Philadelphia Personal Injury Lawyer

Synthes Components Recalled

Jamie Sheller — Wed, 18 Nov 2009 21:17:38 GMT

Recently, Synthes, a Swiss medical device company, voluntarily recalled its Synex II Central Body components. According to the company, all surgeons and hospitals with the recalled devices were to immediately stop implanting them. The FDA has classified the recall as a Class I, which means that they could pose an imminent health hazard. The Synthes devices are used to replace damaged or unstable vertebral body in the T1-L5 portion of the spine. The recall was issued after reports of device failure causing loss of vertebral body replacement height. Those problems could lead to neural injury, increased pain and possible need for further surgery.

Originally posted at InjuryBoard by Jamie Sheller

Public Service Alert - Strollers Recalled

Jamie Sheller — Tue, 10 Nov 2009 23:02:02 GMT

The Consumer Product Safety Commission has announced a recall of about 1 million Maclaren strollers. The stroller recall came after an investigation of 12 reports of the strollers' hinge mechanism amputating the fingertips of children. Strollers affected by the recall have been sold since 1999 by Target, Babies "R" Us and other stores. The recalled Maclaren stroller models include: Volo, Triumph, Quest Sport, Quest Mod, Techno XT, Techno XLR, Twin Triumph, Twin Techno, and Easy Traveller. There is a risk of children having their fingertips amputated if their finger is placed in the Maclaren stroller's hinge mechanism while the stroller is being unfolded. The finger tip can be cut off when the stroller locks into place. To prevent future incidents, Maclaren is offering free hinge covers, which should not be removed unless the stroller is being cleaned. Parents and caregivers should immediately stop using the recalled Maclaren strollers.

Originally posted at InjuryBoard by Jamie Sheller

Merck Discloses Payments To Doctors

Jamie Sheller — Mon, 02 Nov 2009 14:26:08 GMT

Recently, the drug manufacturer Merck disclosed information showing that in the summer of 2009, it paid $3.7 million to doctors and nurses for giving talks to colleagues about Merck products and health issues. Merck is the second major drugmaker to disclose such payments.

There has been a flurry of criticism by media and lawmakers over what appears to be excessive influence over doctors by drug and medical device makers. In the past, companies tried to gain favor with doctors through wining and dining them. However, since Janary 2009, industry guidelines have barred providing expensive meals, trips and gifts. In addition, major hospitals and universities are reviewing their internal policies regarding what staff doctors can accept, and what they must disclose.

According to Merck, the payment data that is discloses on its website, "shines a light" and addresses a misunderstanding about the relationship between doctors and the industry. Merck says that its programs are balanced and cover a variety of issues, including new research and improving patient care.

Critics argue that disclosing payments is a step in the right direction, but is not enough by itself. They see the compensated talks as paid-for marketing for a particular drug or treatment. Such critics urge medical schools and professional medical societies to be a more influential force in teaching doctors about new products.

Originally posted at InjuryBoard by Jamie Sheller

Strangulation Risk Leads To Recall of Window Blinds

Jamie Sheller — Mon, 02 Nov 2009 13:16:25 GMT

According to the Consumer Product Safety Commission, some Roman shades and roller blinds pose a serious strangulation risk for young children. Therefore, recently there was a recall of nearly 1 million roller blinds and Roman shades sold by IKEA, Bed, Bath & Beyond and Hanover Direct.

The following models of IKEA roller blinds, sold between July 2005 and July 2008, were involved in the recall: ISDANS, TUPPLUR and ENJE. These blinds were manufactured in France and Taiwan. IKEA has been involved in 2 previous recalls of blinds, in August 2009 and November 2008, following a child's death. This current recall is not related to any reported incident involving IKEA blinds.

In addition to the IKEA blinds, Dublin Energy Solution Roman Shades, sold exclusively by Bed, Bath & Beyond have been recalled. These shades are Chinese made and were sold between August 2007 and September 2009. These shades have been involved in 2 incidents where small children became entangled in the inner cords. The two children did not receive permanent injuries in these incidents.

