The REACH Regulations established a new system for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in the European Union when implemented on June 1, 2007. With phased implementation over an 11-year period, REACH covers chemicals, and substance mixtures, and articles that contain substances that are manufactured or imported into the EU in certain minimum quantities.… Continue Reading
The article on “Prescription Drug and Medical Device Promotion – New FDA Draft Guidance on Presenting Risk Information” by Reed Smith lawyers Areta Kupchyk, Frederick Branding, Jennifer Goldstein and Kevin Madagan (previously discussed in this post) has now been published in AHLA’s Health Lawyers Weekly.… Continue Reading
Since last year, a number of courts have interpreted and applied the express preemption holdings of Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Miller v. DePuy Spine, Inc., 07-cv-01639, 2009 US Dist LEXIS 49602 (D. Nev. May 1, 2009), is another example and, although it was decided on May 1, has just recently been picked up by LEXIS.
In Miller, the Nevada District Court granted summary judgment for the manufacturer of a PMA approved spinal implant disc called the Charite Artificial Disc. While many courts, including this one, correctly follow Riegel and hold that the state law claims challenging the design, manufacture and labeling claims are expressly preempted, this court also entered judgment for the defendant on warranty and misrepresentation claims that have a received a more mixed reception in some courts...… Continue Reading
On June 9, 2009, Vermont's governor signed S. 48, a new law that revises the state's current pharmaceutical marketing disclosure requirements. The new statute expands the application of Vermont's current requirement that pharmaceutical manufacturers annually disclose certain expenditures made in connection to interactions with Vermont health care professionals. Under the new law, the disclosure requirement now also applies to medical device companies. Further, the new law adds a ban on certain items and expenditures that was not included in the previous version. Notably, this gift ban goes into effect July 1, 2009...… Continue Reading
This post was written by Adam M. Masin. The American Dialect Society named “truthiness” as the word of the year for 2005 and Merriam-Webster followed suit in 2006. Popularized by political satirist Stephen Colbert’s character “Stephen Colbert,” truthiness is generally defined as “knowledge” based on emotion and gut instinct rather than on information, facts, evidence, … Continue Reading
The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:
- FDA Transparency Task Force
- Toll-Free Numbers for Adverse Events Reporting
- Generic Drugs… Continue Reading
Congress has been busy and there is no sign it intends to slow down just because it is summer.
In two weeks, the House Energy and Commerce Health Subcommittee will hold a hearing entitled, "Medical Devices: Are Current Regulations Doing Enough for Patients." The hearing will be on June 18th at 9:30 a.m. in 2322 Rayburn House Office Building and access to the webcast and witness list should be available from this page once available. Information about this subcommittee's May 12th hearing about medical device preemption is in this prior post...… Continue Reading
On May 27, 2009, the Food and Drug Administration ("FDA") announced the availability of a draft guidance titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion" ("Draft Guidance"). The Draft Guidance sets forth the standards FDA intends to consider when evaluating promotional pieces to determine whether they effectively communicate risk information in a non-misleading manner. Under the Food, Drug & Cosmetic Act ("FDCA") and FDA's implementing regulations, promotional materials making claims about a product are deemed misleading if they fail to disclose certain information about the product's risks. FDA is accepting comments on the draft through Aug. 25, 2009. Reed Smith's full alert provides a brief outline of the Draft Guidance and identifies issues for possible comment to FDA.… Continue Reading