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Entries in : Medical Spa Legal (50)

Friday
Jul302010

Medical Spa Horror Stories: Woman Dies From Silicone Butt Injections

Illegal medical spas and filler injection services are up and running, and actually killing people.

If it weren't bad enough that there are websites marketing "do it yourself Botox injections" and "filler injection kits" for home use, there are still people out there who are willing to go to a motel room and have non-physicians inject them will industrial silicon.

Two sisters who were selling Botox, filler injections, and butt augmentation in motel rooms are now on the run. Police say they performed illegal cosmetic surgery from inside their residential home and are the cause of one woman’s death.

Some of their patients (victims) went to police after experiencing infections and hardened body parts after receiving silicon injections. One woman, 22-year-old Mayra Lissette Contreras, would die from respiratory failure a day after getting some silicone shots in her buttocks. The sisters were arrested and charged with practicing medicine without a license but were released on bond and have probably fled to Mexico (see below). 

There's always plenty of  smartass advice to give to anyone who may ever contemplate injecting themselves with fake botox or getting cosmetic surgery while bent over someone’s kitchen counter, but I just couldn’t do better than the advice given by by Deputy Chief Kirk Albanese. “If you are receiving an injection at a home in a residential area, that should be the first warning sign that you shouldn’t be there.” But I will add that whether or not a facility is residential or not,  it’s normally not a good idea to receive cosmetic treatment from a 50-year-old woman who looks like a creature commonly seen in movies being chased around by villagers with pitchforks.

Sisters sought after woman dies from silicone butt injections


Sisters Guadalupe Viveros, left, and Alejandra Viveros, above, allegedly ran an illegal cosmetic filler injection service and squirted silicon into anyone with a check book.

Guadalupe Viveros, 53, and Alejandra Viveros, 50, may have fled the country after Mayra Lissette Contreras, 22, of Pacoima died Friday after receiving the injection, police said. An autopsy was pending Wednesday, said Ed Winter of the Los Angeles County coroner's office. Initial reports indicated that Contreras died from respiratory distress.

The Viveros sisters were investigated last month by the Los Angeles Police Department after other patients complained that the fillers, typically injected in the face or the buttocks, made them ill. The sisters were taken into custody June 21 for practicing medicine without a license, police said. They were held on $20,000 bail before being released.

They were supposed to be arraigned on Monday, but they skipped their arraignment. Police realized that they are probably on the run, and since the two women have connections in Mexico, authorities suspect they have fled south.

Police say the Viveros sisters are not doctors. Neither is licensed to perform medical procedures in the United States.

They have been allegedly operating an illegal cosmetic surgery business and performing expensive procedures in their home rather than in a licensed operating room, cosmetic clinic or doctor`s office. Patients told police they developed infections and said the silicone used by the sisters turned to hard plastic once inside their body.

LA police are searching for these two women and believe they could be in Mexico. People with information on their whereabouts as well as victims are asked to come forward and contact the Los Angeles Police Department.

LA Times article

And if you thought this was a one-of-a-kind event...

San Diego transgender woman dies after illegal silicone injections.

A 45-year-old transgender woman who received illegal silicone injections at a party in a private home in San Diego has died after nearly a month on life support, the county medical examiner said on Monday.

Patricio Gonzalez, who police said received silicone injections to her hips, buttocks, cheeks and lips, died on Sunday. Gonzalez and at least nine other people were injected at a so-called "pumping party" on June 19, police said.

"Pumping parties," where people seeking a more feminine appearance have silicone injected into their bodies, have been on the upswing in the last few years, experts say. The silicone used at the parties is often industrial-grade material like floor sealant.

The Food and Drug Administration banned direct injections of silicone in 1992 and the substance has been known to migrate within the body and cause chronic, degenerative illnesses.

Gonzalez and another transgender woman received more silicone than the other party guests and suffered immediate respiratory problems, prompting the Los Angeles-area woman who was administering the silicone to flee, police said.

Police have issued an arrest warrant for Sammia "Angelica" Gonzalez, 39, who was injecting the party guests with silicone, is believed to have fled to Mexico.

Transgender women often have humiliating experiences with traditional surgery clinics, and surgeons often require a psychological exam before they will consider treatment.

Article

Monday
Jul192010

Is Suing Your Medical Spas Patients Ever A Good Business Strategy?

Your medical spa or laser clinic is going to be the target of negative reviews at some point. How are you going to deal with unhappy patients who have a forum?

In the aesthetic medicine business, reputation management is a big deal. First, of course, you want to do good work for your patients. You want them to be happy with the results, and then you want them to tell all of their friends how happy they are. Good reputations take time to build, but bad ones can be made very quickly. A California plastic surgeon is now dealing with the fallout of some bad online reviews by taking legal action against the people who posted them.

Unhappy patients aren't anything new, but the Internet, with it's assortment of social media and consumer review sites give grudge-holding patients a significant amount of power. A few of those patients recently vented their opinions of Greenbrae, CA, plastic surgeon Kimberly Henry, MD, on consumer rating sites Yelp.com and DoctorScorecard.com. The doctor, in return, sued the patients.

What may have begun as a consumer rant--the sort that goes on every day about restaurants, car dealerships and plumbers-just got serious. According to an article in the Contra Costa Times, Dr. Henry is currently seeking injunctions against 12 reviewers, allegedly former patients, for libel, defamation, invasion of privacy and interference with prospective economic advantage. The doctor is seeking $2 million in damages plus other unspecified costs.

Earl Thurston, the proprietor of DoctorScorecard, confirmed that he provided Nordskog e-mail and IP addresses of Henry critics in January, but has not done so since. Nordskog's subpoena was the first he had ever received.

"I was inexperienced with the law and the way the court system works," Thurston said. "I assumed that if a judge ordered that I provide the information, that I was required to do so by law."

Since then, another lawyer sent him a subpoena for user information for a similar lawsuit in Texas. Thurston said he is fighting the subpoena with the help of Public Citizen, a nonprofit consumer advocacy organization in Washington D.C.

"I spent many hours reading online about the legal process and came to the conclusion that I could fight to keep our users anonymous, even if a judge orders us to reveal their identities," Thurston said.

Stephanie Ichinose, a spokeswoman for www.Yelp.com, a site that posts user reviews on numerous subjects, noted that a similar case played out last year in San Francisco. In that case, dentist Gelareh Rahbar filed a defamation suit against Jennifer Batoon, a patient who wrote a negative review about the dentist on Yelp.com.

"The judge threw out the defamation counts and ordered Rahbar to pay $43,000 for Batoon's legal fees," Ichinose said.

The claim was dismissed because of California's law against so-called SLAPPs - strategic lawsuits against public participation - which are lawsuits aimed to squelch free speech. Batoon was represented by the California Anti-SLAPP Project, a public interest law firm in Berkeley.

John Diamond, a professor at University of California, Hastings College of the Law, in San Francisco, said forum providers such as Yelp.com are immune from defamation suits, and that anti-SLAPP laws provide some protection for online commentators.

But Diamond, who has no knowledge of Henry's case, said reviewers can be held liable if they assert "false facts, not just opinions."

"They actually have to commit defamations, and that is something that is false and damaging to reputation," said Diamond, a Tiburon resident. "I think what's happened is many more people have a forum now to make comments and have a impact. Previously there haven't been that many opportunities."

This guest post is written by Grant Clauser, Editor of Healthy Aging Magazine. Read Grant's post: Plastic Surgeon Strikes Back At Online Reviews on the Healthy Aging blog.

Submit a guest post and be heard.

Friday
Jul022010

Thermage Repetitive Motion Lawsuit

Thermage has been sued by a Dr. Supriya Goyal Bellew on for negligence, strict products liability, and breach of implied warranties.

To be honest this looks somewhat bogus, with a physician claiming that the design of the Thermage handpeice caused recurring pain and that Thermage was negligent. You'll want to read the entire finding though. It's interesting stuff; especially the findings that preclude summary judgement.

GOYAL v. THERMAGE, INC.

SUPRIYA GOYAL, Plaintiff,
v.
THERMAGE, INC., Defendant.

Civil No. WDQ-08-0020.

United States District Court, D. Maryland, Northern Division.

July 1, 2010.

MEMORANDUM OPINION

WILLIAM D. QUARLES Jr., District Judge.

Dr. Supriya Goyal Bellew[ 1 ] sued Thermage, Inc. ("Thermage") for negligence, strict products liability, and breach of implied warranties. For the following reasons, Thermage's motion for summary judgment will be granted in part and denied in part, and Bellew's motion to strike will be denied.

I. Background[ 2 ]

On September 1, 2004, Bellew began working at the Maryland Laser, Skin, and Vein Institute ("MLSVI") as a cosmetic dermatology research fellow. Bellew Dep. 90:17-91:3. Within her first month at MLSVI, Bellew began treating patients using the ThermaCool device developed by Thermage to reduce the signs of aging in skin. Id. 124:3-16.[ 3 ] Dr. Robert Weiss[ 4 ] and his wife Dr. Margaret Weiss—both physicians at MLSVI—taught Bellew how to use the device. Id. 130:9-10; Margaret Weiss Dep. 174:2-8.[ 5 ]

The ThermaCool device has a handheld component (the "ThermaCool handpiece"), which the operator holds to the patient's skin while pressing a manual button or a foot pedal to deliver radio frequency pulses. Pl.'s Dep. 111:8-112:5, 135:4-7. After instructing Bellew on its proper use, Robert Weiss observed her using the ThermaCool handpiece and told her that she "was doing everything properly and appropriately and delivering treatments the way that they were supposed to be done." Id. 131:21-132:6. The design of the handpiece required Bellew to hold her wrist and arm "in a bent, flexed position at a very odd angle for the entire treatment," id. 112:7-10,[ 6 ] and several physicians at MLSVI, including Bellew and Robert Weiss, commented that the device was "awkward" to use, id. 134:9-20.

In October or November 2004,[ 7 ] Bellew began to have soreness and pain, which she associated with her use of the ThermaCool device. Id. 208:13-20. At first, she experienced temporary soreness in her right hand, arm, shoulder, and neck, but her symptoms progressed to intermittent "shooting pain" and "clawing up of [her] ring and pinky fingers" for up to a few days after she performed a Thermage treatment. Id. 206:14-21, 208:13-20. Bellew mentioned these symptoms to the Weisses, who told her that they experienced similar pain and that it was "normal and not anything unusual." Id. 152:16-21. Upon the Weisses' advice, Bellew took over-the-counter pain medications and rested her arm, which completely relieved her symptoms. Id. 151:17-20, 153:8-11. Because the pain was transient and manageable with Advil, Bellew attributed her discomfort to use of new muscle groups that she had not previously used and "did [not] really worry about it." Id. 151:3-20.

On January 4, 2005, Bellew delivered almost 1200 pulses during two Thermage treatments, id. 170:6-8, 209:3-5, and developed pain that was different and more severe than her previous pains, id. 213:18-214:4.[ 8 ] That evening, Bellew wrote to the Weisses to explain that she had "shooting pains and muscle spasms in [her] right hand and wrist," which she attributed to the ThermaCool handpiece. Def.'s Ex. 7 (Jan. 4, 2005 e-mail from Bellew).[ 9 ] On January 5, 2005, Bellew wrote again to say that she was "concerned about nerve damage," planned to schedule an orthopedics appointment, and would not be able to perform Thermage treatments until her hand had healed. Def.'s Ex. 6.[ 10 ]

On January 18, 2005, Dr. Thomas Brushart diagnosed Bellew with "irritation [of her] right ulnar nerve secondary to repetitive motion," which "appear[ed] directly related to her use of the Thermage machine." Pl.'s Ex. 8 at GOYAL:JHH:0010. Although Bellew never again used the Thermage device, her ulnar neuropathy and a resulting chronic pain syndrome have persisted. Pl.'s Dep. 51:13-20, 52:8-17, 209:15-16.

On January 2, 2008, Bellew sued Thermage for negligence, strict products liability, and breach of the implied warranties of merchantability and fitness for its ordinary purpose. Paper No. 1. On March 20, 2008, Thermage moved to dismiss the breach of warranty claims, Paper No. 5, and answered the other claims, Paper No. 6. On June 5, 2008, Judge Andre M. Davis denied the motion to dismiss and ordered Thermage to file an amended answer by June 19, 2008. Paper No. 12.[ 11 ] On October 31, 2008, Judge Davis granted Thermage's motion to amend its answer to include several new affirmative defenses. Paper No. 32. On November 18, 2009, Thermage moved for summary judgment. Paper No. 55. On February 23, 2010, Bellew moved to strike the statute of limitations defense to the implied warranty claims from the motion for summary judgment. Paper No. 66.

II. Analysis

A. Standard of Review

Under Rule 56(c), summary judgment "should be rendered if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). In considering a motion for summary judgment, "the judge's function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). A dispute about a material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. at 248. The Court must "view the evidence in the light most favorable to . . . the nonmovant, and draw all reasonable inferences in h[is] favor," Dennis v. Columbia Colleton Med. Ctr., Inc., 290 F.3d 639, 645 (4th Cir. 2002), but the Court also "must abide by the affirmative obligation of the trial judge to prevent factually unsupported claims and defenses from proceeding to trial," Bouchat v. Baltimore Ravens Football Club, Inc., 346 F.3d 514, 526 (4th Cir. 2003).

B. Statute of Limitations for Breach of Warranty Claims

Thermage argues that Bellew's breach of warranty claims are barred by the four-year statute of limitations. Def.'s Summ. J. Mot. 10-11. Bellew moved to strike this affirmative defense from the motion for summary judgment, arguing that Thermage waived this defense by not timely raising it. Paper No. 66 at 6-12.[ 12 ]

Generally, a defendant waives the statute of limitations by failing to raise that defense in its answer or a pre-answer motion. See Fed. R. Civ. P. 8(c) & 12(b); Erline Co. S.A. v. Johnson, 440 F.3d 648, 653-54 (4th Cir. 2006). However, the court will "freely give leave" to amend pleadings "when justice so requires." Fed. R. Civ. P. 15(a)(2). The Court previously considered and rejected Bellew's argument that Thermage waived the statute of limitations defense by failing to raise it in the original answer and allowed amendment of the answer to include that defense. See Paper No. 28 at 13-14; Paper No. 32. Because Thermage asserted the statutes of limitations as an affirmative defense in its amended answer, see Paper No. 24, Ex. 2 at 10,[ 13 ] that defense was not waived and may be raised on summary judgment. Accordingly, her motion to strike the breach of implied warranties claims will be denied.

Under Maryland law, "[a]n action for breach of any contract for sale must be commenced within four years after the cause of action has accrued." Md. Code Ann., Com. Law § 2-725(1). Generally, a cause of action for breach of warranty accrues "when tender of delivery is made." Id. § 2-725(2). But if "a warranty explicitly extends to future performance of the goods and discovery of the breach must await the time of such performance [then] the cause of action accrues when the breach is or should have been discovered." Id.

Here, no explicit warranty extended the implied warranties to future performance of the Thermage device. Thus, a timely filing would have required Bellew to have been injured by a device delivered between January 2, 2004[ 14 ] and January 4, 2005.[ 15 ] Shipment records indicate that Thermage delivered a ThermaCool system to MLSVI in 2002; no Therma-Cool system handpieces were delivered to Dr. Robert Weiss or MLSVI from January 1, 2004 to January 5, 2005. Julie Hill Aff. ¶¶ 3-6, Nov. 16, 2009. Because Bellew did not bring her breach of warranty claims within four years of the ThermaCool handpiece's delivery, those claims are barred by the statute of limitations.

C. Statute of Limitations for Tort Claims

Thermage argues that Bellew's tort claims are barred by the three-year statute of limitations. Def.'s Mot. Summ. J. 11-18. Bellew argues that this issue cannot be decided on summary judgment because there is a question of fact about when the limitations period began. Pl.'s Summ. J. Opp. 8-33.

Under Maryland law, "[a] civil action at law shall be filed within three years from the date it accrues" unless otherwise provided by another Code provision. Md. Code Ann., Cts. & Jud. Proc. § 5-101.[ 16 ] To determine when a cause of action "accrues," Maryland follows the "discovery rule," which starts the limitations period when the plaintiff had notice of a claim. Pennwalt Corp. v. Nasios, 314 Md. 433, 550 A.2d 1155, 1165 (Md. 1988). Notice requires actual knowledge, either express or implied, of the facts underlying the cause of action. Id. at 1160, 1165-66.[ 17 ] Accordingly, in a products liability tort action, "the statute of limitations [does] not begin to run until the plaintiff knows or through the exercise of due diligence should know of injury, its probable cause, and either manufacturer wrongdoing or product defect." Id.

"[T]he party raising a statute of limitations defense has the burden of proving that the cause of action accrued prior to the statutory time limit for filing the suit." Newell v. Richards, 323 Md. 717, 594 A.2d 1152, 1156 (Md. 1991). To show that a plaintiff was on inquiry notice of her potential claim, the defendant must prove that "(1) the plaintiff[] knew of facts sufficient to cause a reasonable person to investigate further, and (2) a diligent investigation would have revealed that the plaintiff[]" suffered injury probably caused by the defendant's wrongdoing. Pennwalt, 550 A.2d at 1163-64; Quillin v. C.B. Fleet Holding Co., No. CCB-07-00503, 2007 WL 3103903, at *3 (D. Md. Oct. 11, 2007). "[Q]uestions of fact on which a limitations defense will turn are to be decided by the jury or, when sitting as a jury, by the court." O'Hara v. Kovens, 305 Md. 280, 503 A.2d 1313, 1323 (Md. 1986).[ 18 ]

Because Bellew filed this suit on January 2, 2008, her tort claims must have accrued on or after January 2, 2005 to be within the limitations period. The parties dispute when Bellew knew or should have known that she was injured and had a potential claim against Thermage.

Bellew argues that she was not on notice of her injury until January 4, 2005. In support of that position, she has produced an affidavit and deposition from one of her treating neurologists at Johns Hopkins, Dr. Beth Murinson. See Pl.'s Ex. 2 & 3. In her deposition, Murinson explained that neuropathic nerve injury can be difficult to diagnose and requires a "correlation of medical history with . . . diagnostic testing." Beth Murinson Dep. 113:9-13, 115:5-17, Jan. 13, 2010.[ 19 ] Murinson has testified that the symptoms Bellew experienced in 2004 may have "indicat[ed] that [her] ulnar nerve was being temporarily compressed" but that such "[m]inor temporary compression of the ulnar nerve does not ordinarily result in clinically significant injury to the nerve." Beth Murinson Aff. ¶ 7, Jan. 13, 2010. She further explained that "[t]here is no medical evidence . . . to prove . . . with certainty, that [Bellew] suffered a clinically significant, permanent injury during the initial period of months when she first used the Thermage device." Id. ¶ 7; Murinson Dep. 200:21-202:17, 205:2-14. By contrast, the severe and unabating pain that Bellew experienced on and after January 4, 2005, was indicative of a "clinically significant injury." Murinson Aff. ¶ 8; Murinson Dep. 111:16-113:6.

Consistent with Murinson's testimony, Bellew stated that, until January 4, 2005, she attributed her symptoms to normal pain associated with exercising new muscle groups. Her conversations with Thermage-experienced physicians, the transient nature of her symptoms, and her ability to gain relief using over-the-counter pain medications further reinforced her belief that the pain was "normal" and nothing to worry about. Although she may have known that the Thermage device was "conducive to developing a repetitive use injury" before January 4, 2005, Bellew did not suspect that she had suffered such an injury until that date.

Given this evidence, a reasonable jury could conclude that Bellew did not have notice of her injury until after January 2, 2005; accordingly, summary judgment must be denied.

D. Assumption of the Risk

Thermage argues that Bellew assumed the risk of injury because she recognized that the ThermaCool handpiece might cause a repetitive use injury and experienced symptoms of such an injury but continued to use the device until January 4, 2005. Def.'s Summ. J. Mot. 18-19.

To establish the assumption of the risk defense in a products liability action, the defendant must show that the plaintiff (1) knew of and appreciated the risk of danger, (2) voluntarily confronted that risk, and (3) was unreasonable in her decision to encounter the known risk. Ellsworth v. Sherne Lingerie, Inc., 303 Md. 581, 495 A.2d 348, 356 (Md. 1984).[ 20 ] The test of whether the plaintiff knew of, appreciated, and voluntarily confronted "the risk involved in a particular situation is an objective one . . . and ordinarily is a question to be resolved by the jury." Morgan State Univ. v. Walker, 397 Md. 509, 919 A.2d 21, 24, 26-27 (Md. 2007)(internal citations omitted). But, "when it is clear that a person of normal intelligence in the position of the plaintiff must have understood the danger, the issue is for the court." Schroyer v. McNeal, 323 Md. 275, 592 A.2d 1119, 1123 (Md. 1991).[ 21 ] If established, assumption of the risk is "a complete bar to recovery because `it is a previous abandonment of the right to complain if an accident occurs.'" ADM P'ship, 702 A.2d at 734 (quoting Warner v. Markoe, 171 Md. 351, 189 A. 260, 264 (Md. 1937)).

Here, the parties dispute, inter alia, whether Bellew appreciated the risk of danger and was unreasonable in her choice to continue delivering Thermage treatments until January 4, 2005. To support her argument that she did not fully appreciate the risk, Bellew has offered evidence that she (1) had limited experience with Thermage prior to her fellowship at MLSVI, (2) relied on the Weisses' assurance that her pains were "normal," (3) associated her symptoms in 2004 with new muscle use, and (4) used the device for only a few months before her injury occurred. Bellew also argues that, even if she appreciated the risk of danger, she has shown that her choice to continue delivering Thermage was reasonable because the Weisses had experienced similar pain without long-lasting injury and over-the-counter pain medication alleviated her pain entirely. Because a reasonable jury could find that Bellew did not assume the risk of her injury, summary judgment based on this defense must be denied.

III. Conclusion

For the reasons stated above, Thermage's motion for summary judgment will be granted as to the claims for breach of implied warranty and denied as to the negligence and strict liability claims.

The Thermage sumary judgement is here

Monday
May172010

Oklahoma Botox Case: Allergan loses $15 million judgement

Allergan lost a a$15 million dollar award to a physician who evidently had her 'friends' testify that she got botulism from Botox injections for wrinkles.

A jury Tuesday awarded $15 million to an Oklahoma City doctor who said she suffered botulism poisoning after using the popular anti-wrinkle drug Botox.

The Oklahoma County jury found 9-3 that Allergan Inc., the maker of Botox Cosmetic, was negligent. In civil cases, at least nine jurors must agree.

Jurors voted 10-2 to give Dr. Sharla Helton $15 million in actual damages. They did not award punitive damages.

"Hopefully, now people will wake up to the real dangers,” Helton, 48, said of the negligence verdict. "It’s a stepping stone for now for public awareness.”

Her attorney, Ray Chester, of Austin, Texas, said, "I think there’s a lot of people out there that have been hurt by the product and maybe now they’ll have the courage to come forward.”

Allergan that produces Botox plans to appeal.

"The negligence verdict … is inconsistent with all credible scientific and medical evidence,” said a company spokeswoman, Caroline Van Hove. "Botox does not cause botulism.”

Helton complained of severe side effects after getting injections of 50 units of Botox Cosmetic on July 14, 2006. It was her fifth treatment for wrinkles. She eventually sold her medical practice and stepped down as medical director of Lakeside Women’s Hospital in Oklahoma City because of pain and weakness.

Attorneys for Botox told jurors the drug does not cause botulism. They also told jurors the doctor never had botulism. They said the diagnosis of botulism came from her friends, who are not experts.

The trial took three weeks. Jurors were deadlocked 8-4 at one point Monday night after hours of deliberations. They deliberated about three hours more Tuesday.

The jury found Tuesday in Allergan’s favor on a second claim against it – that its product was somehow defective.

A key issue in the trial was whether Allergan gave sufficient warning in product labeling about possible problems from Botox Cosmetic use. The labeling in 2006 did not include botulism.

"All they care about is sales,” Chester told jurors in closing arguments Monday. "They were intentionally concealing this evidence.”

Allergan’s attorney, Vaughn Crawford of Arizona, argued that "every known and even remotely possible side effect was in the labeling.” He said the warning in 2006 even included the possibility of death. He said Helton still was willing to use it.

Jurors were instructed they could find negligence if they decided Allergan failed to act like "a reasonably careful pharmaceutical company would” under similar circumstances. One juror told The Oklahoman that the jury found negligence because Allergan’s 2006 product labeling did not have adequate information about side effects. The juror said the jury came to that conclusion after comparing a 2006 label with the 2009 label.

Millions have used Botox since the Food and Drug Administration first approved it in 1989. Helton said Tuesday she is still debilitated by weakness but hopes to get back to practicing medicine again in some way. story

I guess even physicians want to chase an ambulance when possible... Anyone have some thoughts?

Wednesday
May122010

Fake Botox: Houston physician sentenced

The fake Botox case in Houston comes to a close with this sentence handed down.

A Houston, Texas physician was sentenced to five months and 15 days in federal prison and three years of supervised release for injecting patients with fake Botox, prosecutors said on Friday.

Dr. Gayle Rothenberg is a local physician specialized in providing image enhancement services. She was also ordered to pay $98,426 in restitution to her affected patients. As a condition of supervised release, Rothenberg is prohibited from seeking reinstatement of her medical license.

Rothenberg and her former husband, Saul Gower, a local attorney, operated The Center for Image Enhancement located at 2000 Bering Drive in Houston.

Rothenberg ordered and administered a drug called Botulinum Toxin Type A that was labeled with the warning “FOR RESEARCH PURPOSES ONLY, NOT FOR HUMAN USE.” Despite this label, Rothenberg injected more than 170 patients with the substance and represented to patients that they were receiving Botox Cosmetic, manufactured by Allergan Inc.

Rothenberg also admitted that she advertised in brochures, magazines and websites that she specialized in treating facial wrinkles with Botox Cosmetic, even though she intentionally stopped ordering it due to the price increase in 2004 and began ordering the unapproved drug from a company named Toxin Research International because it was half the price of the other. She admitted that she did not tell her patients that they were receiving a different substance.

Gower pleaded guilty in 2008 to misbranding of a drug while being held for sale and making false statements to an agent. He then, cooperated with agents and testified against his ex-wife in exchange for a sentence of 4 years’ probation.

Friday
Mar192010

Son Of Botax

I was just reading the text of the proposed changes to the Healthcare reform bill. Hidden in the middle of dozens of pages is this gem:

IN GENERAL.—There is hereby imposed on the sale of any taxable medical device by the manufacturer, producer, or importer a tax equal to 2.9 percent of the price for which so sold.

Well guess what, people - Mr. Obama & company may have backed off on the 10% cosmetic surgery tax, but he's still sticking it to you with a 2.9% tax on implants and surgical supplies.  It would also increase the cost of lasers, liposuction equipment, and many other surgical and anesthesia supplies we all use.

That's in addition to the additional 3.9% tax you'll be paying for any profit on investment income. So, if you invested and "saved your pennies" like an honest, hard-working American, you might be penalized up to 6.8% for having cosmetic surgery!

This tax also would apply to pacemakers, stents, heart valves, cataract lenses, artificial hip & knee implants, motorized wheelchairs, and implantable defibrillators. As if these things weren't expensive enough! It's the "Son-of-Bo-tax". Boo!!!

From:  Tom Fiala, MD

Wednesday
Jan132010

The "Donda West Law" is in Effect

On January 1st the State of California put into effect the “Donda West Law”.

For those of you who are not aware of the details behind this law, Donda West was the mother of the much controversial rapper, Kanye West (the one who went up on stage and made an a** of himself when Taylor Swift was receiving her award).

Cosmetic Surgery Times reports that in 2007, Donda West died a day after she underwent an 8 hour procedure for breast reduction, liposuction and a tummy tuck. The L.A. County Coroner stated that Donda died of "coronary artery disease and multiple post-operative factors due to or as a consequence of liposuction and mammoplasty." Apparently, the autopsy results showed Donda died of pre-existing coronary artery disease and “multiple post-operative factors” a day after the procedures. The surgeon who operated on Donda surrendered his medical license in April.

The Donda West Law prohibits doctors from performing elective cosmetic surgery without a physical examination and clearance from a medical professional. The law requires an “appropriate” physical exam within 30 days before a procedure and “written clearance” from a doctor, nurse practitioner or physician’s assistant before cosmetic surgery is performed.

"Clearance of a medical professional" is the confusing part of the equation. Apparently, the plastic surgeon who performed her procedure wasn't declared a "medical professional" in the eyes of the lawmakers. For those practitioners who are currently performing invasive and minimally invasive procedures (such as laser liposuction) in other States, if you are not doing so already, you may want to re-evaluate your pre-operative procedure to include a physical examination, blood work and possibly a sign off from the patient's PCP or cardiologist.

In the infamous words of the sergeant on the 1981 episodes of "Hill Street Blues", "be careful, it's a jungle out there"!

Author: Paula D. Young RN runs internal operations and training at Young Medical Spa and is the author of the Medical Spa Aesthetics Course, Study Guide, and Advanced IPL & Laser Training course for medical estheticians and laser technicians.

Submit a guest post and be heard.

Monday
Dec142009

Nu U Medical Spas Sued By Illinois State Attorney General

Attorney General Lisa Madigan has filed a lawsuit against the Chicago-area medical spas, Nu U Med Spas, for performing unapproved procedures without a physician's supervision and luring patients through deceptive marketing.

This looks like it started with an expose by local Chicago television news.

The seven NuU Medspas in the Chicago area aggressively promote Lipodissolve, a series of injections that supposedly will melt your fat away.

