BOSTON— A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials.
Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.
Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.
The company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.
The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the U.S. Food and Drug Administration.
"The cease and desist was issued after foreign matter was observed in vials of injectable drugs," the Department of Public Health said in a statement.
Pallimed also was ordered to place all its compounded sterile products into quarantine while the investigation continued.
The company said there was no indication the products were tainted or unsafe. The state also said there were no reports of any patient harm.
A message was left with the FDA.
Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid produced at another Massachusetts company, New England Compounding Center.
That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention.
Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.
Pallimed Solutions is a 7-year-old company that does business as Pallimed Pharmacy and has about 15 employees, according to its website. It said it regretted any impact on customers and that patient safety was its top priority.
"By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations," the company said in its statement.
On Nov. 27, the state ordered Pallimed to temporarily stop production of sildenafil citrate — the active ingredient in Viagra — for human use after inspectors found it had been prepared with improper components. The company said those issues were administrative in nature and had been resolved, and Monday's announcement was unrelated.
The state said the earlier order was still in place, pending the board's acceptance of a corrective plan.
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Source: WFAA (AP, 3/25)
Monday, March 25, 2013
Monday, March 18, 2013
Mother of 12-year-old Tuscaloosa boy killed in wreck files lawsuit against tire manufacturer, car repair shop
BIRMINGHAM, Alabama - The mother of a 12-year-old Tuscaloosa boy killed in a wreck on Interstate 65 has filed a wrongful death lawsuit against the manufacturer and the local distributor of a recently replaced tire on her SUV.
12-year-old Octavious Chandler died in a March 25, 2011, wreck in north Jefferson County. The crash happened about 5:50 p.m. on interstate 65 north in Gardendale. His mother, Julia Chandler, was driving, and Octavious was in the front passenger seat.
The lawsuit was filed Tuesday afternoon in Jefferson County Circuit Court by Birmingham attorneys Jeremy Knowles and Amanda Luker on behalf of Julia Chandler. It claims that Michelin North America Inc. and Amigo Tires, a Tuscaloosa car repair shop, acted "negligently and wantonly" in regards to a tire that "detreaded" while Chandler was driving.
A jury trial is requested to decide whether to award compensatory and punitive damages from Amigo Tire and Michelin.
According to the suit, "defendant Michelin designed, manufactured, distributed and/or sold the Michelin XW4 tire made the basis of this lawsuit. Said tire failed and detreaded, thereby causing the fatal accident."
After the wreck, witnesses told investigators that it appeared the vehicle blew a tire, then lost control and flipped several times before landing in the middle of the interstate.
Octavious was pronounced dead at the scene. His mother and three other passengers - an 8-year-old girl, an 8-year-old boy and a 4-year-old girl - were treated for non-life-threatening injuries.
The lawsuit states that on March 15, 2011, Julia Chandler bought a used Michelin tire that Amigo Tire employees selected from the shop's inventory. The employees installed the tire on her 1997 Ford Explorer.
Ten days later, the tire's tread separated as Chandler was driving, "causing the vehicle to go out of control and rollover several times," the suit states.
It claims that Amigo Tire employees "negligently or wantonly selected" the Michelin tire, "which was over 15 years old, and informed Plaintiff that the tire was safe for travel. In fact, the tire was not fit for use."
When contacted by phone, a man who said he was the manager of Amigo Tire said he wasn't aware of the lawsuit and hung up.
The suit also claims breach of warranty against Michelin, which "impliedly warranted" that the tire "was reasonably fit and suitable for the purposes for which it was intended to be used. The Plaintiff avers that the Defendants breached said implied warranties in that the tire was not fit for the ordinary and expected purposes for which such tires are intended to be used; but to the contrary, said tire was in a dangerously defective and unsafe condition."
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Source: Alabama (Stein, 3/14)
12-year-old Octavious Chandler died in a March 25, 2011, wreck in north Jefferson County. The crash happened about 5:50 p.m. on interstate 65 north in Gardendale. His mother, Julia Chandler, was driving, and Octavious was in the front passenger seat.
The lawsuit was filed Tuesday afternoon in Jefferson County Circuit Court by Birmingham attorneys Jeremy Knowles and Amanda Luker on behalf of Julia Chandler. It claims that Michelin North America Inc. and Amigo Tires, a Tuscaloosa car repair shop, acted "negligently and wantonly" in regards to a tire that "detreaded" while Chandler was driving.
A jury trial is requested to decide whether to award compensatory and punitive damages from Amigo Tire and Michelin.
According to the suit, "defendant Michelin designed, manufactured, distributed and/or sold the Michelin XW4 tire made the basis of this lawsuit. Said tire failed and detreaded, thereby causing the fatal accident."
After the wreck, witnesses told investigators that it appeared the vehicle blew a tire, then lost control and flipped several times before landing in the middle of the interstate.
Octavious was pronounced dead at the scene. His mother and three other passengers - an 8-year-old girl, an 8-year-old boy and a 4-year-old girl - were treated for non-life-threatening injuries.
The lawsuit states that on March 15, 2011, Julia Chandler bought a used Michelin tire that Amigo Tire employees selected from the shop's inventory. The employees installed the tire on her 1997 Ford Explorer.
Ten days later, the tire's tread separated as Chandler was driving, "causing the vehicle to go out of control and rollover several times," the suit states.
It claims that Amigo Tire employees "negligently or wantonly selected" the Michelin tire, "which was over 15 years old, and informed Plaintiff that the tire was safe for travel. In fact, the tire was not fit for use."
When contacted by phone, a man who said he was the manager of Amigo Tire said he wasn't aware of the lawsuit and hung up.
The suit also claims breach of warranty against Michelin, which "impliedly warranted" that the tire "was reasonably fit and suitable for the purposes for which it was intended to be used. The Plaintiff avers that the Defendants breached said implied warranties in that the tire was not fit for the ordinary and expected purposes for which such tires are intended to be used; but to the contrary, said tire was in a dangerously defective and unsafe condition."
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Source: Alabama (Stein, 3/14)
Monday, March 11, 2013
Can Doctors Use Copyright Law To Get Rid Of Negative Reviews?
Online review sites are becoming an increasingly important catalyst to digital commerce — when it comes to shopping at local businesses, review sites like Yelp are many consumers’ first stop. Plenty of businesses don’t like the negative reviews they get, but a few thousand doctors have gone the extra mile to try to erase that bad press. Working with a company called Medical Justice, they’ve designed a system that tries to use copyright law to control and remove unflattering reviews. Now, a group of law professors are challenging that system, saying it’s illegal and against the purposes of copyright.
Medical Justice was founded in 2002, and today has about 3,000 members, located in various states and representing different medical specialties, who pay an average of $1,200 a year. The company sells membership as a batch of services, mainly centered around helping doctors that are facing medical malpractice litigation. But the Medical Justice benefit that has drawn the most scrutiny is its program of fighting “physician internet libel and web defamation.” The system works by getting patients to sign contracts that assign away the copyright in any future review they might of a doctor-to the doctor.
Why use copyright at all? A Medical Justice spokesman says the first system the company used-a simple contract doctors could give to all patients that banned reviews outright-was seen as “draconian” and the company was hunting for a more nuanced solution. Additionally, some courts have punished companies that have tried to use contracts to directly stop consumer reviews.
By having patients assign copyright in any reviews to their doctor, Medical Justice hopes to sidestep those problems. It’s also an effort to help doctors get around Section 230 of the Communications Decency Act (an “arcane nuance of cyberlaw,” according to Medical Justice’s website), the law that protects web services from getting sued over content posted by their users. When doctors send review sites a note complaining that a review is false or defamatory, the website is protected by CDA Section 230 and is unlikely to remove the review. But when the same sites receive copyright takedown notices, the law compels them to act-and act quickly. Section 230 doesn’t cover intellectual property claims, and copyright infringement has harsh legal penalties.
Medical Justice argues they’re just leveling the playing field. CDA 230 results in a skewed situation for doctors, who can be reviewed by their patients but are prevented from responding because of privacy laws, it says. “Some sites say, we don’t know if you’re telling the truth, and we don’t know if they’re telling the truth-it’s the internet, so deal with it,” says Shane Stadler, a spokesman for Medical Justice.
But a group of legal academics led by law professor and blogger Eric Goldman have big problems with this interpretation of the law. Today Goldman, together with his partner, UC Berkeley Law Professor Jason Schultz, launched a website called doctoredreviews.com. On the site, the two law professors offer their views on how patients, doctors, and review sites should deal with Medical Justice’s strategy, which they argue is likely illegal and surely unethical.
“There’s a substantial risk a court would deem [the Medical Justice copyright transfer] unconscionable,” Goldman wrote in an e-mail yesterday. Copyright takedown notices sent based on Medical Justice copyright transfers could actually expose doctors to liability, Goldman says, because there are legal penalties associated with sending false takedown notices. In a statement posted on his personal blog, Goldman wrote: “Should the website fail to curb the bad practices, we may need to reconsider more aggressive options.”
Stadler says he’s confident that Medical Justice’s use of copyright transfers is, in fact, legal, and it lets doctors defend their reputations while still letting most patients review away. “Can it be abused? Sure,” says Stadler. “Anything can be abused.” While it’s not a perfect system, most doctors use the power responsibly, he says.
Asked what he thinks of Goldman’s website, Stadler is diplomatic: “The gentleman who launched it is a real ardent advocate of total free speech-that you can say pretty much anything on the internet.”
Goldman admits to being an “ardent advocate” of CDA Section 230. “On that basis, we need to fix any legal artifices-like Medical Justice’s legal ‘hack’-that subvert Section 230′s social benefits.”
How are the review sites themselves handling the requests from Medical Justice? According to Goldman’s website, Yelp has refused to honor one doctor’s takedown notice based on an anti-review contract. Another website, RateMDs, has created a “Wall of Shame” to identify doctors who use anti-review contracts.
