In the past month, at least three new lawsuits have been filed over birth defects parents allege were caused by Zofran, the popular anti-nausea medication prescribed for off-label use during pregnancy by mothers.  This case, filed in California Superior Court on March 30, 2015, follows two others: one filed in the Eastern District of Pennsylvania on February 12, and another in the District of Massachusetts on February 16.  Each case alleges congenital abnormalities, including heart defects, after the mothers were prescribed Zofran for nausea and vomiting associated with pregnancy…a use not approved by the FDA when the drug was approved for market.

The court cases allege, among other things, that the maker of the drug, GlaxoSmithKline, has received more than 200 reports of birth defects in children who were exposed to Zofran during early pregnancy.  Glaxo is also being accused of improperly marketing Zofran to treat pregnancy-related nausea and vomiting, and one lawsuit even notes that Glaxo previously agreed to pay $3 billion to settle charges with the U.S. Department of Justice regarding the marketing of a number of other medications.  This prior settlement with the U.S. government included allegations that Glaxo had improperly marketed Zofran to treat morning sickness…the very same claim now asserted by the plaintiffs.

Recent research by scientists with the University of Colorado, Stanford University, and London’s Royal Free Hospital reveled that when taken during pregnancy, Zofran does in fact cross the placenta to reach the developing fetus, and remains longer with the baby than the mother due to a longer half-life (i.e., the elimination rate of the drug in the body).  This was not the first study done regarding these issues.  A previously published study from the journal Clinical Pharmicokinetics, showed that samples taken from 41 women given Zofran prior to surgical pregnancy termination procedures revealed much higher concentrations of the drug within fetal tissues than was anticipated.

If you or a loved one has taken the drug Zofran during pregnancy, or have a child with a congenital abnormality, birth defect, or heart condition after taking the drug, you should have your claim evaluated by a legal professional as soon as possible.  Complex litigation against large pharmaceutical companies demands specialized legal experience.  If you or a loved one believe you have been harmed by taking Zofran or any other drug or medical devicecontact the firm of Hollis Wright for more information.

Big Pharma has taken it on the chin recently in several trials across the country, with juries awarding millions in damages to individuals who’s health and lives were ruined by defective drugs rushed to market with “reckless indifference” to the health and safety of patients.  Amid growing concerns over FDA oversight, and lack of transparency in the testing and studies for new drugs, two juries in the last 30 days in Philadelphia have awarded $2.5 million against Johnson & Johnson for claims associated with use of its long marketed Risperdal medication, while Takeda Pharmaceutical Co. was hit with $2.3 million in damages to a former teacher who developed bladder cancer after using the company’s diabetes drug, Actos.

The Takeda award amounted to $300,000 in compensatory damages for the plaintiff’s medical expenses, as well as an additional $2 million for pain and suffering related to his cancer diagnosis.  This is the not the first case where Takeda has been accused of, and found liable by a jury, of endangering the health and welfare of potential patients and users of its drugs.  On April 7, 2014, Takeda and Eli Lily where hit with a $9 billion jury verdict related to the same drug, Actos, for failure to disclose and warn of the drug’s potential to cause cancer.  On appeal, that award was cut to $36.8 million; however, this recent award is the fifth jury award against Takeda related to Actos.  Juries in California and Maryland have also awarded a combined $8.2 million against Takeda for its handling of the drugs.

Another Philadelphia jury ordered Risperdal drug manufacturer, Johnson & Johnson, to pay $2.5 million to a 20-year old autistic man from Alabama who developed size 46 DD breasts as a young teenager due to his long time prescribed use the drug.  This condition, called gynecomastia, was never warned about the manufacturer, who now faces thousands more lawsuits in Philadelphia, California, Missouri, and other locations across the US.  Juries aren’t the only problem for J&J related to Risperdal however; in 2013, the company paid $2.2 billion to settle federal and state criminal and civil charges related to illegal marketing of the drug.  Gynecomastia is the growth or enlargement of male breast tissue. The psychological and social injuries can be devastating — especially when gynecomastia affects adolescent males. Many doctors recommend surgery to reduce breast tissue. In mild or moderate cases, liposuction may be an effective option. In severe cases, however, a surgical procedure called a mastectomy may be necessary to remove breast tissue and excess skin.

