Drug Injury Lawyers Blog

May 15, 2014

Androgel, Axiron Users to File Suit against Manufacturer over Heart Attack Risk

Testosterone replacement therapy has grown into a billion dollar industry and is only expected to continue to thrive in the coming years. As the prescriptions have come pouring in, so have the reports of severe side effects caused by the relatively new medication. While it has long been known that Low-T medications can be harmful to women and children, several more recent studies have shown significant signs that the treatment may be linked to increased risk of heart attack. Studies such as one published in renowned science journal PLoS One have shown compelling evidence that Low T medications such as Androgel may triple the risk of a heart attack in men under 65 within 90 days of starting treatment. Those who have suffered a heart attack while taking the medication are urged to consult a Massachusetts Personal Injury Attorney right away.

There have been so many cases that the FDA is now looking into the safety of Low-T treatment drugs. According to Bloomberg News, the “U.S. Food and Drug Administration said it will re-examine the safety of testosterone replacement drugs after two studies showed a higher risk of heart attacks and strokes in men who use them.” The National Cancer institute conducted a study of 65,000 patients in which both patients older and younger than 65 years of age were twice as likely to suffer a heart attack or other cardiac issues. “When the study compared these men to a separate group of patients taking Viagra and Cialis, the men on the erectile dysfunction drugs patients did not experience more heart attacks,” according to forthepeople.com Continue reading

May 13, 2014

Drug Company Founder gets $3.4 Million Fine and Jail Time for Misbranding Cancer Medication

by Altman & Altman

How would you feel if the chemotherapy medication you were relying on to treat your loved one’s cancer was not the drug you thought it was? What if that drug was misbranded and illegally shipped overseas from a different country? One pharmaceutical company and its founder are paying a hefty price for attempting to get away with exactly this scheme, endangering countless patients in the process.

Virginia-based pharmaceutical company Gallant Pharma pleaded guilty last year to distributing thousands of packages of mislabeled drugs to doctors nationwide. Co-founder 39-year-old Syed ”Farhan” Huda of Arlington appeared in Federal Court to answer to charges of illegal importation and introducing misbranded drugs into interstate commerce, according to Boston.com Continue reading

May 12, 2014

Endo Health Solutions to Resolve Majority of Vaginal Mesh Lawsuits for $830M

by Altman & Altman

Endo Health Solutions says it will pay approximately $830 million (pretax) to resolve about 20,000 vaginal mesh complaints against it. The manufacturer acquired American Medical Systems Holding Inc., which makes the mesh implants, in 2011.

As of late February both companies were contending with about 22,000 defective medical device cases over the transvaginal products. Among the Endo devices included in the settlement are the Elevate, Apogee, and Perigee implants.

The implanting transvaginal mesh devices was initially seen as an enhanced alternative to tradition surgery to repair POP (pelvic organ prolapse.) However, the US Food and Drug Administration began to take notice a few years ago that there were a lot of women complaining that the mesh devices had caused them serious complications.

May 9, 2014

Judge Rules that $11 Million Topamax Birth Defect Award Will Stand

by Altman & Altman

The $11 million ruling awarded by a jury in a Topamax birth defect case will stand, according to National Trial Lawyers. Court of Common Pleas Judge George W. Overton denied a motion by Johnson and Johnson subsidiary Janssen Pharmaceuticals for a new trial, upholding the original award for the family of Brayden Gurley.
The US Food and Drug Administration (FDA) has since issued a warning regarding serious birth defects in infants caused by expectant mothers using Topamax. Severe cases of cleft lip, cleft palate and other deformities have been widely reported. However, the Gurley family accused Janssen Pharmaceuticals of “operating in a culture of secrecy, intentionally withholding concerns about Topamax known to the company at the time, together with safety reports that suggested an association between Topamax and birth defects, dating back to 2003,” according to Bloomberg News. It is possible that the pharmaceutical company knew about the issues as far back as 1997, but kept these warnings private.
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May 7, 2014

NECC Meningitis Victims Seek $100 Million Settlement

by Altman & Altman

According to several sources, a judge has been asked to approve a $100 million settlement to aid victims of last year’s Meningitis outbreak, which was traced back to New England Compounding Center. The Massachusetts Pharmacy is believed to have manufactured steroid injections that were tainted with black mold and caused a nationwide outbreak of the deadly disease. WBZ reports that “NECC’s owners, its insurers and one of its affiliates will contribute an aggregate amount estimated to exceed $100 million to a compensation fund to be distributed to NECC creditors, including those who died or suffered significant injuries” as a result of receiving the drug.

The outbreak quickly grew out of control and spread across 20 states. The New England Compounding Center surrendered its license in 2012, but the damage was already done. The Center for Disease Control and Prevention data shows that as many as 750 patients were sickened and 64 people died as a result of the contamination. The pharmacy then filed for bankruptcy.
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April 30, 2014

New Study Shows Testosterone Drugs Have No Link to Certain Types of Cancer; Stroke Risks Remain

by Altman & Altman

A new study presented at the 2014 Genitourinary Cancers Symposium showed that testosterone therapies do not have any links to prostate cancer; an original concern for medical professionals.

According to an article sourced from the National Trial Lawyers, the study used information from several cancer registries to study the risk of prostate cancer in males using androgen-replacement drugs. Androgen replacement and other testosterone therapies are commonly used to remedy male hormonal issues-specifically for men who wish to build greater muscle mass, reduce body fat, and improve health and sex drive. The U.S. Food and Drug Administration has approved hormonal therapy as a beneficial treatment for patients suffering low t-levels as a result of coinciding medical issues, but has not approved testosterone therapy as safe for men without an existing medical condition. Testosterone replacement is typically administered in the form of prescription transdermal gels, creams, pellets, patches, and injections. Common testosterone therapy products include: Androgel, Andoderm, Axirom, Bio-T-Gel, Foretesa, and Testim.

But while many of these treatments are safe for use, there remain some serious risks. Hormone changes have the possibility of influencing certain tissues and organs, including the prostate, and therefore medical professionals had previously speculated that androgen and testosterone could increase the risk of developing prostate cancers. This study, though, found no link between androgen-replacement therapies and prostate cancer.
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April 28, 2014

Lundbeck Pharmaceuticals Hit With Stevens Johnson Syndrome Lawsuit

by Altman & Altman

A Texas family has filed suit against the European drug company Lundbeck Pharmaceuticals for the injuries their son sustained after taking Onfi, an anti-seizure medication. The parents of the 11-year-old allege that the drug caused their son to develop Stevens Johnson Syndrome, a rare and extreme disorder of the skin and mucous membranes.

After developing SJS, the boy incurred serious skin and hair loss, as well as the loss of his fingernails. His parents, Madeline and Rogelio Escareno, said in the lawsuit that Onfi has caused their son to be permanently disfigured and traumatized, and are demanding that Lundbeck pay them compensation for the boy’s injuries.

DEFECTIVE MEDICATIONS AND DRUGS

Onfi (Clobazam) is an anti-seizure medication which falls into the category of drugs called benzodiazepines. Onfi is often prescribed with other medications to help prevent seizures associated with a severe form of epilepsy called Lennox-Gaustaut syndrome. The drug was approved by the FDA in October 2011, for treatment of patients aged 2 years and older. Since being approved, the medication has been prescribed to more than 30,000 patients in the United States. Sadly it has been linked to at least 20 reported cases of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis worldwide.

While the Escarenos’ son did not suffer from Lennox-Gaustaut syndrome, which the drug was specifically formulated to treat, he was prescribed Onfi for the off-label use to treat his epilepsy. However, shortly after beginning this treatment, the boy began developing severe skin lesions, causing skin to detach from various parts of his body including inside and outside of his mouth, throat, and genital areas. According the lawsuit, the condition eventually manifested into SJS’s deadlier and latent cousin, Toxic Epidermal Necrolysis.

