U.S. District Judge Cynthia M. Rufe, who is presiding over the Zoloft birth defect MDL, issued a Pretrial Order (PDF) on May 4, scheduling an initial status conference for Thursday, July 12.

At that time, an attorney will appear on behalf of each party, prepared to “suggest procedures that will facilitate the expeditious, economical and just resolution of this litigation,” according to Judge Rufe’s order.

No later than June 8, each side has been directed to submit a brief written statement outlining the critical legal and factual issues in the Zoloft litigation, as well as a joint proposed case management order.

During or shortly after the conference, it is also expected that Judge Rufe will appointed attorneys to serve in various leadership positions in the MDL, These attorneys will perform certain functions that benefit all plaintiffs who have filed a Zoloft lawsuit; such as conducting discovery that is applicable to all cases, submitting and arguing motions before the Court and negotiating potential settlement agreements or stipulations with the opposing party.

The U.S. Judicial Panel on Multidistrict Litigation centralized the Zoloft MDL before Judge Rufe in the U.S. District Court for the Eastern District of Pennsylvania on April 17. At that time, there were nearly 100 lawsuits filed in U.S. District Courts throughout the country on behalf of children born with birth defects from Zoloft, after their mothers were given the antidepressant during pregnancy. In addition, the litigation is expected to continue to grow as Zoloft lawyers continue to review and file additional cases in federal district courts.

The lawsuits all raise similar allegations that Pfizer, the manufacturer of Zoloft, failed to adequately warn consumers or the medical community about the risks associated with use of the popular antidepressant during pregnancy, which has been linked to a number of serious and potentially life-threatening health problems for babies, including persistent pulmonary hypertension in newborns (PPHN), spina bifida, heart defects, lung defects, abdominal defects, cranial defects and other malformations.

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States.

According to new research, many drugs do not carry pediatric dosing instructions, leaving doctors to make an estimate of the proper drug dose based on the child’s weight. In fact, even when medications do provide dosing information for children, many doctors still estimate based on the weight, simply because they do not expect the information to be there.

In a study published last week in the Journal of the American Medical Association (JAMA), researchers found that less than half of drugs commonly prescribed to children have proper pediatric dosing instructions. Out of the 105 new drugs approved by the FDA between 2002 and 2008, only 43 had such information.

As a result, doctors who prescribe these drugs have no clear instructions about how much is safe or effective for children, who are not only smaller than adults, but who also have a different metabolic rate, different hormones and whose bodies are still in the process of developing.

Prior studies have estimated that about 80% of children who are admitted to U.S. hospitals are given drugs that have never been tested on children. For infants, that number jumps to 90%.

Researchers point out that this has been a concern since 1975, when a study found that 78% of all drugs had inadequate prescribing information for children. While things have improved, researchers in this latest study indicate that the number of drugs with pediatric prescribing information is still far too low, and they say that their estimate of the number of drugs with pediatric data is probably generous.

What improvements there have been are mainly attributable to two laws passed in the last two decades; the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act. Those laws give the FDA the power to ask for pediatric prescribing information for drugs likely to be given to children and provide incentives for drug companies to do so voluntarily.

In April, the CDC released a report that found the number of child drug overdoses is on the rise. According to the report, the poisoning death rate among 15 to 19 year olds skyrocketed 91% from 2000 to 2009, increasing from 1.7 deaths per 100,000 to 3.3 deaths. The number of those deaths that can be attributed to prescription drug overdoses rose from 30% in 2000 to 57% in 2009, suggesting that at the turn of the century less, than one-in-three teen poisoning deaths were caused by prescription drugs, but they now account for more than half. Many of those deaths were attributed to the illegal use of the drugs for recreational purposes, however.

A report in USA Today on Tuesday highlights the case of a woman, Hilary Lane, who had gastric bypass surgery in 2005, which is believed to have activated a dormant genetic mutation that derailed her metabolism, preventing her from processing proteins. Instead, her body turned protein into ammonia, which her liver could not process.

As a result of the problems following gastric bypass surgery, Lane died of urea cycle failure, weighing only 88 pounds.

Some doctors have expressed concern that other people could suffer the same fate following bypass surgery, as there have been at least six women who reportedly developed urea cycle failure since 2007, and five of them have died. In addition, this likely only represents a small fraction of such complications that have actually occurred, as most adverse events are never reported.

Gastric bypass surgery alters the size and shape of the stomach and intestines in order to address issues of extreme obesity and to promote rapid weight loss. The procedure has gained in popularity in recent years, but the changes to the body require recipients to also permanently alter the way they eat to ensure they receive the proper balance of nutrients.

