Author: AboutLawsuits

About 1.2 million Graco Harmony High Chairs have been recalled due to a defect that could cause screws to fall out and plastic brackets to break, causing children to fall to the floor and get hurt. Graco has received hundreds of reports where the high chairs fell over, causing at least 24 children to suffer an injury.

The Graco high chair recall was announced on Thursday by the U.S. Consumer Product Safety Commission (CPSC), indicating that there have been at least 464 reports of problems with the high chair. Reports of injuries associated with children falling from defective Graco high chairs have included head injuries, fractures, cuts, bumps and bruises.

The CPSC says that the high chairs have a problem with the screws holding the front legs in place. The screws can loosen and fall out. In addition, the plastic bracket on the rear legs are prone to cracking. Both of these defects can cause the high chair to become unstable and tip over unexpectedly, creating a fall hazard for children.

The recall affects all of Graco’s Harmony High Chairs, which were manufactured between November 2003 and December 2009. The design is no longer in production. A full list of model numbers is available on the CPSC recall announcement website.

The high chairs were sold at major retailers nationwide, including Toys “R” Us, Sears, Target, Burlington Coat Factory, Walmart, AAFES and USA Baby. The high chairs sold for between $70 and $120 and were on sale from December 2003 through March 2010.

The CPSC recommends that anyone who owns one of the recalled high chairs should stop using them immediately and contact Graco for a free repair kit. Consumers can contact Graco at www.gracobaby.com.

The FDA is expanding a previous Cleviprex recall to include additional lots of the hypertension drug, which are now believed to also be contaminated with stainless steel particles. The particles could reduce blood flow and lead to potentially serious injuries when injected.

The Cleviprex recall expansion was announced on March 17 by FDA. The expansion includes four additional lots of the drug, manufactured by The Medicines Company. The original recall, issued December 17, 2009, affected 11 lots of the drug.

The FDA says that the particulate matter contaminating the drug are stainless steel debris about 2.5 microns in diameter. The FDA warns that the particles could possibly reduce blood flow in capillaries, damage some tissues or cause acute allergic and inflammatory reactions. A reduction in blood flow due to the particles could also cause ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

Cleviprex (clevidipine butyrate) is an intravenously-delivered drug used to reduce blood pressure, manufactured by The Medicines Company. The Cleviprex recall was issued after visible particles were found in vials during an annual inspection.

There have been no injuries reported in association with the contaminated Cleviprex vials.

The new lots affected by the recall are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011. The previous 11 recalled lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. The recall is limited to these lots.

Any health care professionals with recalled lots of Cleviprex in their inventory should return the product to the pharmaceutical distributor or wholesaler where it was purchased. The Medicines Company is currently shipping additional batches from unaffected lots to wholesalers.

Any adverse reactions from the use of Cleviprex should be reported to the FDA’s MedWatch Program at www.fda.gov/medwatch.

Defective manufacturing that caused an infant to suffer an air embolism has resulted in the expansion of a Class 1 medical recall for millions of Q-Syte Luer Access devices, which are used to add drug therapies to intravenous systems. 

The FDA notified health care professionals of the Q-Syte Luer Access recall expansion this week. The device, manufactured by Becton, Dickinson and Company (BD) was sold separately and as a part of millions of medical infusion sets. The company notified the FDA that they received reports that a manufacturing problem could cause air to leak into the device, which has led to at least one French infant suffering an air embolism.

The original recall for the Q-Syte Luer Access device affected about 7.8 million units sold with BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. The expanded recall includes dozens more lots and other medical infusion systems that also include the defective Q-Syte Luer devices.

The FDA has classified the action as a Class 1 Medical Device recall, meaning use of the devices could lead to serious injury or death.

The Q-Syte Luer Access is a needleless valve device that is used to add drugs and therapies, like chemotherapy, blood and fluids, to infusion systems that are providing intravenous feeds to patients. The bottom disc of the septum was cut incorrectly on millions of these devices, allowing air to infiltrate the system.

BD announced in a recent press release that the manufacturing problem has been fixed and additional inspection measures have been added to prevent similar problems in the future.

According to the FDA, the defective Q-Syte Luer Access devices could allow air to leak into a patient’s bloodstream and cause an air embolism. The problem can also cause infusion therapy fluids and blood to leak. Complications that could arise from the defective devices include:

• Hypotension
• Hemodynamic instability
• Requirement for additional blood transfusions
• Blood-borne hospital infections
• Serious patient injury or death

The recall has been expanded to include MPC Acacia IV Extension Sets, Medical Action Industries IV start, venous access trays and dialysis kits, Arrow International central venous access kits and sheath introducer kits. A complete list of the lot numbers of affected devices is available at the bottom of the FDA’s recall notice.

