The daughter of a Tennessee woman who bled to death after using Xarelto, has filed a lawsuit on her mother’s behalf against JANSEN RESEARCH AND DEVELOPMENT LLC, the makers of the drug in the United States. The lawsuit asserts that Jansen failed to adequately warn of the dangerous bleeding that could occur as a result of using Xarelto. According to court documents, the decedent started using Xarelto in October 2013 and suffered two “life threatening bleedings” between November and December 2013 which “eventually led to her death” in March 2014.

Xarelto (Rivaroxaban) is an anticoagulant (blood thinner) that is prescribed to prevent and treat blood clots. It is typically used to treat a type of blood clot known as deep vein thrombosis (DVT) which can occur after certain types of surgery, including knee and hip replacements. Xarelto is also prescribed to lower the risk of stroke for people with atrial fibrillation, “an irregular (and often) rapid heart rate” that causes poor blood circulation. One of the most dangerous side effects associated with Xarelto is a risk of bleeding. People who take the drug are likely to bruise more easily and it may take longer for bleeding to stop. Taking Xarelto with other medications such as aspirin may increase the risk even more.

According to the lawsuit Xarelto’s boxed warning did not adequately address the increased risk of bleeding especially when taken in light of the findings of a clinical trial sponsored by the drug’s manufacturer that noted that in comparison to warfarin, a similar drug, “patients taking Xarelto have more gastrointestinal bleeds and need more transfusions.” In addition the complaint, citing a report by the Institute for Safe Medication Practices, asserts that the most “adverse event” related to using the drug was not the risk of bleeding but pulmonary embolism, a condition where a blood clot generally travels from the legs and causes a blockage in the arteries of the lungs. Ironically, this is a condition that Xarelto is intended to prevent.

The lawsuit also asserts that in spite of this knowledge, Jansen continues to market Xarelto without adequate warning. At present Xarelto does not include a FDA black box warning (the strongest warning required by the FDA) describing the irreversible bleeding related to using the drug, which effectively deprives doctors of critical information in prescribing the drug when could have deadly implications for consumers.
According to the complaint, Jansen’s failure to warn of the severity of the most dangerous side effects of using Xarelto resulted in the death of Emily Pigg, the mother of the plaintiff bringing the lawsuit. Ms. Pigg’s physician prescribed the drug for atrial fibrillation and after using it “suffered a hemorrhagic stroke and internal bleedings in November 2013 and in December 2013.” The complaint further alleges that she was not able to recover and as a result she succumbed to her injuries in March 2014.

If you use or have used Xarelto and have suffered any of the serious side effects discussed here, you may be entitled to compensation for your injuries. The attorneys at Jacoby & Meyers are qualified to assist you in evaluating your case. An attorney experienced in Xarelto litigation can help you file your lawsuit and protect your rights within the statute of limitations allowed by the law.

Please contact our defective drug lawyers today to schedule your free initial consultation. Jacoby & Meyers has offices nationwide.

Zachary Mayberry, student intern Jacoby & Meyers, LLC.

The Center for Disease Control (CDC) reports elevated flu activity for the 2014- 2015 flu season.

The three strains of flu, that are common are:

• Influenza A (H1N1) viruses
• Influenza A (H3N2) viruses
• Influenza B viruses

Influenza A (H3N2) virus is the predominant strain reported this year and is associated with higher mortality rates than Influenza B (H1N1). Death rates from influenza are higher in young children and adults over 65 years of age. Reports indicate that half the country is experiencing elevated flu activity. “Flu season” varies year to year but most typically begins in December, with some periods reported as commencing as early as October. The current flu season is considered to have begun in December.

Typically an annual pattern for flu shows Influenza Like Illness (ILI) increasing first, with increased hospitalization and increased death rates following in order. This year’s statistics follow that pattern. Flu caused death statistics collected by the Center for Health Statistics are considered incomplete and depressed. Several factors contribute to this including the significant numbers of deaths, deaths listed under a different cause because no flu testing was completed, and deaths that occurred due to secondary conditions that are complicated by flu.

Flu viruses change which cause vaccinations to be less effective against a new strain. The 2014-2015 vaccination, called a trivalent vaccine, was developed to prevent 3 strains of influenza:

• A/California/7/2009 (H1N1)pdm09-like virus
• A/Texas/50/2012 (H3N2)-like virus
• B/Massachusetts/2/2012-like virus

Some of the vaccinations developed for this season also protect against an additional B virus (B/Brisbane/60/2008-like virus); this is called a quadrivalent vaccine. Vaccination does not always prevent the flu.

Many factors contribute to the effectiveness or lack thereof, of vaccinations including age, pre-existing health conditions, changes to the virus, and timing of immunization, to name a few. There are indicators that this year’s vaccine is not highly effective against the predominant strains in circulation this year.

It is possible for children 6 months to 8 years of age to need two doses of vaccination administered four months apart. “Starting in 2014-2015, CDC recommends use of the nasal spray vaccine (LAIV) for healthy children 2 through 8 years of age, when it is immediately available and if the child has no contraindications or precautions to that vaccine. Recent studies suggest that the nasal spray flu vaccine may work better than the flu shot in younger children. However, if the nasal spray vaccine is not immediately available and the flu shot is, children 2 years through 8 years old should get the flu shot.”

There are treatments for the flu, including the new FDA approved drug Rapivab. Antiviral drugs are used to treat flu and prevent serious complications from the flu. The CDC recommends that annual vaccination be combined with daily preventative measures such as washing hands and avoiding contact with others that are sick. Though it is recommended that vaccination be sought as early as October, it is not too late in the season to be vaccinated and protected against acquiring the flu. A flu season can last until May.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers.

Viagra (Sildenafil), the popular drug prescribed to treat erectile dysfunction in men, has been associated with an increased risk of skin cancer according to a Harvard School of Public Health study published in JAMA Internal Medicine in April 2014. The study, which began in 2000, involved 25,848 health professionals who used Viagra and excluded participants who reported having cancer at the start of the study. The study found that men who use Viagra are 84% more likely to develop melanoma, the most deadly form of skin cancer. While the study was only preliminary and not sufficient “to alter clinical recommendations,” the findings support a concern that users of Viagra are more susceptible to developing the disease.

Melanoma is caused when the DNA of skin cells (melanocytes) is damaged and unrepaired as the result of intense or occasional ultraviolet exposure (usually from the sun or overexposure in tanning beds) occurring especially in demographics of the population genetically predisposed to this exposure. Signs of melanoma usually appear in the form of an unusual growth on the skin or a change in an existing mole such as discoloration. Melanoma can even appear in areas of the skin that are not normally prone to UV exposure. Traditional risk factors for developing melanoma include UV exposure, fair skin, freckling, light hair, family history of melanoma, age, and gender. Men over 40 have a higher rate of melanoma, while women under 40 have a higher rate of melanoma occurrence.

In December 2014, Edward Corboy Jr. of Illinois filed a lawsuit against Pfizer, the makers of Viagra, claiming that the drug company failed to adequately warn that using Viagra substantially increases the risk of developing skin cancer. Corboy asserts that he was prescribed and began using Viagra in 2008 to treat erectile dysfunction. In December 2012, the plaintiff saw a doctor who noticed a mole on his neck. A subsequent biopsy determined that the mole was a melanoma. The complaint asserts that Pfizer knew or should have known of the increased risk of developing melanoma when using the drug and failed to warn “doctors who prescribed or patients who were prescribed” the drug of this risk. Citing the April 2014 JAMA study, Corboy states that he did not discover the connection between his use of Viagra and subsequent development of melanoma until the study was published. Given that the authors of the study admitted that the findings were not conclusive and more research is necessary, Corboy will likely need more information in order to demonstrate a causal connection between the use of Viagra and the increased risk of skin cancer. In addition to negligence claims, the complaint also includes claims of strict liability, fraudulent concealment, and unjust enrichment.

If you have used Viagra and subsequently developed melanoma you may be entitled to compensation for your injuries. Call 800-977-5614 to speak to a Jacoby & Meyers attorney today.

Zachary Mayberry, student intern Jacoby & Meyers.

Effexor (venlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) manufactured by Wyeth that is prescribed to treat long and short-term depression and anxiety. Effexor was brought into the market in 1993. Pfizer acquired Wyeth in 2009.

There are several side-effects associated with the use of Effexor. One side effect that is the subject of a multidistrict ligation is regarding its effect if taken during pregnancy. Effexor is shown to cause serious birth defects if taken while a mother is pregnant.

In August 2013, the United States Judicial Panel on Multidistrict Litigation grouped nine class actions in Pennsylvania. U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania, is presiding over the cases. The panel believed she is best suited to hear the case since she is already hearing multidistrict litigation (MDL) with parallel claims involving Wyeth and Pfizer over Zoloft’s alleged links to birth defects.

Plaintiffs allege that before Wyeth and Pfizer began selling Effexor on the market, they knew its use during pregnancy increased risk that children exposed to the drug in utero would be born with serious birth defects. Furthermore, they allege that the defendants did not warn mothers or the medical community of the known risks and actively misrepresented the safety of Effexor.

On September 29, 2014, Judge Rufe issued a case management order which would allow any plaintiff whose case would be subject to transfer to the MDL proceedings the ability to file his or her case directly to the United States Court in the Eastern District of Pennsylvania. This was done to eliminate any delays associated with the transfer to the District Court. In order to qualify for direct filing, the lawsuit must be a “single-plaintiff complaint”, involving only one child injured by exposure to Effexor.

