Last week, the Los Angeles Daily Journal reported that the California Pharmacy Board will be citing and fining 94 California hospitals and the head pharmacist at each facility for not removing (and in some cases actually dispensing) contaminated heparin from their hospital pharmacies. (George, Los Angeles Daily Journal, 8/20)

This failure is inexcusable, as these institutions have been warned in writing on numerous occasions, including, for example, the FDA’s April 25, 2008 “Update to Healthcare Facilities and Healthcare Professionals about Heparin and Heparin-Containing Medical Products.”

Patients receiving heparin therefore, should remain cognizant of the recall and demand assurances from their health-care providers that they have complied with the recall.

Labels: Baxter Heparin, california hospitals, FDA, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, SPL

At the American Chemical Society’s national meeting on August 17, 2008, Robert J. Linhardt, a chemist with Rensselaer Polytechnic Institute (“RPI”) in Troy, New York, reported ongoing advances toward developing a safer, fully-synthetic version of heparin. (Am. Chem. Society 09/17/08 Press Release, “Chemists move closer toward developing safer, fully-synthetic form of heparin.”) Specifically, Linhardt said his team from RPI, along with the assistance of Jian Liu at the University of North Carolina, has been able to produce a tiny amount of synthetic heparin. (Id.) The researchers claim that this creation is the largest dose of heparin ever created in a lab. (RPI Website: “Researchers Create Safer Alternative to Heparin.”)

According to the American Chemical Society’s press release, researchers have been trying for years to develop heparin production methods. (Am. Chem. Society 09/17/08 Press Release, “Chemists move closer toward developing safer, fully-synthetic form of heparin.”) In 2003, the first so-called total synthesis of heparin was developed at the Massachusetts Institute of Technology (MIT). However, the result was not practical as it only produced minute batches of heparin — less than 0.000000035 ounces at a time. (Id.)

Linhardt, together with Jian Liu, discovered the synthetic “recipe” for heparin in 2006. (RPI Website: “Researchers Create Safer Alternative to Heparin.”) Since that time, they have worked to piece together the various molecules and grow a complex carbohydrate that is naturally created in the body in the lab. (Id.)

RPI claims that larger amount of fully synthetic heparin could be ready for use in patients in five years. (Id.)

Labels: Baxter, Baxter Heparin, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Linhardt, Liu, synthetic heparin

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) have followed the lead of House lawmakers and introduced a Senate counterpart of the Medical Device Safety Act of 2008 to ensure individuals are not prevented from seeking legal recourse against devicemakers selling defective products under state tort laws. (FDAnews Device Daily Bulletin, Aug. 12, 2008, Vol. 5, No. 157, “Senators Introduce Their Version of Anti-Preemption Bill." See also 08/01/08 Statement of Senator Leahy.)

The bill seeks to reverse the United States Supreme Court’s February 20, 2008 decision in Reigel v. Medtronic in which the Supreme Court severely curbed the rights of injured victims. Specifically, this harsh decision 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.

Baxter and other drug manufacturers argue that Riegel should be even further expanded to include medical drugs. They argue that regardless of misconduct or failures on their part, Americans injured by defective drugs or medical devices should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

As discussed in previous blogs, 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. Without accountability of companies who unapologetically put profits over people, innocent Americans will continue to die from unsafe drugs and medical devices.

To read Senator Leahy’s powerful statement regarding the bill and the dangers of preemption, click here.

We thank Senators Leahy and Kennedy for their efforts to protect the American public from unsafe drugs and medical devices.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, Leahy

In a letter dated July 7, 2008, the FDA warned that Baxter’s promotion for its bleeding treatment FEIBA VH misleads doctors about the drug’s safety and effectiveness. (Chicago Tribune/Bloomberg News 7/31/08: “Baxter Warned on Hemophilia Drug Promotion.”)

The FDA advised that the "clinical thank you e-mail" submitted for review by Baxter violates FDA policies and is misleading with respect to both the efficacy and the safety of the drug. Specifically, the FDA held that the promotion overstated the efficacy of the drug and minimizes the fact that serious thrombotic events can occur with the drug. In its letter, the FDA states:

"This Email makes false or misleading safety and efficacy claims for FEIBA VH. Therefore, this material misbrands FEIBA VH in violation of the Federal Food, Drug and Cosmetic Act (the Act) 21 U.S.C. §§ 352(a) and 321(n), and FDA implementing regulations. Cf. 21 CFR 202.1 (e)(6)(i) and (iv). These violations are concerning from a public health perspective because by promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH."

A complete copy of this letter is available by clicking here.

After the heparin debacle, one would hope that Baxter would not be so quick to overstate the safety of its drugs. Apparently, as the old idiom warns, a leopard can never change its spots.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer