Source: https://lawprofessors.typepad.com/mass_tort_litigation/pharmaceuticals_misc/
Timestamp: 2019-04-26 14:20:07+00:00

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Legalnewsline reports in Ala. SC to hear oral arguments in case over ‘innovator liability’ next week, by Jessica Karmasek. The U.S. Chamber of Commerce's Institute for Legal Reform has more discussion of the issues.
Wall Street Journal article by Jess Bravin on Tuesday's argument, and more from SCOTUSblog.
The conference will take place on November 16, 2012 in Boston, Massachusetts. Here's the brochure.
The PR news wire has more on the case being brought against Wyeth by plaintiffs' firms Beasley Allen, Gregory Holt & Associates, P.A., and Rushall McGeever.
The United States Supreme Court held in PLIVA v. Mensing that federal preemption immunizes generic drug manufacturers from liability for state law failure-to-warn claims. As a result, consumers harmed by a mislabeled generic drug will be unable to bring actions against generic manufacturers under state law. The Court confessed that the resulting federal drug-labeling scheme dealt consumers an “unfortunate hand.” By removing generic manufacturers’ duty to improve the adequacy of their products’ warning labels, the Supreme Court calls into question the safety of generic drugs.
The Economist discusses the growing global problem of fake and substandard pharmaceuticals in Fake pharmaceuticals: Bad medicine -- The world's drug supply is global. Governments have failed to keep up. Absent from The Economist's discussion of government regulators and industry self-policing is the role of private litigation. Couldn't emerging global tort litigation also deter wrongdoers and be part of the solution?
In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority ruling amounts to a vote of confidence for keeping the drugs on the market, though well over a third of panelists voted against the drug's overall benefit, citing numerous alternatives available.
"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."
Two large studies conducted by German drugmaker Bayer have shown no difference in blood clots between patients taking the company's drugs and patients taking older medications.
But since 2009, five large studies have suggested drospirenone-containing pills carry a slightly higher risk of blood clots than older birth control pills, though events in both groups are very rare. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels.
Here's a link to a TIME magazine report and to a recent NY Times piece.
BNA reports that a set of cases (one trial, two plaintiffs) reached a defense verdict in the Levaquin pharma litigation. Beare v. Johnson & Johnson, N.J. Super. Ct. Law Div., No. ATL-L-196-10, verdict 10/14/11; Gaffney v. Johnson & Johnson, N.J. Super. Ct. Law Div., No. ATL-L-4551-09, verdict 10/14/11). The cases are consolidated before Judge Carol Higbee of New Jersey, who also oversaw the New Jersey Vioxx litigation.
The allegations are the the manufacturer of the antibiotic did not provide adequate warnings of its potential to cause tendon injuries. There are six more bellwether cases to go. According to BNA there are approximately 1,900 Levaquin cases before Judge Higbee.
I don't have information about how the bellwether cases were picked or why eight is the number. For an analysis of how judges can do a more rigorous job of using bellwether trials to promote case resolution and equality among litigants, see my latest paper: The Case for "Trial by Formula."
Today, the Supreme Court decided Smith v. Bayer (opinion here), applying the Anti-Injunction Act to reject a federal court's attempt to control state court class certification.
The federal MDL judge in the Baycol litigation had rejected class certification for a class of West Virginia plaintiffs, finding that common questions did not predominate because each plaintiff would have to prove actual injury. One of the members of the putative class filed a lawsuit in West Virginia state court (it was non-removable because it included several West Virginia defendants in addition to Bayer), and sought class certification. Bayer asked the MDL judge for an order enjoining the state court from hearing Smith's motion to certify the class, arguing that Smith's class action was identical to the one the federal court had rejected. The judge granted the injunction and the Eighth Circuit affirmed.
The Supreme Court unanimously reversed in an opinion by Justice Kagan. The Anti-Injunction Act, 28 U.S.C. 2283, generally prohibits federal courts from enjoining state court proceedings. Bayer argued that this case fits within the Act's relitigation exception; according to Bayer, issue preclusion prevents Smith from relitigating the issue of class certification. The Court rejected this argument for two reasons: (1) it's not the same issue, and (2) it's not the same party.
