CPSC delays enforcement of testing and certification provisions

The Products Liability Profs Blog reports that "Under crushing pressure from manufacturers, the CPSC issued a 1-year stay on enforcement of the testing and certification provisions for certain products. However, the CPSC made it clear that manufacturers and retailers can still be fined for selling products after February 10 that violate the lead and phthalate requirements." The post at the Products Liability Profs Blog includes a link to a very informative summary on the arguments related to this controversy.

Tort reform bill introduced in South Carolina Senate

The Charleston Business Journal reported yesterday that a comprehensive tort reform legislation has been introduced in the S.C. Senate. Its supporters claim the legislation will help promote a more favorable business climate and lead to more business investment and job creation. The CBJ says the bill builds on legislation that was implemented in 2005 by placing limits on punitive and noneconomic damages and class action reform. Thanks to Chris Robinette from Torts Prof Blog for the information.

Second Circuit Revives Nigerian Families' Claims Against Pfizer Over Drug Tests

Law.com reports today that a divided federal appeals court has revived the claims of 88 African families for billions of dollars in damages under the Alien Torts Statute arguing that Pfizer subjected their children to medical experimentation without their consent in a Nigerian hospital during a 1996 meningitis outbreak. The opinion is available here. The majority and the dissenting opinions differed over whether the families' claims fall within the Alien Torts Statute which gives foreigners the right to raise tort claims in federal court to vindicate violations of "the laws of nations." In concluding that the law embraces claims of unconsented medical experimentation, Judge Barrington D. Parker wrote for the majority that the dissent took an approach to "customary" international law that is "unselfconsciously reactionary and static." In dissent, Judge Richard C. Wesley described the majority as creating a new norm "out of whole cloth" upon the basis of "materials inadequate to the task."

Punitive claims added to peanut butter suit in light of FDA report

The law firm that filed the first lawsuit tied to the recent salmonella outbreak in certain brands of peanut butter has added claims for punitive damages in light of the U.S. Food and Drug Administration's recent report concluding that the Peanut Corporation of America knowingly released a product that could have been contaminated. The case is called Meunier v. Peanut Corporation of America, No. 1:09-cv-00012 (M.D. Ga.). The FDA report, which came out this month, found that the Georgia plant shipped products that had tested positive for salmonella contamination at least 12 times in the past two years. Federal investigators also found unsanitary conditions and numerous health violations at the plant. On Wednesday, the FDA asked companies and consumers to discard every product made from the plant in the past two years. The plant produced peanut butter and peanut butter paste that was sold to companies that make cookies, cakes, ice cream and dog treats. Since last fall, at least 43 states have reported illnesses, and eight people have died.

Top torts stories of the past week

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

Cap on damages debated in Orgeon

Last week, the Oregon Legislature began debating a bill to cap tort liability. The bill would replace a tort cap struck down over a year ago by the Oregon Supreme Court. The proposed caps for the state and its agencies, $1.5 million per claim/$3 million per occurrence (growing by $100,000 and $200,000 respectively each year until 2014), are much higher than those ruled unconstitutional in 2007. The full story is here. Thanks to Chris Robinette from Torts Prof Blog and to Prof. Colin Miller of The John Marshall Law School for the information.

Lawsuits vs peaunut butter company

At least two lawsuits have already been filed against the peanut processor mentioned in the previous post. One was filed on behalf of a Vermont couple whose son became ill after eating peanut butter crackers, the Boston Globe reports here. Another was filed by the family of a 72-year-old Minnesota nursing home resident who died after eating toast with peanut butter. See story in the Minneapolis Star Tribune reports here.

Peanut butter company knew product was contaminated but sold it anyway

Jonathan Turley reports today that "internal documents from the Peanut Corporation of America reportedly show that the company knew that peanut butter was contaminated with salmonella 12 times in the last two years, but shipped out the contaminated peanut butter to customers. The revelation will most certainly increase the liability facing the company from both the government and civil litigants after the death of eight people and the injury to hundreds across the country. Indeed, it would appear that criminal charges may now be warranted. The Food and Drug Administration and the Centers for Disease Control and Prevention, which have been investigating company and found that over a dozen internal tests in 2007 and 2008 revealed contamination but that the company sold the peanut butter anyway. The peanut butter was used to make crackers, cookies, energy bars, cereal, ice cream, candies and even dog biscuits. Investigators have also found the facility in Blakely, Ga., to be rife with four different strains of salmonella, including one found on the floor near a bathroom. It would be astonishing if the company was not ruined from the expected litigation and, if true, someone needs to face criminal liability in the matter. The case also raises the question over the food safety inspection system and the fact that companies do not have to reveal such tests. The failure to notify federal and state officials of such contamination should be treated as a felony.