The devices were sold worldwide.

The FDA is recommending that health care professionals check the lot numbers on the product packaging to determine if they are using devices affected by the recall. Health care professionals should not use any devices affected by the recall, because the defect cannot be visually detected. If they are unsure whether a device is affected by the recall, they should not use it.

The FDA also recommends that all medical facilities and distributors perform an inventory inspection for the recalled devices, and also suggest patients receiving treatments at home who suspect they are using Q-Syte Luer Access devices immediately contact their home health provider or medical supplies provider.

A New Jersey jury has handed drug maker AstraZeneca a defense verdict in the first trial over claims that side effects of Seroquel, a popular atypical antipsychotic, caused users to develop diabetes. 

The Seroquel diabetes lawsuit was brought by 61-year-old former Vietnam veteran Ted Baker from Louisiana, who claimed that he contracted diabetes from Seroquel after taking it to alleviate his post-traumatic stress disorder. Baker’s lawsuit was the first case to go to trial out of thousands of similar lawsuits against AstraZeneca over the risk of diabetes from Seroquel.

About 26,000 Seroquel lawsuits have been filed in both state and federal court against AstraZeneca. The cases all contain similar allegations that AstraZeneca failed to adequately warn users about the risk of weight gain with Seroquel, which may increase the risk of diabetes, hyperglycemia and other injuries.

Baker’s lawsuit went to trial in New Jersey state court. Following a month-long trial, the jury deliberated for six hours before returning a defense verdict.

The decision was based on the individual circumstances of Baker’s case and does not have any precedential impact on other pending cases. AstraZeneca has indicated that it intends to continue to defend itself at trial in individual lawsuits, adopting a legal strategy of trying to show that each plaintiff either already suffered from diabetes or had a number of risk factors for the disease before taking Seroquel.

All federal Seroquel lawsuits over diabetes are consolidated for pretrial litigation in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida. In November, U.S. District Judge Anne Conway ordered lawyers for both sides to met with a mediator to see if there is any possibility for a Seroquel settlement before as many as 6,000 cases are sent back to the districts where they were originally filed for trial. Dozens of other cases have already been slated for trials, including at least 38 federal cases in the MDL.

In the coming months, trials will start in federal court and state court for lawsuits filed by individuals who allege they suffered jaw damage from Fosamax, with federal trials in New York City scheduled to begin in April and June, and a New Jersey state court trial scheduled to begin in July.

There are an estimated 900 jaw decay Fosamax lawsuits pending against Merck & Co. throughout the United States. The cases all involve similar allegations that the drug maker failed to adequately research their popular osteoporosis medication and warn about the risk of jaw problems from Fosamax. Long-term use of Fosamax has been linked to a rare and painful condition known as osteonecrosis of the jaw, which involves decay or death of the jawbone, often requiring surgery to remove portions of the jaw.

The federal lawsuits over Fosamax jaw problems are consolidated in an MDL, or multidistrict litigation, before U.S District Judge John Keenan in the Southern District of New York in Manhattan. According to an order issued last week, an upcoming Fosamax trial originally scheduled to begin on April 19, has been delayed for one week due to a scheduling conflict. The jury trial, involving claims filed by Louis H. Maley, is now scheduled to begin on April 26.

The Maley case will actually be the second Fosamax jaw decay trial to be presented to a jury, but could be the first in which a final verdict is reached. In the first Fosamax trial, involving a claim filed by Shirley Boles, a mistrial was ordered after the jury was unable to reach a unanimous verdict over whether side effects of Fosamax caused jaw decay suffered by Boles. A retrial of the Boles case has been scheduled to begin on June 2.

Following the two federal trials, the first state court Fosamax trial is set to begin in New Jersey, with a case filed by Alison Rosenberg scheduled for trial to begin in the Atlantic County Superior Court on July 12. Like Maley and Boles, Rosenberg alleges that she developed debilitating jaw damage after taking Fosamax for a number of years to treat her osteoporosis.

These early trials will serve as “bellwether” cases in the Fosamax jaw decay litigation, which are designed to help gauge how juries will respond to expert testimony and evidence that is likely to be similar to what will be presented in other cases. Depending on the outcome of these cases and how the juries value damages in any cases where the plaintiffs are successful, it could lead to widespread Fosamax settlements or other resolution for the litigation.

In addition to the jawbone decay claims, Merck also faces a growing number of lawsuits over Fosamax femur fractures. Although Fosamax is designed to strengthen the bones and reduce the risk of fractures associated with osteoporosis, the drug has been linked to a number of non-impact femur fractures, which is allegedly caused by Fosamax side effects weakening the ability of the bone to repair itself from microdamage.

In December 2009, Judge Keenan remanded at least one fracture Fosamax lawsuit, removing it from the federal MDL and returning it to the court where it was originally filed for seperate litigation. In his ruling, Judge Keenan stated that the evidence of general causation for the jaw decay lawsuits included in the MDL were substantially different from the case involving fractures from Fosamax.

The son of an Illinois woman who died due to a fentanyl overdose has filed a lawsuit against Mylan Laboratories, which manufactures a generic version of the fentanyl pain patch.

The fentanyl patch wrongful death lawsuit was filed in Madison County Circuit Court on March 5 by Jason Pellazari, who claims that his mother, Betty J. Pellazari, died on March 8, 2009, after applying a pain patch the night before. The lawsuit claims that the patch itself was defective, allowing too much of the powerful fentanyl gel to enter her body.

A coroner determined that Betty Pellazari died due to fentanyl toxicity, with excessive fentanyl in her blood. The lawsuit claims she used the patch as directed and was found dead the next morning by her boyfriend.

The Mylan fentanyl patch is a generic version of the Duragesic patch, which is manufactured by a subsidiary of Johnson & Johnson. The pain patch is prescribed to patients suffering from chronic, severe pain. It is designed to slowly deliver a dose of the powerful painkiller Fentanyl, which is an opioid that is considered 100 times more powerful than heroine. If too much of the medication is delivered or if the fentanyl gen contained in the patch comes in direct contact with the skin, it can cause a fatal fentanyl patch overdose.

The fentanyl lawsuit charges Mylan with failure to warn of the risks and negligence in designing and inspecting the patches to make sure they were safe for the public. The lawsuit seeks damages in excess of $400,000 for loss of support and guidance and other costs.

There have been a number of reported problems with fentanyl pain patches due to manufacturing issues since the brand name medication was first introduced by Johnson & Johnson in 1994. At least six different fentanyl patch recalls have been issued by Johnson & Johnson and companies manufacturing generic versions of the patch, raising questions about whether the powerful painkiller can be safely made.

Hundreds of fentanyl pain patch overdose deaths have been associated with different versions of the patch, and dozens of pain patch lawsuits have been filed against the various manufacturers.

Out of the first four fentanyl patch wrongful death lawsuits against Johnson & Johnson to go to trial over problems with their Duragesic patch, plaintiffs have been successful in each case, with juries awarding a combined total of more than $36 million in damages.

A water contamination lawsuit has been filed against Syngenta AG by 16 cities across the Midwest, which claim the company’s weed killer Atrazine, which has been linked to birth defects, has infiltrated drinking water sources. 

The Atrazine lawsuit was filed last week in the U.S. District Court for the Southern District in Illinois. The communities who filed the claim are located in Illinois, Indiana, Iowa, Kansas, Missouri and Ohio. The lawsuit seeks to force the Swiss corporation Syngenta, and it’s U.S. subsidiary, Syngenta Crop Protection, to pay for cleaning the chemical out of the water, according to a story in the Huffington Post.

Atrazine (ethylamine and isopropylamine) is a widely used herbicide, with more than 70 million pounds used in agriculture every year in the U.S. The weed killer has been banned by the European Union due to how easily it contaminates waterways and drinking water supplies. It has also been held in suspicion by critics due to its effects on species such as amphibians, and the growing body of evidence that it causes a variety of birth defects.

The lawsuit alleges that runoff from crop fields sprayed with atrazine contaminated streams and waterways that contribute to a number of communities’ drinking water supplies. To remove the chemical, cities would have to purchase expensive carbon filters, an expense which would be footed by tax payers.

Syngenta officials say that the levels of atrazine in the water are safe.

The lawsuit comes just weeks after a new study was released that linked atrazine to a birth defect known as gastroschisis, an abdominal wall defect which causes some of an infant’s organs, usually intestines, to develop outside of the body. Researchers found that gastrochisis was more common among infants born to mothers who lived within 15.5 miles of a water body that was found to have high levels of atrazine contamination. They also found that the closer the mother lived to the contaminated water source, the more likely the risk of a birth defect, and that the defects were more prevalent among mothers who conceived in the spring, when atrazine use is at its highest.

Syngenta has rejected the findings of the study, saying that atrazine does not cause birth defects or reproductive problems. However, the study is the latest in a series of studies, performed by different groups of researchers, which have linked atrazine to birth defects.

The U.S. Department of Health and Human Services Agency for Toxic Substances and Disease Registry indicates that atrazine at high levels causes birth defects in animals.

A $33.3 million verdict awarded in a wrongful death lawsuit against Walgreens pharmacy over a medication error has been upheld on appeal by a Florida court. 

