Redding Personal Injury Lawyer - FDA & Prescription Drugs

Why Should Manufacturers of Defective Medical Devices be Free From Responsibility for Injuries They Cause?

Todd Slaughter — Fri, 20 Feb 2009 17:18:44 GMT

Anyone following this topic is aware that the U.S. Supreme Court ruled last year that manufacturers of medical devices, even if the devices are defective, are immune from liability if the product was approved by the FDA. The rationale was that the scientists at the FDA should not be second guessed by juries across the nation in determining if a product is defective or safe. This would be true even if the manufacturer voluntarily or involuntarily recalls the product, acknowledging its defective condition. As a result of the Supreme Court's decision, courts throughout the nation have begun dismissing cases against Medical Device manufacturers on grounds of Federal Preemption.

Since the closing days of the Bush administration, we have learned that the scientists at the FDA themselves understood that they did not have the capacity to fully test and "certify" the safety of medical devices being passed through the agency. In fact, the scientists were being threatened with criminal sanctions for demanding an opportunity to perform more testing and scientific analysis before approval. From these developments it is obvious that the manufacturers of these devices have now been placed in the perfect position of being able to push products through the FDA without significant scrutiny, to then become insulated from liability once the FDA's "good housekeeping" seal of approval was obtained.

However, today the tides may have changed and, as sports broadcaster Lee Corso is ever ready to say, "Not so fast my friend!"

In a story in the New York Times following the case of a young widowed mother whose husband was killed during a surgery to remove a defective electric lead on a heart difibrillator, it was reported that two House Democrats, Henry Waxman of California and Frank Pallone, Jr. of New Jersey, were reintroducing new legislation to nullify the Supreme Court ruling. This would allow state courts to act as a "second screening" device to insure the safety of these products.

We hail the efforts of these two Congressman, as well as Senators Edward Kennedy, Massachusetts, and Patrick Leahy, Vermont, who intend to introduce similar legislation in the Senate. The safety and reliability of these types of products that become part of the patient's own body must be paramount. We certainly cannot assure that safety will remain the paramount concern when the wolf is left to guard the hen house!

Originally posted at InjuryBoard by Todd Slaughter

FDA Fundamentally Broken According to FDA Scientists, A Call to Action

Todd Slaughter — Thu, 08 Jan 2009 13:01:32 GMT

Isn't it amazing how liberating the truth is?

This morning the Dow Jones Newswires reported that a group of FDA (U.S. Food & Drug Administration) scientists delivered a letter to President-elect Barack Obama's transition team pleading for fundamental changes in the administration of their agency. The scientist complained that the agency's managers, likely all Bush appointees, used intimidation and reprisals to suppress honest employees from voicing disagreement with policies or scientific findings. The scientists voiced particular concern about the agency's scientific review process for medical devices which was characterized as "corrupted and distorted by current FDA managers, thereby placing the American people at risk." Amazingly, it is this very scientific review process that the U.S. Supreme Court recently ruled "pre-empts the field," precluding people injured by such products from seeking recovery from the manufacturers in court if the product was approved by the FDA. The truth that these scientists are bringing forward is that science is being pushed into the closet when it comes to testing and evaluating these products, and the unlucky consumer damaged by the defective devices now has no recourse. This will be the legacy of the Bush Administration unless drastic changes are made at the management level of the agency, and the Supreme Court ruling is legislatively reversed.

We previously posted on the fact that a group of FDA scientists already reported to Congress that new regulatory changes or interpretations were being forced upon the agency by Bush appointed managers with the clear intent of eliminating civil liability for drug and medical devices manufacturers for their defective products. These scientists and career employees related that the agency had historically considered state court civil actions against the manufacturers as complimentary to their review, with both reviews serving to assure the safety and efficacy of the pharmaceuticals and devices being sold to Americans. This most recent letter reveals the extent to which the current FDA management was willing to sacrifice and suppress science in order to accomplish its goals of non-legislative tort reform. And now the FDA has opened an agency office in China to assist the Chinese government with enhancing product quality and safety? Are we teaching or learning?