There are currently nearly 70 Effexor cases pending in the MDL. November 18, 2014 Judge Rufe directed that 14 bellwether cases undergo discover and the process of setting the cases for trial. The plaintiffs’ bellwether selections were to have be made before Christmas and Pfizer’s due late January 2015. Of the 14 selections, only 12 will ultimately proceed to trial first since each side will be allowed to strike one case from the other’s bellwether list. Trial is expected to begin by winter 2015.

Have you or a loved one used Effexor during pregnancy and delivered a child with birth defects? If so, contact experienced Jacoby & Meyers to speak with an experience dangerous drug attorney who are dedicated to recovering compensation for affected families. For more information, contact us today.

Alexandra Bhatti, student intern Jacoby & Meyers.

The Decisions

In 2011, the Supreme Court’s decision in Pliva Inc. v. Mensing held that in state courts, generic-drug manufacturers could not be held liable for failing to inform the Federal Drug Administration (FDA) when its label inadequately warns consumers of health risks. Pliva claimed that it was impossible for generic drug manufacturers to simultaneously adhere to state and federal law because federal law requires generic labels to be identical to labels approved for the name brand. As a result, Pliva stated that unilaterally strengthening the warning on the generic label to avoid state law liability would violate federal law requiring identical labels. This decision renders states unable to make generic drug makers responsible for the harm their products inflict on those that use them. This ruling impacts millions of individuals in the U.S., because generic drugs make up 75% of the prescription drug market.

In the recent Supreme Court of Alabama decision Wyeth v. Weeks, the Alabama court held that the plaintiffs can seek damages against the brand name manufacturers of the same generic drug that caused their harm, based on a theory of civil liability known as “innovator liability.”

The History

In an attempt to decrease the cost of prescription drugs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984. This act enables generic drug manufacturers to produce drugs without the cost of development, research, and trials required of the brand name manufacturers before approval by the FDA. This act afforded the generic manufacturers to sell their product at a lower cost making prescription drugs more affordable to the general public. The law required that the drug be an exact duplicate of the brand name drugs and that their labels, including their warnings, replicate those of the brand name drug being copied. The restrictions placed on the generic drug manufacturers included the inability to alter their warning labels unless the brand name manufacturer changed its label.

The Cases

In Pliva, each plaintiff filed the equivalent of a failure to warn case against the generic drug manufacturers, Pliva, Inc. and Activus, Inc., in the Minnesota and Louisiana state courts. The plaintiffs won their cases at the state level under state law.

The manufacturers appealed to the Supreme Court. The manufacturers argued federal law does not allow the generic labels to be altered unless the brand name label does so first. The state law requires the generic labels to warn of side effects of the drugs that they knew or should have known could cause harm. The Court ruled in favor of the manufacturers on their “impossibility” defense. Simply put, they could not follow the state law without breaking the federal law. In its decision, the Court cited the Supremacy Clause, which declares that any state law that is in opposition to a federal law is rendered ineffective.

In Wyeth v. Weeks, the Alabama Supreme Court held that brand name drug manufacturers may be held liable for the generic manufacturer’s failure to warn. Wyeth argued that since they had no actual “dealings” with the Weeks, they were not responsible to them for the harm caused by the generic prescription that harmed them.

The court decision used the element of tort law that requires liability for injury if the defendant could reasonably foresee that their negligent behavior may harm a third party. Wyeth should have expected physicians would rely on its label when making decisions to prescribe the drug.

The decision in Weeks cited Conte v. Wyeth, Inc. In this decision, a California court ruled Wyeth, the brand name manufacturer of Reglan, could be held liable for injuries which were reasonably foreseeable due to intentional misrepresentation by the brand name manufacturer of the drug. Also cited in the Weeks decision was a Vermont case, Kellogg v. Wyeth, which also found Wyeth liable for harm to the plaintiff in that case even though the plaintiff had only used the generic form of the drug Reglan or metoclopramide.

The Future

The FDA confirms the “sameness” requirement of generic labels to their brand name counterparts. The agency also clarified that it prohibits changes to generic labels unless the brand name label is changed first. Though generic drug manufacturers have eluded liability under the impossibility defense of tort law, it may be that some state courts are opening the door for compensation of harm to consumers. The courts have possibly created a new avenue for those injured by drug manufacturers negligence to have their day in court by allowing third party liability cases against name brand manufacturers.

Experienced Dangerous Drug Representation

If you or a loved one has suffered an injury due to taking a dangerous prescription drug, the attorneys at Jacoby & Meyers can help you receive compensation for your damages. We have the resources of a national law firm, and we have the skills and experience needed to battle the high powered legal teams of large pharmaceutical companies. Our lawyers can review the facts of your case to determine whether you have a valid defective drug claim.

Please contact our defective drug lawyers today to schedule your free initial consultation.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers.