BPA Exposure Linked to Miscarriage Risk: Study

Published: October 16th, 2013

A new study raises further concerns about the safety of the controversial chemical additive Bisphenol A (BPA), indicating that it could be linked to an increased risk of miscarriage among pregnant women.  

At the American Society of Reproductive Medicine (ASRM)’s annual conference on Monday, researchers presented a study that shows an association between BPA and miscarriage among women who have had difficulty getting pregnant.

BPA is commonly found in many plastic products, food containers and bottles.

The study was a follow up to data from an earlier study that demonstrated mice exposed to BPA had trouble getting pregnant. However, this latest investigation looked at 115 newly pregnant women who had a history of either miscarriages or infertility. During the study, 68 miscarried and 47 had live births.

The researchers discovered that women with the highest BPA levels in their blood had an 80% higher risk of miscarriage than those with the lowest levels of BPA in their blood. The researchers warned that due to the small study size there could be other factors increasing the women’s miscarriage risk and cautioned that the study does not show a causal link between BPA and miscarriage.

The study has not yet been published in a medical journal or peer-reviewed.

BPA Health Concerns

The findings are the latest in a series of studies by researchers around the world that raise concerns over BPA’s effects on the body. A study published this summer in the medical journal Human Reproduction found that BPA may have a direct effect on the maturation of human eggs in the female body. Miscarriages are often the result of problems with the egg.

BPA is a chemical additive used in plastics to preserve food freshness. It is used in some drink bottles, and in the lining of some cans of preserved food. It used to be found in baby bottles as well, but the FDA banned BPA from baby bottles several years ago once concerns regarding BPA side effects began to grow.

Originally designed to be an artificial form of estrogen, BPA can impact the hormone system. Because of its widespread use, it is detected in the urine of virtually every person in the U.S. and many other countries.

A number of studies have linked the chemical with increased risk of obesity and other problems, particularly among children.

In a study published in August in the medical journal Pediatrics, researchers from the University of Michigan found an association between BPA exposure and the risk of childhood obesity and childhood diabetes.

Another study published in June found a link between heightened levels of BPA in the urine of children was linked to obesity in adolescent girls. In fact, girls with high levels of BPA faced a two-fold risk of being obese, compared to girls who had normal levels of BPA.

That study followed research published in the Journal of Allergy and Clinical Immunology this Spring that found exposure to BPA during pregnancy was associated with an increased risk of asthma in children.

Related ArticlesStudy Links BPA to Childhood Obesity, Diabetes Risk (8/22/2013)Study Links BPA Exposure to Fertility Problems (8/2/2013)Bisphenol-A Levels Linked to Childhood Obesity: Study (6/17/2013)Bisphenol A (BPA) During Pregnancy Linked to Asthma in Children: Study (3/5/2013)Exposure to BPA May Be Linked to Childhood Obesity: Study (9/21/2012)Tags: Bisphenol A, BPA, Fertility, Plastic

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Pradaxa Lawsuits in MDL Being Prepared for Early Trial Dates Next Year

Published: October 16th, 2013

In the federal litigation over claims that Boehringer Ingelheim failed to adequately warn about the bleeding risks with Pradaxa, the parties are continuing to prepare a small number of claims for early trial dates, which are expected to begin in August 2014.

More than 1,500 Pradaxa lawsuits filed in U.S. District Courts throughout the country are currently consolidated for pretrial proceedings as part of an MDL, or Multi-District Litigation, The cases are centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.

As part of the coordinated litigation, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. These early trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout a large number of other cases.

According to the minutes (PDF) of a status conference held before Judge Herndon on October 8, the parties recently updated the Court on the progress of the preparations for the bellwether cases, including the status of discovery depositions involving plaintiffs, doctors and sales representatives.

Shortly after the Pradaxa litigation was centralized in August 2012, Judge Herndon indicated that he intended to move the cases toward an “expeditious resolution” for the factual allegations, which is designed to benefit both plaintiffs and the maker of the drug.

In October 2012, a case management order was issued establishing an aggressive bellwether trial schedule that will result in the selection of four Pradaxa suits for early trial dates. The first case is scheduled to begin on August 11, 2014, and the subsequent cases are expected to begin approximately six weeks apart.

Judge Herndon is expected to select the four specific cases that will serve as the first bellwether trial cases next month.

Pradaxa Bleeding Problems

All of the cases centralized in the Pradaxa MDL involve similar allegations that plaintiffs suffered serious or fatal injuries when doctors were unable to reverse the blood thinning effects of the anticoagulant. Plaintiffs argue that Boehringer Ingelheim failed to adequately warn about the hemorrhage risk or disclose that there is no reversal agent for Pradaxa to allow doctors to stop bleeding events that may develop.

Pradaxa (dabigatran) was introduced by Boehringer Ingelheim in October 2010, as the first member of a new class of anticoagulants promoted as a superior alternative to warfarin for stroke prevention, as it is easier to take and requires less medical monitoring.

Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa does require less monitoring, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.

Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.

During the first full year the drug was on the market in the United States, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.

Pradaxa Bleeding Litigation

The U.S. Judicial Panel on Multidistrict Litigation centralized all Pradaxa cases before Judge Herndon in August 2012, to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

At the time the MDL was established, there were only 21 cases pending in 11 different U.S. District Courts. However, as Pradaxa lawyers have continued to review additional lawsuits for individuals who suffered severe injuries from uncontrollable bleeding events, the number of complaints has continued to increase. More than 200 cases have been added to the MDL over the past three months.

As the parties continue to prepare for the early bellwether trials, settlement negotiations continue between plaintiffs and the drug maker. In July, Judge Herndon appointed a mediator and ordered the parties to meet at least once a month to discuss possibly settling Pradaxa lawsuits to avoid individual trials.

If agreements are not reached before the first trial dates, the outcomes of the bellwether trials may help the parties better gauge the relative strengths and weaknesses of their cases and may facilitate a Pradaxa settlement agreement involving a large number of cases.

Following the bellwether trial process, if Boehringer Ingelheim fails to settle or otherwise resolve the Pradaxa litigation, Judge Herndon could begin remanding hundreds of cases back to U.S. District Courts throughout the country where they were originally filed for individual trial dates.

Related ArticlesMediator Appointed to Oversee Negotiations to Settle Pradaxa Cases (7/19/2013)Process Established for Selection of Pradaxa Cases for Early Trials in MDL (4/16/2013)Boehringer Ingelheim Marketing Practices Fair Game in Pradaxa Litigation (1/28/2013)Pradaxa Settlement Negotiations To Be Held In Advance of First Trials (1/4/2013)Pradaxa Lawsuit Trials Scheduled To Begin in August 2014 (10/11/2012)Tags: Bleeding, Blood Thinner, Coumadin, Pfizer, Pradaxa, Warfarin

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Another DePuy ASR Lawsuit Settles Right Before Trial Set to Begin

Published: October 16th, 2013

It appears that Johnson & Johnson’s DePuy Orthopaedics subsidiary has agreed to settle another lawsuit over their recalled ASR hip replacement, once again reaching a resolution only days before trial was scheduled to begin.  

Nearly 12,000 DePuy ASR lawsuits are pending in state and federal courts throughout the country involving allegations that design defects with the metal-on-metal hip replacement increased the risk that users would experience problems with their artificial hip within a few years after it is implanted.

DePuy recalled their ASR hip implanted in August 2010, amid reports that suggested a higher-than-expected number were failing during the first five years. As the first trials approach in state and federal courts, at least two case have now resolved for undisclosed amounts.

A complaint filed by Debora MacDonald was scheduled for trial to begin on October 21 in New Jersey state court, where cases are centralized for coordinated proceedings as part of an MCL or Multi-County Litigation.

According to a Case Management Order (PDF) issued by New Jersey Judge Brian R. Martinotti, the parties have informed the court that the MacDonald case “has been resolved,” resulting in the cancellation of the upcoming trial date.

Earlier this month, a similar DePuy ASR settlement agreement was reported in California state court, where a complaint filed by Robert Eugene Ottman was also set for trial to begin in late October.

Details have not been reported for the terms of either settlement.

DePuy ASR Settlement Negotiations and Early Trials

Prior reports have suggested that Johnson & Johnson was considering an offer of more than $3 billion to settle the DePuy ASR litigation, which would average out to about $300,000 per case. According to a report by Bloomberg News in January 2013, plaintiffs previously rejected an offer that averaged about $200,000 per case because it did not provide sufficient compensation for injuries caused by the recalled hip implant.

While thousands of cases are pending, a small number of lawsuits have been set for early trial dates in state and federal courts to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of claims.

Earlier this year, a California jury awarded $8.3 million in damages in one case. However, a second trial held in Illinois state court resulted in a defense verdict for the manufacturer.

In the federal court system, all DePuy ASR lawsuits are consolidated for pretrial proceedings before U.S. District Judge David A. Katz in the Northern District of Ohio, where the first “bellwether” trials are expected to begin in January 2014. That case was originally set to begin in September, but has been postponed at least two times, leading to speculation that the parties may be considering a settlement.

In New Jersey state court, the next DePuy ASR trial is also expected to begin in January 2014, involving a consolidated trial for two different individuals who have experienced similar problems following DePuy hip replacement surgery.

Related ArticlesCalifornia Bellwether Trial for DePuy ASR Hip Replacement Settled: Report (10/3/2013)Bellwether Trial for DePuy ASR Lawsuit in MDL Postponed Again (9/23/2013)DePuy ASR Hip Replacement Trial in MDL Set to Begin Sept. 24 (9/9/2013)Bellwether Trial for DePuy ASR Hip Implant Scheduled for October in N.J. (6/12/2013)Trials Set to Begin in Lawsuit Over DePuy ASR Hip Replacements (1/7/2013)Tags: Depuy ASR Hip, DePuy Hip Replacement, Johnson & Johnson, Metal Hip Replacement, New Jersey

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