The pharmacy malpractice lawsuit was filed by the family of Beth Hippely, who died in January 2007. According to a report in The Ledger, Hippely’s family sued Walgreens, alleging that a teenaged pharmacy technician accidentally gave her a blood thinner dosage that was ten times more powerful than she had been prescribed.

The drug, Warfarin, had been prescribed to Hippely since 2002 as part of her breast cancer treatment. The pharmacy error caused her to suffer a cerebral hemorrhage and paralysis before her death.

A Florida jury ruled in the family’s favor at trial for the wrongful death lawsuit in August 2007, awarding the $33.3 million, but Walgreen’s appealed the verdict. Last month, the 2nd District Court of Appeals in Lakeland, Florida affirmed the lower court’s decision and upheld the verdict and the award.

According to a 2006 report by the National Academies of Science’s Institute of Medicine, there are about 1.5 million medication errors every year which result in injuries. These mistakes are largely preventable and could be caused by a doctor prescribing the medication incorrectly, the pharmacy filling the wrong dosage or by nurses dispensing a different patient’s drugs.

The U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for next week to consider whether to consolidate all federal product liability lawsuits filed against Blair LLC, over a chenille robe recall issued by the company last year after at least nine people burned to death.

At a hearing in San Diego on March 25, the panel will consider whether to centralize and consolidate at least four Blair chenille robe fire lawsuits that have been filed so far for pretrial litigation. If an MDL is formed, the cases will be assigned to one judge for coordinated management to avoid duplicate discovery, inconsistent rulings from different judges and to serve the convenience of the court, parties and witnesses. At the hearing, plaintiffs and defendants in the claims will have a chance to submit oral arguments for or against the centralization.

The Blair chenille robe recall was originally issued in April 2009 for 162,000 robes after the company received three reports of the garmets catching fire, leading to injuries. In June, after receiving six more reports of Blair robe deaths, the company and federal regulators issued another warning that the robes had been recalled. The robe recall was expanded in October to include an additional 138,000 women’s chenille full-length robes, women’s chenille jackets, women’s chenille lounge jackets and women’s chenille tops after the company continued to receive reports of robe fires and deaths. In most cases, the victims were elderly women who were cooking at the time of the fire.

The cases under consideration for consolidation include wrongful death lawsuits brought by Harold A. Ledbetter, Michelle Putini and Sharon Davis, who all represent the estates of people who died allegedly due to Blair robe fires. Another lawsuit was filed by Agnes Wise, who says she suffered severe injuries due to a Blair robe fire. All of the lawsuits include claims that the robes violated the Federal Flammable Fabric Act, and charge the manufacturer with negligence and product liability.

The clothing, made in Pakistan by A-One Textile & Towel, and was distributed by Blair through Blair Catalogs, online and from the company’s stores in Pennsylvania and Delaware. The U.S. Consumer Product Safety Commission (CPSC) has said that the clothing did not meet federal flammability standards.

The request to consolidate the lawsuits came from Blair, LLC and Orchard Brands Corp., Blair’s parent company. The companies are seeking to have the lawsuits consolidated in the U.S. District Court for the Middle District of Alabama.

A class action lawsuit has been filed in Canada by three women from British Columbia who say that Pfizer did not give enough warning about the suicidal tendencies caused by the smoking cessation drug Champix, which is sold as Chantix in the United States.

The Chantix class action lawsuit was filed in British Columbia Supreme Court last month. The plaintiffs, Patricia Clow, Nicole McIvor and Alicia Pickering, say that Pfizer was required to give patients and doctors more warning regarding the severity of the psychological side effects of the stop-smoking drug.

Clow alleges that her 22-year old daughter committed suicide in October after taking Champix/Chantix. McIvor claims that the drug caused her to become so suicidal that she tried to ram her car into an oncoming logging truck. Pickering says she became so depressed and suicidal while taking the drug that she required hospitalization.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric problems, which have resulted in fatal or catastrophic injuries for many users.

The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.

In October 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal lawsuits over Chantix in the United States. Dozens of similar cases are centralized in the U.S. District Court for the Northern District of Alabama, and Chantix lawyers are continuing to investigate hundreds of other potential cases that are expected to be filed in the coming months.

The Canadian Chantix class action suit claims that Pfizer put profits ahead of public safety. Under Canadian law, if the plaintiffs prove Pfizer was negligent, participants in the class action could be awarded Pfizer’s Canadian profits from the drug, which has been prescribed to 1.5 million Canadians since 2007.

Proctor & Gamble has recently added a information to their denture cream website about the potential risk of problems from zinc in Fixodent, advising users to apply as little of the adhesive as possible. However, the company has given no indication that they will issue a Fixodent recall or reformulate their products to remove zinc, as GlaxoSmithKline recently did with their Super Poligrip denture creams.

