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Judge Edward P. Nickinson, III, upheld a year-old Florida statute that gives likely medical malpractice defendants and their litigation allies the right to seek ex parte interviews with a plaintiff’s treating physicians, including those who treated the plaintiff up to two years prior to the alleged malpractice incident. Such presuit interviews are authorized by a law that went into effect July 1, 2013.  CCL had challenged the law as preempted by the federal Health Insurance Portability and Accountability Act, which explicitly preempts state laws that are less stringent in its protection of patient privacy than provided by federal regulations, and violative of several provisions in the Florida Constitution.  CCL expects to appeal the ruling.

 In his opinion, Judge Nickinson disagreed with the federal District Court for the Northern District of Florida, which found that the state law was preempted.  In Murphy v. Dulay, issued last fall, the federal judge found that the Florida legislature evaded HIPAA’s requirements applicable to judicial proceedings by requiring plaintiffs to execute a state-mandated authorization form.  That case is currently on appeal in the Eleventh Circuit, which will hold arguments in mid-September.

Judge Nickinson, relying on a Texas Supreme Court case, found the state-mandated form was a legitimate alternative to following the stricter federal regulations.  He also found that the authorization requirement was substantive, rather than procedural, so that the Legislature did not intrude on the Florida Supreme Court’s exclusive constitutional authority over rules of procedure, even though a preexisting rule of procedure promulgated by that court conflicted with the new law. The ruling also rejected arguments that the law constituted special legislation, which the Florida Constitution prohibits, as well as burdens a plaintiff’s constitutional right of access to the courts.  Instead, he held that the requirement was a legal precondition to bringing a medical malpractice action, a position that a majority of courts throughout the country have rejected.

On June 27, a panel of the Sixth Circuit handed down its decision in the consolidated appeals from the dismissal of plaintiffs' claims for personal injury in the Darvocet, Darvon and Propoxyphene MDL. The panel largely affirmed District Judge Danny Reeves' rulings dismissing plaintiffs' claims. 

On appeal, CCL Chief Litigation Counsel Louis Bograd had argued that plaintiffs' design defect and negligent marketing claims survived preemption under the reasoning in fn. 4 of the Supreme Court's decision in Mutual Pharmaceutical Co. v. Bartlett, which recognized that state law claims that paralleled federal misbranding provisions might not be preempted. Without reaching the merits of that argument, the panel held that it was inapplicable on the facts in these cases, because the FDA had approved continued marketing of propoxyphene drugs, over the contrary recommendation of its advisory committee, in 2009. The 6th Circuit panel also concluded that the MDL plaintiffs had not adequately pled claims based on the alleged failure by generic manufacturers to update their warning labels to match changes to the Darvon label ordered by the FDA in 2009 and that it was likely that courts in 22 states would not recognize claims for misrepresentation against the manufacturers of Darvon and Darvocet brought by persons injured by the generic versions of those products. 

Plaintiffs are considering their options in response to this ruling. 

On June 19th, CCL Chief Litigation Counsel Louis Bograd argued before the en banc 9th Circuit in two consolidated appeals that address an important issue of federal removal jurisdiction under the Class Action Fairness Act (CAFA). Romo v. Teva, Inc. and Corber v. Xanodyne Corp. both arise out of propoxyphene litigation filed in California state courts. No individual propoxyphene suit in California involves 100 or more claimants, but in total more than 1500 plaintiffs have sued the manufacturers and distributors of propoxyphene there. After plaintiffs invoked a California procedure to coordinate the pending cases before a single judge, defendants removed the cases to federal court, contending that plaintiffs' coordination petition triggered the mass action provision of CAFA, which permits removal where the damage claims of more than 100 plaintiffs are "proposed to be tried jointly." To date, every district court to address the issue has concluded that plaintiffs' petition did not propose a joint trial, and a divided 9th Circuit panel agreed. Before the en banc court, Bograd emphasized that the plaintiffs had never invoked the separate procedure under California law for requesting a joint trial and stressed the differences between coordination and consolidation for trial. Bograd also explained to the court that bellwether trials, the manner in which mass pharmaceutical torts are most often litigated, are not binding on the non-bellwether parties and thus do not constitute a joint trial under CAFA. A decision is expected in a few months. 

