Merck & Co said on Friday it will pay $100 million to resolve all U.S. product liability lawsuits alleging it downplayed serious health risks involving its NuvaRing intrauterine contraceptive device. The product, which contains the hormones estrogen and progestin commonly found in birth control bills, is associated with an increased risk of developing blood clots that can cause heart attacks, strokes or sudden deaths. Available to women in the United States since 2001, NuvaRing is one of several contraceptive products linked to this higher risk. Merck, the second-biggest U.S. drugmaker, denied any fault under the agreement, which must be accepted by 95 percent of about 3,800 eligible patients involved in lawsuits pending in federal and state courts. A lawyer for the plaintiffs, Roger Denton of Schlichter, Bogard and Denton, said the settlement, reached after nearly a year of negotiations, is "an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of Nuvaring." Under the settlement, Merck would pay a fraction of what at least one company has paid in a similar settlement. German drugmaker Bayer AG said last year it had paid nearly $1.6 billion to settle thousands of lawsuits involving accusations that its Yaz and Yazmin birth control pills caused blood clots that led to strokes and heart attacks. Merck shares were up 1 percent at $54.32 on the New York Stock Exchange, in line with a 1.2-percent... |
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Showing posts with label New York Stock Exchange. Show all posts
Showing posts with label New York Stock Exchange. Show all posts
Saturday, February 15, 2014
Merck to pay $100 million in NuvaRing contraceptive settlement
Saturday, November 16, 2013
Class I Recall: Medtronic's Worldwide Voluntary Field Action on Guidewires
Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.
Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.
Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.
The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guide wire
Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website – specifically, http://www.medtronic.com/for-healthcare-professionals/index.htm.
Observations and consequences of the coating issue related to these guidewires should be reported to Medtronic in the United States by calling +1-877-526-7890 on weekdays from 8am to 5pm U.S. Central Time.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or - Call FDA at +1-800-FDA-1088
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
….
Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
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