Dangerous and Defective Drugs

People seek relief in medicine because they want to be well. Unfortunately, it’s all too common for those very same medications to cause harm when they are not safely designed or adequately tested.

At Associates and Bruce L. Scheiner, Attorneys for the Injured, we know the pharmaceutical industry tends to rush products to market in an effort to seize on the latest growing demand without fully vetting the drug or weighing the potential for serious side effects.

Nevertheless, drug manufacturers and distributors have a legal duty to make sure the products they sell are safe for human consumption. But drug companies have been known to downplay or sometimes intentionally conceal the possible risks from federal regulators and the public. If the U.S. Food & Drug Administration (FDA) fails to conduct a thorough investigation and review of the application, this could result in a dangerous drug slipping through the cracks – and into the medicine cabinets of consumers.

While all drugs have side effect profiles, drugs that produce serious, adverse effects that outweigh the intended positive effects may be deemed defective.

The list of allegedly defective drugs runs the gamut from birth control rings to blood pressure pills. Some of those that have made headlines in recent years include:

• Xarelto (blood thinner)
• Nuva Ring/Yaz/Yasmin (birth control)
• Reglan (treats gastric reflux/heartburn)
• Topomax (migraine headache treatment)
• Actos and Avandia (diabetes medications)
• Zoloft/Prozac/Paxil (antidepressants)
• Fosamax (treats osteoporosis)
• GranuFlo (kidney dialysis)
• Pradaxa (anticoagulant)
• Chantix (smoking cessation)

This is a growing problem considering U.S. spending on prescription drugs has ballooned from $40 billion to $234 billion in the last decade. Almost half of us take at least one prescription drug. NPR reports the average American spends $1,000 annually on pharmaceuticals. That’s 40 percent more than the second-highest spender, Canada, and nearly twice as much as patients spend in France and Germany.

That has made drugmakers very wealthy—it’s an $85 billion-a-year industry. And yet people continue to suffer the serious ill effects of dangerous drugs and defective medical devices.

Adverse outcomes associated with defective or dangerous medications have included:

• Liver damage
• Kidney damage
• Heart damage
• Lung dysfunction or pulmonary embolism
• Increased risk of stroke or heart attack
• Increased risk of deep vein thrombosis
• Death

South Florida product liability claims against drug companies are exceptionally complex. These massive companies have been cozying up to legislators for years, which has resulted in the passage of major legal hurdles for drug injury plaintiffs.

For example, the Medical Device Amendments of 1976 usually prohibit state court claims against drugs that have received approval from the FDA. However, it’s worth noting that if a company failed to comply with FDA regulations, it may still be subject to litigation.

Another example is with the 2011 U.S. Supreme Court ruling in Pliva v. Mensing , which essentially held generic drug manufacturers could not be held responsible for inadequate warning labels on drugs modeled after brand name drugs because generic drugmakers can’t make label changes independently. This has been problematic because 80 percent of U.S. prescriptions are generic. However, the FDA has promised to finalize a proposed rule that would allow generic drugmakers to independently update safety warnings – opening up the potential for liability.

Although the FDA may issue recalls on certain medications, that does not relieve drug manufacturers of liability.

Take, for example, the case of the now-shuttered New England Compounding Center Inc., which manufactured and distributed contaminated steroid medications later linked to a massive meningitis outbreak that killed at least 64 people and sickened another 700 nationwide. The Boston Globe reported the company profited $62 million between 2010 and 2012, while routinely sidestepping federal safety regulations and intentionally misrepresenting safety testing procedures. The former president and head pharmacist at the firm were later charged with 25 counts of second-degree murder in seven states for the company’s actions, which prosecutors say clearly placed profits above public health.

Although the drugs were recalled in 2012, hundreds of civil actions are still pending.

Other larger drug companies have paid billions in recent years to settle liability claims with former patients.

In order to succeed in a defective drug lawsuit, plaintiffs need to pursue one of the three applicable legal theories:

• Defective manufacturing. These are drugs that have been improperly made and have somehow become contaminated or tainted. This could be an error in the way the drug was made or packaged or a mistake that occurred in labeling or shipping.
• Dangerous side effects. This assertion holds even though the drug was made properly, it results in dangerous side effects that may cause serious harm. In some cases, plaintiffs need only show the drug increased the risk of a serious health issue (such as heart attack or stroke).
• Improper marketing. These are cases in which drugmakers fail to provide adequate warnings, labels or instructions regarding safe and appropriate use and all relevant side effects.

Victims of dangerous or defective drugs may be able to recover for:

• Past and future medical costs, including hospitalization, corrective surgeries, ongoing therapies, etc.
• Lost wages
• Diminished quality of life
• Pain and suffering

Our experienced South Florida legal team is prepared to fight for just compensation for injuries you or your loved one suffered as a result of defective or dangerous drugs.

If you or a loved one has been injured in Southwest Florida, contact Associates and Bruce L. Scheiner, Attorneys for the Injured, for a free and confidential consultation to discuss your rights. There are no fees or costs unless we win. Offices in Fort Myers, Cape Coral, Naples and Port Charlotte.

Call 800-646-1210 for a Free Consultation.