The warning follows months of scrutiny and calls for the two manufacturers to take action to address the side effects of zinc in Fixodent and Super Poligrip denture cream. For years the products were sold with no warnings or even indication that they contained zinc.

When the products are used over a long period of time, or if too much of the denture cream is applied, high levels of zinc can enter the body. This can deplete copper levels and lead to the development of neuropathy and other neurological injuries.

A number of Fixodent lawsuits and Super Poligrip lawsuits have been filed against Proctor & Gamble and GlaxoSmithKline, alleging that users suffered permanent and disabling problems as a result of the manufacturers’ failure to warn that their denture cream products contained zinc and that use of adhesives could cause zinc poisoning.

In October 2009, GlaxoSmithKline finally added a zinc warning to Super Poligrip, indicating that use of excessive amounts of the adhesive could cause “serious health effects” and last month the company indicated it would discontinue Super Poligrip with zinc in the United States due to the risk of zinc poisoning.

Although the same risk of zinc problems with Fixodent exist, Proctor & Gamble has resisted placing any warnings on their product, claiming that Fixodent does not have as much zinc as Super Poligrip and is safe for use. However, according to a report by NewsInferno.com, new information was added in recent days to Proctor & Gamble’s Fixodent website, DentureLiving.com, warning that zinc is contained in the product and highlighting usage instructions.

The new Fixodent warning reads: “CAUTION: Contains zinc (less than 4%). Some reports suggest that excessive and prolonged zinc intake may be linked to adverse health effects.” The warning recommends that Fixodent be used as directed and that consumers should consult with their doctors if they are using other zinc-based products. It is unclear whether a similar warning and usage instructions will added to Fixodent products themselves.

A new study has found that patients who received drug-coated stents after suffering a heart attack were more likely to die from a heart-related problem than those who received bare metal coronary stents. 

The results of the study, performed by Danish researchers at the behest of coronary stent manufacturers, were revealed at a recent conference held by the American College of Cardiology in Atlanta, according to a story by Reuters. The study’s findings come as drug-coated stents have taken a 77% share of the stent market, eclipsing bare metal stent use in just seven years since the drug-coated stents were first released, but down from a 90% high in 2006.

Coronary stents are wire mesh tubes inserted into previously clogged arteries to prevent them from closing again and possibly causing the recipient to suffer a heart attack or other coronary problems. The drug-coated stents, also known as drug eluting stents, are covered in medication meant to prevent the formation of scar tissue that may clog the stent. However, shortly after they were introduced seven years ago, studies began to show that drug-coated stents carried their own risks.

Studies have identified heart attack, reclogging of arteries and death as potential side effects of drug-covered stents. While it was originally believed that patients would only need to be on blood thinners for three months after receiving a medicated stent, in reality patients often required to take powerful blood thinners, like Plavix, for much longer, which exposes them to other risks and complications associated with those medications.

The most recent study, which has not yet been published, examined the effectiveness and risk of bare metal and drug-coated stents implanted shortly after a heart attack. Researchers found that drug-coated stent recipients were more likely to die from heart problems than patients who received bare metal stents. However, bare metal stent recipients tended to appear to have more non-lethal problems, such as requiring blockages to be alleviated.

Scientists involved in the study said that more research was needed to truly understand the long-term effects and side effects of drug eluting stents.

The results could be of particular concern given two studies published 2007 in the Journal of the American Medical Association (JAMA), which found that more than half of all drug-coated stents are used for “off-label” reasons which have not been approved by the FDA. In at least half the cases studied, researchers found that patients had at least one condition that should have disqualified them from receiving a heart stent.

Some experts have also questioned the widespread popularity of stent placements, indicating that many patients may be able to treat their conditions with medication or diet. In Maryland, a well-known cardiac center has come under fire for implanting hundreds of unnecessary stents. St. Joseph Medical Center in Towson has notified 538 former patients of Dr. Mark Midei that a subsequent review of their records indicates that a heart stent may not have been needed to treat their blockage.

Stent procedures cost $10,000 or more each. Midei was stripped of his position at the hospital last summer and the hospital is still reviewing his records and anticipates more patients will have to be informed about the unnecessary surgeries.

A recall is being issued for approximately 412,000 Honda Odyssey minivans and Honda Element sport utility vehicles (SUVs) due to brake problems that have caused a number of crashes. 

The Honda brake recall was announced on Tuesday by American Honda Motor Co., Inc. after the Japanese automaker received complaints that the brakes in certain 2007-2008 model year vehicles felt “soft” and lost effectiveness over time.

