Articles Posted in defective products

Less than a month after a deadly, national outbreak of fungal meningitis stemming from the New England Compounding Center, it has been revealed that the pharmacy’s sister company, Ameridose LLC, has major issues with sterility as well.

Ameridose, also a Massachusetts pharmacy, based in Westborough, is a major supplier of injectable drugs given to pregnant women, children and asthma sufferers. This company was founded by the brother-in-law of the man who founded the New England Compounding Center. We previously reported this relationship in our meningitis coverage shortly after the outbreak began.

Our Boston meningitis lawyers understand that in the wake of the tragedy stemming from contaminated steroid injections from the NECC, federal officials have found that Ameridose facilities, too, weren’t sterile. In fact, there were leaky ceilings, insect issues and a rouge bird flying around the facility.

So far, there have been no illnesses reported as a result of the Ameridose injections, but there have been complaints with its products dating back to at least 2008. The fact that people didn’t know about the extent of the sterility issues at Ameridose or the complaints made by others probably led to fewer reports. The company has manufactured and shipped some 70 million units of product since 2008.

Specifically, the drugs the company is known for making include fentanyl, oxytocin, heparin and medications used to deliver epidurals.

The U.S. Food and Drug Administration, in a 20-page report, indicated the top complaint made by doctors to the company had been a lack of effectiveness or ineffectiveness. In some cases, children were given medication before surgery to calm them. However, the drug did not work, despite the children being given the maximum dose.

There were also pregnant women given Ameridose-produced oxytocin to bring on labor, and ended up reporting fetal distress, severe post-birth bleeding and shortness of breath.

Additionally, one complaint indicated a patient was given a heparin, a blood-thinner, and ended up having a life-threatening reaction.

And when two cancer patients were given a pain drug called fentanyl, both reported having gone into respiratory distress.

Perhaps more troubling is that when doctors reported these incidents to Ameridose, they were not recorded as “adverse” events.

Additionally, the FDA discovered at least 58 occasions when Ameridose staffers found evidence of contamination with fungi or bacteria in liquids that were supposed to be sterile – liquids that would go on to be used for anesthetic and pain relief injections. And yet, it did not investigate. When testing indicated that the end products weren’t sterile, the company reportedly took no steps to find out what caused the contamination or to correct it.

In another 45 instances when lab staff found mold or bacteria in the manufacturing areas, Ameridose didn’t bother to investigate, the FDA reported.

When reports of the fungal meningitis outbreak first emerged, Ameridose attempted to distance itself from NECC, with NECC’s top pharmacist, who also worked for Ameridose, issuing his resignation.

On Oct. 31, Ameridose recalled all of its unexpired products after FDA inspectors indicated the facility could not consistently assure that its products were safe.

The fungal meningitis outbreak has so far resulted in 32 deaths and caused another 438 people to fall severely ill.
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Our Boston defective drug attorneys were dismayed to learn that the same pharmacy believed responsible for manufacturing the medicines connected with a national deadly meningitis outbreak may have more dangerous drugs on the market.

NBC News is reporting that at least 10 different kinds of bacteria were detected in a number of drugs produced by the firm, including eight separate lots of a drug used to treat serious itching and and at least two lots of a medication used to slow or stop the heart during surgical procedures.

That doesn’t include the five different kinds of fungi that have been linked to the Framingham pharmacy, which the U.S. Food and Drug Administration has dubbed responsible for the meningitis outbreak. As of Nov. 1, there had been at least 377 identified cases of meningitis stemming from drugs distributed by this facility. Others who had been infected suffered strokes and joint infections, as well. At this point, we understand that 28 people have died.

The FDA has also announced tests are underway on two other drugs produced by the facility, though those results aren’t yet in.

As of now, we aren’t aware of any additional infections as a result of the bacteria newly discovered in these other drugs, but that could because it’s not yet been widely reported or diagnosed.

The facility has been forced to halt operations while the FDA and the Centers for Disease Control continue testing and new cases continue to emerge. However, our understanding is that the fungus and bacteria has been located in unopened bottles, which were still on the shelves as of Nov. 1. That means we’re likely to see even more infections.

What’s especially troubling is that those individuals infected with the fungal meningitis may not immediately test positive, as the lab tests used to detect it are not highly sensitive.

Both Massachusetts and federal inspectors have been conducting simultaneous and ongoing investigations at the site, where they reportedly discovered bacteria and mold throughout its “clean rooms” during the past nine months.

The company’s license to operate has been revoked permanently, and all products and drugs produced by the company have been recalled. Unexpired drugs used by its sister company were also recently recalled, after evidence was discovered indicating sanitation concerns.

