Massachusetts Injury Lawyer Blog

After years of close monitoring and label changes for Multaq, the Food and Drug Administration (FDA) has issued a new warning that the heart drug places some patients at an increased risk for serious cardiac events including death.

Multaq is used to treat various conditions, including patients with permanent Atrial Fibrillation (permanent AF). This is the most serious form of AF, which is an abnormal heart rhythm. The two other types are paroxysmal AF and persistent AF.

Permanent AF is a chronic condition in which sinus rhythm cannot be sustained despite treatment.

The FDA issued its Dec. 19, 2011 safety notification based on its monitoring of a 10-year study. In the communication, the FDA stated Multaq doubles the rate of cardiovascular death, stroke and heart failure in patients with permanent AF. The FDA advised healthcare professionals to:

• Not prescribe Mutlaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF).
• Monitor heart rhythm by electrocardiogram at least once every three months.
• If the patient is in permanent AF, Multaq should be stopped or the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF.
• Patients prescribed Multaq should receive antithrombatic therapy.

The study the FDA acted on was called called the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS). The study was stopped early in July 2011. The FDA said it will release more information as it becomes available.

Multaq Background
Dronedarone is the generic name for Multaq. It was approved by the FDA in 2009 to treat several conditions, including permanent AF. Manufactured by Sanof-Aventis, the drug has been prescribed to 500,000 people around the world.

Since 2009, Multaq has been subject to several FDA actions, including in 2010 a revised warning noting cases of worsening heart failure in some patients. In February 2011, the FDA changed the warning label to state that Multaq should be discontinued if liver damage is suspected.

Related Blogs and Websites

• Actos: FDA Warning About Bladder Cancer
• DePuy Hip Recall: Insurers Seek to Collect Settlements
• Transvaginal Mesh: What to Know If You've Been Injured

Continue reading "Multaq Heart Drug Warning from FDA" »

Hundreds of thousands of diabetes patients have been re-considering their medication plans after a recent warning from the Food and Drug Administration (FDA).

On June 15, 2011, the FDA issued a safety communication reporting that use of the oral diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.

The FDA warned that patients with active bladder cancer should not be taking pioglitazone and those with a prior history should only use it after considering the potential medical benefits against the risk for cancer recurrence.

Actos is an oral drug used to treat type II diabetes, the most common form of the illness that plagues 25.8 million Americans. Actos is manufactured by Takeda Pharmaceutical Company and co-marketed by Eli Lilly and Company. It is one of the most widely used medications on the market. Over 2 million patients filled prescriptions for it in 2010.

The communication came as the FDA placed restrictions on Avandia, another popular medication, after studies showed it increased the risk of heart attacks. Both drugs belong to the thiazolidinedione class of drugs.

The warning about Actos came as the FDA made a periodic review of an ongoing 10-year Actos study into the risk for developing bladder cancer. The study reports there may be a 40 percent greater risk for developing bladder cancer among those who take Actos for more than a year.

The FDA's warning came a new epidemiological study out of France suggested an increased risk of bladder cancer with pioglitazone use. As a result, France has suspended use of Actos and Germany has recommended new patients not be placed on the drug.

On August 4, 2011, the FDA reported it had approved new label and medication instructions for Actos. The FDA is continuing to monitor the results of Actos cancer studies.

Patients taking Actos should contact their doctors if they experience any sign of blood in the urine or a red color in the urine or other urinary pain, as these Actos complications may be signs of bladder cancer.

Click here to read the June 15, 2011 FDA Safety Communication on Actos.

Continue reading "Actos Warning From FDA" »

Medical insurance companies are alerting patients who have defective all-metal hip implants that they will seek to recover expenses from any settlement money which patients receive. Medicare is also expected to try and recover its costs.

Thousands of patients have been affected by recent recalls of all-metal hip implants and are expected to seek compensation from manufacturers. Although insurance companies, by statute or contract, often have the right to recover some of their costs, it is unusual for companies to be so assertive for medical device failures. The aggressive actions being taken by the insurers reflect their awareness of just how expensive these defective products are becoming.

In August 2010, DePuy recalled the ASR XL Acetabular System. The hip implant is defective because it causes friction between the metallic ball and socket components, which are implanted to replace the femur and acetabulum.