Even while before the argument, the defendants had filed petitions for certiorari in the U.S. Supreme Court, fearing that a failure to do so would not preserve their appeal under CAFA’s strict timelines.  CCL’s Bograd and Andre Mura filed briefs in opposition to the petitions. On June 30, the Supreme Court denied both petitions, leaving the matter, at this point, to the Ninth Circuit’s en banc panel.

CCL filed a reply brief, responding to the defendants’ cross-motion for summary judgment, in a challenge to a 2013 Florida statute that authorized presuit, ex parte interviews of a medical malpractice plaintiff’s treating physicians.   Late last year, CCL won a federal district court ruling in Murphy v. Dulay, which held the same statute preempted by the federal Health Insurance Portability and Accountability Act (HIPAA). That case is currently on appeal and will be heard in the U.S. Court of Appeals for the Eleventh Circuit in August.

The present case combines allegations that the Florida statute is preempted by HIPAA, with arguments that it violates separation of powers, the ban on special privileges, and the guarantee of access to the courts under the Florida Constitution.  CCL President Robert S. Peck, counsel in both challenges, argued this case, Weaver v. Myers, in a Florida circuit court in Pensacola in May. Because Defendants filed their cross-motion for summary judgment and accompanying 75-page brief less than a week before the hearing, the court granted Peck leave to file a reply afterwards. In the reply, Peck points out that the Defendants request that the court apply a lenient preemption standard to permit the Florida law to coexist with federal law could not be observed because Congress had expressly preempted state laws that were less stringent in the protection of patient privacy than HIPAA.  He further argued that Florida, by requiring putative patient-plaintiffs to execute an authorization form, may not bypass federal requirements by labeling it a condition precedent to filing a lawsuit.  Under those circumstances, Peck said, it would be Florida law preempting federal law, rather than the other way around.  In addition, Peck countered the defendants’ state constitutional arguments by pointing out that existing Florida procedural rules were overridden by the statute, when the Constitution makes the establishment of procedural rules the exclusive province of the Florida Supreme Court.  Precedent holds that any legislation that conflicts with existing rules of civil procedure are void as a violation of separation of powers.

 Defendants also argued that the constitutional prohibition on special privileges applicable to evidentiary rules could not be violated by a statute that gives access to oral interviews of treating physicians when those interviews are not admissible in court, but Peck pointed out that a prohibition on the introduction of evidence is a rule of evidence. Finally, Defendants contended that the constitutional right of access to courts is only violated when a cause of action is completely abolished. Peck demonstrated in his brief that Florida long ago abandoned the lower court precedents that so held and have reiterated that access is denied whenever an unreasonable burden on the right is legislated.

The case now is considered under submission, and a decision is expected soon. 

On May 7, CCL’s Chief Litigation Counsel Louis Bograd appeared before a panel of the U.S. Court of Appeals for the Sixth Circuit in Cincinnati to represent the plaintiffs in 68 consolidated appeals arising out of the Darvon MDL. Plaintiffs had sued the manufacturers of both the brand-name drugs Darvon and Darvocet and the generic equivalent, propoxyphene, for severe cardiac injuries caused by their use of the drug, asserting claims for both products liability and tortious misrepresentation. Judge Danny C. Reeves in the Eastern District of Kentucky had dismissed all of the MDL plaintiffs' claims on various grounds, including federal preemption.

Bograd argued to a panel that included Circuit Judges John Rogers, Jeffrey Sutton, and Richard Suhrheinrich that those rulings were in error and should be reversed. Plaintiffs had pled products liability claims against the generic manufacturers that paralleled the federal misbranding statute and thus were not preempted under the reasoning of the Supreme Court decisions in Pliva, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett. Plaintiffs should likewise have been permitted to proceed against the brand manufacturers under traditional state tort law misrepresentation causes of action for misrepresenting the safety and efficacy of propoxyphene. A decision is expected by this fall.

On March 27, the New York Times published an editorial in support of the FDA's generic drug labeling rule.  CCL Chief Litigaiton Counsel Louis Bograd represented plaintiff Gladys Mensing in the 2011 Supreme Court ruling mentioned in the piece.  You may read the full editorial here.

