Drug Injury Lawyers Blog

November 25, 2013

Johnson & Johnson’s Janssen Must Pay $11M & $4M in Topamax Birth Injury Cases

Johnson & Johnson’s Janssen Pharmaceuticals unit has lost its second drug injury verdict in a month-this one for $11 million. Haley Powell claimed that anti-seizure medication Topamax caused her son to be born with a cleft lip. The ruling comes not long after another jury ordered Janssen to pay $4.06 million to April Czimmer, whose son Blake was also born with a cleft lip in 2007. He had to undergo four surgeries. Czimmer used the drug to treat her migraines.

Jurors in Powell’s Topamax birth defect case found that the pharmaceutical company did not properly warn her about the risks involved with taking the medication even though it knew the drug could cause serious birth defects. Powell’s drug injury legal team argued that Janssen knew of the birth defect risks as far back as 1997 but intentionally kept safety reports hidden. Meantime, the manufacturer’s lawyers argued that cleft lips are common and impact about 4,500 newborns annually.

Now, Powell’s son, Brayden, 5, will have to undergo at least five surgeries before he turns 21 to fix his cleft lip. Many other Topamax injury lawsuits against Janssen are pending.

November 13, 2013

Mirena IUD Lawsuits Continue to Make Their Way into the Courts

by Altman & Altman

Just recently, a woman in Pennsylvania who claims that her intrauterine device moved in her uterus and perforated it has filed a Mirena IUD lawsuit. In her defective medical device complaint, the plaintiff is seeking damages from Bayer Healthcare Pharmaceuticals, the company that manufactured the contraceptive device.

This woman is one of many plaintiffs that are pursuing the medical device maker via the US court system. Just last month, another woman filed her Mirena injury lawsuit in Illinois Northern District Court for similar injuries. She said she had to undergo laparoscopic surgery to get the IUD out of her body. Meantime, in Kentucky, a federal judge has refused a motion by Bayer to dismiss a Mirena IUD case. Instead, the plaintiff was allowed to amend her complaint, which was not pled properly.

In Massachusetts, call our Boston Mirena injury lawyers today to request your free case assessment.

November 13, 2013

Pradaxa’s Deadly Side Effects

by Altman & Altman

Pradaxa is an anti-coagulant that doctors have prescribed to reduce the risk of stroke and blood clots in certain patients. Unfortunately, it carries an incredibly high risk for potentially deadly side effects. The Food and Drug Administration (FDA) had more than 500 complaints of death and serious injury due to internal bleeding associated with Pradaxa in the first three months of 2011. It’s typically used as a substitute for Coumadin, which has a reversal agent. The most dangerous side effects associated with Pradaxa are internal bleeding and hemorrhaging.
Pradaxa in the News A lawsuit has recently been filed against the makers of Pradaxa on behalf of the daughters of a woman who reportedly died after taking Pradaxa. Janine V. McHugh and Jennifer D. Merlino filed a lawsuit against Boehringer Ingelheim Pharmaceuticals and various subsidiaries. Their mother was said to have developed a gastrointestinal hemorrhage four months after she began taking Pradaxa for non-valvular atrial fibrillation. The Pennsylvania Record reports that the lawsuit argues that Boehringer Ingelheim knew or should have known that the original labeling of the drug did not adequately warn the plaintiff of the risks associated with Pradaxa. The lawsuit goes on to argue that the defendants knew or should have known that certain patients were at an increased risk for developing life-threatening “bleeds” as a result of taking Pradaxa.
Continue reading

November 5, 2013

Johnson & Johnson Settles False Marketing Case; Whistleblowers to Be Awarded $168 Million

by Altman & Altman

Johnson & Johnson and two of its subsidiaries have agreed to a multibillion dollar settlement with the federal government and several states after the company was charged with marketing drugs for unapproved uses and paying “kickbacks” to doctors and nursing homes, at the expense of American taxpayers.

Altogether, Johnson & Johnson will pay $2.2 billion in penalties related to its schizophrenia drugs Risperdal and Invega, and its heart failure drug Natrecor. This includes a payout of nearly $168 million to be divided among whistleblowers from Massachusetts, Pennsylvania, and California-the largest whistleblower award in United States history according to the Justice Department.

The case stems back to an initial whistleblower lawsuit filed by Joe Strom of California, a former employee of Johnson & Johnson’s subsidiary Scios, (manufacturer of Natrecor) in July of 2005. Strom, a former area manager at Scios, alleged his company knowingly and unlawfully promoted the cardiac drug for unapproved uses. His suit ultimately helped government attorneys build their case against Johnson & Johnson and helped initiate other whistleblower suits against the company in their marketing of the schizophrenia drugs Risperdal and Invega. As the only plaintiff from California, Strom will be awarded $28 million for his role in the case.

Strom filed his whistleblower lawsuit under the False Claims Act. The False Claims Act contains a qui tam provision which allows citizens of the United States, like Mr. Strom, to sue companies on behalf of the Federal Government and retain a percentage of the damages recovered. The settlement of this case is a huge victory not only for those involved in the case but for whistleblowers across the United States. Whistleblowers are typically awarded between 15% and 30% of the amount recovered in the case they help bring. The whistleblowers involved in this case were awarded nearly 25% of the amount the federal government recovered from Johnson & Johnson.
Continue reading

October 31, 2013

FDA Warns Says There is Rare Risk of Stevens-Johnson Syndrome With Acetaminophens

by Altman & Altman

The Food and Drug Administration says that there is a rare risk that acetaminophens could cause Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), and toxic epidermal necrolysis (TEN). The risk exists in both over-the-counter and prescription meds that contain this fever reducer/pain reliever.

If you developed any of these skin conditions while taking a drug that has acetaminophen in it, please contact our Boston acetaminophen injury lawyers today.

Examples of meds that contain acetaminophen:

October 21, 2013

Women Suffering from Mirena IUD Complications May Have Recourse Against Manufacturer

by Altman & Altman

Tens of millions of women across the United States use contraceptives to prevent unwanted pregnancy. Many of these women use long-term, reversible intrauterine devices (IUDs) which are intended to prevent pregnancy for up to five years by emitting hormones. This method is often chosen as a more convenient option compared to oral contraception, patches, or injections. While most of these types of contraceptive devices are safe, some of contraceptives bare the risk of causing serious complications in women who choose to use them.

What is Mirena IUD?

Mirena Intrauterine Device (IUD), manufactured by Bayer Pharmaceuticals, is one such contraceptive method that has been promoted as a safe and long-term birth-control option for women. Shaped like a “T”, Mirena IUD is a small plastic container that continuously releases the hormone, levonorgesterel, which thickens up the mucus on the walls of the uterus to limit the mobility of sperm and decrease the chances of pregnancy.

Since being approved by the United States FDA in 2000, there have been over 45,000 adverse events reported. Many women have reported device expulsion, device dislocation and vaginal hemorrhage. In addition, complications such as life-threatening ectopic pregnancy (pregnancy which occurs outside of the uterus), uterus embedment and perforation, intestinal obstruction, IUD migration, abscess, and pelvic inflammatory disease (PID) have also been reported.

Already there have been lawsuits filed against Bayer for misrepresenting the benefits of Mirena, deceptive marketing and packaging of the contraceptive, manufacturing a defective and dangerous product, and failing to warn consumers of the potentially dangerous side effects of the IUD. Women who have experienced any of these complications are advised to seek the legal counsel of an experienced Drug Injury lawyer to seek damages for medical expenses, pain and suffering, and lost wages.
Continue reading

October 18, 2013

Massachusetts Vaginal Mesh Lawsuit Can Proceed, Says Appeals Court

by Altman & Altman

The Massachusetts Appeals Court says that the vaginal mesh lawsuit that was dismissed by the Suffolk County Superior Court can proceed. The lower court had said that the plaintiff failed to satisfy pleading standards. However, the appeals court disagrees.

The plaintiff, Billie Allen, is seeking damages from Boston Scientific and American Medical System (Endo Health Solutions). She claims that she experienced the side effects of pain, mesh erosion, and vaginal scarring after she was implanted with their devices.

