The Injury Board Commentary - FDA & Prescription Drugs

Friday Legal & Safety News Roundup: February 10, 2012

Brett Emison — Fri, 10 Feb 2012 10:13:00 GMT

Legal and safety news from around the internet that caught my attention this week:

Justice Kennedy As Healthcare Swing Vote: Which Way Will He Go? [Lee Pacchia at Bloomberg Law]
The Citizens United Catastrophe [E.J. Dionne Jr. at The Washington Post]
Things You Can't Do on a Plane: Vol. 12 [Bruce Carton at Law.com Legal Blog Watch]
The Insurer-Insured Privilege - (A Reason to Talk to an Attorney Before You Talk to the Insurance Company) [Matt Meyerkord at Kansas City Personal Injury Attorney Blog]
Ultra-embarrassing fraternity lawsuit [Walter Olson at Overlawyered]
Another Drug Raid Video From Columbia, Missouri [Radley Balko at The Agitator]
BP - Rolling In It as the Trial Date Nears [The Pop Tort]
Why Same-Sex Marriage Bans Qualify as Sex Discrimination [Ilya Somin at The Volokh Conspiracy]
Thoughts on the Ninth Circuit's Same-Sex Marriage Decision [Eugene Volokh at The Volokh Conspiracy]
No Choice, No Remedy - The Truth Behind Generic Drug Medications [Amber Racine at The Injury Board]
More iPad Apps for Lawyers [Niki Black at Legal iPad]
Why Most People Tend to Talk About Politics Only with those Who Agree with Them [Ilya Somin at The Volokh Conspiracy]
How and why to boycott Apple [Brishen Rogers at Concurring Opinions]

Originally posted at InjuryBoard by Brett Emison

Keeping Hearts In Mind This Valentine's Day

Jackie Fedeli — Wed, 08 Feb 2012 10:25:58 GMT

Eight Days spanning from February 7^th through February 14^th is National Congenital Heart Defect Awareness Week. How appropriate that the last day of the week ends on Valentine’s Day, a holiday that is synonymous with hearts.

If you are not one of the 1.8 million American families affected by this disease, you’re probably asking what is a Congenital Heart Defect?

Congenital heart defects are conditions present at birth that affect how a baby's heart is made and the way it works. The defects can be present on the interior walls of the heart, the valves inside the heart, or the arteries and veins that carry blood between the heart and the body. Congenital Heart Disease is considered to be the most common birth defect, and is a leading cause of birth-defect related deaths worldwide.

Some heart defects can be recognized during prenatal care, such as through an ultra sound. Other defects can be recognized at birth through a bluish tint on the nails or the lips, and if the newborn has trouble breathing. Other heart defects cannot be determined until after birth and may not go undetected through childhood or adulthood. Often individuals who make it to adulthood without the birth defect being detected are a part of the lucky group who have simple conditions that require little to no treatment, and can easily be fixed. Others are born with more complex congenital heart defects. Complex heart defects that are noticed before, during, or shortly after delivery, may require medical care soon after birth.

Heart defects can be detected after birth through a pulse oximetry screening, which is a test to determine the amount of oxygen in the blood and pulse rate. Some hospitals will perform this screening on all babies as part of a routine, but this is not a mandatory procedure, and is not done in all hospitals. Often a screening will be suggested if the doctor or nurse has reason to believe the baby may have a heart defect.

The cause of most congenital heart defects is unknown. Some defects may be an unfortunate, unpreventable, natural occurrence of changes in their chromosomes. There are some risk factors, recently identified by The Centers for Disease Control and Prevention's National Birth Defects Prevention Study. Expectant mothers who are obese, diabetic, and smoke cigarettes during pregnancy increase their chances of having a baby born with a heart defect.

While most of the risk factors for congenital heart defects can be attributed to an unhealthy mother, often heart defects, and other birth defects can be the result of a mother trying to keep herself health and follow her doctor’s orders. Selective serotonin reuptake inhibitors, or anti-depressants, such as Paxil have been determined by the FDA to cause congenital malformations if ingested in the first trimester of pregnancy. Celexa and Zoloft have also been associated with heart related birth defects.

