Kelley & Ferraro

Companies continue to be fined for exposing workers to asbestos

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Asbestos on Saturday, July 11, 2020.

Demolition and renovation are a substantial part of the construction industry here in Ohio and elsewhere. When existing materials are removed from buildings, the odds are good that workers could encounter asbestos if they disturb materials manufactured with it. The companies undertaking these jobs owe their employees a duty to keep them safe from the harmful effects of this and other toxic substances and materials on job sites.

Recently, two companies on the west coast were fined for failing to protect workers from asbestos-laden products on the job site. Remnants of popcorn ceilings and vinyl flooring containing this human carcinogen were just left on site for workers to breathe in and perhaps even ingest. Products containing asbestos are not necessarily dangerous until or unless they are broken or demolished.

Food and Drug Administration approves Elmiron label changes

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Pharmaceutical Litigation on Thursday, July 9, 2020.

Ohio residents suffering from a particular bladder disorder may take Elmiron for the pain and discomfort associated with it. They may or may not know that certain previously unknown and/or unreported dangers from extended Elmiron use became known in recent years. This medication comes with some significant side effects, but up until now, the labels have not indicated that prolonged use could lead to vision problems, including blindness. Only recently did the Food and Drug Administration approve a new label that includes these issues as side effects.

The drug appears to have a cumulative effect in the body, which is why the vision problems may not manifest for months or years. Most people involved in a study regarding this issue took the medication for at least three years before having trouble reading or blurred vision. Patients also complained of their eyes taking longer to adjust to reduced or low light environments. Retinal pigmentary changes can also occur and may serve as a warning sign of more degenerating effects to come.

What is the FDA's involvement in recalls?

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Pharmaceutical Litigation on Thursday, July 2, 2020.

Every year, thousands of medical devices and medications are recalled. Like others, some Ohio residents may wonder how the Food and Drug Administration is involved in this process. As of right now, the FDA cannot force a company to recall a product; it is up to the manufacturers to do the right thing.

With the recent increase in recalls of over-the-counter medications, the perception may be growing that the FDA needs the power to force companies to remove their products from the market. For now, the agency's role focuses on making sure the recall is appropriate, giving it a classification, and supervising the response and strategy of the company involved. Getting the word out to everyone, such as medical providers, pharmacists and even consumers, will then begin in earnest. The classification may be one of the most important pieces of information consumers need.

Does mesothelioma survivial data provide an accurate prediction?

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Mesothelioma on Thursday, July 2, 2020.

Someone exposed to asbestos could live for decades without any repercussions. Then one day, it all changes. After a visit to the doctor, an Ohio resident could receive the diagnosis they hoped would never come -- mesothelioma. More than likely, the doctor will give him or her data on the survival rates for this rare form of cancer, but the real question is whether those numbers apply to everyone.

The way mesothelioma survival rates are calculated depends on three primary factors: if the cancer is localized to the pleura, spreads to regions such as the lymph nodes or nearby structures in the body, or spreads to more distant parts of the body. It is not difficult to imagine that as the cancer spreads through the body, the chances of survival decrease. An important piece of information to know is that these statistics come from when a patient is diagnosed, not as the disease progresses.

The FDA says this hand sanitizer could make you seriously ill

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Pharmaceutical Litigation on Thursday, June 25, 2020.

Right now, nearly everyone here in Ohio and elsewhere is probably using hand sanitizer more often than ever. Of course, due to demand, it has been in short supply, so people are using brands they have not seen on the shelves just to make sure they have some available in order to comply with rules set forth by the Centers for Disease Control and Prevention, the Food and Drug Administration, and other federal and state agencies. The problem is that the FDA recently discovered that one of the previously unknown brands could make users seriously ill.

Even though the agency requested that Eskbiochem SA de CV stop manufacturing and recall its products, the company has so far refused to do so. For this reason, the FDA has put out a notice for everyone to immediately stop using the company's products. The problem is that they contain methanol, which is a wood alcohol not approved for use by humans. Ordinarily, hand sanitizer contains ethanol, which is safer for humans.

Asbestos is still a threat for many, including auto mechanics

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Asbestos on Thursday, June 25, 2020.

Cuts, burns, falling objects, slip-and-fall accidents and more all risks to people in many industries, and auto mechanics are no exception whether they work here in Ohio or elsewhere. Another risk they face is exposure to toxic chemicals and materials. Workers may forget about or not realize they can still be exposed to asbestos.

Older vehicles could still have internal clutch parts, brakes and brake pads containing this toxic material. Another often-seen source is from aftermarket products, especially if made overseas where the use of asbestos is not as regulated as it is here in the United States. People who frequent salvage yards may end up finding products for their vehicles that still contain it as well.

Is a test used to diagnose mesothelioma working as it should?

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP on Monday, June 22, 2020.

Those who suffer from or have a loved one battling mesothelioma know that a fast diagnosis can be the key to a successful treatment plan. A recent study questions the accuracy of a medical procedure used to aid in diagnosis.

Oncologists use video-assisted thoracic surgery (VATS) to help diagnose malignant pleural mesothelioma. But, does it work as well as they say?

Metformin recalls announced by the Food and Drug Administration

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Pharmaceutical Litigation on Friday, June 19, 2020.

Along with others across the country, Ohio residents may be wondering just how many commonly and abundantly used medications will end up containing N-Nitrosodimethylamine? So far, NDMA has been found in blood pressure medications and heartburn medications. Now, the Food and Drug Administration has announced that some pharmaceutical companies are recalling lots of extended release Metformin -- prescribed for type 2 diabetes -- due to the presence of this same probable human carcinogen.

To date, no lots of immediate release Metformin medications have been recalled. This is said to be the most often prescribed here in the United States. At this time, the FDA does not recommend that individuals taking the recalled medications to stop taking them immediately. Instead, they urge individuals to contact their doctors first. In fact, the agency advises that medical professionals continue to prescribe this type of medication if it makes clinical sense to do so.

Asbestos exposure concerns can arise during fires

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Asbestos on Wednesday, June 17, 2020.

When a building is on fire, it releases gases, fumes and debris into the air. One of the substances that could end up in the air is asbestos. As most people know, exposure to this particular substance is toxic and can cause untreatable diseases such as mesothelioma over time. This makes fires on older buildings here in Ohio and elsewhere much more dangerous than many thought.

For instance, a recent factory fire in another state raised concerns of asbestos traveling a substantial distance from the location where the fire was raging. People who were not even near the fire could end up being exposed to this toxic substance. Of course, the firefighters battling the blaze have no choice but to do their jobs despite the fact they end up exposed to numerous toxins, including this one.

The Food and Drug Administration can ban a medical device

On behalf of Kelley Ferraro of Kelley & Ferraro, LLP posted in Pharmaceutical Litigation on Saturday, June 13, 2020.

Occasionally, the potential harm of a medical device far outweighs any benefits patients here in Ohio or elsewhere receive from it. In these cases, the Food and Drug Administration can ban such devices, but it does not use this power very often. When it does use this option, what happens?

First, a medical device will usually only face a ban if the information and evidence available shows that it causes a substantial and/or unreasonable risk to those who use it. In addition, if patients are deceived into believing in the supposed benefits of a product and those benefits do not exist, the FDA could ban it. In many cases, a simple change of labeling could resolve an issue, but when that option will not work, the product could be banned.