Tuesday, December 11, 2012

Lawsuit concerning burns from hot tea bears similarities to '92 coffee case.


www.med-art.com

The Detroit Free Press (12/10, Allyn, 280K) reports that a year ago, a passenger on a Southwest flight bound for Houston spilled hot water for a cup of tea into her lap and "suffered skin blisters and second-degree burns, according to her attorney Rob Anderson, who filed an $800,000 negligence lawsuit against Southwest on her behalf." According to the Free Press, the plaintiff did not have a drop-down table on which to place her cup of tea because she was sitting in the front row. The article notes that "the case echoes one involving a New Mexico woman who won a settlement after spilling a piping hot cup of McDonald's coffee on herself in 1992." The story goes on to say that although the 1992 case was cited by many advocates of tort reform as an example of greed and abuse in the civil justice system, many legal experts argue that the facts and outcome of the case were distorted by time and by propaganda. Daniel Clayton, a medical malpractice attorney, "said the propaganda about the case has helped marshal public opinion in favor of lawsuit reform," adding that such legislation ends up hurting those who have been harmed in some way. The article also describes the coffee case and its effects in further detail.

Thursday, December 06, 2012

Portable baby recliner comes under scrutiny following five infant deaths.


www.med-art.com

The AP (12/6, Kerr) reports that "the government is taking action against the makers of a portable baby recliner called the Nap Nanny after five infant deaths." The story notes that the US Consumer Product Safety Commission "filed an administrative complaint Wednesday alleging that the new model of the Nap Nanny, called the Chill, and two earlier versions 'pose a substantial risk of injury and death to infants.'" The CPSC is now "seeking an order that would require Nap Nanny maker Baby Matters LLC of Berwyn, Pa., to notify the public about what the agency deems a serious product defect," and it also wants the firm to offer consumers a full refund.
        The Boston Globe (12/6, Lipka, 250K) "Consumer Alert" blog reports that "The lawsuit was filed today against Baby Matters, LLC, of Berwyn, Pa., which makes Nap Nanny and Nap Nanny Chill. The CPSC said it was aware of the deaths of four infants in Nap Nanny Generation Two recliners and another in a Nap Nanny Chill." The blog post adds, "The first set of Nap Nanny recliners were recalled in July 2010 - and consumers were offered an $80 coupon for a newer model recliner as well as improve warnings and instructions."
        CNN (12/6, Sperry) reports on its website that "the Nap Nanny recliner is designed for sleeping, resting and playing and includes a shaped foam base with an inclined indentation for the baby to sit and a fitted fabric cover with a three-point harness," according to the CPSC. CPSC Commissioner Nancy Nord is quoted as saying, "My heart goes out to the parents and families of children who are injured or lose their lives in incidents associated with consumer products."
        USA Today (12/6, O'Donnell, 1.71M), Reuters (12/6) and the NBC News (12/6) website also cover this story. 

Wednesday, November 28, 2012

Another person dies from poisonous mushrooms at senior care facility.


www.med-art.com

The AP (11/27) reports that "a fourth person has died from eating a soup made with poisonous mushrooms earlier this month at senior care facility in Northern California, authorities said Tuesday." Local police authorities have identified the latest victim as 92 year-old Dorothy Mary Hart. The article points out that "three others at the six-bed Gold Age Villa care facility in Loomis died from eating the mushrooms in what sheriff's investigators characterize as an accident." According to the AP, "all of the victims were sickened Nov. 8, including the caretaker who made the soup after picking mushrooms in the backyard of the facility." California's Department of Social Services is currently investigating the incident.
        In its "L.A. Now" blog, the Los Angeles Times (11/28, Pool, 692K) notes that "wild mushrooms are in season now, including poisonous North American amanitas that resemble edible mushrooms that are popular in Asia. White with a sprinkling of brown over the cap and known as the 'death cap,' the mushrooms sicken hundreds each year in California." According to the blog, "health officials say toxins in the mushrooms cause liver damage and can lead to comas and, occasionally, death, especially with older people." 

Thursday, November 15, 2012

Caffeinated energy drink cited in reports of 13 deaths over last four years.


www.med-art.comThe Wall Street Journal (11/15, Esterl, Subscription Publication, 2.08M) reports that the US Food and Drug Administration on Wednesday acknowledged that it has received reports of 13 deaths during the last four years that may be related to the caffeinated energy drink 5-Hour Energy, which is distributed by Living Essentials LLC. According to the Journal, the FDA has said that there is no evidence so far linking the drink to deaths or hospitalizations, but that the agency is continuing to investigate the reports.

        The New York Times (11/15, Meier, Subscription Publication, 1.23M) reports that since 2009, "5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of F.D.A. records reviewed by The New York Times showed." The Times mentions that this disclosure of reports marks "the second time in recent weeks that F.D.A. filings citing energy drinks and deaths have emerged." The FDA acknowledged last month that it had received five fatality filings mentioning the energy drink Monster Energy. 

Friday, November 09, 2012

Gas grills recalled over potential fire and burn hazard.



The Wall Street Journal (11/7, Gara, 2.08M) "Corporate Intelligence" blog reports that the Master Forge Gas Grill, made by Chinese firm Guang Vanward Electric and sold at Lowe's stores across the US, is being recalled, according to a statement from the US Consumer Product Safety Commission. As the blog post describes, the grill is being recalled over concerns that, if improperly installed, the grill could pose a fire and burn hazard. The grill's hose connecting the gas tank and regulator to the burner control can touch the burner box and cause the hose to melt and rupture when the grill is lit if it is not installed properly.
        The Jackson (MS) Clarion Ledger (11/7, Moak, 61K) "Consumer Watch" blog notes that "the four-burner Master Forge Gas Grills were sold for about $270.00 from May 2011 through May 2012." The blog post adds, "The CPSC recommends that owners should check the grill to make sure that the gas hose runs along the outside of the grill cabinet and passes through the round hole in the side panel."
        WTVQ-TV Lexington, KY (11/7) reports that the recall "involves Master Forge four-burner gas grills with a single-door base. 'Master Forge' is written on the grill's hood. The model number GD4825 is located on a label inside the door of the grill's base." 

Tuesday, October 23, 2012

Incidents of exploding beer kegs prompt action by brewers.



The Foster's Daily Democrat (10/23, 20K) reports that in a series of recent cases at several breweries involving plastic beer kegs exploding, "the breweries were using plastic kegs manufactured by a company called Plastic Kegs America" in each instance. One such incident in Portsmouth, New Hampshire, resulted in the death of a 26-year-old employee of Redhook Ale Brewery after being struck by debris. The story notes that "in August, an unidentified brewery also submitted a report to the Consumer Product Safety Commission detailing explosions of two plastic kegs, with photographic evidence." The Daily Democrat adds, "The tragedy in Portsmouth has also prompted the largest brewery trade group in the country to begin scrutinizing plastic kegs."www.med-art.com 

Monday, October 22, 2012

Spray-on sunscreen recalled due to fire danger.


www.med-art.com

The AP (10/20, 629K) reported, "The maker of Banana Boat sunscreen is recalling some of its spray-on products after reports that a handful of people have caught on fire after applying the lotion and coming in contact with an open flame." On Oct. 19, Energizer Holdings announced that "it is pulling 23 varieties of Banana Boat UltraMist sunscreen off store shelves because of the risk of the lotion igniting when exposed to fire." Included in the recall are "aerosol products like UltraMist Sport, UltraMist Ultra Defense and UltraMist Kids."
        The Arizona Republic (10/22, Sanchez, 322K) reports, "The Food and Drug Administration acknowledges there is alcohol in these spray sunscreen products. In a statement, Energizer Holdings said the problem appears to be with the products' spray valve." Consumers using the product "may overapply the product, and, as a result, the sunscreen takes longer to dry, which raises the risk of flammability."
        In the Seattle Times (10/21, 252K) "The Wrap" column, Ron Judd observed, "Five cases of burns have been reported in the past year - all by people who failed to read the clear warning about keeping the sunscreen away from 'sources of ignition.'" Reuters (10/20, Wohl) also covered the story. 

Friday, October 19, 2012

Schools told to discard Smucker's Uncrustables over salmonella concern.


www.med-art.com

The AP (10/19) reports Federal and state officials have asked "school lunch programs" to discard any Smucker's Uncrustables sandwiches because they "might contain peanut butter" produced by Portales, New Mexico-based Sunland Inc., which the FDA placed under recall "because of potential salmonella contamination." USDA spokesperson Alyn Kiel said that the USDA "coordinated with state agencies to immediately notify individual school districts." Smucker's spokesperson Maribeth Badertscher said Thursday that the JM Smucker Co. distributed a "'limited production runs' of 72-count bulk packs" of Smucker's Uncrustables sandwiches to "schools under the National School Lunch Program." The move is one of precaution, as Badertscher explained that the "Orrville, Ohio-based company tests all the incoming USDA-supplied peanut butter" and it performs additional tests on "finished products before distributing them." Badertscher said the recalled lots "have either expired or will expire soon." Notably, 35 illnesses in "19 states have been linked to Sunland."
        Separately, the AP (10/19) notes that Sunland, which "operates the country's largest USDA certified organic peanut processing plant, first closed its peanut butter plant late last month," after the FDA and the CDC "linked a salmonella outbreak to peanut butter it produced for Trader Joe's." The company's "roasting and processing facilities were also closed and the recall expanded this month to include peanuts and other nut butters after the FDA found salmonella at the plant." Although the "illnesses have only been linked to the Trader Joe's product, Sunland Inc., which manufactures products for Target, Costco and other major retailers, has recalled everything made in the plant since March 2010 - a total of 240 products." Notably, the FDA classified peanut butter as a "high-risk food" and bolstered its investigations of processing plants "after a 2007 outbreak that sickened more than 400 people who ate peanut butter processed at a ConAgra facility in Nebraska." 

Thursday, October 18, 2012

Target recalling 6,000 sets of children's fleece clothing over concerns about lead levels.


www.med-art.com

Consumer Reports (10/18) notes, "More than 6,000 sets of children's fleece jackets and shirts with Disney characters are being recalled by retail giant Target. According to the Consumer Product Safety Commission, the Disney fleece sets sold at Target have zippers with unacceptable levels of lead." The article mentions that "earlier this year, the Center for Disease Control and Prevention lowered the limits of children's BLL to 5 micrograms per deciliter of blood." 

Wednesday, October 17, 2012

First patient diagnosed with fungal meningitis files suit against NECC.