On March 7, CCL filed a reply brief on behalf of plaintiff Shirley Brinkley before the U.S. Court of Appeals for the Eighth Circuit in Brinkley v. Pliva, Inc. The central issue on appeal in Brinkley is whether a generic drug manufacturer may be held liable for failure to warn when a person is injured as a result of its failure to provide her physician with warnings that the FDA has already approved for the equivalent brand-name product. Pliva failed to provide an FDA-approved warning that treatment with metoclopramide should not exceed 12 weeks, leading to Ms. Brinkley’s injuries. In the brief, CCL Chief Litigation Counsel Louis Bograd replied to Pliva’s arguments that such allegations failed to state a claim under Missouri law and were preempted by federal law, as well as Pliva’s argument that its failure to warn was not the proximate cause of plaintiff’s injuries. The Court of Appeals is expected to hear argument on this appeal in the next few months.

In Lance v. Wyeth, plaintiff brought suit against the manufacturer of the diet drug, Redux, for the death of her daughter resulting from her use of the drug, which was subsequently removed from the market. Because Pennsylvania law does not recognize strict liability design defect claims against drugmakers, plaintiff brought claims for negligent design, negligent marketing, and negligent decision to continue to sell Redux. Wyeth petitioned the Pennsylvania Supreme Court to dismiss these claims, arguing that Pennsylvania law does not and should not recognize such negligence liability for drugmakers. CCL senioar counsel Lou Bogard authored an amicus brief for the American Association of Justice and the Pennsylvania Association of Justice in support of plaintiff.

Finally, more than two years after the case was argued, the Pennsylvania Supreme Court yesterday handed down its decision in Lance. By a vote of 4-2, the Court affirmed a lower court ruling upholding the plaintiff’s negligence claims against Wyeth. The Court characterized Wyeth as seeking a special immunity from traditional common law negligence liability and decided that Wyeth had not provided the Court with sufficient reason to depart from the traditional common law rule. The majority opinion extensively cited, quoted, and relied upon the amicus brief submitted by CCL on behalf of AAJ and PAJ.

Although 2+ years was a long time to wait for this ruling, Lance may well prove to be the rare exception to the maxim: “Justice delayed is justice denied.”

On December 27, the U.S. Court of Appeals for the D.C. Circuit denied a petition from the American Tort Reform Association (ATRA) challenging the Occupational Safety and Health Agency’s (OSHA’s) recent edits to preemption language in the Hazard Communication Standard (HazCom) as ultra vires. Writing for a unanimous panel which included Circuit Judges Griffith and Srinivasan, Senior Circuit Judge Edwards found “no merit in ATRA’s claims.” OSHA’s edits to preemption language, the court concluded, are merely interpretive and thus do not implicate the Administrative Procedure Act’s notice-and-comment requirements. The edits, the court explained, do not definitively determine the preemptive effect of the OSH Act. Rather, they “reflect the agency’s view that HazCom preempts state legislative and regulatory requirements, but not state tort claims.” According to the Court, OSHA acted well within its authority in setting forth its own understanding of the preemptive scope of its regulation. And, because OSHA’s edits were merely interpretive, the court reasoned, “it is not subject to judicial review unless it is relied upon or applied to support an agency action in a particular case.” ATRA’s challenge was thus dismissed as not ripe.

In this case, CCL filed an amicus curiae brief for the American Association for Justice (AAJ) urging dismissal. The brief, written by CCL’s Andre M. Mura, and filed in support of OSHA, expressed AAJ’s concern that if tort remedies against chemical manufacturers are limited through improper application of preemption principles, injured workers will be left without compensation and chemical manufacturers will not have adequate incentive to conduct a thorough hazardous material review, or to update labeling when new hazards emerge. 

On Friday, November 22, CCL Senior Litigation Attorney Louis Bograd spoke on developments in generic drug preemption litigation in the wake of the U.S. Supreme Court’s Mensing and Bartlett decisions, the former of which Bograd argued before the high court, at the Louisiana State Bar Association’s Complex Litigation/Class Action Symposium in New Orleans. The featured presentation by Bograd occurred on a panel on “Recent Preemption Activity: Drugs, Devices & Generics." Recently, the Food and Drug Administration proposed new regulations, now undergoing a comment period, that would effectively reverse Mensing and subject generic drug manufacturers to the same responsibilities to warn consumers of adverse risks that name-brand manufacturers must discharge.