Tuesday, November 25, 2008

Some Interesting Facts About Stefan Lemperle-Kimberly Zolciak's Alleged New Big Papa

Some Interesting Facts About Stefan Lemperle- Kimberly Zolciak's Alleged New Big Popa
Do you want to know more about Kim's new Big Papa, Stefan Lemperle? He was removed by Artes Medical as CEO in 2006 for using his "wrinkle filler" ,ArteFill ,without FDA approval and for marketing the unapproved use of Artefill. He and his father were also sued by an individual for product liability, fraud, negligence and negligent misrepresentation. Based on the following, it appears that Stefan spent big bucks on his legal representation! So, after you read this excerpt from an SEC (Securities and Exchange Commission) filing by Artes Medical Inc. on 11/27/06, you will learn that he is no longer involved in the wrinkle filler business, and it was not his idea to retire as CEO! Maybe we will learn more in 2008. My guess is that Stefan wants to stay under the radar."In August 2005, Elizabeth Sandor, an individual residing in San Diego,California, filed a complaint against us, Drs. Gottfried Lemperle, StefanLemperle and Steven Cohen in the Superior Court of the State of California forthe County of San Diego. The complaint, as amended, set forth various causes ofaction against us, including product liability, fraud, negligence and negligentmisrepresentation, and alleged that Dr. Gottfried Lemperle, our co-founder,former Chief Scientific Officer and a former member of our board of directors,treated Ms. Sandor with Artecoll and/or ArteFill in violation of medicallicensure laws, that the product was defective and unsafe because it had notreceived FDA approval at the time it was administered to Ms. Sandor, and thatMs. Sandor suffered adverse reactions as a result of the injections. Inaddition, the complaint alleged that Dr. Gottfried Lemperle and his son, Dr.Stefan Lemperle, our other co-founder, former Chief Executive Officer and aformer director, falsely represented to her that the product had received anapprovability letter from the FDA and was safe and without the potential foradverse reactions. The complaint also alleged medical malpractice againstDr. Cohen, the lead investigator in our U.S. clinical trial, for negligence intreating Ms. Sandor for the adverse side effects she experienced. Ms. Sandorsought damages in an unspecified amount for pain and suffering, medical andincidental expenses, loss of earnings and earning capacity, punitive andexemplary damages, reasonable attorneys' fees and costs of litigation. OnJune 1, 2006, the parties filed a stipulation to dismiss the case withoutprejudice and toll the statute of limitations. The case was dismissed on June 5,2006, and the plaintiff is allowed to refile the case at any time within18 months from that date.During our recent negotiations with the parties involved in the Sandorlitigation, Dr. Gottfried Lemperle informed us that his counsel had contacted aninvestigator in the FDA's Office of Criminal Investigations to determine whetherany investigation of Dr. Gottfried Lemperle was ongoing. In March 2006,Dr. Gottfried Lemperle's counsel informed us that an investigator at the FDAinformed her that the FDA has an open investigation regarding us, Dr. GottfriedLemperle and Dr. Stefan Lemperle, that the investigation had been ongoing formany months, that the investigation would not be completed within six months,and that at such time the investigation is completed, it could be referred tothe U.S. Attorney's Office for criminal prosecution. In November 2006, wecontacted the FDA's Office of Criminal Investigation. That office confirmed theongoing investigation, but declined to provide any details of the investigation,including the timing, status, scope or targets of the investigation.To our knowledge, prior to, or following this inquiry, neither Dr. GottfriedLemperle, Dr. Stefan Lemperle nor any of our current officers or directors hasbeen contacted by the FDA in connection with an FDA investigation. As a result,we have no direct information from the FDA regarding the subject matter of thisinvestigation. We believe that the investigation may relate to the facts allegedin the Sandor litigation and the following correspondence from and to the FDA.In July 2004, we received a letter from the FDA's Office of Complianceindicating that the FDA had received information suggesting that we may haveimproperly marketed and promoted ArteFill prior to obtaining final FDA approval.In addition, we received a letter from the FDA's MedWatch program, the FDA'ssafety information and adverse event reporting program, on April 21, 2005, whichincluded a Manufacturer and User Facility Device Experience Database, or MAUDE,report. The text of the MAUDE report contained facts similar to those alleged bythe plaintiff in the Sandor litigation.We responded to the FDA's correspondence in August 2004 and again in