FDA scientists complain again

I have been arguing for years that the FDA is a troubled agency with very little credibility to say the least. Today, the Chicago Daily Law Bulletin reports of another statement by FDA scientists alerting of problems within the agency. For a report on the previous one see here. The CDLB article states: "In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration. ''The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,'' said the letter, dated Wednesday, on the letterhead of the agency's Center for Devices and Radiological Health. The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx. The FDA declined to publicly respond to the letter, but said it is working to address the concerns. In their letter, the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. ''Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices … have ignored serious safety and effectiveness concerns of FDA experts,'' the letter said. ''Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.'' A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official. FDA spokeswoman Judy Leon said in response: ''We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action.'' Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes within the agency." The PopTort Blog has a comment on this topic here.

Top torts stories of the past week

Check out the most recent "Personal Injury Roundup" at TortsProf Blog, which lists links to the most interesting stories from the past week.

Hospital throws baby in the trash

Take the a look at this story about a hospital in Jersey City, New Jersey that has reportedly admitted that it threw out the body of a baby in the trash. The still grieving mother was informed that the hospital cannot locate the body of her son as police searched garbage dumps in New Jersey and Pennsylvania.

Cause of action for injuries to child when parents refuse medical services for religious reasons?

Marci Hamilton has published an interesting column in FindLaw.com called "A Roundup of 2008's Developments Relating to Harms Suffered By Children in Religious Settings: Our Disturbing Current Status, and Some Signs of Progress." She concludes that events during 2008 show that children often suffer when their interests intersect with adults' religious beliefs.

The first group of cases she discusses are examples of cases where children died when their parents refused medical treatment because of their religious beliefs. She writes:

"During 2008, there were three widely-publicized deaths of children suffering from treatable medical ailments who had lived in faith-healing homes. In Wisconsin, Kara Neumann died from untreated diabetes at 11 years old; her parents were members of an Internet-based faith-healing organization, Unleavened Bread Ministries. In Oregon, fifteen-month-old Ava Worthington died of bacterial pneumonia and a blood infection; her uncle (or cousin depending on the report) Neil Beagley, 16, died of heart failure prompted by a urinary tract blockage. Ava and Neil's families were members of Followers of Christ, a notorious group responsible for the deaths of more children than just these two.

One medical neglect case appears to be headed in a more positive direction for the child: In late December, a New York judge ordered an Amish couple to permit their 15-month-old son, Eli Hershberger, to have the heart surgery he needed to survive." 

Evidently, the author simply assumes that obtaining medical treatment is the best option, even if it means forcing it upon the child against the parents wishes. I don't doubt a majority of people would agree with this position. But if you are interested in this topic you should take a look at an article by Teresa Stanton Collett called "Life and death lawyering: dignity in the absence of autonomy" published in the Journal of the Institute for the Study of Legal Ethics (1996). The author makes a good case for the position that the parents' wishes should be respected. I am not saying that I agree with it, but I am saying that the argument is not frivolous. I have covered this material in my Torts seminar by assigning Lundman v. McKown, 530 NW2d 807 (Minn App 1995) and having students prepare to argue an appeal based on the facts of the case. I've also had a professor who is a Christian Scientist judge sometimes, which has resulted in very interesting reactions by the students and very interesting discussions.

Vets sue CIA, Defense Dept. over military experiments

A few days ago I posted a comment about a recent decision in a lawsuit related to atomic bomb testing in the 1950s. Today, the Chicago Daily Bulletin reports that six veterans who say they were exposed to dangerous chemicals, germs and mind-altering drugs during Cold War-era experiments filed a federal lawsuit against the CIA, Department of Defense and other agencies Wednesday. If you are interested in Cold War era/atomic testing issues, I recommend a documentary called "Atomic Soldier" which is all about the soldiers who were exposed to testing during the 50s. Unfortunately, it is a difficult movie to find. You can also try the book Justice Downwind and the movies "Atomic Cafe" and "Bikini Radio." In the lawsuit filed yesterday, the veterans say they volunteered for military experiments as part of a wide-ranging program started in the 1950s to test nerve agents, biological weapons and mind-control techniques, but were not properly informed of the nature of the experiments. They blame the experiments for poor health and are demanding that the government provide their health care. Interestingly, the plaintiffs are not seeking monetary damages but have demanded access to health care for veterans, saying they were turned away at Department of Veterans Affairs facilities because they could not prove their ailments were related to their military service.

Is Pac-Man Jones libel proof?

