Editorial, Opinion Piece Address Recent Supreme Court Decision On Pre-Emption

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Public Health;  Regulatory Affairs / Drug Approvals
Article Date: 17 Mar 2009 - 2:00 PDT

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Two newspapers recently published an editorial and an opinion piece related to a recent Supreme Court ruling that patients who experience injuries caused by medications approved by FDA can file product liability lawsuits against manufacturers in state courts. Summaries appear below.

Editorial
"Now that the Supreme Court has ruled that patients can sue drug companies in state courts for harm caused by medicine approved by [FDA], Congress ought to give patients the same right to sue makers of medical devices," a New York Times editorial states. Last year, the court ruled that, under a 1976 law, patients who experience injuries caused by certain medical devices approved by FDA cannot file product liability lawsuits against manufacturers in state courts.

In response, "Democratic leaders in Congress want to make it clear that nothing in the medical device laws should be construed to prevent damage suits in state courts or to protect manufacturers from liability under state laws," the editorial states, adding, "Identical bills introduced in the House and the Senate would accomplish that worthy purpose." The editorial states that such lawsuits "reinforce federal regulations" and that patients who "have been hurt by faulty medical devices should have the right to seek redress there." According to the editorial, state "trials have played an invaluable role in backstopping an all-too-fallible FDA: ferreting out corporate documents, compensating injured patients and giving manufacturers an incentive to exercise extreme care in production and labeling" (New York Times, 3/15).

Opinion Piece
The recent Supreme Court decision highlights the problems with the current system used to regulate the use of medications, Washington Post columnist Michael Kinsley writes. "On the one hand there is a federal agency, the FDA, charged with approving drugs," he writes, adding, "On the other hand there are courts where lawsuits attempt to draw the same line between safe and unsafe."

Kinsley writes, "While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement," adding, "And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit."

According to Kinsley, "someone must decide" whether a medication is "safe and what warnings its label should carry," and "one someone is preferable to two or more." However, under the current system, "everyone decides" (Kinsley, Washington Post, 3/13).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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