The Heparin Disaster

Tuesday, November 18, 2008

FDA Offices in China: A Baby-Step Toward Public Safety

In response to the ongoing public outcry for protection from imported drugs and other products, the U.S. Food and Drug Administration is finally taking some action. This week, the FDA is opening three offices in China. (11/17/08, Washington Post, “FDA to open China Offices After Product Scares.”) The first office will be opened in Beijing on Wednesday, followed by one in Guangzhou and another in Shanghai. According to Health and Human Services (HHS) Secretary Mike Leavitt,13 employees will be assigned to work in the FDA offices in China, but he has not said what their role will be.

While this is certainly a good first step, it is only a baby-step. There are thousands of foreign companies who ship drugs into the United States, let alone other consumer products. Thus, additional presence and regulation is needed. Last year the FDA reported that it only had resources to inspect foreign pharmaceutical companies every 13 years. (U.S. Government Accountability Office, Drug Safety: Preliminary Findings Suggest Weakness in FDA’s Program for Inspecting Foreign Drug Manufacturer. Statement of Marcia Crosse, Director of Health Care, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, November 1, 2007.) It is unclear how much of an impact that three offices with only 13 employees, who must deal with multiple consumer products, (not just pharmaceuticals), will have on the undisputed inability of the FDA to ensure product safety of foreign products.

As often discussed on this blog, this inability to protect the American public underscores why preemption of lawsuits is wrong. Drug and medical device companies argue that Americans injured by defective drugs or medical devices should be barred from bringing suit, because the FDA can adequately protect the American public. The heparin disaster has made it clear that this assumption is inherently flawed.

Indeed, as also reported in this week's news, the House Committee on Oversight and Government Reform released a report showing "that historically the Food and Drug Administration has not sought to preempt state law claims, and that the agency 'viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency's regulatory efforts.'" (11/17/08 Lawyers USA, "Report: FDA Staff Objected to Preemption Policies.") However, during the Bush administration the FDA made a dramatic reversal, adding preemption language to drug regulations. This language has now become "a cornerstone of drug industry preemption arguments."

According to the report, "key career officials" objected to the regulatory changes. The officials "repeatedly warned that the central factual justifications for the agency's new positions were false."

The American Association for Justice ("AAJ") "blasted the FDA over the report, noting that the findings were similar to those in an AAJ report released earlier this month." Geri Voss, Director of Regulatory Affairs at AAJ, said, "In a gift to big negligent corporations, the Bush Administration overrode the advice of career professionals, ignored the agency's history of respect for litigation and put consumer safety on the backburner." For a full copy of “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability” go to: www.justice.org/getoutofjailfree.

Labels: AAJ, Baxter, Baxter Heparin, China, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, imported drugs

posted by Pamela A. Borgess # 9:55 AM 0 Comments

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

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 21, 2008

FDA NEEDS SUBPOENA POWER

At the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” Rep. Bart Stupak, Chairman of the investigations panel of the House Commerce Committee, asked FDA representatives if the FDA needs subpoena authority. This subpoena power would give the FDA the power to demand certain documents from companies who have sold contaminated drugs, such as Baxter and SPL. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, and Deborah Autor, Director of the FDA’s Office of Compliance, replied that this power “would be very helpful.”

Last week, Stupak followed up on his inquiry, sending a letter to the FDA Chief, Andrew C. von Eschenbach, M.D. This letter emphasized the importance of giving the FDA subpoena power and asked the FDA Chief to stand by the statement of Dr. Woodcock and Ms. Autor. (Wall Street Journal, 5/20/08, “Rep. Stupak Nudges FDA Toward Subpoena Power.”)

As noted by Stupak, the FDA is one of the few Federal agencies that lack subpoena power. In his letter, Stupak writes, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.”

After six years of debate whether Congress should give the FDA subpoena power, the most recent heparin disaster and the FDA’s inability to fully investigate what went wrong, should signal the importance and need to immediately provide this power. Stupak is correct. Without the ability to obtain all documents necessary for a full and fair investigation, we will likely never know the full truth as to how fake heparin was allowed to be sold and injected into hundreds of Americans. More importantly, we cannot ensure that it will not happen again.

-Submitted by Pamela A. Borgess

Labels: Baxter, China, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, OSCS, over sulfated chondroitin sulfate, SPL, Stupak

posted by David W. Zoll # 4:39 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

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