The Heparin Disaster

Tuesday, July 1, 2008

Congress Demands Documentation Supporting the FDA’s Change in Position Regarding Preemption of Product Liability Lawsuits

On June 26, 2008, Congressman and Chairman of the House of Representatives’ Committee on Oversight and Government Reform, Henry A. Waxman, sent a letter to the FDA Commissioner demanding production of documents that explain why under the Bush Administration, the FDA changed its position regarding whether FDA regulation should bar liability claims. (To view this letter, click here.)

Prior to the Bush Administration, the FDA had a long-standing position that despite its regulation of medical drugs and devices, “product liability lawsuits in state court complement the agency’s regulation of drugs and medical devices, providing an important additional layer of consumer protection against unsafe products.” (See 06/26/08 Letter to Eschenbach.) As such, the FDA did not interfere or challenge the constitutional right of innocent Americans injured by defective products to hold the drug companies responsible in a court of law.

On May 14, 2008, the House of Representatives Committee on Oversight and Government Reform, held a hearing on the issue of preemption of state liability claims related to FDA-approved drugs and medical devices. (We have previously blogged on this hearing and the problem with preemption. See prior blogs, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” (05/14/08); “FDA Needs Subpoena Power” (05/21/08); “The Preemption Problem” (06/04/08); “Draft Bill Regarding Preemption To Be Introduced” (06/13/08)).

Despite the FDA’s long-standing position regarding preemption, the current FDA Deputy Commissioner for Policy, Randall Lutter, testified at the hearing that under the Bush Administration the FDA reversed its position and calls such suits a “challenge” to the agency that have “detrimental effects on the public health.” (For a transcript of this hearing, click here. For a video, click here.) As such, under the Bush Administration, the FDA now sides with drug manufacturers. They argue that regardless of any misconduct or failures on behalf of the drug companies, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA, giving negligent drug companies almost complete immunity.

Ironically, this position comes amidst the heparin disaster, wherein the FDA has admitted that it does not have the resources, authority and capability to ensure product safety. (See 04/29/08 Video of House of Representatives’ Subcommittee on Oversight and Investigations Hearing, “The Heparin Disaster: Chinese Counterfeits and American Failures; 04/22/08 Video of House of Representatives’ Subcommittee on Oversight and Investigations Hearing, “FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk.”) Indeed, the FDA currently does not even have subpoena power, which would allow the FDA to demand certain documents from companies who have sold contaminated drugs. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. (See prior blog, “FDA Needs Subpoena Power” (05/21/08)).

The June 26, 2008 letter asks that the requested information/documents be produced by July 11, 2008.

Labels: Baxter, China, Chinese, Eschenbach, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, Lutter, MDL, nightline, preemption, Scientific Protein, Waxman

posted by Pamela A. Borgess # 11:25 AM 0 Comments

Friday, June 13, 2008

Draft Bill Regarding Preemption To Be Introduced

On February 20, 2008, the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The problems with preemption have been discussed previously on this blog including, “The Preemption Problem” and “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”)

However, as reported in the 6/10/08 FDA news Device Daily Bulletin, prominent lawmakers are now seeking to introduce a bill in the next few weeks that would render this harsh U.S. Supreme Court decision moot. (FDAnews Device Daily Bulletin, Vol 5 No. 113, “Device Preemption Ruling Threatened by Draft Bill.”) This important bill would add a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” The draft bill is sponsored by Congressmen Pallone and Waxman and is available at: www.fdanews.com/ext/files/FinalBill.pdf.

As this legislation is critical to ensuring the accountability of medical drug and device manufacturers for the safety of their products, we support this new bill.

Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, Pallone, preemption, Scientific Protein, Scientific Protein Labs, SPL, Waxman

posted by Pamela A. Borgess # 9:11 PM 0 Comments

Wednesday, June 4, 2008

The Preemption Problem

Baxter, along with other drug manufacturers, continues to advocate for complete immunity from the majority of suits involving unsafe medical drugs under a legal concept called “federal preemption.” (See Baxter’s “Response to Preemption Discussion to Quaid’s Lawsuit.” See also testimony of Dennis and Kimberly Quaid at the Committee on Oversight and Government Reform’s 5/14/08 hearing, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” The full transcript and video of this hearing is available by clicking here.) Baxter and other drug manufacturers argue that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

This argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Since the contaminated heparin recall, the significant shortcomings in the FDA’s ability to protect this county against unsafe drugs and medical devices, has been on the forefront of the news media, as well as the agenda of Congress. Reports exposing the depth of the problem continue. This week USA Today published an article entitled “Drug Companies Drain Scientific Brains from FDA,” which reports that the FDA continues to lose its most experienced scientific minds to major drug companies with more financial resources. This has led to staffing problems for the agency, which has a turnover rate twice that of other agencies.

A previous study conducted by USA Today and reported in an article entitled “FDA Advisers Tied to Industry,” found that “more than half of the experts hired to advise the government on the safety and effectiveness of medicine had financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.”

With their undeniable influence at this and other levels of our government, it is no wonder that drug companies have gained support for federal preemption of medical drug and device lawsuits. It is also no wonder that Americans continue to die from unsafe drugs and medical devices.

Yet, our constitution gives every-day Americans injured through no fault of their own, a powerful weapon against corporate corruption and greed, the right to a jury trial. In a United States court of law, a regular American can hold even the wealthiest and most powerful corporation accountable. Attempts by Baxter and others to sacrifice that constitutional right for protection of its corporate profits, should be not be permitted.

Labels: Baxter, China, Dennis Quaid, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, nightline, OSCS, over sulfated chondroitin sulfate, preemption, Scientific Protein Labs

posted by Pamela A. Borgess # 4:13 PM 0 Comments

Wednesday, May 14, 2008

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

A hearing today before the House Committee on Oversight and Government Reform will address the question of immunity for drug companies. The drug companies want complete protection from lawsuits even when they fail to properly manufacture, market or package their drugs.

But a formerFood and Drug Administration commissioner told Congress today that FDA approval of a drug or medical device shouldn't bar suits against the product's manufacturer, saying the agency's lack of resources diminishes its ability to detect emerging risks.

"Even if the FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed" by the resources of drug companies, according to David Kessler, FDA commissioner from 1990 to February 1997.

The Bush administration has followed a two-pronged strategy for protecting big pharma. First, seek legal immunity in the Supreme Court for companies on the basis that the FDA's approval amounts to a "preemption" of the rights of individuals injured or killed by the defective drugs to purse claims under state laws.

Second, the Bush administration intentionally underfunds the FDA, thereby preventing it from performing its obligation of inspection and enforcement.

Actor Dennis Quaid also testified today. His six-month-old twins, Thomas Boone and Zoe Grace, were accidentally given adult-doses of the blood thinner heparin in November 2007 because the product looked similar to another drug used to flush IV lines. The overdose of heparin was potentially lethal, but Quaid's children fully recovered.

Quaid said in opening testimony that the similarity of heparin to Hep-Lock, a weaker blood thinner used to flush IV lines, also led to the deaths of three infants in Indianapolis in 2006. Both Hep-Lock and heparin are made by Baxter International Inc. (BAX).

Quaid sued Baxter in November 2007, and the Deerfield, Ill., company has moved to dismiss the case, relying on the preemption doctrine.

Quaid said a federal ban on lawsuits "would relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered - years after their drugs are on the market."

Quaid and the former FDA Commissioner are right. Both the FDA and the manufacturers have absolute non-delegable duties to insure our drugs are safe. The preemption doctrine significantly diminishes the safety of our drugs, permitting companies to hide behind the fallacy that FDA approval amounts to a guarantee of safety.

We have learned the hard way that the FDA does not and cannot protect us from defective drugs. Drug companies that fail to perform their duties should be held to the same standard as every other corporation or person in America, and required to make good the harm caused by their breach of duty.

You can watch the hearing on C-Span here: Hearing: Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

Labels: Baxter, David Kessler, Dennis Quaid, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, OSCS, over sulfated chondroitin sulfate, preemption

posted by David W. Zoll # 4:44 PM 0 Comments

Digg is FREE

Subscribe to
Posts [Atom]