product liability

The website, Pharmalot, which reports on the pharmaceutical industry, reported Monday morning, October 3, a federal court jury decided that the osteoporosis drug, Fosamax, should not be blamed for something called jaw death. A woman had sued Merck, the maker of Fosamax, claiming the drug giant concealed the drug’s risks and that the drug had a flawed design.

This trial against Fosamax was called a bellwether trial used as the basis for similar cases waiting in the wings. Many women who take bisphosphonates to reduce bone loss which leads to osteoporosis, claim the drugs interrupt the bone recycling process in the body and leave behind bad bone that dies or tends to break. Attorneys were looking at this case to evaluate similar cases to determine future strategies. Pharmalot reports as of June, there were 1,650 lawsuits in the pipeline including more than 2,000 groups of plaintiffs filed in federal and state courts.

This is just the latest in a series of setbacks for consumers injured by Fosamax. A former United Airlines flight attendant from Florida who used Fosamax from 1998 to 2005 was told she could not pursue punitive damages against Merck for failing to adequately warn the public about the possible side effects of the drug.

An earlier ruling found the plaintiff could not establish that Merck intentionally concealed risks from consumers. However, in that case, Merck did lose that lawsuit based on design defect.

In three other earlier actions against Merck, the company won the first case, the second ended in a mistrial in September 2009 and Merck lost a retrial in 2010. The plaintiff won an $8 million award which was reduced. Merck is appealing. The drug giant won the third case last November.

Product Liability Law

Under product liability law, a product must be defective in its manufacture, its design, or in failing to warn the public about dangers that can cause injury. It takes an experienced Florida product liability legal team to pursue these actions. Not only do they help consumers, but they send a clear message to manufacturers that they must put out a product that does not harm the public, no matter how profitable it is.

Farah & Farah is always available for a consultation on your defective product case. Call us at 1-800-533-3555 so we can begin the conversation.

Source: http://www.pharmalot.com/

The federal agency that oversees worker safety has issued a revised alert about the hazard to hair salon owners and workers using hair smoothing products that contain formaldehyde. The Occupational Safety and Health Administration (OSHA) investigated the products called Brazilian Blowout Acai Professional Smoothing Solution and Brasil Cacau Cadiveu and issued an alert based on the results of the investigation. The air quality at salons tested showed that workers were exposed to unacceptably high levels of formaldehyde. OSHA also cited two manufacturers and distributors of these products for failing to list formaldehyde on the product label as well as product insert.

On August 22, the FDA sent a warning letter to the importer and distributor of the products calling them adulterated and misbranded.

Methylene glycol releases formaldehyde during normal use even though the product is labeled “formaldehyde free” or “no formaldehyde”. Formaldehyde is a known human carcinogen, according to the US National Toxicology Program and is a colorless gas that’s a precursor to polymers. It can irritate the eyes and nose of users and cause allergic reactions.

Under the Occupational Safety and Health Act of 1970, employers must provide a safe workplace for their employees.

Under state law, employers must also provide workers’ compensation to provide for insurance coverage if a worker is injured while in the scope of employment or in the workplace. If your employer has failed to make your workplace safe and you are injured, an advocate can serve as the go-between representing you to your employer’s insurance company to help you obtain what you deserve. Farah & Farah Jacksonville injury attorneys can help with one call to 1-800-533-3555.

Source: http://osha.gov/pls/oshaweb/owadisp.show_document?p_table=NEWS_RELEASES&p_id=20724

Beginning in early October, the Honda Motor Co. will begin contacting owners of the Pilot crossover vehicle because of a potential defect in the front seatbelts. Honda is recalling about 347,000 of the vehicles from the 2009 to 2011 model years due to a manufacturing error in the Alabama plant where stitching holding the lap belt to the anchor webbing may be missing or incomplete. In an accident, an injury can result if the seatbelt fails to hold the person in place because the webbing disconnects.

Honda will notify owners who need to bring their vehicles into the dealership to have the stitching on the front seatbelts inspected. If they are defective, Honda will replace them free of charge. There are about 10,000 vehicles in Canada and 311,000 in the U.S. as well as 8,000 in Mexico that fall under the recall.

