Monday, August 31, 2009

Stella Awards, Part II

Good stuff from my friend Jere Beasley:

The annual Stella Awards list, a list of the years seven “most outlandish lawsuits and verdicts in the U.S.,” is nothing more than a fraud on the public. The so-called awards deal primarily with fiction, and many of the lawsuits listed never happened. The examples of what they describe as frivolous lawsuits are at best gross misstatements. The Stella Awards are just part and parcel of the carefully planned efforts designed to destroy the civil justice system. Once these awards are announced, they take on a life of their own. That’s because of the Internet. Unfortunately, the media never bothers to investigate the validity of the cases mentioned in the awards, and then write stories that keep the myths alive.

An example of how these myths orginate is this year’s runaway First Place Stella Award winner. Mrs. Merv Grazinski, of Oklahoma City, Oklahoma, who supposedly purchased a new 32-foot Winnebago motor home, was the winner. On her first trip home, from a football game, having driven on to the freeway, she set the cruise control at 70 mph and calmly left the driver’s seat to go to the back of the Winnebago to make herself a sandwich. Not surprisingly, the motor home left the freeway, crashed and overturned. Also not surprisingly, Mrs. Grazinski was supposed to have sued Winnebago for not putting in the owner’s manual that she couldn’t actually leave the driver’s seat while the cruise control was set. It was reported that an Oklahoma jury had awarded the woman $1,750,000 plus a new motor home. It was also said that Winnebago actually changed their manuals as a result of this suit, just in case Mrs. Grazinski has any relatives who might also buy a motor home. The e-mail that announced the award concludes: “Are we, as a society, getting more stupid?”

The truth is that this sort of nonsense relating to a Winnebago lawsuit never even happened. But, the media bought the story hook, line, and sinker, and never even bothered to check it out. Scores of articles – the vast majority buying the Winnebago story as gospel truth – resulted across the country. Apparently, few journalists bothered to do any research to determine whether they were true. Among outlets falling for the hoax were the New York Daily News, CNN and U.S. News & World Report. In fact, the story actually spread around the world. Readers in Canada, England, Australia, Ireland, New Zealand and even Vietnam heard about this fictitious lawsuit that never happened. To his credit, Los Angeles Times reporter Myron Levin, who wanted to learn more about the lawsuit, called Winnebago and found out there was no Grazinski lawsuit. He also learned that the company had not changed the owner’s manual to avoid a swarm of copycat claims as claimed by the Stella awards.

The next time an “Internet tale” makes you believe things are even worse than you thought, check it out. Especially when the story suggests that the American court system is stacked against wealthy Corporate America. If you want to check out the “Stella Awards” and decide for yourself whether they are on the level, a good place to go is, an excellent site that investigates urban myths. Simply search for “Stella Awards” and find out if the lawsuit stories are true or false.

Stella Awards -Fabricated

The Stella Awards® were inspired by Stella Liebeck, the Plaintiff in the McDonald's coffee case. Some folks may know that The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body,
including her inner thighs, perineum, buttocks, and genital and groin areas. She was hospitalized for eight days, during which time she underwent skin grafting. Liebeck, who also underwent debridement treatments, sought to settle her claim for $20,000, but McDonalds refused.

There are many debunked jury "award" reports linked to the claimed awards.

From their own site:

"Many stories are going around the 'net saying they are "The Stella Awards". Many of these stories are false, made-up, or (sometimes) true stories with false elements added to them.

The sad part: despite these stories having been debunked years ago, they not only still circulate, but many reporters, columnists and radio "personalities" still talk about them as if they were true, which says a lot about their professionalism. In many outrageous cases, these lazy "news" people will even link to this site as the source of these silly lies."

Claimed Cases -Status:

Kathleen Robertson of Austin, Texas, was awarded $780,000 by a jury after breaking her ankle tripping over a toddler who was running amuck inside a furniture store. The owners of the store were understandably surprised at the verdict, considering the misbehaving tyke was Ms. Robertson's son. Fabricated.

Carl Truman, 19, of Los Angeles won $74,000 and medical expenses when his neighbor ran his hand over with a Honda Accord. Mr. Truman apparently didn't notice someone was at the wheel of the car whose hubcap he was trying to steal. Fabricated.

Terrence Dickson of Bristol, Penn., was exiting a house he finished robbing by way of the garage. He was not able to get the garage door to go up because the automatic door opener was malfunctioning. He couldn't re-enter the house because the door connecting the house and garage locked when he pulled it shut. The family was on vacation, so Mr. Dickson found himself locked in the garage for eight days. He subsisted on a case of Pepsi he found, and a large bag of dry dog food. Dickson sued the homeowner's insurance claiming the situation caused him undue mental anguish. The jury agreed to the tune of half a million dollars and change.Fabricated.

Jerry Williams of Little Rock, Arkansas, was awarded $14,500 and medical expenses after being bitten on the buttocks by his next door neighbor's beagle. The beagle was on a chain in its owner's fenced-in yard, as was Mr. Williams. The award was less than sought after because the jury felt the dog may have been provoked by Mr. Williams who, at the time, was shooting it repeatedly with a pellet gun. Fabricated.

A Philadelphia restaurant was ordered to pay Amber Carson of Lancaster, Pennsylvania $113,500 after she slipped on a spilled soft drink and broke her coccyx. The beverage was on the floor because Ms. Carson threw it at her boyfriend 30 seconds earlier during an argument. Fabricated.

Kara Walton of Claymont, Delaware, successfully sued the owner of a nightclub in a neighboring city when she fell from the bathroom window to the floor and knocked out her two front teeth. This occurred while Ms. Walton was trying to sneak through the window in the ladies room to avoid paying the $3.50 cover charge. She was awarded $12,000 and dental expenses. Fabricated.

The "winner" every year: In November, Mr. Grazinski purchased a brand new 32 foot Winnebago motor home. On his first trip home, having joined the freeway, he set the cruise control at 70 mph and calmly left the drivers seat to go into the back and make himself a cup of coffee. Not surprisingly, the Winnie left the freeway, crashed and overturned. Mr. Grazinski sued Winnebago for not advising him in the handbook that he could not actually do this. He was awarded $1,750,000 plus a new Winnebago. Fabricated.

Don't be fooled into believing all that you read on the web.

Sunday, August 30, 2009

Katrina: New Orleans Four Years Later

It's easy for many to simply forget that Katrina hurt much more than New Orleans. It devastated parts of lower Mississippi and damaged coastal Alabama as well.

I flew out of New Orleans the weekend before Katrina hit. I was there this weekend, on the 4th Anniversary of the storm's passing. In between, I have been back to New Orleans more than 25 times in the last four years. I was there for the first Mardi Gras post storm, and walked the fairgrounds for the 1st Jazz Fest after the storm.

I spent time reading about the city. Reading about its history, about the history of the French Quarter. I walked (and ran) its streets post storm. I went to St. Bernard Parish, saw the Lower 9th's destruction, as well as that of East New Orleans.

This is a city that deserves to be rebuilt just as much - more so - than the cities being rebuilt in Iraq by the US Military. Sure, the politics of the city are god awful. The spirit of the people though, is coming back. At least in areas away from where the flooding was at its worst.

In case you are wondering, the Central Business District is coming back. Surely the economy has hurt the rebuilding of the CBD. The Garden District is looking much better, where thankfully the damage was not as severe. The Quarter is seemingly back to its nearly normal tawdry self.

The area between the Port and the edges near Canal Street are hit and miss, but there is development.

I won't rant about what happened, didn't happen, or which politician was most incompetent (not on these pages, anyway). I will simply say this: Go. Visit the city. Eat at its 100+ year old restaurants. Take a walking tour of the Quarter, which while universally known as the French Quarter, has most of its standing buildings being of Spanish origin. Have a two hour plus dinner at Antoine's, or Bayona. Drive - like I just did - from the edge of the city out to the south and west, taking Highway 90 through cajun country.