Though badly injured, the boy was able to survive the disease after undergoing nearly a month of treatment at Fort Worth’s Cook Children’s Medical Center in March 2013. The proof of his injuries is still clear-the Escarenos say that their son is both physically and psychologically scarred. According to the Escarenos’ lawsuit, there were no warnings or indications printed on the drug’s label of the possibility of SJS or TEN developing from its use. The family said that had they known about those side effects, that they would never have put their son on the medication. In the lawsuit, it was confirmed that no warnings of SJS or TEN were available by March 2013, and that warnings were announced by the FDA in December 2013. In the lawsuit, the family accuses Lundbeck of knowing these warnings, and intentionally withholding the information to protect their profit margins.

Additionally, the family also alleged Lundbeck of illegally promoting Onfi for uses not approved by the FDA. Because the company had marketed the drug to treat a much broader range of epilepsy conditions, the Escarenos say that is why their son was prescribed the drug for off-label use. Doctors are permitted to prescribe medications for any reason deemed medically relevant, however it is illegal for drug companies to promote drugs for off-label uses.
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April 24, 2014

Pfizer to settle $190M Class Action Settlement over Neurontin

by Altman & Altman

Pharmaceutical giant Pfizer has tentatively agreed to a $190 million class action settlement that would essentially resolve claims made by thousands of direct purchasers that the company delayed the production and implementation of generic versions of its drug Neurontin and heavily marketed it for uses unapproved by the FDA.

There have been numerous lawsuits filed in reference to the drug, which is only FDA-approved to treat epilepsy and Shingles. According to medical advocate Tuum Est , “In 1996, Pfizer employee Dr. David Franklin filed a whistleblower lawsuit on the basis that 88% of the revenue from Neurontin was from off-label uses, yet much of the evidence supporting those off-label uses was known to be fabricated.” Since then, Pfizer is accused of continuing to market the drug for off-label uses in order to push out competition from the cheaper generic brand, Gabapentin.
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April 18, 2014

Certain Spinal Implants May be Linked to Paralysis

by Altman & Altman

According to an analysis by the Wall Street Journal, over 100 patients have developed partial or permanent paralysis in recent years after receiving spinal-cord stimulator implants in their backs. A number of defective medical devices have been filed as a result.

A lot of the cases involved patients with spinal cords that were compressed or punctured by stimulator electrodes. These are usually inserted in the spine’s epidural space. The spinal stimulators that were involved came from different manufacturers, including Boston Scientific Corp. and Medtronic.

About 50,000 people in the US a year are implanted with a spinal cord simulator device to treat back pain and other issues. The simulator sends low electrical currents through wires up electrodes close to the spine. This is supposed to distract the brain from identifying pain signals.

April 15, 2014

Lawsuit Claims Bayer Failed to Warn Patients of Yaz/Yasmin Blot Clot Risk

by Altman & Altman

A California woman claims to have suffered a painful blood clot after taking Yaz/Yazmin oral contraceptive. She is suing the drug manufacturer, Bayer Healthcare Pharmaceuticals, Inc. for allegedly ignoring the warning signals raised by numerous injuries and deaths related to the drug early on in its distribution. The lawsuit states that, “Bayer marketed the pills as safer than older generation oral contraceptives, despite early reports of at least 50 deaths linked to blood clot complications.

Plaintiff Tatiana Barnes is hardly alone in her criticism and legal action against the manufacturer. Countless complications have been attributed to the birth control pills, and many of them have been consolidated into a class action lawsuit against Bayer Healthcare Pharmaceuticals. Barnes has yet to join the class action suit.

She suffered complications from a blood clot in 2009, after being prescribed Yaz/Yasmin/Ocella. The oral contraceptives were only on the market in the United States for ten years; a very short amount of time considering the birth control pill has been in production since the 1960s. Barnes and many other plaintiffs who filed suit against the company say they were never accurately warned of the risks associated with a drug that promised to be safer than previous contraceptives. The FDA has already publicly scolded Bayer for its insistence on the benefits of Yasmin.
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