The TortsProf Blog reports today that Pac-Man Jones has announced he will sue ESPN in response to a report that he instigated a strip-club shooting in 2007. I assume the report was false, of course, because otherwise there simply would be no basis for the claim to begin with. But, as Mike Florio comments on proffootballtalk.com the claim would raise the always interesting question of whether the plaintiff is "libel proof." "Libel proof-ness" is an interesting concept that has been adopted by a number of jurisdictions. Essentially, it states that a plaintiff should not be allowed to waste a court's time to try to recover damages to his or her reputation if the reputation is already so low that it can't be "damaged" much more. There is no point in wasting the court's time and resources in trying a case that is likely to result in a nominal recovery -- whether it is the traditional $1 or a very small amount awarded by a jury. It makes logical sense. There are a couple of objections to the concept, though. First, it eliminates the right of the plaintiff to seek redress. If the plaintiff wants to spend a million dollars to recover one, well, maybe that's their choice. Maybe they are not interested in money; maybe they want a public apology, or publicity about the conduct of the defendant. Then the question becomes whether the court system is the proper forum, which is, of course, a whole different debate. Is a case that is likely to result only in nominal damages frivolous by definition? Second, dismissing the case because the plaintiff is libel proof eliminates the possibility that the plaintiff may be awarded punitive damages. It is possible that a jury may want to impose punitives on the defendant for its outrageous conduct even if the plaintiff suffers minor injuries. This happened in one of the first cases where a court discussed the libel proof doctrine. If I remember correctly, it involved the publisher of Penthouse magazine. At trial, the jury found for the plaintiff and found damages in the amount of $1 for compensatories but millions for punitives. Obviously, again, this leads to another debate on whether a case like that is the proper way to impose a penalty for misconduct on the part of the defendant -- particularly when the value imposed as the penaly is going to benefit a plaintiff the jury found unworthy to get damages in the first place. If a case that is likely to result in nominal compensatory damages is frivolous by definition, is it not frivolous if it has a chance to generate punitive damages? Food for thought. Thanks to Torts Prof Blog for the update.

Another article on the Obama administration and the FDA

The Philadelphia Inquirer has a new article on the Obama administration's efforts to find a new chairman for the FDA. The article is available here. For previous posts on this topic on this blog see here, here, here, here, here and here.

Illinois enacts new law to regulate lead paint in toys

On December 23, Gov. Rod Blagojevich signed into law that requires toys, children's jewelry and baby items containing even small amounts of lead to have a warning label about the potentially toxic substance. The legislation is one of the nation's toughest warning label provisions. State law had already barred the sale of toys containing more than 600 parts per million of lead. Unfortunately, the new more stringent labeling does not apply until on Jan. 1, 2010. Not too long ago, the Chicago Tribune ran a long article on the dangers posed by lead paint in toys (available here). The article announcing the new law is available here.

Case vs 3M for groundwater contamination

The Minneapolis Star Tribune reports today on an interesting case involving the spread of a 3M Co. chemical through groundwater. Because there is no evidence that the plaintiffs have been physically harmed, Washington County Judge Mary Hannon blocked a claim by the residents that they had sustained health problems. However, because trace amounts of PFCs, used in the manufacture of nonstick cookware, stain-resistant carpets and fabrics and other products, have been found in public and private wells, the judge allowed the residents to seek punitive damages, against the company for negligence and trespass. Also pending is a claim that the pollutants have harmed the plaintiffs' property values. Thanks to William Childs of TortsProf Blog

Nordstrom To Pay a $60,000 Civil Penalty For Failure To Report Drawstrings In Children’s Outerwear

A few days ago, I posted on the Consumer Product Safety Commission recently filed lawsuit against a manufacturer. I mentioned this was surprising. Usually, the CPSC negotiates with the manufacturer or seller to agree on a civil fine. Here is an example of this more common approach. About a month ago, Nordstrom Inc. agreed to pay a $60,000 civil penalty to settle allegations that the firm knowingly failed to report to the CPSC immediately, as required by federal law, that its children’s hooded jackets and sweaters were sold with drawstrings at the hood and neck. In February 1996, CPSC issued drawstring guidelines to help prevent children from getting entangled and possibly strangling on hood and neck drawstrings in upper outerwear, such as jackets and sweatshirts. In May 2006, CPSC’s Office of Compliance announced that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and a substantial risk of injury to young children. Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or violates any consumer product safety rule, or any other rule, regulation, standard, or ban enforced by the CPSC. Nordstrom sold about 2,400 drawstring jackets and sweaters in the United States between November 2007 and December 2007. In February 2008 and March 2008, CPSC and Nordstrom announced the recall of the drawstring jackets and sweaters. In agreeing to settle the matter, Nordstrom Inc. denies CPSC's allegations that it knowingly violated the law.