In honor of National Congenital Heart Defect Awareness Week, Women who are pregnant or hoping to become pregnant, should talk to their doctors about their own health & pregnancy risk factors, as well as talk about current medications they are taking and how they could affect their pregnancy, or a potential pregnancy. Following delivery, be sure to ask your doctor about any heart defects screenings that may be performed, and whether or not a screening would be a good idea if it is not already part of their routine treatment.

To learn more about National Congenital Heart Defect Awareness Week please visit: tchin.org/aware

Originally posted at InjuryBoard by Jackie Fedeli

No Choice, No Remedy – The Truth Behind Generic Medications

Amber Racine — Tue, 07 Feb 2012 13:34:16 GMT

Generic drugs are often defined as medications that are comparable to or copies of brand name medications. They are released after a brand name drug’s patent (or exclusive right to the product) has expired. The generic medication has the exact same dose as the original drug, but has a different appearance and may have different inactive ingredients. Another key difference is the fact that generic medications are far cheaper than brand name drugs - 80 to 85% lower than the brand name product.

This cost differential often means that insurance companies, both private companies and Medicare, automatically switch their insureds to the generic version of a drug as soon as it becomes available - leaving consumers with little choice over their own drug consumption. Until recently, most people happily took the generic version of their drug without a second thought. However, last summer, the Supreme Court issued an opinion which has many consumers worried about their use of generics.

Pliva v. Mensing was a case which sought to determine the state law duties of generic medication manufacturers. The Court decided that generic manufacturers are not subject to “failure to warn” claims under state law, because generic manufacturers are required by federal law to have the exact same warning label as their brand name counterpart. Essentially, this ruling means generic companies have no duty to warn the consumers of their drugs. This is a bigger ruling that many of the other, more publicized, 2011 decisions issued by the Supreme Court. Why? Because the vast majority, up to 75%, of prescription medications consumed in America are generics. Justice Sotomayor, who issued the dissenting opinion, recognized the issue this decision made for every day consumers. “Today’s decision eliminates the traditional state-law incentives for generic manufacturers to monitor and disclose safety risks.”

State Courts are still grappling with the Mensing decision. Some have dismissed cases against generic drug manufacturers, while others have maintained the claims – agreeing that there were other actions that the generic company could have taken to protect their consumers, such as sending letters that warn of dangerous side effects to physicians and consumers.

While this issue develops, it is important for consumers to be aware of the risks associated with all medications – brand name and generic – and to consider requesting that your doctor issue your prescription as “brand name only” to protect your rights in the event that you suffer an injury caused by your medication.

For more info on generic drugs, check the FDA website: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm

Originally posted at InjuryBoard by Amber Racine

Court Moves for NuvaRing Settlement

Shezad Malik MD JD — Tue, 07 Feb 2012 11:19:37 GMT

The litigants in the federal NuvaRing litigation are scheduled to meet with the Court to discuss a plan to settle the lawsuits filed by women who allege that they suffered serious blood clot injuries from side effects of NuvaRing birth control.

All NuvaRing lawsuits filed in federal district courts are consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Rodney W. Sippel in the U.S. District Court for the Eastern District of Missouri.

NuvaRing is a ring birth control device that releases a combination of etonogestrel and ethinyl estradiol and is inserted into the vagina once a month.

The complaints all involve similar allegations that Merck and their Organon Pharmaceuticals subsidiary failed to properly research the birth control ring or adequately warn about the risk of blood clots from NuvaRing.

Plaintiffs claim that they have suffered injuries after taking NuvaRing birth control, including deep vein thrombosis (DVT), pulmonary embolism, heart attacks and strokes.

Following a status conference last week, the Court issued an Order that directed the parties to be prepared to discuss a preliminary plan for alternative dispute resolution at hearing set for February 28.

In January the Court ordered the attorneys to submit proposed plans for alternative dispute resolution, which would be designed to assist the parties in negotiating a potential NuvaRing settlement agreement.

While attorneys for the plaintiffs submitted a plan that calls for the appointment of a special master to oversee the negotiations, attorneys for Merck and Organon have suggested that it is premature to consider such efforts.

The parties are currently preparing a handful of lawsuits, known as “bellwether” cases, for early trial dates. The cases are designed to help the parties gauge how juries are likely to respond to certain evidence that will be introduced throughout other cases in the litigation. In complex pharmaceutical litigation, the results of such trials often factor heavily into settlement negotiations.

Read more here and visit my website for further information.

Originally posted at InjuryBoard by Shezad Malik MD JD

Pfizer Recalls Birth Control Pills

Craig Kelley — Mon, 06 Feb 2012 17:00:00 GMT

On January 31, 2012, Pfizer announced a voluntary nationwide recall of a million packs of oral contraceptives. The recall affects both the brand-name Lo/Ovral-28, and the generic Norgestrel and Ethinyl Estradiol Tablets. Both of these drugs are marketed and labeled by Akrimax Rx Products, carrying the label of that company on the packaging.

According to the FDA press release announcing the recall, Pfizer took action after their own investigation revealed that some packages of the oral contraceptive may contain the incorrect amount of active-ingredient tablets and that the tablets in the packages may be out of sequence. The problem has since been remedied, but not before 28 lots of the drug were packaged and put on the shelves. The FDA announcement includes a list of all lot numbers that were affected. That same press release also has photographs to help patients identify if their product is included in the recall.

Typically these birth control pills contain 21 white pills with an active ingredient and then seven pink pills that are inert. The effectiveness of the contraceptives depends on the pills being taken in a specific sequence. Simply taking the pills in the wrong order—which is much more likely in the recalled packages—can eliminate the contraceptive effect of the pills and increase the likelihood of pregnancy. While there are no other health risks, the FDA advises users of the product to begin using a non-hormonal contraception immediately. In addition, patients prescribed these birth control pills should immediately notify their physician and return the product to the pharmacy.

Originally posted at InjuryBoard by Craig Kelley

Pfizer Recalls Birth Control Pills

John Inserra — Mon, 06 Feb 2012 17:00:00 GMT

Originally posted at InjuryBoard by John Inserra

Hello Baby - Pfizer Birth Control Pills Recalled

Darren Tobin — Mon, 06 Feb 2012 13:58:10 GMT

One million packets of Pfizer birth control pills are now subject to a recall after a packaging error surfaced. The error could reduce the effectiveness of the birth control pills for those who used them and cause unintended pregnancies.

If you are currently on birth control pills, please check below from the FDA to see if your birth control pills are subject to the recall:

NDC	Product	Lot	Expiration	Configuration/Count
24090-801-84	LO/OVRAL® 28	E15678	08/31/2013	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E15679	08/31/2013	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E15686	08/31/2013	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E15687	01/31/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E15690	01/31/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E15698	01/31/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E15700	02/28/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E80434	07/31/2013	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	E80438	08/31/2013	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	F36908	02/28/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	F36909	02/28/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	F43915	03/31/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	F43926	03/31/2014	6 Pilpacks® of 28 tablets each
24090-801-84	LO/OVRAL® 28	F43927	03/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	E15677	08/31/2013	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	E15704	01/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	E15706	01/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	E80440	08/31/2013	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F16388	01/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F16390	02/28/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F22132	02/28/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F31330	02/28/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F36911	03/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F36913	03/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F43924	03/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F43925	03/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F43934	03/31/2014	6 Pilpacks® of 28 tablets each
24090-961-84	Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg	F53238	03/31/2014	6 Pilpacks® of 28 tablets each

Half of the packets were from 14 lots of Lo/Ovral-28 tablets and the other half were 14 lots of generic Norgestrel and Ethinyl Estradiol tablets. These recalled birth control pills were packaged in blister packs containing 21 active tablets and seven inactive tablets. They were manufactured by Pfizer and then sold under the Akrimax Pharmaceuticals brand. The recalled birth control pills were distributed to retail pharmacies, warehouses, and clinics around the United States.

This recall raises serious problems. According to MSN News, this huge error can mean that the daily regimen for the birth control pills could be incorrect resulting in women without adequate contraception and further the risk for unintended pregnancy.

Dr. Jill Rabin, the chief of ambulatory care, obstetrics and gynecology and head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y., said, “Sequence and content of active versus inactive pills is crucial in determining efficacy, including whether or not unwanted pregnancy will be actually prevented.” The doctor recommends that women must determine if they have the recalled birth control pills and then ensure they are not pregnant if signs or symptoms of pregnancy are showing. Women who have taken these recalled birth control pills should also contact their health care provider immediately and switch to a non-hormonal form of contraception. They also need to return the defective product to the pharmacy.

Pfizer said that the cause of the error was identified and then corrected immediately.

Originally posted at InjuryBoard by Darren Tobin

Pfizer Hid Risk of Zoloft Congenital Birth Defects

Shezad Malik MD JD — Mon, 06 Feb 2012 11:20:00 GMT

Plaintiffs from Louisiana have filed a lawsuit against Pfizer that alleges the drug maker intentionally hid the link between their popular antidepressant Zoloft and congenital birth defects when the drug is taken by pregnant women.

The two Zoloft birth defect lawsuits were filed in January in the U.S. District Court for the Eastern District of Louisiana by Terry and Nelda Rolling and Joseph and Meg Mitchell.

The complaints involve children born with congenital birth defects after the mother’s use of Zoloft during pregnancy.

Many families have filed a similar Zoloft lawsuit against the drug maker, with allegations that use of the antidepressant during pregnancy caused children to be born with a variety of birth defects and malformations.

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States. Zoloft belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

In recent years, medical research and adverse event reports have indicated that side effects of Zoloft use during pregnancy may increase the risk of serious and potentially life-threatening health problems, including persistent pulmonary hypertension in newborns (PPHN), spina bifida, heart defects, lung defects, abdominal defects and cranial defects.

Studies have suggested that Zoloft may increase the risk of birth defects when used as early as the first trimester of pregnancy, a time when many women do not even know they are pregnant.

Recently, Swedish researchers published a study suggesting a link between PPHN and all SSRI antidepressants.

The lawsuits allege that data was available to Pfizer as early as 1996 that suggested their SSRI antidepressant may increase the risk of problems for children when taken during pregnancy, yet the drug maker failed to provide adequate warnings to consumers or the medical community.

By 2007, the lawsuits claim, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken by pregnant women due to another New England Journal of Medicine study that year. Those results were confirmed in a 2009 study.

The lawsuits allege that Pfizer willfully failed to warn consumers of the risks in order to maximize profits, resulting in a negligent breach in its duties to the medical community, users of their medication and their unborn children.

Originally posted at InjuryBoard by Shezad Malik MD JD

Did You Know... Safety Groups Question FDA Conflict Of Interest As Yaz Settlement Talks Continue?

Brett Emison — Mon, 06 Feb 2012 11:15:00 GMT

I've written before about settlement talks underway between thousands of women with Yaz, Yasmin, and Ocella lawsuits and Bayer, the pharmaceutical giant who makes the Yaz birth control pill. You can read those posts here and here. Though no settlement has yet been reached, the talks continue and the parties remain optimistic about settlement possibilities.

Last month an FDA advisory panel narrowly voted that while Yaz and Yasmin did pose a blood clot risk, the increased risk was worth it in order to prevent pregnancy. However, as the web site jezebel.com noted, "the narrow margin didn't quite inspire confidence."

Now, it turns out, that 3 of the 26 panel advisor's had research or financial ties to Bayer, the drug giant who makes Yaz. A fourth advisor had ties to Barr Laboratories and Teva Pharmaceuticals, who make generic version of the Yaz contraceptive pill. According to the Project on Government Oversight (POGO), all four of these advisers voted in support of Yaz and Bayer, saying that Yaz's benefits outweighed its risks.

"The American public must be able to trust the FDA and its advisory committees are making decisions based on science, not industry influence," POGO Executive Director Danielle Brian said.

Source: Huffington Post

POGO has asked the FDA to throw out the previous vote and convene a new advisory panel that is truly independent and without ties to Bayer or generic makers of Yaz and Yasmin.