In all, the FDA has indicated there are an estimated 14,000 people in nearly two dozen states that received the tainted steroid injections that led to the meningitis infections. Typically, stroke, severe illness or death occurs within the first five to six weeks after injections were received. FDA officials say this means that the danger should mostly have subsided by next week, but those who received the injections should still be on high alert and under close medical supervision.
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Chances are that there are some products in your home that can cause serious injury to you and your family. Chances are also that dangerous products like these are listed on the U.S. Consumer Product Safety Commission‘s (CPSC) website.

defective products injuries also commonly impact children. You ca’t deal with defective products or reduce your risks if you don’t know about them. That’s why we’re asking families to check out the CPSC’s recall site and to check it often. We’re here to get you started and to give you some information on some of the latest recalls.

42-inch LED-TVs Recalled by Haier America:

There have been roughly 5,000 of the Haier® 42-inch LED TVS recalled by Haier America Trading L.L.C., of New York, N.Y. because the neck of the stand for the TV support can snap and can cause the TV to come toppling over. This poses a serious risk of injury to your household. There have been close to 200 reports of these incidents. If your TV has the model number LE42B1380 on it, then we’re talking to you. If you have this television, you should contact Haier America for a free replacement stand neck. Call the company at (877) 813-8516.

Off-Road Utility Vehicles Recalled by Kubota:

There have been close to 1,000 Off-road Utility Vehicles recalled by Kubota Manufacturing of America Corporation, of Gainesville, Ga. because there are some serious risks for carbon monoxide poisoning. What can happen is that the carbon monoxide can accumulate in the vehicle cab when the engine is idling and the vehicle isn’t moving. The vehicle involved in the recall is the Kubota RTV500 with cab. The model number is “RTV500.” If you have one of these vehicles, you’re urged to contact the company at (800) 752-0290 to schedule a free repair of the recalled vehicle.

Early Model Suspension Trainer Devices Recalled by Fitness Anywhere:

There are close to 50,000 Suspension Trainer Devices that have been recalled by Fitness Anywhere LLC, of San Francisco, Calif. What can happen is the strap length-adjustment buckles can break and can pose a serious fall hazard to users. There have already been more than 550 reports of the buckles breaking. More than 80 users have fallen and close to 15 have sustained injuries to the shoulder, face, head and/or hip. Falling under the recall are the “Professional” (P1) and “Tactical” (T1) TRX Suspension Trainer devices. If you have one of these devices, you’re urged to stop using it immediately and contact the company at (888)-221-7417 to arrange to return the recalled product for a replacement TRX Suspension Trainer device.
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Dangerous products find their way into the homes of many residents in the state of Massachusetts. Unfortunately, not many consumers are alerted to the dangers of these products and their recalls. Oftentimes, these recalls never even get to consumers until a fatal accident in Boston or elsewhere has already occurred, according to TIME.

Statistics show that about 90 percent of dangerous products stay in consumers’ homes. After being recalled, there are very few products are ever returned by consumers to the manufacturer for a refund or for the necessary repairs.

Our Boston defective product attorneys understand that our day to day lives are busy. We’ve got a lot to do and a seemingly little amount of time to do it. Still, there’s no excuse to bypass safety, there’s no excuse not to be up to date with the latest recalls and there’s no excuse to hang on to a dangerous product. Residents are encouraged to check out the recalls from the U.S. Consumer Product Safety Commission frequently. If you notice that you have a product that’s been thrown on the recall list, you’re strongly urged to get rid of it, to return it for a refund or take it back to the manufacturer for a repair. Keeping these items in your household and around your children is a quick recipe for disaster.

“We know that the majority of products that are recalled remain in consumers’ homes,” said the executive director Kids in Danger, Nancy Cowles.

Remember the furnaces that the CPSC recalled? There were about 200,000 recalled be federal officials. Still, more than 90 percent of the accident reports that were submitted were submitted after the recall. Consumers still decided to hang on to these furnaces long after they were deemed unsafe.

But why do consumers hang on to dangerous products?

-Because they feel that they won’t be affected by the risks or the dangers of the product. It’s the “bad things happen to other people, not me” complex.

-Because recalls happen all too often and they’ve lost their sense of urgency and the importance that they once had.

-Because consumers never hear about the recalls in the first place. Safety officials believe that there needs to be a more efficient way to spread the word.

You’ve got to be an active and engaged consumer and you need to stay up to date with the latest safety recalls if you’re going to help to protect your loved ones. It’s important to know what dangers lie in products before going shopping and long after. Knowledge is your key in this battle and it can help to prevent serious injuries to both you and your family members.
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A 29-year-old woman left a young daughter and a husband behind to grieve when she was reportedly killed by a defective product in Andover five years ago, according to the $20.6M award in pool slide death, By Julie Manganis, The Eagle Tribune

More Blog Entries:
CPSC Releasing Even More Recalls to Help Prevent Boston Child Injury