Science, Computers & Technology, Health Law, Products Liability

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

by Fuerst Ittleman David & Joseph, PL on 5/10/2013

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

Supreme Court Denies Certiorari in MAO’s Double Damages Case

by Edward Waller | Fowler White Boggs P.A. on 5/3/2013

On April 15, 2013, the United States Supreme Court denied a petition for certiorari brought by GlaxoSmithKline (“Glaxo”) seeking review of a Third Circuit decision in favor of Humana Medical Plan (“Humana”), as a Medicare...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

by Matthew A. Reed | Sedgwick LLP on 4/26/2013

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

by Erin M. Bosman, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 3/28/2013

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

by Mark Spatz | Cohen & Gresser LLP on 2/7/2013

As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

by Erin M. Bosman, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 1/18/2013

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

by Fuerst Ittleman David & Joseph, PL on 1/14/2013

As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted...more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

by James A. Hoover | Burr & Forman on 12/6/2012

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

Pro Te Solutio - Vol. 5 No. 3 August 2012

by Butler, Snow, O'Mara, Stevens and Cannada,... on 11/12/2012

In This Issue: - Diversity In Clinical Trials: The Need For Diversity To Ensure Safety And Efficacy - Federal Removal Statutes: A Review Of The Federal Courts Jurisdiction And Venue Clarification Act Of 2011 -...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

Confounding Issues about Compounding Pharmacy Regulation

by Mintz Levin - Health Law on 10/18/2012

Originally published in the American Health Lawyers Association, Washington, D.C. on October 17th, 2012 New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing...more

Baker & McKenzie: Life Sciences Update - September 2012

by Baker & McKenzie Australia on 9/11/2012

September 2012 edition featuring: - Australia introduces compulsory licences for pharmaceutical products - Raising the Bar – Significant Reform of Patent Laws - E-Health - You'll Feel Better: Swisse...more

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

by Morgan Lewis on 4/3/2012

State and federal courts reject efforts to categorize salmonella as a "communicable disease." While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more

Getting the Best Medical Care: A Newsletter From Patrick Malone - October 2011

by Patrick Malone & Associates P.C. | DC Injury... on 10/10/2011

In this issue: "NNT" -- What It Means and Why You Should Care; Finding NNT's for Any Condition; and Eye-Popping NNT's for Breast Cancer Screening. Every single recommendation you will ever get for health care -- at least...more

FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

by Morgan Lewis on 8/10/2011

On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more

Electronic Medical Records

by Jingna Zhao on 7/6/2011

You may never need to fill out a form when you visit a doctor's office. Instead of having a different medical record number at each hospital or doctor's office, patients can have their entire medical history accessible online...more

The Evolution of the Electronic Cigarette

by Azim Chowdhury on 5/25/2011

What are electronic cigarettes? Medical devices or tobacco products? On December 7, 2010, the U.S. Court of Appeals for the District of Columbia Circuit put that question to rest....more

Assessing Protections for Biomaterials Suppliers 12 Years After the Biomaterials Access Assurance Act

by McDermott Will & Emery on 11/18/2010

The growth of the biomaterials market, which analysts expect to reach $58.1 billion by 2014, shows that biomaterials suppliers have flourished by relying on the Biomaterials Access Assurance Act of 1998 (BAAA), 21 U.S.C. §§...more

Client Alert: FDA Issues Order Requiring Safety and Effectiveness Information from Older Medical Devices

by Foley Hoag LLP on 4/10/2009

On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the...more

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Science, Computers & Technology › Health Law › Products Liability

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Supreme Court Denies Certiorari in MAO’s Double Damages Case

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

Pro Te Solutio - Vol. 5 No. 3 August 2012

FDA Unveils New System to Track Medical Devices

FDA Unveils New System to Track Medical Devices

Confounding Issues about Compounding Pharmacy Regulation

Baker & McKenzie: Life Sciences Update - September 2012

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

Getting the Best Medical Care: A Newsletter From Patrick Malone - October 2011

FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

Electronic Medical Records

The Evolution of the Electronic Cigarette

Assessing Protections for Biomaterials Suppliers 12 Years After the Biomaterials Access Assurance Act

Client Alert: FDA Issues Order Requiring Safety and Effectiveness Information from Older Medical Devices

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