Tylenol Infants and Children Recall (Certain Lots)

From tylenol.com

You may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' TYLENOL® liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U.S. Food and Drug Administration (FDA). The company is implementing this voluntary recall at the warehouse and retail levels, because examination of one of the inactive ingredients did not meet internal testing requirements. However, the packaged product, shipped to retailers by the company, has met all specifications.

These actions do not apply to Children's Tylenol Meltaways and Junior Strength Tylenol Meltaways. The voluntary recall applies only to select lots of Children's and Infants' TYLENOL® liquid products.

If you have any of the potentially affected products in your home and have questions you can contact the McNeil Consumer Call Care Center at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time.)

Parents and caregivers who have given the product to their child or infant and have concerns should contact their child's health care provider.

The full list of affected products is below. Consumers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If you have more questions, please contact our consumer call center at 1-800-962-5357.
UPC # Code # Lot # Product Description
300450391049 3910400 SBM041, SBM067, SCM037, SDM027, SEM109 Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
300450296047 2960400 SBM042, SCM015, SCM036, SDM034 Children's Tylenol Suspension 4oz. Grape
300450407047 4070400 SBM043, SBM044, SCM029 Children's Tylenol Suspension 4oz. Bubble Gum
300450493040 4930400 SBM045, SCM011, SCM030, SDM035 Children's Tylenol Suspension 4oz. Strawberry
300450122407 1224000 SBM064, SCM033, SDM020 Infant’s Tylenol Grape Suspension Drops 1/4oz.
300450186157 1861500 SBM065, SCM005, SCM006, SDM032 Infant's Tylenol Suspension 1/2oz. Cherry
300450166043 1660400 SBM066, SCM068 Children's Dye Free Suspension 4oz. Cherry
300450123046 1230400 SBM068, SCM035, SCM070, SCM080, SDM005 Children's Tylenol Suspension 4oz. Cherry
300450249043 2490400 SBM069, SBM070, SCM081, SDM006 Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
300450122155 1221500 SCM012, SCM067, SDM007, SDM068 Infant's Tylenol Suspension Drops 1/2oz. Grape
300450386045 3860400 SCM013, SCM014, SCM069 Children's Tylenol Plus Flu 4oz. Bubble Gum
300450387042 3870400 SCM016, SFM024 Children's Tylenol Plus Cold Suspension 4oz. Grape
300450247049 2470400 SCM017 Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
300450122018 1220100 SCM082, SDM039, SDM040 Infant's Tylenol Suspension Drops 1oz. Grape
300450167019 1670100 SCM083, SCM084, SDM008 Infant's Tylenol Dye Free Suspension 1oz. Cherry
300450123015 1230100 SDM064 Children’s Tylenol Pediatric Suspension 1oz. Cherry
300450186300 1863000 SDM038, SDM009 Infant's Tylenol Suspension Drops 1oz. Cherry
300450390042 3900400 SDM033 Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
300450122100 1221000 SDM078 Infant's Tylenol Drops 1oz. Grape
350580144183 1221800 SCM034 Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
350580123034 1230300 SDM028 Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.

Seroquel Litigation News

A federal judge in Orlando, Florida, ordered AstraZeneca to unseal certain sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians’ names on privacy grounds.

For more, go to the Bloomberg site here.

FDA Bans Flavored Cigarettes

The FDA this week banned cigarettes with fruit, candy or clove flavors.

Authorized by the Family Smoking Prevention and Tobacco Control Act enacted in June, the ban represents an effort to reduce an easy entry point for youth into smoking and tobacco addiction. Some cigarette makers favored and others opposed giving the FDA this new authority.

Smoking is the leading preventable cause of death in the U.S., the government says.

The FDA also is considering bans on menthol cigarettes and other flavored tobacco.

Source here.

Flooding in Atlanta

It's bad here. Real bad. A North Georgia city has been evacuated because of levee failure fears. The above pic is of downtown Atlanta during rush hour today.

Study Finds a Possible Link Between Denture Cream and Imbalance

From ABC.com:

Thirty- four million Americans rely on dentures to replace their missing teeth. But a small number of denture wearers have had difficulty with balance and walking -- a medical mystery that some experts have linked to their denture creams.

More here.

Necrosis Caused by Intra-arterial Injection of Promethazine: Case Report

I found this report after hearing more about the recent black box warning issued by the FDA regarding Promethazine:

"The first reported cases of intra-arterial promethazine (Phenergan) injection causing complications were in the late 1960s." There have been literature reports of adverse outcomes after accidental intra-arterial injections of drugs since the 1940s.

The study presented two cases of intra-arterial promethazine injection that led to digital necrosis. Both cases eventually led to amputations.


The study may be found here.

STLA Meeting in Asheville Sept. 24 and 25, 2009

This week the Southern Trial Lawyers Association meets in Asheville, N.C.

The essential mission of the Southern Trial Lawyers Association is as simple as it is straightforward: To promote fellowship, learning, and networking among trial lawyers throughout the 13 southern states. We do not engage in political activity or fundraising of any kind.

STLA here.

FDA warns about eyelash thickener claims

The FDA has warned Allergan Inc. that the Web site for its eyelash thickener Latisse is misleading because it avoids or downplays risks associated with the product.

In a letter dated Sept. 10 and posted to the FDA Web site Wednesday, the agency said the Latisse site either doesn't mention potential side effects including bacterial eye infection, allergic reactions, excess hair growth outside the intended treatment area, and permanent changes in iris and eyelid pigmentation, or presents them in small text that is much less prominent than statements about the product's effectiveness.

For more, go to fda.gov.

Promethazine Gets Black Box Warning for Tissue Damage/Amputation Risk

Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

More here.

GA Supreme Court to Hear Oral Argument on Damages Caps on 9/14

Supreme Court to Hear Oral Arguments on Caps on Damages
Statute is challenged after a medical malpractice victim’s face
literally falls off after surgery

Atlanta, GA-- On Tuesday, September 15, 2009, the Georgia Supreme Court will hear oral arguments regarding the constitutionality of the provision that caps the amount of damages a victim of medical malpractice can secure from a jury. The plaintiffs in the case of Betty Nestlehutt and Bruce Nestlehutt v. Atlanta Oculoplastic Surgery, P.C., will argue that the Georgia Supreme Court should uphold the trial court judge’s finding that O.C.G.A. § 51-13-1, as enacted in 2005, is unconstitutional.

The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.

Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.

After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.

“Betty Nestlehutt was the face of her real estate business,” said Malone. “Her face was so horrifically disfigured that she was no longer able to even leave her house. Photographs of her disfigurement are even too gruesome for public distribution. The damage is permanent. Years later she has to wear layers of special makeup to try to give the appearance of normalcy.”

After hearing the testimony and considering all of the evidence, a jury of 12 returned with a verdict in the Nestlehutts’ favor which included a recovery of money damages for her past and future medical expenses, for damage to her relationship with her husband and $900,000 in “non-economic” damages for the devastation of her quality of life. The verdict exceeded the $350,000 cap on noneconomic damages enacted as part of SB 3 in 2005. Judge Diane Bessen declared unconstitutional the statute capping a jury’s verdict and now her decision, upon the defendant’s appeal, is before the Supreme Court.

“Judge Bessen’s order appropriately concluded that a one-size fits all predetermined cap on damages violates several protections guaranteed by the Georgia Constitution,” said Malone. “Her order balances the rights of all Georgians, young and old, rich and poor, and restores the guarantees set forth by our Constitution that were stripped away in 2005.”

Judge Bessen’s order declares the caps on damages provision unconstitutional because it violates three basic constitutional tenets: the right to trial by jury, the separation of powers doctrine and equal protection of the laws.

Under SB 3, the jury’s deliberation regarding the amount of damages to be awarded is preempted by a legislatively imposed cap—no matter how severe or catastrophic the case before them. Historically, a jury had the ability to decide the fate of its peers constrained only by the particular facts of an individual’s case, as the Founding Fathers intended. Thomas Jefferson once said, “I consider trial by jury as the only anchor yet imagined by man, by which a government can be held to the principles of its Constitution.”

In her order, Judge Bessen wrote:

A limit or cap on noneconomic damages, however, invades the right to a jury trial by usurping one of the fact-finding responsibilities of the jury. If the amount of noneconomic damages awarded by the jury exceeds the statutory cap, this Code section automatically and arbitrarily reduces the verdict, without consideration of the evidence, the record, or any other fact produced at trial and found by the jury. The limitations imposed by O.C.G.A. 51-13-1 render the right of the jury to assess damages meaningless… The cap so interferes with the determination of the jury that it renders the right of a jury trial wholly unavailable.