The recalled DePuy hip implants can wear down and produce a substantial amount of metallic particles in patients' bloodstreams. Patients reported signs of metallosis, including pain, swelling, problems walking and rashes. Other serious problems may include bone fractures, joint inflammation, hip dislocation and damage to the tissue, hip implant loosening, nerves and muscles near the implant.

DePuy recalled the defective hip implants after the Food and Drug Administration (FDA) received about 400 complaints in two years from patients. That number has grown significantly following the recall. In just the first six months of 2011, the FDA received more than 5,000 reports about problems with all-metal hip implants, according to an analysis by The New York Times. DePuy hip implants accounted for 75 percent of the complaints.

It is still unclear how many patients have been affected by defective metal hip implants. The New York Times reports one estimate that 500,000 patients have received an all-metal replacement hip.

The newspaper reports another estimate that 250,000 hip replacements are performed in the United States each year. Until recently all-metal hip implants accounted for nearly one-third of these procedures.

As of October 2011, 3,500 patients filed lawsuits against DePuy in connection with last year's recall. DePuy also faces over 560 lawsuits in connection with the Pinnacle, another defective all-metal hip implant.

More lawsuits are expected against DePuy and other manufacturers as patients start experiencing pain and requiring corrective surgery. This procedure can be painful, require substantial post-operation bed rest and treatment and cost hundreds of thousands of dollars.

Click here to read more about all-metal hip implants in the New York Times.

Continue reading "DePuy Hip Implant Recall Leads Insurers to Seek Recovery" »

Walmart pulled Enfamil baby formula from more than 3,000 stores this week after a newborn's death in Missouri.

Walmart voluntarily removed the cans of Enfamil Newborn from its store shelves on Monday night. The baby formula is under investigation by health officials after the 10-day-old baby boy's death Sunday from Cronobacter, a bacteria linked to newborn illness and milk-based powder baby formula. The formula had been used by the baby's family. A second infant was infected by the bacteria, but recovered.

The 12.5-ounce cans of Enfamil Newborn are marked with the lot number ZPIK7G. This includes at the chain's 35 stores, 12 super centers and 2 Sam's Club locations in Massachusetts.

The formula has been sent for testing to the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). In the meantime, the Missouri Department of Heath and Senior Services is urging consumers who purchased the formula to return it to the store or discard it.

The manufacturer Mead Johnson said that the batch of infant formula used by the child's family tested negative for Cronobacter when it was produced and packaged.

Mead Johnson and Walmart representatives say the companies are working with authorities. Neither of the companies has implemented a formal product recall. The government has not requested one.

Click here to read a recent news article about this product liability case.

Continue reading "Infant's Death Prompts Walmart To Remove Baby Formula" »

Consumers are advised to stop using a second type of CooperVision's Avaira contact lenses due to a defect that may result in blurry vision and other eye injuries.

On Nov. 16, an unknown quantity of CooperVision Avaira (enfilcon A) Sphere contact lenses were recalled due to the unintended presence of a silicone oil residue.

CooperVision, a Fairport, NY-company, recalled the lenses in cooperation with the Food and Drug Administration (FDA), which states that the silicone oil residue can result in a wide range of symptoms, including eye discomfort, hazy and blurry vision and eye injuries requiring medical treatment. The FDA regulates contact lenses as a medical device.

The recalled lenses were manufactured from Feb. 1, 2011 to Aug. 24, 2011 and distributed from March 2, 2011 to Nov. 15, 2011.

The contact lenses were used to correct myopia and hyperopia and non-aphakic individuals with non-diseased eyes. The lenses may be worn by individuals who have astigmatism of 2.00 diopters or less that do not interfere with visual acuity.

Lens wearers have been instructed to stop using the lenses immediately and contact their eye care professional. They can visit the CooperVision recall website and enter the defective medical device package numbers to determine if their lenses have been recalled.

The medical device recall expanded another in August 2011 for limited lots of Avaira Toric contact lenses. CooperVision said the product defect on that line has been corrected through its quality system process.

Contact lens injuries are prevalent, due to product defect or improper use. They are most common among children and adolescents. In a study published in the July 2010 Pediatrics, FDA researchers reported 23 percent of total medical device injuries in 2004 and 2005 in the U.S. involved children and contact lenses. Children ages 11 and over were the most affected.

Common personal injuries include corneal contusions and abrasions, hemorrhage and conjunctivitis.

Click to read the FDA notice about the CooperVision recall.

Continue reading "Medical Device Recall for CooperVision Contact Lenses" »

As the Christmas season begins, one Massachusetts company remains bogged down in Thanksgiving, after issuing a recall for its popular dried cranberry snacks.

The day after Thanksgiving, Ocean Spray of Middleboro issued a recall for four package sizes of its Original Flavor Craisins Dried Cranberries product. The company voluntarily recalled the snack because of the possibility packages contained small hair-like metal fragments. The metal fragments resulted from an equipment malfunction on a production line, a company official told Vitals, an MSNBC.com blog.

Ocean Spray said it has received no consumer complaints or injury reports. Dried cranberry snacks are a growing product line for Ocean Spray. Last summer, a company official told the New England Business Bulletin that it was planning to expand its Middleboro facility and produce a third dried cranberry product.

The following Ocean Spray Original Flavor Craisins Dried Cranberries are part of this product recall:

• 5 oz Craisins® UPC: 00293-000
• 10 oz Craisins® UPC: 29456-000 and 29464-000
• 48 oz Craisins® UPC: 00678-318
• 10 lb bulk ingredient & foodservice UPC: 03477-000

Consumers who have purchased the recalled products are advised to discard them and preserve the UPC label and best by date. They should contact the Ocean Spray Consumer Hotline at 1-800-662-3263 for a coupon replacement.

Continue reading "Food Recall for Ocean Spray Dried Cranberries" »

For a quarter century, the U.S. PIRG Education Fund (U.S. PIRG) has educated the public about toy safety for the holiday shopping season.

This year, U.S. PIRG's "Trouble In Toyland: The 26th Annual Survey of Toy Safety," warns consumers about over a dozen potentially dangerous toys, including those with dangerous levels of lead, phthalates and cadmium. Other warnings were issued for toys posing choking and strangulation hazards as well as those that create an excessively loud noise. The Boston product liability lawyers at Breakstone, White & Gluck urge you to glance at the report's findings before you do your holiday shopping:

Toys With Dangerous Lead Limits. Lead has been banned in paint, children's products and cookware in the United States since 1978, but it remains a problem in toys which are imported from other countries. Between October 2010 and November 2011, nearly 200,000 toys were recalled because of excessive lead limits, U.S. PIRG reported.

This year's U.S. PIRG review found two toys on the market with lead levels which exceed the current 300 ppm standard, one toy that exceeded the prospective 100 ppm standard and four toys that exceeded the American Academy of Pediatrics recommendation of 40 ppm. This is the limit supported by U.S. PIRG.

Phthalates in Toys. Exposure to phthalates has been linked to have adverse health effects for children in the womb, including premature delivery and reproductive defects. U.S. PIRG identified two toys with limits exceeding the amount allowed by the Consumer Product Safety Improvement Act of 2008. The two toys include the Funny Glasses, manufactured by Joking Around, and the Sleep Mask, manufactured by Claire's. Both exceed the 1000 ppm of banned phthalate standard.

Cadmium. Cadmium is a frequent additive in children's jewelry. In response to a legal action in September, retailers agreed to sell only products that have less than 300 ppm cadmium. U.S. PIRG found no cases of noncompliance, but urged the Consumer Product Safety Commission to proceed with setting limits for cadmium in children and toy jewelry.

Choking Hazard. Choking on toys with small parts is the leading cause of toy-related deaths and injuries. Between 1990 and 2010, over 200 children in the United States died from choking.

Toy makers face complex regulations for testing and labeling their products. U.S. PIRG found several violations, including toys with no warning labels indicating they included small parts. The group called on the Consumer Product Safety Commission to take actions such as enlarging the small parts test tube size.

Loud Toys. U.S. PIRG reported several toys on the market exceed the ASTM 2003 standards for sound-producing toys, including Elmo's World, Talking Cell Phone, manufactured by Fisher-Price; Victorious Stereo Headphones, manufactured by Nickelodeon; and Hotwheels, Super Stunt RAT BOMB, manufactured by Hotwheels.

Our recommendations:

• Shop wisely. If you have small children in the house, avoid toys for your older children which might represent choking hazards for your younger children.


• Avoid products which are obviously intended to generate loud noises or which may have headphones that cannot be turned down.


• Common sense says look for toys that have been on the market for more than a year because they are more likely to have been tested and proven safe.


• Buy toys that will promote physical activities to help your children stay strong and healthy.

To read the full U.S. PIRG "Trouble In Toyland: The 26th Annual Survey of Toy Safety," click here.

Continue reading "Dangerous Toy Report Details Lead, Choking Hazards" »

As the holidays approach, the lawyers at Breakstone, White & Gluck, PC urge you to shop carefully to avoid dangerous toys.

Each year, companies recall thousands of toys that put children at risk for injuries such as strangulation, lacerations, falls and death. According to the Consumer Product Safety Commission, the 34 toy recalls in fiscal 2011 were a marked decrease from 172 in 2008, but toy-related deaths rose slightly last year, with 17 children suffering wrongful deaths from defective toys.

In 2010, about 181,500 children were treated in emergency rooms for toy-related injuries. Non-motorized scooters continue to cause the most injuries, while toys with small parts and unsafe cords are also involved in many recalls.

Each year, a non-profit Boston organization, World Against Toys Causing Harm Inc., (WATCH) releases a list warning parents about the hazards of certain toys. The toys present hazards for burn injuries, strangulation injuries, and other bodily injury. This year's "WATCH's Most Dangerous Toys of 2011," includes:

1) The Incredible Shrinky Dinks Maker
Potential hazard: Possible electric shock and burn injuries.

2) Sword Fighting Jack Sparrow
Potential Hazard: Possible eye and other bodily injuries.

3) 'Gigan' Godzilla Figure
Potential hazard: Possible puncture wounds.

4) Twist 'n Sort
Potential hazard: Small parts cause a choking hazard.

5) Power Rangers Samurai Mega Blade
Potential hazard: Blade can cause injuries.

6) Fold and Go Trampoline
Potential hazard: Can cause injuries to people using it, including to the head and neck.

7) Pulling Animal Duck
Potential hazard: Potential for strangulation injuries.

8) School Bus
Potential hazard: Choking hazard.

9) Z-Curve Bow
Potential hazard: Danger to eyes.

10) Stepper 'Low Rise" Stilts
Potential hazard: Head and other injuries from impact.

Click here to read more about this year's WATCH list.

Related Entries

• Avoid Dangerous and Defective Toys During the Holiday Season, Dec. 4, 2008.
• Don't Buy Your Children These Toys This Holiday, Nov. 19, 2010.

Continue reading "Defective Products: The 10 Most Dangerous Toys of 2011 " »

A defective crankshaft pulley is driving a new Toyota recall that will affect thousands of car owners. The Nov. 8 recall of 550,000 vehicles includes 420,000 cars in the United States. Toyota has now issued recalls for more than 13 million vehicles nationwide since September 2009. More vehicles have been recalled in other countries.

Toyota recalled the vehicles due to a crankshaft pulley defect that may cause steering problems. The vehicles have V6 engines and the U.S. models include 283,200 Toyota brand cars like Camry and Highlander vehicles and 137,000 Lexus vehicles.

Toyota said no injuries have been reported. The car manufacturer said the crankshaft pulley may have an inadequate amount of adhesive agent between the outer ring and the inner ring. This can cause the crankshaft pulley to become misaligned with the inner ring, possibly causing a noise or warning signal to light. When this happens, the belt for the power steering pump can detach from the pulley, making it hard for drivers to steer.

Toyota recalled 8 million vehicles between Nov. 2009 and the first quarter of 2010, most for defective pedals. In April 2010, the United States government fined the world's largest automaker a record $16 million for its delayed response in notifying the National Highway Traffic Safety Administration regarding the defects.

Recalls have continued through 2011, including last February's recall of 2.17 million vehicles to repair mechanical defects that could cause the cars to accelerate out of control.

The Nov. 8 recall involves these defective motor vehicles: the 2004 and 2005 Camry, Highlander, Sienna and Solara; the 2004 Avalon; and the 2006 Highlander HV. The affected Lexus models are the 2004 and 2005 ES 330 and RX 330 and the 2006 RX 400h.

