Recently in Pharmaceuticals Category

February 1, 2012

Pfizer Recalling Approximately 1 Million Birth Control Pills

Pfizer today announced that it is recalling two kinds of oral contraception because some of the packages had the pills in the wrong order. Obviously, while attempting to avoid unwanted pregnancy it is absolutely imperative that the person take the proper dose at the right time. Because the packages were filled with the wrong dose at the incorrect time, the drug may prove ineffective in preventing unwanted pregnancy. It is possible that some women have unwillingly become pregnant.

The effected medicines are Lo/Ovral-28 or generic norgestrel/ethinyl estradiol pills. Any woman currently taken these medications should contact their ob/gyn immediately and contact the pharmacy that filled the prescription so that the recalled drugs may be replaced. If you became pregnant while taking these recalled drugs, it is imperative that you contact an experienced personal injury attorney right away. If it can be established that the unwanted pregnancy was caused by the negligence of Pfizer you may be entitled to significant compensation.

It has been a tough couple of months for birth control drugs. Yaz, in particular, has been hit with hundreds of lawsuits claiming that it causes dangerous bloodclots and also results in other unwanted and dangerous side effects. In addition, the FDA has indicated that its dosage may be too low to adequately prevent unwanted pregnancy.

Drug makers profit heavily by pushing drugs on our society and they must be held to a very high standard of quality control and safety, else we are putting ourselves at serious risk of harm.

March 5, 2010

Concern over Avandia Liability Grows

Financial giant, UBS is weighing the potential costs of GlaxoSmithKline Avandia drug in light of the growing concern of its dangers. Over 13,000 lawsuits have already been filed concerning the diabetes drug and Glaxo's expected liability ranges from $1-$6 billion dollars.

Avandia has had a long and sordid history yet despite well supported claims that the drug greatly increases the risk for heart attack, it remains on the market.

Just one week ago, the U.S. Senate Finance Committee was highly critical of the drug in a recent report. The report criticized Glaxo's handling of heart risk associated with the drug, Avandia, claiming that Glaxo minimized safety risks and withheld vital date from the FDA. Avandia is linked with 83,000 heart attacks in a little over eight years. The FDA added a warning about heart attacks to the prescription drug in 2007.

A group of Harvard researchers recently offered a study of 26,375 diabetes patients between the years of 2000 and 2006. They found that diabetes patients taking Avandia had twice as much risk for heart attack as patients taking other diabetes medications. Twice as much! And for those that fear such numbers might be skewed, consider that Glaxo sponsored its own study which showed that Avandia users had a 35-41% heightened risk for heart attack.

This is compelling evidence that Avandia does increase the risk of heart attack. Some early liability trials against Glaxo are set for July.

Continue reading "Concern over Avandia Liability Grows" »

October 5, 2009

Botox Sues for Right to Promote Off-Label Use of Drug

Allergan Inc., the makers of Botox, and it's sister product, Botox Cosmetic, are bringing a lawsuit against the United States, the FDA and it's commissioner, Margaret Hamburg, as well as the Kathleen Sebelius, secretary of Health & Human Services.  The suit alleges that the country's current stance concerning off-label use of drugs is unconstitutional.

A doctor can legally prescribe a medicine to treat an illness even if that medicine is not approved for that purpose.  This is a so-called off-label use.  While this practice is legal, drug companies are not allowed to "push" off-label uses to doctors. 

Drug companies, obviously find this unfair.  They argue, that if a drug works to treat an illness they should be able to promote it even before they have proceeded through the countless clinical trials needed in order to gain approval from the FDA.  The basis of their argument - Free speech!

Allergan's complaint claims the FDA "has promulgated a series of overlapping and interlocking regulations that combine to render unlawful virtually all manufacturer communication, through any avenue, to any audience, about the lawful off-label use of a prescription drug."  Furthermore, "the inability to share such important information proactively with the medical community violates the First Amendment and potentially diminishes the quality of patient care."

I think the First Amendment argument is a novel approach.  The Courts, however, have often limited free speech if necessary for the greater good.  One could argue that the FDA is already hopeless in combatting the power of drug companies, and this lawsuit is an attempt to cripple the FDA which serves an important and valid purpose for the general public.

A victory for Allergan clearly creates a slippery slope for drug manufacturers who will be able to enter a product into the market for one purpose and then promote it for countless others without the safeguards created by the FDA.
September 2, 2009

Pfizer Settles Fraud Allegations for Astonishing 2.3 Billion!

That's right - 2.3 BIllion. 