The genetic disorder that killed Hilary Lane and others is called acquired urea cycle failure. In a normal urea cycle, protein metabolism creates nitrogen, which is removed from the blood stream and converted into urea, which is then removed from the body in the form of urine.

Someone suffering from acquired urea cycle failure lacks an enzyme that helps the process work. The nitrogen becomes ammonia and the ammonia cannot be processed by the liver. The ammonia is toxic and damages the body over time. In adults, it can cause what appear to be psychiatric problems, delirium, lethargy and symptoms similar to those of stroke victims. In cases where the person underwent gastric bypass surgery, it is also usually accompanied by weight loss that will not stop and cannot be controlled.

Most cases of acquired urea cycle failure are diagnosed in children because they are born with the genetic disorder already active. But some doctors say that gastric bypass surgery appears to be activating dormant genetic mutations that then cause the disorder to appear later in life.

It is unclear if the genetic disorder is activated solely by gastric bypass surgery, or by other types of bariatric weight loss surgery as well, which include the Lap-Band, duodenal switch, vertical sleeve gastrectomy and Roux-en-Y.

About 220,000 people in the U.S. underwent bariatric surgery in 2009. Gastric bypass is the most popular, and duodenal is only performed in about 1% of those operations and is reserved for the most extreme cases of obesity.

The product liability complaints were brought against Boehringer Ingelheim in Illinois, Louisiana and Tennessee, alleging that the drug maker failed to adequately warn about the risk of bleeding from Pradaxa, or the lack of a reversal agent that could be used to stop or stabilize bleeding that may occur while using the anticoagulant.

Two of the lawsuits were brought on behalf of the estates of individuals who bled to death after Pradaxa use. According to estimates provided in one of the complaints, at least 500 people in the United States have likely died due to side effects of the anticoagulant, which was just introduced in October 2010 as a new treatment for individuals at risk of stroke due to atrial fibrillation.

One of the wrongful death claims (PDF) was brought on May 14, by the daughter of Ray Herndon Celsor, in the U.S. District Court for the Middle District of Tennessee. The complaint alleges that Celsor was prescribed Pradaxa in March 2011 and suffered severe gastrointestinal bleeding on May 14, which required him to undergo surgery. However, his condition deteriorated and he died due to excessive in May 2011.

The other death lawsuit over Pradaxa (PDF) was filed on behalf of the estate of Bonne Fitzgibbons on May 11, in the U.S. District Court for the Southern District of Illinois. Fitzgibbons was prescribed Pradaxa in August 2011, for treatment of non-valvular atrial fibrillation. She subsequently developed uncontrollable bleeding from Pradaxa, and died in October 2011.

Other recent complaints involving serious, but non-fatal injuries, were brought by Thelma Hawthorne (PDF) of Louisiana, Eva Smith (PDF) of Illinois, Jacqueline Boston (PDF) of Illinois and Carole Richardson (PDF) of Illinois.

Pradaxa (dabigitran) is marketed by Boehringer Ingelheim as an alternative to Coumadin (warfarin). Although the medication has been promoted as superior and easier to use, because it requires less monitoring, Pradaxa does not have a reversal agent that can be used to quickly stop bleeding problems that may develop.  With warfarin, doctors can give patients a dose of vitamin K if bleeding problems occur, but no such antidote is available for Pradaxa users.

In recent months, concerns have increased about the Pradaxa bleeding risk, as hundreds of adverse event reports have been filed with the FDA involving hemorrhages and uncontrollable internal bleeding, which have caused many users to bleed to death due to the lack of a reversal agent.

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of bleeding problems with Pradaxa were reported to the FDA during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin, which was second on the list.

Pradaxa safety investigations are now underway in the U.S. by the FDA, as well as in the European Union and Canada.

The complaint was filed by Howard Midkiff, who tested positive for HIV after a blood transfusion while undergoing coronary bypass grafting surgery in October 2010 at Baptist Medical Center in Montgomery, Alabama.

According to allegations raised in the blood bank lawsuit, LifeSouth discovered the following May that HIV-contaminated blood had been collected the same month as Midkiff’s surgery and may have been distributed to Baptist Medical Center. The hospital was notified of the possibly HIV infected blood and Midkiff was tested.

Midkiff accuses LifeSouth of negligence in providing HIV-tainted blood, as well as failing to design and/or implement reasonable screening and testing procedures that would have detected the tainted blood.

Baptist Medical officials have indicated that they believe Midkiff was the only patient to receive the HIV-contaminated blood.

