Answers - Real Estate

In 2001, black mold cases cost insurance companies over 1.2 billion dollars. This includes the cost of inspection and testing, remediation, attorney fees and p

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

unitive damages for builders' neglect in dealing with the problem.

Since 2001, the number of black mold cases has steadily risen. Every year there are billion

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

of dollars in lawsuits. Because of this, insurance companies have stopped carrying mold coverage. The new suits are brought against landlords, builders and p

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

operty owners.

Unfortunately, many of these individuals do not fully understand their insurance coverage as it pertains to mold. Mold liability suits are on t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

he rise, and you don't want to be the next one!

So, What Can You Do?

Getting Coverage

Due to these recent mold case

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

, many insurance policies have included a "mold exclusion" to their insurance policies. If you are lucky enough to have an earlier policy that doesn't have a m

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ld exclusion, you should hang onto it.

The mold exclusion clauses are making it tough to get coverage for mold. You can often only get mold coverage as a stan

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

d-alone policy, and it carries high premiums. You can get it as an add-on to your existing policy as well, but it is often expensive.

If you live in a humid a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e such as the Pacific Northwest, it may be a good investment to get the extra coverage. Also, if the building property is old, you might want to be covered. O

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

der buildings were built before there were strict guidelines for builders to deal with toxic black mo

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

d removal.

You also may be able to reduce the cost of coverage by developing an Operation & Maintenance plan for dealing with mold. Your O&M may include a

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

plan for dealing with mold, a schedule for inspection and training for your employees in dealing with black mold remediation.

Fighting Mold

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

>

The best thing you can do is take care of mold problems when they occur and keep the mold out of your buildings. If your properties have a history of mold,

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ou have to keep an eye on them. Talk with your tenants or employees and work on communicating with them. Make sure they understand how to check for mold, and

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

notify you when they do.

If you are a landlord, you can revise your lease to include a section about black mold. Some landlords make their tenants fully respo

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

sible for mold cleanup, as long as it's not a structural problem with the house. A better idea is to simply put a clause in the lease saying that it's the tena

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ts' responsibility to notify the landlord of any black mold problems. This will keep you from being legally negligent.

It's a really good idea to periodically

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

pay for mold testing and inspection. This is expensive, but it may save you from a lawsuit. It also may save your tenants from suffering mold-related health

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

roblems.

Note that a high number of these cases have been brought in the states of Florida, Texas, California and the southwestern states. That's because thes

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

places are prone to mold problems. If you are a landlord or developer in these areas, you need to take special care in mold prevention, inspection and removal

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Answers - Black Mold and Liability Insurance: Tips on Getting Covered

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