Botox Lawsuit Highlights Reuse of Single-Use Vials

A recent federal lawsuit throws a spotlight on the practice of physicians using single-use medication vials on more than one patient. That practice at the Endoscopy Center of Southern Nevada, public health officials have repeatedly said, contributed to a recent hepatitis C outbreak in the Las Vegas Valley.

The lawsuit filed in California by Las Vegas physician Ivan Goldsmith argues that sales representatives for Botox manufacturer Allergan Inc promote multipatient use of its 50-unit or 100-unit single-use vials. Goldsmith's lawsuit alleges that physicians can only make a profit using Botox if they reuse the single-use vials that the drug comes in.

The Botox business model "created an unacceptable and unreasonable risk of serious and debilitating injuries and illnesses, including HIV and Hepatitis B and C," states the lawsuit, filed September 29 in US District Court for the Central District of California.

Allergan spokeswoman Kellie Reagan said the product's prescribing label has always been clear: single use only. She wouldn't comment, however, on how Allergan's sales representatives promote the drug's use. Goldsmith said in the lawsuit that Allergan misrepresented to him "the true and permissible use of the product."

Most patients need far less Botox than is provided by Allergan in either its 50-unit or 100-unit vials, the lawsuit said. According to the suit, the medication can't be saved for later use on the same patient because once a vial is opened it must be thrown away within 4 hours of first use.

Physicians and medical spa providers of Botox contacted by the Las Vegas Review-Journal said Allergan's sales representatives have consistently said vials of Botox could be used for multiple patients.

I can see no reason why Botox or Dysport can't be labeled and used as multiple patient vials other than neither company bothered to get FDA approval for such. If the only FDA indication for Botox Cosmetic is glabellar lines and the product insert says to use 20 u for women and 30 u for men then WHY is the vial 100u!!! Dysport (U.S.) will only recommend 50un for glabellar lines, then again WHY is their vial 300u!!! Of course they are meant to be multi-use.

The problem in the NV gastroenterology lab is tha although they changed the needles, they reused the syringes to draw up the med from multi-use vials and inject into different patients. In my office, numerous vials of meds are multi-use and safe, to include influenza vaccine, kenalog, depo-medrol, lidocaine, etc.

Here in Australia, just interestingly, the government has issued multi dose vials
for it's mass swine flu immunisation program

Botox Lawsuit Highlights Reuse of Single-Use Vials

A recent federal lawsuit throws a spotlight on the practice of physicians using single-use medication vials on more than one patient. That practice at the Endoscopy Center of Southern Nevada, public health officials have repeatedly said, contributed to a recent hepatitis C outbreak in the Las Vegas Valley.

The lawsuit filed in California by Las Vegas physician Ivan Goldsmith argues that sales representatives for Botox manufacturer Allergan Inc promote multipatient use of its 50-unit or 100-unit single-use vials. Goldsmith's lawsuit alleges that physicians can only make a profit using Botox if they reuse the single-use vials that the drug comes in.

The Botox business model "created an unacceptable and unreasonable risk of serious and debilitating injuries and illnesses, including HIV and Hepatitis B and C," states the lawsuit, filed September 29 in US District Court for the Central District of California.

Allergan spokeswoman Kellie Reagan said the product's prescribing label has always been clear: single use only. She wouldn't comment, however, on how Allergan's sales representatives promote the drug's use. Goldsmith said in the lawsuit that Allergan misrepresented to him "the true and permissible use of the product."

Most patients need far less Botox than is provided by Allergan in either its 50-unit or 100-unit vials, the lawsuit said. According to the suit, the medication can't be saved for later use on the same patient because once a vial is opened it must be thrown away within 4 hours of first use.

Physicians and medical spa providers of Botox contacted by the Las Vegas Review-Journal said Allergan's sales representatives have consistently said vials of Botox could be used for multiple patients.

Is there any update on this lawsuit?

I am a US Navy Hospitalman (Retired). I've done thousands of injections (maybe more). If a vial is sterile when you get it.. it is possible to contaminate it as you use it. It does not happen often or you would see all injectables packaged ONLY as single dose units. The more you handle it .... the more this increases. It really depends on the skill and concern used during the process. Sloppy, less experienced injectors, will have te most problems. If only one injector used a multiple dose vial and that person has more than one problem, you have isolated the problem.

FDA maintains a rule that is for manufacturers.... Anything said by a rep is the same as if the President of the company told you IN PERSON. The rep is supposed to STICK TO THE INFORMATION ON THE PACKGE INSERT THAT ACCOMPANIES EVERY VIAL. ANY DEVIATION FROM THAT OR THE ADVERTISING IS AGAINST THE LAW. ANY and ALL advertising and labeling is reviewed by FDA before it is approved. ALL changes are either at the insistence of FDA or by manufacturer when it becomes necessary. What ever the rep says is an EXTENSION of the manufacturer. The rep can not deviate from the labeling under any circumstance.

.I WAS A SALES REP FOR A MAJOR DRUG MANUFACTURER FOR 10 YEARS.