Mass. pharmacy recalling some compounded products

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)

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)

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)

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:

• 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)

Losing My Leg to a Medical Error

LAST Fourth of July, during a day at the beach, I experienced a sudden pain in my left calf. Two months later, I required an above-the-knee amputation. Compounding my distress was the fact that my doctors had no explanation for why the blood flow to that leg had been cut off. I had none of the usual risk factors for atherosclerosis, the hardening of the arteries. I had low cholesterol and no evidence of diabetes, and I had never smoked. No blood vessels were blocked elsewhere in my body.

It took some further detective work to reveal what must have been the cause. Seventeen years earlier, in 1995, I had surgery on my left Achilles’ tendon. To prevent bleeding during the procedure, a pressurized cuff was placed above my left knee to block the blood flow. Apparently, the cuff was left on too long, injuring the arteries. In the years since, the vessels progressively scarred and calcified, which eventually blocked all blood flow to my lower leg.

I lost my leg because of a preventable error. The loss of a limb is traumatic, and I experience waves of sorrow and regret. I struggle with continual pain in my residual limb, and am trying to learn how to walk with my prosthesis. My work as a physician has been put on hold.

For the past two decades I have been studying how to prevent errors in health care, and the irony of my present predicament strengthens my motivation to continue the quest. No one should ever have to experience such preventable harm.

And yet many people do. Exactly how many, we can’t say, because there is no national registry for injuries or deaths caused by medical errors. Over a decade ago, in the best study of its kind, the Institute of Medicine estimated that there were 44,000 to 98,000 deaths per year because of preventable errors in the American health system. For every death there are likely to be at least 10 serious injuries, so we can assume that roughly a million patients are seriously injured each year.

Despite calls to action by patient advocates and the adoption of safety programs, there is no sign that the numbers of errors, injuries and deaths have improved. Why? Because those responsible for the delivery of health care have been unable to change how they do things.

They could help themselves by embracing the lessons of great manufacturing companies to improve quality and efficiency. Automatic alarm systems and shut-off switches can be designed to make it nearly impossible for caregivers to do the wrong thing. Checklists and specific protocols based on best practices for each procedure can also help.

In my case, if an alarm had alerted the doctor to how long the cuff had been in place, if the cuff had automatically deflated after a period of time, or if a checklist had reminded the doctor to remove it, my leg might never have been injured. Better yet, if the doctors had not used the cuff, which evidence has shown can be dangerous to patients, I would still be walking on that leg today.

Most of all, perhaps, we need better coordination and communication among caregivers. Consider what happened to Mary, my former wife and the mother of our two children. In 1988, she was lying in an intensive care unit with less than a 10 percent chance of survival. Her first symptom, a pain in the sole of her right foot, had seemed so innocent. A neurologist said she had most likely injured a nerve during aerobic dance and the doctor ignored our requests for further tests. But when Mary’s leg began to swell, we sought the help of an internist. She diagnosed thrombophlebitis, inflammation from blood clots. Mary was then admitted to the hospital for a blood thinner, but the medical team gave her too small a dosage. Her clots extended into her lungs. Next she suffered a heart attack, respiratory failure, renal failure and shock.

In desperation we transferred her care to another physician, who finally began treating her with corticosteroids for inflammation of the blood vessels. Over the next 24 hours, Mary’s symptoms reversed and she fully recovered. But we nearly lost her as a consequence of delayed decision-making, poorly coordinated care and a medication error.

Eliminating errors has the added dividend of reducing costs. The cost for treating Mary’s thrombophlebitis should have been $16,000; the complications pushed the cost nearly six times higher. The hospital bill for my leg amputation was approximately $150,000, my prosthesis cost more than $50,000, and I have lost months of work.

The Affordable Care Act has recognized this reality and is creating new reimbursement systems that reward the quality rather than the quantity of care. The act has also empowered an expert panel to create evidence-based treatment recommendations.

I wish I could go back in time and implement these changes before my surgery. But there is no way to turn back the clock. My life will never be the same, nor will the lives of roughly a million other patients who suffer similar preventable injuries each year. But we can make sure that future patients don’t suffer the same life-changing harm.

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Source: The New York Times (Southwick, 2/19)

Despite Counsel, Victim Is Hindered by Tort Laws

SAN ANTONIO — When Connie Spears arrived at a Christus Santa Rosa hospital emergency room in 2010 with severe leg pain, she told medical staff members about her history of blood clots. Doctors sent her home with a far less serious diagnosis.

Ms. Spears in a pre-surgery photograph. She has run into problems with the state’s expert-witness rule and its time frame.

Days later, swollen and delusional, Ms. Spears was taken by ambulance to another hospital where doctors found a severe clot and extensive tissue damage. With her life on the line, they amputated both of her legs above the knee.

Nearly three years later, Ms. Spears contends that she is a victim not only of a medical mistake but also of Texas’ tort reform laws.

The huge tort reform package that Texas lawmakers approved in 2003 capped noneconomic damages that a plaintiff could receive for medical malpractice at $250,000 and set a “willful and wanton” negligence standard — interpreted as intentionally harming the patient — for emergency care. It also required plaintiffs to find a practicing or teaching physician in the same specialty as the defendant to serve as an expert witness and to demonstrate evidence of negligence before a trial. Under the strengthened rules, if plaintiffs fail to produce adequate expert reports within 120 days of filing their cases, they are liable for defendants’ legal fees.

Ms. Spears said the laws obstructed her ability to find a malpractice lawyer and forced a judge to order her to pay thousands of dollars to cover some defendants’ legal bills. Her lawyers plan to file a motion that challenges the laws’ constitutionality.

“How can that law be?” Ms. Spears asked. “Maybe the law was too loose before, but they went way too far the other way.”

