For the past six years, the Food and Drug Administration (FDA) has put out a short video segment called “Patient Safety News,” which FDA says is:
“a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.”
About a year ago, FDA started posting these video snippets on YouTube.
One can assume that FDA is posting these so that they reach a broader audience, and not just health professionals. Since they’re aimed at health care personnel, it’s not surprising that the language in them is not all that consumer friendly. But the videos end up sound like little more than the announcers reading text from a drug’s FDA label. Do, for instance, doctors and nurses catching these short snippets in, say, a hospital staff lounge or cafeteria, really stop and listen to the droning text of a drug’s label? Even if they do, does the content penetrate and get retained in the probably busy and distracting environments in which they’re shown?
The FDA might be better off not simply reciting label text in these videos, but rather summarizing the warnings/label changes/what-have-you in a more consumer-friendly fashion. If the purpose behind posting these videos on YouTube is to reach consumers, then the the FDA is failing miserably on that front, as the language used in impenetrable and inaccessible. It’s safe to assume that consumers watching these videos have no idea after they’ve watched them whether it was good news, bad news or no news about the drug in question.
It says things like “these findings support an earlier study that also concluded that women in this group were at higher risk for venous thromboembolism. Another earlier study found that women using the patch did not have a greater risk, but the results from the two positive studies support the concerns that the patch could increase the risk of blood clots in some women.”
And then it concludes that women with concerns should talk to their health care providers. But the overall message is completely unclear — is there a risk? is there not a risk? How much of a risk? This is likely confusing not just to consumers but to prescribers as well.
The FDA did much better in a segment it did on Over-the-Counter cough and cold remedies for kids, Caution Giving Children Cough and Cold Medicines. It had clear recommendations, and the visuals reinforced the message, even if the language was a bit unnecessarily complicated (how many consumers know what an “active ingredient” is?):
It would also be useful if FDA were to do versions of these videos in other languages, particularly Spanish.
The production values of the series are a bit low-tech, which is to be expected, I suppose. Perhaps the FDA needs to take a cue from the very Direct-to-Consumer Advertisements it regulates?
To see all of the videos FDA has posted on YouTube, go here.
You can also view the videos on the FDA website here.
Wyeth v. Levine, a case being heard by the Supreme Court in November, has been in the news a lot lately. The case concerns the injuries suffered by Diana Levine, a professional musician in Vermont who Wyeth [NYSE:WYE] nausea medication called Phenergan in a visit to the emergency room. The drug was given incorrectly, causing her to lose her right arm below the elbow. She sued Wyeth, arguing that Wyeth’s warning in its FDA-approved labelling for the drug was insufficient.
A Vermont state court jury awarded her $6 million, and Wyeth appealed, all the way to the Vermont State Supreme Court, which sided with Levine. Wyeth argued that Levine’s state law personal injury and failure-to-warn claims should be “preempted” by the FDA’s authority to regulate the labels of prescription drugs. Since their argument is based on federal law, on which the U.S. Supreme Court is the ultimate authority, they were able to appeal the decision to the Supreme Court.
We frequently get on our soapbox here at the PAL blog on the topic of preemption – to see our previous posts on this subject, go here.
Earlier this year, the Supreme Court ruled in Riegel v. Medtronic that state law claims concerning medical devices are preempted, by the federal Medical Device Amendments. However, that decision does not mean that the Court will necessarily rule the same way in the Wyeth case, since they concern two different federal laws — and the Medical Device Amendments specifically address preemption, while the Food Drug and Cosmetics Act (FDCA) does not. (PAL joined an amicus brief in that case too, arguing against preemption).
