The Supreme Court held yesterday that O.C.G.A. § 9-3-99 tolls the statute of limitations for any tort action from the date of the defendant’s traffic offense until the prosecution of the traffic offense becomes final or is terminated, as long as that time does not exceed six years. See Benke v. Parker, S08G2078, S08G2082, Sept. 28, 2009.
A violation of one of the Uniform Rules of the Road, such as the rule that a OCGA § 16-2-1 (a) provides that “[a] ‘crime’ is a violation of a statute of this state in which there is a joint operation of an act or omission to act and intention or criminal negligence.” A driver must not follow another vehicle too closely. Doing so is a is a misdemeanor, OCGA §40-6-1 (a), and a misdemeanor is “any crime other than a felony.”
To impose a more stringent definition of “crime” within the context of the statute would render superfluous its language that the statute of limitation is tolled from the date of the alleged crime “or the act giving rise to such action in tort” until the prosecution or other termination of such crime “or act.”
Find the opinion online here.
News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation. Lawyers for consumers and injured people.(No advice on this blog, though) mark(at)markzamora.com
Tuesday, September 29, 2009
Friday, September 25, 2009
Exjade and the FDA
The US Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients who are prescribed deferasirox (Exjade). This information suggests there may be a greater risk for adverse events such as kidney failure, gastrointestinal haemorrhage, and deaths in patients with myelodysplastic syndrome (MDS) compared with patients without these conditions.
Source here.
Source here.
Januvia/Sitagliptin: Pancreatitis Risk?
The Food and Drug Administration said on Friday that there may be a connection between Merck & Co.'s diabetes treatment Januvia/Sitagliptin and occurrences of acute pancreatitis, the same issue that sunk sales of Amylin Pharmaceuticals Inc.'s Byetta.
From the FDA site:
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009.
It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis.
Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.
More from the source, at Forbes:Here.
From the FDA site:
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009.
It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis.
Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.
More from the source, at Forbes:Here.
Tylenol Infants and Children Recall (Certain Lots)/More
It’s a voluntary recall, which according to NY Pediatrician Dr. Seth Gordon came because “examination of bulk raw material detected that one of the inactive ingredients contained gram-negative bacteria Burkholderia cepacia (B. cepacia). The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product.”
There are also raised that the carton labeling for Junior TYLENOL® Meltaways (160mg) may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen. Some may assume two tablets are standard and this is not the case.
In addition, some Children’s TYLENOL® Meltaways 80mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton for Children’s TYLENOL® Meltaways 80mg may be confusing to some consumers in determining the proper dosage. The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet of Children’s TYLENOL Meltaways contains 80 mg of acetaminophen. Caregivers should be guided by the dosage directions on the bottle label for the correct number of individual tablets to be given based on the child’s age and weight.
Source here.
There are also raised that the carton labeling for Junior TYLENOL® Meltaways (160mg) may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen. Some may assume two tablets are standard and this is not the case.
In addition, some Children’s TYLENOL® Meltaways 80mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton for Children’s TYLENOL® Meltaways 80mg may be confusing to some consumers in determining the proper dosage. The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet of Children’s TYLENOL Meltaways contains 80 mg of acetaminophen. Caregivers should be guided by the dosage directions on the bottle label for the correct number of individual tablets to be given based on the child’s age and weight.
Source here.
Thursday, September 24, 2009
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.
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.
For more, go to the Bloomberg site here.
Wednesday, September 23, 2009
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.
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.
Monday, September 21, 2009
Flooding in Atlanta
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.
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.
"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.
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.
Friday, September 18, 2009
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.
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.
Thursday, September 17, 2009
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.
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.
Monday, September 14, 2009
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.
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.
Sunday, September 13, 2009
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.
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.
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.
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.
Thursday, September 10, 2009
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
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.
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.
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.
Wednesday, September 02, 2009
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.
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.
Tuesday, September 01, 2009
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.
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.
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