Archive for September, 2007
Friday, September 28th, 2007
Readers of this blog know that we here often get our knickers in a twist over federal preemption arguments by pharmaceutical defendants seeking to avoid liability in lawsuits. Prescription drug and medical device companies have been arguing with increasing frequency in recent years that lawsuits against them brought under state law are “preempted” by the FDA’s authority under federal law. (Remember that 8th Grade U.S. Civics course? Under the Constitution’s “Supremacy Clause,” federal law trumps state law when the two conflict).
Unfortunately, the FDA has been aiding and abetting them by intervening in products liability lawsuits and by adding a preamble to a Guidance on Drug Labellng, making the same arguments. Given the FDA’s abdication of its responsibility to aggressively enforce drug and device safety, this amounts to “We won’t enforce it, and we won’t let anyone else either.”
There’s a pendulum effect to corporations’ approach to federalism, and we’re at one apex of its swing. When the federal government is aggressive with regulation and enforcement, business is all about “states’ rights.” When the federal government moves away from enforcement and regulation, states step in to fill the void. Suddenly, the federal government is paramount to business, and those pesky states are “interfering” in the unique and exclusive prerogatives of federal agencies. We’ve witnessed the recent odd spectacle of various industries pushing for federal regulation, as ably documented in this recent New York Times article: “In Turnaround, Industries Seek U.S. Regulations” (Sept. 15, 2007). The shifting allegiance of course reeks of what it is – opportunism.
But the Constitution remains, and its delicate balance of federal and state powers. (Digression into the 10th Amendment omitted for your comfort). The Supreme Court has agreed to hear two cases concerning whether federal law preempts the rights of consumers to bring lawsuits under state law against drug and device manufacturers. The first, Riegel v. Medtronic, is summarized below, by Public Citizen Litigation Group, which represents the Riegels:
After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter’s manufacturer, Medtronic, Inc (NYSE:MDT). Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The court agreed and dismissed the case.
Public Citizen represented the Riegels on appeal and represents them now before the U.S. Supreme Court. The Supreme Court granted cert. on June 25, 2007, and will hear the case next Fall. The question before the Court is whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.
[PAL joined an amicus curiae ("friend of the Court") brief submitted by Community Rights Counsel to the Supreme Court. That brief can be found here.]
The second was covered in an AP Story earlier this week (“Court Takes Drug Liability Case“):
The case involves a product liability lawsuit against Pfizer’s (NYSE:PFE) Warner-Lambert unit. A group of Michigan plaintiffs led by Kimberly Kent in April 2000 sued Warner-Lambert Co. over alleged injuries caused by its Rezulin diabetes drug. Rezulin was ordered off the market in March 2000 by the Food and Drug Administration after it was linked to nearly 400 deaths and hundreds of cases of liver failure.
The District Court dismissed the case, arguing that a Michigan state law that prohibits virtually all lawsuits against drug companies applied, and then also ruling that a narrow exception in that law — that suits are allowed when the drug company misled the FDA to get the drug approved — was preempted. Talk about damned if you do, damned if you don’t! The Court basically ruled that state law applied, except when it might benefit the injured consumers, in which case federal law applied and preempted the exception written into state law. The 2nd Circuit Court of Appeals disagreed, reinstating the suit, and of course Warner Lambert appealed to the Supreme Court, which agreed to hear the case.
Hopefully the Supreme Court will rein in the running joke that federal preemption has become, acknowledge that state law litigation does not interfere with the FDA’s regulation of drugs (a position the FDA itself took for years, and only changed under the current administration) and restore the balance set out in the Constitution that protects the states’ historic “police powers” to protect the health and safety of their citizens.
Friday, September 28th, 2007
PAL member Breast Cancer Action announced today its 6th Annual Think Before You Pink campaign. This campaign has tirelessly worked to urge consumers to ask critical questions about the hundreds of pink ribbon products and promotions that are marketed every October in honor of Breast Cancer Awareness Month (BCA calls it Breast Cancer Industry Month). This year’s campaign focuses on “pinkwashing” — the practice of companies that increase sales by putting pink ribbons on their products, even though these products contribute to the breast cancer epidemic.
Here’s the press release. We wish Think Before You Pink the best of luck.
FOR IMMEDIATE RELEASE
415.243.9301 xt 16
415.243.9301 xt 19
Breast Cancer Action Launches 6th Year of Think Before You Pink
San Francisco, CA — (October 1, 2007) — Breast Cancer Action (BCA) today launched its annual Think Before You Pink campaign with a new focus — “pinkwashing” companies that increase sales by putting pink ribbons on their products, even though these products contribute to the breast cancer epidemic.
Since its inception in 2002, BCA’s Think Before You Pink campaign (www.thinkbeforeyoupink.org) has been urging consumers to ask critical questions about the hundreds of pink ribbon products and promotions that are marketed every October in honor of Breast Cancer Awareness Month (BCA calls it Breast Cancer Industry Month). Calling for transparency and accountability from companies that use pink ribbons to sell products, BCA believes that consumers can and should ask questions about how the money is being raised and where the money is going.
The big question of the campaign this year is which companies are engaging in pink ribbon marketing while manufacturing products that are contributing to the epidemic. Toward this end, BCA is singling out the car, dairy, and cosmetics industries.
“These pinkwashing companies are trying to have it both ways,” says BCA Executive Director Barbara A. Brenner. “If they care as deeply as they say they do about women’s lives, they’ll clean up their products.”
For example, Ford, Mercedes, and BMW are each raising funds with campaigns that urge consumers to buy and drive cars for breast cancer awareness and research. However, car exhaust contains toxic chemicals that are linked to the disease, and by urging consumers to buy and drive polluting cars in the name of breast cancer, they are also encouraging consumers to unwittingly help increase the incidence of the disease.
“We’re not telling anyone not to buy these products or not to drive,” says Brenner. “We’re asking that consumers think before they buy, contact the companies to demand cleaner products, and remember that they have options. That’s why it’s called ‘Think Before You Pink’.”
The Think Before You Pink web site, www.thinkbeforeyoupink.org, features an updated “Parade of Pink,” a list of some of the hundreds of pink ribbon products and promotions on the market, as well as a list of the six critical questions consumers can ask before buying a pink ribbon-wrapped product.
Thursday, September 27th, 2007
The Guardian today reported on GlaxoSmithKline’s (NYSE:GSK) over-the-counter weight loss drug alli (“A bitter pill for slimmers?“) and its possible introduction in Europe. PAL was featured in the article, and in particular the Bitter Pill Award we gave to GSK for introducing alli in the U.S., the “With Allies Like This, Who Needs Enemas? Award”
The article pointed out just how minimal the results from alli are:
Indeed, research found that people who took the 120mg dose of orlistat for a year lost between two and five kilograms more than people who took a dummy treatment. And while the weight might drop off quite quickly in the beginning, the drug doesn’t work for everyone and some will lose more weight than others. Research has also shown that people tend to put the weight back on when they come off the drug. This has led critics to speculate that it is the makers’ intention for people to take Alli long-term – though there is little evidence about how well the drug works in reducing weight for periods of longer than 12 months.
“The additional weight loss people have on this drug is quite minimal and this only lasts as long as they’re on it,” says Alex Sugarman-Brozan, director of the US consumer group, Prescription Access Litigation (Pal). “This isn’t the kind of drug people are supposed to take once and then stop taking. I think GlaxoSmithKlein is hoping and anticipating that people who aren’t disgusted by the side-effects will take it on an ongoing basis.”
One main question about alli is, given people’s general apparent unwillingness to make changes in lifestyle (diet and exercise), why would they make these changes as part of the alli diet plan if they weren’t willing to make those changes due to their own merits?
But some experts suggest that it is difficult enough for people to lose weight under regulated conditions with medical guidance, and are sceptical that many people buying Alli will have the motivation to reap the full benefits. Moreover, there are limited studies looking at the long-term benefits of Alli and research suggests the optimum dose of orlistat is 120mg, three times a day. So why is GlaxoSmithKlein selling something that contains only 60mg?
The company says there is little difference in the effects of the two doses – both are effective in aiding weight loss. Kaplan disagrees. He says that orlistat was never successful when it was only available on prescription. “It’s clearly a business decision. This wasn’t an efficacy decision. If the drug was efficacious it would be a blockbuster drug at 120mg, and it’s not,” he says. “Essentially, it’s a failed prescription drug from a marketing perspective. Here’s a situation where you have a drug that wasn’t a big success-a very modest success as a prescription drug-and they’re hoping, through marketing approaches and direct-to-consumer advertising, that it can be more successful as an over-the-counter drug.”
It is this that has led Pal to award GlaxoSmithKlein one of its Bitter Pill awards, “With Allies Like This, Who Needs Enemas?”
