Friday, September 5, 2008

FDA Adds Warnings on Arthritis Drugs

Thursday, September 4, 2008

"Infuse Bone Graft" Linked to Life-Threatening Complications

The FDA has received 38 reports that Medtronic Inc.'s "Infuse Bone Graft," typically used to encourage bone growth in spinal surgeries, causes neck and throat swelling--life threatening injuries.  The Wall Street Journal has a lengthy article by David Armstrong and Thomas Burton on the topic and the related lawsuits.  Here's an excerpt:

Doctors with financial relationships with Medtronic have written favorably about off-label uses of Infuse on Web sites, in medical journals and at educational meetings. Some of the most influential spine surgeons in the country are consultants to the company. Several of them benefit from sales of the product through royalty deals, according to disclosures they have made in professional journals and at medical meetings.

Three "whistleblower" lawsuits brought by former employees have alleged illegal marketing, seeking refunds for the federal government on Medicare and Medicaid payments to the company. The former employees, who share in any recovery under federal law, asserted in the suits that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, which were filed in federal district court in Memphis, Tenn., without admitting wrongdoing. One of the whistleblowers has challenged the company's agreement with the federal government, saying the sum is too small.

The lawsuit that hasn't been settled was filed last year in federal district court in Boston by two former Medtronic employees. It alleges that the company illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulting fees and bogus royalty payments. Marketing off-label uses is not allowed under FDA regulations.

ECB

September 4, 2008 in Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)

Wednesday, September 3, 2008

Laura Dooley on National Juries for National Cases

Lauradooley06 Professor Laura Dooley (Valparaiso; picture, left) has published her article, National , 83 N.Y.U. L. Rev. 411 (2008)Logo_social Juries for National Cases: Preserving Citizen Participation in Large-Scale Litigation.  Here's the abstract from SSRN:

Procedural evolution in complex cases seems to have left the civil jury behind. The trend toward centralization of cases pending on the same topic in one court results in cases of national scope being tried by local juries; this reality is a catalyst for forum shopping and a frequent justification for calls to eliminate jury trial in complex cases altogether. Yet the jury is at the heart of a uniquely American understanding of civil justice, and the Seventh Amendment still mandates its use in federal cases. This article makes a bold new proposal designed to preserve the constitutional and functional value of citizen participation in the civil justice system by aligning the jury assembly mechanism with the scope of the litigation. Thus, in cases of national scope, juries should be assembled from a national pool. This idea would eliminate incentives to forum-shop into local jury pools, and would make the decisionmaking body commensurate with the polity that will feel the effects of its decisions. We might also expect a higher level of legitimacy for decisions rendered by a national jury in national cases because they would not be subject to the criticism that a local jury is imposing its values on the rest of the country, and because geographical diversification of the jury would enhance the quality of decisionmaking.

BGS

September 3, 2008 in Mass Tort Scholarship, Procedure | Permalink | Comments (0) | TrackBack (0)

Roger Williams Law Review Symposium Issue on Genuine Tort Reform

The Roger Williams University Law Review has published its symposium issue on Genuine Tort Reform.  Included are the following:

Carl T. Bogus, Introduction: Genuine Tort Reform, 13 Roger Williams U. L. Rev. 1 (2008)

Deborah Hensler, Jurors in the Material World: Putting Tort Verdicts in Their Social Context, 13 Roger Williams U. L. Rev. 8 (2008)

Valerie P. Hans, Empowering the Active Jury: A Genuine Tort Reform, 13 Roger Williams U. L. Rev. 39 (2008)

Peter H. Schuck, FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot, 13 Roger Williams U. L. Rev. 73 (2008)

Joseph Sanders, Reforming General Damages: A Good Tort Reform, 13 Roger Williams U. L. Rev. 115 (2008)

Ellen Wertheimer, Calling It a Leg Doesn't Make It a Leg: Doctors, Lawyers, and Tort Reform, 13 Rogers Williams U. L. Rev. 154 (2008)

Jay M. Feinman, Incentives for Litigation or Settlement in Large Tort Cases: Responding to Insurance Company Intransigence, 13 Roger Williams U. L. Rev. 189 (2008)

Ross E. Cheit, Tort Litigation, Transparency, and the Public Interest, 13 Roger Williams U. L. Rev. 232 (2008)

BGS

September 3, 2008 in FDA, Mass Tort Scholarship, Settlement | Permalink | Comments (0) | TrackBack (0)

NEJM Says Too Early to Dismiss Cancer Concerns for Vytorin

Article in the Wall Street Journal -- Medical Journal Raises Concern About Vytorin, by Alicia Mundy and Jared Favole.  Here's an excerpt:

The editors of the New England Journal of Medicine, in a rare move, said that it is too soon to dismiss concerns about cancer risks linked to the popular cholesterol drug Vytorin, even as the journal published a report saying a previously reported cancer link was likely due to chance.

The NEJM's editorial was formally released just as experts were defending the drug's safety at a major medical conference in Europe. A study formally presented Tuesday, known as SEAS, raised questions about potential cancer links, and whether Vytorin helps prevent cardiovascular problems better than a placebo. Those conclusions were made public in July. But a prominent Oxford University researcher said the cancer risk wasn't credible. The New England Journal published both the SEAS study and the Oxford review of the cancer issue.

Later Tuesday, a powerful congressional committee that has been investigating Vytorin's safety and marketing sent a letter to Merck & Co. and Schering-Plough Corp., who sell the drug in a joint venture, asking for extensive details about the Oxford review that dismissed links between Vytorin and cancer deaths.

BGS

September 3, 2008 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)