Additionally, Judge Bessen also found that the cap on damages violates the Separation of Powers Doctrine contained in the Georgia Constitution. Three other states’ supreme courts, with similar constitutional provisions, also have struck down caps on damages on this basis. The Georgia Constitution states that: “The legislative, judicial and executive powers shall forever remain separate and distinct, and no person discharging the duties of one, shall, at the same time, exercise the functions of either of the others.” One distinct function of the judicial branch is that judges have the exclusive right to award to a party a “remittitur” – or a new trial – if a judge finds that a verdict is either excessive or inadequate. Judge Bessen’s order declares the cap on damages statute to be a “legislative remittitur” and that the legislature has unconstitutionally invaded the exclusive role of the judiciary to find facts and control judgments.

“Equally important,” the judge writes, “it does so without the option of a new trial for the injured plaintiff. As such, it unduly encroaches upon the judiciary’s constitutional right and prerogative to determine whether a jury’s assessment of damages is either too excessive or too inadequate within the meaning of the law.”

The third violation of the Constitution Judge Bessen found was that a cap on damages violates the Equal Protection provisions of the Georgia Constitution which state: “No persons shall be denied the equal protection of the laws.” To examine this violation, Judge Bessen explored whether there was a “rational relationship” between the government’s purpose and its enacted statute which treats similar parties in very different, unequal ways.

The rational relationship test basically states that a statute may be valid as long as it has a rational relationship to a governmental purpose. In the case of SB 3, the government’s stated purpose was to “promote predictability and improvement in the provision of quality health care services and the resolution of healthcare claims..., assist in promoting the provision of healthcare liability insurance by insurance providers…, [and addressed concerns about] medical providers and facilities leaving the state and the cost of malpractice awards.” For a law to be valid, a rational relationship to those goals must be proven. Judge Bessen found that the cap on damages failed the rational relationship test completely.

In holding the cap on damages provision unconstitutional, Judge Bessen wrote:

After review, this Court finds that there is no rational relationship between statute and the expressed government interest. Most obviously, it is a complete contradiction to state that the overall quality of healthcare would be improved by shielding negligent healthcare providers from liability. In fact, as recognized by other courts, a cap on noneconomic damages actually diminishes tort liability for healthcare providers and diminishes the deterrent effect of tort law… There is absolutely no evidence that these objectives are achieved by imposing a financial burden on the most victimized of plaintiffs… Based on current statistics, limiting noneconomic damage caps is not rationally related to the state purpose of reducing medical malpractice insurance rates… it appears that this statute was enacted arbitrarily, based upon speculation and conjecture rather than empirical data.

Finally, Judge Bessen found that the cap on damages violates Equal Protection because it creates different classes of victims—those injured by healthcare providers and those injured by others and those who are catastrophically injured and those who are less severely injured. Judge Bessen penned, “The cap’s greatest impact falls on those who are most severely injured, and creates classes of fully compensated victims and those only partially compensated… Similarly, the noneconomic damages cap discriminates against low-income individuals who are unable to prove large economic damages but nonetheless may sustain large noneconomic damages.”

The President of the Georgia Trial Lawyers Association, Chris Clark, has been following this case closely.

“As a trial lawyer, I represent the person, who, through no fault of their own, has been injured—sometimes severely. They miss work, accrue medical bills and—often most important to them—they suffer a loss of the quality of life that they once had,” said Clark. “Betty Nestlehutt’s severe disfigurement – which she had no part in creating – has diminished her quality of life and, in turn her husband’s and her family’s. Judge Bessen’s order was fair, upheld our Constitution, and reflected the rule of law that has stood firm since the inception of this nation.”

The argument on Tuesday was prepared by Malone and attorneys Darren Summerville of Bird Law Group, P.C. and Michael Terry of Bondurant, Mixson & Elmore, LLP. AARP, Voices for Georgia’s Children, Georgia Women for a Change and Georgia Watch all filed Amicus Briefs in support of Betty and Bruce Nestlehutt.

Conmed Recall of Surgical Instruments

Medical device maker Conmed Corp. on Wednesday issued a voluntary recall of certain surgical instrument products, saying the devices may self-activate and cause injury in rare cases.

Conmed said the recall affects certain model numbers of its PRO5 and PRO6 series battery hand pieces manufactured before May 31, 2008.

The recall also affects certain lots of the MC5057 Universal Cable manufactured before Dec. 1, 2006, the company said.

The company estimated the pretax cost of the recall at $6 million. The expense will be factored into the company's financial results during the quarter ending Sept. 30.

Source here.

Penumbra Catheter Recall

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.

Source here.

Window Blinds Recall

The Consumer Product Safety Commission is announcing a major recall on several types of winder blinds and shades. Here are three of the largest recalls.

The first set of shades on our recall list is the kind that rolls up. It's called the Oval Roll-Up Blinds. There is the potential for a child to be strangled in the pull cord.

The Consumer Product Safety commission is recalling more than four million of the blinds.They were sold national retail stores across the country.

The second recall is for bamboo shades called Matchstick Bamboo Roman Shades. They too could strangle a young child if that child gets caught in the inner cord. They were sold at Target stores nationwide.

The third recall is for the Melina Roman Blind which can also catch a child around the neck. The problem here is the exposed inner cord. These shades were sold at IKEA stores.

go to the cpsc site for more.

Levaquin and Link to Vision Problems?

From the journal Opthamology:

According to World Health Organization criteria, the relationship between fluoroquinolone therapy and diplopia is “possible.” This causality assessment is based on the time relationship of drug administration and ADR development, the multiple positive dechallenge and rechallenge reports, and the plausible mechanism by which diplopia could occur: Possible tendinitis of the extraocular muscles.

Link here:

http://www.ophsource.org/periodicals/ophtha/article/S0161-6420%2809%2900655-1/abstract

Zyprexa: Allegations that Lilly Paid Docs to Prescribe it

From Bloomberg:

Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.”

More at the link above.

Fosamax: Jury Deliberations Marked by Threats and Intimidation?

From CNNMoney.com I can tell you I've never heard of any Judge offering to have court officers escort jurors home:

A U.S. judge called for a daylong "cooling off" period in a product-liability case over Merck & Co.'s (MRK) osteoporosis drug Fosamax after jury deliberations became tense on Wednesday.

U.S. District Judge John F. Keenan suspended deliberations until 11:15 a.m. EDT Friday and offered to have court security officers escort individual jurors to the subway after two separate notes were sent out of the jury room Wednesday afternoon about the tenor of the deliberations.


Outside the presence of the jury, the judge said that he would declare a mistrial in the case if a verdict isn't reached by 5:30 p.m. EDT Friday.

The article notes that one juror had complained of threats.

Actiq Deaths

Actiq is a powerful narcotic painkiller in the form of a lollipop that is manufactured by Cephalon, Inc. The drug is delivered to the bloodstream by a lollipop-like lozenge; when placed against the inner cheek, pain is relieved in minutes. Actiq is also administered by transdermal patches and by injection. The active ingredient, fentanyl citrate, is a highly addictive narcotic which is approximately 80 times more potent than morphine.

The FDA approved the Actiq lollipop in 1998 for treatment of severe pain in cancer patients. However, Actiq is apparently being prescribed to thousands of people for off label treatment of non-cancer related pain. It has been estimated that in the first half of 2006 approximately 99% of the 187,076 Actiq prescriptions filled in the U.S. were not for cancer patients.

The Actiq lollipop has been associated with the deaths of at least 127 people. There have been another 91 FDA reported incidents of severe side effects. Side effects have ranged from dehydration to respiratory problems along with further issues associated with the highly addictive nature of the narcotic. Forty-seven of the deaths have been linked to addiction, misuse, or overdose. Two deaths have reportedly involved children who mistook the Actiq lollipop for candy.

College Football Arrives

Tailgating at Ole Miss in the Grove

My passions are typically every day ones - my labs, the outdoors. This week (Thursday, actually) is the start of the real passion/religion 'down here' in the South - big time college football. My team? The Gators.



What's it like for me and others in SEC Country? Here is a comparison of North v. South College Football:


Stadium size
North: College football stadiums hold 20,000.
South: High school football stadiums hold 20,000.

Fathers
North: Expect their daughters to understand Sylvia Plath.
South: Expect their daughters to understand pass interference.

Campus décor
North: Statues of Founding Fathers.
South: Statues of Former Coaches.