The ads talk about reduced inches with no knives, no tubes, and no pain -- a deceptive ad, patients say.

NuU does not tell clients that Lipodissolve is not approved by the Food and Drug Administration.

"There is no study out there that shows clearly whether it works and what specifically are the risks of it," said Northwestern Memorial Hospital's Dr. Michael Lee.

That's not a problem, said NuU district supervisor Laura Rowsey, formerly a modeling school sales manager.

"This is a soy-based mineral with amino acids," Rowsey said. "Bruising and swelling is like your worst case scenario with this treatment."

But doctors have seen a number of Lipodissolve complications.

Cynthia Sacramento, who went to the Lincoln Park spa, suffered painful scar tissue buildup around her injection site that will require surgery.

Dr. David Song of University of Chicago Hospital said the entire injection area will have to be excised.

Sacramento said she's devastated.

Even proponents say Lipodissolve is for treating pockets of fat, not for bigger weight problems.

NuU in Lincoln Park signed another former client, who preferred to remain anonymous, up for $2,400 in treatments on his belly.

"I think it's a big scam, a waste of money," he said. "The only thing that got thin on me was my wallet."

NuU sales people are pressured to meet sales goals and arrange for many clients to finance their treatments. The money is collected up front and NuU claims it's not refundable.

"Our goal was to get $15,000 a day," said former NuU spa manager Patti Feinstein.

Feinstein recalled how Rowsey scolded her for turning away a skin cancer patient saying, "You are not going to make quota if you don't sell," Feinstein said.

Records show her spa sold made more than $200,000 a month.

Ouch. You have to love how a reporter makes a point of stating that the Nu U spokesperson was fromerly a sales manager for a modeling school. Looks like another slap-down for Nu U Medspas. Madigan's complaint claims that Nu U Med Spas try to lure customers into buying "Lipodissolve, which is an injected therapy used to dissolve fat cells." Here's the full press release:

MADIGAN FILES LAWSUIT AGAINST CHICAGO AREA Nu U MEDICAL SPAS

Attorney General Alleges Nu U Performed Unapproved Procedures Without Physician Supervision And Used Deceptive Marketing to Lure Patients

Chicago — Attorney General Lisa Madigan today filed a lawsuit in Cook County Circuit Court against Nu U Med Spas for deceptively marketing and performing unapproved, unsupervised cosmetic treatments that caused some patients to experience extreme pain and lasting injuries.

“These procedures have yet to be thoroughly researched and sanctioned by the proper medical authorities,” Madigan said. “Despite lacking concrete scientific evidence, Nu U purposefully misleads consumers into believing that their medical spa treatments are safe and effective. I’m very concerned that the health and safety of Illinois consumers who visit Nu U Med Spas are at risk.”

The Chicago-based medical spa chain allegedly uses high-pressure sales tactics based on deceptive marketing claims to induce consumers into purchasing a series of medical and beauty treatments, including Lipodissolve, which is an injected therapy used to dissolve fat cells, according to Madigan’s complaint. Nu U allegedly claims its treatments will “liquefy fat quicker” and can “rid your system of that life long battle of the bulge,” but Nu U fails to inform consumers that its treatments haven’t been approved by the U.S. Food and Drug Administration (FDA) as safe and effective treatments. Both the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons do not recommend using Lipodissolve for fat reduction due to the lack of research that shows its effectiveness.

Further, because Lipodissolve is an injected treatment, it requires a physician’s order, but Nu U allegedly administers the fat-reducing treatment without a doctor’s order. In fact, despite its outward claims, Nu U allegedly fails altogether to monitor and evaluate patients by licensed physicians at all seven of its Chicago area locations.

Madigan’s complaint further alleges that the Nu U personnel rush consumers into signing contracts, medical consent forms and financing documentation for treatments but fail to review the documents with consumers. The defendants allegedly pressure consumers to sign up for health care financing but fail to inform consumers that by signing the financial documentation they are authorizing an automatic credit card charge. Nu U allegedly refuses to provide refunds when requested, even in the event that a consumer has not received all of the contracted treatments.

Madigan’s lawsuit charges Nu U with violating the Illinois Food, Drug and Cosmetic Act, the Illinois Medical Practice Act and the Illinois Consumer Fraud and Deceptive Business Practices Act. It asks the court to permanently enjoin the defendants from owning or operating medical or beauty clinics in Illinois and to order the company to pay civil penalties of $50,000, an additional $50,000 penalty for each violation committed with the intent to defraud, an additional $10,000 penalty for each violation committed against a senior citizen 65 years of age or older, and the costs associated with the investigation and prosecution of the lawsuit.

To be honest, this looks like some grandstanding on the part of the Attorney General. Lipodissolve is used in perhaps thousands of medical spas and cosmetic practices around the country without 'painfull scar tissue build up' and complications.

And what does it actually mean when. "Dr. David Song of University of Chicago Hospital said the entire injection area will have to be excised."? An entire treatment area excised from needle sticks? Seems fishy to me. Might well be something of a hatchet-job.

Anyone have thoughts on this?

Wednesday
Oct212009

Medical Spa Lesson: The least recommend way for handling your medical spa PR problems.

Note: The identities that were in this post have been changed but the events are all as described.

A Medical Spa chain is not happy with what someone else has posted about them in the community forums of this site.

The negative comments are directed at one of the management team. I became aware of this medical spas concerns a few days ago after I received a string of emails from the medspa chain's 'CS Manager'. (Im guessing that CS is short for customer service.)

I can certainly understand why this medical spa is unhappy. Evidently the individual named in the comments was previously part of a failed franchise called Skin Nuvo and was one of three Skin Suvo operating officers who was sued by the SEC for 'Swindling investors of $11 million'. However, charges against the individual in question were dropped.

Here's an excerpt on the Skin Nuvo suit from the San Francisco Chronicle article:

Three men, including a Concord resident, were sued by the Securities and Exchange Commission on Wednesday on charges that they swindled more than $11 million from investors in a skin-care business that later filed for bankruptcy.