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Source: Paid Content (Mullin, 4/14)
Medical Justice was founded in 2002, and today has about 3,000 members, located in various states and representing different medical specialties, who pay an average of $1,200 a year. The company sells membership as a batch of services, mainly centered around helping doctors that are facing medical malpractice litigation. But the Medical Justice benefit that has drawn the most scrutiny is its program of fighting “physician internet libel and web defamation.” The system works by getting patients to sign contracts that assign away the copyright in any future review they might of a doctor-to the doctor.
Why use copyright at all? A Medical Justice spokesman says the first system the company used-a simple contract doctors could give to all patients that banned reviews outright-was seen as “draconian” and the company was hunting for a more nuanced solution. Additionally, some courts have punished companies that have tried to use contracts to directly stop consumer reviews.
By having patients assign copyright in any reviews to their doctor, Medical Justice hopes to sidestep those problems. It’s also an effort to help doctors get around Section 230 of the Communications Decency Act (an “arcane nuance of cyberlaw,” according to Medical Justice’s website), the law that protects web services from getting sued over content posted by their users. When doctors send review sites a note complaining that a review is false or defamatory, the website is protected by CDA Section 230 and is unlikely to remove the review. But when the same sites receive copyright takedown notices, the law compels them to act-and act quickly. Section 230 doesn’t cover intellectual property claims, and copyright infringement has harsh legal penalties.
Medical Justice argues they’re just leveling the playing field. CDA 230 results in a skewed situation for doctors, who can be reviewed by their patients but are prevented from responding because of privacy laws, it says. “Some sites say, we don’t know if you’re telling the truth, and we don’t know if they’re telling the truth-it’s the internet, so deal with it,” says Shane Stadler, a spokesman for Medical Justice.
But a group of legal academics led by law professor and blogger Eric Goldman have big problems with this interpretation of the law. Today Goldman, together with his partner, UC Berkeley Law Professor Jason Schultz, launched a website called doctoredreviews.com. On the site, the two law professors offer their views on how patients, doctors, and review sites should deal with Medical Justice’s strategy, which they argue is likely illegal and surely unethical.
“There’s a substantial risk a court would deem [the Medical Justice copyright transfer] unconscionable,” Goldman wrote in an e-mail yesterday. Copyright takedown notices sent based on Medical Justice copyright transfers could actually expose doctors to liability, Goldman says, because there are legal penalties associated with sending false takedown notices. In a statement posted on his personal blog, Goldman wrote: “Should the website fail to curb the bad practices, we may need to reconsider more aggressive options.”
Stadler says he’s confident that Medical Justice’s use of copyright transfers is, in fact, legal, and it lets doctors defend their reputations while still letting most patients review away. “Can it be abused? Sure,” says Stadler. “Anything can be abused.” While it’s not a perfect system, most doctors use the power responsibly, he says.
Asked what he thinks of Goldman’s website, Stadler is diplomatic: “The gentleman who launched it is a real ardent advocate of total free speech-that you can say pretty much anything on the internet.”
Goldman admits to being an “ardent advocate” of CDA Section 230. “On that basis, we need to fix any legal artifices-like Medical Justice’s legal ‘hack’-that subvert Section 230′s social benefits.”
How are the review sites themselves handling the requests from Medical Justice? According to Goldman’s website, Yelp has refused to honor one doctor’s takedown notice based on an anti-review contract. Another website, RateMDs, has created a “Wall of Shame” to identify doctors who use anti-review contracts.
______________________________________
Source: Paid Content (Mullin, 4/14)
Thursday, March 7, 2013
Texas Bill Would Make Service via Facebook the Law
Texas lawmakers will consider a bill that would specifically allow for service of legal process via Facebook or other social media sites.
House Bill 1989 was introduced earlier this week by Rep. Jeff Leach (R – Plano), a recently elected lawmaker and an associate at a Dallas law firm.
The short bill provides that a Texas court may permit as a method of service “an electronic communication sent to the defendant through a social media website,” provided the court finds that:
As we have previously noted, courts in Australia, New Zealand and the UK have permitted service via social media when traditional means of service have failed, while U.S. courts have been more reluctant to take the plunge.
If House Bill 1989 is made law, Texas would become the first state to formally recognize social media as an alternative means of service.
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source: Social Media Law Brief (Nelson, 3/1)
House Bill 1989 was introduced earlier this week by Rep. Jeff Leach (R – Plano), a recently elected lawmaker and an associate at a Dallas law firm.
The short bill provides that a Texas court may permit as a method of service “an electronic communication sent to the defendant through a social media website,” provided the court finds that:
- the defendant maintains a social media page on that website;
- the profile on the social media page is the profile of the defendant;
- the defendant regularly accesses the social media page account; and the defendant could reasonably be expected to receive actual notice if the electronic communication were sent to the defendant’s account.
As we have previously noted, courts in Australia, New Zealand and the UK have permitted service via social media when traditional means of service have failed, while U.S. courts have been more reluctant to take the plunge.
If House Bill 1989 is made law, Texas would become the first state to formally recognize social media as an alternative means of service.
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source: Social Media Law Brief (Nelson, 3/1)
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