Archive for the ‘FDA Preemption’ Category

From conception to childbirth, pregnant women are challenged with managing their own health while worrying about the welfare of their unborn child. Every year, approximately 500,000 pregnant women in the U.S. battle conditions that require medical treatment, such as cancer, psychiatric illness, autoimmune disease, and influenza. Numerous warnings exist about the use of any type of medication whether prescription or over the counter. These battles leave a pregnant mother and her doctor carefully considering the proper dosage necessary to maintain health without harming the child.

Pregnancy Presents Unique Prescription Rules

Determining what is appropriate for a pregnant mother has not been easy. Shifts in the metabolism of a pregnant woman are substantial compared to a woman who is not pregnant, and, therefore, require changes in treatment. To what extent change is necessary has become difficult to determine. Conducting scientific studies on a pregnant woman to make these determinations raises both ethical and legal issues. 

Better Information About Pregnant Women About the Impact of Medications
 
The Second Wave, a movement begun this spring in Washington and composed of 30 doctors, ethicists, scientists, and government officials, aims at providing better information regarding how drugs affect pregnant women. Only in the 90’s did studies begin to include women, and, as recent as twenty years ago, members of the medical community were still using the male body as their research models and adapting those results to women. A recent 2003 law made it possible for not only women, but in some cases, children to be included in these scientific studies.

Second Wave encourages doctors and agencies to gather data on pregnant women and eases any fears by emphasizing that a lot can be done on a less dramatic level. Blood samples can be drawn and analyses conducted on pregnant women who are already taking medication out of necessity. Unfortunately, chronic illnesses that many women have do not disappear during pregnancy. It is inevitable that pregnant women will be taking medication, and studies show that two thirds of women take up to five drugs over the course of their pregnancy and labor. It is these women that can be used for the study.

While the Second Wave program looks for pregnant women willing to participate, the U.S. Food and Drug Administration is proposing to revamp its system for notifying pregnant women about adverse effects of drugs. Strikingly, only a dozen prescription drugs are approved for use by the FDA and most of these are all pregnancy related, leaving mothers with other common conditions in the dark as to effects of most medications on their unborn child.

Right now the FDA’s notification system consists of classifying drugs into one of five pregnancy-related categories, with A being the safest and X being the least necessary. Research on Category C drugs, which the FDA believes covers nearly 70% of all drugs, is much less conclusive in terms of safety for unborn children. Consequently, the FDA is moving towards eliminating these categories in favor of a system that more narrowly defines each individual drug and its effect on pregnant and nursing women. Below is a brief description of each of the five categories:

- Category A: Large number of human studies show no increased risk of birth defects when used by pregnant women. Examples include: Levothyroxine (thyroid hormone), B6, folic acid.

- Category B: Large number of animal studies show no increased risk of birth defects. No well done human studies have been conducted. Examples include: Zofran (antiemetic), amoxicillin (antibiotic).

- Category C: Animal studies suggest an increased risk and there are no large well-done human studies. Drug’s benefits may be worth the potential risk. Examples include: Zoloft, Paxil (antidepressants); Tamiflu (antiviral); Amitiza; any ACE inhibitors.

- Category D: Human studies show an increased risk of birth defects, but drug’s benefits may outweigh that risk. Examples include: tetracycline (antibiotic); Cytoxan (chemotherapy).

- Category X: Human studies show increased rates of birth defects and animal studies suggest an increased risk. The risk usually outweighs the benefits. Examples include: Accutane (acne treatment); Lipitor (cholesterol reducer).

If you or a loved one thinks you have been the victim of medical negligence because you have been wrongly prescribed medication during pregnancy or experienced adverse side effects as a result of being wrongly prescribed medication during pregnancy, you may be entitled to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact a medical malpractice lawyer today for a free and confidential case evaluation.

Several skin care products, marketed under various brand names, have been recalled after inspections revealed high levels of bacterial contamination. Clarcon Biological Chemistry Lab Inc., of Roy, Utah, recalled several of its skin sanitizer and skin protectant products which were discovered to contain bacteria capable of causing opportunistic infections of the skin and underlying tissue. On June 8, the U.S. Food and Drug Administration issued a Clarcon warning to all consumers to refrain from using any Clarcon products.

The results of the inspection contradict what Clarcon Labs promises its consumers.  The company promises its users skin care products that will safely protect and enhance the skin. Even more alarming, results of the inspection proved the existence of high levels of bacteria within products marketed as antimicrobial agents that claim “to treat open wounds, damaged skin, and protect against various infectious diseases,” the FDA’s statement reported. Use of these products should be discontinued and the products thrown away. Read more for a list of Clarcon products affected by the recall.

