Category Archives: Medical Device

This Week’s Life Science Headlines

        Litigation

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First New York Court Rejects Controversial Drug Developer Liability Rule

In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…

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Tolling Agreements Cause Coverage Concern

An insurance coverage dispute has arisen in connection with litigation involving a robotic surgery medical device maker. A declaratory judgment action seeking rescission of product liability insurance policies issued to the manufacturer was filed in the U.S. District Court for the Northern District of California. If successful, the insurer may avoid obligations under its primary and excess insurance policies providing $15 million per occurrence and $50 million aggregate. To read the rest of this article, visit Life Science Matters – An inside look at the

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Tolling Agreements Cause Coverage Concern

An insurance coverage dispute has arisen in connection with litigation involving a robotic surgery medical device maker. A declaratory judgment action seeking rescission of product liability insurance policies issued to the manufacturer was filed in the U.S. District Court for the Northern District of California. If successful, the insurer may avoid obligations under its primary and excess insurance policies providing $15 million per occurrence and $50 million aggregate. The declaratory judgment action stems from allegations that the manufacturer entered into tolling agreements with several potential…

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This Week’s Life Science Headlines

        Litigation

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Philadelphia Jury Returns $4 Million Verdict in Topamax Lawsuit, But Will it Stand?

A Philadelphia County jury returned a verdict in excess of $4 Million on behalf of plaintiffs who alleged that their child suffered birth defects related to his mother’s use of Topamax during pregnancy, but the complex procedural battle which occurred before the October 30th verdict suggests that the final chapter has yet to be written in this case. Plaintiffs, April and Blake Czimmer, filed suit in 2011 alleging that April took the anti-seizure medication Topamax (Topiramate) for six months during her pregnancy, and their child…

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The Manufacturer Made Me Do It – One Claim By Negligent Surgeon Survives

California certainly breeds interesting cases. In the Chao case, available here, recently decided by a federal judge in the Southern District of California, the plaintiff was not an injured person. He was an orthopedic surgeon found to be negligent in his treatment of a patient by an arbitration panel, which awarded in excess of $2 million to the patient. The surgery was a hip replacement surgery during which the surgeon lacerated the patient’s femoral artery. Following the award, the orthopedic surgeon brought an indemnity action…

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This Week’s Life Science Headlines

        Litigation

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D.C. Circuit to Determine if FDA can Regulate Stem Cell Treatments

The intersection of what is the practice of medicine and what is a regulated drug or biologic is an interesting place with constitutional and regulatory implications. These issues have come to the forefront in a significant case involving an autologous stem cell procedure used by an orthopedic group in Colorado.  In United States of America v. Regenerative Sciences, LLC, 878 F. Supp. 2d. 248 (D.D.C. 2012), available here,  a D.C. district court judge issued an opinion addressing many of these constitutional and regulatory issues, which…

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Last Week’s Important Headlines

Here are some other notable decisions and developments from last week in the Life Science area: Litigation

Regulatory

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