What happened? 1.5 million current and former female Wal-Mart employees alleged Wal-Mart discriminated against them in violation of Title VII of the Civil Rights Act of 1964.  They said that local managers disproportionately exercised their discretion over pay and promotions in favor of men, which was unlawful.  The employees were seeking a favorable judgment that would give backpay, injunctive relief (stop Wal-Mart from physically discriminating against women), & punitive damages (punish Wal-Mart financially for disobeying the law).

What was the issue before the Supreme Court? In order for a “class” in a class action to be certified, the Federal Rules of Civil Procedure require: (i) numerosity, (ii) commonality, (iii) typicality, & (iv) adequate representation.  Once Rule 23(a) is satisfied, the class then must then satisfy Rule 23(b).  Specifically, the issue was whether the Wal-Mart employees met the requirements of the Rule 23(a)(2) commonality requirement and  Rule 23 (b)(2).

What happened before it arrived to the Supreme Court?: The District Court certified the class and found that the employees satisfied the class action requirements. The 9^th Circuit Court of Appeals “substantially affirmed” and said that the employees met the 23(a)(2) commonality requirement and that their backpay claims could be certified as part of a (b)(2) class because those claims didn’t predominate over the declaratory and injunctive relief requests.

What was the outcome? Not in favor of the employees. The Court said that the employees’ certification was not consistent with Rule 23(a) and should not have been certified  The Court also said that the employees’ backpay claims were also improperly certified under Rule 23(b)(2).

Scalia wrote the opinion for the court and noted that a “Title VII discrimination suit requires ‘the reason for a particular employment decision.’ Cooper v. Federal Reserve Bank of Richmond, 467 U.S. 867, 876 (1984) and the employees [wanted] to sue for millions of employment decisions at once.  Without some glue holding together the alleged reasons for those decisions, it will be impossible to say that examination of all the class members claims will produce a common answer to the crucial discrimination question.”

Justice Ruth Bader Ginsburg’s Concurrence/Dissent: She agreed with the majority in Parts I & III of the opinion (the class should not have been certified under Rule 23(b)(2)). However, she disagreed with Part II of the Court’s opinion because the majority imported into Rule 23(a) concerns that are addressed in Rule 23(b)(3).  Justice Ginsburg wrote “23(a) does not require that all questions of law or fact raised in the litigation be common, indeed even a single question of law or fact common to the members of the class will satisfy the commonality requirement.” Justice Breyer, Justice Sotomayor, and Justice Kagan agreed.

How far will this opinion reach? This opinion could have some real consequences on class actions in the future.  I would agree with Justice Ginsburg that the class did meet the commonality requirement.  Scalia cited General Telephone Co. of Southwest v. Falcon , 457 U.S. 147, 157-158 (1982) and said “commonality requires the plaintiff to demonstrate that the class members have suffered the same injury.” Well, if he didn’t think a group of 1.5 million women  who all alleged they were discriminated against simply because of their sex suffered the same injury, what will happen when defective products (that are not part of Multi-District Litigation) injure individuals in different ways (i.e. some lose an arm, while others lose their life).  Will this not be properly satisfy the Rule 23(a) commonality requirement according to the majority? Time will only tell.

Gladys Mensing took metoclopramide, the generic form of Reglan, a nausea medication that was marketed and prescribed off-label for the treatment of reflux disease and other chronic conditions.  Unfortunately, use of metoclopramide or Reglan for more than a few months can cause patients, like Gladys Mensing, to develop severe and debilitating neurological disorders known as tardive dyskinesia.  This movement disorder includes involuntary movements of a patient’s limbs, facial tics, weakness, inability to walk, and other disabling symptoms.  In reference to her grandmother’s disease, Roxanne Mensing stated, “it’s really taken a hit on all of us, and her especially.”  Mensing hoped that justice would be served and the manufacturer, Pliva, would be held liable for failing to adequately warn of the risk of tardive dyskinesia, especially when the drug is taken for more than a few months.

But Mensing did not receive justice.

The Supreme Court of the United States ruled on June 23, 2011, that federal law makes generic drug manufacturers immune from liability for failure-to-warn claims under state law because the generic manufacturers alone do not have the power to change their labels.

