Canada's current regulations don't go far enough, said he would like to see a mandatory system established to track implant failures and to contact patients when devices are recalled.

Youngstown Fracking Disposal Well Eyed in Swarm of Earthquakes

Tue, 03 Jan 2012 00:00:00 -0800

More earthquakes, this time near Youngstown, Ohio, have been blamed on a fracking-related operation. According to various media reports, 11 earthquakes have occurred since March 2011 near a Youngstown fracking wastewater injection well. The latest, a 4.0 magnitude tremblor was felt Saturday as far away as Toronto, Canada and Morgantown, West Virginia.

The Youngstown injection well, owned by D&L Energy Group, is used to dispose of millions of gallons of brine and other waste liquids produced at natural-gas wells being fracked in Pennsylvania. According to a report from The New York Times, the well reaches a depth about 9,200 feet.

The Ohio Department of Natural Resources first asked that injections at the well be halted on December 30, following a 2.7 magnitude Christmas Eve tremblor that occurred less than 2,000 feet below the well. A moratorium was imposed on injections there after the latest New Years Eve quake. A Depth estimate on that quake should be available this week.

Scientists who have been studying the Youngstown quakes seem fairly certain that the fracking injection well is to blame.

“In our minds, we were already pretty convinced that these events were connected to the well,” John Armbruster, a seismologist with Columbia University's Lamont -Doherty Earth Observatory, told the Times. “Having that many earthquakes fairly close to a well in Ohio, where there aren’t a lot of earthquakes, was suspicious.”

He also warned that the tremblors will likely continue, despite the moratorium on injections.

“This one year of pumping is a pulse that has been pushed into the ground, and it's going to be spreading out for at least a year," he told the New York Daily News.

Abercrombie Fitch, Hollister Hit with Gift Card Lawsuits

Thu, 29 Dec 2011 00:00:00 -0800

Two major clothing retailers face class-action lawsuits alleging they dishonored their own gift card promotions following the 2009 Christmas holiday season.

According to separate reports at TopClassActions.com, Hollister Co. and Abercrombie & Fitch each held promotions during the holiday shopping season of 2009, offering “free” $25 gift cards to customers who spent more than $100 at their stores during a given visit. In fact, a $25 gift card was offered to consumers for every $100 worth of merchandise they purchased. These gift cards had an extra perk, they purportedly had no expiration date.

For thousands of people who took advantage of the promotion, spending the money at the stores then receiving the $25 gift cards, they soon learned the promotion was mostly a scam. They were encouraged to spend more at the stores than they may have originally planned (for example, spending an extra $20 to reach a new $100 plateau just to receive the promoted gift card).

Presumably, the consumers who purchased enough merchandise at these stores would give these gift cards as an additional gift or as a gift to someone else.

In each case, the retailers voided those $25 gift cards after Jan. 30, 2010, about a month after they were likely given as gifts. The stores either eliminated the total worth of the card or the remaining balance on it, despite promoting the cards as having “no expiration date.”

The class-action lawsuit against Hollister is filed in Circuit Court of the 18th Judicial Circuit of Illinois but states no restrictions on who can be considered part of the class. The legal action accuses the retailer of breach of contract because it devalued the gift cards offered through the promotion. It seeks “actual damages, court costs, prejudgement interest and other relief” for consumers included in that class.

The lawsuit against Abercrombie & Fitch is currently limited to Ohio consumers who made purchases before the Christmas 2009 promotion expired. According to the report on this lawsuit, the gift cards offered at Ohio A&F stores specifically state they have “no expiration date” but because the retailer voided the credit included on the card after a specific date just a few months after they were awarded, it is “impossible for [Class Members] to receive the benefit of their bargain.”

Abercrombie & Fitch is accused of violating Ohio’s Consumer Sales Practices Act in the lawsuit and it seeks “compensatory damages, punitive damages, attorney fees and other relief” for those who took part in the promotion.

The lawsuit was filed in Ohio, where the retailer is located. It was filed initially by Beth Seaver, of Richfield, Ohio, who spent more than $300 at an A&F store in December 2009 and for her purchase she received three separate $25 gift cards.

The store’s gift card policy is printed on the back of each card and the last sentence in that policy on these specific cards indicates they have “no expiration date.”

CSST Flexible Tubing Tied to Ohio Fires

Wed, 28 Dec 2011 00:00:00 -0800

A recent outbreak of lightning-related fires in central Ohio has renewed a call to place stricter regulations on the use of Corrugate Stainless Steel Tubing (CSST) as residential natural gas piping.

Four fires in central Ohio during a one-day period raised the eyebrows of several local safety officials who blame CSST flexible tubing for the incidents.

CSST, according to a Washington Post report, has been implicated in house fires in at least a dozen states in recent years but it’s unsure whether the product itself is unsafe or whether it was installed improperly, thereby leading to unnecessary hazards.

Homeowners impacted by these incidents have continued to file lawsuits against the manufacturers and installers of CSST, attempting to hold them accountable for millions of dollars in property damage. The same report notes a 2006 settlement worth as much as $29 million struck between homeowners who suffered varying levels of property damage and the manufacturers of CSST.

The surviving members of a South Dakota family are still awaiting resolution on their lawsuit which claims a 2008 fire that killed four members of their family was the result of fault CSST.

CSST is an alternative to rigid metal piping used to move natural gas to different points in a home. It was thought to be a safer alternative to the traditional rigid piping because it required using less joints in the pipe’s path, lowering the risk of gas leaks which could prompt an explosion or fire. The revolutionary product was used primarily in Japan where it reduced the risk of gas explosions and fires during severe earthquakes, when rigid piping was more likely to fracture and leak gas.

Despite it carrying a heftier price tag than traditional rigid piping, CSST has become commonplace in new American homes, or homes retro-fit with natural gas lines. Its flexible nature allows for a quicker installation but as its use increases, so do the questions about its safety.

In the recent string of Ohio fires, a local Fire Chief believes CSST was at least partially to blame for the incidents. According to the report at WaPo.com, Genoa Township Chief Gary Honeycutt said, “lightning struck at or near the homes and the electrical charge traveled along the CSST before jumping to a less resistant pathway nearby such as a metal ventilation duct.” The moving charge then punctured a small hole in the flexible gas tubing, but large enough to create a gas leak. Once lighting struck again, it ignited.

Though it’s become ubiquitous in newer homes outfitted for natural gas, many believe CSST is an unproven product in terms of safety. Some local municipalities have enacted building codes which require CSST be away from other conducting building materials in a home’s infrastructure and at least one manufacturer of the product has recently changed its design to make it less likely to leak or cause fire, indicating it may not have been as safe as it could have been. Washington Post reports Omega Flex, based in eastern Pennsylvania, has begun wrapping its line of CSST in a plastic covering to make it “more resistant to lightning strike damage.” The head of a homebuilder’s advocacy group in Ohio said he believes CSST is safe when installed properly and grounded.

A recent outbreak of lightning-related fires in central Ohio has renewed a call to place stricter regulations on the use of Corrugate Stainless Steel Tubing (CSST) as residential natural gas piping.
Four fires in central Ohio during a one-day period raised the eyebrows of several local safety officials who blame CSST flexible tubing for the incidents.
CSST, according to a Washington Post report, has been implicated in house fires in at least a dozen states in recent years but it’s unsure whether the product itself is unsafe or whether it was installed improperly, thereby leading to unnecessary hazards.
Homeowners impacted by these incidents have continued to file lawsuits against the manufacturers and installers of CSST, attempting to hold them accountable for millions of dollars in property damage. The same report notes a 2006 settlement worth as much as $29 million struck between homeowners who suffered varying levels of property damage and the manufacturers of CSST.
The surviving members of a South Dakota family are still awaiting resolution on their lawsuit which claims a 2008 fire that killed four members of their family was the result of fault CSST.
CSST is an alternative to rigid metal piping used to move natural gas to different points in a home. It was thought to be a safer alternative to the traditional rigid piping because it required using less joints in the pipe’s path, lowering the risk of gas leaks which could prompt an explosion or fire. The revolutionary product was used primarily in Japan where it reduced the risk of gas explosions and fires during severe earthquakes, when rigid piping was more likely to fracture and leak gas.
Despite it carrying a heftier price tag than traditional rigid piping, CSST has become commonplace in new American homes, or homes retro-fit with natural gas lines. Its flexible nature allows for a quicker installation but as its use increases, so do the questions about its safety.
In the recent string of Ohio fires, a local Fire Chief believes CSST was at least partially to blame for the incidents. According to the report at WaPo.com, Genoa Township Chief Gary Honeycutt said, “lightning struck at or near the homes and the electrical charge traveled along the CSST before jumping to a less resistant pathway nearby such as a metal ventilation duct.” The moving charge then punctured a small hole in the flexible gas tubing, but large enough to create a gas leak. Once lighting struck again, it ignited.
Though it’s become ubiquitous in newer homes outfitted for natural gas, many believe CSST is an unproven product in terms of safety. Some local municipalities have enacted building codes which require CSST be away from other conducting building materials in a home’s infrastructure and at least one manufacturer of the product has recently changed its design to make it less likely to leak or cause fire, indicating it may not have been as safe as it could have been. Washington Post reports Omega Flex, based in eastern Pennsylvania, has begun wrapping its line of CSST in a plastic covering to make it “more resistant to lightning strike damage.” The head of a homebuilder’s advocacy group in Ohio said he believes CSST is safe when installed properly and grounded.

Maker of Defective French Silicone Breast Implants Warned by FDA in 2000

Tue, 27 Dec 2011 00:00:00 -0800

The French company that manufactured silicone breast implants now at the center of worldwide cancer panic has also had run-ins with U.S. regulators. According to a report from Reuters, the U.S. Food & Drug Administration (FDA) sent Poly Implant Prothese (PIP) a warning letter in 2000 regarding manufacturing problems at the French facility where it made saline implants. The PIP saline breast implants have also been named in lawsuits by U.S. women who received them in the late 1990s.

The FDA letter, dated June 22, said the PIP saline breast implants were "adulterated" and cited at least 11 deviations from good manufacturing practices, Reuters said. The FDA's letter was cited in a lawsuit filed in the U.S. District Court for the Southern District of Texas on behalf of U.S. patients who received the saline implants in the late 1990s, and one who received them as recently as 2000.   The plaintiffs said that the implants deflated several years later. The FDA letter, dated June 22, 2000, cited PIP's failure to investigate the deflation of its saline implants and a failure to report more than 120 complaints in France and elsewhere to the FDA, Reuters said.

While the problems cited by the FDA had to do with PIP's saline implants, the same manufacturing facility also made the silicone breast implants at the center of the recent scandal. PIP silicone breast implants, which were already among the cheapest and most fragile on the market, were recalled last year after it was learned that they contained industrial, rather than medical grade, silicone.    Those implants ignited cancer fears last month, after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. At least eight cases of ALCL have been reported among French women with the PIP implants.

So far, investigators haven't been able to prove the implants caused the cancer. Nevertheless, the French health ministry last week urged women to have them removed because they may rupture. French health officials also said the government would cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.

As many as 300,000 women throughout the world received PIP silicone breast implants.   The company faces a French criminal probe for misreporting the type of silicone used in the implants. Some 2,000 French women, and 250 in Britain, have filed legal claims against the implant maker.

The PIP silicone breast implants were never sold in the U.S. But the saline variety that sparked the FDA warning letter were brought to the U.S. market in 1996 via the agency's 510(k) approval process, which does not require human testing. In 2000, however, concerns over complications prompted the FDA to finally require all implant companies to submit formal applications for saline breast implants. In the end, the FDA refused to approve the PIP's saline implants, and they haven't been sold in the U.S. since.

It isn't known why the FDA's 2000 warning letter didn't trigger greater scrutiny of PIP's activities by regulators in France and elsewhere, Reuters said.

French-Made Silicone Breast Implant at Center of Cancer Scare

Thu, 22 Dec 2011 00:00:00 -0800

Fears that a recalled silicone breast implant could cause a rare form of cancer are spreading around the world. According to a report in The New York Times, regulator in at least a half dozen countries are trying to ease fears among women who have received silicone breast implants made by Poly Implant Prosthese (PIP), a now-defunct French company.

The fears are most acute in France, where 30,000 women received PIP silicone breast implants before they were pulled from the market last year. The company faces a criminal probe there for using industrial silicone, rather than medical-grade material, in the implants. French regulators have received about 1,000 reports of PIP silicone breast implants rupturing. But most worrisome, at least 8 cases of a rare cancer called anaplastic large cell lymphoma (ALCL), including one death, have been reported in French women who received the implants.

So far, investigators haven't been able to prove the implants caused the cancer. Nevertheless, the French health ministry said yesterday it would recommend that the government there cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.

Alexandra Blachere, the leader of a French PIP implant patient group, told Reuters that en from Italy and Spain had been in touch with her with worries about their implants, and she'd seen reports of problems in other countries, including in Venezuela and Brazil.

"It's not just France that's concerned. We're looking at 300,000 to 400,000 potential victims in the world," Blachere said.

According to CNN, PIP never sought approval from the U.S. Food & Drug Administration (FDA) to sell the silicone breast implants in the U.S., so they were never available to women here. In March 2000, the FDA decided not to approve saline PIP implants for sale here.

Proscar, Propecia Litigation Heating UP

Wed, 21 Dec 2011 00:00:00 -0800

The litigation surrounding Merck's Proscar and Propecia medications continues to grow, with several plaintiffs seeking mass tort status for their lawsuits. Proscar and Propecia lawsuits claim the drugs caused users to suffer from erectile dysfunction and other problems, and that Merck failed to warn that such side effects could persist even after treatment was stopped.

According to a report from Lawyers USA Online, the first Propecia lawsuit was filed in New Jersey federal court in February on behalf of a Texas man and a Nevada man who took the medication for male pattern baldness. The plaintiffs in that complaint are seeking mass tort status. Another petition for a mass tort was filed in state court in New Jersey on behalf of 46 plaintiffs, and will likely include hundreds of plaintiffs. Just this month, a New York plaintiff filed a motion to centralize the cases in a multi-district litigation.

At least one class action lawsuit has also been filed in Canada on behalf of a Proscar user there.

All of the lawsuits claim the men suffered serious side effects, including erectile dysfunction, infertility, depression and suicidal thoughts because of the drugs.

Plaintiffs’ lawyers told Lawyers USA Online that a key to winning the lawsuits would be Merck's failure to include adequate warnings on the drugs’ labels. In 2008, Merck changed the Propecia label to warn that the drug could lead to permanent erectile dysfunction. Similar changes to the labels in the U.K. and Italy followed in 2009 and 2010. Though Merck did update its U.S. label in 2011, the change didn’t warn about persistent sexual side effects after discontinuation of use. The Canadian label continues to state that side effects are rare and symptoms resolve themselves if users either stay on the drug or stop using it.

Health Canada Revises Bisphosphonate Labels with Fracture Warning

Tue, 20 Dec 2011 00:00:00 -0800

Health Canada has announced that its review of bisphosphonates has shown a slightly increased risk of atypical thigh fractures among people who use these medications. Bisphosphonates, a class of drugs used to treat osteoporosis, are sold in Canada under the brand names Fosamax, Fosavance, Didrocal, Actonel and Aclasta. In the U.S., brand names bisphosphonates include Actonel, Aredia, Bonefos, Boniva, Fosamax, Didronel, Reclast, Skelid and Zometa.

Canadian labels for or brand name bisphosphonate drugs have been updated with new warnings and precautions regarding their association with atypical thigh fractures, according to Health Canada The new information includes signs of a possible atypical femur fractures that patients and health professionals should watch for. Labeling for generic bisphosphonates will be updated with this new information in the near future.

According to Health Canada, atypical femur fractures are rare, accounting for less than 1% of all hip and femur fractures overall. While the agency’s review of the evidence has shown a slightly increased risk of this type of fracture with bisphosphonate use, Health Canada said that benefits of using bisphosphonate drugs in preventing broken bones from osteoporosis may outweigh the risk sustaining an atypical femur fracture.

An atypical femur fracture can occur with minimal or no impact to the thigh area, and can occur in both legs in the same person. Symptoms of these types of fractures include dull, aching pain in the thigh, hip or groin area. A partial fracture could take weeks or months to become a complete fracture. Health Canada is advising patients currently taking or who have taken a bisphosphonate drug in the past, and who notice any of these symptoms, to seek medical attention immediately, as they may be a sign of an atypical femur fracture. However, patients should not stop taking their bisphosphonate drug unless advised to do so by their healthcare professional, the agency said.

Health Canada has also advised doctors to be aware of the possible risk of atypical femur fractures in patients taking bisphosphonates. They should evaluate patients who report new hip, thigh or groin pain to rule out a partial femur fracture. Patients with an atypical femur fracture should also be assessed for possible signs of fracture in the other leg.

Discontinuation of bisphosphonate therapy should be considered pending an assessment of the patient or the risk/benefit of using it. Health Canada also reminded doctors that the need for continued bisphosphonate therapy should be periodically re-evaluated.

Pfizer Settles More Premarin, Prempro Breast Cancer Lawsuits

Tue, 20 Dec 2011 00:00:00 -0800

Nearly 5,000 of the 10,000 breast cancer lawsuits Pfizer faced over its Prempro and Premarin hormone therapy drugs have been settled. According to a Bloomberg News report, Pfizer disclosed the Prempro and Premarin settlements in its latest 10Q report filed with the U.S. Securities and Exchange Commission (SEC) on November 10.

Pfizer inherited thousands of Prempro lawsuits when it acquired Wyeth in 2009, and at one time faced as many as 10,000. In a May filing with the SEC, Pfizer disclosed it has set aside $772 million to settle the lawsuits which it said represented “the minimum expected costs to resolve all of the other outstanding” lawsuits. At the time, the company said it had settled roughly 3,300 Premarin and Prempro lawsuits

Now, in the November filing, Pfizer put the number of settled lawsuits at almost 5,000. The company also reported that it had added $68 million to the $772 million it already reserved. About $260 million remains, but Pfizer acknowledged that “additional charges may be required" to resolve the remaining complaints.

Hormone therapy drugs like Prempro and Premarin, which are used to treat the symptoms of menopause, became controversial in 2002, after a study linked them to a higher risk of breast cancer. More than 6 million women took Prempro and related menopause drugs before that study was released.

Prempro and Premarin lawsuits claim Wyeth did not adequately test the drug, and that the company failed to adequately warn that they may increase the risk of breast cancer.

Heart Risks Garner New Restrictions for Multaq

Tue, 20 Dec 2011 00:00:00 -0800

The U.S. Food & Drug Administration (FDA) has warned that Multaq should not be used to treat temporary atrial fibrillation because it may place such patients at a higher risk of serious cardiovascular problems, including heart failure, stroke and death. Multaq was only approved to treat temporary atrial fibrillation when the FDA cleared it for sale in 2009.

Because of findings from its latest review, the FDA announced yesterday that the Multaq drug label has been revised with the following changes and recommendations:

Healthcare professionals should not prescribe Multaq to patients with atrial fibrillation who cannot or will not be converted into normal sinus rhythm (permanent atrial fibrillation), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in atrial fibrillation, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
Multaq is indicated to reduce hospitalization for atrial fibrillation in patients in sinus rhythm with a history of non-permanent atrial fibrillation (known as paroxysmal or persistent atrial fibrillation).
Patients prescribed Multaq should receive appropriate antithrombotic therapy.

This marks the third time this year that the FDA has issued a safety alert for Multaq. The first warning, issued in January, came after serious cases of liver failure - some requiring transplant - were reported in Multaq patients. At the time, the label for the drug was updated to state that “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq."

In July, the FDA launched another safety review of Multaq after the PALLAS trial was halted. PALLAS was studying the use of Multaq in people over 65 with permanent atrial fibrillation, but was shut down after Mutaq-treated subjects experienced a higher-than expected frequency of adverse heart events, including cardiovascular death and stroke.

In yesterday's safety announcement, the FDA said that in addition to PALLAS, it had also taken another look at data from the ATHENA trial, which was used to garner approval for Multaq. Because patients in that study did not have an increased risk of cardiovascular death, stroke or heart failure, the FDA said it continues to believe that Multaq provides a benefit for patients with non-permanent atrial fibrillation.

Medtronic Infuse Concerns Prompt Questions from Senators

Mon, 19 Dec 2011 00:00:00 -0800

Medtronic Inc. is taking more heat over its controversial Infuse bone graft product. Now, three U.S. Senators are asking questions about Infuse, and want to know if research for the bone growth protein downplayed serious side effects, including cancer, associated with it.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery. However, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complication.

In their letter, Senators Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn. inquire about Medtronic's tracking of safety information for devices once they have been released to the market. But the Senators also ask specifically about side effects linked to Infuse.

"A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials," the letter states.

The researcher mentioned in the letter is Dr. Eugene Carragee, who published a highly critical analysis of Infuse clinical trials in The Spine Journal this summer. According to the article, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Then just last month, during a presentation at the North American Spine Society, Carragee said a new analysis he performed of another Medtronic clinical trial raised serious concerns about a cancer risk posed by rhBMP-2. That analysis involved a Medtronic trial for its Amplify product, which contains a higher dose of rhBMP-2. Earlier this year, the FDA declined to approve Amplify because of its association with cancer.

In an interview with The New York Times, Carragee said the cancer findings could have serious implications for people receiving Infuse. Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said.

Thousands of Chinese Drywall Lawsuits Settled

Fri, 16 Dec 2011 00:00:00 -0800

Thousands of homeowners with Chinese drywall may finally soon have their home remediated, following yesterday's announcement that Knauf Plasterboard Tianjin Co., a major manufacturer of the defective wallboard, had agreed to settle claims.   About 4,500 Chinese drywall claimants, mostly those from Florida, Louisiana, Mississippi and Alabama, could be eligible for the Knauf settlement.

According to a report from Bloomberg News, plaintiffs' lawyers say the Chinese drywall settlement could cost Knauf between $800 million and $1 billion.   Two funds will be set up, including an uncapped fund to take care of home repairs.   The second fund will be capped at $30 million, and will pay for other types of losses, including those by people who blame drywall for health problems.

The remediation could cost as much as $150,000 for a 2,500-square-foot house, and would include removing and replacing drywall, as well as electrical wiring, smoke alarms, fire alarms and other safety systems, according to a report from The Wall Street Journal.   As an alternative, claimants may opt for a cash option, but they will receive a discounted amount.

The total number of claimants ultimately covered by the settlement will depend on how many are able to prove they have Knauf-made drywall in their homes. However, as many 8,000 claimants who have drywall made by units of Taishan Gypsum Co. and Beijing New Building Materials Public Limited Co. aren't covered in the settlement. Those companies have not participated in the Chinese drywall litigation.

To date, the U.S. Consumer Products Safety Commission (CPSC) says it has received 3,924 reports from residents of 43 states and the District of Columbia, American Samoa, and Puerto Rico, who believe their health symptoms or the corrosion of certain metal components in their homes are related to problem drywall.

St. Jude Recalls Riata Leads, Says Defect Rate Higher Than Thought

Fri, 16 Dec 2011 00:00:00 -0800

A year after stopping sales of its Riata family of defibrillator leads, St. Jude Medical Inc. is officially recalling the defective devices. The ST. Jude Riata defibrillator lead recall has been deemed Class I by the U.S. Food & Drug Administration (FDA), meaning the leads pose a risk of serious injury or death.

According to the recall notice, Riata and Riata St. Silicone leads are being recalled because the wires can penetrate their insulation. When this occurs, the implantable defibrillator may not deliver shocks to the heart when it's needed. In other cases, the defibrillator may deliver unnecessary shocks.

Last December, when St. Jude announced it was phasing out the Riata leads, it said the abrasion rate was around 0.047 percent. In a letter sent on November 28 to doctors, the company acknowledged that the defect is more prevalent than first thought, and increased the abrasion rate to 0.063.

Despite the phase-out, Riata leads remain implanted in an estimated 79,000 U.S. patients. Around 227,000 Riata defibrillator leads were sold worldwide.

So far, two deaths and one serious injury have been reported in connection with attempts by doctors to remove Riata lead wires. In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors, St. Jude said.

The company has advised doctors to continue monitoring their patients' implanted defibrillator systems and use X-rays or fluoroscopy if there is evidence of a lead electrical failure. The potential risks associated with externalized conductors as well as the potential risks and benefits of management options should be considered and discussed with patients. St. Jude isn't advising doctors on whether or not defective leads should be removed.

