This week the FDA made game changing
moves dealing with American health and drug manufacturer liability. Their hope,
is that fair game will be established between brand name and generic
manufacturers—and that means equal liability.
FDA’s movement for parity stems from
the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011).
The
Mensing ruling was a big win for generic drug makers, who make up about 80% of
the pharmaceutical market. It states that generic drug manufacturers cannot be
sued for failing to warn consumers of dangerous side effects, as long as their
labels mirror brand labels. Two years later, the ruling has evolved to be
called the “Mensing preemption” because, as a federal law, it overrides state personal
injury laws.
In turn, brand name labels are held
more severely for liability, while generic labels are essentially granted
immunity. A growing post-Mensing trend is that courts will dismiss cases
with allegations of design defect, fraud, negligence, and breach or implied or
expressed warranty, as essentially failure to warn claims. Ironically,
while generic drug makers are actually liable for negligent manufacturing
processes and monitoring their mirrored-labels in a timely manner, the
over-arching “failure to warn” statute has stonewalled such cases from being
heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow
generic drug companies to initiate CBE changes (“Changes Being Effected”). This
would essentially overrule Mensing, by permitting generic drug companies add or
strengthen a warning label without prior FDA approval. The proposal also sates
that once approved, drug companies must conform their labels within 30 days (it
used to be an ambiguous “as soon as possible”). And finally, both brand and
generic labels may use the CBE process to add new warnings to the “Highlights”
section of new drug labels (which was previously restricted). With such
changes, generic and brand name companies will have no excuse for inappropriate
labeling or have immunity from harm caused to American consumers.
The proposed action is a positive
step toward protecting the checks and balances of the civil justice system and
the pharmaceutical market. Above all, it is a prospective change on behalf of
the rights and wellbeing of American consumers.
Stay tuned for news on the official
ruling in weeks to come.
This
week the FDA made game changing moves dealing with American health and
drug manufacturer liability. Their hope, is that fair game will be
established between brand name and generic manufacturers—and that means
equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf
This
week the FDA made game changing moves dealing with American health and
drug manufacturer liability. Their hope, is that fair game will be
established between brand name and generic manufacturers—and that means
equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf
