CCL Wins Important Preemption Victory Before 6th Circuit

March 13th, 2013

In an important preemption case, Fulgenzi v. Pliva, Inc., the 6th Circuit unanimously ruled today that a generic drug manufacturer may be sued under state law where it failed to provide all of the warnings approved by the FDA for the equivalent brand-name drug.

The court rejected the argument that plaintiff’s claim was preempted on grounds of impossibility under the U.S. Supreme Court’s 2011 ruling in Pliva, Inc. v. Mensing, stating: “not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process, but it had a federal duty to do so. As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.”

The court also rejected defendant’s argument that Ms. Fulgenzi’s claim was preempted under Buckman v. Plaintiffs Legal Comm. (2001), as an attempt to privately enforce federal law: “Here, Fulgenzi’s suit is not even premised on violation of federal law, but rather on an independent state duty. The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.”

The Fulgenzi decision represents a significant limitation on the reach of the Supreme Court’s generic drug preemption ruling in Mensing. The decision takes on added significance in light of a recent study which found that more than 2/3 of generic drug labels lack warnings found on the labels of the equivalent branded drugs. Consistency in the safety labeling of bioequivalent medications, Pharmacoepidemiology and Drug Safety (2012).

The appeal in Fulgenzi was briefed and argued by CCL Senior Litigation Counsel Louis Bograd.  Find news coverage here.

Peck Addresses Law Students

March 12th, 2013

On March 12, CCL President Robert S. Peck addressed law students at George Washington University about issues affecting the practice of tort law today, as part of a panel sponsored by that school’s student chapter of the American Bar Association’s Tort Trial and Insurance Practice Section.  Peck spoke from the perspective of an appellate lawyer, who sees the obstacles placed before plaintiffs seeking compensation for wrongful injuries and often challenges the constitutionality of those impediments.  He noted that recent U.S. Supreme Court decisions, particularly in the areas of arbitration and treatment of class actions, have made an already steep climb even more acute.  Others on the panel addressed similar issues from the perspectives of insurance and defense counsel, as well as that of an arbitrator.

CCL Submits Initial Comments Concerning Proposed Changes to Discovery Rules

March 4th, 2013

Proposals that would significantly narrow the ability to conduct discovery in federal courts will be considered at the April meeting of the advisory committee on civil rules.  Proposed changes have been drafted by a subcommittee chaired by federal district court Judge John G. Koeltl. The full committee, chaired by federal district court Judge David G. Campbell, is expected to revise those proposals and recommend that they be submitted for formal public comment. In advance of that meeting, CCL’s John Vail has submitted initial comments.

The letter singles out three proposals under consideration: a proposed re-definition of the scope of discovery; new presumptive limits on discovery; and a proposed restriction of the time for effecting service of process. It concludes that these proposed revisions are not warranted by empirical evidence or litigation experience and likely would have adverse impacts on access to justice, which is the core value the civil rules should implement.

CCL Files Two Amicus Briefs In Critical Preemption Case Before The U.S. Supreme Court

February 21st, 2013

In Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, the Supreme Court of the United States will consider whether the Federal Food, Drug, and Cosmetic Act supersedes state-law claims against manufacturers of generic prescription drugs for design defects. CCL has filed two amicus curiae briefs in support of the injured plaintiff, Karen Bartlett, whose adverse reaction to the generic pain medication ‘sulindac’ included burns, disfigurement, and blindness.

An amicus brief written by CCL’s Andre M. Mura, and filed on behalf of the American Association for Justice, a voluntary national bar association, and Public Justice, PC, a national public interest law firm, argued that Congress did not intend to deprive persons injured by unreasonably dangerous drugs of long available compensation. Responding to the generic drug manufacturer’s argument that it was impossible for it to comply with both state tort law and federal drug-safety law, the brief explained that even a state-law prohibition against the sale of an unreasonably dangerous drug would not impose an impossibility conflict with federal law because federal law does not require drug manufacturers to sell drug products. Lastly, the brief criticized the United States’ position on preemption, which favors the generic manufacturer in this case, for failing either to acknowledge the Food and Drug Administration’s (FDA’s) shortcomings, which hamper its ability to monitor the safety and efficacy of prescription drugs, or to credit product-liability litigation for providing a critical layer of consumer protection.

CCL filed a separate amicus brief on behalf of persons injured by the prescription drug propoxyphene, which is alleged to have caused serious cardiac injuries or death to thousands, and which has now been withdrawn from the market. The brief, written by CCL’s Louis M. Bograd, argued that state-law design-defect claims are entirely consistent with and complementary to the FDA’s regulatory system. Further, the brief explained that the Supreme Court’s recent decision in Pliva, Inc.  v. Mensing, 131 S. Ct. 2567 (2011), which held that failure-to-warn claims against the manufacturers of generic prescription drugs were preempted by federal law, is not controlling here because design-defect liability differs in important ways from liability for failure to warn.

This critical preemption case is set for argument on March 19.  A decision is expected by end of the Court’s Term in June.

Peck Speaks at University of Michigan Law School on Constitutional Objections to “Tort Reform”

February 20th, 2013

CCL President Robert S. Peck addressed students at the University of Michigan Law School about the constitutional flaws in the types of proposals that go under the umbrella of “tort reform,” at a lecture sponsored by the school’s student chapter of the American Constitution Society on February 20.  In his remarks, Peck talked about the false premises underlying tort reform, the various ways in which it seeks to shut the courthouse door, make proof more difficult, and then limit legitimate compensatory recovery.  He called various constitutional provisions bulwarks against the type of one-sided favoritism that undergirds “tort reform,” describing cases that invalidated various restrictions on tort cases under separation of powers and the rights to a jury trial, a complete remedy, equal protection, and due process.

Peck Helps ABA Adopt Policies on Medicare, Jury, and Ethics Reform

February 12th, 2013

On February 11 at the American Bar Association Midyear Meeting in Dallas, Texas, CCL President Robert Peck helped the ABA adopt policies to bring sensible reforms to the Medicare reimbursement process, address jurors' access to social media, and adopt amendments to the Rules of Professional Responsibility.

Representing the Tort Trial and Insurance Practice Section in the House of Delegates, the ABA's policymaking body, Peck helped write the report supporting Medicare reform.  In December, Congress approved the SMART Act, legislation that streamlined the process when Medicare claims a right to reimbursement for medical expenses paid before a beneficiary receives compensation from a tortfeasor.  The new law, supported by all stakeholders in the process, enables a beneficiary to receive timely information about any obligations to Medicare and proceed to settlement or trial without the guesswork or delays that the process has long entailed.  The new ABA policy is in line with the SMART Act and allows the organization to comment on regulations that will be promulgated to implement the new law.

The new jury guidelines provide advice on the conduct of trials where social media could bias the proceedings.  The amended ethical rules were the product of a multi-year effort to study changes in the legal profession and the growing globalization of legal issues.

In Mensing’s Wake: Two Cases of Note

February 8th, 2013

In Pliva, Inc.  v. Mensing, 131 S.Ct. 2567 (2011), the U.S. Supreme Court held that failure-to-warn claims against the manufacturers of generic prescription drugs were preempted by the Federal Food, Drug, and Cosmetic Act. In the wake of this decision, two courts recently issued opinions that permit plaintiffs injured after taking generic prescription drugs to pursue different claims against generic and brand-name prescription drug manufacturers.

In Wyeth, Inc. v. Weeks, the Alabama Supreme Court, answering a question certified to it by the U.S. District Court for the Middle District of Alabama, held that a brand-name drug manufacturer may be held liable for fraud or misrepresentation, based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff who was physically injured by a generic version of that drug. The Alabama Supreme Court noted that the vast majority of the cases that came to the opposite conclusion preceded the U.S. Supreme Court’s decision in Mensing, and falsely presumed that generic manufacturers could be held responsible for the representations on their labels. Trial News, an electronic publication of the American Association for Justice, quoted CCL’s Louis Bograd on February 7, 2013, calling the Alabama decision “a lifeline to plaintiffs injured by inadequately labeled generic drugs.”  The Alabama Supreme Court also found that earlier cases had conflated strict products liability and tort law. The decision in Weeks is in line with the California Court of Appeals’ decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008), which was argued by CCL’s Valerie M. Nannery.

In Arters v. Sandoz Inc., the U.S. District Court for the Southern District of Ohio allowed a man blinded by the generic drug amiodarone to pursue design defect claims against the manufacturer of the drug, while holding that his state law failure-to-warn claims were preempted by federal law. The court also allowed the plaintiff to move forward on claims sounding in negligence, breach of implied warranty and fraud for the manufacturer’s promotion of off-label use of the drug. While recognizing that under the Supreme Court’s ruling in Mensing, federal law requires generic drugs to have the same labels as their name-brand counterparts, the court noted that federal law does not require generic manufacturers to sell an unreasonably dangerous product in Ohio or to promote their drugs for off-label use. Thus, the court denied, in part, the manufacturer’s motion for judgment on the pleadings.

On March 19th, the United States Supreme Court will hear arguments in Mutual Pharmaceutical Co. v. Bartlett, which presents the question of whether state law claims against manufacturers of generic prescription drugs for design defects are preempted by federal law. CCL’s Bograd, representing plaintiffs in the Darvon litigation, and CCL’s Andre Mura, representing AAJ, are preparing amicus curiae briefs in Bartlett.

MAJ Journal Covers Two CCL Cases

February 6th, 2013

The 2013 Special Issue of the Maryland Association for Justice's Journal, Trial Reporter, includes two articles covering CCL cases.  The first, Has the Time Come for Comparative Negligence in Maryland? by David Wildberger discusses Coleman v. Soccer Association of Columbia.  The second, Is Dram Shop Liability Coming to Maryland? by Chaz Ball and Lucy Hirsch discusses Warr v. JMGM Group, LLC.  CCL's John Vail is counsel in both cases.

CCL: “Arbitration is Not Health Care”

February 5th, 2013

When Massachusetts passed a law making it easier for family members to make health care decisions for their incapacitated relatives, it did not authorize family members to make decisions about litigation, CCL’s John Vail told the Massachusetts Supreme Judicial Court in a brief filed today.

Dalton Johnson gave his wife, Barbara, a proxy allowing her to make “health care decisions” if he became incapacitated.  At issue in the case is whether that proxy gave her authority to bind him to an arbitration clause she signed when arranging nursing home care for him, before there was any dispute about his care.

The Massachusetts statute at issue limits “health care decisions” to decisions consistent with good medical practice.  This excludes arbitration, Vail’s brief told the court, because it is not medical practice.  The brief noted that predispute arbitration clauses like the one here have, in fact, been condemned by the medical profession.  

The plaintiffs are represented, in addition to Vail, by David J. Hoey and Nicole Paquin of North Reading, MA.  The case is Johnson v. Kindred Healthcare, Inc.  Oral argument has not yet been scheduled.

Supreme Court Denies Review of Jurisdiction Case

January 23rd, 2013

On January 22, the Supreme Court denied review of a case in which a Taiwanese battery charger manufacturer argued that the courts of Oregon should not have jurisdiction to force the company to defend itself in a products liability lawsuit.  China Terminal and Electric Corp. (CTE) manufacturers batter chargers that are incorporated into motorized wheelchairs manufactured by an Ohio company, Invacare. Oregon resident Karlene J. Willemsen, who suffered from advanced multiple sclerosis, purchased one of the Invacare FDA-approved wheelchairs.  On February 1, 2008, Willemsen, physically incapable of escaping the in-home hospital bed she was in, died as a result of a fire that engulfed her bedroom and immolated her.  Her estate subsequently brought suit against, among others, Invacare and CTE.  CTE resisted jurisdiction in the Oregon courts, even though more than 1100 CTE-equipped chairs were sold in Oregon, claiming that due process prohibited Oregon from making it answer the complaint and arguing that CTE never “purposely availed” itself of the Oregon market.  Instead, it said that Invacare alone targeted consumers in Oregon. 

CCL President Robert S. Peck, as counsel for the Willemsen family, argued against CTE’s petition, showing that CTE would be responsible for any liability resulting from a faulty battery charger because it had agreed to hold Invacare harmless and participate in any investigation of harm caused.  For that reason, CTE’s due-process claim did not affect the liability CTE might be assessed, only whether its participation in the case was behind-the-scenes or as a named party.  Moreover, Peck’s brief demonstrated that the Oregon courts had carefully and correctly applied existing U.S. Supreme Court precedent in asserting jurisdiction over CTE.  Given the case’s unique facts, the brief contended that it was a poor vehicle for any reexamination of precedent by the Supreme Court.  With the Court’s denial of certiorari, the case can now proceed to trial.  Oregon co-counsel before the U.S. Supreme Court included Jeffrey Bowersox and Kathryn Clarke.