Defective manufacturing allows air to slowly enter into the Vehicle Stability Assist (VSA) modulator, which is part of the brake systems of the recalled vehicles, Honda said. This results in the brakes not engaging until the pedal is pushed closer to the floor than usual, and the Honda brake problems may worsen over time.

The Honda recall comes about a month after the company was forced to expand an airbag recall that now encompasses more than 826,000 2001 and 2002 model year Honda vehicles. The Honda airbag problems can result in the airbags exploding, sending deadly shrapnel into the passenger compartment. At least one person has been killed and several others injured by defective Honda airbags.

Honda said it has received reports of several crashes and at least three minor injuries as a result of the Element and Odyssey brake problems, but no serious personal injury or deaths have been attributed to the problem.

The company says that the defect does not affect all of the recalled vehicles, however the company decided to recall all of them “to assure all customers that their vehicles will perform correctly,” the Japanese automaker said in its statement. Recall notifications will be mailed to registered Honda owners at the end of April, the company has announced.

Photo Courtesy of: http://www.flickr.com/photos/hectoralejandro/ / CC BY 2.0

About 700,000 remote control kits for electric fire places and stoves, manufactured by Dimplex North America, have been recalled due to a risk of overheating problems that may cause a fire or burn hazards. At least one house fire has been linked to problems with the electric fireplace and stove remote controls. 

The stove and fireplace remote control recall was announced on March 16 by the U.S. Consumer Product Safety Commission (CPSC), which said that the plug-in wall units for the remote controls can overheat, leading to potential fire and burn hazards for consumers. The recall comes after Dimplex North America, based in Ontario, Canada, received about 5,000 reports that the wall units had overheated.

In at least 19 cases, defective remote control kits caused damage, and one incident led to a house fire in Columbus, Ohio which the CPSC says resulted in “considerable property damage.” There were no reports of injuries or deaths connected to the remote controls.

The recall affects remote control kits used with electric fireplaces, stoves and fireplace inserts sold under the Dimplex, Electraflame, Symphony, Optiflame, Electralog and Charmglow labels. The model numbers of the recalled remote control kits are 47-1001, 47-1010-R and APT-1315. The remote controls are black or dark gray and come with a hand held unit and a wall unit that plugs into an electrical socket. The model number is printed on either the remote control or the wall unit, and the brand name of the fireplace or stove is printed on both.

The remote control kits were sold with the fire places and stoves at home improvement, mass merchandise, and specialty fireplace and furniture stores nationwide from January 1998 through December 2008 for between $200 and $1,500.

The CPSC recommends that users immediately stop using the remote control kits and completely unplug the power cord and wall unit. Consumers can contact Dimplex for a free repair kit at www.recall.dimplex.com. The fireplaces and stoves can continue to be used by plugging them directly into an electrical outlet.

A new study links a high rate of lead poisoning in some children to Indian spices and ceremonial powders, which contained a higher than expected amount of lead. 

The study, published Monday in the medical journal Pediatrics, found that several reports of lead poisoning among Indian children in the Boston area were linked to Indian spices used in traditional dishes and ceremonies. The spices, such as cardamom, fenugreek and chili powder contained high amounts of lead.

The researchers, from Children’s Hospital Boston and the Harvard School of Public Health, tested nearly 160 different cultural powders, spices and food products and found that most of the products tested contained more than 1 microgram per milliliter (1 µg/mL). The FDA has an enforceable action level of .5 micrograms of lead per milliliter in food. Some products, such as sindoor, Sindav salt and one type sindaloo powder, were found to contain many times that amount.

Researchers say that even when the levels are not dangerous, but still high, the products can add to the overall amount of lead exposure, cumulatively causing elevated blood lead levels in children. The effect could be especially exacerbated when multiple powders are used frequently in one household for a variety of uses.

Blood lead levels traditionally considered to be lead poisoning can result in nervous system injury, brain damage, seizures or convulsions, growth or mental retardation, coma and even death. Most cases of elevated lead blood levels in children are caused by exposure to lead paint, which is still present in many older homes throughout the United States. If the paint flakes off the wall, young children could ingest the paint chips or breathe in the dust, causing elevated levels of lead in the blood.

Recent studies have also found that lead exposure could be a leading cause of attention-deficit hyperactivity disorder (ADHD), can cause depression and panic disoders in young adults, and have also suggested that even low levels of lead exposure can cause kidney damage in children.

A Florida woman whose daughter was found strangled to death in a defective drop side crib manufactured by Simplicity, Inc., has reached a wrongful death lawsuit settlement with Walmart and the now defunct crib maker.

The September 2007 death of Constance Bergey’s 2-year-old daughter, Serenity, was one of the factors in a series of nationwide Simplicity drop side crib recalls spanning 2006 through 2009. One of those Simplicity recalls, affecting one million cribs, was issued just two days after Serenity’s death.

Defective Simplicity cribs have been linked to at least 11 infant deaths, including the death of a seven-month-old baby from Kentucky as recently as September 2009.

The Simplicity drop side crib deaths, which kept occurring after federal regulators recalled the cribs, and after the company went out of business, have led the U.S. Consumer Product Safety Commission (CPSC) to issue new child furniture safety rules that require manufacturers of cribs, high chairs, gates, strollers and other infant and toddler furniture to provide registration cards with each product and maintain a list of registered consumers. The registration would be used to alert as many consumers as possible if there is a product recall.

The settlement was approved on March 3 between Bergey, Walmart and Simplicity, but the details were kept confidential.

More than 2 million Simplicity drop side cribs have been recalled in recent years due to the failure of the crib’s plastic hardware, which can cause the drop side to detach or separate from the crib. The Simplicity recalls were issued in December 2005, June 2007, September 2007, September 2008 and July 2009.

Simplicity Inc. went out of business in 2008 in the wake of the crib recalls and infant deaths. Many of the major retailers who sold Simplicity products, such as Toys “R” Us, Wal-Mart, Target, J.C. Penny and Kmart have agreed to accept returns.

Bergey’s lawsuit, which was originally scheduled to go to trial in February, is one of several baby crib lawsuits that have been filed against both Simplicity and major retailers, such as Wal-Mart, in connection with Simplicity drop side crib deaths. In addition, a number of major retailers and manufacturers have stopped selling drop side cribs due to repeated problems with drop side cribs.

The settlement in the Bergey lawsuit was reached just after the Palm Beach County Sheriff’s Office reopened an investigation into Serenity’s death, after originally wanting to charge Bergey with manslaughter in 2008. Originally, detectives and Florida child welfare officials said that Serenity was kept in filthy conditions in a home with a history of drug use, and were concerned that her body showed signs of being dead far longer than the family reported. However, prosecutors declined to press charges against Bergey at the time.

Boston Scientific has been forced to recall several models of implantable heart defibrillators after failing to notify the FDA that it made changes to the devices’ designs. 

The company announced that it was stopping shipment and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in a press release on March 15. The company said that it decided to pull the devices from the market after realizing that some changes in how the devices were manufactured were not submitted to FDA for approval, as required by federal law. The FDA has classified the action as a medical device recall.

The implants are used to monitor patients’ hearts for abnormal heart rhythms and then deliver electric shocks to keep the heart beating at the proper rhythm.

Boston Scientific says that it does not believe there is any safety concern for people who have had the devices implanted, and have classified the defibrillator recall as a filing error. However, analysts say that the recall of the defibrillators, which account for 15% of the company’s revenue, could cost $5 million per day until the manufacturing processes are approved.

The recall comes less than a month after the Department of Justice filed criminal charges against Guidant LLC, a Boston Scientific subsidiary, for allegedly hiding information regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs that, in some cases, resulted in death. Boston Scientific announced last November that it intends to pay $296 million in connection with the charges against Guidant. The DOJ says it expects that Boston Scientific is likely to enter a guilty plea in connection with the charges.

The criminal charges are related to earlier defibrillator manufacturing changes that prosecutors say were done to cover up deaths from defective defibrillator designs. The DOJ charges say that Guidant failed to inform the FDA of the changes in order to avoid scrutiny. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

The FDA determined that the warnings constituted Class 1 medical device recalls, the most serious category of recalls, which indicate that a product has the probability of causing serious injury or death.

The Prizm series, which was included in the criminal investigation, is also one of the units affected by the latest recall for unapproved manufacturing changes. Other defibrillator lines affected by the recall include the Cognis, Confient, Livian, Renewal, Teligen and Vitality ICDs and CRT-Ds.

Boston Scientific says it plans to work closely with FDA to get the manufacturing changes approved and quickly make the defibrillators available on the market again.

A lawsuit has been in filed in Indiana by the parents of a 10-year-old girl who died after receiving injections of Botox to treat cerebral palsy, which has been linked to a number of deaths and serious adverse reactions throughout the United States. 

The Botox wrongful death lawsuit was filed against Allergan, Inc., the makers of Botox, by Brandon and Jill Wells, whose daughter, Audrey, died in 2008. Also included in the lawsuit are doctors from the Riley Hospital for Children, who treated Audrey with the Botox injections to help reduce muscle spasticity associated with cerebral palsy, even though the medication is not approved by the FDA for that use.

