Stoughton / Canton Area Personal Injury Lawyer - Medical Devices & Implants

CPSC Urges Parents Not To Use "My Baby Soother" Pacifiers

Chrissie Cole — Fri, 09 Oct 2009 13:17:00 GMT

Parents and caregivers should stop using the “My Baby Soother” pacifier, according to a recent safety alert by The U.S. Consumer Product Safety Commission (CPSC).

The pacifiers, distributed by T & L Trading Corp, fail to meet federal safety standards because the nipples can easily separate from the base, posing a choking hazard to infants and toddlers.

The agency announced a safety alert after the company refused to recall these pacifiers.

The recalled pacifiers have a ring-shaped handle and a blue, pink, red, white or yellow heart-shaped mouth guard. The packaging displays the words "My Baby Soother."

The agency urges parents to take the pacifiers from infants and toddlers and discard them.

Originally posted at InjuryBoard by Chrissie Cole

FDA Asked to Overhaul its Medical Device Testing System

Carrie Strasser — Fri, 16 Jan 2009 09:28:09 GMT

Finally, reform may be coming to the Food and Drug Administration's medical device testing system. On Thursday, the Government Accountability Office released a report requiring the FDA to take "immediate steps" to fix this system.

The New York Times reported that the FDA has been promising this change for decades, but has failed time and time again to act on those promises. Congress's Accountability Office has been criticizing the FDA, in recent years, for failing to protect our food supply, failing to adequately inspect foreign drug plants that provide our medicines and failing to detect certain drug dangers.

While the FDA has mostly agreed with Congress's criticisms, this time, nine scientists within the FDA's medical device branch are also sounding the alarm on the faulty review process. These scientists have written letters to both Congress and President-elect Obama seeking the changes needed to improve this system.

The current medical device approval system allows medical devices that are similar in operation to older devices already on the market to be approved more quickly with minimal testing requirements.

"So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, 'Look, it's a car just like the Model T,'" said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center in New York and a former senior adviser to Medicare and Medicaid. "Then they go out in the marketplace and say to doctors, 'Why would you drive anything but a Ferrari?' This drives up the cost of care without any necessary actual improvement in outcomes."

This system was created by the FDA in 1976 and divides products into three classes. Class I devices, like forceps, are mostly exempt from the review process. Class II devices, for example, a Mercury thermometer, get quick reviews. Class III devices, including pacemakers and heart valves, are able to receive expedited review if they are found to be similar enough to devices already on the market.

In 1990, the FDA was instructed to write rules that would provide for more rigorous testing for these Class III devices, but the agency never followed through. The Accountability Office told the FDA that they still needed to write those new rules.

Dr. Susan Alpert of Medtronic explained that many of the devices currently designated as Class III would, once the system is fixed, be reclassified as Class II, or less risky, devices.

If you or someone you know is dependent on a medical device, here is some information. For information on the FDA and prescription drugs, click here.

Originally posted at InjuryBoard by Carrie Strasser

Boston Scientific Recalls NexStents for Defect

Chrissie Cole — Thu, 14 Aug 2008 12:17:00 GMT

Boston Scientific announced a Class I recall of about 2,200 NextStents due to a defect that can cause part of the devices to break off during surgery.

The devices are used in patients to treat blockage in the carotid artery, known as carotid artery disease. The device is specifically used in a procedure called carotid artery stenting (CAS), in which the physician places the self expanding stent into the artery to keep it open and to help prevent future narrowing of the artery.

The following NexStents distributed worldwide to hospitals between Jun2007 and May 2008 are included in the recall:

Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303.

[OUS Material Number (UPN) M001553000, Catalog Number 55-300]

Please Note: this recall does not involve NexStents that have already been implanted.

Originally posted at InjuryBoard by Chrissie Cole

Prescription for Disaster/Preemption and the FDA

Bruce Bierhans — Sun, 08 Jun 2008 20:22:02 GMT

In todays Boston Globe, there was a review of a new book authored by Melody Petersen. The book is entitled" Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves Into Slick marketing Machines and Hooked the Nation on Prescription Drugs." The book describeswhy Americans increased their spending on prescription drugs between 1980 to 2003 from 12 billion to 197 BILLION, a seventeenfold increase. As one might imagine, junkets, grants to medical centers, marketing and lies had lots to do with the dramatic increase. But...we read daily about suicides, heart attacks, depression and a host of other unseemly disorders and side effects related to this increase in the use of prescription drugs.

But...on the other hand, courts nationwide including the Supreme Court now are considering the issue of preemption. The possibility of prohibiting consumers from seeking justice from pharmaceutical companies if a drug ormedical device was approved by the FDA. On the other hand, politicians are calling for increased and improved oversight by the (Bush) FDA.

Imagine this scenario. People continue to become victimized by the drug companies and their deception...and the SC says they have no recourse. What incentive is there for the FDA to be diligent in their oversight responsibility? People continue to die and the concept of accountability...which drives the civil justice system, is rendered ineffectual.

Without both judicial accountability as well as a diligent FDA doing it's job, the consumer will continue to be victimized. But...don't forget to call your doctor and ask if drug XYZ is right foryou!

Originally posted at InjuryBoard by Bruce Bierhans