“At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads,” said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo, former Heart Rhythm Society (HRS) president and a member of St. Jude Medical’s Medical Advisory Board (MAB).

No Conclusion From FDA on Possible SSRI Antidepressant, PPHN Link

Wed, 14 Dec 2011 00:00:00 -0800

The U.S. Food & Drug Administration (FDA) still can't answer the question of whether taking selective serotonin reuptake inhibitor (SSRI) antidepressants during pregnancy may increase the risk that a baby will be born with pulmonary hypertension of the newborn (PPHN). In a Drug Safety Communication issued yesterday, the agency said studies on the possible connection between SSRIs and PPHN are conflicting, making it too soon to draw any conclusions about the risk.

The FDA reviewed a total of five studies as part of its SSRI - PPHN safety review. Two indicated an increased risk. The first, published in 2006 in the New England Journal of Medicine, reported a six-fold increase in PPHN among newborn babies whose mothers were exposed to an SSRI after 20 weeks of gestation. The 2008 study in the journal Pharmacoepidemiol Drug Safety found a statistically significant association between SSRI use and PPHN, though the majority of exposures occurring during the first trimester of pregnancy. However, three additional studies reviewed by the FDA did not report a higher risk of PPHN among children born to mothers who used SSRI antidepressants.

"At present, FDA does not find sufficient evidence to conclude that SSRI use in pregnancy causes PPHN, and therefore recommends that health care providers treat depression during pregnancy as clinically appropriate. FDA will update the SSRI labels as any new data regarding SSRI use and PPHN become available," the FDA statement said.

For now, the FDA said it is updating the SSRI drug labels to reflect the new data and the conflicting results. The agency advised doctors and patients to weigh the possible risk of PPHN against risks associated with under-treatment or no treatment of depression during pregnancy when deciding whether or not use of an SSRI is warranted during pregnancy.

SSRI antidepressants are the most commonly prescribed drug to treat depression in pregnant women. But as the FDA points out, there are no adequate and well-controlled studies of SSRIs in pregnant women.

Ban Texting, Talking on Cell Phones While Driving, NTSB Tells States

Wed, 14 Dec 2011 00:00:00 -0800

Citing the terrible danger posed by distracted driving, the National Transportation Safety Board (NTSB) voted unanimously yesterday to recommend that states institute near-total bans on the use of cell phones - including those employing hands-held technologies - while driving. The proposal goes further than any current state law that regulates texting or other cell phone use while driving.

"No call, no text, no update, is worth a human life," NTSB Chairman Deborah A.P. Hersman said in a statement announcing the Board's proposal.

The NTSB wants all 50 states and the District of Columbia to ban the nonemergency use of portable electronic devices - with the exception of those that support the act of driving - for all drivers. The states would have to pass such laws, as the NTSB lacks the authority to do so.

According to the Associated Press, Hersman acknowledged that complying would involve changing what has become ingrained behavior for many Americans.

"We're not here to win a popularity contest," she said.

The NTSB's call for the drastic measure came on the heels of its investigation of a fatal pile-up in Missouri last year that killed two passengers on a school bus. The probe revealed that just prior to the accident, the teenaged driver of the pickup that started the chain-reaction crash had sent or received 11 text messages within 11 minutes.

According to a survey of more than 6,000 drivers by the National Highway Traffic Safety Administration, two out of 10 American drivers overall - and half of drivers between 21 and 24 - say they've read messages or emailed from the while driving. According to the NTSB, more than 3,000 people lost their lives last year in distraction-related accidents.

Numerous studies have highlighted the danger that comes with cell phone use and driving. A Virginia Tech Transportation Institute study of commercial drivers found that a safety-critical event is 163 times more likely if a driver is texting, e-mailing, or accessing the Internet, according to the NTSB. Research from Carnegie Mellon University (CMU) has found that simply listening to someone speak on the other end of a cell phone reduces by 37 percent the amount of brain activity associated with driving, compared to driving alone. Another CMU study revealed that making cell phones hands-free or voice-activated is not sufficient in eliminating distraction to drivers.

Judge Grants Parker Waichman LLP Motion to Remand Marlboro Lights Cigarette Lawsuit

Tue, 13 Dec 2011 00:00:00 -0800

A federal judge has granted Parker Waichman LLP's motion to suggest that a light cigarette class action lawsuit it filed on behalf of a New York man be remanded back to U.S. District Court for the Eastern District of New York. The lawsuit, Bryant Tang vs. Philip Morris, USA, alleges purchasers of Marlboro Lights suffered economic damages as a result of misrepresentations made by Philip Morris and Altria Group about the cigarettes.

The Tang lawsuit was one of several consolidated in a multidistrict litigation before John A. Woodcock, Jr., Chief District Judge for the U.S. District Court, District of Maine. On November 24, 2010, Judge Woodcock denied class certification to four test cases submitted in the multidistrict litigation, finding non-commonality. Defendants then sought to apply Judge Woodcock's ruling to dismiss complaints remaining in the multidistrict litigation, including the Tang lawsuit.