The settlement brings an end to numerous civil and criminal filings against Pfizer and subsidiary, Upjohn, regarding the painkiller Bextra which was pulled from the market in 2005, as well as a few other drugs.  As part of the settlement, the corporation will plead guilty to misbranding Bextra with the intent to defraud.

The Dept. of Justice initially brought the charges alleging that Pfizer promoted Bextra for off-label uses that were not approved by the FDA.  The Department also alleged that Pfizer gave kickbacks to doctors to encourage them to prescribe Bextra (a charge that Pfizer still denies).

I'd like to believe such settlements will cause drug companies to re-think the way they rush drugs to the market and promote them to the public, but alas, much like the tobacco companies, such settlements are a small drop in the ocean.  I wouldn't be surprised if Pfizer still made a profit on Bextra despite the settlement.
August 6, 2009

Are Ghostwriters paid by Drug Companies Controlling Our Medical Treatment

There is a shocking story in the New York Times that shows in equal measures how far drug companies will go to push their agenda, and how necessary the plaintiff bar is to prevent such abuses.

I have helped represent a woman who was diagnosed with breast cancer after being prescribed Premarin for decades, so this story was very relevant to me.  Drug companies pushed the publication of 26 articles that downplayed the risk of hormone replacement therapy while emphasizing the benefits.  Wyeth paid a medical communications firm to draft the documents while sales of Premarin and Prempro soared to over $2 billion in 2001. 

In 2002, a federal study led to the discovery that menopausal woman who ingested certain hormones had a heightened risk of invasive breast cancer, stroke, and heart disease.

Many doctors rely on such medical literature to decide when and what to prescribe their patients.  The system is inherently flawed when that information is biased and drafted by drug companies themselves.  This information became public following as a result of discovery in one of the thousands of lawsuits that Wyeth now faces.
July 27, 2009

Does Neurontin Increase Risk of Suicide?

That is the question that a Boston Federal Court will decide as trial is set to begin.  Superstar plaintiff attorney Mark Lanier is bringing the suit alleging that the Pfizer anti-epilepsy drug increases a patient's risk of suicide.  This case, the first of some 1200 prepared to go to suit in the coming years is predicted to mirror the Vioxx lawsuits.

Attorney Lanier has admitted that he is starting with a tough case to test the waters.  He represents the family of Susan Bulger, a thirty-nine year old woman who took the drug before hanging herself in 2004.  The case is made difficult by the fact that Ms. Bulger attempted suicide no less than three times previously. 

A win for the plaintiffs in this early case would be devestating to Pfizer with over a thousand lawsuits pending.
May 19, 2009

New York Most Recent State to Challenge Validity of Learned Intermediary Rule

The learned intermediary rule, which roughly holds that a manufacturer (typically pharmaceuticals) satisfies their duty of care by providing a "learned intermediary" (usually a doctor) with all necessary information including risk of harm, because the learned intermediary will interact with the consumer and relay the risks.

The Rule has been challenged in a number of states with a wide ranging difference of opinion... And now it comes before New York.

I do not think I could state the justification for abolishing the rule any better than the sponsors of the bill, Brodsky and Weisenberg:
In 1997 the F.D.A. relaxed its guidelines for
direct-to-consumer advertisement of pharmaceuticals. Since that time,
there has been an onslaught of marketing in an attempt to influence a
patient's choice of a drug. These efforts have become an essential
part of manufacturer's marketing plans, resulting in an increase from
$843 million in 1997 to annual costs in the billions for print and
broadcast advertising. This change has also resulted in an increase in
the number of prescriptions written: fifteen months into the
relaxation of the guidelines, one heavily marketed drug saw an
increase in sales of more than one hundred times that of prescriptions
written prior to advertisement.

This controversial new marketing technique, opposed by the American
Medical Association, undermines the patient-physician relationship by
encouraging consumers to ask for advertised products by name. As
"patient choice" becomes an increasingly popular concept, physicians
are being relegated to a passive role where, upon demand, the patient
receives a prescription for the advertised drug 73% of the time.

The purpose of the bill, as stated by the sponsors, echoing the opinion of all those who oppose the learned intermediary rule is:
To require that pharmaceutical
manufacturers who engage in direct-to-consumer advertising of
prescription drugs satisfactorily advise consumers of the risk
involved in the ordinary use of the prescription advertised. This bill
also requires that, in products liability actions, the adequacy of the
warning be a question of fact for the jury.

I applaud the New York assembly for challenging this rule and hope that it abolished.  Such a doctrine may have been appropriate in 1966 when it was first raised in Sterling Drug v. Cornish, 370 F. 2d 82), but it is a dangerous doctrine today when pharmaceutical companies directly advertise their product to the public.