Vaginal Mesh Cases

October 8, 2013

Stryker “ShapeMatch Cutting Guide” and its Complications During Knee Replacement Surgery Lead to Voluntary Manufacturer Recall

by Altman & Altman

When implanted medical devices cause injuries to a patient, are improperly labeled or defectively manufactured, or otherwise fail after being implanted, a device manufacturer or the Federal Drug Administration will initiate a recall. Too often though, these recalls come after there have been hundreds of complaints filed by injured patients.

Most recently, Stryker, a leading medical device manufacturing company that specializes in developing orthopedic, neurotechnology and spine products, has issued a voluntary recall of one of its knee replacement products ShapeMatch Cutting Guides.

What Are ShapeMatch Cutting Guides?

ShapeMatch Cutting Guides are single-use, disposable cutting guides that are intended to be used as surgical instrumentation to assist surgeons in positioning the Stryker Triathlon Knee System. This software is used to guide where surgeons will cut and shape a patient’s bone before implanting the replacement knee device.

About the Recall

In April of 2013, Stryker Orthopedics issued a Level 1 voluntary recall of the Shape Match Cutting Guides, after becoming aware of the potential issues with the software. It was found that the software did not meet surgeon’s pre-operative planning parameters, and some manual edits used in the software did not meet the standards of the FDA. The overall effects these discrepancies in the software resulted in improper cutting of bones, as well as many serious adverse health consequences for patients who had Stryker system knee replacements including poorly-fitting, loose knee implants, knee fractures, chronic pain, and the need for revision surgery.

Your Consumer Rights

Like all knee replacement device manufacturers, Stryker has a legal obligation to properly design, test, and ensure their products are working correctly. They also are responsible for warning the public of any problems with their products, no matter how minor.
Continue reading

September 26, 2013

Vicodin, Oxycontin, & Percocet Linked to Birth Defects

by Altman & Altman

According to a new study just published online in the journal Obstetrics & Gynecology, women who took Percocet, Oxycontin, or Vicodin during their early stages of pregnancy are two times as likely to deliver babies with serious neural tube defects, including spina bifida. However, researchers qualified this doubled risk as “modest” and occurring in just almost six out of every 10,000 live births. Still, not even one baby should be born with a birth defect because his/her mom took medication while pregnant.

Prescription painkillers are the number to choice of drug when it comes to drug abuse-marijuana being the first-and some 22 million Americans have misused prescription pain meds in the last decade. That’s a lot people using painkillers-and if this use can lead to birth defects in babies, consumers should know.

The U.S. Centers for Disease Control and Prevention funded the study, which was authored by Slone Epidemiology Center postdoctoral associate Mahsa Yazdy, who is at Boston University. The study looked at data from phone interview with new mothers during a 12-year span. Moms of more than 305 children who were born with neural tube defects were compared to the moms of over 20,000 infants belonging to two groups: one of babies with other birth defects not linked to opioid use and the other of ‘healthy” babies.

September 19, 2013

Study Links Antidepressant Use to Birth Defects

by Altman & Altman

While the use of antidepressants during pregnancy is not a new topic, it continues to be a growing concern for mothers all over the world. Though the U.S. Food and Drug Administration does not entirely discourage women from using antidepressants, it has issued a warning that use of certain SSRI’s (selective serotonin rebuke inhibitor) during pregnancy carry a risk of causing serious birth defects.

SSRI (selective serotonin rebuke inhibitor) antidepressants such as Prozac, Paxil, Zoloft, Celexa, and Lexapro are commonly prescribed medications used in the treatment of depression. While it is often safe for women to take these medications during their pregnancy, there still lies a risk for the baby. A study done by a Danish research group in 2005 found a significant risk of heart malformation in children born to women who took antidepressants. The study showed that babies born to mothers who had filled prescriptions for more than one SSRI medication had a fourfold increased risk for developing septal heart defects (malformation of the wall that divides the left and right sides of the heart).

The research compared the incidence of birth defects among more than 400,000 children born to Danish women who took antidepressants and women who did not take antidepressants during their first trimester of pregnancy (first three months). According to the data collected, 0.5% of children born to mothers not taking medication developed septal heart defects, and 0.9% of children born to mothers who did take medication developed septal heart defects.

Common SSRI antidepressants that fall under Category C include: Zoloft, Celexa, Lexapro, Prozac, however another SSRI, Paxil is classified as a Category D medication.