Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

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.

Statistics on the pre-registration phase give a clear indication that REACH's reach has been longer than expected: The European Chemical Agency (ECHA) anticipated that approximately 30,000 chemical substances would be pre-registered, but in the end closer to 150,000 substances were pre-registered.

Nick Elliott's article, "The Next Steps," published in a recent edition of Hazardous Cargo Bulletin, discusses this new EU chemical regime, what companies need to do next, and some of the pitfalls to be avoided. The first registration deadline, applicable to high-volume and high-risk chemical substances, is only 18 months away – November 30, 2010. As Elliott explains, potential registrants have no time to waste in order to ensure compliance with the REACH registration obligations. REACH potentially impacts not only the EU chemical industry but also any entity, such as those operating in the life sciences industry, that manufactures in or imports substances/products into the EU.

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The article on "Prescription Drug and Medical Device Promotion – New FDA Draft Guidance on Presenting Risk Information" by Reed Smith lawyers Areta Kupchyk, Frederick Branding, Jennifer Goldstein and Kevin Madagan (previously discussed in this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 (log in required).

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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.

As to express warranty, Miller concluded that the plaintiff failed to establish the receipt of any express warranties, and that such warranty claims directly challenged the safety and effectiveness established through PMA approval of the device. The Court further held that even when couched as a warranty claim , claims are preempted when they would "impose liability for the defendant's use of labeling approved and required by the FDA." 

The plaintiff also claimed to assert "parallel claims" contending  that the implanted device was "out of conformity with the materials or manufacturing specifications approved by the FDA," but the court dismissed these as well because plaintiff failed to meet his burden in demonstrating that there was a genuine issue of fact. As the Court succinctly noted: "Only a departure from such FDA-approved specifications could conceivably escape preemption, and absence of any evidence of such departure justifies summary judgment." 

Plaintiff's claims that the manufacturer allegedly made misrepresentations or omissions of material information to the FDA in order to "secure or maintain the PMA" were also dismissed. Not only had the plaintiff offered only "argument about this hypothesis" rather than admissible evidence, under 21 U.S.C. Section 337(a), any attempt to enforce the FDCA and its regulations were preempted; and any contention that the manufacturer provided inaccurate or incomplete information to the FDA was impliedly preempted under Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). 

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This post was written by Matthew Wetzel.

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.

For more information, please read Reed Smith's full alert summarizing the revised Vermont law, including key dates for compliance.

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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, or logic. A true proponent of truthiness, for example, would “feel” the definition and would never look it up in a book. Whether on Colbert’s show, in academic and political circles, or in the pages of the New York Times, the concept of truthiness has been on a lot of important minds lately. Add the United States Supreme Court to that list. Although the Court did not explicitly invoke that word in discussing why the Complaint had to be dismissed in Iqbal v. Ashcroft, 2009 WL 1361536 (May 18, 2009), truthiness, it said in essence, is not the pleading standard under Rule 8. Welcome to the world of reality-based pleading.

Finally, our clients might add. As the Drug and Device Law Blog recently noted, defenders of the Iqbal decision have been more reticent that those horrified by it. The authors of that blog have ably raised a number of defenses for Iqbal and its older brother Twombly and took issue with plaintiffs’ claims that Iqbal and Twombly stand as obstacles to filing meritorious cases, arguing that “the hallmark of a meritorious case is that it’s factually supported from the get go.” That is undoubtedly true, and it should be added that all Iqbal and Twombly require is that plaintiffs give the trial judge some reason to belief that their case is meritorious “from the get go.”

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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

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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.

Earlier this week, the House Judiciary Committee held a hearing on a bill to curtail the discretion of federal judges in issuing litigation protective orders under Federal Rule of Civil Procedure 26(c ) and limiting the use of confideniality provisions in litigation settlement agreements subject to court approval or filed with the court. Proponents of this bill, the "Sunshine in Litigation Act of 2009", H.R. 1508, suggest that it is needed to help keep defendants in civil litigation from "hiding" health and safety hazards.

As the Supreme Court recognized in Seattle Times Co. v. Rhinehart, 467 U.S. 20, 33 (1984), discovery materials are not public components of a civil trial. Until information produced in discovery is filed with the court or introduced into evidence for determination of a merits issue (such as on a motion for summary judgment or at trial), protective orders routinely protect the confidential and proprietary information of parties to civil litigation.

Testimony by the Hon. Mark R. Kravitz of the District of Connecticut, on behalf of the Conference’s Committee on Rules of Practice and Procedure and its Advisory Committee on Civil Rules, opposed the bill on the ground that it effectively amends the Federal Rules of Civil Procedure outside the rulemaking process, contrary to the Rules Enabling Act (28 U.S.C. §§ 2071-2077). He testified that the bill is not needed (emphasis added):

In 1994, the Rules Committees asked the Federal Judicial Center (FJC) to do an empirical study on whether discovery protective orders were operating to keep information about public safety or health hazards from the public. The FJC completed the study in April 1996. . . . The FJC study showed that discovery protective orders were requested in only about 6% of the approximately 220,000 civil cases filed in federal courts in that time period. Most of the requests are made by motion. Courts carefully review these motions and deny or modify them in a substantial proportion. Less than one-quarter of the requests are made by party stipulations and the courts usually accept them. In most civil cases in which discovery protective orders were entered, the empirical study showed that the orders did not impact public safety or health. . . . The empirical data showed no evidence that protective orders create any significant problem of concealing information about public hazards.
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Even when a protective order is entered, it usually does not result in the sealing of all, or even many, documents or information submitted to the court. Case law shows that courts are rightly protective of the public’s right to gain access to information and documents submitted to the courts.
* * * *
Requiring courts to review discovery information to make public health and safety determinations in every request for a protective order, no matter how irrelevant to public health or safety, will burden judges, further delay pretrial discovery and inevitably increase the cost of civil litigation in federal courts.

We've attached a copy of the Federal Judicial Center's Report.  Additional testimony on the bill is available here.

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This post was written by Areta Kupchyk, Frederick Branding, Jennifer Goldstein and Kevin Madagan.

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.

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