May2006. In our responses, we informed the FDA that based on our internalinvestigations, Dr. Gottfried Lemperle had used Artecoll, a predecessor productto ArteFill, on four individuals in the United States. Artecoll has beenmanufactured and sold by third parties outside the United States under a CE marksince 1996. In 2004, we acquired all worldwide intellectual property rightsrelated to Artecoll. Following this acquisition, we requested these thirdparties to cease manufacturing their product named Artecoll. We currently do notmanufacture, and we have never manufactured, distributed or received anyrevenues from Artecoll. We initially named the product used in our clinicaltrials as Artecoll, but later changed the name of our product candidate toArteFill to reflect refinements that we have made to the PMMA microspheremanufacturing process following our acquisition of the rights to Artecoll.We stated in our correspondence to the FDA that we found no evidence thatany of the Artecoll used in the U.S. clinical study was used improperly beforeor after receipt of the approvable letter from the FDA in January 2004. We alsoinformed the FDA that we could not conclusively determine the source of theArtecoll used on these individuals, that Dr. Gottfried Lemperle's use ofArtecoll was not part of a study or any activity sponsored by us and thatDr. Gottfried Lemperle had resigned from his position as Chief ScientificOfficer and as a member of our board of directors. In addition to ourcorrespondence to the FDA, we also informed the FDA of these matters during itsinspection of our manufacturing facilities in San Diego, California in April2006. In May 2006, we received the FDA's EIR for its investigation of our SanDiego manufacturing facility. The EIR referenced two anonymous consumercomplaints received by the FDA. The first complaint, received by the FDA inDecember 2003, alleges that Dr. Stefan Lemperle promoted the unapproved use ofArteFill, providing, upon request, a list of local doctors who could performinjections of ArteFill. The second complaint, received by the FDA in June 2004,alleges complications experienced by an individual who had been injected withArteFill by Dr. Gottfried Lemperle in his home. The second complaint furtheralleges that Dr. Stefan Lemperle marketed unapproved use of ArteFill. In May2006, we terminated Dr. Gottfried Lemperle's consulting relationship with us.Dr. Gottfried Lemperle no longer provides services to us in any capacity. InOctober 2006, our board of directors removed Dr. Stefan Lemperle from theposition of Chief Executive Officer, and in November 2006, Dr. Stefan Lemperleresigned as a director and employee. Dr. Stefan Lemperle no longer providesservices to us in any capacity.In July 2006, the FDA requested us to submit an amendment to our pre-marketapproval application for ArteFill containing a periodic update covering the timeperiod between January 16, 2004, the date of our approvable letter, and the dateof the amendment. The FDA requested our periodic update to include, among otherthings, all information available to us regarding individuals who had beentreated with Artecoll outside our clinical trials and any adverse events theseindividuals had experienced. In response to this request, we completedadditional inquiries regarding Dr. Gottfried Lemperle's unauthorized uses ofArtecoll outside our clinical trials in contravention of FDA rules andregulations. In August 2006, we filed an amendment to our pre-market approvalapplication that included the periodic update requested by the FDA. In theamendment, we informed the FDA that as a result of our additional inquiries, wehad identified nine individuals who had been treated with Artecoll in theUnited States by Dr. Gottfried Lemperle, four of whom we had disclosed to theFDA in our prior correspondence. We also informed the FDA that 16 individualshad been treated with Artecoll by physicians in Mexico or Canada, where Artecollis approved for treatment, in connection with physician training sessionsconducted in those countries. Further, we informed the FDA that Dr. Stefan M.Lemperle, our then serving Chief Executive Officer and director, had beeninjected with Artecoll in the United States in 2004 by his father, Dr. GottfriedLemperle. Prior to the time we conducted the additional inquiries to prepare ourperiodic update for the FDA, Dr. Stefan M. Lemperle had failed to disclose tous, and to the FDA, that he had been injected with Artecoll in contravention ofFDA rules and regulations. In October 2006, our board of directors removedDr. Stefan Lemperle from the position of Chief Executive Officer, and inNovember 2006, Dr. Stefan Lemperle resigned as a director and employee.Dr. Stefan Lemperle no longer provides services to us in any capacity. We received FDA approval to market ArteFill on October 27, 2006. "

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