State tort law requires that a drug manufacturer that is aware or should be aware of a product’s dangers must label their product accordingly.  However, the FDA requires that generic drugs must have the same warning labels as their brand-name counterparts.  The manufacturer alleged that they were unable to change the warning label because it would then differ from the brand-name version of the drug.  The court sided with the manufacturer and held that the FDA requirement preempts state law.

So what does this mean for those who have been injured by the generic form of a drug? If their pharmacist filled their prescription with a generic form instead of the brand-name, they are out of luck.  According to Justice Sotomayor’s dissenting opinion, this decision will affect 75 percent of all the prescription drugs in the country.  As a patient, do you want to take drugs manufactured by a company who has legal immunity or one that will be held responsible for providing adequate warnings for their products?  The final chapter in this area has not yet been written, and one can only hope that Congress and the FDA will find a way to close this legal loophole and ensure that personal responsibility applies not only to patients but also to generic drug manufacturers who should not enjoy this legal immunity, especially when their products have the potential to cause great harm to patients.

Tragically, it is too late for 2-year old Harrison Kothari. Harrison died as a result of using a anit-bacterial wipe that was contaminated with life-threatening bacteria.

Wipes manufactured by Triad and H&P have been linked to very serious illnesses in the cases of four patients with multiple sclerosis. A Tennessee gentleman contracted a life threatening Bacillus cereus infection and required open heart surgery.

On June 13, 2011, a Wisconsin federal judge granted a legal injunction against the Triad Group and H&P Industries, prohibiting the company from manufacturing or distributing drugs or medical devices.  The injunction was issued following the seizure of $6 million of the company’s products from their headquarters in Wisconsin.

The court order will remain in effect until the company creates and follows a quality assurance program that will allow their products to meet federal guidelines.

The company has failed a series of FDA inspections and has issued five voluntary recalls since December due to bacterial contamination found in its products.

Triad’s products, including cold medications, sprays, and wipes, were widely used in medical facilities across the country and were sold at Safeway, City Market, and Walgreens. Some of the products include:

• All lots of alcohol prep pads, alcohol swabs and alcohol swab sticks.
• Sterile lube products: Triad, McKesson, Select, Cardinal, Imco, Schein and Novation.
• Povidone Iodine Prep Pads with labels: Amerinet, Cardinal Health, Versapro, Novation, Triad, Triad+, Total Resources and north Safety.

Please check your medicine cabinet for Triad products and make sure you are not using products that have been recalled.  You can visit the Triad’s website, in order to find out more information about the recalled products.

A product that should have carried a very clear and detailed warning of its dangers is causing severe injuries. The product is called “Napafire”, distributed through Bed, Bath & Beyond (and other national distributors); and is packaged and distributed by Napa Home & Garden, Inc.

The NAPA product is manufactured with a gelatin type consistency and contains ethanol as its primary flammable component. NAPA promotes the product as “clean burning” and good for the environment. The victims of what becomes an explosive fire ball have described it differently:

• A Molotov cocktail.
• Like gasoline in a bottle.
• A lethal weapon.

Every flammable compound has a “flash point” and each varies from substance to substance. The “flash point” is the temperature at which a compound, liquid or material can ignite into flame and begin to combust. Gasoline, for example, has a flash point at a much lower temperature than does fuel oil.

Napafire is a compound with a reasonably low flash point. It oxidizes into a gaseous form slower than many compounds and ignites slow. It does, however, burn at a high temperature and results in heating the containing vessel to high temperatures. As a result, whatever Napafire is contained within is going to heat to significant temperatures and will probably remain there for a period of time. So, it is not only the compound burning, but its container that provides a hazard for flash ignition.

Add to these issues, Napafire burns relatively hot and clean and can burn with what the manufacturer describes as a “nearly invisible flame.” This presents a hazard for the consumer in determining whether the Napafire flame is extinguished or not.

Napafire might fairly be compared to napalm. Napalm was a highly flammable weapon used in Vietnam extensively. Napalm was used primarily because of its gel-like consistency. When ignited and dispersed, it would adhere to everything it touched with a hot, searing burn. Efforts to extinguish napalm are largely unsuccessful and the burning gel flows along everything it touches.

These are some of the problems, which have led to serious injuries resulting in explosions and serious burns caused by the fuel-gel burning pots, Napafire.

Our firm is currently investigating the details of serious  and tragic injury to a person in South Florida recently. Immediately, our analysis has led us to identify very significant design, use and warning problems with these devices and the fuel gel being used in them, such as this pictured below.

Napa Home & Garden’s president, Jerry Cunningham has admitted that the “warning label on the firepot was a small sticker on part of the pot’s packaging,” which was meant to be thrown away.”

Take great care in using these fuel gel burning pots, including not trying to refill them unless you are absolutely sure they are extinguished and have had ample time to cool before adding additional fuel gel to them. Better advice would be to simply not use these devices at all.

Reports of other incidents include:

• June 10, Granger, Ind.: A contractor, was at his neighbors house watching their dogs romp in the yard when his neighbor tried to refill a firepot and it erupted with a fireball into his lap. Nothing would put it out, he said from his hospital bed on Monday.
• June 3, Omaha, Neb.: A food-industry executive, tried to refill a Napa Home & Garden firepot that he was sure had burned out. It sent a fireball streaming out of the fuel bottle like a flamethrower, Mr. McCutcheon said, seriously wounding his wife, his 9-year-old daughter, and his sister-in-law.
• May 28, Huntingtown, Md.: A woman was visiting old high school friends for a cookout when someone tried to refill a Napa Home & Garden firepot that seemed to have run out of fuel. It exploded on her. Tragically, this lady is still on a respirator at Washington Hospital Centers burn unit, according to Maryland fire marshals.
• March 31, Encino, Calif.: A nine year old girl was with a friend when the friends father started performing tricks with a Napa Home & Garden firepot, according to a lawsuit accusing the hosts of gross negligence. When the man poured more fuel into the pot, it erupted onto the young girl, sending her to the hospital for 14 days with severe burns.
• June 10, 2010, Carlstadt, N.J.: A teenager was seriously burned on more than a third of her body when a firepot made by a different company, BirdBrain Inc., erupted as her mother refilled it. She spent more than five weeks in the hospital.
• April 3, 2010, Baltimore: A young boy was in his aunts backyard when a BirdBrain firepot tipped over, spilling flaming fuel gel over his left side and leg. He spent 51 days in the hospital. His arduous rehabilitation has been chronicled in videos on YouTube by his mother.

I just heard about a really cool idea.  If you join in, you can help the world without really trying and without spending a dime.  Interested?  Keep reading.

How many times have you spent the night at a hotel, taken one shower and had your soap thrown away with 90% of it left remaining in the soap dish as you check out or had the soap replaced each day of your stay?  The answer is:  almost every time you have spent the night at a hotel.

I travel a lot for business and I cannot tell you the number of times this thought has crossed my mind, “What is going to happen to this soap?  It’s perfectly good and I’ve only used a little and now it’s just going to be thrown away?  Hmmm, maybe someone could take this soap and sterilize it and give it someone in need.”

If you’ve ever had a similar thought, luckily for all of us, the practice of throwing that soap in the garbage is slowly changing, thanks to Derreck Kayongo and his Atlanta-based Global Soap Project.  Kayongo, a native of Uganda who is now a U.S. citizen, thought of the idea in the early 1990’s, after he emigrated from Uganda to escape the dictatorship of Idi Amin.  He was staying at a hotel in Philadelphia and noticed that each day he received a new bar of soap and his old one was thrown away.  Flabbergasted by the waste, the idea for his charity was born.

[vimeo]http://vimeo.com/7586824[/vimeo]

Kayongo knew that many of the diseases which have been largely wiped out in the United States are still causing deaths in other parts of the world.  He also knew that collecting soap could be the “first line of defense” to eliminate unnecessary deaths around the world.  Each year, more than 2 million children die from diarrheal illness (predominantly among children younger than four living in low-income countries); deaths which can be largely eliminated through the simple act of washing of hands.

“The issue is not the availability of soap. The issue is cost,” Kayongo said. “Make $1 a day, and soap costs 25 cents. I’m not a good mathematician, but I’m telling you I’m not going to spend that 25 cents on a bar of soap. I’m going to buy sugar. I’m going to buy medicine. I’m going to do all the things I think are keeping me alive.

Right now, 300 hotels in the United States have joined Kayongo’s effort and their donated barely used soap bars have amounted to nearly a quarter million pounds soap. Volunteers across the country collect the hotel soaps and ship them to the group’s headquarters in Atlanta. Once each week, on Saturdays, volunteers clean, reprocess and package the bars.

So, the next time you plan a business trip or a family vacation, print out a copy of this form and turn it in to the manager at the front desk.  That simple act, at no cost to you, could very well save a child’s life.  Does it get any better than that?

Pretty much everyone has one these days!  In fact, according to Facebook, there are currently over 500 million active users on Facebook.  Statistics show that 50% of these active users log on every day.

So, just as you would in any crowd, you need to make sure you are protecting yourself in cyber world.  Because you are sharing photos, opinions and personal details from your daily life – you don’t want this data to fall into the wrong hands! But if you don’t set your privacy settings correctly, that’s exactly what can happen.

The USA Today posted a short article today regarding 5 Facebook privacy settings that you need to double-check, they are:

Friend List & Education

These two tell a LOT about you and can be helpful insight to allow hackers into your facebook.  Make sure you are aware how much of this information you are sharing to the world. This information could be used to trick others into becoming your friend and then sending you viruses.

To hide your friends list, education and work and likes, click Account>>Privacy Settings. Click View Settings under Connecting on Facebook. You’ll see the options for these items. Set each to Friends Only.

Birthday, Address, & Phone number

These three seem obvious but still people share this information.  This information is often used to steal your identity!   Also, nobody wants a creepy Facebook user to find out where you life or how to get a hold of you! Be very careful on what personal information you share with the world.

To hide this data, click Account>>Privacy Settings. Click Customize Settings. A list of information appears. Delete what isn’t necessary. You should set most of this to Friends Only. In some cases, you will want to restrict items to You only. For example, you may not feel like sharing your religion.

Places and photos

There are two settings to watch particularly closely. The first relates to Facebook’s Places feature, which lets you check in to real-world locations. Facebook contacts will be able to see where you are. By default, friends can check you in without your permission.  Sometimes, you might not want the world to know exactly where you are at any given moment so make sure these settings are properly set.

The other item you need to watch is photo and video tagging. You probably don’t want everyone to see photos and videos you’re tagged in. This can lead to embarrassing moments at work.

Click Account>>Privacy Settings and click Customize. Find “Friends can check me in to Places” under “Things others share.” Click Edit Settings. Select Disabled and click Okay. Next, click Edit settings beside “Photos and videos you’re tagged in.” Set it to Friends Only. Click Okay.

Games and apps

You’ve probably seen the pop-ups on your news feed about Farmville and the like. However, many do not know that Facebook games and apps use your information to access these features. You can’t revoke access entirely. But you can block access to certain items. Click Account>>Privacy Settings. Click Edit under Apps and Websites. Click Edit Settings under “Apps you use.” Select an app to specify what it can access.

You also have to worry about your friends’ apps. By default, they see everything that your friends can. Click Account>>Privacy Settings. Click Edit under Apps and Websites. Click Edit Settings under “Info accessible through your friends.” You should make much of this information unavailable. Click Save Changes when done.

Creating lists

Facebook lets you limit postings and photos to friends, friends of friends and everyone. You may want more control over who can access your information. You can do this by creating friend lists. You can then grant or block access to specific information by list.

To create a list, click Friends and then Edit friends. Click the Create a List button. Enter a descriptive name for the list. Next, select the friends to include on the list. Finally, click Create List.

Once you’ve created lists, you can specify them in privacy settings. Just click the button beside a privacy option and select Customize. To grant access to a list, select Specific People under “Make this visible to.” Type the name of your list. To block access to a list, type the list name under “Hide this from.” When you’re done, click Save Setting.

1 more recommendation if we may

There is one more important recommendation that the USA Today’s article failed to include and that is how to change your Facebook to browse websites “secured” whenever possible.  This makes your page URL change to https:, as opposed to just http:/.  If you’ve ever done your shopping or banking online, you may have noticed a small “lock” icon appear in your address bar, or that the address bar has turned green. This indicates that your browser is using a secure connection (“HTTPS”) to communicate with the website and ensure that the information you send remains private.