Owners can contact Honda directly at 1-800-999-1009. The recall campaign number is R95.

Manufacturing Defect
Farah & Farah’s Florida seatbelt injury attorneys would like you to know that you have legal rights if you have been injured in a car crash that you believe was caused by a defective auto part.

Product liability cases are pursued following an injury from a defective product. Fortunately in the case of Honda, there are no known injuries or deaths resulting from this defective seatbelt, however, an investigation into an auto accident must always include the possibility that a seatbelt failure may have contributed to the deaths or injuries that resulted.

Source: http://www-odi.nhtsa.dot.gov/recalls/results.cfm?rcl_id=11V468&searchtype=quicksearch&summary=true&refurl=email

The U.S. Food and Drug Administration (FDA) meeting over the use of drugs for osteoporosis and related conditions indicated it might want the duration of treatment limited, but couldn’t agree on a timeline. The class of drugs is called bisphosphonates and the FDA advisory committee was supposed to come up with some direction after data showing long-time use of bisphosphonate therapy can lead to atypical fractures and jaw bone death. Meeting Friday, September 9, the advisory committee voted 17-6 to endorse a label change but what that should include panelists were uncertain about.

Bisphosphonates are prescribed to about five million Americans to prevent bone mass loss. Some of the common brand-names are Actonel, Atelvia, Boniva, Fosamax, and Reclast. The panel heard from women who heard their femur snap suddenly and unexpectedly after they had been on bisphosphonates for some time. In 2005, the FDA added a warning about a rare osteonecrosis where the jaw bone dies. That may occur after four years or more of taking the drug. There are also some reports of a link between the drug class and esophageal cancer.

It may make the most sense to take a “drug holiday” but panelists don’t agree whether that should occur after three years or sooner.

Farah & Farah’s products liability attorneys in Jacksonville remind us that if a drug is defective in its manufacture, in its design, or in labeling and a failure to warn, the patient who is harmed may be able to receive compensation for medical costs, rehabilitation, pain and suffering, and lost wages. #

Source: http://www.medpagetoday.com/Endocrinology/Osteoporosis/28442#ayk

Things have been heating up for manufacturers of controversial synthetic surgical mesh used for pelvic organ prolapse (POP) repair in women. The U.S. Food and Drug Administration (FDA) is now proposing the medical device should undergo a premarket review process which involves a much more stringent review including clinical studies looking for safety and efficacy prior to approval.

Presently, the medical devices are considered Class II and of moderate risk. Clinical studies are not required while the devices are approved only for marketing under the 510 (k) process where manufacturers claim it is “substantially equivalent” to a product already on the market bypassing safety and efficacy assurances.

According to an FDA Executive Summary report released Wednesday, August 31, on the FDA website, the agency said, “Because of the outstanding safety and effectiveness concerns for mesh products indicated for vaginal POP repair and an inability to adequately address these concerns via the 510(k) pathway, the FDA believes that 510(k) premarket notification is no longer an appropriate premarket pathway for devices indicated for vaginal POP repair. Therefore the FDA believes that reclassification of these devices to Class III and evaluation via the PMA process is warranted.”

Side effects of surgical mesh include immobility and pain, infection, mesh erosion and a return of pelvic organ prolapse where a woman’s organs fall because of weak muscles and connective tissue. Repeated surgeries are often needed to try and remove the mesh, which is extremely difficult.

The FDA reports it received 1,503 reports of adverse side effects associated with synthetic plastic surgical mesh for pelvic organ repair, which is five times the number from 2005 to 2007.

Synthetic mesh, which is also used to treat incontinence, would not have to be reclassified from Class II to Class III, or most high risk, even though it is the same mesh.

An expert FDA panel will gather September 8 and 9 to consider reclassifying the medical device. According to the FDA, about 75,000 pelvic surgeries were performed with synthetic mesh last year.

The agency cleared 85 surgical mesh products to treat pelvic organ prolapse from 1992 to 2010, according to Bloomberg.

The Consumer Product Safety Commission (CPSC) has announced that at least 51,000 tires made by China-based Shandong Youngtai Chemical Group Co. Ltd. will be recalled because they may blister or bubble on the tire sidewalls, which can lead to a tire failure and crash. The tires are designed for commercial vehicles and are called Negotiator Commercial H/T and the sizes are LT265/75R16 and LT235/85R16. The tires were made between April 2009 and May 2011.