The Tennessean (10/17, Roche, Wilemon, 136K) reports, "The widow of Thomas Rybinski, the first patient diagnosed with fungal meningitis in the national outbreak, filed suit against new England Compounding Center on Tuesday. Colette Rybinski of Smyrna is asking a Davidson County jury to award her $15 million in damages. Her lawsuit is the second one filed this week by Nashville attorney Randy Kinnard against the Massachusetts-based company" linked to the meningitis outbreak. The lawsuit Kinnard filed Monday "was on behalf of Janet Russell, who remains hospitalized, and her husband, Robert Russell. The Russells are also seeking $15 million. Both suits were filed in circuit court."
        Howell man avoids meningitis that killed wife. The Detroit News (10/17, 128K) reports, "A man whose wife died in the national meningitis outbreak has good news: Tests show he doesn't have the illness. George Cary received pain injections and was treated at the same Brighton-area clinic as his late wife, Lilian Cary, who died Sept. 30. Cary had a spinal tap to check for meningitis more than a week ago." He confirmed on Tuesday, "there's no evidence of meningitis." Meanwhile, the family of a "Howell woman has filed a class-action lawsuit in federal court" against the NECC. The suit was "filed Monday by the husband of Brenda Bansale in US District Court in the Eastern District of Michigan." 

Tuesday, October 16, 2012

F.D.A. Warns of Further Risk From Tainted Drugs




www.med-art.comThe
 Food and Drug Administration reported on Monday that the company’s products may have also caused other types of infections in patients who have had eye operations or open-heart surgery.Health officials are warning that more people may be at risk from contaminated drugs made by a Massachusetts company linked to a growing meningitis outbreak.
The new warning is based on only two cases, and it was not known for sure whether the company’s drugs had caused the infections. Officials did not say how many people may be at risk, but the number is potentially significant, and a statement from the agency warned doctors, “The F.D.A. recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today’s announcement.”
The company, the New England Compounding Center in Framingham, Mass., has already been linked to a meningitis outbreak that has killed 15 patients and infected 199 others in 15 states. The drug implicated in that outbreak is methylprednisolone acetate, asteroid used in spinal injections for back and neck pain. The drug is believed to have been contaminated with a fungus called Exserohilum, which causes a type of meningitis that is severe but not contagious.
Now, several other drugs made by the company are also possible suspects in infections. A heart-transplant patient exposed to a product that is used during open-heart surgery developed a chest infection with a different fungus, Aspergillus, the Food and Drug Adminstration said. The product is a cardioplegic solution, which is chilled and poured into the opened chest to stop the heart while surgeons work on it. Such solutions have caused problems in the past, according to the F.D.A., which reported that it issued a warning letter in 2006 to a firm that had produced a solution that caused fatal infections in three heart-surgery patients.
The agency emphasized that the heart case was still being investigated, and that it was possible that the infection had come from a source other than the cardioplegic solution. A second heart-surgery patient who had an Aspergillus infection and was initially reported to have received a solution made by the New England Compounding Center had been treated with solution made by another company.
Another patient contracted meningitis after receiving a spinal injection of another one of the company’s steroid solutions, triamcinolone acetonide.
The statement from the F.D.A. also warned of possible contamination in drugs made by the company that are injected into the eye or used during eye surgery.
The agency is recommending to doctors that all patients exposed to any of these products from the New England Compounding Center be notified of the risks and told to be on the alert for signs of infection, even though it is not clear whether the products caused the two additional infections.
Meningitis symptoms that patients are being told to watch for include feverheadache, neck stiffness, nausea, vomiting, sensitivity to light and altered mental status.
Symptoms of other infections may include fever, swelling, increasing pain, and redness and warmth at the injection site. Eye infections may cause vision problems, pain, redness in the eye or discharge from the eye. Patients infected during heart surgery may havechest pain or drainage from their incisions.
The New England Compounding Center has shut down and recalled all its products. At least five states, besides Massachusetts, have suspended the company’s license: Michigan, New Hampshire, Ohio, Maryland and Virginia.
Senator Richard Blumenthal, a Democrat from Connecticut, said on Monday that the fresh information “further underscores the need for an immediate criminal investigation.” The Massachusetts attorney general’s office has declined to comment.
A spokeswoman for the New England Compounding Center said on Monday that the company would “continue to cooperate with the F.D.A.”
The meningitis outbreak has opened a debate among legal scholars about how much authority the Food and Drug Administration has over the compounding industry.
Compounding — traditionally a practice in which pharmacies mix medicine for an individual patient — is regulated by states. But in recent decades, some pharmacies began to push the legal limits, becoming mini-drug companies largely out of reach of federal authorities. Federal officials say they do not know what share of the compounding market large-scale pharmacies represent.
“Our drug experts went into some of these operations, and they said, ‘Whoa, these don’t look like ordinary pharmacies,’ ” said Gary Dykstra, who was the F.D.A.’s deputy associate commissioner for regulatory affairs in the 1990s.
Some scholars argue that the agency had more power than it is willing to admit and simply failed to use it.
“They have adequate authority to act, full stop,” said Peter Barton Hutt, a lawyer at Covington & Burling L.L.P. in Washington, who has written extensively on compounding law. “The issue is priorities and resources. Large-scale compounding expanded because the F.D.A. was focusing on other things.”
Even when the United States Supreme Court overturned the first clear legal definition of compounding in 2002, the F.D.A. could still invoke the 1938 Food Drug and Cosmetic Act, which forbids new, unapproved drugs to be sold across state lines, Mr. Hutt argued. The act was passed after more than 100 people died from an antibiotic that was prepared using a poisonous solvent.
But others contended that the agency had been more timid in pursuing compounders since the Supreme Court decision, in part because building a case meant figuring out how to defend it in court, and anchoring an argument is difficult because there are no laws or regulations formally defining compounded medications.
“There’s no bright line in statute distinguishing what the F.D.A. can regulate,” said Daniel Carpenter, a political scientist at Harvard University who specializes in regulatory law. “The only real attempt to draw one was in 1997, and that was struck down. Now to make a case they have to confront an army of industry lawyers.”
Politics were also important. Mr. Dykstra said the industry was adept at applying political pressure, which combined with the litigation, he argued, drained the enthusiasm in F.D.A. leadership to investigate.
“All the inspection work and the amount of time the F.D.A. was putting into it started to dry up,” said Mr. Dykstra, now a professor at the University of Georgia College of Pharmacy.
According to the Center for Responsive Politics, the main trade association, theInternational Academy of Compounding Pharmacists has spent about $1.1 million on lobbying since 2000. It has also contributed, through a political action committee, to lawmakers’ campaigns
.

