Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

Judge Lord's comments are not surprising in view of his previously expressed dislike of corporate America. What is surprising and distressing is the fact that a federal judge has abandoned his role as an impartial arbiter and, acknowledging from the bench his prejudice against the company, become an open advocate for one side. As counsel for the company noted, the judge's comments, based on a selective review of only a part of the evidence that would have been presented had the cases been tried, constituted a gross abuse of judicial discreion and power. Contrary to the judge's accusation, the company believes it has acted responsibly in the handling of the Dalkon Shield. The court chose to overlook the fact that in September 1980 Robins mailed a letter, recommending the removal of the Dalkon Shield from any woman still using the device, to approximately 200,000 physicians, clinics and govt. agencies. At the same time a news release was distributed to major wire services and newspapers in order to make the general public aware of the recommendation. The company believes this action was an adequate means of informing both the medical profession and any remaining users of the device of the desirability of removal. It should be noted that the FDA utilized essentially the same channels of dissemination nearly three years later when it issued a recommendation for removal of the device from remaining users.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts