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