Homecoming queen
North: Also a physics major.
South: Also Miss America.

Heroes
North: Rudy Guiliani.
South: Bear Bryant, Steve Spurrier, Eli Manning.

Getting tickets
North: Five days before the game, you walk into the ticket office on campus and purchase tickets.
South: Five months before the game, you walk into ticket office on campus and put your name on waiting list for tickets.

Parking
North: An hour before game time, the university opens the campus for game parking.
South: RVs sporting their school flags begin arriving on Wednesday for the weekend festivities.

Game day
North: A few students party in the dorm and watch ESPN on TV.
South: Every student wakes up and rushes over to where ESPN is broadcasting “GameDay Live” to get on camera and wave to the fans up North who wonder why “GameDay Live” is never broadcast from their campus.

Tailgating
North: Raw meat on a grill, beer with lime in it, listening to local radio show with truck tailgate down.
South: 30-foot, custom pig-shaped smoker fires up at dawn. Cooking accompanied by live performance by Dave Matthews Band, who come over during breaks.

Getting to the stadium
North: You ask, “Where’s the stadium?” When you find it, you walk right in.
South: When you’re near it, you’ll hear it. On game day, it becomes the state’s third largest city.

When National Anthem is played
North: Stands are less than half full, and less than half of them stand up.
South: 93,000 fans, all standing, sing along in perfect four-part harmony.

Announcer
North: Neutral and paid.
South: Announcer harmonizes with the crowd in the fight song, with a tear in his eye because he is so proud of his team.

After the game
North: The stadium is empty way before the game ends.
South: Another rack of ribs goes on the smoker. Planning begins for next week’s game.

Fans
North: Women comment "My, what a rough sport."
South: Women scream "DON'T JUST TOUCH HIM, TAKE HIM DOWN!"

Womens' Attire

North: Chapstick in their back pocket and a
$20 bill in their front pocket.

South: Louis Vuitton bag and a fifth of bourbon, barnoculars.

North: Fans wear a team tshirt.
South: Fans wear a team tshirt, pants, shoes, face paint, and sunglasses.

Vehicles:
North: Cars and trucks have a removal window flag.
South: Cars and trucks are custom painted w/ team colors, Flat screen TV, portable
satellite, and Honda generator.

Alumni
North: Take prospects on sailing trips
before they join the law firm.
South: Take prospects on fishing trips so
they don't leave for the NFL their senior year.


In case you have made it this far, a special lagniappe, this video:

Steam Dietary Supplement Recalled

Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

Brand Name Size Lot EXP. UPC

STEAM 1 Bottle – 5 Capsules 90260 6 11 8 52263 30033 1

No illnesses have been reported to the company to date in connection with this product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

The FDA has been apprised of this action.

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 www.snopes.com, 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.

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?

Image via Wikipedia

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.

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.

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.

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.

www.segeorgialaw.com

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.

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.

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 www.fda.gov/medwatch.

Source here.

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.

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.

Tort Reform Champion Loses Med Mal Case

I pulled this from my good friend Chris Hellum's blog, analabamalawyer

"Elliott Kaplan is a prominent Kansas City attorney. For years, he railed against judges, juries, and trial attorneys. He was well known as one of the founders of the modern tort reform movement in America. He was named "Legal Reform Champion" by the American Tort Reform Association.

In a cruel twist of fate, it appears he may have reaped what he sowed.

According to its website, The American Tort Reform Association was founded in 1986 by the American Council of Engineering Companies and shortly thereafter, the American Medical Association followed them. They have worked to enact tort reform legislation in 45 states. They have led grassroots efforts which have resulted (they claim) in 85% of Americans believing that frivolous lawsuits clog our courts.

Their efforts have paid off, perhaps to the detriment of one of their own. According to the National Practitioner Data Bank, the number of U.S. malpractice payments in 2008 was the lowest since creation of the federal National Practitioner Data Bank, which has tracked payments since 1990.

WHAT HAPPENED TO LAWYER KAPLAN

Lawyer Kaplan was diagnosed in 2003 with pancreatic cancer by his doctor in Kansas City. Kaplan sought the best care money could buy. He went to the Mayo Clinic in Rochester, MN. There he was again diagnosed with pancreatic cancer.