The issue is hardly academic. If Wyeth prevails, injured consumers will be all but precluded from suing drug companies when they are injured by unsafe drugs. The FDA’s authority to approve prescription drugs and their labels will stand as a shield to liability — and therefore to accountability. Given that the drug safety scandals of the past four years have underscored the FDA’s inability and unwillingness to do its job, this should scare the daylights anyone who ever takes a pill. It is part of a larger attack on consumers’ access to the Courts by industries that seek to avoid responsibility when they harm, deceive, injure and even kill consumers through carelessness and greed. Preemption, as some like to say, is the new tort reform.
Prescription Access Litigation has joined an amicus curiae (”friend of the Court”) brief in the case, supporting Diana Levine and arguing against preemption. The brief was written by AARP, and is also joined by the National Women’s Health Network, a member of the PAL coalition.
And if this isn’t enough, you can sift through Levine’s brief, an interview with Levine, the Wyeth brief and the brief filed by the US Solicitor General. And if you look here, you can read friend-of-the-court briefs filed earlier by PhRMA, BIO, the General Pharmaceutical Association, the US Chamber of Commerce, the American Enterprise Institute and the Washington Legal Foundation in support of preemption.”
We’re pleased to announce that SEIU Health & Welfare Fund, the two individual plaintiffs in the class action and Abbott agreed to a proposed settlement of the case on August 13, 2008. Abbott has agreed to pay between $10 Million and $27.5 Million, depending on court rulings to come, to settle the nationwide claims by consumers who were overcharged for the medicine.
There have been a number of important decisions by the Court to date that have set the stage for this settlement. On June 11, 2007, the Court certified the case as a nationwide class action. On May 16, 2008 the Court issued a ruling that was a partial victory for the plaintiffs and a partial victory for Abbott. The Court held that Abbott could not claim a patent that it holds on Norvir as a defense to the plaintiffs’ claims (the partial win for the plaintiffs). However, the Court also dismissed the plaintiffs’ claims for “unjust enrichment.” These claims alleged that Abbott was “unjustly enriched” by its allegedly illegal Norvir price hike.
What’s important about this dismissal is that these common law unjust enrichment claims were the only nationwide claims for monetary damages (as opposed to claims for “injunctive relief,” that is, for changes in company practices) in the case. When the Court dismissed these claims, the only claims for damages that remained in the case were under California state law. Thus, in a nutshell, after the Court’s May 16 order, the case for monetary damages was narrowed to cover just consumers and health plans in California.
Abbott had asked the Court to allow an “interlocutory appeal.” This means, basically, that Abbott asked the District Court to ask the 9th Circuit Court of Appeals to make a decision on a particular question of antitrust law that Abbott felt could determine the outcome of the case. The Court refused, since the trial was at that point only three months away.
The proposed settlement attempts to get the Court of Appeals to resolve this and several other legal issues, and to tie the amount of the settlement to the decisions of the Court of Appeals. Abbott and the plaintiffs will ask the court hearing the case (the federal District Court for the Northern District of California) to allow them to appeal three legal issues to the 9th Circuit immediately. These legal issues are ones that have been essential to the plaintiff’s success so far, and which Abbott would likely appeal if the plaintiffs were to win at trial.
There are several different forms the settlement could take, depending on how this appeal goes:
If the District court ”certifies” all three questions up to the Ninth Circuit for appeal, and the Ninth Circuit accepts at least two of them, Abbott will pay a non-refundable $10 Million in to a settlement fund. That $10M (and possibly more – see below) would eventually be distributed to 13 different non-profit organizations that benefit people with HIV/AIDS. (See a list of those organizations here).
How much Abbott would have to pay beyond the initial $10M depends on how the 9th Circuit rules on the appeals questions:
If Abbott wins the appeal of any of the three questions before the Ninth Circuit, then it doesn’t pay anything beyond the initial $10M.
If the plaintiffs win on all the questions before the 9th Circuit, then Abbott must contribute another $17.5 Million to the settlement fund.
If the 9th Circuit “remands” (sends back) the case to the District Court for any reason (such as asking the District Court to make findings of fact), then Abbott must contribute only $4.375 Million more to the settlement fund.
In a nutshell, Abbott will ultimately pay between $10M and $27.5M. After the attorneys’ fees and expenses are paid (approximately 1/3 of the total), here is how the rest of the settlement will be divided:
If Abbott wins any one of the questions before the Ninth Circuit, then the $10M, reduced to $6-7 M after costs and attorneys’ fees, will be distributed equally to all the cy pres recipients on the list above.
If, however, the court remands any question, or if the Plantiffs win all the questions, then the settlement amount ($14.3M or $27.5M respectively, before legal costs and fees, or between $9.6 and $18.4M after) will be divided, with
70% of it (between $6.7M and $12.8M approximately) going to the 13 organizations described above, and
30% (between $2.9M and $5.5M approximately) going to consumers and TPPs in California)
Confusing? Yes. But the settlement is a creative resolution of the lawsuit. It takes into account the different possible outcomes to a trial and inevitable appeal, and essentially adjusts the amount of the settlement accordingly.
The Court has scheduled a hearing for August 19 on whether to grant “preliminary approval” to the Settlement. If it does grant that approval, notice will be published to alert members of the class about the proposed settlement. Consumers and TPPs that paid for Norvir will have the option of opting out of the settlement (if they want to pursue their own individual lawsuits against Abbott), objecting to the terms of the settlement, and, if they are located in California, filing claims forms to receive a portion of the settlement proceeds. The Court will schedule a Final Approval hearing for several months from now. After that hearing, the Court will decide whether to grant Final Approval to the settlement. If it does grant that approval, and after any appeals, the money in the settlement will be distributed as described above.
Earlier PAL blog entries on the plaintiff’s successful class certification, Abbott’s attempt to keep damaging documents from public view, or the plaintiff’s anti-trust claims.
The Prescription Access Litigation blog’s resident Advice Columnist, Ask Pharmie, has been on hiatus for a while — but now he’s back! Ask Pharmie answers readers’ questions about the pharmaceutical industry, drug marketing, drug pricing, and the like. Send him your questions! (Keep in mind, he does not answer medical or treatment questions, or render medical advice.)
So, reaching into Ask Pharmie’s mailbag, here’s our latest question:
Question: I recently switched from a brand name drug to a generic version to save money. Although the generic works just as well, the pill is a different color and shape from the brand-name. This is confusing. Why don’t the generic pills look the same as the brand name pills?
Answer:
Good question! After all, generic drugs are the same medicine as the brand-name – they have the same active ingredient, and the same effectiveness. So it stands to reason that the pill would look the same, right? Not necessarily.
When a brand-name drug first comes on the market, the manufacturer has a patent on the drug that prevents any other companies from making or selling that drug. However, when the patent expires or gets invalidated, generic drug companies can apply for FDA approval to sell identical generic versions of the drug.
Generic drugs are required to have the same active ingredient and to work the same as the brand name. But this does not also mean that generic drug companies can copy the appearance of brand name drugs. If the appearance, shape, name and/or color of the drug is trademarked, it cannot be copied. Trademarks are words, names and symbols used to identify goods from a particular manufacturer. Unlike patents, which last a maximum of 20 years, trademarks never expire. While many brand name drug companies have traditionally only trademarked the names of their drugs, there is a trend towards trademarking the appearance of the drug as well.
For example, Pfizer has trademarked both the name Viagra and the well-known blue diamond shape of the Viagra pill. AstraZeneca has trademarked not just the name Nexium, but also the phrase “Purple Pill” and the characteristic purple-with-yellow-stripes appearance of Nexium.
So why have drug companies started to trademark the appearance of their drugs? In the past several years, brand name drug companies have started to make the appearance of their pills part of their marketing campaigns. By making consumers associate a particular appearance of a pill with the medicine contained in the pill, the drug company builds what’s called a “brand identity.” This helps convince the consumer that the product is superior and builds what’s called “brand loyalty.”
Drug companies use this strategy to stand out from their competitors. They also use it to try to convince patients to keep paying for the more expensive brand-name version of the medicine when a generic version becomes available. They hope that the patient will equate the look of the pill with its effectiveness. A generic pill can look “drab” in comparison, to, say a colorful Nexium pill, with its bright purple and its yellow stripes. It is a testament to how effective drug company marketing has become that consumers even notice the color of their pills!
Unfortunately, this serves to confuse patients. For patients that take many medications, the shape and color of the pill can help them remember what it is and what it’s used for. If drug companies didn’t trademark the appearance of their pills, then generic drug companies could make their pills look the same as the brand-name. This would help patients remember what each of their medications is, and avoid potentially dangerous errors (such as taking a drug at the wrong time, taking too much of the drug, missing a dose, etc).
The main thing to remember is that the appearance of a drug has nothing to do with its effectiveness. By using the color and shape of a drug as a marketing tool, brand-name drug companies are trying to fool you into thinking that these things matter, and to trick you into using an expensive brand-name drug when a less expensive one (generic or a different brand-name drug in the same category) would work just as well.
One last thing to keep in mind: The same generic drug can be made by many different generic drug companies, and each of their pills may look different not just from the brand-name pill, but from each other. If your pharmacy changes which generic drug company it buys your medication from, or if you switch pharmacies, your pills might suddenly look different than they did the last time you filled your prescription. Don’t panic! This doesn’t mean that you got the wrong pills. But, if you are at all uncertain or concerned, talk to your pharmacist. Better safe than sorry.
Below is a press release that we here at Prescription Access Litigation (PAL) issued today. Three members of the PAL coalition filed a formal objection to a settlement proposed in the class action lawsuit, Carpenters & Joiners Welfare Fund et. al. v. SmithKline Beecham, (U.S. District Court, Minnesota, Case #04-cv-3500). Details of the settlement are at www.pediatricpaxiltppsettlement.com.
A key component of PAL’s mission is to ensure that settlements of pharmaceutical class action lawsuits genuinely benefit the consumers, health plans and union benefit funds on whose behalf they are brought. When we learn of a settlement that does not benefit them, that makes it harder for them to derive a benefit, or that undermines their rights, we work with our coalition members to object to the settlement. And that is what our members Sergeants Benevolent Association Health and Welfare Fund, AFSCME District Council 37 Health and Security Plan and IUOE Local 4 Health and Welfare Fund did yesterday. Here is the press release:
Labor Unions File Objection to Paxil Pediatric Class Action Settlement Union Benefit Funds Criticize Settlement as Unfair, Call on Court to Reject it
Boston, MA – Three labor union benefit funds filed a formal objection yesterday to the proposed $40 million nationwide settlement of a class action lawsuit against GlaxoSmithKline (NYSE:GSK). The lawsuit alleged that Glaxo defrauded health plans, union benefit funds and other “third party payors” by failing to disclose the increased risk of suicidal thoughts and behavior among children and adolescents taking the prescription antidepressants Paxil® and Paxil CR®. The $40M settlement is to reimburse third party payors for payments they made to pharmacies for Paxil prescribed to children and adolescents from 1998 to 2004.
Under the terms of the proposed settlement, TPPs can be reimbursed up to 40% of their costs for Paxil prescribed for Major Depressive Disorder, while all other prescriptions for Paxil for other conditions will only be reimbursed at 15%. This requires TPPs to list a diagnostic code for each and every pediatric prescription for Paxil that they paid for during the seven year period. The objectors challenged this distinction, arguing that almost no one will really get a 40% refund, because almost no TPPs have diagnostic codes for the prescriptions they pay for.
In addition, millions of prescriptions for Paxil were written during the seven years covered by the lawsuit (1998-2004), yet the settlement requires any claim for more than $1,000 in reimbursement to include exhaustive details regarding every individual prescription of Paxil paid for during that seven-year period.
