Comments on: J&J To Pay $16.6M For Duragesic Patch Death

By: Jamie Taylor

Jamie Taylor — Mon, 30 Nov 2009 04:19:42 +0000

My mother Died last month. I got her autopsy results on my birthday. Fentanyl was listed as cause of death. I dont want anyone else to feel my pain. I will do everything I can to make sure of that.

By: Hubdar Ali

Hubdar Ali — Wed, 04 Feb 2009 15:22:20 +0000

In Pakistan J@J importing and marketing the same patches since 2002 and they neither recalled the patches manufactured by ALZA Corp nor publised any information in this regard for the users.

Company like J@J and USFDA should take appropriate action and compensation to avoid discriminative attitude with third world like Pakistan. As none of the company paid any compensation to Pakistani victim. Pfizer, MSD, BMS, Aventis, GSK etc have paid penalty in developed world like US but ignored the same here. They even do not bother to recall the such products from Pakistan voluntrarily while knowing the safety and threat potential associated with certain drug products.

I hope authorities will also consider the same in the spirit of WTO to ensure equal behaviour with people and country too.

By: Jamie Mikle

Jamie Mikle — Sun, 21 Dec 2008 01:42:32 +0000

The 34 yr old mother of 5 that died from the pain patch was my mother and I just want to send sympathy to the families that have lost their loved ones due to the neglectfulness of the company producing these patches. Though these cases disappear for the companies after they are settled it is something that the families will live with forever. In deepest symathy to the loved ones of the ones we lost, stay strong for eachother and hang in there.

By: Webb Margaret

Webb Margaret — Wed, 03 Dec 2008 17:59:21 +0000

My mother died on February 23rd 2008. She had been wearing duragesic patchs for approximately two years. Is it possible that the patch had something to do with her death? She had been to her doctor and her heart specialist within two weeks of her death and everything was fine. They listed the cause of death as cardiogenic encephalopathy. My mom had been doing so well that this taking place so suddenly really confused everyone. My concern is, was her death related to her wearing the duragesic patch?

By: An FDA Reviewer

An FDA Reviewer — Tue, 18 Nov 2008 13:16:09 +0000

This is exactly the type of problem that FDA reviewers have been detecting while doing reviews during the initial approval of new drugs and during supplemental reviews for manufacturing changes.

This is why companies such as J&J and in particular their Alza division have been pushing Quality by Design (QBD). In effect saying to us we know so much about how to manufacture drugs and change them that we don’t need to do any testing on changes, the quality is already built in.

J&J is definitely in my opinion the strongest advocate of QBD, not only taking the attitude that who are reviewers to question us, but also when a reviewer does question J&J have FDA management retaliate.

An FDA Reviewer