The article goes on to discuss our concern that it will be abused by people with eating disorders. The experted cited, Dr. Kaplan at Mass. General Hospital, disagrees with that concern but seems to miss the point:
Sugarman-Brozan is concerned that people with eating disorders might abuse it – but Kaplan isn’t convinced. He says the drug isn’t effective enough to be abused. In the end, he thinks the market will decide how well Alli works.
This presumes that people with eating disorders will only abuse weight loss drugs that are “effective.” Many people with eating disorders will employ strategies that are dangerous, regardless of their effectiveness, if they merely believe that they will be effective — such as binging and purging, misusing laxatives and the like. And while the modest weight loss that an overweight person would experience with alli might be dangerous additional weight loss in, say, a person with anorexia.
Let us hope that European regulators take a more skeptical look at alli than the FDA did.
Tuesday, September 25th, 2007
Our friends at The Prescription Project have announced the launch of Postscript, their new blog on pharmaceutically-related medical conflict of interest issues:
PostScript, a blog from the Prescription Project, adds another dimension to the Project’s goal of raising awareness around the medical conflict-of-interest issues that are created when drug companies open their wallets to influence prescribing. The Prescription Project Weekly Reader, an e-newsletter that highlights relevant news stories of the week, will continue its regular circulation. You can sign up to receive the Weekly Reader at the Prescription Project website, www.prescriptionproject.org, where you can also find project news, press releases and media resources, and information on upcoming events.
We wish them the best of luck! Welcome to the pharmablogosphere!
Monday, September 24th, 2007
The New York Times ran an excellent op-ed on Sept 21, “Shy on Drugs,” by Christopher Lane. Professor Lane takes psychiatrists to task for too readily diagnosing shy children as having “social anxiety disorder.” He pins a chunk of the blame on the Diagnostic and Statistical Manual of Mental Disorders (“DSM” for short), the diagnostic bible of the psychiatric profession:
[A] glance at the manual reveals that the diagnostic criteria for shyness are far from clear. The third edition, which was published in 1980, said that a person could receive a diagnosis of what was then called “social phobia” if he was afraid of eating alone in restaurants, avoided public restrooms or was concerned about hand-trembling when writing checks.
The same guidelines could hardly apply to youngsters heading to kindergarten, children not yet potty-trained and toddlers just learning to eat. So in 1987, the revised third edition of the manual expanded the list of symptoms by adding anticipated concern about saying the wrong thing, a trait known to just about everyone on the planet. The diagnostic bar was set so low that even a preschooler could trip over it.
The definition of this “disorder” then sets the stage for wholesale manipulation by pharmaceutical companies all too eager to offer up a pharmaceutical solution:
Then, having alerted the masses to their worrisome avoidance of public restrooms, the psychiatrists needed a remedy. Right on cue, GlaxoSmithKline [NYSE:GSK], the maker of Paxil, declared in the late 1990s that its antidepressant could also treat social anxiety and, presumably, self-consciousness in restaurants. Nudged along by a public-awareness campaign (“Imagine Being Allergic to People”) that cost the drug maker more than $92 million in one year alone…social anxiety quickly became the third most diagnosed mental illness in the nation, behind only depression and alcoholism. Studies put the total number of children affected at 15 percent — higher than the one in eight who psychiatrists had suggested were shy enough to need medical help.
In 2005, we gave one of our Bitter Pill Awards to GlaxoSmithKline for its marketing of Paxil, the Cure For the Human Condition Award. We pointed in particular to this fact:
In June , the FDA issued a warning letter to GlaxoSmithKline for its “Hello, My Name is.” television ad campaign for Paxil. The FDA said that this ad wrongfully “suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR” when these are simply not approved uses of the drug. Despite the warning letter, the harm had already been done as millions of consumers had already seen the ad.
This type of marketing, and the widespread diagnosing of shy children (and adults) as having a medical disorder as opposed to run of the mill shyness, is often cited as an example of “disease mongering.” It’s a symptom of a larger problem — the medicalization of an ever-increasing portion of the spectrum of normal human behavior. Anything that deviates from some pharmaceutically-determined median is now a candidate for an expensive, brand-name drug, from how shy we are to whether or not we occasionally can’t sleep to whether our legs twitch when we sit still to whether we have toenail fungus.
The prescribing of expensive, strong and often dangerous prescription drugs to ever growing numbers of children with shyness is ironically happening at the same time that an also every growing numbers of children are being prescribed expensive, strong and often dangerous prescription drugs for Attention Deficit Hyperactivity Disorder (ADHD). Children generally are being prescribed more and more prescription drugs, even when such drugs have often not been tested on or approved for children. (We reported on another example recently: “Doctors widely prescribing drugs for kids’ sleep problems”)
There are no doubt some children who benefit from SSRIs such as Paxil and drugs for ADHD, for whom the benefits outweigh the often considerable risks. But they are undoubtedly a fraction of those children who are prescribed these drugs. We as a society are turning too quickly to the pharmacist for a solution to complex issues. Shyness, inability to pay attention, hyperactivity — these are not merely — or often even primarily, if at all — medical or biochemical issues. They’re affected by a broad range of factors, such as class size, nutrition, sleep, the quality of housing and one’s environment, the stability of home and family life, etc. It’s far easier to write a prescription than to tackle these larger problems. But the underlying problems will remain. Pharmaceutical companies are all too willing to pitch their solution, regardless of the harm it causes or whether it actually addresses any underlying problem.
Monday, September 24th, 2007
Several PAL members are plaintiffs in class action lawsuits concerning alleged schemes by publishers of drug price data and a prescription drug wholesaler to inflate the Average Wholesales Prices of prescription drugs. Notices have been issued concerning settlements in these cases, New England Carpenters Health Benefits Fund, et al. v. First DataBank, Inc., et al. (U.S. District Court, Massachusetts, Case No. 1:05-CV-11148-PBS) and District Council 37 Health & Security Plan v. Medi-Span (U.S. District Court, Massachusetts, Case No. 07-cv-10988-PBS).
The settlements do not provide cash payments by First Databank or Medi-Span. The settlements call for First Databank and McKesson to roll back increases in the published Average Wholesale Prices of hundreds of drugs, and to cease publication of Average Wholesale Price data within 2 years of the settlement becoming final. These changes are expected to have a significant impact on drug prices which will benefit the members of the class.
The classes in the settlements includes consumers who paid for all or part of the cost of certain prescription drugs based on data published by FDB or Medi-Span. You must have made these purchases based on First Databank published prices between January 1, 2000 and the date of Final Court Approval of the FDB Settlement and/or purchases based on Medi-Span published prices between December 19, 2001 and the date of Final Court Approval of the Medi-Span Settlement. The classes also include third party payors. Pharmacy Benefit Managers and consumers who paid “flat” (i.e. fixed) copayments are excluded.
Deadlines related to these settlements are:
- To exclude yourself from the class, you must mail a signed letter, postmarked no later than December 21, 2007, asking to be excluded to: FDB/Medi-Span Settlement Administrator, c/o Complete Claim Solutions, LLC, P.O. Box 24730, West Palm Beach, FL 33416. Include your name, the name of the person or entity seeking exclusion, an address and telephone number.
- To object to the settlements, you must file a written statement with the Clerk of the Court, John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Suite 2300, Boston, Massachusetts 02210, postmarked no later than December 21, 2007.
- The Court will hold a fairness hearing on January 22, 2008 at 2 PM at the John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Boston, Massachusetts 02210, to:
- determine whether the Settlements are fair, reasonable and adequate and in the best interests of the Class, whether it should be approved by the Court, and whether judgment should be entered;
- consider the application of Class Counsel for an award of attorneys’ fees and expenses; and
- consider any other issues the Court thinks necessary.
This is just a paraphrasing of the notice. The official note, with forms, instructions and copies of Court documents, can be found at fdbmedispansettlement.com.
McKesson Corporation, the other defendant in the New England Carpenters case, has not agreed to settle, and the case against them is proceeding.
More information about these lawsuits can also be found here.
Monday, September 24th, 2007
In June 2005 and February 2006, members of Prescription Access Litigation’s coalition filed class action lawsuits against First Databank, Inc. and McKesson Corp, alleging that the companies conspired to raise drug prices by inflating the “Average Wholesale Price” (AWP) of hundreds of drugs. AWP is used to set the retail price of prescription drugs. The case seeks to get reimbursement for consumers and health plans, and to end this type of scheme.
You may be eligible to join this lawsuit if you:
- Had no insurance at any time between 2001 and 2004, and
- Paid for brand-name prescription drugs (not generics) yourself
OR if you paid for brand-name prescription drugs yourself that were not covered by insurance.
