Posts Tagged ‘“product liability lawyers”’
Meningitis Outbreak: Over 300 Now Infected, 23 Dead as State Calls for Licenses
State officials have announced they will seek permanent surrender of New England Compounding Center’s (NECC) pharmacy license in the wake of a fungal meningitis outbreak which has infected more than 300 people and left 23 dead.
At a Tuesday press conference, state officials announced they will seek the pharmacy’s license and permanent license revocation for NECC’s three pharmacists. Recent state inspections of the closed-down Framingham facility found dirty and defective equipment and showed the company had failed to follow its own safety tests and properly sterilize tools.
Governor Deval Patrick said a federal criminal investigation has been launched, while Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said the company had been violating its state compounding license. The facility was licensed to produce medicine with a patient-specific prescription in hand, not manufacture large shipments.
As of this week, 304 people had contracted fungal meningitis or joint infections linked to the injectable steroid produced by NECC, reported The Boston Globe. Testing has found the fungus matches a type found in unopened vials of the steroid shipped from NECC, though they are still investigating how the fungus got into the vials. The injectable steroid is methylprednisolone acetate.
The 23 deaths linked to the defective steroid come from seven states. No one has been reported ill in Massachusetts. But federal officials say as many as 14,000 people may have been exposed to the contaminated drug between May 21 and Sept. 26, when it was recalled. The company went onto recall all its drugs.
The Food and Drug Administration released a list this week of more than 3,000 NECC customers who received products other than the injectable steroid blamed for the meningitis outbreak. They included 215 Massachusetts doctors, health centers and hospitals. The shipments fell within the time frame of when the defective steroids were produced at the facility.
Ameridose, a Westborough pharmacy with the same owners as NECC, has also been closed down since Oct. 10 in an agreement with state officials. It is scheduled to remain closed until Nov. 5 for state inspections.
Related:
- CDC: 10 more people have fungal infections linked to Framingham pharmacy, The Boston Globe.
- New England Compounding did not follow sterility procedures, investigators find; state orders regular inspections of similar pharmacies, The Boston Globe.
- Corrected list of New England Compounding customers includes 215 in Massachusetts, The Boston Globe.
DePuy Orthopaedics Recalls Hip Implants–Massachusetts Patients Affected by Defective Product
The DePuy Orthopaedics unit of Johnson & Johnson has recalled two types of hip implants that have failed one in eight patients and required a second surgery within five years. The standard hip implant lasts for 15 years.
DePuy recalled its ASR XL Acetabular System, a traditional hip implant procedure, and the ASR Hip Resurfacing System last week. Only the traditional hip implant procedure is available in the United States. About 93,000 DePuy devices have been implanted worldwide.
The recall was issued because of friction between the implant’s metal components. The friction generates metal ions which affect the healing of the joint in some people. The device is also difficult for surgeons to properly implant in the precise location.
In the past two years, the Food and Drug Administration has received about 400 complaints about DePuy hip implants.
The product recall is the latest in a series for Johnson & Johnson, which has pulled Tylenol and Acuvue contact lenses from shelves in recent months. The Tylenol recall is the subject of a federal inquiry over the company’s handling of over-the-counter product recalls.
If you have a DePuy hip implant, it is important you consult your surgeon. To find out what to expect, visit the Breakstone, White & Gluck website.