Audrey died just days after receiving Botox, which contains small quantities of the toxin associated with the muscle paralyzing condition Botulism, when the medication spread from the injection site and caused breathing difficulties. According to a story in the South Bend Tribune, the family alleges that neither the doctors or drug makers warned them about the potentially life-threatening side effects of Botox.

Botox is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label at high doses to treat stiff and jerky movements associated with cerebral palsy in children.

A number of adverse event reports have been associated with side effects of Botox, where the medication spreads from the area of the injection to other parts of the body. These Botox problems have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.

Under Indiana state law, the Wellses first had to file a medical malpractice claim with the Indiana Department of Insurance (IDI). A panel of medical experts will review the case to see if it has merit. If they approve, it will move on to state or federal court.

Earlier this month, Allergan won a similar Botox lawsuit filed in California by Dee Spears, the mother of 7 year-old Kristen Spears, who also died after receiving Botox for cerebral palsy. The jury found that the girl died of cerebral palsy complications, not Botox complications.

In February 2008, the FDA issued a warning about the risks associated with use of Botox to treat cerebral palsy, after receiving a number of adverse event reports involving sudden death, breathing problems and other potentially life-threatening injuries. A “black box” Botox warning was added to the medication in August 2009, warning about the risk of botulism-like side effects, such as swallowing and breathing difficulties, that can occur if the injection spreads to other areas of the body.

More than a dozen people have filed lawsuits over Botox against Allergan, alleging that the company illegally promoted the medication for non-approved uses and failed to adequately warn about the risk of these severe and potentially life-threatening Botox injuries.

The FDA has denied approval for a once-weekly version of Eli Lilly’s and Amylin Pharmaceuticals’ diabetes drug Byetta, saying that the agency needs answers to certain questions about the drug makers’ manufacturing processes and how it intends to mitigate Byetta health risks to users. 

Amylin announced the FDA’s rejection of their new Byetta formulation on Monday. The proposed drug, Bydureon, would allow users to take one dose a week to regulate their diabetes, as opposed to Byetta, which is a twice-daily injection. Bydureon has also been commonly referred to as Byetta LAR.

While the FDA has not asked for lengthy additional clinical trials, which would delay release of the drug significantly, Amylin officials say the agency sent the company a letter indicating that they need to provide finalized information for what will be on the new drug’s label, a risk evaluation and mitigation strategy (REMS) for reducing the health risks to users, and clarification on the manufacturing processes for the medication.

Last week the FDA released an inspection report about problems at the Byetta manufacturing plant in Ohio, which cited a number of quality control and staff training issues. Among problems found at the plant, FDA inspectors said that raw materials used to make Byetta were not properly inspected coming into the plant, and workers in a variety of positions have not been properly trained to ensure quality control.

Byetta (exenatide) is a type 2 diabetes drug that is manufactured and distributed jointly by Amylin and Eli Lilly & Co. The drug is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels.

In November, the FDA issued a warning indicating that they had received at least 78 post-marketing reports which raised concerns about Byetta kidney problems, with 62 of those reports involving users experiencing kidney failure. The alert followed FDA warnings issued in October 2007 and August 2008 of reports involving cases of pancreatitis with Byetta, including severe reports of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.

In cases where a drug that is deemed important to patients also causes serious health problems, the FDA can require a REMS report that details how the drug maker intends to provide the drug in a way that reduces risk to patients as much as possible.

Amylin and Eli Lilly also currently face a number of Byetta lawsuits involving allegations that the drug makers failed to adequately warn about the risk of pancreatitis and kidney failure.

European scientists say that a number of children’s fruit juice drinks contain more than twice the amount of a potentially fatal carcinogen than is usually found in tap water.

Researchers from the University of Copenhagen found that bottles of fruit juice contained up to 2.5 more antimony, a cancer-causing substance, than is considered safe in tap water. The team, which did not name any brand name products, had their findings published by the Royal Society of Chemistry late last month.

Scientists who participated in the study said that there needs to be an immediate investigation into the health effects of antimony in fruit juice, according to a story published in the U.K.’s Daily Mail. The researchers say the findings raise concerns that the health of millions of children could be adversely affected by the chemical.

It is unclear whether any of the juices examined, which included flavors like blackcurrant and strawberry squash, are sold domestically in the U.S.

Antimony is a heavy metal often used as a flame retardant. It is also used to make polyethylene terephthalate (PET) bottles used by many bottled water companies. It is toxic, and can cause dizziness, depression and headaches at low levels. Prolonged exposure can result in lung and heart problems, as well as ulcers and diarrhea. At high levels, it can cause violent, severe vomiting and death.

Researchers who took part in the study say that the antimony is likely leaching into the juices from plastic bottles. Some speculate that the citric acid in the juices could accelerate the leaching process.