Popular birth control pills, Yaz, Yasmin and Ocella, have been linked to serious and potentially deadly side effects. Yaz side effects and health problems affect women of all ages, including teens and young women.

Yaz, Yasmin and Ocella have been linked to serious side effects, such as heart attack, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease and sudden cardiac death.

Despite these serious side effects, Bayer marketed these drugs to young women not only as a contraceptive, but to relieve symptoms of severe PMS and as an acne fighter.

The dangerous culprit in Yaz, Yasmin, and Ocella is drospirenone, a synthetic (artificial) hormone that has been linked to blood clotting disorders and gallbladder disease. Yaz, Yasmin, Ocella and their generic-brand counterparts (including Beyaz and Vestura) combine estrogen with the synthetic progestin Drospirenone. No other oral contraceptive (or birth control pill) contains Drospirenone.

Drospirenone has been linked to serious side effects including blood clots, heart attack, stroke, pulmonary embolism, deep vein thrombosis (DVT), and even gallbladder disease.

In a recently released FDA funded study that compared several different types of oral contraceptives, those that contain drospirenone were shown to increase blood clot risks by 75%.

It's time for Bayer to stop putting profits over safety. It's time for Bayer to accept responsibility for its dangerous birth control pills that have ruined the lives of thousands of young women. It's time for Bayer to end this litigation through mediation and pull this dangerous drug from the market.

[More on Yaz Side Effects, Risks, and Yaz Lawsuits]

US Group Seeks Re-Vote On Birth Control Clot Risk [Anna Yukhananov at Reuters via Huffington Post]
FDA Advisers Who Approved Yaz Tied to Drug Companies [Margaret Hartmann at Jezebel.com]
FDA Panel That Declared Yaz-like Birth Control Safe May Care More About Big Pharma Than Young Women [Samantha Kimmey at The Faster Times]
In Bed with Big Pharma? Industry Liaisons Raise Questions at the FDA [Adam Zagorin at POGO]

Follow @BrettEmison on Twitter.

Originally posted at InjuryBoard by Brett Emison

Fentanyl Patch Wrongful Death Lawsuit Filed

Shezad Malik MD JD — Sun, 05 Feb 2012 11:22:00 GMT

A wrongful death lawsuit has been filed against ALZA Corporation by the family of a Utah woman who died in 2010, after using one of the company’s fentanyl pain patches.

The fentanyl patch lawsuit was filed by the family of Janine Ward last month in Salt Lake City’s 3rd District Court. The complaint names ALZA Corporation, a subsidiary of Johnson & Johnson, as a defendant.

According to the claim, the fentanyl patch, also known as a transdermal patch, was defectively designed and leaked fentanyl gel when applied to Janine Ward’s skin.

Johnson & Johnson, ALZA’s parent company, first developed the first pain patch as the Duragesic patch in 1994. Since it was introduced, the fentanyl patch has been associated with manufactured problems and many wrongful death lawsuits filed by families of individuals who overdosed on fentanyl.

Fentanyl is a painkiller about 100 times more powerful than morphine, and poses a severe risk of overdose and death if the gel contained within the patch leaks out and comes into direct contact with the skin of patient or caregiver.

The gel in the patch is supposed to be contained and delivered in a regulated fashion through a membrane placed on the skin. Over the last several years the FDA has received hundreds of reports of fentanyl overdoses and deaths associated with the use of fentanyl pain patches.

In many of the cases, too much of the fentanyl was delivered through the skin due to manufacturing defects. There have been a number of fentanyl patch recalls due to defective manufacturing.

According to Ward’s family, that is what s killed her in May 2010 after using one of the patches. A toxicology report found she had lethal levels of fentanyl in her blood at the time of death.

The lawsuit claims that ALZA used a reservoir design that failed to protect Ward from a potential overdose. According to the complaint, the death may have been avoided if ALZA had used a much safer matrix design; technology the plaintiffs say was known to the company.

Read more here and visit my website for further information.

Originally posted at InjuryBoard by Shezad Malik MD JD