Let's trust the truth. The call to action by these scientists should be heard throughout the White House, the Congress, the courts and the media of this country. Do you really think that medical devices and pharmaceuticals will become safer when courtroom doors are closed to those that are injured by them? If not, then the FDA must be revamped and pre-emption in these fields reversed. These scientists are calling upon all of us to assert ourselves for our own protection, and the protection of our progeny. We must move to act now!

Originally posted at InjuryBoard by Todd Slaughter

Pharmaceutical Immunity Inexcusably Sought Over Objections of Career FDA Officials

Todd Slaughter — Thu, 30 Oct 2008 21:24:42 GMT

I start with the simple question: Does the Food and Drug Administration exist to protect the public health, or to shield pharmaceutical giants from responsibility for defective drugs or inadequate labeling?

After reviewing an astonishing report just submitted to Representative Henry Waxman's Committee on Oversight and Government Reform, I regrettably conclude that for the last 7 years the current adminstration has carried on an unprecedented and relentless assault upon this agency with the sole purpose of removing any meaningful protections for the consuming public in favor of insulating pharmaceutical interests from responsibility for the harms their products cause. The article makes it plain that even the career administrative heads and scientists were helpless to defend against the politically motivated "sea change" in philosophy that the administration forced upon them. The goal was to wipe out , once and for all, civil responsibility for defective drugs and devices under the auspices of "Federal Pre-emption," and not to follow the FDA's primary charter, "to protect the public health."

In the report entitled, "FDA Career Staff Objected to Agency Preemption Policies," it is first noted that the FDA's regulatory role in approving drugs and labeling requirements has historically been viewed as only one arm of the consumer protection process. Before the Bush administration, the FDA always viewed private litigation in State courts as a complimentary and "additional layer of protection against unsafe drugs." After all, the FDA must rely on the sponsors of the drugs for their testing and truthful reporting to evaluate the drug's effectiveness and dangers. Where the testing was inadequate, or the risks and hazards were concealed or understated, the results would be determined "in the field," i.e., when consumers were harmed or sickened by the drug.

In an effort to reverse this long-embedded viewpoint of the FDA, the Bush administration, through a series of modest regulatory changes, sought to make the FDA's approval of a drug or device sacrosanct and unassailable. To do this, the new regulations prohibited manufacturers from disclosing any new safety risks to the public without obtaining FDA approval first. Prior to this, manufacturers had been encouraged to make immediate changes for the sake of public safety, with the requirement that the supplemental labeling be submitted afterwards for agency approval. The purpose of Bush's new regulation was to offer support to the manufacturer's protest that they should not be held liable for the inadequacies of a label when they had no power to change it. The power was in the FDA. And as the FDA was a Federal agency, the supremacy clause preempted state court actions.

At the time that these new regulations were being proposed, the justifications offered by the political bosses of the Department were rebuked by the highest ranking career officials and scientists of the FDA as being "false and misleading," "gross overstatements," and based upon an essential "false assumption" that "FDA approved labeling is fully accurate and up-to-date in a real time basis." These officials recognized that these changes would "undoubtedly help shield drug manufacturers from liability." That was their sole unvarnished purpose.

On November 3, 2008, the day before our country goes to the polls to determine the next administration, the case of Wyeth v. Levine will be argued before the U.S. Supreme Court. Potentially, this case will decide if the FDA has preempted the field and thereby nullified any ability on the part of individual consumers to recover for their injuries caused by defective drugs. The Supreme Court should look to the historical role that the FDA and state courts have had since 1906 and uphold and honor the protections that these complimentary forums have provided to the otherwise helpless individual. Should the goal be to protect the citizen, or the asset?

Originally posted at InjuryBoard by Todd Slaughter