It's not the same issue because states are entitled to interpret their own procedural rules differently from federal courts' interpretation of the Federal Rules of Civil Procedure. Last year's ruling in Shady Grove Orthopedic Associates v. Allstate (2010) emphasized that Rule 23 applies in federal courts and state courts apply their own class action rules. The text of West Virginia's Rule 23 is nearly identical to the federal rule, but as Justice Kagan explained, federal and state courts "can and do apply identically worded procedural provisions in widely varying ways." In the Rezulin litigation, the West Virginia Supreme Court announced that it did not necessarily follow the federal approach to class certification, particularly on the question of predominance. Given that the state does not follow the federal interpretation of Rule 23, issue preclusion cannot prevent relitigation of class certification and the injunction was improper.
It's not the same party because Smith was not a named plaintiff in the federal court case. You can't bind a non-party, as the Supreme Court emphasized in Taylor v. Sturgell (2008), where it rejected nonparty preclusion on a theory of virtual representation. Bayer argued that Smith was bound as a member of the class, but the Supreme Court pointed out that there was no class because class certification was rejected: "The definition of the term 'party' can on no account be stretched so far as to cover a person like Smith, whom the plaintiff in a lawsuit was denied leave to represent."
The Court got it right. It's a complicated case but it was an easy decision. State courts have their own rules and are entitled to decide what procedures to follow. Even though a federal judge concluded (correctly, in my view) that the mass tort litigation involving Baycol was not suitable for a class action under Federal Rule 23, the West Virginia state court is entitled to decide that issue under the West Virginia class action rule. But the decision shows how messy things get when mass disputes are litigated in both federal and state courts. Justice Kagan's opinion acknowledges the "special problems of relitigation" that can be presented by class actions, but suggests that the solution lies in removal under CAFA and transfer under the MDL statute, rather than departing from fundamental principles of preclusion.
Merck has won the second of three bellwether trials on Fosamax, Graves v. Merck & Co., 1:06-cv-05513 (S.D.N.Y.). Judith Graves, a Florida resident, sued the company and alleged that Fosamax (an osteoporosis drug) caused her jawbone to deteriorate. The jury asked the judge for the date of the first report from which Merck could have known of an association between Fosamax and jawbone problems and found that the report appeared six months after the plaintiff's problems started. Accordingly, jurors might've decided that Merck couldn't have known about the risks in time to warn the plaintiff.
Merck faces more than 1,500 claims in federal and state courts alleging various defects in Fosamax. So far it has won two of the three cases that have gone to a jury trial; the third awarded damages of $8 million to the plaintiff, which was reduced to $1.5 million.
The New York Times article on the trial is available here, and the Wall Street Journal article is available here. TheStreet provides the most detailed coverage, which is available here.
Southern District of NY Judge John F. Keenan reduced the verdict from 8 million to 1.5 million dollars. He also sanctioned the lawyer 2,500 dollars for referencing another Fosomax trial when explicitly told not to do so by the judge.
See the New York Law Journal and Torts Prof Blog for coverage.
I think we need to open up (or reopen) the question of what juries in bellwether cases ought to know about other cases, the range of verdicts that this "type" of case usually gets, and other information that will help them reach decisions. For more on why this might be a good idea see my newest piece, Rough Justice.
American Conference Institute will be hosting a conference on Chemical Products Liability and Environmental Litigation on April 28-29, 2010 in Chicago, IL. I will be speaking on mass torts and ethics, with particular attention to the ethics of mass settlements. Here's the brochure (Download ACI Brochure).
The Albany Law Journal of Science & Technology has published a symposium issue on Regulating the Cure: Topics Arising Out of the Prescription of Drugs Off-Label. My article, Promotion of Off-Label Drug Use: In Favor of a Regulatory Retreat, 19 Alb. L.J. Sci & Tec. 609 (2009), is included.

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