Injuryboard Commentary - Preemption

Preemption Victory in Generic Drug Labeling Case Mensing v. Wyeth

Camryn Hansen — Thu, 03 Dec 2009 20:15:40 GMT

Following on the heels of the preemption victory in Wyeth v. Levine, in which the Supreme Court decided that consumers can sue a drug company for inadequate prescription drug labeling even if the FDA has approved the label, the US Court of Appeals for the Eighth Circuit has ruled that generic drug manufacturers cannot claim federal preemption to avoid liability for inadequate drug warning labels.

According to the ruling, FDA approval of a generic drug’s label does not preempt claims against the drug makers for failing to sufficiently warn consumers of a drug’s risks.

The case involves Gladys Mensing, who was prescribed metoclopramide to treat her diabetic gastroparesis. The drug caused her to suffer serious and permanent tardive dyskinesia, a neurological disorder that causes facial grimacing, lip twisting, tongue thrusting, gait instability, difficulty swallowing, and difficulty controlling her hands and arms. Ms. Mensing sued several manufacturers of generic metoclopramide, among others, alleging that the manufacturers failed adequately to warn of the drug's side effects. -Public Justice

The generic drug manufacturers moved for dismissal, on grounds that an FDA regulation requiring generic drug labels to contain the same language as the labels of brand-name versions conflicted with, and thus preempted, failure-to-warn claims. The district court agreed to dismiss the case, but the Eighth Circuit overturned the dismissal, disagreeing with the preemption argument.

The Eight Circuit emphasized that generic manufacturers, like name-brand drug companies, "bear primary responsibility for their drug labeling at all times." Lawsuits like Ms. Mensing's, the court said, do not "obstruct the purposes and objectives" of federal drug regulation "in any way." Instead, they help achieve the "fundamental" purpose of federal regulation—ensuring that "all marketed drugs remain safe." -Public Justice

This is a great win for the American consumer. It’s gratifying to see all drug companies being held accountable for the harms they cause when they’re not careful enough with their products.

Originally posted at InjuryBoard by Camryn Hansen

Now The U S Chamber Is Attacking TV Ads

Mike Bryant — Mon, 02 Nov 2009 09:23:00 GMT

What do you think that members of the US Chamber spend each year on TV? I would guess it's billions and billions looking at the annual TV advertising numbers. Well apparently, like the courthouses , they want the airways to only be for them.

Proof is the recent study they are touting, which shows that ads are up for medical malpractice in the country. So what? The claim is that it's creating more claims? If you define "creating" by informing people of their rights , then maybe. But, their implication is that these claims are simply made up or sprung from the lawyer's mind.

With the number of deaths that have been reported in American hospitals and the amount of people who come out sicker than they went in, it seems that more people need to know they have a claim. This is just a ridiculous example of how they love to bash lawyers.

But, lets get serious about their claim for a moment. How about a ban on all advertising? Or maybe a limit on the number of ads that anyone can run about anything? I bet their members might get a little concerned about that. I bet they would even say something about the First Amendment.

Originally posted at InjuryBoard by Mike Bryant

Great Website For Information About Our Food

Mike Bryant — Sun, 01 Nov 2009 16:21:00 GMT

If you spend some time looking around the Injuryboard website, you will find hundreds of articles about various issues with food. The peanut butter salmonella issue was covered from a number of angles. If you look under the toxic substances tab, you will see the many different issues we specifically have looked at from the Minnesota perspective. Usually, there is death or serious illness involved with the stories.

But, today it is great to be looking at a great website that hopefully will help cut down on the need for future stories. Yet another example of what a difference an administration makes with the way the FDA is handled. We are seeing signs of actual action on food from overseas, forcing companies to pay for hurting people, and information that helps the consumer, instead of taking rights away.

The site has email alerts and an RSS feeder, which will make it easier for people to get information. Hopefully, more and more people will find the site and use it for vital health information.

If you suffer from food poisoning, you need to get immediate medical care. If it continues or there are long term affects, you should contact an attorney concerning the problem. Early investigation can include the collection of samples, checking for health alerts, and the proper notifying of those who caused the problem.

Originally posted at InjuryBoard by Mike Bryant

House Financial Services panel debates federal preemption in CFPA.

Wayne Parsons — Wed, 21 Oct 2009 14:19:29 GMT

The Washington Post (10/21, Dennis) reports that the House Financial Services Committee "continued to wrangle over a provision that would allow state governments to protect bank customers by imposing restrictions that go beyond existing federal laws. The move...would eliminate a doctrine called preemption that has allowed big banks to answer solely to federal regulators." According to the Post, the Obama Administration "has supported the change, but the nation's largest banks have vigorously opposed the idea, saying it would lead to a conflicting patchwork of regulation." Reps. Melvin Watt and Dennis Moore "introduced an amendment to the legislation that seeks a middle ground," which "would dictate that national banks comply with state laws except when a state law has a 'discriminatory effect' on national banks in comparison with state-chartered banks."