To find out if you qualify, please email pal(at)communitycatalyst.org (remove the “(at)” and replace with a @ when you write your email) or call 617-275-2931 or 866-208-9800 ext. 2931 by October 4th. Or complete this form and mention that you’re inquiring about the First Databank/McKesson case.
To receive updates about PAL’s cases and other projects, sign up for our occasional email alerts. To be contacted about class action lawsuits and settlements that you may eligible to participate in, please complete this form. All information will kept confidential.
Tuesday, September 18th, 2007
The Attorney General of New York state and Mayor of New York City issued this announcement yesterday, of a lawsuit against Merck (NYSE:MRK):
Attorney General Andrew M. Cuomo and New York City Mayor Michael Bloomberg today filed a joint lawsuit against the maker of Vioxx for misrepresenting the dangers the drug posed to its users. The lawsuit seeks damages and civil penalties in addition to restitution for tens of millions of taxpayer dollars wrongfully spent on Vioxx prescriptions, and marks the first time the State and City have brought a joint action to fight Medicaid fraud.
One question concerns what New York is seeking restitution for:
As a result, Merck is accused of having caused New York doctors to prescribe Vioxx to patients whose cardiovascular conditions made them especially susceptible to the drug’s negative effects. Had the doctors been adequately informed, the suit alleges, they would not have prescribed Vioxx and thus Medicaid and EPIC would not have paid for its dispensation.
The group of “patients whose cardiovascular conditions made them especially susceptible to the drug’s negative effects” is but a small subset of the patients for whom Vioxx was improperly prescribed. With Vioxx, Merck’s deception caused the entire health care system to pay for prescriptions not only for people who were at risk of heart attacks and thus shouldn’t have taken Vioxx, but also for people who wouldn’t have taken it had they known the risks (regardless of whether they were individually at higher risk) and also for people who simply didn’t need it — that is, the vast majority, for whom over-the-counter Ibuprofen or Naproxen Sodium would have worked just as well.
The press release makes it seem that NY is only seeking to recoup the payments it made for patients who were “especially susceptible” to the side effects. How will New York determine which patients those are? And why are they not seeking to recoup the payments made for the much larger groups of patients who were prescribed Vioxx unnecessarily? The deception allegedly undertaken by Merck was not just about the side effects — but also about the efficacy: Merck made Vioxx seem like a vast improvement over other drugs, when for pain relief it was no better than ibuprofen.
The main question that springs to mind is “What took them so long?” Vioxx was withdrawn from the market at the end of 2004. Here it is, nearly three years later. The filing of this lawsuit comes on the heels of the recent decision of the New Jersey Supreme Court, refusing to allow a class action on behalf of “third party payors” (TPPs) to go forward. Third Party Payors are those entities that pay for drugs and medical care on behalf of individuals — i.e. health plans, union benefit funds, self-insured employers. Government programs like state Medicaid programs are also third party payors, but are almost always excluded from these class actions because only state Attorneys General can bring lawsuits on behalf of their states.
In all likelihood, the timing of this new lawsuit, so soon after the New Jersey Supreme Court Vioxx decision, is coincidental. But it does make one consider the patchwork system in which the different players in the health care system try to get restitution when a drug company rips them off.
When a consumer goes to the pharmacy counter, numerous different entities may pick up part or all of the tab:
- The consumer him or herself (either out of pocket entirely, or a fixed copayment or a percentage co-insurance)
- A private health plan, perhaps through an employer or union, or purchased individually, or a Medicare supplemental plan, or a Medicare drug plan
- A state government program, such as Medicaid, an AIDS Drug Assistance Program, a state program for seniors, or a state employee health plan
- A federal government program, suchs as the VA, Tri-Care (the military health plan), a federal employees health plan, or Medicare Part D
When a drug company (or any health care company, for that matter) deceives the public about the safety or efficacy of its products, each of these “payors” is harmed when it unnecessarily pays or overpays for the drug in question.
Let’s focus for a moment just on the payments that all of these different people and payors made unnecessarily for Vioxx (and not on the untold suffering and medical cost imposed on those who actually had heart attacks, and their families). How do each of the types of payors described above get reimbursed for their payments? Through a fragmentary and overlapping and somewhat illogical system of separate lawsuits, in which the same facts have to be demonstrated again and again (unless, as hopefully will happen, Judges apply the doctrine of “collateral estoppel,” in which Merck would not be able to argue again and again in each suit that they didn’t know about the risks until they withdrew the drug). So, in a situation such as this you have:
- Class action lawsuits on behalf of third party payors and consumers — sometimes in the same lawsuits (as in the consolidated proceedings currently before the U.S. District Court in New Orleans), and sometimes in separate lawsuits (as in New Jersey state court, where a consumer class action was filed separately from the TPP class action which the NJ Supreme Court just ruled on recently).