To do this:

Under “Account” (top RH of screen) go to:

“Account Settings” go to:

“Account Security” – select “change” then choose:

“secure browsing” https://

Remember to SAVE!

Finally, and while we’re on the topic – connect with us on our page.  “Like” Searcy Denney Scarola Barnhart Shipley, PA for updates on important issues, links to our blogs, etc.

Are you taking the cholesterol lowering drugs: Zocor, Vytorin or Simcor?

The Food & Drug Administration published a release recommending new safety criteria for high does simvastatin; which is a key ingredient in all these drugs:

“The FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions. The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. Patients who are unable to adequately lower their level of LDL-C on simvastatin 40 mg should not be given the higher 80 mg dose of simvastatin;  instead, they should be placed on an alternative LDL-C-lowering treatment(s).”

Do not stop taking these medications if you are already on them. Instead, call your physician and discuss this new report with him or her. The FDA reports that most patients, who have been on these drugs for 12 months or more, show a low incidence of myopathy damage from them.

Myopathy is a condition that affects muscle tissue and causes damage resulting in weakness, inflammation, spasms, or paralysis. A common cause of myopathy is dehydration, which many of us have experienced secondary to extreme exercise; particularly in hotter climates.

Progressed myopathy is called rhabdomyolysis and is the most serious form of myopathy. Rhabdomyolysis can lead to severe kidney damage, kidney failure, and sometimes death.

It has been estimated that approximately 2.1 million patients have been prescribed simvastatin containing drugs during 2010. The dangerous level of simvastatin, according to the FDA, is 80 mg or an amount in combination with other ingredients that may cause it to potentiate its effect in the body.

The Food & Drug Administration has provided the following additional information for patients:

Patients currently taking 80-mg simvastatin-containing medicines should:

• Not stop taking their medicine unless told to by their healthcare professional.
• Review their medical history with their healthcare professional, the currently prescribed dose of simvastatin, and a list of their other current medications to determine if the medicines they are taking are appropriate. Know that certain medications should never be taken with simvastatin.
• Immediately contact their healthcare professional if they experience muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.
• Talk to their healthcare professional about any questions or concerns they have about simvastatin-containing medicines.
• Report side effects from the use of simvastatin-containing medicines to the FDA MedWatch program.

Prescription drugs are not the solution to all of our health problems.  In fact, they can be the cause of many of them.

Many patients who are being prescribed bisphosphonates for the treatment and prevention of osteoporosis, such as Fosamax, Aredia, and Zometa, are unaware of the risk of long bone or atypical femur fractures associated with the use of these drugs.  Although the risk is small, some patients are at a higher risk for these fractures than others.

Studies have shown that the use of bisphosphonates for 5 years or longer is associated with a higher risk of femoral shaft fractures than transient use of bisphosphonates.  The risk decreases substantially once the use of bisphosphonates is discontinued.  However, bisphosphonates remain in a patient’s system for up to 10 years and have the potential to cause harm long after they have been discontinued.  Additionally, women who ingested these osteoporosis drugs at the same time as corticosteroids or hormone replacement therapy may face greater risks of atypical fractures.

Patients should assess their individual risk of long bone fractures.  In order to determine if they are at risk, patients should read the drug warning label and ask their physician whether their risk of developing long bone fractures outweighs the benefits that the drug can provide.

Osteoporosis affects one in three women and one in five men over the age of 50.  Each year, 22 million prescriptions for bisphosphonates are written for the treatment of osteoporosis.  Bisphosphonates have been demonstrated to impair the body’s ability to regenerate bones, leaving bones weak and brittle.  Patients taking bisphosphonates may actually be increasing their risk of osteoporosis by taking these drugs.

Drugs are not the only way to maintain healthy bones.  Bone health can be maintained without the use of drugs by eating a diet high in amino acids, vitamin D, consuming a healthy balance of omega 6 and 3 fats, and avoiding processed foods, gluten, soda, and sugar.  Exercise is also important for the maintenance of bone health.

