Drug and Medical Device

Thanks to the United States Supreme Court's recent decision in Mensing v. Pliva, litigants now enjoy some clarity regarding the fate of plaintiffs' claims against generic pharmaceutical manufacturers. And given the overwhelming rejection of the California Court of Appeals' decision in Conte v. Wyeth (at least until the Alabama Supreme Court's recent decision in Wyeth v. Weeks), branded manufacturers can predict that they are not likely to face liability under existing case law in a number of states when the plaintiff took only a generic competitor's medication. But what happens when a plaintiff took branded medication originally, switched to its generic bioequivalent, and then suffered the alleged injury? Despite the growing number of courts rejecting "innovator liability," case law to date has not addressed this scenario, due in large part to the fact that the vast majority of decisions addressing "innovator liability" have focused on metoclopramide, a medication that has been available in generic form for decades. Nevertheless, an increasing number of widely prescribed drugs that have been embroiled in litigation have now lost their exclusivity or will soon do so. As a result, cases in which the plaintiff started on the branded drug and switched to the generic have already been filed, and more are likely in the near future. This is particularly true where the drug in question is often prescribed over an extended period of time, making it more likely for the plaintiff to have started on the branded version of the drug. 

Most trial lawyers know that a favorable judgment can and often will result from persuasive motions practice at the district court level. But regardless of whether a drug or device manufacturer seeks to affirm or reverse a judgment on appeal, effective motions practice is almost always the key to winning on appeal. This article provides a succinct primer of common trial and post-trial motions and also offers direction on less common motions that can constitute grounds for a successful appeal by pharmaceutical and medical device defendants.

"Speech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech Clause of the First Amendment." Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2659 (2011). That sentence, which appears prominently in the first paragraph of the Court's decision last Term in Sorrell, doomed a Vermont law restricting the sale of pharmacy records of individual doctors. The principles which underlie that sentence sweep more broadly than that, however, to cast a First Amendment shadow over a range of governmental regulatory activities, including those of FDA. This shadow may well have important implications for product liability tort litigation.

Jurisdictional gamesmanship has long been a source of frustration for pharmaceutical and medical-device defendants. Plaintiffs have frequently avoided federal jurisdiction – and by extension, inclusion in federal multidistrict litigation ("MDL") proceedings – either by joining non-diverse defendants for the sole purpose of staying in state court or by misjoining plaintiffs in a manner that defeats diversity jurisdiction. Recent case law has suggested that judges are finally growing skeptical of plaintiffs' tactics, although the success of fraudulent joinder arguments often varies based on underlying state law (such as innocent-seller statutes).

This article explores recent developments in the law of fraudulent joinder and misjoinder, with a particular focus on theories for removing cases involving distributors, sales representatives, hospitals and pharmacies. It also sets forth several practical tips for defense lawyers seeking to successfully remove pharmaceutical cases to federal court.

A recent decision by the California Supreme Court may signal the end of so-called "innovator liability" under Conte v. Wyeth. The Conte decision arguably has spent three years on the ropes, with a long list of courts declining to hold brand-name manufacturers liable for injuries allegedly caused by generic-equivalent drugs. Nevertheless, undeterred litigants clinging to the California Court of Appeal's 2008 decision in Conte have continued to push for expanded tort-law duties in drug products litigation. The California Supreme Court's decision in O'Neil v. Crane Co., 266 P.3d 987 (Cal. 2012), however, could be the blow that puts Conte on the canvas.

People often hear the phrase “the only thing certain in life is death and taxes.” In the realm of labor and employment law, however, the “most certain” principle with respect to employee compensation is that employees must be paid a minimum wage. In the case of overtime, employees must be paid not less than 1½ times their regular rate under the Fair Labor Standards Act of 1938 (FLSA), a federal law that is applicable in all states. There are exceptions to these principles, however. Employers are not required to pay overtime to employees who satisfy one of the FLSA “exemptions.” But determining whether an employee is overtime exempt under the FLSA can be difficult; and failure to classify an employee properly can be costly for employers. Some exemptions are well established. Doctors, for example, are overtime exempt under the FLSA. The exemption status is not as well settled for other professionals.

The digital age has rendered formal memoranda explicitly requesting or reflecting legal advice nearly obsolete. Instead, employees and counsel send and receive hundreds or thousands of informal e-mails that implicitly request or reflect legal advice. The result is a corresponding increase in the volume of documents withheld based on the attorney-client privilege during litigation. Unfortunately, courts have reacted to the increase in privilege claims by increasingly raising the bar required to establish the privilege.

By now, likely all who represent pharmaceutical manufacturers are familiar with the United States Supreme Court's recent decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567, 180 L.Ed.2d 580 (2011), its latest pronouncement on the scope of federal preemption of state law failure-to-warn claims. Considerable recent commentary has discussed the merits of the opinion, which undoubtedly was a huge victory for generic manufacturers. But will Mensing lead to renewed attempts by the plaintiffs bar to file claims against the name-brand manufacturers in similar factual situations? 

At the direction of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) recently reviewed the 510(k) clearance process for medical devices. Established in 1970, the IOM "is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public." The IOM seeks to improve the nation's health and conducts studies mandated from Congress, federal agencies, and independent organizations, in furtherance of that goal. About the IOM, Institute of Medicine, http://www.iom.edu/About-IOM.aspx (last visited 8/20/11). On July 29, 2011, after a 16-month review, the IOM released its much-anticipated report titled Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years (the "Report"), and called for the elimination of the 510(k) clearance process. This article examines the conclusions and recommendations of the Report and the process by which the IOM arrived at its conclusions. While recognizing that the Plaintiffs' bar will attempt to use the Report's conclusions to their advantage in products liability litigations, this article suggests that the Report's conclusions do not provide plaintiffs with new arguments. Moreover, the Article sets forth how defense counsel can benefit from the IOM's statements throughout the Report. 

Product liability cases often lack a critical piece of evidence: the product.  Plaintiffs allege a drug or medical device was defectively manufactured, but when the surgical device was lost after surgery, the pill was swallowed, or the implant was discarded, the product cannot be examined to determine how it was defective or what caused it to malfunction. 

On May 11, 2010, the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) sent a letter to 33,000 health care professionals "deputizing" them in the battle against misleading advertisements. (FDA, "Bad Ad Program: 2010-2011 Year End Report," available at http://tinyurl.com/3nog6b8 ("Year End Report")).  As the FDA's year-end report from this "Bad Ad" program makes clear, this deputization has yielded results and the program will likely be expanded in coming years.

During the decades that the Supreme Court interpreted Fed. R. Civ. P. 12 as allowing vague, formulaic pleadings, see Conley v. Gibson, 355 U.S. 41 (1957), the pleading standard applicable to complaints removed to federal court from state court was of little import. Plaintiffs rarely objected to federal pleading standards that were often being more liberal than their state counterparts. But since the Supreme Court in TwIqbal (that is, Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009)), toughened federal pleading standards considerably, plaintiffs now routinely advocate post-removal application of state standards.

Introduction

Federal Rule of Civil Procedure 26 was amended December 1, 2010. The effect of this federal rule change is significant to drug and device lawyers practicing in federal court as it substantially changes the requirements governing what may be discovered from a party's testifying expert. In general, the amendments provide increased work-product protection for testifying expert draft reports. As drug and device lawyers are aware, before the 2010 amendment went into effect, federal jurisdictions did not uniformly apply the discovery guidelines set forth in Federal Rule of Civil Procedure 26. Numerous jurisdictions applied extremely broad interpretations of Rule 26, which resulted in both parties seeking discovery of any and all communications between counsel and the expert witness, including drafts of expert reports. The effect of the old rule was that parties often entered into early negotiations regarding the scope of permissible discovery for expert reports and communications. Frequently, the parties would enter a stipulation preventing all or part of expert discovery. At the minimum, the parties were forced to vigilantly, and at great cost, guard against the disclosure of potentially discoverable information exchanged with their own expert witnesses. The 2010 amendments to Rule 26 seek to address these concerns and provide uniformity in the federal courts regarding discoverability of expert communications and draft reports. This article examines the changes to Federal Rule of Civil Procedure 26 and provides practical guidance for utilizing the new protections.

Introduction

Federal Rule of Civil Procedure 26 was amended December 1, 2010. The effect of this federal rule change is significant to drug and device lawyers practicing in federal court as it substantially changes the requirements governing what may be discovered from a party's testifying expert. In general, the amendments provide increased work-product protection for testifying expert draft reports. As drug and device lawyers are aware, before the 2010 amendment went into effect, federal jurisdictions did not uniformly apply the discovery guidelines set forth in Federal Rule of Civil Procedure 26. Numerous jurisdictions applied extremely broad interpretations of Rule 26, which resulted in both parties seeking discovery of any and all communications between counsel and the expert witness, including drafts of expert reports. The effect of the old rule was that parties often entered into early negotiations regarding the scope of permissible discovery for expert reports and communications. Frequently, the parties would enter a stipulation preventing all or part of expert discovery. At the minimum, the parties were forced to vigilantly, and at great cost, guard against the disclosure of potentially discoverable information exchanged with their own expert witnesses. The 2010 amendments to Rule 26 seek to address these concerns and provide uniformity in the federal courts regarding discoverability of expert communications and draft reports. This article examines the changes to Federal Rule of Civil Procedure 26 and provides practical guidance for utilizing the new protections.

In 2008, the First Appellate District of California jolted the drug and medical device defense bar when the Conte court, in essence, imposed a new duty on brand-name manufacturers for alleged injuries sustained by consumers of its competitors' products. Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal. App. 1st Dist. 2008). In December 2010, the concern of a possible extension of Conte presented itself when the U.S. Supreme Court granted certiorari in Pliva, Inc., et al. v. Gladys Mensing, a case that may have the unintended impact of expanding Conte to other jurisdictions. While Conte and Mensing dealt with traditional pharmaceutical products, the industry's rapid advancement into biopharmaceuticals means practitioners must be prepared for Conte and Mensing to spill over into the emerging legal field of follow-on biologic products.

The reports of my death have been greatly exaggerated. – Mark Twain

Like the reports of Mark Twain’s death that circulated while he was abroad in Europe, the learned intermediary doctrine has also been reported as dead in West Virginia.  Unlike Mark Twain, however, the reports of the learned intermediary doctrine’s demise were well-founded, at least at the time, given the Supreme Court of Appeals of West Virginia’s decision in State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A. Karl, 220 W. Va. 463, 647 S.E.2d 899 (2007), which specifically declined to adopt the doctrine.  Fortunately for drug and device companies, and the attorneys who represent them in West Virginia, the learned intermediary doctrine has made something of a comeback since 2007, based on a well-reasoned decision from the federal judiciary and the recent enactment of Senate Bill No. 474 by the West Virginia legislature.