NYT article criticizes the FDA

Last week, the Government Accountability Office issued a report (available here) critical of the FDA and suggesting it needed broad-based changes. Today The New York Times published an editorial that states: "The Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over. Officials will also have to make clear that the Bush administration’s practice of distorting science and weakening regulation to favor industry also is over." The NYT article is available here.

CPSC meeting with manufacturers

Kenneth Ross of the Products Liability Profs Blog reports today: The CPSC has posted details of a meeting with various trade associations including the Craft Yarn Council and Needlearts Association on January 22 where the CPSC was presented information about the lack of lead in certain materials. Here is a summary slide for one of the presentations: "In conclusion, all the test data gathered to date on products made from pre-dyed or un-dyed fibre, have shown that consumer craft products sold and distributed in the US are essentially lead and phthalate free. While materials and test data presented today has focused on the manufacturing of handknit products, all other products made from natural or synthetic fibres would yield very similar results. We believe that consumer craft products manufactured and distributed in the US markets today are significantly below the minimum lead and phthalates content levels established by the CPSIA 2008, and all consumer craft products should be exempt from testing requirements." Go here for links to the meeting materials and videos. If the CPSC's scientists agree, then the CPSC will have to go through the exemption/exclusion procedures set forth in the Notice of Proposed Rulemaking.

Questions for voir dire

The folks over at Drug and Device Law Blog have posted an interesting short comment on questions you should ask possible jurors in a drug and device case. The first one is: "Has your confidence in the FDA increased, decreased, or stayed about the same in recent years?" This is a fair question and probably a good one to ask whether you are representing a plaintiff or a defendant. Another set of questions, which they say they heard a federal judge suggest for the defense in drug product liability cases, is: "Are you currently taking any medications? Do you need those medicines? Do they help you? Do you know how much money the drug company spent to develop that drug? Do you understand that, although the drug is helping you, the drug has possible side effects? Do you understand that every drug has possible side effects?" What do you think of these? Is it fair to ask a juror about their use of pharmaceuticals or is it too much of an invasion of privacy? By the way, in response to the post someone posted a long comment very critical of the FDA and the pharmaceutical industry. It is not exactly on the same subject as the original post but worth reading. It is available here (scroll down to the comments).

Update on the controversy regarding the Consumer Product Safety Improvement Act

Kenneth Ross at Products Liability Blog has posted the following update on the controversy over the Consumer Product Safety Improvement Act: "After Congressional leaders sent their letter of January 16th to the CPSC (see January 20 post), two Republican Congressman sent a letter to Chairman Waxman (see Barton letter to Waxman 1.21.09 ) on the 21st demanding hearings. Business leaders and small manufacturers have jumped in vociferously on what needs to be done (see Rick Woldenberg's letter). It is clear that there is not enough time for the CPSC to clarify the issue by the implementation date of February 10. There are time deadlines for passage of final rules pursuant to the APA that would not allow the current proposed final rules to be implemented until well after February 10. Therefore, the only feasible alternative is for Congress to delay implementation. Many in Congress will not agree to this, in part, because of pressure from the consumer groups (see Consumer's Union letter to CPSC Acting Chair ). This is a fascinating conundrum created by Congress and/or the CPSC. And small business owners are stuck in the middle. Many are throwing away inventory and going out of business. Many are trying to get their products tested. There is a group of manufacturers planning to file suit, possibly by next week, asking for a court to stop implementation of the the Act. Virtually no one will be in full compliance by February 10 and there is a question about enforcement of these rules, many of which are unclear and incomplete. And then what will the State Attorneys General do?"

False arrest suit for being held in jail for six months without probable cause

A Chicago man is suing the Chicago police department after officers arrested him without probable cause and then held him for six months in jail. During that time he lost his job and missed the birth of a child. The suit alleges that the prosecution was malicious and caused emotional distress. One of the arresting officers was stripped of his police powers in 2008 for his involvement in another false arrest and plot to frame his estranged wife. The full story is available here. Thanks to Jonathan Turley for the information.