Occasionally we will report here on the ConsumerInjuryLawyers.com blog some of the good deeds and hard work we are doing for our clients and consumers generally.  One of the many ways that Bernstein Liebhard looks out for our consumers is to stay active on issues important to them, their families and their legal rights.  We even do this sometimes without getting paid or the prospect of getting paid.  Ms. Levine, whose case was argued before the U.S. Supreme Court yesterday, is not our client.  But, earlier this Summer, Bernstein Liebhard, pro bono (we did not get paid for our work), filed an amicus (friend of the court) brief with the U.S. Supreme Court on behalf of third party payor clients (union health and welfare funds) and doctors supporting Ms. Levine’s position before the U.S. Supreme Court.  Our clients on the brief share our fundamental belief that consumers should have the right to sue drug companies when they are injured by dangerous drugs in a way that could be avoided had drug companies provided the proper warnings to patients and doctors.  The Wyeth case has been widely reported as the “business case of the century” and the Chamber of Commerce has sunk millions of dollars framing the issues for a win for drug companies in FDA preemption cases such as Wyeth.  The case is important to Big Pharma because it represents the strongest attempt in history by big business to eliminate consumer rights and protect them from lawsuits.  

Bernstein Liebhard’s briefing was led by Ann Lipton, a former Bernstein Liebhard associate and former law clerk to U.S. Supreme Court Justice David Souter.  Ann and the team did a brilliant job putting together the brief with the clients.  Our brief traced out a long history of the drug at issue in the case, Phenergan, and how it was marketed and sold by Wyeth without a contraindiciation on its label warning not to inject Phenergan directly into the vein.  In plain English, it means that Wyeth knew that Phenergan given to a patient in an IV could escape the vein and kill tissue — causing gangreen and potentially requiring amputation.  In the Levine case, Ms. Levine, a professional musician, was administered the drug by IV push, the drug went outside the artery and caused gangreen, necessitating the amputation of her arm.  For Ms. Levine, she luckily at least able to sue in her home state of Vermont alleging that the pharmaceutical company failed to warn doctors that they should not administer Phenagren by IV push.  This right is what Wyeth is looking to the U.S. Supreme Court to take away from consumers.

Like many of the consumers who come to us on a daily basis, Ms. Levine was injured by a product and looked to her attorneys to help her recover compensation that would cover her losses (she lost her job as a musician) and pain and suffering.  Ultimately, a jury sided with Ms. Levine, awarding her $6.7 million.  Wyeth claims, however, that because the FDA had approved the warning label for the drug, individual consumers should not be allowed to sue the company.  Wyeth’s argument undoubtedly placed corporate profits and distractions from lawsuits ahead of individual consumers.  Unfortunately, however, the Bush administration’s FDA, counter to long standing FDA policy supporting consumers, filed a brief supporting Wyeth and opposing Ms. Levine.  This news was of course shocking and horrifying to Ms. Levine, who lost her arm, and also to many other consumers out there who look to the FDA to keep them safe.  All too often, the FDA has failed and it seems to lack the legal teeth or resources to keep the pharmaceutical industry in tact.  

David Frederick, Ms. Levine’s counsel, cited to the amicus brief that Bernstein Liebhard drafted a number of times when arguing the case to the Supreme Court.  You can read the full transcripts here, but excerpts from the argument transcript where the amicus brief prepared by Bernstein Liebahrd is cited include:

MR. FREDERICK [in response to a question from Justice Scalia]: That was not our burden and that was not how the testimony came in at trial. But as the amicus brief by Dr. Budhwani, et al. at pages 54 establishes had Wyeth been a reasonably prudent manufacturer over the years, it would have known that the risks of IV push so far outweigh any bearing negligible benefits, that it would have offered a stronger instruction, it would have moved to revise its label either with FDA approval or - 

(11/3/08 Argument Transcript at 28)

MR. FREDERICK [in response to a question by Justice Scalia]: I think that the dispute is — is what constitutes new information, because we don’t take issue with the notion that new information can be new analysis of prior submitted data; and what the amicus brief by Dr. Budhwani et al. points out is that there was a lot of unpublished information about the harms of Phenergan that was known to Wyeth or should have been known to Wyeth in the ’80s and ’90s that would have justified a change under the CEE regulations.

(11/3/08 Argument Transcript at 33)