If you or a loved one has taken the drug Actos, you should be aware of the following symptoms potentially associated with bladder cancer: bloody urine, pain with urinating, increased urge to urinate, and unusual back pain.  Complex litigation against large pharmaceutical companies demands specialized legal experience.  If you or a loved one believe you have been harmed by taking Actos, Risperdal, or any other drug or medical devicecontact the firm of Hollis Wright for more information.

 

Civil law can generally be divided into two categories: substantive and procedural. Many substantive laws are commonly experienced and understood by the general public. For instance, the tort of negligence is present in everyday occurrences such as car wrecks, and breaches of contract can occur in virtually any type of business dealing. Procedural laws, on the other hand, are often much more mysterious to a layman, simply because they regard the actual nuts and bolts of how a lawsuit is administered by a court.

An example of procedural law exists in the distinction between state courts and federal courts. Most lawsuits are handled in state court, because the only way a federal court can hear a suit is if (1) the parties to the lawsuit are from different states and the amount in controversy exceeds $75,000, or (2) the case primarily involves an issue of federal jurisdiction, rather than state jurisdiction. Though this may sound basic enough, there can be much dispute. If the case is held in federal court, there may also be a dispute as to which state’s laws the court should apply.  This issue most commonly arises when the accident or injury happens in one state, but the lawsuit is filed in a different state because of where the plaintiff and/or defendant reside.

A federal court case in the Northern District of Alabama currently being handled by the law firm of Hollis Wright provides a nice illustration of the juggling act between substantive and procedural laws. In this case, the plaintiff, a resident of Alabama, is suing the manufacturers of a surgical robot for injuries he sustained while undergoing surgery in Tennessee. The defendants did not dispute that the case should be held in federal court; rather, they maintained that the federal court should apply Tennessee’s statute of limitations, which is only one year, over Alabama’s, which is two years. If the federal court employed Tennessee’s statute of limitations, the plaintiff would have been time-barred from bringing his suit.

According to Judge Madeline Haikala, “[a] federal court sitting in diversity [i.e., parties from different states where the dispute is for more than $75,000] applies the substantive law of the state in which the court sits, including the state’s choice-of-law rules.” Alabama’s choice of law rules say that the court should apply the substantive laws of the state where the injury occurred – in this case, the substantive law of the State of Tennessee.  Already, this is quite a confusing piece of law, and it illustrates the need for plaintiffs to hire experienced attorneys who can navigate the tricky legal road. However, still the question of whether Tennessee’s statute of limitations should be considered substantive or procedural needed to be addressed. The one-year statute of limitations came from the Tennessee Products Liability Act.

“By legal tradition, most statutes of limitation are deemed procedural rather than substantive.” However, the federal court cited some Alabama Supreme Court cases where statute of limitations were deemed substantive. These cases made a distinction between statutes that merely have a limitations period, and “statutes of creation,” which actually grant plaintiffs an entirely new “legal right” (claim) that was not previously available to them before the statute was enacted. According to the Alabama Supreme Court, a statute of creation contains “a statute of limitations [which] is so inextricably bound up in the statute creating the [new legal] right that it is deemed a portion of the substantive right itself.” The TPLA was enacted by the Tennessee legislature in 1978, however, product liability claims had been brought in Tennessee for many years before 1978. Accordingly, the federal court determined that the TPLA did not actually create any new legal right, thus, it could not be regarded as a substantive “statute of creation.”

Determining that the TPLA’s statute of limitations was procedural rather than substantive, the federal court determined that Alabama’s two-year statute of limitations was applicable. “[T]he law of the forum [the state where the federal court sits] . . . governs procedural matters.” The federal court denied the defendant’s motion to dismiss, finding that Tennessee’s substantive laws, and Alabama’s procedural laws would apply in the case.  This issue is currently being handled by Carter Clay, a partner with the law firm of Hollis Wright, and this victory secured the continuing viability of his clients’ claim against the defective product manufacturer.  This illustration stands for the greater point that a plaintiff should consult the services of an experienced law firm with the expertise to handle such complicated legal matters.

The law firm of Hollis Wright is currently representing numerous individuals who have been injured by defective medical devices.  If you or a loved one believe you have been harmed by a defective medical device or product, contact the firm of Hollis Wright for more information and evaluation.

 

Additional contributors: Tyler Flores

On Monday, November 3, 2014, a Kalamazoo, Michigan-based orthopedic device manufacturer, Stryker Orthopedics and Howmedica Osteonics Corp., agreed to pay at least $1.43 billion to settle lawsuits pending around the United States.  The lawsuits were filed by thousands of patients who received two (2) different defective hip implants, which were recalled by Styker in 2012 due to corrosion and other various problems.  Defective hip litigation has seen several large settlements over the past few years, with John & Johnson agreeing to a $2.5 billion settlement just last year to settle some 8,000 lawsuits from patiets alleging that the company’s metal ball-and-socket hip implant caused them injury or had to be replaced or removed entirely.

The Styker settlement will include all pending state and federal claims, and will include plaintiffs from 39 different states.  The claims include corrosion which occurred in the patients’ bodies causing illness, as well as removing and replacing the implant with a new device, a procedure known as a revision.  According to attorneys who lead the settlement negotiations,   “[t]he settlement represents one of the largest medical device settlements with an unlimited compensation fund.”  Stryker expects to make most of the payments under the settlement by the end of 2015.

The law firm of Hollis Wright is currently representing numerous individuals who have been injured by these Stryker productsComplex litigation against large medical device manufacturers demands specialized legal experience.  If you or a loved one believe you have been harmed by a defective medical device or product, contact the firm of Hollis Wright for more information and evaluation.

While Halloween is a night of fun, the special circumstances surrounding trick-or-treating and parties mean a variety of opportunities to commit actionable negligence. Here are a few thoughts on protecting yourself from liability on Halloween:

 

  1. Don’t leave open candles anywhere outside. While your sidewalk may look great lined with real lanterns, this creates a foreseeable risk that someone could accidentally knock them over or that a child’s costume could catch fire.

 

  1. Keep pets inside. Even if your dog is normally well-behaved, strangers, Halloween costumes, and props can cause your dog to get scared or territorial and lead to a dog bite incident. Especially if your dog has had a history of biting (even one time), a dog bite could expose you to liability.

 

  1. Beware of the “pop-out and scare.” Many homeowners like to add to the atmosphere of Halloween by dressing up as a monster and popping out from the side of a porch or from behind trees or bushes to scare trick-or-treaters. If you choose to engage in this fun, ensure that the “scare zone” is away from stairs or any other tripping hazard.

 

  1. Be watchful of your child’s costume props. If your kid’s costume comes with pointed or sharp props—think swords, bow-and-arrows, etc.—consider buying plush or softer props or only using the props at home for pictures. If your child accidentally harms another child with a toy sword, you could be held liable for negligent entrustment or negligent supervision.

 

  1. Label candy with allergens. If you are giving out candy with peanuts, be sure to either label the candy or tell parents of trick-or-treaters.

 

  1. Provide a safe terrain. Ensure that the walking areas leading up to your front door are safe. Fix loose boards or uneven areas of concrete, and remove roots that trick-or-treaters could trip over. If you don’t afford to fix these issues before Halloween, make sure the area is well-lit.

 

  1. Avoid social host liability. If you host a party on Halloween night, you run the risk of being held liable as a social host if one of your guests, after leaving your party, drives drunkenly and injures someone. A “Bring Your Own Beer” policy may not shield you from liability. As safe alternatives, offer to call taxis for intoxicated guests or provide a place for intoxicated guests to sleep.

Have you been injured while driving or riding in a GM manufactured vehicle? As of August 2014, GM has set up a settlement program to compensate persons injured in several recalled cars. The problem noted in the recall is an ignition defect which cuts power to the airbags, power steering, and brakes. In these cases, the ignition switch moves out of the “run” position, resulting in a partial loss of electrical power and turning off the engine. These issues can cause an accident or make an accident far worse. As of September 22, 2014, the official death toll from the ignition defect stands at twenty-one (21). 143 alleged death claims have been filed, out of 675 total filed claims.

The affected models include:

Buick

Cadillac

Chevrolet Oldsmobile Pontiac

Saturn

Lacrosse

(2005-2009)

CTS(2003-2014) Camaro(2010-2014) Alero(1999-2004) G5(2007-2010)

Ion

(2003-2007)

Lucerne

(2006-2011)

Deville(2000-2005) Cobalt(2005-2010) Intrigue(1998-2002) Grand Am(1999-2005)

Sky

(2007-2010)

DTS

(2006-2011)

HHR(2006-2011)

Grand Prix

(2004-2008)

SRX

(2004-2006)

Impala(2000-2014)

Solstice

(2006-2010)

Malibu

(1997-2005)

Monte Carlo (2000-2007)

 

If you were injured while driving or riding in one of these vehicles, it is important to consult with an attorney as soon as possible. The compensation expert hired by GM to manage the recall settlement has stated that GM will only accept claims until December 31, 2014. The settlement manager has also stated that GM has not placed a cap on the payments, so anyone with an eligible claim has an opportunity to recover damages. Those with an eligible death claim will automatically receive $1 million in addition to the awarded amount.

Eligible claims must meet the following criteria:

  • The injured party must have been a driver of or passenger in one of the car models (and years) listed above;
  • There must be a physical, personal injury—GM is not compensating for property damage;
  • The airbags must not have deployed—if the airbags deployed, then this ignition defect was not the cause of the accident.

Finally, the compensation program will not consider driver negligence in determining eligibility for a settlement award.  The law firm of Hollis Wright is currently representing numerous clients with potential GM claims.  Complex litigation against large pharmaceutical companies demands specialized legal experience.  If you or a loved one believe you have been harmed by a transvaginal mesh device, contact the firm of Hollis Wright for more information and evaluation.

 

Additional authors: Alison Almeida

One intensifying social controversy concerns the vaccination of children. A June 2014 article in the journal Pediatrics reports that 1 out of 10 parents in the United States are refusing to vaccinate their children. The momentum of the so-called “Anti-Vac” movement has been aided by the endorsement of celebrities such as Jenny McCarthy, who publicly claims that vaccination is the likely cause of her son’s autism.

In 2000, the Center for Disease Control announced that measles had been eradicated in the United States. In May of 2014, the CDC proclaimed that the number of measles cases in the country is the highest it has been since the disease was eliminated, opining that unvaccinated individuals travelling abroad have brought the disease back to the States. Pertussis, or “whooping cough,” has also made a comeback in the last decade.

With many states across the country requiring parents to provide documentation of their children’s immunizations prior to allowing those children to attend school, a constitutional controversy, which will likely be addressed by the United States Supreme Court at some point, is brewing.

In one recent case, a New York City mother has sued the city’s Department of Education for refusing to grant her five year-old daughter a religious exemption from the state’s policy that children must be vaccinated against several diseases—including measles, mumps, rubella, and polio—before they can attend public school. That lawsuit actually consolidated separate challenges from three (3) families whose children were banned from school for up to one month during various disease outbreaks.

The most outspoken mother, who claims to be a devout follower of the Catholic faith, says that immunizing her child would represent “a lack of faith in God and his way.”  Judge William F. Kuntz II of the Federal District Court of Brooklyn disagreed with that argument, stating that the Supreme Court has “strongly suggested that religious objectors are not constitutionally exempt from vaccinations” and concluding that New York City’s strict vaccine guidelines are meant to safeguard its residents’ health and well-being.

United States Supreme Court precedent states that religious exemptions from state laws may only be granted in light of “genuine and sincere” religious beliefs, so as to prevent persons from feigning “sham” religious beliefs to escape things like recreational drug use laws and military conscription. School officials say that this mother’s claims regarding vaccinations have not been substantiated as being genuine or sincere. Will this be the case that takes this issue through the Supreme Court doors?

