Thursday, September 5, 2013
Wednesday, September 4, 2013
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.
Wednesday, August 21, 2013
Professor Kate Greenwood (Seton Hall) has posted to SSRN her article, 'Litigant Regulation' of Physician Conflicts of Interest, Ga. St. L. Rev. (forthcoming). Here's the abstract:
While physicians’ financial relationships with pharmaceutical and medical device manufacturers are increasingly of concern to legislators and regulators, plaintiffs have had only limited success pursuing private law remedies for the harms that result from conflicts of interest. Courts have long channeled individual patients’ claims against their conflicted doctors into the medical malpractice cause of action, where patients have difficulty establishing that their physicians’ conflicts caused them to suffer concrete and compensable injuries. With recent notable exceptions, courts have also blocked patients’ claims against drug and device manufacturers. Courts apply the learned intermediary doctrine to dispose of failure-to-warn personal injury suits, without regard to whether the plaintiff’s physician had a financial relationship with the defendant manufacturer. Third-party payers, such as employers, insurance companies, and union health and welfare funds, have similarly struggled to overcome a strong presumption of physician independence. Courts routinely find that a physician’s prescribing decision breaks the chain of causation between a manufacturer’s illegal promotional efforts and a payer’s obligation to pay for a prescription, even when those promotional efforts include the payment of kickbacks.
Courts can and should move beyond the often counterfactual presumption of physician independence. In personal injury cases, this can be achieved through a nuanced analysis of alleged conflicts of interest that distinguishes between kickbacks, on the one hand, and legitimate financial relationships between manufacturers and physicians, on the other. Limited early discovery would allow plaintiffs to develop their claims about the influence of conflicts on their physicians’ decision-making without putting an undue burden on defendants. In economic injury cases, courts can move beyond the presumption of physician independence by allowing plaintiffs to use standard statistical methods to demonstrate that physicians’ prescribing decisions were not independent in the aggregate. If the doctrine were to evolve in these ways, it would amplify the role “litigant regulation” plays in the regulatory structure governing physician-industry relationships and bring closer the goal of ensuring that patients and payers are fairly compensated for the harms caused by conflicts of interest.
Wednesday, March 20, 2013
SCOTUS Oral Argument in Mutual Pharm. Co. v. Bartlett: Generic Pharmaceutical Manufacturers' Potential Immunity from Suit
Friday, October 19, 2012
Wednesday, October 17, 2012
Professor Stacey Lee (Johns Hopkins, Carey School of Business) has posted to SSRN her article, Pliva v. Mensing: Generic Consumers' Unfortunate Hand, Yale J. Health Pol'y L. & Ethics (forthcoming 2012). Here's the abstract:
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.
Saturday, October 13, 2012
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?
Friday, October 12, 2012
A Wall Street Journal article, Pharmacy in Outbreak Acted Like Drug Maker, by Mark Maremont, Jonathan D. Rockoff, and Timony W. Martin explores the history of the companies allegedly involved in the fungal meningitis outbreak. The article notes that a class action has already been filed in federal court in St. Paul, Minnesota.
Tuesday, January 17, 2012
The New York Times reports that under new regulations to be announced by the Obama administration, pharmaceutical companies will have to report payments to non-employee doctors for "research, consulting, speaking, travel and entertainment." The reporting requirements are to cover any company that has a product covered by Medicare or Medicaid, and the reporting information is to be subsequently posted by the government on a publicly accessible website.
Tuesday, December 13, 2011
Last week the FDA voted 21-5 to revise the labeling on Yaz, Yasmin, Beyaz, Safyral, and its generic versions to clarify the potential risk of blood clots in the legs and lungs from taking the pills. After debating the conflicting data for more than nine hours, the panelists disagreed on the evidence's quality but agreed that the risks should be clearly stated in the label. Here's an excerpt from the Huffington Post's report:
"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."
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.
Thursday, October 20, 2011
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."
Thursday, June 16, 2011
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.
Sunday, November 21, 2010
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.
Tuesday, October 12, 2010
Barry Meier of the NYTimes reports. The issue is whether the plaintiff can bring products liability suits or whether they must bring the suit only in the vaccine court, created by the 1986 National Childhood Vaccine Injury Act.
This case concerns a woman who suffered seizures as a result of a DPT vaccine administered when she was a baby and has resultant developmental problems. But there are many parents of children with autism who believe there is a link between vaccines and autism and would like to bring their cases outside of the adminsitrative system set up by the Act.
Thomas Burke, a political scientist at Wellesley College, has written on this topic. Click here for his website.
Monday, October 11, 2010
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.
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.
Monday, April 19, 2010
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).
April 19, 2010 in Aggregate Litigation Procedures, Conferences, Environmental Torts, Informal Aggregation, Mass Tort Scholarship, Pharmaceuticals - Misc., Products Liability, Settlement | Permalink | Comments (0) | TrackBack (0)
Tuesday, March 16, 2010
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.
March 16, 2010 in Aggregate Litigation Procedures, FDA, Mass Tort Scholarship, Off-Label Drug Use, Pharmaceuticals - Misc., Procedure, Products Liability, Regulation, Resources - Federal Agencies, Science | Permalink | Comments (0) | TrackBack (0)
Monday, February 22, 2010
Saturday, November 28, 2009
Last Monday Judge John Keenan of the Southern District of New York dismissed the second of three bellwether cases set for trial on Merck's osteoporosis drug, Fosamax. As David Bario of The American Lawyer reports, "the plaintiff in the second test case, a 74-year-old Mississippian named Bessie Flemings, had failed to present admissible evidence of specific causation tying her jaw problems to Fosamax." Judge Keenan found that one of Fleming's medical experts had no opinion and that the other did not qualify as an expert. Consequently, Fleming couldn't establish causation under Mississippi's Product Liability Act.
The first bellwether trial ended in a mistrial after a juror complained about physical threats from other jurors. That case is set for a new trial in the spring and the third test case is set for trial in April of 2010. Judge Keenan still has roughly 900 Fosamax cases consolidated before him through multi-district litigation.