ITR USA is the importer which does business as ITA.

The CPSC says the tires failed to meet the Federal Motor Vehicle Safety Standard Number 139.
Owners of these tires should contact the National Highway Traffic Safety Administration (NHTSA) on their hotline at 1-888-327-4236 or go to http://www.safercar.gov. Or consumers can contact ITA USA at (818) 715-7080. The recall number is 11T006.

Promoting Tire Safety
Motorists should plan to check their tires for inflation once a month. You should use a tire gauge to determine the pressure and measure when the tires are cold, meaning they have not been driven for at least three hours. The correct pressure for your tires (PSI) will be listed in your owner’s manual under cold tire inflation procedure. Look at the psi recommended for the front and rear tires.

Since blowouts are such a problem because the heat in Florida tends to wear tires prematurely, you are advised to check the amount of tread on your tires at least once a month. Using the Lincoln head penny, put the penny with the Lincoln head facing into the tire. If you can see the top of Lincoln’s head, it is time for new tires. Tires also have a built-in wear bar indicator.

Patients considering having surgical mesh surgery for pelvic organ prolapse (POP) or a hernia repair may want to think twice. The Food and Drug Administration (FDA) on Wednesday, July 13, issued its second warning about the use of synthetic plastic mesh made by Boston Scientific, Covidien plc, CR Bard Inc., American Medical Systems and Johnson & Johnson after noting that in 2008 there was one death and five times the adverse events of 2005 to 2007.

At least 10 percent of patients have had to have multiple surgeries to try and remove the petroleum-based mesh after it migrated and eroded into organs, causing extreme pain and infections. It is almost impossible to remove mesh once it is implanted and scar tissue and inflammation forms around it.

In 2010, 75,000 female patients had surgery to repair pelvic organ prolapse, a condition where organs fall and press up against the vagina. The synthetic mesh is used to hold up the pelvic wall and is inserted through the vagina. An article in the Boston Globe quotes one surgeon who says the procedure through the abdomen has a much lower complication rate of about four percent.

Plastic mesh is also used for hernia repair and the FDA has received reports of adverse reactions to the mesh including adhesions, and mesh migrating to perforate nearby organs, nerves and blood vessels, chronic infection, pain, and hernia recurrence. In a rare mea culpa, the FDA scientists said the 2008 public health advisory calling the problem “rare” was wrong. Medical literature now suggests problems occur in at least 10 percent of women within 12 months of surgery.

Even with the high rate of complications, the FDA does not plan to remove mesh from the market at this time but urges patients and surgeons to first consider traditional surgery using stitches to tighten the pelvic floor which has a failure rate reported to be 20 to 45 percent. Plastic mesh was approved under the fast track approval for medical devices, largely unchanged since the 1970s, reports AP.

As with some drugs approved without adequate testing, many patients have found out that the plastic mesh medical device has more complications and risks than benefits. As evidence mounts against this defective medical device, a patient who suffers injures from synthetic mesh should be able to file a product liability lawsuit against mesh manufacturers for a defective design and the failure to adequately warn the public. Unfortunately in the meantime, thousands more women and men are having synthetic mesh surgeries to repair POP, incontinence and hernias every year.

Sources: http://www.boston.com/Boston/dailydose/2011/07/fda-warns-against-surgical-mesh-repair-pelvic-problems/Yf5Ukjj5JiACnJ515sPPVL/index.html and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm

As summer heats up, portable pools are being blown up and filled in yards across the country, but a new study from The Research Institute at Nationwide Children’s Hospital shows a child drowns in a portable pool every five days. This is the first study of its kind and underscores just how dangerous these inexpensive pools can be.

The study was published on Thursday, June 16, in the journal Pediatrics and found that from 2001 to 2009, 209 children under the age of 12, died in portable backyard pools. Another 35 survived after being submerged. Children under the age of 5 are most at risk. The author of the study reminds us it only takes an inch of water to take a life in a drowning. The study reports a brief lapse in supervision is all it takes to lead to drowning and 40 percent of the children who drowned were being supervised. Even just answering the phone or talking to a neighbor is enough time and unlike in-ground pools, portable pool manufacturers provide no drowning prevention tools such as pool covers or alarms.

An inexpensive above-ground pool installed by parents may not instill the same sense of risk as an in-ground pool and that is the problem. The authors conclude that consumers need to be educated about the inherent risks of these pools and the steps that can be taken to prevent injury and death such as installing a four-foot fence, an alarm and safety covers. Failing to understand the risk is no excuse if a child dies in your backyard. Parents should check with the nonprofit group, Safe Kids, and its campaign for pool safety – “Lock, Look, and Learn.”

Learn all you can about product risks and recalls and if you believe your child has been injured by a toy or device that was intended for their use and may be dangerous and defective, contact the child safety lawyers in Jacksonville at Farah & Farah for a review of your case.

Source: http://www.washingtonpost.com/blogs/the-checkup/post/portable-pools-pose-dangers-to-kids/2010/12/20/AGPrM7YH_blog.html

The U.S. Consumer Product Safety Commission (CPSC) announced the recall of about 1.7 million video baby monitors with electrical cords that were linked to the strangling of two infants on Friday, February 11. By law, the CPSC must work in cooperation with the manufacturer, Summer Infant Inc., of Woonsocket, R.I., to issue the recall and to put additional warning information on the label. The company will recommend that the monitors be placed farther than three feet from a crib.

The babies who were strangled included a 10-month-old girl from Washington, D.C. who had the cord wrap around her neck when the monitor was placed on top of the crib rail. The other fatality occurred in a six-month-old boy from Conway, S.C. who strangled in the cord of the monitor placed on his changing table. Another baby was found with the cord around his neck but he survived and was not injured.

Parents are urged to check their baby monitors to make sure they are secured and out of the reach of the baby. Summer Infant can be reached at (800) 426-8627 and the CPSC provides photos on its website of the monitors and the dangers they pose.

There have been 7 strangulations from baby monitor cords since 2004, according to the CPSC, and the agency is interested in hearing from any consumers who’ve had any experience with the cords. Online consumers can call the CPSC Recall Hotline at 1-800-638-2772.

Farah & Farah’s Florida product liability lawyers want you to know that the manufacturer, designer, and distributor can all be held accountable if you or a loved one have been injured by a defective and dangerous product. Call us for a consultation on your injury and we’ll see how we can help.

They are the latest over-the-counter sexual enhancement dietary supplement that’s advertised as a “natural” alternative to Viagra, but a Food and Drug Administration (FDA) news release announced on December 13 that they are warning men not to use Man Up Now capsules because they can lower blood pressure to a dangerous level.

According to the FDA, the capsules contain sulfoaildenafil, which is similar to sildenafil, the active ingredient in Viagra. The chemical can interact with other prescription drugs such as nitroglycerin and cause blood pressure to drop to a dangerously low level, depriving the brain of an adequate blood supply.

Man Up Now can be purchased on the internet and in retail stores and many of these dietary supplements actually contain the active ingredient, or a variation of the active ingredient, in the FDA-approved formulation. The FDA has not received any adverse health reports associated with Man Up Now. Consumers are told not to use Man Up Now capsules and to discard the product if they experience any side effects such as lightheadedness.

The FDA says that Synergy Distribution LLC, the maker of Man Up Now, makes claims that the supplement works as well as prescription products and in doing so, may be exposing consumers to unpredictable risks and the potential for death and injury. Presumably, the prescription drug would have the same risk to consumers, but the FDA has approved Viagra which explains to consumers the risks and side effects in the package labeling. Over-the-counter (OTC) sexual enhancement supplements may promise to work in minutes and last up to 72 hours in formulations that have not been approved by the FDA.

A defective product is one that is made of substandard ingredients, is poorly designed, or does not adequately warn the consumer about the potential for side effects or injury. The Florida product liability lawyers at Farah & Farah have experience investigating defective products and uncovering the line of distribution, all of who may be held liable if their product causes an injury or illness to an unsuspecting consumer. Almost any type of accident resulting from a dietary supplement should be evaluated as a potential defective product claim in Florida.