I'll be back to my favorite city in America soon. Join me?

Jackson Square in New Orleans.Image via Wikipedia

Wednesday, August 26, 2009

Diet Drug Reviewed by FDA: Orlistat (Xenical)

The FDA said it has received 32 reports of serious liver injury -- including six cases of liver failure -- among users of diet drug orlistat, which is sold as a prescription drug under the trade name Xenical and as an over-the-counter diet aid under the name Alli.

As a result of those reports, the FDA said it had initiated a safety review of the product, which works by blocking the absorption of ingested dietary fats.

Orlistat 120 mg (Xenical) was approved in 1999 for weight loss in conjunction with a reduced caloric diet and for prevention of rebound weight gain after weight loss. The OTC version, orlistat 60 mg, was approved in 2007 for use by overweight adults ages 18 and older.

The FDA said that in addition to the 32 reported cases, orlistat safety "was discussed at the CDER Drug Safety Oversight Board in April 2009, and the FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time."

Source here.

Tamifoxen News

A report recently released suggests that a drug used to prevent the recurrence of breast cancer may have a rare but dangerous side effect: increasing the odds that long-term users may develop an uncommon but aggressive new tumor.

The report was called into question right away, noting clinical trials had repeatedly found that the drug, tamoxifen, reduced the recurrence and spread of common breast cancers and that its benefits exceeded any possible risks.

For more, go here.

Tuesday, August 25, 2009

Sports and the Law

A few items of interest for me, given my love of sports. Always a fun read when law intersects with Sports:

Delaware Lottery and NFL? Scratch that.

"In a rare move, the appellate court not only found that a lower court judge had erred in refusing to issue a preliminary injunction, but declared that the answer to the ultimate question in the case was indisputably clear -- and that a permanent injunction must be issued.

Lawyers for Delaware had urged the appellate court to greenlight the new lottery, arguing that it was protected under a PASPA exemption that grandfathered in the existing sports betting statutes in four states.

But lawyers for the sports leagues argued that Delaware was strictly limited to restarting the sort of sports betting it had conducted for a few months in the mid-1970s -- a multi-game football pool limited to betting on at least three NFL games at once.

Delaware should be blocked from launching a sports lottery at three racetracks or "racinos" that allows for single-game betting on any sport other than games played by Delaware college teams."

Read more here at the source.

FSU and NCAA: Judge says NCAA must publicly release FSU documents

Circuit Judge John C. Cooper said he'd give the NCAA two days from when he signs a written order next week to turn the documents over to The Associated Press and other media, which filed a public records lawsuit.

NCAA lawyers said they will appeal to block the release.

The documents focus on Florida State's appeal of an NCAA plan to strip coaches and athletes of wins in 10 sports.

That includes football coach Bobby Bowden, who stands to lose 14 victories. It would dim his chances of again becoming major college football's winningest coach. Bowden has 382 victories -- one behind Penn State's Joe Paterno.

The NCAA said in a statement it was "very disappointed this court has determined the NCAA's private records could be transformed to public records."

Source here.

Atlanta Spirit Lawsuit:

"Boston-based partner Steve Belkin had asked his Atlanta Spirit partners to buy out his 30 percent stake in the two teams back in August 2005, a process that was supposed to take 125 days. Ever since, the Spirit has been embroiled in a high-profile legal battle that has lasted nearly four years and earned the group a reputation as the most fractious ownership in North American professional sports.

Their arguments wound through the Maryland circuit court system and finally to the Maryland Court of Special Appeals, which overturned the lower court’s ruling as too vague.

The ruling, issued Monday afternoon, tossed out the initial purchase and sale agreement to buy out Belkin and keeps him in the partnership as a minority owner. The partners are now placed back in precisely the same position they were in before August 2005. The judge’s decision came after a trial that began in February and wrapped in early May.

“We won on every single point,” Spirit co-owner and NBA Governor Michael Gearon Jr. said in a statement released by the team. “The court did exactly what we asked it to do. We are back under the operating agreement which we think is a good agreement. We no longer have any obligation to buy out Belkin nor does Belkin have any right to purchase the Hawks and Thrashers.”

Read the whole story here at the AJC site.

Yaz & Yasmin Injury, Georgia

Our office is investigating claims of injury related to the birth control pills known as Yaz or Yasmin:

Yasmin and Yaz are two types of birth control pills manufactured by Bayer Healthcare, and the generic, Ocella, is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in “The Pill” since the 1970s, but the progestin in Yasmin and Yaz is new. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin – no other birth control pills contain drospirenone, except for a recently approved generic version, Ocella.

Side Effects of Yaz/Yasmin Birth Control Pills

Yaz/Yasmin was approved by the Food and Drug Administration (FDA) in 2006 as an oral contraceptive, and was marketed by its manufacturer, Bayer. Once the drug hit the market, however, the FDA started to receive reports of side effects when taking Yaz/Yasmin, including:

* Deep Vein Thrombosis (DVT): Deep vein thrombosis commonly affects the leg veins (such as the femoral vein or the popliteal vein) or the deep veins of the pelvis. Occasionally the veins of the arm are affected (if spontaneous, this is known as Paget-Schrötter disease). The most serious complication of a DVT is that the clot could dislodge and travel to the lungs, which is called a pulmonary embolism (PE). DVT is a medical emergency, present in the lower extremity there is 3% chance of a PE killing the patient.

* Pulmonary Embolism (PE): Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has travelled from elsewhere in the body through the bloodstream (embolism). Usually this is due to embolism of a thrombus (blood clot) from the deep veins in the legs, a process termed venous thromboembolism. A small proportion is due to the embolization of air, fat or amniotic fluid.

* Heart Arrhythmia: An irregular heartbeat is an arrhythmia (also called dysrhythmia). Heart rates can also be irregular. A normal heart rate is 50 to 100 beats per minute. Arrhythmias and abnormal heart rates don't necessarily occur together. Arrhythmias can occur with a normal heart rate, or with heart rates that are slow (called bradyarrhythmias -- less than 60 beats per minute). arrhythmias can also occur with rapid heart rates (called tachyarrhythmias -- faster than 100 beats per minute). In the United States more than 850,000 people are hospitalized for an arrhythmia each year. There are types of this condition:

Premature atrial contractions; Premature ventricular contractions (PVCs); Atrial fibrillation; and Atrial flutter, among others.

* Heart Attack/Myocardial Infarctions and
* Stroke and Transient Ischemic Attacks

What is in the pill:

Yaz/Yasmin contains a synthetic progestin called drospirenone, which some claim will raise blood potassium levels. Doing so may result in a dangerous condition known as hyperkalemia. Hyperkalemia can lead to life-threatening heart problems.

Monday, August 17, 2009

Xolair- Investigate for Link to Cardiac Problems?

In Canada news:

The safety of the asthma drug Xolair is under review to investigate a potential link to cardiovascular problems.

The probe was triggered by interim findings in an ongoing U.S. study into the long-term safety of Xolair, known generically as omalizumab.

The early data point to a disproportionate increase in cardiovascular problems among people treated with Xolair compared with those who did not take the drug. The reported problems include heart attacks, abnormal heart rhythms, heart failure, fainting, mini-strokes and blood clots.

That's part of an article you can find here.

Cellcept Warning Label Updated

A warning of a risk of pure red cell aplasia (PRCA) has been added to the label and prescribing information for mycophenolate mofetil (CellCept).

Drug manufacturer Roche reported 41 cases of PRCA in patients given mycophenolate mofetil. In 16 of the cases, reduction of the dose or discontinuation resolved the condition.

The mechanism causing the side effect is unknown, but the manufacturer noted that some of the cases were also receiving other immunosuppressants, which may have contributed to the aplasia's development.

"When PRCA occurs in a patient on multiple immunosuppressants, the relative contribution of the drugs to PRCA and the prophylaxis of rejection must be considered before a decision is made to discontinue a drug," according to the letter to healthcare professionals sent by Roche announcing the new warning.

Other adverse effects reported with mycophenolate mofetil include increased likelihood of opportunistic infection, fetal damage in pregnant women, and lymphoma in patients taking the drug as part of an immunosuppressive regimen.

From Medpage Today.

Thursday, August 13, 2009

What Should a Solo/Small Firm Focus on to build a practice?

I have been reading on several sites the opinions of what a solo lawyer or small law office should do when it comes to building a client base. There can never be a set list of what is important, but I do shudder when (at least in the consumer law/personal injury field) I see people blindly touting Social Networks as the key to all things, or a key building block. They're wrong.

On twitter, someone posted this: Solo/small should focus on social networking, blogging, thought leadership and niche focus more than "advertising." Doing so is folly. What matters on any list, at least for my areas of law noted above?

1.Competency: Knowing the area of the law- Really knowing it. Because if you say you do, and you don't, a potential client will learn of it. Sometimes, while you talk to that person at an event.

2.Networking: Live, real world networking. Not Twitter, not Facebook. Affinity groups, volunteering, law associations, meetings, conventions. Shaking hands, taking people to lunch or breakfast.

3a.Web presence- Each day I am amazed/appalled at what some lawyers/firms try to pass off as a web site. No phone number on page one. Impossible to locate office address. Spend the time building a website. Keep it current. One firm's website I saw listed under "Recent News" an article from April ... of 2008 ... as the lead news story.

3b.Learning Google Adwords: Most lawyers will mention how many hours are spent preparing for a deposition in a case, but simply slough off Google and internet advertising. Learn it. Google Adwords training can be done over time. Even if all you do is put up a google ad with your name or firm name, limited to your state, you must do it. I bet that what one Gen Y staffer calls a "kick ass" website for your firm, with Google, will generate more work than all SN sites you work on combined.

4.Blogging- This site for me is an outlet, sort of my office without the suit jacket and tie. I blog about law, pharma, and more - even the loss of my beloved dog. After three years, it's not uncommon for our office to receive 50+ emails or calls a month from the blog. With zero cost (thanks blogger!) to run and zero advertising.

5.Marketing to current clients:Good work is nice, but the last thing I need to hear is a person telling me, "I didn't know you practiced that type of law, or I would have told my brother/neighbor/pastor about you." We send out to every client a glossy "important papers" folder, a current (and not cheap) 8 1/2 by 11 Calendar, and more. Each year, new Calendar. In fact, when we miss a couple, I get the call asking "Where's my calendar?" We're working a birthday cards now.

6.List Servers: Speaking only for trial lawyers, our list servers are terrific sources of information as well as work. I contribute from time to time, I read daily, and I offer to assist. If you don't have one for your practice, dig. ABA and a State Bar may be a good start.

Way down on my list is Social Networks like Facebook and others. I no longer use two of them to build my office's work.

The Twitter post mentioning "thought leadership." Jargon. Worthless. How many of you reading this blog post even know what that means. That makes no list. For now.

Social Networks? Sure. I spend 1-5% now on it. I like Twitter- For the rapid rush of information. In certain areas- news, entertainment - great. For law? Not so much at least in my vast area - consumer law and injury practice. I spend time on it.

The point of all this is - learn by doing. I think SN will perhaps be like a yellow pages ad- a good but small part of your practice.

If you think I am wrong when it comes to SN on any list, I'd love to hear from you. Tell me your area of practice, and please - PLEASE- don't merely mention how you now have 1 or 2 clients from SN. If you have a practice where more than 15% have come from SN, my guess is you're a lawyer in tech, IP, or Entertainment.

Actos and Avandia News

A large study from British Columbia, Canada is pointing to an increased fracture risk with thiazolidinediones (TZDs), used in the treatment of type 2 diabetes [1]. The study, which reviewed fracture risk in more than 84 000 patients receiving either rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) vs a sulfonylurea, found that both men and women are at increased risk of broken bones when taking a TZD and hints that pioglitazone may be more strongly associated with fracture risk. Two years ago, the FDA requested that a warning on fracture risk be added to the pioglitazone labeling.