Parker Waichman LLP opposed the dismissal and moved to have the Tang lawsuit remanded back to the Eastern District of New York, asserting that Section 349 of New York State's General Business Law provides a common element of damages applicable to all New York class members.

In an order issued yesterday, Judge Woodcock refused to dismiss any of the remaining lawsuits. He also granted the Parker Waichman LLP’s Motion to Suggest Remand of the Tang lawsuit to the Eastern District of New York. The final decision on whether to remand the complaint will be made by the U.S. Judicial Panel on Multidistrict Litigation.

Medtronic Infuse Shareholder Class Action Lawsuit Certified

Tue, 13 Dec 2011 00:00:00 -0800

Medtronic, Inc. got more bad news on the Infuse front yesterday, when a federal judge granted class action status to an investor shareholder lawsuit alleging the company illegally promoted off-label use of the controversial bone growth protein, causing stockholders financial harm. According to a report from Newsinferno.com, Medtronic is already facing investigations by the U.S. Department of Justice, the U.S. Senate Finance Committee and the state of California regarding its marketing of the Infuse bone growth product.

In August 2009, the Minneapolis Firefighters’ Relief Association and other institutional investors alleged in an amended complaint that Medtronic had deliberately promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses. The lawsuit sought class action status on behalf of holders of the company's stock who purchased or acquired their shares between November 2006 and November 2008 and suffered financial losses.

Yesterday, U.S. District Judge Paul Magnuson of Minnesota certified the class, rejecting Medtronic's assertion that Plaintiffs’ counsel was inadequate and that the Plaintiffs had misrepresented witness statements. Judge Magnuson also rejected Medtronic’s opposition to the definition of the class and refused to strip the class of its lead plaintiff.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery, however, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complications.

85 Arrested in Orthodox Jewish Child Sexual Abuse Investigation

Mon, 12 Dec 2011 00:00:00 -0800

A three-year investigation into child sexual abuse in the Orthodox Jewish community is paying off, according to the Brooklyn District Attorneys office. Since the project, known as Kol Tzedek, was launched in 2009, 85 alleged child molesters have been arrested.

According to The New York Post, Kol Tzedek has also resulted in:

•    117 victims: 89 under age 17, the rest up to age 23, when the statute of limitations expires
•    47 cases pending; 38 closed
•    14 offenders sentenced to jail, from a month to 10-to-20 years
•    24 free—on probation, after pleading to lesser charges or after cases were dismissed.

Kol Tzedek is Hebrew for “voice of justice. The aim of the program is to convince child sexual abuse victims to come forward, even though the Orthodox Jewish community has long exerted pressure on victims to stay quiet about their abuse. Ultra-orthodox rabbis enforce a rule that prohibits reporting fellow Jews to secular authorities. Coming forward can result in an entire family being made outcasts.

“The first thing they say almost every time is, ‘Please don’t tell anybody. I don’t want to go public. Make sure this never goes to the press,’ ” Henna White, the Orthodox Jewish liaison for the Brooklyn DA's office, told The New York Post. “I can’t begin to tell you how important that is.”

Sadly, dismissals often came after victims and their parents bowed to immense community pressure to stop cooperating with law enforcement, White said.

EPA Cites Fracking for Pavillion, Wyoming Aquifer Pollution

Fri, 09 Dec 2011 00:00:00 -0800

Chemicals in a contaminated aquifer in Pavillion, Wyoming, are "likely associated with gas production practices, including hydraulic fracturing,” according to a statement issued late yesterday by the U.S. Environmental Protection Agency (EPA). Environmentalist are hailing the EPA's finding, saying the agency's draft report on the Pavillion aquifer finally provides the evidence they need to push for more regulation of fracking.

“It’s a game-changer. EPA experts and scientists have recognized that there is real contamination, that there is a real scientific basis for linking it to fracking," Amy Mall, senior policy analyst for the Natural Resources Defense Council, told Bloomberg News.

The EPA has been investigating groundwater contamination since 2008, and last year dug two deep monitoring wells to sample water in the aquifer. According to the statement released by the agency yesterday:

"EPA’s analysis of samples taken from the Agency’s deep monitoring wells in the aquifer indicates detection of synthetic chemicals, like glycols and alcohols consistent with gas production and hydraulic fracturing fluids, benzene concentrations well above Safe Drinking Water Act standards and high methane levels. Given the area’s complex geology and the proximity of drinking water wells to ground water contamination, EPA is concerned about the movement of contaminants within the aquifer and the safety of drinking water wells over time."

The agency also said that chemicals detected in the most recent samples from Pavillion area water wells were consistent with those identified in earlier EPA samples and include methane, other petroleum hydrocarbons and other chemical compounds that are consistent with migration from areas of gas production. However, detections in drinking water wells are generally below established health and safety standards, according to the agency.

Calgary-based Encana Corp. (ECA), Canada’s largest natural- gas producer, owns about 150 wells in Pavillion. A spokesperson for the company told Bloomberg he wasn't sure if Encana used any of the chemicals detected in the aquifer in its wells.

According to Bloomberg, Encana has been providing drinking water to about 21 families in Pavillion since August, 2010. Last year, the EPA warned residents not to cook with or drink their well water, and to ventilate homes when they showered.

Yaz, Yasmin Blood Clot Risk Warnings Need to be Stronger, FDA Advisors Say

Fri, 09 Dec 2011 00:00:00 -0800

Two U.S. Food & Drug Administration (FDA) committees voted overwhelmingly yesterday to recommend stronger label warnings for Yaz, Yasmin and similar oral contraceptives regarding their possible association with blood clots. The outside advisors voted 21-5 that current label warnings for Yaz, Yasmin and other pills made with the progestin, drospirenone, are inadequate and need to include clearer information about data that have linked the pills to a higher risk of blood clots.

The FDA is not legally obligated to follow the recommendations of its outside advisory panels, but it usually does so.

According to a report from Newsinferno.com, a total of five large studies have found evidence that drospirenone birth control pills pose a higher risk of blood clots compared to those containing an older form of progestin. Most recently, an FDA-Funded study that involved 800,000 American women taking some birth control between 2001 and 2008 found that those taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives. Only two large studies, both funded by the maker of Yaz and Yasmin, have failed to find a higher risk.

The conflicting studies are noted on the labels for Yaz, Yasmin and similar birth control pills. But the FDA's advisors found those to be confusing, and some members were bothered only Bayer-sponsored studies seemed to find Yasmin equally safe as other birth control pills, according to a Reuters report.

"I found that disturbing," said Dr. Maria Suarez-Almazor, a professor at the University of Texas MD Anderson Cancer Center, to applause from numerous women's advocates and patients.

Some patient advocates argued for the advisors to recommend even more drastic action, Reuters said, asserting they should be pulled from the market entirely.

"Most people only see the watered-down label ... We know that labels just don't change behavior," said Cynthia Pearson, executive director of the National Women's Health Network.

However, the FDA advisors did not agree, and voted 15 to 11 that the benefits of the birth control pills still outweigh their risks.

According to a report from The New York Times, the advisors stopped short of recommending that the labels for Yaz, Yasmin and similar contraceptives warn that they are more dangerous than other birth control pills. The experts also suggested that the labels note that the evidence about blood clots is conflicting.

Pradaxa Bleeding Reports Prompt FDA Review

Thu, 08 Dec 2011 00:00:00 -0800

Reports of serious and sometimes fatal bleeding among Pradaxa patients have prompted the U.S. Food & Drug Administration (FDA) to open a safety review of the blood thinner. In a Drug Safety Communication issued yesterday, the FDA said it evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa, but did not indicate how many such reports it had received.

In the past several months, regulators in various countries have pushed Boehringer Ingelheim to increase warnings on Pradaxa recently. In August, for example regulators in Japan told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 patients taking it there suffered heavy bleeding.

Just last month, European regulators advised doctors to subject Pradaxa patients older than 75, as well as those with renal impairment, to annual kidney checks in order to mitigate any bleeding risks. Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding.

Also last month, Boehringer Ingelheim, the maker of Pradaxa, said that 260 reports of fatal bleeding among Pradaxa patients had been made worldwide between March 2008 and October 31, 2011. The drugmaker maintained that the number was in line with expectations for bleeding events based the drug's clinical trials.

According to the FDA Drug Safety Communication, bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial involving 18,000 patients that compared Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs, the FDA said. The agency also noted that the Pradaxa label does bear a warning about this potentially serious bleeding.

Despite the new safety review, the FDA said it continues to believe that Pradaxa "provides an important health benefit when used as directed". It has advised patients taking the drug not to stop taking without talking to their doctor.

Medtronic Discloses California Infuse Investigation

Thu, 08 Dec 2011 00:00:00 -0800

Medtronic continues to be plagued by investigations into its controversial Infuse bone growth product. According to its most recent 10-Q filing with the Securities and Exchange Commission (SEC), the California Attorney General issued a subpoena to the company in October seeking information regarding Infuse.

According to the filing, the California Attorney General is just the latest state or federal official to express an interest in Infuse:

"On October 6, 2008, the Company received a subpoena from the United States Attorney’s Office for the District of Massachusetts pursuant to HIPAA requesting production of documents relating to Medtronic’s INFUSE Bone Graft product. The Company has since received supplemental subpoenas or document requests in connection with the INFUSE Bone Graft product, including a December 18, 2008 civil investigative demand from the Massachusetts Attorney General’s Office, an October 14, 2011 subpoena issued by the California Attorney General’s office, and several inquiries from the United States Senate Finance Committee. The Company is fully cooperating with these investigations."

Medtronic also revealed that Infuse sales fell 16 percent in the second quarter, something it blamed on the June 2011 publication of articles in The Spine Journal, which called the safety of Infuse into questions. According to the journal, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic Discloses California Infuse Investigation