Tort reform proponents say that such restrictions are the only way to curb frivolous lawsuits against health care providers and that they have drawn more medical professionals to a state with exploding population growth.

“Our purpose had never been to have a procedural hurdle,” said Mike Hull, a lawyer for the pro-tort-reform Texas Alliance for Patient Access. “It had been to have the plaintiffs really get the case reviewed.”

For two years, Ms. Spears struggled to obtain legal representation, because several lawyers said they feared her case did not meet Texas’ new negligence standards. Justin Williams, a Corpus Christi lawyer who eventually took the case, said, “Her life has basically been ruined by all of this, and there was just no way I could turn her down.”

But the case fell apart under the new expert-witness rules. After the first attempt at an expert-witness report failed to identify the proper defendants, Mr. Williams said, he was unable to find another expert witness in a time frame that would satisfy Texas’ requirements.

Tina York, a lawyer for Christus Santa Rosa, said it was unusual for a case to be dismissed because of problems with an expert-witness report. The rules are in the statute, she said, to weed out plaintiffs who “can’t legally support their claim” from the beginning. (Christus Health is a corporate sponsor of The Texas Tribune.)

Ms. York said Christus Santa Rosa did not pursue compensation for its legal fees out of sympathy for Ms. Spears. But Ms. Spears said other defendants in the case had. With her retirement savings tapped and her husband out of work, she is afraid they will lose their home.

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Source: The New York Times (Aaronson, 1/24)

5 tips to survive emergencies on the road

Here are some potentially catastrophic driving situations that can be turned into quickly forgotten incidents with simple, but effective, action. For most, passengers can save the day. PM contributor Mac Demere, a former racing driver and driving instructor, offers a few simple tips to keep you alive out there.

Keep calm and drive on

Most fatal single-vehicle crashes involve the vehicle running off the road. Here's what happens in many of them: An inattentive or distracted driver allows the car's right tires to drop off the pavement or onto Interstate rumble strips. The loud noise suddenly alerts the driver that he's drifting to the right, causing him to yank left on the steering wheel. The wayward front tire regains grip while one or both rear tires are in the loose stuff. With little or no rear traction, the vehicle spins out and leaves the highway—and could even flip.

The way to avoid this fate is to stay calm and not overreact. If you find yourself drifting off the road, let off the gas and allow the car to slow down, and gently ease back on the road. Do not depress the brake unless you see an obstacle approaching and need to get back in your lane faster. Whatever you do, be smooth with the steering; a little goes a long way at high speeds.

Put It in Neutral

A stuck throttle is an automotive mugging: It's unexpected, petrifying, and what you do in the next few seconds may change your life forever. The solution is easy: Slap the shift lever into neutral. In the vast majority of cars, the passenger can do this as easily as the driver. Almost all modern cars have physical or electronic devices that prevent the transmission from going into reverse or park while you're driving down the road, as well as electronic limiters to preclude engine damage, so you don't have to worry about hurting the car by putting it in neutral. A manual transmission car might take a little bit more force to put into the neutral gate, but it'll go as well.

I've experienced stuck accelerators caused by faulty cables, misplaced floor mats, and panicked driving-event students who mistakenly mash the throttle pedal rather than brake. I've always quickly cured the problem by bumping the shifter into neutral or, when driving a manual-transmission car, depressing the clutch.

Get a spotter

Every car has blind spots. And today's cars increasingly have thick, airbag-filled A-pillars (the vertical post that connects roof and body) that can hide cars around you. If you're riding with a passenger, then, employ him or her as your spotter. I ask my passengers to say, "clear right" or "traffic right," when I'm trying to turn left. I'm also happy to have them point out things I might have missed, such as "bicyclist ahead." Stay away from saying "no" and "go." (At ages 6 and 8, my kids said, "clear, high!" when I passed a car on a two-lane. The things that happen when you're a race driver...)

This might take some getting used to. Most of us don't like back-seat (or front-seat) drivers, nor are we accustomed to offering advice or watching the road with care when we're not driving. But having a little help from the passenger seat will make everybody's ride a little safer.

I can't see clearly now

"I can't see," the driver shouted at me. As he ineffectively batted at the suddenly fogged windshield, I switched the heating system from "recirculation" to "fresh air" and engaged the air conditioner. Within seconds the windshield was clear, except for the smudgy patch left by his fingerprints.

Engaging the air conditioner (regardless of the temperature setting) and allowing the system to suck in fresh air lowers the humidity inside the car. Many vehicles now automatically engage the air conditioner and disengage recirculation when you select the defroster to avoid a fogged-up windshield.

Speaking of poor visibility, there's probably been a time in your life that you've forgotten to change your wiper blades soon enough and have been caught out in a rainstorm with blades that did more smearing than clearing. You might be able to revive them for one last storm with a quick cleaning. Rub the wiper blade with the sponge side of a gas-station squeegee (or the sponge from the office coffee room) and a clean, dry towel. Get the windshield, inside and out, while you're at it. Don't procrastinate about buying new blades the next day.

Make a plan B. And C. And D...

Recently I was following someone who was driving while texting who almost ran off the left side of a two-lane, as a car approached from ahead. Watching this unfold just in front of me, I had to figure out how to avoid it. Plan A was to pound the brakes. Plan B, backing up, was not a great option because I couldn't see far enough around the previous curve of this heavily traveled road to know whether other cars were coming. I crossed out Plan C, escape routes, because of earthen banks on both sides of the road. Plan D was to employ Plan B and go into reverse if the oncoming driver veered around the errant driver and into my lane.

Fortunately, the texter completed his text and returned to his lane, while the oncoming driver stopped. The moral of the story: Don't text and drive, but also work through possible options before an emergency happens. Then if it does, you'll be better prepared and able to think your way out of it.

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Source: Yahoo News (AP, 1/30)