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New law would ensure right to sue

Imagine someone rams into your car on the Schuylkill Expressway, causing you serious, permanent injury and costing you your livelihood.

Then imagine the courts say you can't sue for damages because the other person had a driver's license, which proves he is a safe driver and therefore immune from legal responsibility. Or that, although the driver who rammed you was going 50 m.p.h. on an ice-covered highway, he is not liable because that was under the posted speed limit.

Sounds crazy, doesn't it? But when the new Congress convenes next month, it will consider whether that kind of immunity should be granted to big corporations whose products do serious harm to Americans. Our own Sen. Arlen Specter, the ranking Republican on the Judiciary Committee, could play an important role.

Based on a controversial interpretation of a federal law passed in the 1970s, the Supreme Court ruled this year that Americans can't sue corporations that manufacture harmful or faulty medical devices if the Food and Drug Administration allowed the device to be marketed. The case effectively precludes relief for anyone harmed by, for example, an FDA-approved but faulty defibrillator, heart pump, artificial heart valve, or hip replacement.

The ruling takes away the long-standing rights of Americans such as Bridget Robb, 34, a mother from Gwynedd. Robb's heart received 31 unintended electrical shocks from her defibrillator within a few minutes due to a malfunction of equipment manufactured by Medtronic, she testified before the Judiciary Committee in June. The Supreme Court's new ruling apparently will prevent her from recovering the cost of the operations and trauma she suffered as a result.

The Supreme Court recently heard a case that could deny the same rights to Americans harmed by prescription drugs. Many drugs marketed with federal permission have caused serious harm later on, including Vioxx, Zoloft, fen-phen, Avandia and Celebrex.

The FDA's own experts have said agency approval to market is based only on the evidence available at the time, much of which comes from the drug companies themselves. FDA approval to market is a tentative, minimal permission to sell a drug or device, not an assurance of safety or a basis for corporate immunity.

But the Bush administration has nevertheless supported this attack on Americans' legal rights. Already, it has inserted this new protection for big corporations into more than 60 regulations, removing a powerful incentive for manufacturers to ensure the safety of a medication, car seat, crib, toy or other product. If a manufacturer's paid experts and lobbyists can get an initial OK from a regulatory agency, there's no liability later - no matter how bad their conduct or widespread the harm.

The new Congress and President-elect Barack Obama will have an opportunity to enact legislation ensuring that regulatory approval to market does not relieve manufacturers of responsibility. They can also appoint federal judges who understand that our legal system is supposed to protect the rights and health of Americans, not just corporations.