In January, Toyota will mail car owners a notification to make an appointment to have their vehicle inspected. Toyota will fix any vehicle in need of repair at no cost to consumers.

Continue reading "Toyota Recalls 550,000 Toyotas and Lexus Models" »

A Food and Drug Administration (FDA) advisory panel has recommended that some transvaginal mesh products be reclassified as the process for approving mesh and other medical devices comes under scrutiny.

On July 13, the FDA updated a 2008 public health notification, reporting that complications from transvaginal mesh are not rare and that it is not clear that transvaginal mesh surgery is more effective than non-mesh repair of pelvic organ prolapse (POP). Having received over 3,800 reports of complications, the FDA urged surgeons to consider other options before performing transvaginal mesh surgery.

Since then, more than 600 women have filed lawsuits over complications from transvaginal mesh, which is surgically implanted to treat both POP and stress urinary incontinence (SUI). POP occurs when a women's pelvic muscles and organs are weakened and stretched, often after child birth or hysterectomies.

Women reported painful complications such as internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems. Corrective surgery is often required and is not always successful. In one report by Bloomberg News, a woman reported she had undergone 17 procedures to reverse damage from transvaginal mesh, including five surgeries, and is still suffering from the condition.

The FDA approved the first transvaginal mesh product, ProtoGen by Boston Scientific, in 1996. Two years later, Johnson & Johnson won approval for a similar device called Gynecare VT, but was not required to conduct human testing on it. Using the FDA's 510(k) process for medical devices, Johnson & Johnson was allowed to bypass testing by claiming the device was "substantially equivalent" to the Boston Scientific mesh product.

The FDA approves 90 percent of medical devices under the 510(k) process, including defective hip implants and external heart defibrillators that have been subject to recalls in recent years.

Critics say the 510(k) process is flawed and needs to be overhauled. In the case of Boston Scientific, the Massachusetts manufacturer recalled its surgical mesh product in 1999 as other companies were just starting to bring their product to market. There are a total of nine manufacturers of transvaginal mesh products.

In January, the FDA announced it was considering 25 changes to the 510(k) system. In July, the non-profit U.S. Institute of Medicine issued a warning about it and Congress has pushed the FDA to make changes.

As for transvaginal mesh, the FDA convened an advisory panel to review the safety of the medical device in September. The 17-member panel recommended that some transvaginal mesh be reclassified as high-risk devices and require new studies be conducted to stay on the market. The FDA has yet to make a decision.

Continue reading "FDA Considers Next Step for Transvaginal Mesh, Medical Device Approvals" »

More than a year after DePuy Orthopaedics recalled two popular hip implants, the large number of patients affected and severity of injuries caused by metal-on-metal hip implants is starting to emerge.

The DePuy hip implant recall has broadened concern over all metal-on-metal hip implants. All-metal hip replacements are now on the track to become the largest and most expensive medical implant defect since 2007, when Medtronic recalled a defective heart device component associated with 7,700 complaints. An estimated 500,000 patients have received all-metal hip replacements.

In August 2010, DePuy recalled two ASR hip implants, the ASR XL Acetabular System, which is available to patients throughout the world, and the ASR Hip Resurfacing System, which is not available in the United States. The hip implants are defective because they cause friction between the metallic ball and socket components which are implanted to replace the femur and acetabulum.

DePuy recalled the defective medical devices after the Food and Drug Administration (FDA) received about 400 complaints in two years from patients. While most hip implants last for 15 years, data released at the time showed one in eight patients required a replacement surgery within five years of being surgically implanted with the defective DePuy hip implants.

The recalled DePuy hip implants can wear down and produce a substantial amount of metallic particles in patients' bloodstreams. Patients reported signs of metallosis, including pain, swelling, problems walking and rashes. These may be symptoms of more serious problems such as the hip implant loosening, bone fractures, joint inflammation, hip dislocation and damage to the tissue, nerves and muscles near the implant.

In the first six months of 2011, the Food and Drug Administration (FDA) received more than 5,000 reports about problems with all-metal hip implants, according to an analysis by The New York Times. The Articular Surface Replacement (A.S.R.) recalled last year by DePuy Orthpaedics accounted for 75 percent of the complaints.

Another recent study in England found that all-metal hip implants were failing early at three times the rate of hip implants made from metal-and-plastic components.

Massachusetts General Hospital in Boston and other medical facilities across the country have reported seeing a growing number of patients requiring corrective surgery, according to The New York Times. In most cases, corrective surgery takes months of rehabilitation. In some cases, complications require longer medical supervision.

In May, the FDA ordered manufacturers of all-metal hips to develop studies determining how widespread device failures are and implications for patients. But it may be several years before results of those studies are available.

If you have a defective DePuy hip implant and are experiencing pain, it is important to contact the hospital where you received your implants immediately. You should also contact an experienced Massachusetts product liability lawyer. The product liability lawyers at Breakstone, White & Gluck of Boston are experienced in handling cases involving DePuy hip implant recalls and other defective medical devices. Call us today at 800-379-1244 or use our contact form.

Anyone who has recently purchased a $100 bike at Walmart wants to pay attention to a bicycle recall issued this week.

Bridgeway International of Naples, Florida has recalled 91,000 "NEXT"-branded men's 26-inch hybrid bicycles. The products have a defective bicycle chain that can break and cause the bicyclist to lose control and fall in a bicycle accident.

The importer is aware of 11 reported incidents, including nine involving lacerations and other personal injuries.

The bicycles are red and orange and are marked "Power X" and "Suspension." They were sold at Walmart from February 2011 through July 2011 for about $100. The model numbers are LBH2611M and LBH2611M2. The bicycles were manufactured in China.

Consumers are advised to stop using the recalled bicycles. They can contact the company for a free repair at 877-934-3228 or visit www.powerxbike.com for more information.

Defective Specialized Bicycle Recall. Separately, 14,200 bicycles with a defective brake component were recalled this week by Specialized Bicycle Components, Inc., a Morgan Hill, California distributor.

The bicycles have Advanced Group carbon forks and were manufactured by Advance Group, of Taiwan. The brake component housed within the bicycle's carbon fork can disengage from the fork, allowing the brakes to contact the wheel spokes while rotating, posing a risk for falls and bicycle accidents.

There have been two reports of brake components disengaging from the carbon fork. No injuries have been reported.

The bikes were sold at authorized specialized retailers nationwide from June 2010 through August 2011 for $700 to $2,000. Consumers should stop riding these bicycles and return them to an authorized specialized retailer for a free repair or replacement. More information is available at 877-808-8154 or www.specialized.com.

Continue reading "Walmart Recall of 91,000 Defective Bicycles; Specialized Also Issues Bike Recall" »

Consumers want to take note of two recent product safety announcements, one involving a popular blender sold at Target stores and another concerning an antinausea drug which has been linked to a potentially fatal heart rhythm.

Defective Blender: On Sept. 15, 2011, Target Corp. and manufacturer Select Brands, Inc. announced the recall of the Chefmate(r) 6-Speed Blender. Target and the Consumer Product Safety Commission have received 11 reports of the blender's blades separating from the pitcher. In seven cases, consumers using the recalled Target product suffered serious lacerations and injuries to fingers and hands.

Approximately 304,000 defective blenders were sold at Target stores in Massachusetts and nationwide between September 2007 and Febrauary 2011. The blenders have the model number BL-10.

Consumers are advised to return the recalled product to Target stores for a full refund or contact the store's guest relations department at 800-440-0680.

Drug Danger: Also on Sept. 15, the Food and Drug Administration (FDA) announced clinicians should avoid prescribing the drug ondansetron to patients with congenital long QT syndrome, which is a syndrome affecting the electrical functions of the heart. These patients are at risk for developing an abnormal and potentially fatal heart rhythm called torsades de pointes.

Ondansetron is widely known as Zofran, manufactured by GlasxoSmithKline. It is prescribed to prevent nausea and vomiting experienced during cancer chemotherapy, radiation therapy and surgery.

The FDA is revising the drug's label to warn about the risk for the heart arrythmia. It will include recommendations for electrocardiogram monitoring for patients with electrolyte abnormalities, congestive heart failure and bradyarrhythmias and for patients taking other medications.

The FDA is also requiring GlaxoSmithKline to conduct a study to determine the degree to which ondansetron may trigger the complications.