Controversy regarding the Consumer Product Safety Improvement Act

The "Consumer Product Safety Improvement Act of 2008” was enacted last summer to permanently ban the sale of toys and child care products that contain certain phthalates and lead after February 10, 2009. Unfortunately, the implementation of the law has not been going as smoothly as expected. (See here and here.) Forbes magazine has published an article attacking the law titled "Scrap The Consumer Product Safety Improvement Act." (The article is published in two parts, available here and here.) It argues, among other things, that "the testing requirements of the Consumer Product Safety Improvement Act (CPSIA) threaten to drive out of business tens of thousands of small makers of children's products; the law also menaces thrift shops with legal liability if they deal in children's secondhand goods, whether or not those goods put any child at real risk." In response, the Pop Tort Blog has posted a short comment. In part, it says: "Business groups have always hated this law. But now, they are in full hyperbolic rage because of the difficulty some small business are having complying right away. Consider the recent Forbes magazine piece called “Scrap The Consumer Product Safety Improvement Act” by a Manhattan Institute fellow, who also called it “on one of the worst pieces of legislation I’ve seen in many a year.” "Gee, let’s see, a bill that makes sure children are no longer lead poisoned from chewing their Mattel toys, that was so thoroughly studied and dissected that it took months to write, was agreed to by both parties in Congress, and then passed the Senate 89-3, the House 424-1, and signed by President Bush, of all people – oh, the horror." The comment is available here.

More on the issue of manufacturer liability for another's generic product

Back in November I reported on a new case in California holding that drug manufacturers can be held liable for harm caused by a competitor's generic version of the same drug. The opinion is available here. Needless to say, the decision is very controversial. The California Supreme Court has denied review. Today, the folks over at Drug and Device Law Blog have posted a very interesting comment on the case. It starts stating that the case "is a particularly dangerous expansion of tort liability because it simply ignores what product liability has been about for 50 years – that responsibility for product-related injuries follows profit obtained from the manufacture and sale of products." Their comment is available here.

Indiana Supreme Court allows nuisance claim vs gun manufacturers

Jonathan Turley reports today that, the Indiana Supreme Court has ruled that a lawsuit by the City of Gary against a gun manufacturer on a nuisance theory can proceed to trial. These lawsuits have been uniformly rejected on various grounds. Yet, Gary with one of the nation’s highest homicide rates will be allowed to sue companies like Smith and Wesson, Beretta and Colt as well as gun dealers for the harm caused by their products. Professor's Turley's comment (including links to a decision in Rhode Island which reached the opposite conclusion) is available here. The Court's opinion is available here.

Congress applies pressure on CPSC

Kenneth Ross, of Products Liability Profs Blog, reports today that Congress has sent a letter to the CPSC last Friday concerning CPSIA and implored CPSC to clarify things for manufacturers in four areas so they could comply with the February 10 implementation date of some of the Act's provisions. As Ross, points out, however, procedurally this is impossible. The exemptions being proposed cannot take place until after February 10. The Notices of Proposed Rulemaking have a comment period until February 17. CPSC has said that products are not exempt from testing until the proposed rulemaking is finalized and published in the Federal Register.

GAO report on FDA approval process

The Washington Post.com has an interesting report today on a report by the Government Accountability Office on the FDA approval process for high risk medical devices. Currently, there are two ways to get FDA approval for medical devices. Manufacturers of low-risk devices can get cleared by notifying the FDA before going to market. High-risk devices such as pacemakers and heart valves have to go through tighter scrutiny, and their manufacturers are supposed to provide evidence of safety and effectiveness. However, manufacturers can get approval for new versions of high-risk devices already on the market by convincing the FDA that these devices were "substantially equivalent" to their precursors. According to the article, in 1990 Congress ordered the FDA to end the practice, but it has continued. The FDA acknowledged the problem, but has not set a timetable for resolving it. The GAO report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints, external defibrillators, and electrodes for pacemakers. According to Public Citizen's health research group, "It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk." The article also quotes Rep. Frank Pallone, who heads the House Energy and Commerce Committee's health panel, who said "GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate." Apparently, there is some support to make the FDA review all medical devices through pre-market approval, rather than the less rigorous pre-market notification. Doing so, would increase the amount of time it takes to get new devices in the market, but it may reduce the risks that those devices will malfunction or cause other problems - as a number of (now recalled) devices approved under the less rigorous process have.

