Supreme Court should protect public

Published 10:35 am Friday, December 19, 2008

In the 2007 session of the U.S. Supreme Court there were 30 cases heard that involved Big Business.

In 22 of those cases the Court ruled against individual Americans and for business. One of those cases involved this writer.

I have congestive heart failure and because of an irregular heartbeat I have an internal defibrillator manufactured by Medtronics, Inc. Unfortunately, the specific model that is residing in my shoulder and extending into my heart has a potential defect that could kill me.

Email newsletter signup

So far about 3 percent of these devices have failed. But last spring, in a February decision, Medtronics won a case in Reigel vs. Medtronics, Inc. The case affirmed a principal of “preemption,” that is, that federal law precludes state law.

Because there are no product liability laws at the federal level, the effect of preemption is that there is no legal venue for suing the manufacturer for product liability once the FDA has approved the product. This is good news for Medtronics, but not so good news for consumers who hope Medtronics has incentive to make better devices.

This year, on Nov. 3, the High Court heard the case of Wyeth vs. Levine. This case, if ruled in favor of Wyeth, and following the Medtronics ruling, should scare every American.

Diane Levine was a songwriter, singer, composer and band member since the 1970s. She has produced a dozen CDs and several children’s songs. But her career as a musician is over. You see, Diane had her right arm amputated as a result of a misused medication that caused irreversible gangrene.

Eight years ago, struggling from the pain of a migraine headache, Diane went to the hospital and was given Phenergan, a drug often used to reduce the effects of migraines. But she was given the drug, not as an IV drip, its correct application, but as an IV “push” where the dosage is suddenly pushed into the vein. This decision resulted in the gangrene and the loss of Diane’s right arm.

But it did not need to happen. Wyeth had known for more than a year that if Phenergan came into direct contact with an artery that the result could be irreversible gangrene, but had not shared this information with doctors or patients. The Phenergan label did suggest that the preferred usage was by IV drip, but did not mention the possible result if used as an IV “push.”

Wyeth claimed that both the drug and its label were approved by the Food and Drug Administration, and therefore it had met its responsibility. Further, the company claimed “preemption,” that because the FDA had approved the label that approval precluded any state litigation because federal law overrides state law.

The preemption claim is what the Supreme Court will now decide. Should the court decide that Wyeth met its responsibility by having the FDA approve the label, then consumers will have virtually no protection in the courts from any pharmaceutical products.

It should be known that the FDA has very limited testing resources, and that the FDA has only access to information provided to it from the manufacturers of pharmaceutical products.

Consequently, FDA approvals would provide very little, if any, assurance of the safety of the product. This means products that are unsafe, that have suspicious testing results, will reach the market protected from any product liability.

Diane lost her arm and her career. Wyeth could have provided a warning on its label and did not.

Will the Supreme Court make the Wyeth decision legal and standard practice? Or will the Court protect the American people?