Rhode Island Injury Lawyer Blog

Articles Posted in Pharmaceuticals

I have seen an avalanche of new medical malpractice inquiries coming to my office regarding overdoses caused by prescription painkillers, most notably fentanyl.  Just during July I received three inquiries from families of people killed while using the fentanyl patch.  It may come as a surprise to most readers of this post to find that an FDA approved drug has caused so much disaster.  The fact is prescription painkillers killed over 16000 people in 2013.  Heroin?  Just 6200.  I will leave it for a different blog and more analytical political observers to ask why drugs that kill tens of thousands of people are approved by the FDA while marijuana (which killed zero, yes 0) people in 2013 remains illegal.  (check out drugwarfacts.org for more information and the total chart of which drugs kill people.)

Just because a drug is FDA approved does not mean that an overdose or death caused while using the drug is not a case of medical malpractice.  After all, if legally prescribed and used, where is the negligence?  Quite the opposite, there is a strong chance of malpractice.  I have handled these cases in the past and I am quite familiar with the power of this drug.  Fentanyl is shockingly strong and intended for use only for the most severe cases such as dying cancer patients in hospice.  Prescription of the patch outside of its recommended use or for the wrong patient can be grounds for a medical malpractice claim.  In other words, a person with a marginal history of back pain should not legally be prescribed such a powerful drug.  Fentanyl patch overdose can often be caused because it is prescribed to the wrong person or the person is not properly informed how to use the patch.

The patch itself can cause an overdose but it is particularly dangerous when paired with other drugs, particularly anti-anxiety drugs.  This interaction can be fatal and it is graded as a moderate drug interaction, meaning that it should be avoided and only used under close observation.

A potential settlement in Federal Court will create a 100 million fund for victims of the Meningitis outbreak caused by a Massachusetts pharmaceutical company. The outbreak of meningitis caused by a tainted steroid has sickened over 700 people and killed 64 according to the Center for Disease Control. Victims were from over twenty states with Michigan, Tennessee and Indiana the hardest hit.

The pharmaceutical company filed bankruptcy soon after the outbreak hit. Under federal bankruptcy laws, the company would not have to pay their civil lawsuits and debts. As part of the agreement to enter bankruptcy, a trust fund worth approximately 100 million has been created to aid the victims.

Meningitis is a very serious illness which inflames the lining of the spinal cord and brain. It can result in paralysis and death. If approved the money will be set aside to pay the victims much like the multi-billion dollar trust created for asbestosis/mesothelioma victims created by the manufacturers of asbestos.

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.

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.

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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!

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).

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.

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.

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.