Bloomberg News (10/21, Vekshin) also reports on the partisan split over "limiting state enforcement of national banks as the House Financial Services Committee debated a proposed consumer protection agency. Republicans said rules written by the Consumer Financial Protection Agency should prevail, sparing national banks from needing to comply with separate state laws. Democrats said state regulators should have power to impose tougher rules to protect their residents from lending abuses."

Dow Jones Newswires (10/21, Holzer) also reported on the debate, suggesting that Democrats are edging closer to siding with state regulators.

MarketWatch (10/21, Orol) similarly reports that the committee "moved closer to approving a contentious provision that would give state regulators more authority to impose consumer protection restrictions that go beyond federal laws on mortgage and other products issued by big banks. ... The Watt-Moore measure is being considered as part of a House Financial Services Committee effort to create a controversial proposed Consumer Financial Protection Agency, which Democratic lawmakers are seeking to set up to write rules for mortgage products and credit cards. Big banks are currently exempt from key state laws and they complain that with the measure they could be required to comply with 51 different sets of regulations, including state and federal rules, which would make doing business nationally more difficult." Law360 (10/20, Dye) also covered the story.

Originally posted at InjuryBoard by Wayne Parsons

Democrats Stuck Again Over Creation of Consumer Financial Protection Agency

Wayne Parsons — Fri, 02 Oct 2009 03:57:40 GMT

Politico (9/30, McGrane) reported, "Creation of a new consumer protection agency is still uncertain, as Democrats fight over whether federal laws should trump those written by individual states. A bloc of moderate Democrats on the House Financial Services Committee are negotiating with Chairman Barney Frank (D-Mass.) over this 'pre-emption' issue as the panel convenes a hearing Wednesday on a proposed consumer financial protection agency." The moderates, members of the centrist New Democrat Coalition, "want to maintain the status quo, in which financial institutions that elect to have a national charter are exempt from additional state consumer protection laws." The current draft of the bill would "require national financial institutions to comply with state-issued rules, even though their federal charters currently exempt them from state consumer protections. On top of that, state attorneys general would be able to bring civil suits against national financial firms for violating federal laws, including regulations issued by the consumer agency."

Dow Jones Newswires (10/1) reports that at Wednesday's hearing, American Bankers Association President Edward L. Yingling said, "We believe that without such preemption we will have a patchwork of state, and even local, laws that will confuse consumers, greatly increase the cost of financial services and serve as a strong disincentive to create new products of value to consumers." The Washington Post (10/1, Dennis) also covered the story.

Originally posted at InjuryBoard by Wayne Parsons

Phenergan Gets Black Box Warning from the FDA

Camryn Hansen — Mon, 21 Sep 2009 20:09:37 GMT

One woman’s horrific experience with Phenergan, the migraine drug formerly sold by Wyeth, has finally ended in a black box label—the strongest warning offered by the FDA—on the drug.

When in April of 2000, violinist Diana Levine went to her local health center seeking migraine treatment, a physician’s assistant administered Phenergan intravenously via the IV push method. But because the syringe missed Levine’s vein, the arm became gangrenous in a couple of weeks, and ultimately had to be amputated.

Levine sued Wyeth in Vermont State court, but the case was taken all the way to the US Supreme Court. Ultimately, the question the Court had to decide was whether or not Wyeth should be liable for Levine’s gangrene and subsequent arm amputation because the company knew of the risks of gangrene from the IV push method (more than 50 patients have developed gangrene as a result of using this specific method with Phenergan), and nevertheless marketed the drug to be used this way.

The Supreme Court sided with Levine, rejecting Wyeth’s arguments in favor of federal preemption and awarding the plaintiff $6.7 million in damages. Until last week, however, the FDA didn’t respond by placing any more regulations on Phenergan, also known as promethazine.

Now, promethazine will carry a black box label warning physicians that the safest way to administer the drug is through intramuscular injection (not IV push).

While it would have been gratifying to see the FDA ban the IV push method altogether with this drug, as Levine has indicated herself, the black box warning is nevertheless a win for consumer protections.

Originally posted at InjuryBoard by Camryn Hansen

Pharmaceutical Company Writing Good Stuff About Their Product

Mike Bryant — Sun, 06 Sep 2009 09:19:00 GMT

Usually when pharmaceutical companies are writing good stuff about themselves they are called advertisements. But, when they write it about themselves, except do so in ghostwritten "scientific papers", it should be called fraud. I guess it was a way to save money from just paying doctors to make up test results.

This past week, the New York Times reported the recently released court documents show that Wyeth Pharmaceuticals produced 26 scientific papers backing the use of hormone replacement therapy in women. They hired a medical communications firm to publish their papers in medical journals between 1998 and 2005.

