Articles Posted in Pharmaceutical Drugs

The Supreme Court’s ruling in Medtronic v. Riegel has largely been ignored by broadcast media. But I found a clip from MSNBC’s “Countdown with Keith Olbermann” on preemption and President Bush’s efforts until the bitter end to push for preemption.

Keith Olbermann’s portrait on these things is not exactly “fair and balanced.” I think it is a mistake not to present more fully both sides of the argument because it is hard to change minds without presenting all of the facts. But I’m just thrilled to see some broadcast media discussion – albeit MSNBC – of the perils of preemption.

The Wall Street Journal has an article today on the oral arguments before the Supreme Court in Wyeth v. Levine. In an unrelated but very related story, The Washington Post had an article from a Republican suggesting that the RNC drop the focus on McCain and turn to salvaging the Senate races.

These stories are related because if the Democrats get to 60 senators, I think Wyeth v. Levine and Riegel v. Medtronic will become a moot point. There are interesting landmarks on the path to 60. The first is the outcome of Ted Stevens’ trial. If Stevens is acquitted, Republicans should hold that seat. Who knew Alaska could have the impact it is having in this election? The second is whether Al Franken can unseat Norm Coleman in Minnesota. I hope Franken wins and, like most of us, I enjoyed Stuart Smalley on “Saturday Night Live.” But after reading one of his books, I’m not sure he is a step towards a post-partisan movement. Franken sings the “all conservatives are evil and all liberals are righteous” spiel that the whole country is tired of hearing.

Insurance Settlements, a two volume treatise for which I am the lead author, is now available from James Publishing. This treatise is for personal injury lawyers handling auto accident, truck accident, medical malpractice and product liability cases with a lens toward getting the best possible outcome at all stages of these cases (though trial). The better title for the book – with the benefit of hindsight – would have been “Maximizing the Value of Personal Injury Cases.” Maybe I can convince James Publishing to change it down the road.

I’m excited about the book. If you are interested getting a copy, click on this James Publishing link.

The Wall Street Journal has an editorial with an anti products liability lawyer spin. No surprise. But what is surprising is that I actually agree with it.

In light of Enron and other business collapses that left stockholders holding the bag without any real picture of the financial condition of the company, the Financial Accounting Standards Board wants to tighten standards. One requirement would make companies account for the potential cost of ongoing litigation not just with respect to attorneys’ fees but with respect to the actual value of the claims. The Wall Street Journal editorial says product liability lawyers will be able to use the information to extort settlements and influence jury verdicts.

I’m not worried about either of those outcomes no matter how many times the editorial uses the phrase “extort settlements.” But I do think there is a risk of forcing a defendant to publicly estimate settlement and verdict values because I think it does tip off product liability lawyers and creates a floor for the value of any mass tort claim. I also think the editorial is correct that predicting the trajectory of long and complex litigation is inherently unscientific. Mass tort cases are like the stock market in that their values are always changing. A good trial outcome or even a good expert deposition in an MDL can increase or decrease the value of a case. Moreover, I’ve been involved with mass torts from both sides and believe knowledge of the true value of the case is rarely known even to the insiders until the advanced stages of the settlement process.

The Wall Street Journal has a good article online about the preemption battle that is being waged the FDA’s bureaucrats in the courts and in Congress.

The last line of the article says that “Some drug companies are telling plaintiffs’ lawyers that if they settle their cases now, they won’t pay as much to the plaintiffs as they would have six months ago, before the Supreme Court announced that it would hear the Wyeth case. A lawyer negotiating a settlement with one drug maker said company executives told him it wants the ‘Wyeth discount.'”

I don’t think many cases are going to be settled for a “Wyeth discount” because both sides seem to think they are going to win. I cannot imagine how the court could find that there is conflict between state and federal law in drug cases because I think it is clear that federal labeling requirements create a floor for state tort claims, not a ceiling.

A New York Times article yesterday on the Zimmer Durom Cup’s problems underscores the post-market surveillance problem with drugs and medical devices, pointing to the Zimmer Durom Cup problems that have led to Zimmer recalling their hip replacement component. This is a Zimmer fault; they should have a system of tracking and honestly responding to reports of problems with their hip replacement components. But we clearly cannot expect drug and medical device companies to police themselves. In this case, the Zimmer Durom Cup recall was precipitated by Larry Dorr, an orthopedic surgeon who is the medical director of the Dorr Institute for Arthritis Research and Education in California, essentially outing Zimmer by courageously (he was well paid by Zimmer as a consultant) speaking up in public about the problems and Zimmer’s blind eye to them.

Safety and speed are the yin and yang of the regulation of drugs and medical devices. Americans want both; we want safe medical devices that have been tested, but we also want instant access to breakthrough products. But the reality is that not all new drugs and devices should be treated equally. We needed to rush new AIDS drugs onto the market without much testing 10 years ago because the risk-benefit analysis demanded it. But some of this other stuff? Sure, the marketing department of the drug and device companies would prefer it that way, but is that the best thing for the consumer or even the pharmaceutical company in the long run?

Adding to the problem is the Prescription Drug User Fee Act in 1992, which was a deal between the FDA and the drug industry. Drug and medical device companies agreed to pay millions of dollars in fees, and the FDA promised that drug and medical device reviews would be completed within a year for those products on the fast track.

Since the Supreme Court’s disaster in Riegel v. Medtronic, I have been hoping and expecting Congress would step in to fix the Supreme Court’s ruling, because it was clear from the amicus briefs submitted in Riegel, from history and from common sense, that Congress did not intend to preclude medical device tort claims. Yesterday, California Congressmen Henry Waxman and New Jersey Congressman Frank Pallone, along with 62 bipartisan supporters, introduced HR 6381, the Medical Device Safety Act. This bill would effectively undo the wrong the Riegel does to medical device victims. The Senate is expected to offer a similar bill next month.

As the Wolf said in Pulp Fiction, we can’t start congratulating ourselves yet (I’m paraphrasing). This bill has not even made it out of a committee yet. But at least something is happening.

The Baltimore Sun reported last week that the FAA has banned pilots and air traffic controllers from using the quit-smoking drug Chantix following a study that found it had apparently contributed to auto accidents and other mishaps that posed risks to both users and others.

emptycourt-300x199Chantix began as a success story, billed as a relatively risk-free drug that helps you quit smoking in a far more civilized way than just quitting cold turkey.

The “easier to quit smoking” part of the hype was as advertised: 44% of people taking Chantix were able to quit smoking in comparison to 17.7% percent of those taking placebos.

Dennis Quaid testified yesterday before the House Committee on Oversight and Government Reform considering the reversal of the Riegel v. Medtronic Supreme Court decision finding that state tort claims regarding medical devices were preempted if the FDA granted pre-market approval for the medical device. Dennis Quaid told Congress on Wednesday that taking away the right to sue pharmaceutical companies would turn consumers into “uninformed and uncompensated lab rats.” Quaid emotionally described the near fatal drug mix-up in which his newborn twins were given 1,000 times the appropriate dose of Baxter’s blood thinner heparinin November at Cedars-Sinai Medical Center in Los Angeles.

Quaid has a lawsuit pending against Baxter for his twins’ heparin overdose. Medtronic v. Riegel does not bar his lawsuit but the Supreme Court will consider this Fall whether to extend the preemption umbrella to pharmaceutical drugs in Wyeth v. Levine. Congress has the ability to shut down all of this preemption talk by passing a bill negating Medtronic and Wyeth.

Apparently, Tom Davis from Virginia, the ranking Republican on the committee – fresh off his lovefest with Roger Clemens (any regrets on that one, Congressman?) – fell apart again, frozen by the presence of a star. He told Quaid that if this happened to his family, “I’d be suing everybody in sight.” Interesting admission. What does this tell us? I’m just curious, Congressman, do you think you should get access to the justice you would seek but deny others because you are rich, famous, powerful, or all of the above?

On Wednesday, the House Committee on Oversight and Government Reform begins hearings on the reversal of the Riegel v. Medtronic holding that state tort claims regarding medical devices were preempted if the FDA granted pre-market approval for a medical device.

Pharmaceutical drug manufacturers have been on a real hot streak of late before this conservative Supreme Court. They are looking to extend their streak by asking the Supreme Court to extend the preemption umbrella to pharmaceutical drugs in Wyeth v. Levine, which is expected to be heard this fall. Congress has the opportunity to cut this pro-business Supreme Court off at the knees although I doubt they could get a bill past President Bush. Things may change in 2009.

The star studded cast of witnesses includes Dennis Quaid (whom I imagine will speak to the heparin overdose of his twins), William Maisel, (Medical Device Safety Institute), Aaron Kesselheim (Harvard Medical School’s Division of Pharmacoepidemiology), David Kessler (former FDA head), David Vladeck, (Georgetown law professor who has written on preemption) Gregory Curfman (New England Journal of Medicine editor); Christine Ruther (drug company consultant) and State Representative David Clark (Republican state legislator from Utah who I suspect is in favor of preemption).

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