Also, some Roman shades sold by Hanover Direct, also known as Domestications, have been recalled. These shades are Chinese made faux suade, and were sold between January 2004 and December 2008. A small child had become entangled in the inner cord of these shades, with no permanent injury.

Originally posted at InjuryBoard by Jamie Sheller

Antipsychotics Cause Rapid Weight Gain In Children and Youth

Jamie Sheller — Thu, 29 Oct 2009 21:51:54 GMT

According to a study recently published in The Journal of the American Medical Association, the newest generation of antipsychotic medications can cause rapid weight gain and metabolic changes in young children and adolescents. These side effects could lead to diabetes and hypertension. On average, the patients in the study gained one to one and a half pounds per week. One expert, Dr. Wayne Goodman, said that, "the degree of weight gain is alarming." Dr. Goodman is the chairman of psychiatry at Mount Sinai School of Medicine, as well as head of an FDA advisory panel on antipsychotic drugs. Previous studies had detected the drugs' influence on weight and metabolism, but this recent study demonstrated that the speed and magnitude of the effects were greater than previously known.

The study involved 257 patients, ages 4-19 and the four most popular antidepressants, Abilify, Risperdal, Zyprexa and Seroquel. The drugs are used to treat schizophrenia and bipolar disorder. Of the four drugs, Zyprexa had the most severe effects on weight and metabolism. The study was the largest of childhood use of these drugs called atypical antipsychotics. Only 2 of the 4 drugs studied, Abilify and Risperdal, are approved for pediatric use. According to one expert, "more than 70% of atypical antipsychotic use in young children and teenagers has been off-label prescriptions for non-psychotic conditions like attention deficit hyperactivity disorder."

Originally posted at InjuryBoard by Jamie Sheller

Doctors Lack Knowledge About Off-Label Uses

Jamie Sheller — Wed, 28 Oct 2009 21:17:14 GMT

Off-label use is the practice of prescribing medications for uses other than those approved by the FDA. Many doctors engage in the practice. However, according to a recent survey, a substantial minority of doctors mistakenly believe that certain off-label uses are FDA-approved. These off-label uses are often not supported by scientific evidence. "Overall, physicians were able to correctly identify the FDA-approved status of just one half (mean 55%) of the 22 drug-indication pairs (i.e. a particular drug prescribed for a particular condition) that were included in the survey." The mistaken belief that off-label uses are FDA approved may encourage some doctors to practice off-label prescribing. The study was published in the journal Pharmacoepidemiology and Drug Safety. The study's authors urge the need for physicians to learn more about off-label drug use and whether there is support for such uses, especially uses that are ineffective or have unacceptable risks.

The FDA approves drugs for specific indications, and regulates the marketing of drugs. Drug makers are prohibited from promoting their drugs for off-label uses. However, doctors are free to prescribe approved drugs for uses not indicated in the drug's label. Patients are often not aware that they are being prescribed a drug for an off-label use.

Originally posted at InjuryBoard by Jamie Sheller

Plaintiffs Win First Paxil Birth Defects Case

Jamie Sheller — Tue, 20 Oct 2009 21:08:18 GMT

A jury awarded a $2.5 million verdict in the first Paxil birth defects case to go to trial. GlaxoSmithKline is liable for the verdict, after the jury found that it was negligent. The verdict is for compensatory damages. No punitive damages were awarded because the jury did not find that Glaxo's conduct was outrageous. Jamie Sheller of Sheller, P.C. was one of the lawyers representing plaintiff Michelle David who alleged that Paxil caused the life-threatening heart defects suffered by her son Lyam Kilker. Paxil is an antidepressant, and Ms. David took it while she was pregnant. From 1992 through 2005, Paxil was classified as a drug with no known link to increased birth defects. In September 2005, the FDA began warning of a possible association between Paxil and birth defects. Four months later the Paxil warnings were strengthened. Meanwhile, Lyam Kilker was born in October 2005. At two months old, he was diagnosed with heart defects, and he underwent surgery to repair two holes in his heart, spending five months in a Philadelphia hospital. He will also need at least one more heart surgery as he grows. According to Jamie Sheller, Glaxo could have known about the risks of birth defects much sooner.