Addressing the hormone drugs Premarin (conjugated estrogens) and Prempro (conjugated estrogens/medroxyprogesterone acetate), the papers emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. At the same time, Wyeth saw sales rise to nearly $2 billion in 2001.

These were companies that until recently were protected by federal preemption from many lawsuits. Companies that paid defense lawyers millions of dollars to question the honesty and integrity of injured plaintiffs. It's to bad none of this evidence was available before too uncover the lies so many of these cases were based on.

Originally posted at InjuryBoard by Mike Bryant

The U S Chambers Doublespeak Is Always Frivolous

Mike Bryant — Thu, 27 Aug 2009 20:00:00 GMT

It's amazing what the U S Chamber will do or say. They are for free enterprise and against governmental interference while they beg for government hand outs. They claim to represent all businesses, while regularly being the voice of big business. They support business lawsuits as protected litigation, while attacking the rights of the consumers all out.

But we may have found the winner of doublespeak. When opposing a bill which would allow plaintiff attorneys to deduct costs when they are spent, they come out with the following statement:

Those who practice plaintiffs’ lawyer work learn quickly that it is a business similar to other capital businesses. Capital is placed at risk and a judgment is made whether or not it will bring a profit. Today the costs of litigation act as a curb against marginal and frivolous litigation.

Well isn't that interesting:

1) First it's not true that other businesses are forced to wait to deduct their costs. They get to deduct them at the time they are spent.

2) Nice to see that they are finally admitting that we are businesses.

3) The last two lines are exactly what we have been saying for years. You don't make money off of frivolous cases. It will be interesting how their next video of extreme claims against lawyers will forget that they ever said these words.

The tax change would be nice. Now we have to wait until the end of a case to deduct the costs no matter how many years before the costs were incurred. But, it's been like this for years and it's not going to really change what cases we take. I wonder if this is the first tax change the U S Chamber has ever opposed.

The thing is that the U S Chamber really isn't against frivolous suits. They just don't want their Big Business welfare recipients to be sued. They want to take away the rights of the consumer. They will say and do anything to achieve these plans. Hopefully, people will stop believing it.

Originally posted at InjuryBoard by Mike Bryant

Medtronic Paid Surgeon May Have A Different Definition Of Full Disclosure

Mike Bryant — Wed, 26 Aug 2009 20:40:00 GMT

There have been a number of stories about doctors who have been paid big money by Medtronic at the time they were doing studies or prescribing the use of Medtronic products. One of those researchers has been under scrutiny about whether he really did the tests. The reasoning behind the University of Minnesota requirement for their doctors to disclose links to outside companies was to make sure patents get full disclosure.

Despite these changes, a Senate committee is claiming that Dr. David Polly, head surgeon of the University of Minnesota Department of Orthopedic Surgery:

1) Testified before a Senate committee without disclosing that he was being paid by Medtronic.

2) Told Medtronic about the progress of government-sponsored research.

3) May have given inaccurate information to a university ethics committee.

All at the same time that the doctor was receiving $1.2 million in consulting fees, honoraria, and expenses from Fridley-based Medtronic between 2003 and 2007. The response has been that there was proper disclosure, which you would think would be able to be confirmed.

Medtronic needs to continue to disclose their payments to doctors. Hopefully, the investigation of what happened here will continue. It is vital that patients get the right information about the products that are being used.

Originally posted at InjuryBoard by Mike Bryant

Manufacturer Responsibility for Defective Medical Devices is Getting Closer

Todd Slaughter — Wed, 05 Aug 2009 12:21:21 GMT

Tuesday, 8/4/09, patients and doctors testified before the Senate Health, Education, Labor and Pensions Committee in support of the Medical Device Safety Act of 2009 which will restore manufacturer responsibility for defective medical devices. This law will overturn the holding in the U.S. Supreme Court case of Reigel v. Medtronic decided two years ago. Background on that case can be found at the author's website.

Though the opposition claims that this law will give unsophisticated juries more authority than the FDA experts, the FDA has conceded for years that it does not have the wherewithall to monitor and control the medical product performances in the field. The FDA has relied on state court actions brought by injured consumers as a "complimentary review" of the medical devices it authorizes into the marketplace.

Following the Reigel decision, the FDA has had to rely on manufacturers to correct defects in their products, something that manufacturers are naturally reluctant to do. Contrary to the opposition's view, profit most often motivates the actions of the manufacturers. The "initiative" and "inventiveness" that the opposition claims will be stifled by the law seldom overrules the profit motive in favor of safety innovations. This is particularly true when the manufacturer is made completely immune from responsibility to those hurt by its defective products.

We commend Congress for its work to correct the "black hole" that the Supreme Court created, and to return responsibility to those that place defective medical products into the medical marketplace and our bodies.

Originally posted at InjuryBoard by Todd Slaughter