..."Skin Nuvo was projecting a glamorous image with their stores in very flashy and high-end malls, but beneath the surface, the company was in deep financial trouble," said Michael Dicke, an SEC supervising attorney.

Skin Nuvo, based in Henderson, has since filed for bankruptcy. During the alleged fraud from 2002 to 2004, the company's Bay Area stores -- which sold skin care and hair removal products -- were located in shopping malls in San Francisco, San Jose, Richmond, Concord, Corte Madera and Walnut Creek.

The SEC suit seeks to bar the men against any future violations of securities laws, a civil monetary penalty and the recovery of any ill-gotten gains.

So here's some of the emails that I received, and my response, over the course of the next three or four days. They start with an email from S.H. the CS (Customer Service?) Manager.

First email: S.H. of Nu U

Subject: Slanderous blog agiainst N.V./___ Medspa
Message: I need to speak with someone ASAP re: several slanderous remarks that have been made on your forum against N.V., owner of _____ Medspa.
Please contact me at 702-xxx-xxxx to discuss.

Thank you,
S.H.
CS Manager

My same-day response to S.H.:

Hello S,
What can I do for you?

S.H. want's to talk immediately. He's entirely too irate to just communicate that a comment may have gone over the line and violated Medical Spa MD's own terms. No, S.H. want's to talk. Now. Here's the next two emails:

Is it possible to call you?  Too much to put in an email.

S.H.

Jeff – there is a blog on your website re: N.V., owner of _____ Medspa.  The blog is dated 3/4/09 and is authored by “_____ Isn’t For You”.

The blog states Mr. V. only hires attractive females and then tries to date them / makes sexual advances towards them.  It goes on from there.

This is slanderous and libelous and a complete and total lie!  I am formally requesting this particular blog entry be removed immediately.  If you are unwilling to remove said blog then I will forward onto my legal department for further handling.  Please reply at your earliest convenience.

Thank you for your attention to this urgent matter.

S.H
CS Manager
_____ Medspa

I got another email amost immediately. Evidently my inability to grasp just how urgent this issue is and my lack of action in removing an anonymous post is getting under S.H's' skin. He dicides to forgo any more niceities and threaten me with his 'legal department'. Ouch. Here's S.H's next email.

This is slanderous and libelous and a complete and total lie! I am formally requesting this particular blog entry be removed immediately. If you are unwilling to remove said blog then I will forward onto my legal department for further handling. Please reply at your earliest convenience.

Have to give it to S, he's a silver-tongued devil. I mean, having an entire 'legal department' set on my like wild dogs? Terrifying.

So now I'm dealing with the 'legal department'. Here's what they sent.

Our firm, Kamensky Rubinstein Hochman & Delott, LLP, represents ___ medical spas.

Our client has informed us of various outrageous and defamatory blog postings/comments made on your website http://www.medicalspamd.com/ that impugn the character of Mr. N.V. of ___, specifically postings from "___ Isn't For You!" dated 3/4/09 and 4/10/09 and "former skin medique employee" dated 3/25/09.

In the March 4, 2009 posting, "__ _ Isn't For You!" falsely states that Mr. V only hires attractive females and then tries to date them or makes sexual advances towards them. In addition, "__ _ Isn't For You!" falsely states that if such sexual advances are not accepted, the employee does not get paid. In addition, in "__ _ Isn't For You"'s April 10, 2009 posting it falsely accuses __ _ of "multiple violations of state and federal labor laws, multiple instances of unwanted sexual advances and harassment." Similarly, "former skin medique employee" falsely states that Mr. V is "crooked," a "con artist," and "shady" and further falsely states that "if N.V. is involved . . . It is a scam from the word go."

This is not the type of content expected from a thoughtful website regarding medspas. Accordingly, we request that you immediately remove the postings posted by "__ _ Isn't For You!" dated 3/4/09 and 4/10/09 and "former skin medique employee" dated 3/25/09. We also request that you provide us with the names and all information in your possession relating to "__ _ Isn't For You" and "former skin medique employee."

Now isn't that nice? Within something like 72 hours we've progressed from a simple email request to this Medical Spas' demand that I turn over information on individuals who've made negative comments about them. This medical spa went from trying to get a single comment removed, to making the front page of Medical Spa MD. (Medical spas usually have to pay for that privledge.)

Of course this may not be the kind of publicity that __ _, S.H, and N.V wanted. I can't think that this medspa would really want the fact that one of their corporate officers was once sued by the SEC. But with the nasty-grams that S and his legal department are sending me it made me wonder what all the hubbub's about.

__ _ Medspa: Lessons for S.

Let me take a moment here and discuss what I think S could have done that would have better fit his medical spas business needs.

First: Don't take it personally. Every medical spa is going to have unhappy patients and ex-employees. You can't shut them up. Don't try. Perhaps they're unhappy for a reason. Your best bet is to engage in civil conversation. If you're making decisions on behalf of your medical spa or laser clinic, you need to keep your emotions out of the way. You're going to have dissagreements and sometimes they'll get personal. Don't let it affect your 'actions'. Medical Spa MD doesn't have any interest in harming this medical spa and no Medspa MD author wrote those comments.

But I wasn't responding fast enought to S and he took that as a slight. It wasn't. I don't know S and my first response, 'how can I help you', was an invitation for him to lay out his case. He didn't take advantage of that. Instead he lost focus on what he was trying to accomplish.

Second: Focus on your goal. Sean's goal was simply to get me to remove a comment. It's not unreasonable. I've done it before. I've removed any number of comments that attacked individuals in a way that had nothing to do with their business and was just an attempt to hurt them personally. I don't like those attacks and when I find them, I often remove them and at times, block an IP address so they can't make more.

S lost sight of the goal which was to get a comment removed. Instead, he switched his goal to getting to me. If he'd not been so agressive he'd probably have gotten the offending comment edited or removed. Instead, S pulled a gun by threatening me with his 'legal department'.