The Massachusetts product liability lawyers at Breakstone, White & Gluck are experienced in representing individuals injured by defective products, including defective medical devices and improperly used medications. If you have been injured, contact us toll-free at 800-379-1244 for a free legal consultation. You can also use our contact form.

Continue reading "Product Liability Warnings For Blender and Antinausea Drug" »

A Food and Drug Administration (FDA) panel will begin discussing the safety and effectiveness of urogynecologic mesh products Wednesday. Surgical mesh is a medical device that is implanted into a woman during transvaginal mesh surgery.

On July 13, the FDA issued an update on a 2008 public health notification reporting complications from surgical mesh used in transvaginal mesh surgery are not rare. It also reported it was not clear that transvaginal mesh surgery is more effective than non-mesh repair of POP.

Transvaginal mesh surgery is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the tissues that hold the pelvic organs become weakened or stretched. SUI is a bladder condition.

In its July 13 update, the FDA reported it had received more than 3,800 reports of complications about transvaginal mesh surgery between 2005 and 2010. It urged surgeons and physicians to consider other options before performing the surgery.

Possible transvaginal mesh complications include internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems.

The FDA warned that surgical mesh is a permanent implant that may require several surgeries to correct. Full removal of surgical mesh may not be possible.

The FDA will convene its Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee on Wednesday and Thursday (September 8 and 9, 2011). The panel will discuss the safety of transvaginal surgical mesh for POP and SUI.

One consumer advocacy group has called for the FDA to recall surgical mesh. Public Citizen of Washington, D.C. - the organization founded by Ralph Nader - has also asked the FDA to reclassify surgical mesh so that future releases must undergo a more stringent approval process.

Other medical professionals support the procedure. A nationwide group of 600 pelvic surgeons has submitted a letter to the FDA challenging findings involving surgical mesh injuries.

Nine companies manufacture surgical mesh, including Boston Scientific and Johnson & Johnson.

If you have been injured during transvaginal mesh surgery, it is important to contact an experienced Boston medical device recall lawyer who can protect your interests as the FDA conducts its review. An attorney can advocate for you and ensure you obtain compensation for your injuries.

For a free legal consultation, contact the Boston lawyers at Breakstone, White & Gluck in Boston at 1-800-379-1244 or use our contact form.

Continue reading "Surgical Mesh Complications Under FDA Review" »

Following thousands of reports about serious injuries among women, a Food and Drug Administration (FDA) panel will begin examining the safety of surgical mesh on Sept. 8 and 9.

Surgical mesh is implanted during transvaginal mesh surgery, the treatment for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The procedure is performed to repair weak or stretched vaginal tissue, often after childbirth.

The panel's review comes almost two months after the FDA's July 13 public safety advisory on surgical mesh and as special interests step into the debate about a possible surgical mesh recall.

In the July 13 advisory, the FDA said transvaginal POP repair with mesh has no advantage over traditional non-mesh repair. The FDA's finding was based on a review of scientific literature published between 2006 and 2011.

Between 2005 and 2010, more than 3,800 women had reported complications and injuries following transvaginal mesh surgery, according to the FDA.

The most prevalent complaint was mesh erosion within the body, but other injuries included bleeding, pain during sexual intercourse, organ perforation, vaginal scarring, muscular and emotional problems. Remedies include corrective surgery, hospitalization and intensive follow-up medical treatment.

On August 25, 2011, Public Citizen, a Washington D.C.-based consumer advocacy group, called for a recall of all non-absorbable synthetic material used in transvaginal mesh surgery. It also wants a reclassification of the approval process for new surgical mesh products.

The same day, a coalition of 600 pelvic surgeons submitted the FDA a letter challenging its findings about the risk for complications during transvaginal mesh surgery. The letter was obtained by the CommonHealth medical website. Among their challenges, the surgeons argued mesh erosion is not a major complication.

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.

Nine companies manufacture transvaginal mesh products, including Boston Scientific and Johnson & Johnson. Bloomberg News reported one recommendation from the FDA staff administration would require the manufacturers to submit additional safety data to regulators.

The FDA cleared 85 mesh devices to treat pelvic organ prolapse from 1992 to 2010.

Continue reading "Surgical Mesh To Be Reviewed By FDA Sept. 8-9" »