Additional authors: Alison Almeida

Unless you’ve been living in exile for the past 4 years, you probably have heard your fill about the BP oil spill and oil rig explosion.  However, a closer look at what happened, and what continues in the settlement process is a cautionary tale for future contract drafters and negotiators (and good news for those with active claims pending against BP).

On April 20, 2010, an explosion on BP’s Deepwater Horizon offshore oil rig caused the deaths of eleven people and the largest oil spill in the industry’s history. After the Deepwater Horizon rig sank, oil leaked into the Gulf of Mexico for an astounding eighty-seven days. This disaster led not only to massive wildlife relief efforts, but also to federal criminal charges and civil claims against BP.

Several investigative groups, following the spill, jointly concluded that BP’s conduct in cutting corners to save money and time—thereby increasing its profit margins—had created an irresponsible and unsafe environment that inevitably bred the tragedy. Knowing reparative action was essential for the company’s survival in the midst of the enormous legal and public relations fallout, BP announced the Gulf Coast Claims Facility (GCCF), a $20 billion fund from which it agreed to settle claims related to the spill. The GCCF began accepting claims in August of 2010. $6.2 billion in settlement funds was paid from this account until June of 2012, when the GCCF was replaced by a court-supervised settlement program.

What BP seems to have overlooked prior to opening the GCCF for claims is that claimants without “actual damages” could receive payment from BP, pursuant to the formula drawn up by BP itself. Bleeding money, BP made a motion to a federal court to stop payment on thousands of claims, in July of 2013. The federal judge who heard the motion refused to halt the program. BP, overwhelmed by the enormity of its self-imposed payment obligations, sought relief from the Fifth Circuit Court of Appeals. The Fifth Circuit Court in New Orleans affirmed the lower court’s decision, finding that, under the terms of the BP-drafted settlement agreement, businesses claiming damages were under no obligation to prove direct harm from the spill in order to recover. BP appealed to the United States Supreme Court.

On June 9, 2014, the Supreme Court refused to stay the Fifth Circuit Court of Appeals’ mandate to BP to make payments per the settlement agreement. Not only does this serve as a good lesson in contract drafting (as, by law, a contract is construed against the party who wrote it), but also, it leaves the door open for businesses affected by the oil spill to make claims against the fund.

The law firm of Hollis Wright is currently representing numerous business owners who have been injured as a result of the Deepwater Horizon oil spill. In order to recover, a business need not be based on the Coast, and need not have a direct loss associated with the spill. Virtually any business can qualify. In fact, we represent all different types of businesses, including distribution companies, law firms, car dealers, restaurants, and oil station companies, just to name a few.  The evaluation process is efficient and non-invasive; however, these claims require specialized legal experience.  If you believe you may have been harmed by the BP spill, contact the firm of Hollis Wright for more information and an evaluation of your case.

Additional authors: Alison Almeida

On April 30th, Endo International Plc (“Endo”) agreed to pay $830 million to resolve legal claims filed by women who have been injured by various transvaginal mesh devices.  In its annual report filed with the U.S. Securities and Exchange Commission, Endo reported that as of February 2014, the company and its American Medical Systems (“AMS”) subsidiary faced approximately 22,000 lawsuits over the devices, and that in 2013, Endo agreed to pay $54.5 million to settle an undisclosed number of the cases.

This most recent settlement is aimed at resolving all of Endo’s pending legal claims across the country related to these devices; however, several other manufactures, including C.R. Bard, Inc. and Johnson & Johnson’s Ethicon unit manufacturer, remain pending and are not part of the announced settlement.  At last count, nearly 44,000 cases filed by injured women were pending in the U.S. District Court for the Southern District of West Virginia, alleging varying injuries, including pain during intercourse, bleeding, and additional complications, many of which have required additional surgeries to remove the devices.