The Lyam Kilker case was one of over 600 similar cases against Glaxo. Another case is scheduled for trial in Philadelphia in November.

Originally posted at InjuryBoard by Jamie Sheller

Emergency Alert Regarding MTD Snow Throwers

Jamie Sheller — Tue, 20 Oct 2009 19:32:37 GMT

Winter is quickly approaching, and snow has already fallen in parts of the country. Along with snowfall, comes the use of snow throwers. However, some snow throwers should not be used. In 2006, there was a recall of snow throwers manufactured by MTD. The snow throwers were recalled due to the risk of injury from bursting wheel rims when the tires are inflated. Exploding plastic wheel rims have caused numerous injuries, including lacerations and fractures. The snow throwers involved in the recall are two-stage compact snow throwers with Troy-Bilt, Yard Machines or Craftsman printed on the snow thrower's housing. Yard Machine and Troy-Bilt brand snow throwers were sold at independent dealers, home improvement and hardware stores. Craftsman brand snow throwers were sold at Sears and Kmart stores. Snow throwers involved in the recall were sold between July 2004 and March 2006. The MTD snow thrower recall was done in cooperation with the Consumer Product Safety Commission.

Despite the fact that the recall was done in 2006, people are still using the recalled machines, and being injured. Anyone who has one of the recalled MTD snow throwers should not try to inflate the tires. There is a risk of injury caused by the tire rim exploding.

If you have been injured by an MTD snow thrower, contact Jamie Sheller, at Sheller, P.C. to discuss your potential legal rights. The Sheller firm has a long history of successfully representing individuals and classes of individuals who have been injured by defective products.

Originally posted at InjuryBoard by Jamie Sheller

Paxil Birth Defect Trial In Philadelphia

Jamie Sheller — Sun, 18 Oct 2009 22:40:09 GMT

According to the lawyer representing a family suing GlaxoSmithKline, company executives intentionally ignored the possibility that Paxil could cause birth defects. Paxil is an antidepressant, and there were studies showing that Paxil posed a risk of birth defects. However, the plaintiff's lawyer argued that due to the fear of harming sales, Glaxo never followed up on those studies. The lawyer made these comments during closing arguments at the Paxil trial in state court in Philadelphia. The Philadelphia case is the first to go to trial, alleging that Glaxo was aware of the Paxil birth defect risks and hid those risks to increase profits. There are more than 600 such cases against Glaxo, the U.K.'s largest drugmaker. The Philadelphia case was filed by Michelle David, the mother of Lyam Kilker, who claims that Paxil wasn't properly tested, and that it caused Lyam's life-threatening heart defects. Mrs. David alleges that information about Paxil's risks was withheld from consumers and regulators.

Paxil was approved in 1992 for U.S. use, and generated approximately $942 million in sales for Glaxo in 2008.

Jamie Sheller, of Sheller, P.C., is one of the lawyers trying the Paxil case in Philadelphia. Sheller lawyers have a long history of succesfully representing individuals and classes of individuals who have been injured by pharmaceuticals and medical devices.

Originally posted at InjuryBoard by Jamie Sheller

Philadelphia Personal Injury Lawyer

Synthes Components Recalled

More Problems For Acne Drug Accutane

Public Service Alert - Strollers Recalled

Merck Discloses Payments To Doctors

Strangulation Risk Leads To Recall of Window Blinds

Antipsychotics Cause Rapid Weight Gain In Children and Youth

Doctors Lack Knowledge About Off-Label Uses

Plaintiffs Win First Paxil Birth Defects Case

Emergency Alert Regarding MTD Snow Throwers

Paxil Birth Defect Trial In Philadelphia