Illinois Deserves the Truth

Madigan Taking it to Distributor of Flawed Children's Product

You may have heard the phrase “profits over people”, but how about “profits over little people”?  Sounds even worse, doesn’t it?  IL Attorney General Lisa Madigan filed a lawsuit yesterday to force the distributor of a dangerous crib to stop peddling the product once and for all.  The Simplicity bassinet made the news earlier this year when we learned that its flawed design caused at least two infant deaths.  But despite knowing this, distributor SFCA refused to participate in a recall.  Their argument, in a nutshell: ‘Hey, we’re not the ones who designed it’.  Details on the suit:

Madigan’s lawsuit asks the court to prohibit SFCA from selling and distributing the unsafe bassinets in Illinois and to require SFCA to:
* Hire an independent consultant to develop a product safety protocol and review all of SFCA’s product designs to ensure compliance with safety standards;
* Recall all Simplicity bassinets that use the recalled design;
* Provide refunds to retailers who issued refunds or store credits to consumers who returned Simplicity bassinets; and
* Notify the public of CPSC recalls by advertising in newspapers throughout Illinois.

Let’s hope the suit accomplishes all of these objectives.  Go to the website for Kids In Danger for more on children’s product safety.

Illinois News Roundup

Illinois will pocket $3 million from a 33-state settlement over deceptive marketing practices by drug manufacturer Pfizer.

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The FDA announced a new website for consumers looking into current FDA safety efforts.  Visit it at http://www.fda.gov/cder/drugSafety.htm.

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Doctors misdiagnosed a 33 year old Chicago man's heart condition five times, leading to an infection and eventually a permanently disabling stroke.  Last week, the man settled his lawsuit with those responsible.

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Another faulty children’s product recall: this time it’s 1.6 million Delta cribs responsible for several infant deaths.

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The Department of Justice and AGs from 13 states – including neighbors Iowa and Missouri - filed a lawsuit to stop a merger of two of the nation’s top beef packers. 

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The FDA denied Illinois-based Abbott Labs’ request for approval of their extended-release Vicodin.

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Read this sobering article about how seniors have had to watch their legal rights slowly stripped away in recent years.

Memo to U.S. Supreme Court: Immunity Bad! Reading the Newspaper Good!

Cross posted from The Pop Tort by Andy Hoffman

As we count down the days before the U.S. Supreme Court hears arguments in the big “preemption” case, Wyeth v. Levine, the news has been filled with compelling evidence that granting drug companies complete immunity from lawsuits is a truly terrible idea.  Here are a few samples…

Citing a new report by the Government Accountability Office (GAO), the Wall Street Journal reported today  that the Food and Drug Administration (FDA) “is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections.”

A new study out of the Netherlands found that “Nearly one in four recently approved products in a relatively new class of medicines needed some type of regulatory action because of safety issues that arose after they came on the market,” according to the USA Today.

Meanwhile, the Journal of the American Medical Association (JAMA), in anticipation of Wyeth, has written an editorial forcefully condemning blanket immunity for drug and medical device manufacturers.  Here’s an excerpt.

“Given the current imperfect process for approval and the flawed postmarketing surveillance system, the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. Just as with other consumer products that cause harms, consumers (ie, patients) who are injured by defective medical devices or by pharmaceutical products with inadequate warnings of potential harms may have to resort to legal action as recourse for their injuries…Litigation and state tort law ‘provides a system of civil justice designed to compensate patients, deter unreasonably hazardous conduct, and encourage innovation in product design, packaging, labeling, and advertising.”

“Thus, tort law serves in effect as a way to close regulatory gaps in the FDA premarketing approval process and to provide a mechanism for postmarketing surveillance. Moreover, litigation has been a rich source of information about how drug and device manufacturing companies behave, such as with off-label promotion, guest and ghost authorship, and reporting of safety findings. Without the information revealed by the public release of documents in tort liability actions, many of these behaviors would remain unknown, some drug manufacturers’ judgments about safety issues would be hidden from view, review, or oversight, and the FDA would not be able to uncover them either…”

Complete Immunity from Lawsuits – The Lasting Damage of the Bush Administration

Cross post from The Pop Tort by Andy Hoffman

A fantastic new investigative report from the American Association for Justice (AAJ) called “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability”  finds, through documents obtained from a series of Freedom of Information Act requests, that “multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections,” for the purpose of giving total immunity to corporations instead.

This issue – preemption – is one of the hottest civil justice topics today.  The anti-consumer U.S. Supreme Court could soon give its blessing to this massive Bush Administration effort, which was also highlighted today by  the Wall Street Journal.  Check out the article and video detailing how the Bush administration intends to spend its last days in office rewriting “a wide array” of federal rules that could prevent product-safety suits by injured consumers for years to come…  According to the article,

The administration has written language aimed at pre-empting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain medicine. The latest changes cap a multiyear effort that could be one of the administration's lasting legacies, depending in part on how the underlying principle of pre-emption fares in a case the Supreme Court will hear next month.....The use of rulemaking to protect corporations from product liability was discussed from early in the Bush administration, said former Bush domestic-policy adviser Jay Lefkowitz, who was instrumental in the process.

 

Ethics Lesson for Inventor/Surgeon

Ran across this AP story this morning.  A Chicago-area woman has filed suit against a surgeon who implanted a new heart device inside her without her consent.  The device eventually had to be removed, and now the woman may face a heart transplant.  What makes the story unusual is that the surgeon, also the inventor of the device, collects royalties for using it.  He says he gives away the royalty money, but ethically, it seems he still finds himself in a little hot water.

Medical ethics experts say surgeons should inform their patients if they will receive royalties on a device they may use in surgery. Patients involved in medical research also must be told and agree to take part by signing an "informed consent" form.

"It's not hard to tell a patient, 'You may be receiving a device for which the physician receives royalties,'" said Maisel, who also is former chair of the U.S. Food and Drug Administration's Circulatory System Devices Panel. "Then the patient may say, 'I'm not comfortable with that. Pick one of the other devices.'"

Illinois News Roundup

The New York Times reports that 94% of nursing homes violated federal health and safety standards last year.  The rates were high for all types of facilities, but it's no surprise that for-profit homes were the worst offenders.

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Chicago-based Walgreen must pay $10 million for submitting false claims to Medicaid programs in four states.

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The editorial writers at the Southern urge the Department of Justice to investigate the Marion VA hospital deaths for criminal actions.

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The Urbana school district and negligent employees agreed to settle a lawsuit with a girl sexually abused by her former teacher, Jon White.

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A jury recently sided against the Belleville Diocese in a sex abuse trial.  With the diocese trying to wiggle its way out of taking responsibility for its actions, victim advocates want an audit conducted to prove it has the ability to pay.

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Memo to meat-eaters: beginning today, the new 'Country of Origin Label' rule will tell you the nationality of your every entree.

Special Supreme Court Sneak Peak

Cross Post from The Pop Tort by Andy Hoffman

Attention civil justice fans!  The U.S. Supreme Court is about to start a new term, so we thought we’d give you the heads up on some interesting cases coming your way…

Wyeth v. Levine:  We’ve already mentioned that this case was front-page news in the New York Times last week.  Expect to hear a lot more about it in the days ahead.  At stake are tens of thousands of product-liability suits by consumers against drug companies for causing injuries or death, and whether the pharmaceutical industry should have complete immunity when they put unsafe, sometimes lethal drugs on the market.  (Not to mention, Levine’s compensation for her amputated arm!)

Van de Kamp v. Goldstein:  Thomas Goldstein, imprisoned for 24 years on a wrongful murder conviction, says that prosecutors failed to share crucial information about a jailhouse informant’s testimony during his trial, leading to his wrongful conviction.  The justices must decide whether someone in Goldstein’s position may sue prosecutors for damages, or whether the prosecutors are entitled to absolute immunity. 

Fitzgerald v. Barnstable School Committee: This case involves a kindergarten student in Hyannis, Mass., who was sexually harassed on the school bus by an 8-year-old boy. The parents sued the school district over their daughter’s treatment.  The suit was based on several different laws, one of which was federal Title IX, which prohibits sex discrimination in federally funded schools. Title IX doesn’t allow individual lawsuits, so the issue is whether a suit can still be brought under other laws, including the U.S. Constitution.

