Recent Posts:

Oxycontin Manufacturer Admits Deception
Pharamaceutical Company Settles Off Label Marketing to Infants Case
New Case Against Glaxco
Texas Vioxx Verdict
New Study Involving Birth Control Pills
New FDA Rule May Hinder Failure to Warn Claims
Grants Used to Market Drugs
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Date: May 23, 2006 Title: Study raises concern about Diabetes Drug Author: Ronald V. Miller, Jr. Comments: Select here

A study found in the online version of in the New England Journal of Medicine found that the diabetes drug, Avandia, may significantly increase the risk of heart attack. The FDA advises patients taking the Avandia, manufactured by GlaxoSmithKline, to seek advice from their doctor. The FDA is convening an advisory panel to investigate the risks associated with Avandia.

Date: May 22, 2006
Title: Utah sues Zyprexa maker Eli Lilly
Author: Ronald V. Miller, Jr.
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Utah filed suit last week Utah filed suit last week against pharmaceutical giant Eli Lilly alleging that the company misled about risks to patients who received the antipsychotic drug Zyprexa. Utah seeks civil damages and penalties, including $5,000 to $10,000 for each prescription that was "not medically necessary."

Date: May 11, 2006
Title: Oxycontin Manufacturer Admits Deceptive Marketing Practices
Author: Ronald V. Miller, Jr.
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On the heals of yesterday's post, the Washington Post reported this morning that the manufacturer of the potent painkiller Oxycontin and three current and former executives at the company pleaded guilty yesterday to falsely marketing the drug in a way that masked its addictive properties and led to many people becoming addicted to Oxycontin.

The Purdue Frederick Co. and its chief executive, top lawyer, and former medical chief agreed to pay a total of $635 million to resolve charges filed by the United States attorney in the Western District of Virginia, who called said that Purdue "put its desire to sell OxyContin above the interests of the public," Assistant U.S. Attorney General Peter D. Keisler said.

Date: May 10, 2006
Title: Pharamaceutical Company Settles Off Label Marketing to Infants Case
Author: Ronald V. Miller, Jr.
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An Arizona pharmaceutical company agreed to settle a whistleblower lawsuit filed by four former sales representatives for $9.8 million. Medicis Pharmaceutical Corp. illegally marketed a topical anti-fungal preparation called Loprox as a treatment for diaper rash. Loprox is not approved for children under age 10. Incredibly, Medicis actually trained its sales force to promote the product as an effective treatment for infants.  

On the Maryland Injury Lawyer Blog yesterday, I expressed some question yesterday as to whether Novartis should have known to take Zelnorm off the market before the FDA essentially recalled Zelnorm, wondering aloud whether the expected millions of dollars in profits motivated their decision making process. Seeing these kinds of cases, where drug companies are risking patient safety - infants in this case - in the name of market share, leads to the cynicism.

Date: February 22, 2006
Title: New Case Against Glaxco
Author: Ronald V. Miller, Jr.
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      The American Statesman, a newspaper in Austin, Texas today reported that an attorney, citing a 2005 Mayo Clinic study that documented 11 Parkinson's patients who became compulsive gamblers while on a drug called Requip, filed suit against manufacturer GlaxcoSmithKline on behalf of a retired doctor in Austin, Texas. His Complaint alleges that after taking Requip in 2004, the plaintiff "developed an irresistible compulsion to gamble," which lead to his losing over $13 million. The Complaint also claims that the casinos knew or should have know of his Parkinson's and the Mayo Clinic study (conveniently ignoring that the study came out after he lost most of his money).

      I worked for GlaxcoSmithKline as an outside lawyer about five years ago defending their antidepressant Paxil. I cannot imagine a scenario where they would ever consider resolving a claim like this. You cannot blame Glaxco in this case. This lawsuit seems frivolous. (I use the word "seems" only because I do not have access to the same information that the attorney filing the suit may have.) A study of 11 patients is not enough for Glaxco to rely upon given the side effect is not life threatening. I find these claims frustrating because there are many meritorious claims pending against Glaxco and the other drug companies. Pharmaceutical lawsuits like this one weaken by association those deserving pharmaceutical cases.

Date: February 20, 2006
Title: Texas Vioxx Verdict
Author: Ronald V. Miller, Jr.
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      A federal jury on Friday in Texas found Merck not liable in the 2001 death of a Florida man who apparently had been on Vioxx for less than a month. Vioxx cases vary in strength and this case was clearly a factually weak case for the Plaintiffs. Plaintiffs are expected to have a far better chance when trials begin for long-term Vioxx users come to trial. Moreover, this was the second time this case was tried. In Houston, where the case was heard in November and December last year because of Hurricane Katrina, the judge declared a mistrial because the jurors could not agree on a verdict. The data on Vioxx indicates that stroke and heart attack risk are more grave after longer term use. This presents a very different case against Vioxx and makes the data that Merck ignored not only inflammatory but relevant. The next Vioxx case for a long-term user is expected to start in early March in New Jersey.