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.

More on the Eli Lilly fines/settlement

There is an interesting article in the The Legal Intelligencer (via Law.com) today about Eli Lilly’s agreement to pay "the largest criminal fine in history” and plead guilty to violating the Food, Drug, and Cosmetic Act, settling charges for illegal marketing of Zyprexa, an anti-psychotic drug, for off-label use. Here is an excerpt: Zyprexa was approved by the Food and Drug Administration only as a treatment for schizophrenia and bipolar disorder, prosecutors said, but Lilly allegedly set out to market the drug to elderly patients as a treatment for dementia, Alzheimer's, agitation, depression and generalized sleep disorder. In doing so, prosecutors said, Indianapolis-based Lilly ignored explicit warnings from the FDA that Zyprexa should not be so widely prescribed because of side effects such as weight gain that could lead to obesity and even the onset of diabetes in some patients. . . . .In a press conference Thursday, Acting U.S. Attorney Laurie Magid . . . said Lilly knew that its patent for Prozac was expiring and "wanted Zyprexa to be their new blockbuster drug." Magid said Lilly mounted an "elaborate marketing campaign" and deployed an "army" of sales representatives who were trained to persuade doctors to use Zyprexa for a much larger patient base than the relatively narrow category of schizophrenics and manic depressives. Because one of Zyprexa's side effects is sedation, Magid said, Lilly instructed its long-term care sales force to tell doctors in nursing homes that Zyprexa would help patients with sleep problems, behavioral issues and dementia. "They claimed this side effect was a therapeutic benefit, not an adverse event, with the sales slogan '5 at 5,' meaning that five milligrams of Zyprexa at 5 p.m. would help their patients sleep," Magid said.

Comments on the FDA's guidance for industry on off label marketing

Yesterday I reported that the FDA has issued a final "Guidance for Industry" which provides "the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses" for FDA-approved drugs and medical devices. Today, the folks at the Drug and Device Blog have posted a long comment on it. It is available here.

Eli Lilly will pay $44 million to Illinois

Update on the previous post: The Chicago Daily Law Bulletin reports now that Illinois will receive $44 million in the Eli Lilly settlement and that Attorney General Lisa M. Madigan's office said the state Medicaid program will get $27 million, and the state will receive the other $17 million.

Eli Lilly To Pay $1.4 Billion To Settle Zyprexa Suits

Yes, your read right; that's billions, with a B! CNN reports today that Eli Lilly & Co. reached a deal to pay $1.4 billion and plead guilty to a federal misdemeanor charge (violation of the Food, Drug & Cosmetic Act) over promoting an antipsychotic drug to treat dementia when it wasn't approved to do so. The actual fine for the misdemeanor was $515 million, reportedly the largest individual corporate criminal fine in history. An additional $800 million will be used to settle civil charges, with $432 million going to the federal government and up to $362 million to individual states. Thanks to Bill Childs of TortsProf Blog.

Editorial on medical malpractice reform

Kia Franklin has posted a short comment on the subject of med-mal reform over at Tort Deform Blog (available here). The first paragraph states: "The debate about medical malpractice often centers around whether patients hurt by it should be able to ask for non-economic damages, or whether those awards should be capped at a certain amount. I’ve chimed in on this from time to time but maintained that paramount to any discussion about the health care system is the welfare of the people who go through it. Patient safety is most important, which is why a focus on measures to improve patient safety, and cut costs to the health care system, should be the primary objective."

Opposition to Georgia tort reform plan

Yesterday I reported on Georgia Governor's plan for tort reform (see below). Today, the Atlanta Journal Constitution has responded with an editorial opposing it. It states, in part: "[The Governor] proposes to grant drug companies immunity from legal action if the drug in question was approved by the federal Food and Drug Administration. Vioxx and the other three drugs all had FDA approval. All were later pulled from the market after being linked to sometimes fatal problems, including hypertension, stroke, liver failure, severe allergic skin reactions and cardiac failure. FDA approval doesn’t guarantee that a drug will be 100 percent safe. The agency acknowledges that approved drugs arrive on the market with the possibility of unforeseen risks. The question is who should bear those risks —- patients or pharmaceutical companies? Under Perdue’s plan, consumers bear all the risks. The governor is willing to barter away the common-law right of product liability actions to entice biotech companies to the state. . . . . Rather than casting the FDA and the tort system as opponents, they should be seen as dual regulators of a billion-dollar industry that impacts the lives and health of millions of Americans. Liability laws exert pressure on Big Pharma to maintain the highest safety standards and to act fast to yank products when problems arise. And when the FDA gets it wrong, the tort system offers insurance to harmed consumers that they can seek corrective justice." The full editorial is available here. Thanks to Bill Childs of TortsProf Blog for the information

Tort Reform in Georgia

A press release from the Governor of Georgia released yesterday has this interesting section on "tort reform." Note how it makes a connection between "tort reform" and making Georgia "more friendly to business." The full press release is available here. It states, in part: "This session, I will propose two pieces of legislation that will make Georgia more friendly to business. First, we will cement our position as a leader in the biotech industry by enacting laws that respect the role of the federal Food and Drug Administration as the regulator of the safety of drugs and medical devices. "As other states have decided, I believe that FDA approval should mean something. It certainly should imply protection from tort lawsuits. This legislation will say that companies with a significant presence in Georgia will not be subject to product liability claims within this state if the FDA approved the medical device, drug or the labeling along with it. The legislation will make Georgia an even more attractive environment for biotechnology companies. "Secondly, Georgia’s courts are crowded with nuisance lawsuits, but unfortunately, they are often cheaper to settle than to litigate. Current law provides almost no deterrent for frivolous lawsuits and that must change. "I’m asking the General Assembly to pass another tort reform bill that will provide relief to individuals and companies wrongly sued. In short, if a claim is dismissed at the earliest possible stage, the litigant bringing the claim will be responsible for the prevailing party’s attorneys’ fees. "If the attorney fails to notify the client of this provision, that attorney could pay the award. Lastly, the bill will make sure that the costly discovery process will not begin until the legal merits of a complaint have been tested. "This will free up our courts to pursue justice in cases with merit, protect our existing businesses that provide jobs for Georgians and attract new investment. With the help of the General Assembly, we’ll make plain that the threat of meritless litigation is not a viable business strategy in Georgia." In other words, the Governor is proposing to pass legislation that would eliminate the right of plaintiffs to sue in state court for certain types of cases and procedural barriers to their claims when they do have the right to bring them. Interestingly, Illinois tried the approach of instituting procedural barriers a number of years agon but they were declared unconstitutional by the state supreme court. Also, the "loser pays" proposal has been considered and rejected in some form or another by the ABA in an old ethics opinion. It will be interesting to see if anything comes out of this. Thanks to Sheila B. Scheuerman of TortsProf Blog for the information

Product liability plaintiffs and the issue of proximate cause

Next week's (January 19) National Law Journal (available here now if you have a subscription) will feature a column by J. Russell Jackson on products liability in which he discusses the fact that courts continue to expand the reach of who can be a plaintiff in products liability cases and how this forces courts to discuss the issue of proximate cause. Here is an excerpt: "The plaintiffs in products liability lawsuits today often have little, if any, relationship to the underlying sale of the challenged product. Increasingly, lawyers are creatively defining their plaintiff classes — particularly in the pharmaceutical context — to be comprised of so-called "third-party payors," such as insurance and health benefit funds. Typically, they argue that the product seller has perpetrated a fraud on the entire medical profession, and that therefore proof of reliance for any individual's purchase should not be required. Cf. In re Zyprexa Prods. Liab. Litig., 253 F.R.D. 69, 190 (E.D.N.Y. 2008) ("The [U.S. Supreme] Court held that the person who suffered the loss need not be the one to whom the fraudulent words were directed . . . .The fraud was directed to prescribing doctors. The overpayments were made by third-party and individual payors").One consequence of using plaintiffs who are so far removed from the underlying transactions, however, is that courts increasingly are forced to confront the issue of proximate cause in early motion practice. Recent decisions suggest that the further a plaintiff is removed from the underlying sales transaction, the less likely it is that the court will find proximate causation."

Settlement is not a bar to malpractice claim

Suppose a lawyer prepares a prenuptial agreement for a groom shortly before the wedding. then, after a few years of marriage, the wife files for divorce. When the husband's new lawyer tells him that there are serious doubts about the enforceability of the agreement, the husband enters into a settlement with his wife for "fear[ that the original agreement] would not be upheld..." The husband then sues the lawyer who had drafted the agreement for malpractice. Should the claim be recognized? The trial court dismissed the legal malpractice action on grounds of public policy and judicial estoppel but the New Hampshire Supreme Court reversed, holding that the divorce settlement did not bar the malpractice action on either grounds. Posted by Mike Frisch at Legal Profession Blog.

Top legal blogs

The ABA Journal recently conducted a poll to select the top legal blogs. The voting closed at the end of the year and the results are in. The complete list of the ABA Journal's Top 100 blogs is now available here. The list is organized in the following categories: news, law professors, crime, niche, technology, quirky, careers, students, podcasts and regional. I am happy to report that many of my favorite blogs made the list.

State liability for court appointed counsel's negligence?

Should a state be subject to liability if court-appointed criminal defense counsel provides negligent representation? According to a recent decision of the Arizona Supreme Court the answer is NO. The court held that the duty of the state begins and ends with the appointment of counsel. Counsel is an independent contractor that the state does not control or supervise. Thus, the state may not be held vicariously liable for counsel's negligence. Orginally posted by Legal Profession Blog

FDA issues guidance on "off label" drug literature

The TortsProf Blog reports that the FDA has issued a final "Guidance for Industry" which provides "the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses" for FDA-approved drugs and medical devices. Thanks to Sheila B. Scheuerman for the information.

Attorney for Wyeth shares his thoughts on preemption

The attorney who represents Wyeth in Wyeth v. Levine has published his thoughts on the case over at Drug and Device Law Blog. For more on this case, search this blog for posts on the topic of preemption.

More on the California decision on Good Samaritans

A few days ago I reported (here) that the California Supreme Court ruled that a woman who pulled a co-worker from a crashed vehicle isn't immune from civil liability because the care she rendered wasn't medical. I suggested that the decision was based on the widely accepted "no duty to help" concept that applies in pretty much all jurisdictions, but that, unlike in most jurisdictions, the "good samaritan law" in California offers immunity depending on the type of conduct involved rather than on the training of the person providing it. In response to the case, legislators in California are introducing legislation that would offer greater legal protections to good samaritans. Two of those bills are available here and here. The bills would extend the same legal protection to any good samaritan offering emergency care at the scene of the emergency unless it is a place where emergency medical care is available (ie, a hospital or clinic, etc). This proposed approach would also be unusual. The rule in most states is that medical personnel who cause an injury in an attempt to help a person they don't have a duty to help are immune from claims for having caused the injury, but that any other person could be liable. This approach is essentially based on the notion that rescue attempts should be left to those with training to perform them. Is it really a good idea to encourage people with no training whatsoever to try to help others in need of medical attention? As Prof. Anthony Sebok, whose column I have recommended here many times, suggests in his most recent column, "California should be wary of providing blanket tort immunity to rescuers attempting either medical or non-medical aid." His column on this subject is available here.

California Court Revives Secondhand Smoke Case

Law.com reports that the California Court of Appeals has reversed the dismissal of an asthmatic 7-year-old girl's public nuisance suit against her family's apartment complex over secondhand smoke in outdoor common areas. The court ruled that the girl not only had standing to file suit as a tenant, but also that she has pleaded a cause of action sufficient to withstand a motion to dismiss. This may be the first time that a court has suggested that outdoor secondhand smoke can constitute a public and private nuisance. Law.com's article is available here.

More on the FDA

Public Citizen has published a short note on the letter sent by nine scientists at the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency. According to the letter, the FDA has "placed the American public at risk." According to the note on Public Citizen's blog, "among the charges are that scientists have been threatened and told, on occasion, to ignore FDA regulations, that FDA managers have ignored serious safety and effectiveness concerns, and that FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."" You can find more on this story on CNN.com and AP. On a related story, TortsProf blog is reporting today on a New York Times article titled "F.D.A. Is Lax on Oversight During Trials, Inquiry Finds" that states that the FDA "does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting."

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.