The funds also objected to other requirements, including the way that TPPs are required to calculate the net cost of the payments they made, and to misleading and inaccurate statements in the settlement notice about class members’ rights to object, appear at the hearing, or appeal final approval of the settlement.
“A $40 million settlement may sound very positive, but the devil is very much in the details,” said Gina Alongi, Administrator of IUOE Local 4 Health and Welfare Fund. “The way the settlement is currently structured will prevent many health plans and union benefit funds like ours from getting any real compensation from it.”
The three union funds objecting to the settlement are all members of Prescription Access Litigation (PAL), a national coalition of more than 130 unions and consumer advocacy groups that works to challenge illegal practices by the pharmaceutical industry.
“TPPs will have to comb through mountains of medical records and bury themselves in paperwork before they ever see a penny from this settlement,” said Alex Sugerman-Brozan, director of PAL. “Class action settlements are only as good as their claims process, and this one fails at a very fundamental level.”
Last year, Prescription Access Litigation objected to an earlier Paxil class action settlement (Hoorman et. al. v. SmithKline Beecham). That $63M settlement was of a class action brought on behalf of consumers who paid for Paxil prescriptions for children and adolescents. As a result of that objection, important changes protecting consumers’ rights were made to the settlement.
A settlement of a class action must be approved by the Court where the case is brought. Because class actions affect the rights of people and entities that aren’t even aware of the lawsuit, the Court reviews settlements to make sure they are “fair, reasonable and adequate.” Members of the class may object to the settlement, and request to speak at a hearing before the Court.
The case is Carpenters and Joiners Welfare Fund et. al. v. SmithKline Beecham Corp. (U.S. District Court for Minnesota, Case #04-CV-3500). The Final Approval hearing in the case is scheduled for September 30, 2008 in the U.S. District Court in Minneapolis, Minnesota. The deadline for third party payors to submit claims for payment from the settlement is December 12, 2008. More information about the settlement, including claims forms, can be found at www.pediatricpaxiltppsettlement.com. A full copy of the funds’ objection to the settlement can be found at www.prescriptionaccess.org/docs/pediatric-paxil-objection.pdf
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About AFSCME District Council 37 Health & Security Plan
AFSCME District Council 37 Health & Security Plan is a union benefit fund that provides supplemental health and welfare benefits, including a prescription drug benefit, to over 300,000 individuals, consisting of active municipal employees, their spouses and dependants, as well as retirees, who work or worked for New York City, the New York State Court System, various authorities, cultural institutions and the NYC Health and Hospital Corporation.
About Sergeants Benevolent Association Health and Welfare Fund
Sergeants Benevolent Association Health and Welfare Fund provides supplemental health and welfare benefits, including a prescription drug benefit, to 10,000 active and retired sergeants of the New York City Police Department.
About IUOE Local 4 Health and Welfare Fund
IUOE (International Union of Operating Engineers) Local 4 Health and Welfare Fund provides a health and welfare plan, including a prescription drug benefit, to 10,000 covered members of IUOE Local 4 and their families. IUOE Local 4 represents heavy equipment operators, apprentices, mechanics, surveyors, equipment house employees, as well as waste water technician and some public sector employees in Eastern Massachusetts, Eastern New Hampshire and Maine.
About Prescription Access Litigation Prescription Access Litigation (PAL) is a nationwide coalition of over 130 state, local, and national senior, labor and consumer health advocacy groups fighting to make prescription drugs affordable. The organizations in the PAL coalition have a combined membership of over 13 million people. PAL, a project of the national nonprofit health care advocacy group Community Catalyst, works to end illegal drug industry practices that increase the price of prescription drugs beyond the reach of the American consumer, using class action litigation and public education. PAL members have filed more than 30 lawsuits targeting such practices. News about PAL’s cases and public education efforts is published regularly on the PAL Blog.
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