Monday, October 15, 2012

A Factory’s Closing Focuses Attention on Tort Reform



Crusading against what it considers frivolous lawsuits, the United States Chamber of Commerce has had no shortage of cases to highlight, like the man suing a cruise line after burning his feet on a sunny deck or the mother claiming hearing loss from the screaming at a Justin Bieber concert.
Brandi Simons for The New York Times
Rocky Flick, Blitz’s former chief executive.
Tim Shaffer for The New York Times
Diane Breneman, a lawyer in several cases against Blitz, accused the company of putting money before safety.
Now, the lobbying group’s Institute for Legal Reform is showing a 30-second commercial that uses Blitz USA, a bankrupt Oklahoma gasoline can manufacturer, to illustrate the consequences of abusive lawsuits. The ad shows tearful workers losing their jobs and the lights going out at the 46-year-old company as a result of steep legal costs from lawsuits targeting the red plastic containers, according to the company and the institute.
The closing of the 117-employee operation this summer became a rallying point for proponents of tort reform. But the commercial ducks the complexities of the product liability cases surrounding Blitz by making no mention of the dozens of casualties linked to explosions while people used the cans in recent years. In interviews, the company and the lawyers suing it seek to frame the conflict in stark terms: devious lawyers with spurious claims piling on a valuable manufacturer, or a greedy company hurting consumers by refusing to fix a defective product.
The Blitz cases show the inherent conflicts “between makers of products that have some hazard or danger and consumers who on occasion are injured by those products,” said Marshall S. Shapo, an expert on product liability at Northwestern University School of Law. “It is an ancient rivalry that will go on forever.”
The suits generally make the claim that the cans were susceptible to “flashback” explosions caused when gasoline vapors outside the cans ignited and followed the vapor trail back into the container. The lawyers argue that the company should have installed “flame arrester” shields at the mouth of the containers to prevent explosions.
Blitz executives note that the company, which was the nation’s leading gas can producer, sold more than 14 million cans a year over the last decade, with fewer than two reported incidents per million cans sold. The company said the most serious incidents usually involved obvious misuse of the cans, like pouring gasoline on an open fire.
Frank J. Vandall, an Emory University law professor, said there was probably no way Blitz could have avoided at least some of the lawsuits, although he questioned why the company paid settlements if it thought it could win in court.
“There is no way you can avoid liability for a can like this,” Mr. Vandall said, “because there is going to be injury, and when there is injury, there is going to be lawsuits.”
Blitz has been sued 62 times since 1994, according to the company. Only two cases have made it to court; the others were settled or dismissed, or were unresolved at the time of the bankruptcy. The company says the cases cost it $30 million in legal fees. Insurance companies paid well over $30 million more in settlements and other payouts.
The gas can explosions can be powerful. In one case, two emergency workers heard an explosion more than two miles away. In a 2010 test, a federal fire research laboratory found that a two-gallon gasoline container could produce a flame jet 13 feet long.
Chad Funchess, a volunteer firefighter from South Carolina, was seriously burned over half his body in 2007 when he was filling up a chain saw in the back of his convenience store and the can exploded. In his lawsuit, Mr. Funchess said there was no open flame to set off the blast. But the company said the store was razed before it could investigate what happened. Mr. Funchess said his fiancée left him when he was hospitalized. The case was stayed when the company filed for bankruptcy, and is one of 36 cases still open.
In the one case Blitz lost, in 2010, a Utah jury awarded more than $4 million to the father of a 2-year-old girl killed when a Blitz can exploded after the father, David Calder, tried to start a fire in a wood-burning stove in his trailer home by pouring gasoline on the flame.
Mr. Calder argued successfully that the explosion would not have happened had the can been equipped with a flame arrester, a piece of wire mesh placed at the opening of a container that blocks flames from entering. The company is appealing, claiming that the can was misused and that the child’s death was a result of a gas explosion outside the can, not inside.
Blitz won the other case that went to trial, in 2008, involving a Texas man named Brody Green, who died in an explosion when he poured gasoline from a can onto a fire. But last year, a Texas court forced the company to pay Mr. Green’s mother $250,000 for failing to provide all the documents it had on flame arresters before the trial. The court also said its order must be provided to every other plaintiff who sued Blitz over the last two years. Again, the company is appealing.
Among the documents Blitz had neglected to disclose was a 2005 internal memo from Rocky Flick, the company’s chief executive, titled “My Wish List” and “Expectations for Gas Cans.” In it, Mr. Flick appears to request that in two years the company “develop and introduce device to eliminate flashback from a flame source.”
United States District Judge T. John Ward ruled that, had the memo been disclosed in the original case, it “would have hurt, if not potentially eliminated, Blitz’s defense that they did not add a flame arrester because it would not have been useful.”
Diane Breneman, a lawyer who has been involved in several cases against Blitz, claims the company dropped its plan to add the flame arrester around the time it was acquired by theprivate equity firm Kinderhook Industries in 2007. The company, she said, was more concerned with saving money than lives, and was “guilty of greed and completely irresponsible corporate behavior.”
Mr. Flick, the chief executive, countered: “We’re not the evil empire. We just make gas cans. It helps their case to demonize us.”
The “wish list,” he said, “was a handwritten document that should have been produced in the Green trial but was stuck in a different file. It proves nothing.”
He said that the list was not a definitive plan and that the company was never against adding arresters. But Blitz officials said that after conferring with experts, they decided the devices would lead to other safety issues, including giving consumers a false sense of confidence when pouring gas on fires.
“There was no proven device that we could get that we thought would prevent somebody from getting hurt when they elected to pour gasoline on a fire,” Mr. Flick said.
Typically, businesses want to lessen government regulation. But Blitz and the trade group that represents manufacturers of portable gasoline containers have repeatedly asked theConsumer Product Safety Commission to regulate their products, requesting last year that the agency either prohibit or require use of the arresters. The commission denied the request on the ground that the petition did not provide supporting documentation.
“We are always in favor of any approach, including the use of flame arresters, that can provide additional safety protections for children and adults,” said Scott Wolfson, a spokesman for the commission.
Mr. Flick said Blitz was forced to settle cases, mostly against its will, by a series of insurance companies. “We’d get an insurance company that would insure us for one year, and they would settle and then drop us,” he said. “Then we’d have to get another insurance company, and they would do the same thing.”
Ms. Breneman countered that “insurance companies don’t settle when they can win in court, and they have no problem telling plaintiffs to take a hike.”
A decade ago, Mr. Flick said, the company would face one or two lawsuits a year. The number grew to six or seven a year, and finally to 25 or so last year when Blitz filed for bankruptcy.
Smaller companies that have taken Blitz’s place are now facing lawsuits, too.
“It’s the same thing with asbestos litigation, with 80-plus companies that have gone bankrupt because of asbestos litigation,” said Lisa A. Rickard, president of the Chamber’s Institute for Legal Reform. “They settle, they settle, they settle, and there is a feeding frenzy of lawyers.”
But the Blitz factory, in Miami, Okla., may be reopening soon. Scepter, a Canadian plastics manufacturer, bought the operation for $9.5 million and may rehire at least some of the laid-off workers. Philip Monckton, a Scepter vice president, said the company did not use flame arresters on the cans it made in Canada. But he said it might decide to use them on cans that it will produce in Oklahoma, depending on the results of technical studies. The company settled a lawsuit against it in the United States last year.
“We have concerns about expanding our presence,” Mr. Monckton acknowledged, “but we are going to make a product at the highest levels we know how.”

Friday, October 12, 2012

Google asks judge to seal patent talk records

Google Inc. (GOOG)’s Motorola Mobility unit asked a judge to seal “highly confidential” records of its patent-licensing talks with Samsung Electronics Co. that appeared in the South Korean company’s intellectual property lawsuit against Apple Inc. in California.
The document at issue in a hearing yesterday before U.S. Magistrate Judge Paul Grewal in San Jose, California, is a summary of a licensing negotiation between Motorola and Samsung that took place several weeks before the two companies reached a 2000 agreement, according to a court filing by Motorola Mobility. It was filed as an exhibit supporting Apple’s attempt to depose Samsung witnesses, according to the filing.
The document reveals a “pattern of financial offers” in the cellular cross-licensing negotiations and may reveal monetary terms, license rates, the direction of payments, names of licensed products and technologies, and the geographic scope of the deal, according to the filing. The information is “highly sensitive” because other firms could use it unfairly to gain leverage in their own negotiations with Motorola Mobility, the company said.
During negotiations for patent licenses, competitors “negotiate concerning the relative values of their respective patent portfolios as well as the values of other terms in the agreement,” according to the filing.
An Aug. 24 jury verdict in San Jose federal court in which Cupertino, California-based Apple won $1.05 billion in damages from Suwon, South Korea-based Samsung is part of a global fight for dominance in the $219 billion global smartphone market. The world’s two biggest makers of high-end phones have accused each other of copying designs and technology for mobile devices and are waging patent battles on four continents.
Google is based in Mountain View, California.
The case is Apple Inc. v. Samsung Electronics Co. (005930) Ltd., 11- cv-01846, U.S. District Court, Northern District of California (San Jose).www.med-art.comwww.med-art.com

Thursday, October 11, 2012

Kansas Supreme Court upholds medical malpractice cap


www.med-art.com

   A five-member majority of the Kansas Supreme Court today upheld the constitutionality of a Kansas statute limiting a medical malpractice plaintiff's jury award for noneconomic damages to $250,000.
   The Kansas Legislature enacted the damages limitation in 1988 as part of an effort to restrict personal injury lawsuits based on a belief that a statutory cap would reduce medical malpractice insurance rates and make insurance more readily available to physicians and others in the state. Two justices dissented from the majority decision.  
   The medical malpractice plaintiff, Amy C. Miller, sued Dr. Carolyn N. Johnson in Douglas County District Court for mistakenly removing her left ovary during a surgery intended to take the right ovary. The jury found the doctor at fault and awarded Miller $759,679.74 in damages.
   But $575,000 of that award was for noneconomic loss subject to the $250,000 limit, so the trial judge lowered the judgment to comply with the statute. Non-economic loss typically includes pain and suffering, mental anguish, injury and disfigurement not affecting earning capacity. Miller appealed and challenged the statute's constitutionality, as well as the judge’s post-trial ruling that reduced her claim for future medical expenses. Dr. Johnson also appealed, claiming Miller failed to prove malpractice caused her injuries and that the trial judge improperly restricted expert witness testimony. 
   In the court's majority decision, Justice Dan Biles acknowledged that the constitutionality of statutory caps on jury awards was "a long-standing and highly polarizing question nationwide."  He noted two other Kansas Supreme Court decisions had reached contradictory results on the subject in 1988 and 1990. But in the decision filed today, the majority held that K.S.A. 60-19a02 did not violate a medical malpractice plaintiff's right to a jury trial, right to remedy by due course of law, right to equal protection under the law, or the separation of powers doctrine under the Kansas Constitution.
   Justices Carol A. Beier and Lee A. Johnson dissented in part. They would have held that the statutory cap violated Miller’s constitutional rights to trial by jury and remedy by due course of law, while reserving judgment on the equal protection challenge. All seven members of the court agreed the statute did not violate the constitutional separation of powers doctrine.
   In another portion of the decision that drew unanimous agreement, the Supreme Court reinstated $100,000 in future medical expenses the jury awarded Miller that had later been struck by the trial judge in post-trial rulings. The Supreme Court held there was sufficient evidence to support the jury's determination for those future medical expenses.
   The court’s decision means Miller's damages award will be set at $84,679.74 for medical expenses incurred up to trial, $100,000 for future medical expenses, and $250,000 for noneconomic damages. The Supreme Court unanimously rejected Dr. Johnson's arguments in her appeal. It remanded the case to Douglas County District Court for further proceedings to conform to the Supreme Court's decision.

Death rises to 12, with nearly 120 sickened in rare meningitis outbreak


www.med-art.com(CNN) -- Florida recorded its first death connected to the outbreak of a rare, noncontagious form of meningitis, raising he toll Tuesday to a total of 12 fatalities nationwide.
Earlier in the day, federal authorities reported 11 deaths and 119 persons becoming ill in the outbreak, the Centers for Disease Control and Prevention announced Tuesday. Those figures were an increase from Monday's count of eight deaths and 105 illnesses.
Florida health officials also reported a total of six cases connected to the outbreak -- all in Marion County.
That figure -- one more than federal officials have so far counted in Florida -- means that a total of 120 persons nationwide have become ill, according to state officials.
The outbreak is linked to contaminated steroid injections, and as many as 13,000 people may have received the medicine between May 21 and September 24, the CDC said.
The death of a 70-year-old Florida man occurred in July, prior to the discovery of the contamination, the state's health department said.
"Our disease investigation process discovered the link of this individual's death to the contaminated medication," State Surgeon General and Secretary of Health Dr. John Armstrong said. "We will continue to work closely with our health partners to ensure that individuals who may have received the contaminated medicine are treated immediately."
The number of reported cases grew significantly in recent days as federal and state authorities continued to investigate the outbreak.
Tennessee is the hardest-hit state, with 39 infections and six deaths, according to the CDC.
Of the remaining deaths, three occurred in Michigan and one each in Maryland and Virginia, the CDC said.
Patients contracted the deadly fungal meningitis after being injected in their spines with a preservative-free steroid called methylprednisolone acetate that was contaminated by a fungus. The steroid is used to treat pain and inflammation.
The New England Compounding Center (NECC), the Massachusetts-based pharmacy that made the contaminated injections, voluntarily recalled three lots of the injected steroid last week.
On Tuesday, President James T. DeVita of the Massachusetts State Board of Registration in Pharmacy sympathized with the individuals affected by the contamination.
"On behalf of the board, I want to express our deepest sympathy for the patients and the families who have been impacted by this tragedy," DeVita said, reading from a statement during a board meeting. He added that "NECC voluntarily surrendered its license and recalled all implicated products."
On Saturday, the pharmacy announced a voluntary nationwide recall of all its other products as well. NECC said the new recall was being announced out of an abundance of caution and that there is no indication any of its other products are contaminated.
The Food and Drug Administration has already asked doctors, clinics and consumers to stop using any of the pharmacy's products. Last week, the pharmacy voluntarily surrendered its license to operate until the FDA investigation into the contamination is complete.
Health officials say 75 medical facilities in 23 states received the contaminated steroid injections from NECC.
Other than Tennessee, deaths have been reported in Maryland, Michigan and Virginia.
There are also confirmed cases of the disease in Florida, Indiana, Minnesota, North Carolina, and Ohio.
The other states that received the contaminated products are California, Connecticut, Georgia, Idaho, Illinois, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, South Carolina, Texas and West Virginia.
Federal health inspectors began inspecting the NECC plant October 1. Inspectors found foreign particles in unopened vials, and after testing one of them, they determined the substance was a fungus.
The investigation is still under way.
Nearly 10% of drugs administered in the United States come from compound pharmacies, according to a 2003 Government Accountability Office report.
Drugs manufactured by compound pharmacies do not have to go through FDA-mandated premarket approval. Instead, state health pharmacy boards are responsible for the oversight and licensing of these pharmacies.
Compound pharmacists create customized medication solutions for patients for whom manufactured pharmaceuticals won't work, according to the International Academy of Compounding Pharmacists.
Meningitis is an inflammation of the protective membranes covering the brain and spinal cord. It is usually caused by an infection, frequently with bacteria or a virus, but it can also be caused by less common pathogens like fungi, according to the CDC.
Fungal meningitis is very rare and, unlike viral and bacterial meningitis, is not contagious.
Symptoms of fungal meningitis are similar to symptoms of other forms of meningitis, but they often appear more gradually and can be very mild at first, the CDC says.
Dr. William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University Medical Center, told CNN that fungal infections are not usually mild. He said when a fungus invades small blood vessels, it can cause them to clot or bleed, which can lead to symptoms of small strokes.
In addition to typical meningitis symptoms like headache, fever, nausea and stiffness of the neck, people with fungal meningitis may also experience confusion, dizziness and discomfort from bright lights. Patients might just have one or two of these symptoms, the CDC says.
Health officials say any patients who received an injection at one of the facilities beginning May 21 and who began showing symptoms between one and three weeks after being injected should see their doctor right away.
The earlier a patient gets treatment, the more likely he or she will survive.
Patients are treated with anti-fungal medication, which is given intravenously, so patients have to be admitted to the hospital, the CDC said. Patients may need to be treated for months.
The FDA is urging anyone who has experienced problems following an injection with the NECC product to report it to MedWatch, the FDA's voluntary reporting program, by phone at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Monday, October 08, 2012

Meningitis outbreak exacerbates over weekend.


www.med-art.com

Extensive media coverage of the meningitis outbreak continued throughout the weekend as the Centers for Disease Control and Prevention reported that the number of related illness increased from 35 to 91; and the number of deaths increased from five to seven.
        ABC World News (10/7, lead story, 2:35, Muir) reported, "That deadly outbreak of meningitis...is quickly spreading. All because of those steroid shots to the spine for patients who thought they were getting relief from their pain." ABC (Greenblatt) added, "The pharmacy at the center of the meningitis outbreak today announced a voluntary recall of every product it makes saying 'this action is being taken out of an abundance of caution due to the potential risk of contamination.'"
        NBC Nightly News (10/6, story 5, 0:20, Holt) reported, "Federal health officials say that a rare meningitis outbreak has now claimed seven lives." The CBS Evening News (10/5, story 7, 2:15, Pelley) reported, "Michigan has become the seventh state to become hit by a deadly case of meningitis." The CBS Evening News (10/7, story 2, 0:25, Glor) added, "Federal health officials have confirmed a total of 91 ill victims in nine states."
        In a front-page story, the Wall Street Journal (10/8, A1, Martin, Burton, McKay, Subscription Publication) reported that the CDC said several of the patients who had the contaminated epidural steroid injections have had strokes. AFP (10/8) adds that the CDC "urged doctors to 'actively contact' any patients who received doses of the potentially contaminated steroid injection - typically used to treat back pain - as far back as May 21."
        USA Today (10/8, Szabo) reports Dr. Benjamin Park, "medical officer, at the CDC's mycotic diseases branch" said, "It is possible that if patients with infection are identified soon and put on appropriate anti-fungal therapy, lives may be saved." The agency previously reported cases in "Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana;" and this "weekend, Michigan, Minnesota and Ohio joined the list." According to the Los Angeles Times (10/8, Pearce), "Tennessee has reported the most outbreak cases, with 32; Michigan has seen 20 and Virginia, 18."
        The AP (10/8) reported that the New England Compounding Center in Framingham, Massachusetts "has said it is cooperating with investigators." According to Bloomberg News (10/8, Hart), the FDA on Oct. 4 "identified Framingham, Massachusetts-based NECC as the pharmacy that supplied the steroid tainted with a fungus. The steroid, methylprednisolone acetate, was shipped to facilities in 23 states from July to September." 

Friday, October 05, 2012

Fungal-meningitis outbreak widens.


www.med-art.com

An update from the US Centers for Disease Control and Prevention, indicating the meningitis outbreak has now been reported in six states, spurred extensive media coverage, most of which noted that Federal health authorities are expecting more cases to emerge.
        ABC World News (10/4, story 7, 1:30, Sawyer) reported, "A CDC warning about a growing outbreak of meningitis: At least five people have now died; and there 35 cases across six states." NBC News (10/5, Fox) in its "Vitals" blog reports that the 35 cases "include 25 people in Tennessee, one in North Carolina, two in Florida, three in Virginia, two in Maryland, and in Indiana," according to the CDC; and "three of the deaths were in Tennessee, one in Virginia and one in Maryland."
        The CBS Evening News (10/4, story 4, 2:20, Pelley) reported, "The suspected source is tainted vials of steroids that were shipped to 23 states." In a subsequent story, the CBS Evening News (10/4, story 5, 0:40, Pelley) added, "The CDC is investigating how the vials were contaminated."
        The Los Angeles Times (10/5, Muskal) reports that officials from the CDC and the Food and Drug Administration provided the update during a "telephone news conference" Thursday. The FDA's Center for Drug Evaluation and Research, Office of Compliance Director Dr. Ilisa Bernstein said that all of the reported cases "have been blamed on three product lots from the New England Compounding Center, a specialty pharmacy" in Framingham, Massachusetts. She noted that the lots date is from July, but added that "out of an abundance of caution," the agency is "advising medical practitioners to discontinue using all of the company's products." Dr. Benjamin Park, a CDC medical officer, told the news conference that the "scope of the outbreak is difficult to determine because the medication has been distributed in 23 states to an estimated 75 facilities." Therefore, Dr. Park added, "We expect to see additional cases soon."
        The Wall Street Journal (10/5, A3, Rockoff, Martin, Subscription Publication) reports that officials at the Massachusetts Department of Public Health said the New England Compounding Center relinquished its state operating license on Oct. 3, after the FDA found the fungi, aspergillus, on the inside of a sealed, steroid-injection vial.
        The Washington Post (10/5, Brown, Sun) adds that the Dr. Park said the vials contain "methylprednisolone acetate," which is "injected around the spinal cord in the lower back to relieve pain caused by ruptured disks or spinal stenosis" and is transported to the brain through cerebrospinal fluid. He said in can take "one to four weeks" for symptoms, which include "fever, headache, nausea and stroke-like weakness" to appear. Park emphasized that if infected patients are identified quickly, and "started on antifungal therapy, some of the unfortunate consequences may be averted."
        According to the AP (10/5, Stobbe), Massachusetts Health Department officials said the compounding center has "recalled three lots consisting of a total of 17,676 single-dose vials of the steroid." Health regulators said that "several hundred of the vials" have been returned unopened, but many "were used." Federal health authorities said Thursday that prior to the recall, an "unknown number of those vials reached 75 clinics and other facilities in 23 states between July and September."
        Reuters (10/5, Ghianni) reports that during the conference call, the CDC's Dr. Park said the 75 clinics that received the compounded steroid vials are in California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia.
        Also covering the update are Bloomberg News, (10/5, Edney) the Orlando (FL) Sentinel (10/5, Connolly), ABC News (10/5, Moisse) on its website, the CBS News (10/5) website, NPR (10/5, Knox) in its "Shots" blog, the Boston Globe (10/5, Kowalczyk) "White Coat Notes" blog, the St. Paul Pioneer-Press (10/5, Snowbeck), the Time (10/5, Szalavitz) "Healthland" blog, CNN (10/5, Falco) on its website, BBC News (10/5), MedPage Today (10/5, Smith), HealthDay (10/5, Reinberg, Steele) and WebMD (10/5, DeNoon). 

Wednesday, October 03, 2012

Three Tennessee women workers claim discrimination by Wal-Mart.


www.med-art.com

The AP (10/3) reports, "Three Tennessee women sued Wal-Mart Inc. on Tuesday claiming they lost pay and promotion opportunities because of their gender." As the AP notes, this latest discrimination suit against Wal-Mart "represents three women who each worked for Wal-Mart for more than 10 years and seeks class-action status to cover current and former female employees at Wal-Mart and Sam's Club stores in Tennessee and parts of Alabama, Arkansas, Georgia and Mississippi." The story mentions that in 2011, the US Supreme Court "tossed out a class action lawsuit representing 1.6 million women who worked at Wal-Mart on the grounds that their allegations were too varied to show the company engaged in a specific nationwide pattern and practice of gender bias." Similar cases against Wal-Mart since then have been pursued on a regional basis. 

Tuesday, October 02, 2012

Grocery retailers join peanut butter recall


www.med-art.com

ABC World News (10/1, story 4, 2:00, Sawyer) reported, "And, now, the latest on the major recall of a staple in American kitchens, peanut butter. The recall is growing. The Centers for Disease Control has now confirmed that at least 30 people in 19 states were all sickened by salmonella, most of them children."
        The AP (10/2, Jalonick) adds that the CDC linked the salmonella illnesses to Trader Joe's Creamy Salted Valencia Peanut Butter. But thus far, "no other foods have been linked to the illnesses." Still, New Mexico-based Sunland Inc. recalled 101 products because they were "manufactured on the same equipment as the Trader Joe's peanut butter"; and now, "several retailers have issued additional recalls" for product that were "made with Sunland ingredients." In addition to Trader Joe's, the recall now includes "some nut butters and nut products sold at Whole Foods Market, Target, Safeway, Fresh & Easy, Giant Food, Harry and David, Sprouts, Heinen's, Stop & Shop Supermarket Company" and several other stores that "used Sunland ingredients in items they prepared and packaged themselves." 

Monday, October 01, 2012

General Motors recalling more than 40,000 cars due to fuel leak concerns.

www.med-art.com

WDIV-TV Detroit (10/1) reported, "General Motors is recalling more than 40,000 vehicles, citing concerns that a fuel pump module could crack and cause a fire in the event of a fuel leak." According to the story, this recall "affects five models from 2007 through 2009: the Chevrolet Cobalt (2007-2009), Chevrolet Equinox (2007), Pontiac G5 (2007-2009), Pontiac Torrent (2007) and Saturn Ion (2007)." The piece added, "GM said the models were originally sold or registered in Arkansas, Arizona, California, Florida, Nevada, Oklahoma and Texas." 

Friday, September 28, 2012

Judge approves $42.6 million class-action settlement involving tainted trailers


www.med-art.com

The AP (9/28, Press) reports, "A Federal judge gave his final approval Thursday to a $42.6 million class-action settlement between companies that made and installed government-issued trailers after hurricanes in 2005 and Gulf Coast storm victims who claim they were exposed to hazardous fumes in the shelters." As the piece notes, "roughly 55,000 residents of Louisiana, Mississippi, Alabama and Texas will be eligible for shares of the $37.5 million paid by more than two dozen manufacturers. They also can get shares of a separate $5.1 million settlement with FEMA contractors who installed and maintained the units."