“Every donor, every time is medically screened prior to donation and every unit of blood collected by LifeSouth undergoes nine separate tests to screen for infections disease, and those tests are the most thorough and exacting possible, meeting all federal and industry standards,” said LifeSouth General Counsel Kim Kinsell in a press release issued on May 15, in response to concerns raised by the lawsuit.

Kinsell indicated that testing for HIV is not perfect. While it is extremely rare, there is a small window of time between when a person is infected and when the antibodies begin to show in their blood stream where they could donate and the disease could go undetected. Estimates are that less than 1 in 1.9 million blood components that test negative for HIV are actually contaminated, Kinsell maintained.

The U.S. Centers for Disease Control and Prevention estimates that it takes most people two to eight weeks to develop detectable HIV antibodies after they become infected, with an average of 25 days. It is those antibodies that the tests look for. About three percent of those who become infected take longer than three months to develop the antibodies.

The complaint was filed on May 10 by Crystal Stevens in Jefferson County Circuit Court in Kentucky, alleging that Medtronic actively and illegally promoted their Infuse bone graft, which can cause uncontrolled bone growth that may damage spinal nerves.

Medtronic Infuse features an absorbable collagen sponge that is treated with a genetically engineered bone morphogenetic protein, referred to as BMP, to stimulate bone growth and fuse vertebrae when used during bone graft procedures.

For spinal surgery, the Medtronic Infuse BMP has only been approved by the FDA for use during single-level anterior lumbar fusions, where the spine is approached from the front. However, the device has been widely used “off-label” for other types of spine surgery, including cervical fusions and posterior lumbar fusion.

Off-label use of Medtronic Infuse BMP has been linked to reports of serious and potentially life-threatening complications, including inflammatory reactions, airway compression when used in the cervical spine, nerve damage and other problems.

If the Infuse BMP leaks out of the small cage it is placed in, unwanted bone growth may result.

Stevens’ lawsuit claims that she underwent spinal surgery in 2006 and the bone growth caused by the Infuse migrated out of the cage and caused her to suffer nerve damage. As a result, she now has severe pain that requires her to spend most of her time lying flat on her back and her husband’s help is needed to perform simple tasks, such as tying her shoes.

In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving reports of fatal complications caused by swelling of the neck and breathing difficulties.  A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse during a cervical spine surgery.

The U.S. Department of Justice initiated an investigation into the actions of Medtronic that same year, investigating whether the manufacturer illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.  While doctors are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such uses that they have not established as safe and effective.

Last year, concerns also emerged that side effects of the Medtronic Infuse bone graft may increase the risk of cancer or sterility in men.

Stevens joins a growing number of people throughout the United States who have filed a Medtronic Infuse BMP lawsuit after experiencing complications associated with unwanted bone growth. The complaints involve similar allegations that Medtronic failed to adequately research the BMP bone graft or warn doctors about the risks associated with off-label use of the product.

In a drug safety communication issued on May 14, the FDA indicated that side effects of Gilenya on the heart may be dangerous or perhaps fatal in some cases.

The FDA launched an investigation into Gilenya late last year, after at least one patient died within 24 hours of taking the medication.

Although the agency was unable to determine whether Gilenya played a role in the death, they have contraindicated Gilenya for patients with pre-existing heart conditions or heart problems that have occurred within the last six months, such as heart attacks, unstable angina, heart failure or decompensated heart failure that required hospitalization, among others. The FDA also contraindicated Gilenya’s use by patients who have suffered a stroke or who take Class Ia or Class III anti-arrhythmic drugs.

The FDA is also recommending extended heart monitoring in patients who are at higher risk for or who may not tolerate bradycardia.

Gilenya has been found to lower the heart rate when first taken, according to the FDA. The reduction in heart rate is biphasic, with the first happening within the first six hours. The second decrease occurs between 12 and 20 hours after that first dose, which the FDA believes to be tied to the body’s circadian rhythm.

While the FDA did not give the number of deaths linked to Gilenya use, it did note that the number due to heart problems did not appear to be higher than in MS patients who were not treated with Gilenya.

Gilenya (fingolimod) was approved by the FDA in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

Despite concerns over the safety of Gilenya when it was reviewed, the FDA agreed to fast-track the drug’s approval with minimal testing under a program aimed at getting crucial drugs to the market to address medication needs that have not been met by other drugs. It is the only oral MS drug on the market.

Prior to approval, the risk of some heart irregularities after the first dose were a concern, as side effects of Gilenya are known to include a decrease in heart rate and/or atrioventricular condition after the first does.  It is also known to increase the risks of vision loss and developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers.

According to a new study published in the June issue of the medical journal Pediatrics, emergency room visits involving children who were injured by small batteries has more than doubled over the past twenty years.

Researchers used the National Electronic Injury Surveillance System to track battery-related emergency room visits in the United States from 1990 to 2009. They looked at injuries linked to swallowing, mouth exposure, and insertion into ears and the nose, finding that over that time period an estimated 65,788 youths under 18 visited emergency rooms due to battery-related injuries. Most of those injuries occurred in boys and the mean age was four years old. More than three-quarters of the injuries were due to the button-sized batteries being swallowed.

Over the course of the study, the number of emergency room visits per year has risen, with the most significant increases coming in the last eight years. In 1990, the number of button-battery ER visits was 1,301. By 2009, that number had more than doubled, reaching 2,785.

Fortunately, about 92 percent of the children who visit the ER for battery-related injuries are treated and released. However, the small batteries do pose a risk of severe internal damage and other injuries that can cause more serious problems. The batteries can get lodged in the esophagus and create a small current which could burn a hole. In some cases, the hole could lead into the aorta, potentially allowing the child to bleed to death.

Dr. Gary A. Smith, the lead researcher and director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio, has said that the findings are a sign that manufacturers need to take steps to reduce the risks of child injury from button-sized batteries, and parents need to be made more aware of the dangers.

The researchers suggest a focus on child-resistant battery covers as one potential avenue. They also point out that it is not just toys, but numerous household devices that these batteries are coming from, such as remote controls and flashlights.

In a court order (PDF) issued on May 2, U.S. District Judge Joel A. Pisano sided with plaintiffs, saying that it would be inappropriate for Merck’s attorneys to directly contact prescribing or treating physicians in any way outside the presence of plaintiffs’ attorneys.

The order came after Merck sought permission to directly initiate and participate in “ex parte” communication with physicians in states where such communications are permitted. The drug maker also sought to limit Plaintiffs’ counsel to discussing only certain documents and topics during any “ex parte” communications they have with those physicians outside of the presence of Merck’s counsel.

Judge Pisano is overseeing all federal Fosamax lawsuits over bone fractures, which have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of New Jersey.

Hundreds of Fosamax fracture suits have been filed against Merck, alleging that the drug maker failed to adequately research their medication or warn about the potential increased risk of femur breaks from Fosamax side effects, which typically occur with little or no trauma.

In his order, Judge Pisano cited the protected relationship between doctors and their patients as a primary reason for denying Merck’s requests and barring direct contact in any state between the drug maker and plaintiffs’ physicians without involvement of plaintiffs’ counsel, stating that any violation shall result in sanctions.

Judge Pisano indicated that while the decision may, on its face, appear one-sided and unfair, it is not. He noted that Merck “still has access to the information it seeks by way of a variety of mechanisms” such as depositions and plaintiff profile forms.

Fosamax (alendronate sodium) is the most commonly used bisphosphonate medication in the United States, which was introduced by Merck in 1995.  The medication generated over $3 billion in annual sales before it became available as a generic in 2008.

Long-term use of Fosamax has been linked to an increased risk of atypical femur fractures, which can occur with falls from standing height or less, which would not usually cause a complete break of the femur bone.

In October 2010, following an investigation by the FDA, Merck was required to add new warnings to the Fosamax label about the risk of bone fractures from Fosamax and other bisphosphonate medications. Earlier this week FDA researchers published a review noting that they found no long-term benefits in taking Fosamax or other bisphosphonates, like Actonel and Boniva.

In a study published this month in the Proceedings of the National Academy of Sciences, researchers investigating fetal exposure to BPA in rhesus monkeys, found that female offspring had glandular changes that are often a risk factor in breast cancer.

Among the female monkeys who were exposed to BPA while they were in the womb, mammary glands had significantly increased density and were also significantly more developed, suggesting that BPA was working as an endocrine disruptor as well.

BPA was originally developed as an artificial form of estrogen, a female hormone. The chemical is used to make many plastic products hard and shatterproof, such as bottles, cans, cups, baby bottles and other food containers.

Exposure to BPA is suspected of causing hormonal changes by impacting the human endocrine system. It has previously been linked to cancer, heart disease, diabetes, obesity and asthma. Some research has suggested that BPA can cause developmental abnormalities and other problems over time in infants and young children.

In March, the FDA determined there was not enough data for the agency to change current regulations that continue to allow the use of BPA in food packaging, denying a petition to ban BPA, which was filed by the National Resource Defense Council (NRDC) in 2008.

More than a dozen class action lawsuits over BPA have failed since 2008, with most ending in dismissal primarily due to a lack of evidence.