Transvaginal mesh devices are net-like implants used to treat various conditions, including pelvic organ prolapse and stress urinary incontinence – common conditions for women after a hysterectomy, menopause, or childbirth.  However, over time and beginning in 2008, the U.S. Food and Drug Administration (“FDA”) began notifying manufacturers of reports of complications linked to the devices.  This ultimately led to post-marketing safety studies mandated by the FDA to be conducted by AMS and other manufacturers to monitor the rate at which adverse events were being reported.  The effect of these reports has been that at the beginning of May, the FDA announced that it is considering proposals which would tighten safety standards for mesh devices used to treat pelvic organ prolapse.  These proposals, if adopted, would require manufacturers to submit data which proves the devices’ safety and efficacy before allowing the manufacturer to take the device to market.

According to Endo, the settlement is still subject to several conditions, including confirmation of medical records for plaintiffs, but the company stated that it has already set aside $520 million for legal claims associated with the devices.  In addition, the company issued a statement saying that it would also incur a pretax, noncash charge of $625 million in the first quarter to cover the costs of the settlement and insure claimants are paid as the settlement is implemented over the next year.

The law firm of Hollis Wright is currently representing numerous women who have been injured by these transvaginal mesh products.  Complex litigation against large pharmaceutical companies demands specialized legal experience.  If you or a loved one believe you have been harmed by a transvaginal mesh device, contact the firm of Hollis Wright for more information and evaluation.

On April 7th, a jury in the first federal court Actos bladder cancer trial returned a verdict for almost $9.15 billion dollars against co-defendants, Takeda Pharmaceuticals USA Inc. and Eli Lilly & Co. Inc. (In Re: Actos [Pioglitazone] Products Liability Litigation, MDL Docket No. 2299, No. 6:11-md-2299, Allen v. Takeda Pharmaceuticals North America Inc., et al., No. 12-62, E.D. La.), the seventh largest verdict in U.S. history.

The plaintiffs in the case, Terrence and Susan Allen, were awarded $1,475,000 in compensatory damages (i.e., damages for medical bills, lost wages, pain and suffering, emotional distress, and/or mental anguish), and $9 billion in punitive damages.  The jury found that Takeda was 75% liable and Eli Lilly was 25% liable, and split the punitive award accordingly – $6 billion against Takeda and $3 billion against Lilly.  The plaintiffs’ case was premised on the theory that the drug manufacturers had marketed Actos knowing it could cause cancer, but failed to disclose this information to doctors and failed to warn consumers about the risks associated with taking the drug.  The plaintiffs alleged that the pharmaceutical companies failed to disclose this information in order to reap the substantial profits Actos supplied.  For example, in 2011, Actos sales revenue was $4.5 billion and accounted for nearly 27% of Takeda’s total revenue for that fiscal year.  Since its release in 1999, Actos has generated more than $16 billion in sales for Lilly and Takeda, who partnered together to produce and market the drug in the United States.

Actos was originally approved by the FDA in 1999 as an oral medication for type 2 diabetes blood sugar control.  According to the original drug applications and approval literature, it was recommended for patients who have been unsuccessful at regulating blood sugar levels through diet and exercise alone.  However, at the heart of this litigation was an FDA mandated 10-year safety study which was required at the time of approval, to assess whether Actos had any link to bladder cancer.  That study was concluded in 2011, and found that the use of the drug for more than one year continuously might be associated with an increased risk of bladder cancer.

Due to this finding, the drug’s warning label was subsequently changed nearly 12 years after it had already been on the market and had seen widespread use.  In addition to the links to bladder cancer, Actos also has other serious potential side effects, including heart failure, hypoglycemia, weight gain, and even liver toxicity.

Takeda and Lilly still face an additional 2,923 cases in the MDL pending in the Western District of Louisiana, but plan to pursue all legal avenues following the verdict, including post-trial motions and appeals, according to its senior vice president and general counsel, Kenneth D. Greisman.

The following symptoms are potentially associated with bladder cancer: bloody urine, pain with urinating, increased urge to urinate, and unusual back pain.  Complex litigation against large pharmaceutical companies demands specialized legal experience.  If you or a loved one believe you have been harmed by taking Actos, contact the firm of Hollis Wright for more information.