Replies to post #138976 on Biotech Values

[DewDiligence]

From reading the NYT article, where we stand now leads to serious inequities.

Indeed it does, but what is the solution? Allowing generic-drug companies to craft their own labels to avert and defend against patient lawsuits would give the generic-drug companies a powerful incentive to load up their labels with mountains of superfluous warnings, rendering the labels unreadable from a practical standpoint. The generic-drug companies wouldn’t worry about a loss of sales from the mountains of extra warnings in the label because US-style substitutable generic drugs are not marketed.

[DewDiligence]

The Bartlett v. Mutual Pharma case* described in today’s NYT has no good solution, IMO; there was a grievous injury, but no one in particular did anything wrong:

http://www.nytimes.com/2013/03/05/business/justices-to-take-up-case-on-generic-drug-makers-liability.html

This case is sort of a rerun of the Debbie Schork case described in #msg-73530507 with the notable difference that Bartlett knew which generic drug she had taken while Schork did not.

[DewDiligence]

GSK faces lawsuit re patient who took generic Paxil:

http://blogs.wsj.com/pharmalot/2014/06/06/a-case-of-mistaken-identity-glaxo-faces-a-lawsuit-over-generic-liability/

Under current FDA regulations, generic drug makers cannot change the labeling on their copycat medicines, even if they learn of safety concerns, unless a brand-name drug maker makes that move first.

The notion was affirmed by a pair of U.S. Supreme Court rulings over the past three years [#msg-89329075, #msg-73530507]. As a result, generic drug makers can’t be held liable for harm, which is why some consumers have turned their attention toward brand-name drug makers. So far, though, brand-name drug makers have been able to fend off lawsuits. But this may change.

In an unusual instance, a federal appeals court this week denied a bid by GlaxoSmithKline to dismiss such a lawsuit. The case was filed by a woman who claims her husband committed suicide after taking a generic version of its Paxil antidepressant that was made by Mylan Laboratories.

The lawsuit is far from over, but the move raises the specter that a precedent may be set.