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Protecting Pharmaceuticals

November 13, 2008

Your editorial "Protecting pharmaceuticals" (Nov. 7) omits two important facts about the case before the Supreme Court and proposes policy changes that are both ill-considered and ultimately harmful to patients.

The editorial neglects to mention that the method of administration of the drug in question had risks that were disclosed to the Food and Drug Administration and specifically stated in warnings that came with the drug. Those warnings were approved by the FDA. Second, the patient sued and obtained a settlement with the wrongdoer, i.e., the health care provider that administered the drug in the manner warned of by the manufacturer and the FDA.

As to the policy changes, The Baltimore Sun apparently advocates that juries in the context of personal injury litigation should be free to engage in complicated and scientifically based risk-benefit analysis of medications and the appropriate standards for warning labels to go on drugs. It seems to think that six or 12 people off the street can do a better job than the agency created by Congress to perform this function. I am sure that trial lawyers who bring such lawsuits enthusiastically support that idea, but patients in need of potentially life-saving medications will be the losers.

Fifty different states with 50 different jury pools and 50 different rules of evidence could be establishing 50 different standards for the manufacturing, testing and labeling of drugs. Such chaos will add substantial costs to those medicines, thereby pricing them beyond the reach of average citizens. But even worse, manufacturers will be reluctant to put on the market drugs that may benefit many while having unfortunate side effects on a few.

It is precisely these reasons why immunity and the doctrine of federal pre-emption are critical to the pharmaceutical industry and to patients in need of high-quality and innovative medications.

Robert C. Erlandson, Lutherville

The writer is a partner in a law firm.

The editorial "Protecting pharmaceuticals" is blatantly off-base.

The drug produced by Wyeth Pharmaceuticals was properly marked, and the markings were furthermore approved by the FDA after a long approval process. The preferred method of administering the drug was not taken by the physician in charge; instead, the secondary method that had warnings attached to it was used.

This product was not placed on the market in a cavalier method, as your editorial strongly suggests.

Furthermore, the Bush administration is not attempting to deregulate the market but to avoid situations of jeopardy where the manufacturer and the government did everything possible. In fact, it is just asking for the same ruling that applies to medical devices.

Joseph Weiss, Annapolis

A recent editorial argued that a Supreme Court ruling in favor of Wyeth Pharmaceuticals could "leave thousands of consumers vulnerable to potentially harmful drugs for years to come" ("Protecting pharmaceuticals," Nov. 7). But what about the millions of consumers hoping for cures who would be left behind as companies diverted money from research and raised prices in order to deal with an onslaught of frivolous liability litigations?

Without some reasonable assurances that the FDA approval process insulates drug companies from unqualified state juries dictating what the companies should or shouldn't have done, they have little reason to venture into the drug-development process. Far more victims are created when innovation is slowed and when medicines are not discovered. A ruling against Wyeth and against federal pre-emption of state law would retard or even halt the introduction of new, potentially groundbreaking therapies.

Merrill Matthews Jr., Lewisville, Texas

The writer is a visiting scholar with the Institute for Policy Innovation.

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