To save his life, he underwent a Whipple resection, a highly invasive surgery that can cause more harm than good. It was only after the surgery that the diagnosis was determined to be wrong, that he only suffered from pancreatitis, and that the Whipple resection made the condition worse, leaving him debilitated and a broken man.

Believing that the doctor had committed malpractice, Kaplan sued the pathologist alleging negligence in the diagnosis. He assembled an army of attorneys to represent him. Unfortunately, the jury found against Kaplan and awarded him no damages. He has moved for a new trial. The motion is currently pending.

I certainly feel for Lawyer Kaplan. Unfortunately, he and the organization which he was a "Champion", foster the belief that all lawsuits are frivolous and that they compromise access to affordable health care, punish consumers by raising the cost of goods and services, chill innovation, and undermine the notion of personal responsibility.

I don't know if his lawsuit was meritorious or not. If it is, then I pray that justice will prevail. I do know that his organization, the American Tort Reform Association, has perpetuated the belief among most Americans that all lawsuits are frivolous. The beneficiaries of this belief are not injured or defrauded people, but the insurance companies and large corporations who fund these organizations."


Chris Hellums can be reached at Chrish@pdkhlaw.com

Denture Cream Issues: Fixodent and Poligrip

Approximately 35 million Americans use denture creams and several of the popular adhesives, such as Fixodent and Super PoliGrip, have been linked to serious and debilitating injuries caused by excess levels of zinc contained in the products that may enter the body.

Some users may have suffered from neuropathy or other injuries caused by zinc poisoning, which could cause symptoms like:

* Paralysis
* Numbness
* Loss of Sensation
* Tingling or Pain in Hands or Feet
* Muscle Weakness
* Loss of Balance
* Difficulty Walking
* Unexplained Pain or Weakness

The makers of each product believe their products work as advertised.

Blair Robe Recall - Important News

Women’s Chenille Robes Recalled by Blair Due to Burn Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Full Length Women’s Chenille Robes

Units: About 162,000

Retailer: Blair LLC, of Warren, Pa.

Hazard: Some robes fail to meet federal flammability requirements and present a risk of serious burns to consumers if they are exposed to an open flame.

Incidents/Injuries: Blair has received three reports of the robes catching on fire, including one report of second-degree burns.

Description: The recall involves the Full Length Women’s Chenille Robe with the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. The item number is identified on a label in the garment’s neckline. This is a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robe has a full-button front with seven matching button closures, long sleeves with self cuffs, a straight bottom with self hem, and two sideseam pockets. The robe’s sewn in label states: “100% Cotton, RN 81700, Made in Pakistan”. Robes with other item numbers are not included in the recall.

Sold at: Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009 from about $20 to $40.

Manufactured in: Pakistan

Remedy: Consumers should stop wearing the garment immediately. Contact Blair LLC for information on returning the robe and to receive a refund or a $50 gift card for Blair merchandise.

Court Decisions: Sealed Container Defense Rejected in AL as to Retailers

News regarding an Alabama Supreme Court decision, and cases are before the Court on a certified question from the United States District Court for the Northern District of Alabama. The USDCT concluded that it was not clear under Alabama law whether claims alleging the breach of the implied warranties of merchantability and fitness for a
particular purpose are subject to the defense of the sealed-container doctrine.

Supreme Court held that they were not. Opinion here.

Medtronic Recalls Lots of Paradigm® Quick-Set® Infusion Sets in the United States

Medtronic, Inc. has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

More about the recall here.

segeorgialawblog.com

Image by TeecNosPos via Flickr

I'm working on a new blog for Southeast Georgia. I've been litigating in Brunswick, Glynn County, Woodbine, Folkson, Camden County and other cities there for nearly a half decade, and have opened an office there.

For a dose of segeorgia flavor, visit that blog.

News from A Friend's Firm: Lawsuit in MD

I count Rick Kuykendall as one of those lawyers whom I trust. He's with the Murphy Firm in Baltimore, and there is this news this week:

The Murphy Firm of Baltimore and Henry & Associates of Largo have announced the filing of a 12-count civil suit that charges Prince George's county officials and some of the County's correctional and law enforcement officers with responsibility for the 2008 death of 19-year-old Ronnie L. White, who, the suit states, was “assaulted and killed by the very same correctional officers who were supposed to be there to insure his safety.”

White died of a broken neck and asphyxiation 34 hours after he was received in custody by the Prince George's County Correctional Center. Following an autopsy, the Office of the Chief Medial Examiner for the State of Maryland ruled that White's death was a homicide.

The suit, filed on behalf of White's mother, Angela L. White, states that Ronnie White’s death was “the direct result” of excessive force and gross negligence by County officials, and that his constitutional and civil rights were violated. The suit is seeking $153,600,000 in compensatory and punitive damages.

Link here
.

We talked this morning, and he said his real issue front and center today is making sure his daughter Amalee Kuykendall gets to college on time. I worry about that day as well!

Weight Loss Supplements Recalled

The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes. Sibutramine, an FDA approved medication used as an appetite suppressant for weight loss, is a prescription approved medication by the federal government. The FDA has not approved the use of this prescription medication ingredient in 34 different Universal ABC Beauty Supply’s products.

The FDA issued a strong advisory to U.S. Consumers about the undeclared , Sibutramine, because the medication is known to cause the following harmful side effects:

-Substantially increase blood pressure and/or pulse rate in some patients
-High risk for patients with a history of coronary artery disease
-Harmful to consumers with congestive heart failure
-May be risky for patients who have arrhythmias
-Possible injury to patients with a medical history of stroke

Here's the product list:

PRODUCT NAME

1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

Dietary Supplement Recall

Hi-Tech Pharmaceuticals and the FDA have notified healthcare professionals and consumers of a nationwide recall of all products sold under the name Stamina-Rx.

An FDA lab analysis found that the product contained the undeclared ingredient, benzamidenafil. Benzamidenafil is in the same pharmacologic class as the phosphodiesterase type 5 (PDE5) inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved and poses a threat to consumers because it may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the most susceptible to adverse effects from this product.

Source here.

FDA To Discuss Liver Risks With Tylenol,Other Painkillers

Image via Wikipedia

The FDA will be taking a look at painkillers such as Tylenol next week.




The issue front and center relates to acetaminophen, a drug found in Excedrin as well as NyQuil and Theraflu, that can cause liver damage. Acetaminophen is the most widely used drug in America.


Acetaminophen is found in more than 100 products, including many prescription drugs administered by pharmacies. Much of its popularity is because - when taken at recommended doses - acetaminophen does not cause stomach discomfort or bleeding, unlike other drugs commonly used to reduce pain and fever, such as aspirin, ibuprofen and naproxen.

When, however, it's taken over the maximum amount of 4 grams per day, acetaminophen can cause liver damage, ranging from abnormalities in blood tests used to assess liver function to acute liver failure (ALF), and even death; a problem not caused by other over-the-counter painkillers.

Despite efforts since the early 1990s to reduce the incidence of acetaminophen-related liver damage, liver injury from acetaminophen overdose remains a serious public health problem. Source.



You'll be able to see the FDA at work by logging on to FDAAdvisoryCommittee.com


Source here.

Problems With Homeopathic Remedies?

An Associated Press analysis of the FDA's side effect reports has found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.


According to reports:

The AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. At least 20 ingredients used in conventional prescription drugs, such as morphine for pain, are used in homeopathic remedies.

Source here.

Given recent recalls of over the counter products, it's imperative that consumers carefully read the label of products like Zicam and others.

Zicam Recalled

Intranasal spray Zicam is being recalled as the FDA warns of 130 cases of anosmia- loss of the sense of smell.

Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms did not appear until multiple doses had been administered. Officials have not yet determined if the condition is permanent, and fear the intranasal gel spray may be damaging nerves. The FDA expressed concern that consumers are using Zicam for a minor, “self-limiting condition” (such as a cold) and inadvertently risk damaging their quality of life permanently.

The affected products have been pulled from store shelves across the country and the FDA have advised that all remaining product should be discarded and not used for any reason.

Source here.

Zyprexa news

From Public Citizen and other sources:

Eli Lilly urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the FDA showing Zyprexa was not effectively alleviate dementia symptoms in older patients, the company started to market the drug to such patients, so says documents unsealed in insurer suits against the company.

Lilly has pleaded pleaded guilty earlier this year to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date.

Source here.

Liberty National Life Insurance News: Florida Licensure At Risk?

Liberty National Life Insurance could have its license suspended or revoked in Florida for refusing to write life policies based on nationality or travel to certain countries, state insurance regulators said Thursday.

