Court Orders Sales Injunction of Botox and Juvederm Competitors

MakenzieR on 13 Mar 2012 at 9:30am

Updated March 15, 2012


Botox competitor Xeomin and the dermal filler Radiesse will be largely unavailable for cosmetic purposes for the next 10 months. Their makers, Merz Pharmaceuticals and Merz Aesthtics (Merz), have been hit with an injunction by Allergan, the maker of Botox.

If you’ve had Xeomin or Radiesse, don’t freak out. It’s not about faulty products -- just faulty business. 

To make a very long story short, what was found is that while preparing to launch Xeomin as a thereapeutic product in 2010 (it was approved for cosmetic use in 2011), Merz hired a handful of Allergan employees. Before giving Allergan their notice, many of those employees sent to their personal emails A LOT of confidential Allergan documents

According to the Court’s Findings of Fact and Conclusions of Law, the documents contained Allergan’s customer information for both Botox and Juvederm (a Radiesse competitor), as well as confidential training information.

Xeomin before and after
It states:

Through the discovery and investigation process, Allergan ultimately learned that, contrary to the statements made at the [Temporary Restraining Order] hearing, Merz Pharma and Merz Aesthetics had in fact been in possession of potentially confidential Allergan information for months before that hearing.

The court findings also state that “Monetary damages would be insufficient to address Allergan’s  injuries resulting from Defendants’ misappropriation,” and that “an injunction in this case would serve the public interest.”

What does this mean for patients and doctors?

According to a Merz spokesperson, for the next 10 months (as of March 9, 2012), Merz has been prohibited from “providing or selling...or soliciting purchases of” Xeomin AND Radiesse for cosmetic purposes

They add that only exception is that Merz may solicit and sell Radiesse (and their other dermal filler, Belotero) to customers who have used it between July 1, 2009 and June 30, 2010 as long as "a sworn declaration will be provided to the judge that confirms that these customers did in fact purchase dermal filler products" in this period.

A customer may also request to purchase Radiesse, but must "certify that such requests were made voluntarily and without solicitation."

Radiesse injunction

Xeomin was just beginning to gain some consumer recognition as a rival to Botox. It was supposed to be commercially introduced as a cosmetic product at the annual meeting of the American Academy of Dermatology on March 12.  

The injunction may be especially painful for Radiesse, which has been FDA approved and widely-used since 2006. 

According to Bloomberg.com, "in his closing argument, [Merz attourney] Rick McKnight said the proposed 12-month ban on Xeomin sales 'puts the companies out of business.'"

See comments below for full interview with Merz. Read their official press release here.

If your preferred anti-aging treatment was off the market for 10 months, would you switch to another product, or wait it out? 


Comments (13)

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I wish radiesse will be banned for cosmetic use . I pray for that .
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Any legal experts that can offer any clarification?
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Just as a side note, please keep in mind that if someone does answer this with legal advice we have not verified their credentials and have no way of knowing the validity of their claims.

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In the above who is the "customer" that can request without solicitation, the patient or the physician?
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That is a great question. The way I understood it was it was the physician (the customer of Merz) but I don't know that was necessarily the correct interpretation.

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This hurts the consumer Botox wants a monopoly and they are being allowed to have it I switched to Xeomin because I cant stand my rep and the way the company treats me. I had a relationship with Merz from Radiesse and that info does not pertain to me so I should be able to prchase it.
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While it does hurt the consumer a bit, even without Xeomin Botox does not have a monopoly. Dysport is another botulinum toxin that is still on the market. Hopefully they won't end up in a similar situation.... :/

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Official RealSelf Q&A with Merz spokesperson:

RS:  Xeomin may only be purchased for therapeutic purposes by "customers who voluntarily and without solicitation request to purchase Xeomin for therapeutic purposes from Merz Defendants, provided that sworn declarations are submitted that such requests were made voluntarily and without solicitation."
Merz:  To clarify, Merz Pharmaceuticals, LLC will continue to sell XEOMIN for therapeutic uses, although it is restricted from selling to certain physicians in certain areas in the United States during the time the injunction is in effect, unless customers voluntarily and without solicitation request to purchase XEOMIN for therapeutic purposes.

RS:  Xeomin may in no way be purchased for cosmetic purposes for the duration of the injunction (10 months from March 9, 2012)
Merz:  The terms of this injunction limit Merz from providing or selling XEOMIN, or soliciting purchases of XEOMIN, in the facial aesthetics market for a period of ten months. However, we hope that we will be able to modify parts of this injunction earlier than ten months from now after we have satisfied the Court that both companies have completed full remediation.

Per the terms of the injunction order, Merz may seek to modify or terminate the provisions of portions of this injunction, including the limitations placed on sales of XEOMIN, on the grounds that we have satisfied the examination and remediation process.  We are committed to an expeditious examination and remediation process that will enable us to quickly resume business as usual.

RS:  The Injunction Order also states (page 2, line 17) that "providing or selling dermal filler products, or soliciting purchases of dermal  filler products, in the facial  aesthetics market for a period of ten months  from the date of this Order, except to:

  • customers who voluntarily and without solicitation request to purchase dermal filler products from Merz Defendants, provided that sworn declarations  are  submitted that such requests were made  voluntarily  and without  solicitation, or
  • customers who purchased dermal filler products from Merz Defendants (including BioForm Medical) between  July 1, 2009 and June  30, 2010, provided that sworn declarations are submitted identifying such customers."

Merz:  The above statements are correct; however, as mentioned, we hope that we will be able to modify parts of this injunction sooner than ten months.

RS:  Does "dermal fillers" apply to Merz' Radiesse? Are there other fillers that fall into this category?
Merz:  Yes, “dermal filler” refers to Radiesse.  Belotero Balance Dermal Filler, which was approved by the FDA in November 2011, also falls into this category.

RS:  Are the defendants allowed to solicit for purchasing to customers who have used Merz' dermal fillers between 7/1/09 - 6/30/10?
Merz:  Yes, a sworn declaration will be provided to the judge that confirms that these customers did in fact purchase dermal filler products from Merz between July 1, 2009 and June 30, 2010.

RS:  To confirm, any customer can still buy Merz' dermal fillers for aesthetic purposes, provided they sign the declaration mentioned above.
Merz:  Yes, customers who voluntarily and without solicitation request to purchase dermal filler products from Merz can do so, provided that these customers certify that such requests were made voluntarily and without solicitation.

RS: Does Merz intend to lower its prices for Xeomin for therapeutic purposes and/or their dermal fillers?
Merz:  We cannot comment on future plans for pricing of Merz products at this time.

RS:  I read Xeomin was scheduled to commercially launch as a cosmetic product at the AAD meeting on March 12, 2012. Did that happen?
Merz:  XEOMIN has not yet been commercially launched for aesthetic use. Merz has confirmed to the judge that it is pursuing an expeditious and effective file examination and remediation process that will enable the Company to return quickly to business as usual, which includes the launch of XEOMIN in the facial aesthetic market.

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In the second question, that addresses whether Xeomin can be sold for cosmetic purposes during the injunction Merz responds with "The terms of this injunction limit Merz from providing or selling XEOMIN, or soliciting purchases of XEOMIN, in the facial aesthetics market for a period of ten months."

I'm curious if the price of Xeomin is reduced, if doctors will simply purchase it for "theraputic uses" then use it for cosmetic purposes. I'm assuming this wouldn't be considered any more unethical than the off-label use of other drugs, but would love to hear the opinions of some doctors on this!

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No wonder our Radiesse rep came through with some exceptional product pricing recently.
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Interesting! So do you think this could be a good thing for consumers because it may drive the prices down?

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I'm a little unclear, but from what I'm gathering Merz can sell Xeomin & Radiesse, they just can't solicit business, is that correct?

If so, all Merz really has to do is drop the prices. The doctors will be aware Merz can't solicit business, but will know Merz needs to move the product before the shelf life is up, so it seems many would approach Merz looking for better prices on the products. I know it was the first thought that entered my mind when I heard about this. If this is the case it seems like a pretty big loop hole.

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This is so crazy, I guess Botox, Dysport, and Sculptra will be used more then for the next year.

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