Ashcroft v. Iqbal: the court will consider whether Attorney General Ashcroft and FBI Director Robert Mueller can be “sued damages by the Muslim men who were rounded up and imprisoned under harsh conditions in the immediate aftermath of the terrorist attacks of Sept. 11, 2001.”  The government settled with one victim, but another, “a 33-year-old cable television installer on Long Island at the time of his arrest” who was tortured in a Brooklyn prison, is pursuing his case.

Product Safety Law Already Making a Difference

Last year was dubbed the year of the recall, but 2008 has had its share of product disasters.  This week, the CPSC issued a safety warning after two babies died inside a popular bassinet.  Not surprisingly, there’s now a question of whether the product has a fatal design flaw.

The U.S. Consumer Product Safety Commission, which regulates most children's products, knew about the first baby's death within days after it happened last September in Missouri but did not recall the product. Then last Thursday, a Kansas baby died in a similar bassinet.

The deaths once again raise questions about the safety commission's response to deadly hazards, the subject of a Pulitzer Prize-winning Tribune investigation last year.

The CPSC, following inquires from the Tribune and internet reports of the baby's death last week, has issued a safety alert for Simplicity 3-in-1 and 4-in-1 convertible "close-sleeper" bassinets, "due to the serious threat these bassinets pose to babies. Parents, the agency said, should stop using the bassinets immediately. Such an alert sidesteps a voluntary recall to more quickly alert the public of a potentially deadly product.

It’s important to note that the only reason this safety warning was possible was because of the landmark Consumer Product Safety legislation passed earlier this summer.  The product safety law increased the CPSC's funding, expanded their oversight powers, and established higher safety standards in children's toys.  If the CPSC had had the ability to respond in this way after the initial accident in Missouri, the baby in Kansas may not have had to die.  And, who knows if any of us would have heard about this dangerous product if the legislation never had been passed?

Lawsuits Help Guarantee Drug Safety, Doctors Say

Cross posted from The Pop Tort by Amanda

Can we just reflect on this headline for a moment?  Nothing to take away from the important views coming from the New England Journal of Medicine, which has filed a crucial brief in the U.S. Supreme Court arguing against immunity for the drug industry.  But when was the last time doctors have been this honest about the importance of the civil justice system’s critical “deterrence” function – providing the financial incentive for companies and professions to act safely.  (And, by the way, this is aside from the fact that doctors  have been incredibly hypocritical when it comes to filing lawsuits themselves.

Before someone starts jumping through hoops trying to find some way to differentiate drug company misconduct from the medical malpractice itself, we have another incredible piece from Besty McCaughey, New York’s former Lt. Governor in tort-reform Governor George Pataki’s’ administration, arguing that juries are right to hold hospitals liable for the epidemic of infection there because lawsuits, and new Medicare rules, provide the incentive for hospitals to fix the problem!  So here’s what she says:

Hospitals being sued are saying that their infection rates are within national norms. But for most infections, the only acceptable rate is zero...

Medicare calls certain device-related bloodstream infections, urinary tract infections and surgical infections after orthopedic and heart surgery "never events." Starting in October, Medicare will stop reimbursing hospitals for treatment of these infections. Hospitals will be barred from billing patients for what Medicare doesn't pay, forcing them to take a loss. Next year Medicare will add other types of infections to the list of "never events."

No wonder Medicare calls these infections "never events." Why should jurors reach a different conclusion in a lawsuit?

We have the knowledge to prevent infections. What has been lacking is the will. A recent survey from the patient-safety organization Leapfrog found that 87% of hospitals fail to consistently practice infection prevention measures. Insurance companies that sell liability coverage to hospitals could change that by offering lower premiums to hospitals that rigorously follow infection-prevention protocols.

To be sure, lawsuits are not the best way to improve patient care. Many verdicts are unjustified, and few truly injured patients find a lawyer to take their case. Still, the coming wave of lawsuits, as well as financial incentives from Medicare and insurers, will fight complacency about hospital hygiene.

Not a perfect ending, but pretty damn close. 

New CJ&D Report on Playground Safety

The Center for Justice & Democracy has a new report out about playground safety, taking on the views of corporate groups that argue that newer playgrounds aren't "fun" anymore and therefore we should go back to the days of prison-style steel structures from years ago - before regulation and lawsuits made playgrounds "boring".  This, of course, is completey untrue, as this report shows.  Release and Report