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Top Adding - More From Symons - Piercing the Corporate Veil
The March 31, 2007 opinion in Symons International v. Continental Casualty Company, et al., 2007 U.S. Dist. LEXIS 27356 (S.D. Ind.) discusse
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
s Indiana’s common law theory of piercing the corporate veil. The legal principle, not unlike the principles in Indiana’s Uniform Fraudulen
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t Transfer Act, which also is analyzed in the case, provides a method for collecting a debt from someone other than the actual, named borrow
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
er. If applicable, the piercing doctrine provides a nice remedy for Indiana creditors victimized by shady debtors hiding behind the corpora
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e shield.
Piercing the corporate veil. It’s frustrating when a lender knows that there are assets to cover the debt but that the assets ar
Piercing the corporate veil. It’s frustrating when a lender knows that there are assets to cover the debt but that the assets ar
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e protected from collection because they are in the hands of the individual owners of a corporate entity or by entities separate from the bo
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
rrowing entity. The theory of “piercing the corporate veil,” in rare circumstances, will permit lenders/creditors to chase the assets of th
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
e individuals or entities who actually have the money.
Persons/Owners. “Indiana courts are reluctant to disregard a corporate entity and e
Persons/Owners. “Indiana courts are reluctant to disregard a corporate entity and e
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tend the liabilities of one corporation and its affiliates, shareholders and/or officers; however, they may do so to prevent fraud or injust
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
ice to a third party.” Symons at 56. The issue is “highly fact sensitive.” Id. With regard to targeting individuals, here are eight fact
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ors Indiana courts look to, but the factors are not exhaustive or ranked:
1. Undercapitalization;
2. Absence of corporate records;
3. Fra
1. Undercapitalization;
2. Absence of corporate records;
3. Fra
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
udulent representation by a corporation’s shareholders or directors;
4. Use of the corporation to promote fraud, injustice or illegal activ
4. Use of the corporation to promote fraud, injustice or illegal activ
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ties;
5. Payment by the corporation of individual obligations;
6. Commingling of assets and affairs;
7. Failure to observe required corpo
5. Payment by the corporation of individual obligations;
6. Commingling of assets and affairs;
7. Failure to observe required corpo
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
rate formalities; and
8. Other shareholder acts or conduct ignoring, controlling or manipulating the corporate forum.
Other entities. In
8. Other shareholder acts or conduct ignoring, controlling or manipulating the corporate forum.
Other entities. In
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
addition to these eight factors, Indiana courts look to at least four other factors when a plaintiff seeks to pierce the corporate veil in o
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
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
rder to hold one corporation (or LLC, etc.) liable for another corporation’s debt:
1. Similar corporate names;
2. Common principal corpora
1. Similar corporate names;
2. Common principal corpora
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e officers, directors and employees;
3. Similar business purposes; and
4. The same offices, telephone number and business cards.
Id. at 5
3. Similar business purposes; and
4. The same offices, telephone number and business cards.
Id. at 5
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
7. Again, this is not an exhaustive or ranked list. On pages 57-62 of Judge Young’s opinion, he addresses many of the factors in detail an
.
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
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
d provides an excellent analysis of the remedy should you want a better understanding of what it takes to pierce the corporate veil. He hel
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
d there to be questions of fact and denied the defendants’ motion for summary judgment. Symons is a favorable opinion for Indiana creditors
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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