Investigators from Florida's Office of Insurance Regulation spent nearly five months reviewing life insurance policy applications from Florida residents and found that consumers of Haitian descent were more likely than others to have their applications denied.

The OIR order to Liberty National gives the company 21 days to provide proof that it didn't violate state laws that prohibit discrimination.

Liberty National, based in Birmingham, Ala., didn't return a call from The Miami Herald asking for comment on Thursday's order.

According to OIR's order, 52.6 percent of Haitian applicants were denied compared to 18.2 percent of other foreign-born applications. For instance, although Liberty National's life insurance application asks if consumers have lived in the United States for more than a year, it applied a selective 10-year residency requirement to customers born in certain countries such as Haiti or Colombia.

TRAVEL CONCERN

Applicants with plans to travel to such countries as Haiti, Liberia or Honduras were also denied.

Investigators reviewed some 7,000 applications and found 1,149 violations, including 1,053 involving discriminatory practices.

Read more here.

Calrcon Skin Product: Partial Recall and Warning

he Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.

Consumers should not use any Clarcon products and should throw them away, the FDA said.

Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions, according to the agency. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage.

Examples of products that should be discarded include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon, Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

Link here.

Recent Avandia Medical Article

Avandia doesn't increase overall heart risks, according to final results of a large clinical study sponsored by the world's second largest drugmaker.

The study does seem to confirm that the medicine doubles the risk of heart failure -- a chronic condition where the heart struggles to pump enough blood around the body -- and also increases the danger of bone fractures.


You can find the article here.

Graves Disease Drug: Increased Risk for Liver Injury?

The FDA warned physicians that a drug used for 62 years to treat Graves' disease -- propylthiouracil, or PTU -- carries an increased risk for life-threatening liver injury.

The FDA said it has received 32 adverse event reports -- 22 in adults and 10 in children -- including 12 deaths and six transplants among adult users of the medication. In the pediatric population, the FDA said there were one death and six transplants linked to PTU use.

"Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy," the FDA said.

Source here.

Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

412(i) Tax Shelter Litigation

My friend Alabama attorney Chris Hellums is investigating abusive tax shelter creation. Here's his post from his blog:

Typically, these transactions will include an Insurance company, accountant, tax attorney, and a promoter (someone with an insurance background, perhaps an actuary, who knows how to structure the policy itself). These groups will use insurance brokerages and sub-agents (licensed in the various states) to sell the policies themselves.

HOW THESE PLANS WORK:

In the late 1990’s, the individuals and groups above devised a scheme to sell abusive tax shelters under the auspices of Section 412(i) of the tax code. A 412(i) is a defined benefit pension plan. It provides specific retirement benefits to participants once they reach retirement and must contain assets sufficient to pay those benefits. A 412(i) plan differs from other defined benefit pension plans in that it must be funded exclusively by the purchase of individual life insurance products. To create a 412(i) plan, there must be a trust to hold the assets.

The employer funds the plan by making cash contributions to the trust, and the Code allows the employer to take a tax deduction in the amount of the contributions, i.e. the entire amount. The trust uses the contributed funds to purchase some combination of life insurance products (insurance or annuities) for the plan. As the plan participants retire, the trust will usually sell the policies for their present cash value and purchase annuities with the proceeds.

The revenue stream from the annuities pays the specified retirement benefit to plan participants. These defendants (with the aid and knowledge of the insurance companies) used the traditional structure and sold life insurance policies with excessively high premiums. The trust then uses the large cash contributions to pay high insurance premiums and the employer takes a deduction for the sum of those large contributions. As you might expect, these policies were designed with excessively high fees or “loads” which provided exorbitant commissions to the insurance companies and the agents who sold the products.

The policies that were sold were termed Springing Cash Value Policies. They had no cash value for the first 5-7 years, after which they had significant cash value. Under this scheme, after 5-7 years, and just before the cash value sprung, the participant purchases the policy from the trust for the policy’s surrender value. In theory, you have a tax free transaction.

The IRS does not recognize the tax benefit of such a plan and has repeatedly issued announcements indicating that such plans are contrary to federal tax laws and regulations. These plans were targeted to high net worth individuals, including doctors, dentists, corporate executives, and professional athletes.

Read more at his blog, here.

Bausch and Lomb Settles Fungal Infection Lawsuits

Image via Wikipedia

Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

Read more from this article here.