Black and Decker to Pay $1.575 Million For Faulty Lawn Mower

The Department of Justice and the Consumer Product Safety Commission (CPSC) jointly announced today that Black & Decker Inc. has agreed to pay a $1.575 million penalty to settle allegations that it knowingly violated the reporting requirements of the Consumer Product Safety Act (CPSA) with respect to cordless electric lawnmowers that started spontaneously and that continued to operate after consumers released the lawnmower handles and removed the safety keys.  Black & Decker has also agreed to establish and maintain a compliance program with internal recordkeeping and monitoring systems to keep track of information about product safety hazards.  The settlement agreement is awaiting judicial approval.

Black & Decker has previously paid four civil penalties relating to Black & Decker’s untimely reporting of defects and risks presented by other Black & Decker products. 

“Not for the first time, Black & Decker held back critical information from the public about the safety of one of its products,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.  “The Department of Justice will continue to protect the public against companies that put profits over safety.”

“Black & Decker’s persistent inability to follow these vital product safety reporting laws calls into question their commitment to the safety of their customers,” said Chairman Elliot F. Kaye of the CPSC.  “They have a lot of work to do to earn back the public’s trust.  Companies are required to report potential product hazards and risks to CPSC on a timely basis.  That means within 24 hours, not months or years as in Black & Decker’s case.”

The complaint relates to cordless lawnmowers manufactured and sold by Black & Decker from 1995 to 2006.  According to the complaint, in as early as November 1998, Black & Decker started receiving reports that its cordless electric lawnmowers continued to run even after a user released the lawnmower’s handle and removed the safety key, referred to as a continuous-run defect.  A second defect involved lawnmowers that unexpectedly started even though the handle was released and the safety key removed, referred to as a spontaneous ignition defect. 

The United States alleged that between 1998 and 2009, Black & Decker received more than 100 complaints regarding the continuous-run or spontaneous ignition defects.  Dozens of these complaints specifically reported that the lawnmower continued to run or exhibited spontaneous ignition after the lawnmower’s handle was released and the safety key was removed.  The United States further alleged that, after consulting an outside expert, the company knew in 2004 that the lawnmowers could continue to run even if a user released the handle and removed the safety key.  Despite knowledge of all of this information, Black & Decker failed to report to the CPSC until early 2009, even though federal law requires “immediate reporting.”

The complaint further notes that at least two consumers informed Black & Decker that the lawnmower’s blades started unexpectedly while the consumer cleaned them, resulting in injury.  The complaint states that in one case, the lawnmower continued to run, with the handle released and without the safety key, for several hours while the consumer sought treatment in a hospital emergency room for injury to the consumer’s hand, and after fire department personnel arrived and removed the blade.

In addition to the civil penalty, Black & Decker agreed to be bound by a consent decree of permanent injunction that prohibits the company from committing future violations of the CPSA.  The consent decree requires that Black & Decker continue to implement and maintain a robust compliance program that ensures timely, truthful, complete and accurate reporting to the CPSC as required by law.  In addition Black & Decker is subject to liquidated damages for each day the company is not in compliance with the consent decree.

Health Canada VS FDA Did They Really Think They'd Win?



Whatever the FDA told Health Canada has had an effect. Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.

Health Canada initially responded to the FDA putting Apotex's finished dose plant in Bangalore, India under import alert by asking the company to quarantine products manufactured at the facility. The quarantine bought Health Canada time to learn why the FDA issued the import alert and formulate its own response. Six days after calling for the quarantine, Health Canada has banned the import of 30 finished products--and a similar number of APIs--that Apotex manufactures at its Bangalore plants.

The regulator has also banned almost 20 APIs--and 50 products in which they are used--from IPCA Laboratories. A common thread links the regulatory actions: Data integrity. "This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products," Canadian health minister Rona Ambrose said in a statement.

Reports of data integrity failings at IPCA emerged after FDA visited a plant in July and issued a Form 483. Staff at the IPCA site allegedly falsified temperature records, tweaked integration parameters and overwrote raw data. FDA inspectors visited Apotex around the same time, leading to a warning letter detailing the discarding of undesirable assay results and other data integrity problems.

Valeant Shortcomings Caught By FDA

 

Pharma Manufacturing  reports that the FDA has

posted a warning letter stating that management at

Valeant Pharmaceuticals failed to properly oversee a

contract manufacturer that supplied it with Sculptra

Aesthetic (injectable poly-L-lactic acid). In particular, the

FDA found no evidence that anyone at Valeant had

reviewed and approved the vendor’s deviation report

after the manufacturer stopped production to fix

problems affecting drug quality. The article says that the

FDA “wants to see evidence Valeant has taken steps to

improve its monitoring of CAPAs and review of supplier

deviation reports.” However, Valeant is confident it can

resolve the issues raised and has already divested

Sculptra Aesthetic as part of a deal with Nestle’s

Galderma unit.

Sculptra Aesthetic, a facial injectable that is marketed to smooth wrinkles. The product competes with Juviderm, which is sold by Allergan. Valeant is trying to buy Allergan, which also sells Botox, for $53 billion in conjunction with Pershing Square Capital Management.

 

Nonetheless, the letter raises the possibility that Allergan and its supporters may use the agency warning to support their argument that Valeant cutbacks focus too heavily on areas other than marketing, which may jeopardize R&D or patient safety. Earlier this week, the Allergan board reiterated that the Valeant offer is “grossly inadequate and substantially undervalues” Allergan.

We asked Valeant for comment and will update you accordingly. [UPDATE: Shortly after we posted, Valeant released a statement that says, in part, the warning letter "pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing."  A Valeant spokeswoman adds that Sculptra Aesthetic was sold shortly after the inspection.]