- Lawsuits brought by state Attorneys General on behalf of their state Medicaid programs, state employee health programs, state prisons, programs for the elderly and disabled, and others. At times, these Attorneys General participate in the class actions described above.
- Lawsuits on behalf of cities and counties, to recoup funds spent on Vioxx for city and county employees
- False Claims Act lawsuits on behalf of federal programs such as Medicare (however, Medicare Part D didn’t go into effect until 2006, long after Vioxx was off the market
In this mix you have private attorneys, state Attorneys General and federal prosecutors. It makes for a rather complicated situation. It also makes for strange bedfellows – in a single class action lawsuit, you can have state Attorney Generals, large for-profit commercial insurers that cover millions of people (e.g. Aetna, Humana, United Healthcare, and some Blue Cross plans), small non-profit health plans, union health and welfare funds, self-insured employers, and millions of individual consumers. A class action is really the only way to seek restitution in these situations, in which virtually none of the people and entities who were harmed would be able to bring a lawsuit on their own. But it does make things tangled.
New York is not the first state to sue Merck over Vioxx payments (Texas, for instance, sued Merck back in June 2005). But New York in the past few years has been a leader among states in prosecuting pharmaceutical fraud, under former-New York AG Eliot Spitzer, now Governor of New York). So other states may jump on this bandwagon, in New York’s wake (to mix metaphors).
It will be interesting to see whether Merck’s promise to try every case will hold true for state Attorney Generals, whom corporate defendants are often loath to try to intimidate.
Tuesday, September 18th, 2007
In June, we reported that the Judge hearing the class action lawsuit against Abbott Laboratories for its Norvir price hike had certified the case as a nationwide class action (“Judge certifies class action in Norvir case“). Back in October 2004, PAL member SEIU Health & Welfare Fund filed a class action lawsuit against Abbott Laboratories (NYSE:ABT), alleging that Abbott’s 400% price increase for its HIV/AIDS drug Norvir violated federal antitrust laws. (In re Abbott Laboratories Norvir Antitrust Litigation, Case 4:04-CV-01511)
Abbott Laboratories asked the 9th Circuit Court of Appeals for permission to appeal that decision to certify the class. As we explained back in June:
Class Certification is the stage at which the Judge determines whether or not the lawsuit can proceed as a class action or not. Given that any individual patient’s financial harm is comparatively small, class actions are almost always the only way in which illegal pharmaceutical industry behavior such as that alleged in this case can be challenged. The cost of bringing an individual lawsuit to challenge actions such as this would outweigh that individual financial harm by orders of magnitude. Class Actions allow for thousand or even millions of individuals to combine their claims into one lawsuit that challenges the actions that caused harm to all of them….
Class certification is a watershed moment for a class action. If Class certification is denied, that is often the end of the case, since most class actions cannot feasibly be pursued as individual lawsuits. The Judge’s granting of class certification is an important intermediate success in this case.
Last Thursday (9/13), the 9th Circuit Court of Appeals denied Abbott’s request for permission to file an appeal. Thus, the case against Abbott will proceed.
The 9th Circuit’s decision was just an entry on the Court’s docket. The Judge’s Order granting class certification can be found here.
Friday, September 14th, 2007
1. As we’ve reported, preemption arguments are all the rage these days among pharmaceutical company defendants seeking to avoid liability for deceptive advertising, patients’ injuries, and the like. The pharmaceutical industry, always ready to bemoan FDA regulation as excessive, has the temerity to come into court to argue that only the FDA can regulate it!
The Senate Judiciary Committee held a hearing this past Wednesday, on “Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority?” You can watch a webcast of the hearing here, and view the witnesses’ testimony here.
2. Public Justice has recently published a new edition of its “Preemption Update,” tracking recent developments in federal preemption. Find it here.
The report details a number of recent federal and state Court decisions in which arguments that consumers’ claims that they were injured by drugs are NOT preempted. This might suggest that the Courts are scrutinizing such preemption claims more closely, and not relying on the FDA’s preemption preamble, in which the FDA argued that state “failure to warn” claims are preempted by the FDA’s authority over prescription drug labels.