The study appears in the August 10/24, 2009 issue of the Archives of Internal Medicine.

"Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty," Dr Colin R Dormuth (University of British Columbia, Vancouver) and colleagues write.

Dormuth et al point out that the research linking fractures to TZD use has not been entirely consistent, with some trials (but not all) suggesting different effects for the two commercially available TZDs and others pointing to a different degree of risk according to gender.

Permax Information

Earlier in 2007, the FDA announced that Permax (generic: pergolide) was withdrawn. There are additional drugs in the same class that can be substituted.

Studies had been released linking Permax with heart valve damage. A study by Italian researchers found that approximately one-fourth of Parkinson's patients taking Permax had moderate to severe heart valve troubles. An additional study, by German doctors, established that users of Permax were five to seven times more likely to have leaky heart valves than those on other types of Parkinson's medications. Both studies can be found in the New England Journal of Medicine.

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Tuesday, August 11, 2009

Avandia - Diabetes Drug- Heart Attack Link?

Avandia is manufactured by GlaxoSmithKline for type 2 diabetes. It was first approved for use in 1999. Since then more than 6 million people worldwide have taken this drug. Avandia helps sensitize the body to insulin and helps control blood sugar. According to a recent study by the New England Journal of Medicine, patients taking Avandia have a 43% higher rate of heart attacks.

Several published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

If you believe you were injured because of your use of Avandia, talk with me.

Fosamax: First Trial Approaches

Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial this week. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three cases to go this summer.

The Fosamax plaintiffs claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, causing jawbone-tissue death and leading to partial removal in some patients. Jawbone tissue death is called osteonecrosis of the jaw, or ONJ.

The patients claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005. “They were the only drug company not to use the language that the FDA requested,” O’Brien said, referring to the U.S. Food and Drug Administration.

Merck says the drug is safe and effective.

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Monday, August 10, 2009

Fentanyl Patch Recall News

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between April 2, 2009 and May 20, 2009. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No serious injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Anyone who has 100 mcg/hr Fentanyl Transdermal System patches should check the box or foil pouch for the lot number and expiration date to see if they have patches that are being recalled. Affected patches should not be handled directly. Anyone with 100 mcg/hr Fentanyl Transdermal System patches being recalled should call 888-345-2656, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using fentanyl patches who have medical questions should contact their healthcare providers.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at

Source here.

Wednesday, August 05, 2009

Courts: Remand Order Worth a Read

Below is a link to a recent US District Court Order regarding a case that had been removed from a State Court (in Alabama) to a Federal Court based on diversity as well as Defendants' claim that the jurisdictional amount had been met.

The Federal Court Judge assigned to the case wrote:

"The question [before the Court[ is whether this specific settlement demand, given all the evidence presented, established by a preponderance of that evidence that the amount in controversy exceeds $75,000 ... The defendants insist that the plaintiffs’ demand of $155,000 must meet this standard simply because the demand was made. The proper assessment of settlement offers is not so facile. “While [a] settlement offer, by itself, may not be determinative, it counts for something.” Burns v. Windsor Insurance Co., 31 F.3d 1092, 1097 (11th Cir. 1994). What it counts for, however, depends on the circumstances."

The case may be found here.

Tuesday, August 04, 2009

What Should a Solo/Small Firm Focus on to build a practice?

From the FDA:

The U.S. Food and Drug Administration announced an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.

The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death.

These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are:
- Botox (new established name: onabotulinumtoxinA)
- Botox Cosmetic (new established name: onabotulinumtoxinA)
- Myobloc (new established name: rimabotulinumtoxinB)
- Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes at this time.

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different. To help reduce the potential for dosing errors, the botulinum toxin products have changed their established drug names (often referred to as the drug’s “generic” name). Neither the brand names nor the formulations of the products have changed.