Third: Never pull a gun unless you intend to use it. S went nuclear when he had his 'legal department' fire off a demand. If S was smarter, he would have done his homework and seen that Medical Spa MD has been threatened many times by medical spa francises and their lawyers and knows well how to handel cyber-slap lawsuits. Read this Medical Spa MD post on cyberslap lawsuits, legal rights and anonymous comments on the web.

S went 'legal team' way, way too fast. I wasn't being unreasonable. I didn't tell him to 'go to hell'. It just wasn't at the top of my list of things to do. Medial Spa MD can get twenty or thirty contacts a day. I could care less that S demands to talk to me on the phone right away. Get in line. A single anonymous comment doesn't rise to the need of emergency care. S would have done much better with a simple, "I know you're busy" and a written explianation of his need to get a medspa comment removed.

__ _ Medspas legal team doesn't have a leg to stand on demanding information about people who comment on Medical Spa MD either. Anyone has a perfectly legal right to post anonymously on the web. Comments on Medical Spa MD are most commonly anonymous for exactly that reason. Physicians don't want to be held liable for the advice they give to other doctors, and laser technicians working at some laser clinic franchise don't want to lose their job.

Last: Never pull a gun on the person holding the mic. If you don't know what that means... From the begnning, S is making demands and acting pretty agressive, but he's only got one weak pair of twos (his 'legal team') and he plays them right away. Now he's got nothing left. If he's emailing some ex-employee that kind of intimidation might work, but not in this case.

By threatening Medical Spa MD and myself directly he's chosen to make an adversarial relationship when he needed a helpful one. While I don't have any axe to grind against S or __ _ Medical Spas, I don't really appreciate this kind of interaction. Any new threatening communications S or his 'legal department' they'll be posted right here on Medical Spa MD's front page where our 50,000 monthly visitors can decide for themseleves. (I can't think that any named Medspa's physicians will welcome questions about it.)

So where does that leave Medical Spa MD and __ _ medical spas?

For my part I'll put a quick notice up on the Medical Spa comments and take a look at them sometime in the next few days. If there's something that violates our terms, I'll edit or delete it.

I can't think that S has solved his Medical Spas business needs though.

Thursday
Mar192009

1800LaserHair.com: Another laser clinic directory wannabe spamming Med Spa MD.

Ok, I'm more than just a little tired of some of the bull shit that certain laser clinic and plastic surgery directories spamming the site and posting positive anonymous reviews of their services and laser hair removal listings.

So, there are about to be some very public spankings.

Medical Spa MD has attained some popularity, and some clout with physicians running laser clinics. I receive regular iquiries from docs looking for advice on cosmetic lasers and I personally know of a number of doctors who have printed out reviews from Med Spa MD and asked cosmetic laser sales reps about them. There are laser companies who are now Medspa MD members and (to my current understanding) are welcome members to the community.

However, there are some cheap laser clinc and plastic surgery directories that think that you're an idiot and post comments like those below. (There've also been some physicians offering their 'expertise' as trainers who have tried this to promote their training.) Don't. You've been warned.

1800laserhair.com: I don't know if 1800laserhair.com is posting these comments as part of their corporate policiy or if it's just a rogue individual salesman who's doing it for them. I also don't care. My guess is that they're some small little hack job outfit. It pisses me off personal that whoever this is thinks that this won't be found out.

Here's an example of laser clinc directory, 1800laserhair.com who posted this rave review to Med Spa MD under the name Dr. Don:

I have the two Candelas yag alexandrite and a light sheer diode. I use a service tech that is awesome and reasonable. I can't remember his name right off but I got his name from this great referral network I belong to. Call 1-800 Laser hair ask for Nancy or go to their website WWW.1800laserhair.com There may be a link but I think I got the guys name directly from Nancy. His name is Robert something... BTW anyone slow or having advertising or marketing issues, I am getting tons of referrals from the 1-800-laser hair network. You have to meet their criteria, they are very picky and exclusive but if they will accept you join!!! Two colleagues of mine were denied I am not sure why. The leads are great worth every dime. I resisted their advice at first, them I put my wife in charge of all of it, she followed their program to the letter now we are so overwhelmed with calls for laser (Not really what I want to be doing but I better not complain because laser hair removal is supporting my practice through this crappy economy. Nice plug for them...tell them Dr. Don sent you...I may get some referral bonus!! LOL

Back to Laser Hair removal service. I don't have a service contract. Don't get them. I regularly get laser check-ups. Robert (the service guy) calls my office when he is in my area. By getting him in when he is already in my area he gives me a break on service costs. I get the check-ups and do preventative laser maintenance. Also Nancy (the 1-800 laser hair removal lady) gave me a monthly weekly and daily check list that tells us how to properly maintain our lasers in between service visits. I have not had a significant laser repair cost in 7 years and I haven't had to replace a laser yet going on 10 years. After we got our staff to follow the checklist diligently we saw a significant drop in repair costs. My staff was going through thousands of dollars worth of parts yearly and I was watching our profits go to Candela, I too despise them. They have terrible service and they have been so shady. I think they would sell their grandmothers if they could make a buck!!! Their service contracts are totally over priced. bad plug!!

I really don't use the light sheer much but I keep it for a back up, just in case. Robert can usually fly in for emergency repairs next day. So I have never really needed it.

Posted As: DrDon

Posted Email: wtawtawdba@yahoo.com

Posted Link: www.1800laserhair.com

Comment Posted From This IP Address: user-24-96-114-40.knology.net (24.96.114.40)

I have to laugh at these claims of exclusivity. "You have to meet their criteria, they are very picky and exclusive but if they will accept you join!!!" Sure.

If I were Candela I'd be contacting my legal department about now. This is a perfect case of liable; posting damaging comments as fact under an assumed name. Candella can't be happy that these laser hair removal guys are bad-mouthing them and servicing their lasers at the same time.

Does anyone fall for these laser hair removal guys? I'd be interested in hearing what any identified physician using 1800laserhair.com thinks about their "tons of referrals from the 1-800-laser hair network."

If anyone has an email from 1800laserhair.com that they have archived in their inbox, I'd be interested in seeing it since the IP address is included. We could compare the two. I'd expect that they change their IP address shortly if they happen to match.

PS: This IP address has been banned.