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

The article on "Prescription Drug and Medical Device Promotion – New FDA Draft Guidance on Presenting Risk Information" by Reed Smith lawyers Areta Kupchyk, Frederick Branding, Jennifer Goldstein and Kevin Madagan (previously discussed in this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.
* * * *
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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On June 3, 2009, the House Judiciary Courts and Competition Policy Subcommittee will hold a hearing, "Pay to Delay: Are Patent Settlements That Delay Generic Drug Market Entry Anticompetitive?", sure to interest all prescription drug manufacturers. No witness list is posted yet.

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This post was written by Kevin G. Lohman.

On May 26, 2009, the U.S. Supreme Court denied a petition for writ of certiorari to review a decision from the Supreme Court of Tennessee that upheld an award of punitive damages for over $13 million dollars, which amounted to a 5.35-to-1 ratio of punitive damages to actual damages. See DaimlerChrysler Corp. v. Flax, NO. 08-1010, 2009 WL 357533, (2009). ProductLiability.com deserves recognition for flagging this decision. 

The case arose out of a motor vehicle accident in June 2001, which resulted in the death of an eight-month-old baby. Plaintiffs, the parents of decedent, filed suit alleging wrongful death and negligent infliction of emotional distress (NIED) against the other driver involved in the accident and against DaimlerChrysler Corp., who was the manufacture of plaintiffs’ 1998 Dodge Caravan. The jury assigned fault evenly against the defendant driver (for speeding) and DaimlerChrysler Corp. (for defective design of the car seats), and awarded plaintiffs $5 million dollars in compensatory damages for their wrongful death claim, and $2.5 million damages for their NIED claim. During the second phase of the trial, evidence was presented that DaimlerChrysler Corp. was aware of the defective design of their car seats, they failed to warn customers, they hid evidence of the of the defective design, and they continued to market the Caravan as a vehicle that put safety first. The jury awarded punitive damages against DaimlerChrysler Corp. in the amount of $65.5 million for the wrongful death claim, and $32.5 million for the NIED claim. The trial judge remitted the punitive damages down to $13,367,345.00 for the wrongful death claim and $6,632,655.00 for NIED. 

On appeal, the Tennessee Court of Appeals reversed, holding that there was insufficient evidence to award any damages pertaining to the NIED claim. Further, the court held that there was not clear and convincing evidence that DaimlerChrysler Corp. acted recklessly or intentionally in order to warrant punitive damages, and struck the entire punitive damage award.

On further appeal, the Supreme Court of Tennessee affirmed the court of appeal’s holding pertaining to the NIED. However, they reversed the portion of decision pertaining to punitive damages. Holding that there was in fact sufficient evidence to support a finding of punitive damages, the court reviewed whether the size of the punitive damages award is excessive in violation of the due process standards set out by the United States Supreme Court in BMW of North America, Inc. v. Gore, 517 U.S. 559 (1996) and State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408 (2003). Specifically, the court relied on the first two guideposts set out in Gore and Campbell (the reprehensibility of the defendant’s conduct; and the ratio between the punitive damage award and the compensatory damages). 

With regard to the first guidepost, the court noted that the evidence in this case “clearly demonstrates that [DaimlerChrysler Corp.’s] conduct was reprehensible.” As to the second guidepost, the court noted that the punitive-to-compensatory ratio was 5.35-to-1 and acknowledged the language of the Supreme Court decisions in Gore (suggesting that a ratio of greater than 4-to-1 approaches the outer limits of constitutionality) and Campbell (suggesting that a ratio of 1-to-1 may be all that is permissible in cases where compensatory damages are “substantial”). However, the court also noted that in Campbell the Supreme Court declined to adopt a fixed mathematical formula to determine the appropriateness of punitive damages and stated that “the precise award in any case, of course, must be based upon the facts and circumstances of defendant’s conduct and the harm to the plaintiff.” The Tennessee court held that “In light of the first two guideposts, we believe that a ratio of 1 to 5.35 would be warranted in this case,” noting that the evidence pertaining to the defendant’s conduct demonstrated their conduct was reprehensible and the harm to the plaintiffs in this case was tragic (the death of an eight-month-old baby). 

Interestingly, the Tennessee court chose not to acknowledge the Supreme Court’s most recent punitive damage decision from Exxon Shipping Co. v. Baker, ___ U.S. ___, ___, 128 S. Ct. 2605 (2008), which was decided one month prior and established a 1-to-1 ratio between punitive and compensatory damages under federal maritime law and contained implications for applying the 1-to-1 ratio to limit punitive damages in state court actions. (The Exxon decision is discussed in this prior post). Despite the fact that Supreme Court of Tennessee did not acknowledge Exxon, the United States Supreme Court denied DaimlerChrysler’s petition for writ of certiorari.

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