Blog Topic
Defective Products
Several injured at carnival in Angels Camp
Posted by: Spencer Pahlke
May 18, 2008
These carnival cases are always scary--high speed movements and many people involved can often mean severe injuries. Mike Kelly recently handled a defective product matter very similar to this one arising from a fall of more than 50 feet from a ride at the Orange County fair. As we've come to expect from Mike, it resulted in a very favorable settlement.
In the Angels Camp accident, 23 or 24 people were involved--the number varies based on the news source (News 10 says 23, the AP says 24). The ride--called the Yo Yo--is basically a vertical column with several arms radiating out from it. On each arm is a basket, which holds people on the ride. A properly operating one is shown here (courtesy of Ocala.com):
The ride up in Angels Camp malfunctioned such that the radiating arms quickly collapsed to the ground, sending all the riders some 25 feet downward before striking the ground. Three were seriously injured, and 20 were less seriously injured. Our best wishes go out to the families for a quick and full recoveries.
Merck's "independent" authors
Posted by: Spencer Pahlke
May 17, 2008
I know this happened a few weeks ago, but I've got to blog about it. As it turns out, Merck is so helpful in the studies written by "independent doctors" about its products that it actually does the writing for them. How convenient is that?
In the Vioxx litigation, attorneys for the plaintiffs uncovered millions of documents related to Merck's development and marketing of Vioxx. The authors of the JAMA article, entitled, "Guest Authorship and Ghostwriting in Articles on Rofecoxib," searched the database of documents for articles related to clinical trials, authorship of articles, and the development process for getting those articles published. This turned up 20,000 relevant documents, of which some 250 spoke directly to Merck's efforts to have favorable articles published about its various products.
I'll avoid a rehashing of the methodology of the research conducted for the article (though it's well laid out in the article here), and get to the conclusions.
Among the early clinical trials and their associated published articles, the researchers found articles related to 20 protocols between numbers 010 and 902. Among these 20 protocols, all the initial manuscripts were drafted by internal Merck scientists. Then, surprisingly, 16 of the 20, when actually published, were "written" by "external, academically affiliated investigator[s]." Of course, "written" is used lightly: with protocol 078, for instance,
there are minor differences in language and organization between the draft and final versions of the manuscript (particularly in the abstract, as opposed to the text), the results presented are almost identical, reinforcing that the trial itself and the analyses were complete before the academically affiliated investigators were involved in the manuscript.
Even more shocking is an email in the JAMA article. Written by an outside publishing company and sent to Merck, it provides a list of several articles that already have titles--and were already being drafted--before they had an author. That's a little strange.
Finally, why would doctors sign on as external authors? Here's some indication:
Documents were found describing Merck compensating investigators with honoraria for agreeing to serve as authors on review manuscripts to ghostwritten on their behalf by medical publishing companies. Honoraria varied, ranging from $750 to $2500.
It's pretty frustrating that, for these sums of money, patients and doctors alike were misled as to the actual authorship of articles that could have directly affected treatment decisions.
But I think it's a bit more nuanced. For these doctors to be willing to accept these payments--which must pale in comparison to their usual salaries--there must be little in the way of obstacles to accepting such payments. Perhaps such practices are common in the medical publication industry, meaning that these external authors had little pause about accepting payment. Of course, if that's the case, the public deserves far more disclosure of these financial connections.
Finally, as the authors point out, this was a unique situation because the Vioxx litigation provided unprecedented access to Merck documents. Without the litigation, we would never have learned that Merck writes so many articles for external authors. Not only does the litigation directly help those injured (or killed) by Vioxx, it has the added benefit of shedding some light on these shady publication practices.
As I've said several times before, this access to justice and access to information is at grave risk due to federal preemption of state lawsuits. The Supreme Court will consider blocking products liability actions like the ones brought against Merck for the dangers presented by Vioxx.
Why FDA Preemption should worry ordinary folks
Posted by: Melinda Derish
April 16, 2008
In response to the Supreme Court's recent decision in Riegel v. Medtronic, FDA preemption has been in the news a lot recently. It should stay there until people get the message loud and clear. This year the Court will hear Wyeth v. Levine, which may take preemption even farther than it has gone already, to the delight of drug and medical device companies.
This weekend's letter to the editor of the New York Times - "Drug Makers' Advantage" is right on target. In his letter, Henry Greenspan, faculty scholar at the University of Michigan, explains that FDA preemption makes as much sense as preemptive war - neither is connected to the way the real world works.
In the real world, drug and pharmaceutical companies already wield the clout of billion dollar industries. In the real world, in the name of saving taxpayer money, drug companies pay the salaries of FDA scientists who are supposed to regulate them. FDA preemption will have drastic effects on real folks who don't have that kind of clout, but most don't think about preemption very often, or at all! And if they do, they may not understand how FDA preemption can hurt them.
The pharmaceutical and medical device industries have sought FDA preemption for years. Preemption for them means that whenever the FDA says a drug or a medical device can be marketed in the United States, the patient's right to sue in state court is preempted. That's right, patients who are negligently harmed by drugs or medical devices sold in the U.S. could not sue for their injuries. The same would be true whether the drug or device was negligently designed, manufactured, tested, or marketed.
FDA preemption might not be quite so scary if the FDA had a good track record for keeping dangerous drugs and devices off the U.S. market. But it's pretty clear by now that the FDA's record for protecting patients from dangerous drugs and medical devices (e.g., Vioxx and Medtronic defibrillators) is seriously flawed.
Congress knows the FDA isn't getting the job done. For example, Senator Charles Grassley of Iowa, who has conducted oversight of the FDA's reviews for drugs and medical devices, believes that the FDA's relationship with the drug industry is "too cozy." In September 2007 he wrote: "Congress needs to do everything it can...to make the FDA more independent, rigorous and responsive in its work. Unfortunately, the case for reform gets stronger all the time, as new questions continue to emerge about FDA actions and inaction."
The medical profession also tracks the FDA's poor performance. For example, the Institute of Medicine ("IOM") published a 2006 report, The Future of Drug Safety, that identified several FDA deficiencies and made recommendations to fix them. The FDA has not followed those recommendations. As one advisor to the FDA and consultant to the IOM explains, the FDA "is in need of monumental change...." (Sheila Weiss Smith, Sidelining Safety- the FDA's Inadequate Response to the IOM, New England Journal of Medicine, September 6, 2007, Volume 357, pp. 960-963.)
Since 1992, the FDA has relied heavily on the pharmaceutical industry to pay the salaries of the FDA scientists who review new drug applications. Prominent doctors who have worked at the FDA worry that because of this, the agency has a growing sense of accountablity to the industry it regulates instead of to the people it is supposed to protect. (Dr. Jerry Avorn, Paying for Drug Approvals- Who's Using Whom?, New England Journal of Medicine, April 26, 2007, Volume 356, pp. 1697-1700.) To those who argue that having the industry pay its own regulatory agency helps save the taxpayers' money, the obvious response might be that you get what you pay for.
It's pretty interesting that the FDA has reversed its own position on whether preemption is a good idea. During the Clinton administration, the FDA argued that the agency's approval of medical devices should not preempt state lawsuits. Under the Bush administration, the FDA has reversed its position. Does anyone think the Bush administration could be pro-corporation, anti-ordinary folks?
Many people are surprised to learn that once the FDA lets drugs and medical devices onto the U.S. market, it has no active surveillance system to monitor their safety. Instead, it waits passively for adverse event reports or complaints by doctors or hospitals to come to the manufacturer, who is responsible for investigating. After the manufacturer conducts its own investigation into the complaints, it makes a report to the FDA. (Again, you get what you pay for.) As former FDA commissioner Dr. Mark McClellan explains: "One key reason drugs may be used for years by millions of patients before risks become evident is that the United States has no active drug surveillance system." (Mark McClellan, Drug Safety Reform at the FDA- Pendulum Swing or Sytematic Improvement?, New England Journal of Medicine, April 26, 2007, Volume 356, pp.1700-1704.)
It is during the time when active drug surveillance should be happening that some patients are harmed, and some of them (or their families) bring a lawsuit in their state's court. Frequently, that is when the public learns for the first time about why a drug or device on the U.S. market is dangerous. And it is in response to lawsuits, and the information they uncover, that the FDA often acts for the first time to recall a drug or device.
As Mr. Greenspan points out: "It is not often that doctors defend trial lawyers." But this should be one of those times. Because trial attorneys who devote their careers to representing negligently injured patients and doctors who devote their careers to caring for patients should be fighting together to fight FDA preemption. The public should call on their legislators to do so. And this is the year to do it, before it's too late.
Study Highlights the Importance of Consumers Right to Bring Suit Against Big Pharma
Posted by: Emily C. Wecht
March 28, 2008
A study published in the New England Journal of Medicine on Thursday, March 27, 2008 shows that drugs approved by the FDA under tight deadlines are more likely to harm consumers.
The Associated Press reports: "Approval deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision - either approve or reject - on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority. Congress tightened the deadline for most drugs to 10 months in 1997."
The FDA has approved a host of infamous drugs at or near the approval deadlines, including: Vioxx, Bextra, Rezulin, and Baycol. All were withdraw from the market because they were unsafe only after they harmed hundreds of consumers.
The study's findings highlight the importance of a consumer's right to bring suit against pharmaceutical companies that produce dangerous drugs - regardless of whether the FDA has approved the drugs.
For many years, we have fought hard to preserve that right. As Spencer Pahlke reported yesterday, that right is now under attack. The U.S. Supreme Court should consider the realities that this study exposes when deciding Wyeth v. Levine: a federal agency under enormous political and economic pressure cannot unfailingly protect the public. The public must retain the right to pursue justice through the courts.
Think these drugs are dangerous now?...just wait
Posted by: Spencer Pahlke
March 27, 2008
This post would fit equally well in our threats to plaintiff's rights section because it goes along with Riegel v. Medtronic case that Mike Kelly discussed a few days ago.
The New York Times reports that a major defective drug case has settled in Alaska. The case, between the citizens of Alaska and Eli Lilly, the manufacturer of Zyprexa, had reached its 3rd week of trial when the Alaska Attorney General decided to settle the case for pennies on the dollar. The reason?--fear that the Supreme Court would extend blanket protection (called preemption) to drugs like Zyprexa in October when it hears a case entitled Wyeth v. Levine.
The Alaska Attorney General's fear--that the suit would be thrown out after the Supreme Court's decision--is sadly appropriate. As Mike explained, in Riegel v. Medtronic, the Supreme Court decided that because the FDA had approved the medical device that hurt Mr. Riegel, no plaintiff should be allowed to sue when that device later proves to be defective. What's the impact here?--if the FDA approves a device, no one can sue when that device later injures them. Sound scary?
The Alaska Attorney General feared the same outcome with drugs approved by the FDA: if the Supreme Court decides in Wyeth v. Levine that the FDA's approval "preempts" all state-court lawsuits, then people injured by FDA approved products have no legal recourse. None.
And, consider these additional problems. First, during the Alaska trial, documents had proven that Eli Lilly "encouraged its use for off-label conditions." That means that the drug was used for purposes that the FDA did not test for--imagine not being able to sue after being instructed to take the drug for an off-label purpose. Second, as the Times reported, "federal prosecutors in Pennsylvania are investigating Lilly's marketing of Zyprexa and whether the company hid Zyprexa's dangers from doctors and the Food and Drug Administration." So here's the rub: even though Eli Lilly--and other drug manufacturers--may be hiding dangers from the FDA, it may still get protection from all lawsuits for those very drugs.
The result, as explained by an attorney in the case: "without the threat of lawsuits in state courts, drug makers would be even more aggressive about hiding risks and promoting drugs for unapproved uses." So, "If you think these guys speed now, wait and see what happens when they get pre-emption."