Date: February 18, 2006
Title: New Study Involving Birth Control Pills
Author: Ronald V. Miller, Jr.
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      The FDA said yesterday that a new study demonstrates that women using the Ortho Evra birth-control patch have double the risk of developing blood clots compared to women who are using birth control pills. Dr. Daniel Shames, director of the division of reproductive and urological drugs at the FDA, said the risk of a blood clot was about one per year in 10,000 women not using a contraceptive. For those using a hormonal contraceptive like the patch or pill, the risk rises to 3 to 5 per 10,000, Dr. Shames said. This patch is made by Ortho Women's Health and Urology, which is owned by pharmaceutical giant Johnson & Johnson.

Date: January 19, 2006
Title: New FDA Rule May Hinder Failure to Warn Claims
Author: Ronald V. Miller, Jr.
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      A new rule promulgated by the Food and Drug Administration yesterday to make drug labels more calculated to warn and inform patients and doctors also seeks to preempts state laws in failure to warn cases.

      The new rule - the first revision of its kind in 25 years - includes language preempting state laws, stating that an FDA-approved label preempts conflicting or contrary state law, regulations, or decisions of a court of law for purposes of product liability litigation. This mirrors the position FDA attorneys have taken for the past 5 years in amicus briefs filed in products cases around the country arguing that agency labeling guidelines preempt state law.

      The attorneys for the pharmaceutical companies for years have been pushing preemption as means of getting around their failure to properly inform health care providers of the risks associated with their drug or medical device. They have inundating plaintiffs' lawyers with mountains of briefs on preemption, arguing that it is impossible to comply with FDA approved labeling and still give a more stringent warning about a drug's risks. These lawyers further argue that more explicit warnings would frustrate congressional purpose by overdeterring the use of that drug by physicians and patients. These arguments have generally been rejected. For an example opinion, click here.

      Pfizer's "impossibility of compliance" argument has been rejected because the FDA regulatory requirements only established minimum safety standards. The federal regulations themselves actually encouraged strengthened warnings in appropriate situations. 21 C.F.R. §314.70 is the federal regulation governing supplements to approved new drug applications. This regulation states that a change to labeling that "add[s] or strengthen[s] a contraindication, warning, precaution, or adverse reaction" is within the category of changes that "may be made before FDA approval." 21 C.F.R. §314.70(C)(2)(i). Plaintiffs' attorneys in drug injury cases have also historically relied 21 C.F.R. §201.57(e), which requires a warning whenever there is a "reasonable possibility" of an association between the drug and a serious, particularly life-threatening, side effect. At the time section 201.57(e) was promulgated, the FDA Commissioner made clear that "these labeling requirements do not prohibit a manufacturer, packer, relabeler, or distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered...additions to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drugs, or the issuance of letters directed to health care professionals (e.g. "Dear Doctor" letters containing such information) is not prohibited by these regulations." 44 Fed.Reg. at 37,447 (June 26, 1979).

      These new regulations may change the landscape. Expecting that the FDA would take this position on preemption the National Conference of State Legislatures, a bipartisan group representing state legislators, issue a statement that the FDA would be seizing authority that it did not have. But frankly, much of the law surrounding warnings and preemption revolves around interpretation of these FDA regulations. Congress may need to get involved to remedy this wrong but no one should expect that this Congress will. Accordingly, I think the hill for plaintiffs' attorneys representing drug injury victims just got steeper.

Date: January 12, 2006
Title: Grants Used to Market Drugs
Author: Ronald V. Miller, Jr.
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      The New York Times reported today in an article titled, Drug Makers Scrutinized Over Grants, that a congressional investigation of the money that drug companies are given by pharmaceutical companies as educational grants are often steered by marketing executives to doctors and groups who push unapproved uses of drugs. Incredibly, 23 pharmaceutical companies spent a total of $1.47 billion on educational grants.

      Unfortunately the committee could not estimate what percentage of the grants are used for marketing purposes. But this underscores a reoccurring problem in patient safety: the fact that with many pharmaceutical products, the drug companies are providing direct or indirect funding to all of the leading doctors in a particular field, the opinion leaders whose views are of interest to the scientific community.

      One classic example was with Dr. David Healy who was offer a post in the department of psychiatry in Toronto. Shortly thereafter, Dr. Healy wrote an article in the Hastings Center Reports issue of March 2000. The article referenced the capacity of Prozac to induce suicidality. When the issue of the Hastings Center Reports was published, Lilly withdrew their funding from the Center, citing specifically the Healy article. Eli Lilly, the manufacturers of Prozac, provided significant funding to the University of Toronto. Not surprisingly, the University withdrew their offer of employment. Professor Healy lost his job because he stood up for the rights of patients. After a lawsuit, the University of Toronto settled Dr. Healy's claim.

      So the problem is that the drug companies are setting up a paradigm where fewer and fewer reputable doctors have the impartiality to be the first to step up and say that a drug is hurting the people who are using it. This money only buys so much time. Eventually, there are enough good doctors out there that enough will eventually stand up once the evidence that the drug is harmful reaches a critical mass. But, practically, it makes it more difficult for a doctor to stand up and be the first to say a drug or medical device should be taken off the market. As a result, critical time is lost.

Date: January 12, 2006
Title: Welcome!
Author: Ronald V. Miller, Jr.
Comments: Select here

      Welcome to the Pharmaceutical Drug Injury Lawyer Blog presented by Miller & Zois. The purpose of this site is to be able to comment on issues relating to pharmaceutical drug injuries, associated litigation as well as solicit input and feedback. We hope that you enjoy the site and will participate.

Thank you,

Ronald V. Miller, Jr.

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