Suppose I am a physician and as a part of my practice I want to know whether my patients own guns and whether they properly secure their guns. Suppose I, too, own guns and suppose that as a result of poor gun security someone in my family was tragically shot and killed by a poorly secured gun in the hands of a child. In fact, suppose that I am unwilling to accept as patients anyone who owns guns, has children and refuses to take reasonable measures to secure the guns in their home.

Anything wrong with this? Don’t I have the right to accept or not accept patients as I see fit? Can I put a sign up in my waiting room that says something like:” We reserve the right to refuse treatment to careless gun owners? Be aware that I will ask you about your gun ownership.”

According to the Florida legislature, apparently an enormous problem exists over physicians asking patients about gun ownership. Ask about sexual practices, drinking or drug taking practices; ask about the financial ability to pay fees; but “don’t tread on my guns”.

A group of physicians recently filed a lawsuit over the recently enacted HB 155 which places financial and other penalties on physicians who have the temerity to ask patients about guns in their home. Not surprisingly, the physicians who filed suit are largely pediatricians. This is where the conversation most always arises. New parents and the physician’s general conversation about child safety are old practices of good physicians.

Apparently, though, the bill seems to prohibit every doctor from asking patients about gun ownership. The doctor can ask about knives, poison, explosives, and other potentially lethal accouterments, but is forbidden from asking about guns.

Supporters of the law, like Florida NRA lobbyist Marion Hammer, have a unique view on their normal cry of “less government”:

“We pay doctors to be doctors and give us medical care,” Hammer said in an interview with the Capital News Service last week. “Instead, they are trying to be social workers and bring their gun-ban politics into the examining room.”

Last I checked, confidentiality exists between physician and patient. In addition, patients are free to “fire” their doctor and seek another professional if they do not like what the doctor does or says. Believe me; I have fired my share of opinionated doctors.

The Florida Medical Association withdrew its opposition to the law after assurances were included in the bill “allowing physicians, nurses and other practitioners to ask questions about gun ownership if they feel the patient or a family member might be in danger.”

I suppose that suggests the question: what about the rest of us? Can a physician ask if someone says they just read something written by say, me, and they feel strongly about wanting to me harm?

The NRA is very protective of the Second amendment, but they apparently do not care about the whole free speech thing in the First amendment to the constitution.

Johnson & Johnson has been ordered by a South Carolina court to pay $327 million for minimizing the links between its antipsychotic drug, Risperdal, and diabetes.

The case centers on allegations that Johnson & Johnson marketed Risperdal in a way that was misleading in product labels, “Dear Doctor letters” and in personal sales calls to physicians.

In 2004, the Food & Drug Administration sent Janssen Pharmaceuticals (the division of Johnson & Johnson responsible for Risperdal) a warning letter. The FDA had received post-marketing reports of diabetes mellitus developing in patients who were prescribed Risperdal. The FDA had previously demanded that Jannsen send a warning letter to physicians and it its 2004 correspondence sets forth that Johnson & Johnson minimized the “…risks associated with Risperdal and claims that Risperdal is safer than other atypical antipsychotics, when this has not been demonstrated by substantial evidence or substantial clinical experience”.

In the South Carolina case, the state sued Johnson & Johnson and alleged that deceptive information was disseminated about the dangers of Risperdal and, in particular, that the company downplayed the significant dangers of diabetes secondary to taking the drug. In the ruling, the judge, Judge Roger Couch, wrote a 17 page decision that the drug maker’s executives had “allowed the profit-at-all-costs mentality to cloud” good judgment that would have resulted in a clear warning about Risperdal.

Risperdal was a very big seller for Johnson & Johnson until it lost its patent on the drug. Sales in 2007 were $4.5 billion and declined to $527 million last year. The drug maker still made over $8 billion in the years 2007 to 2010 in sales of the drug.

Judge Couch found that Johnson & Johnson had marketed the drug using labels with deceptive information, marketing letters to physicians and sales calls to doctors’ offices. He fined the drug manufacturer in hundereds of thousands of individual instances for violation of South Carolina’s state consumer protection laws.

Similar cases have been heard in Pennsylvania, Louisiana, and West Virginia.

Johnson & Johnson has indicated they will appeal Judge Couch’s decision.