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Digitek, heparin and the likelihood of lawsuit success

By Nick Taylor , 22-Jul-2008

The heat is being turned up on Actavis Totowa as Federal lawsuits begin to pile up following the Digitek (digoxin) recall.

A recall was initiated in April following the discovery that the pills contained dosages of the active ingredient exceeding the intended levels.

Following this there has been a flurry of suits filed, with over 30 cases currently passing through Federal courts in states including New Jersey, California and Alabama.

Some of these suits claim that Actavis had knowledge of risks that were not clearly communicated on Digitek’s label and deliberately misrepresented the dangers posed by the product.

This is tied in with a warning letter issued by the FDA in 2006 that resulted in the suspension of new drug production at Actavis’ New Jersey manufacturing facility.

Digitek was cited specifically in the warning, with the FDA reprimanding Actavis for not submitting periodic safety reports for some drugs. As a consequence at least 26 adverse drug experiences (ADEs) were caused, six of which could be classed as potentially serious.

Shifting legal landscape

The likelihood of success for the plaintiffs in the Digitek and also heparin cases could be significantly impacted upon by another suit currently going through the courts.

Oral arguments in Wyeth v. Levine are scheduled to begin in the autumn and could potentially set a significant precedent for all cases that follow.

In February the Riegel v Medtronic case laid down a marker for the device industry, with the US Supreme Court ruling that patients injured by certain medical devices that gain US Food and Drug Administration (FDA) approval cannot sue the product's manufacturer.

The Justices voted 8-1 in favour of Medtronic, believing that allowing lawsuits against device makers disrupts the FDA regulatory process, which should be regarded as the gold standard.

Justice Antonin Scalia wrote the findings, communicating the opinion that only an objective regulatory body is capable of viewing the big picture.

She wrote: "A jury, on the other hand, sees only the cost of a more dangerous design and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."

However, there is a counter-argument that given the difficulties faced by the FDA in regulating the industry the courts provide another, important balance and safety net.

Regardless of this Wyeth v Levine may mark a similar watershed for pharmaceutical manufacturers, ushering in an era when allegedly defective drugs are dealt with solely by the FDA with the mechanism for personal liability claims stunted.

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