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The competition to develop and win approval from the U.S. Food and Drug Administration (FDA) is incredibly fierce. Pharmaceuticals, supplements, and medical devices are frequently released without sufficient testing and are later found to be unsafe.

The FDA releases hundreds of warnings and recalls for these products. Exposure to harmful prescription medications and defective medical devices can result in life-threatening conditions, lasting medical complications, and even death.

Drugs and Medical Devices With Recent FDA Safety Warnings

Actos (type 2 diabetes)

Linked to bladder cancer, heart failure, liver failure, bone fractures, and eye problems.

Artificial Hips

Products from Johnson & Johnson, DePuY, Stryker, Biomet, Zimmer, Wright and Smith & Nephew are potentially linked to high metal toxicity in the blood, severe pain, swelling, and tissue and muscle damage.

Risperdal (schizophrenia, bipolar disorder, autism)

Potentially causes gynecomastia (male breast development), pancreatitis, diabetes, or movement disorders.

Invokana (type 2 diabetes)

Reportedly causes diabetic ketoacidosis, which can lead to kidney failure, heart attack, stroke, or death.

Onglyza (type 2 diabetes)

Under investigation for causing heart failure or cardiac arrest.

Transvaginal mesh (pelvic and bladder support)

Can erode through the vaginal walls or other organs and hinder sitting, walking and sexual intercourse.

Yaz / Yasmin (IUD birth control)

Reportedly causes blood clots which can lead to life threatening deep vein thrombosis and pulmonary embolism.

Other Drugs and Devices That May Have Dangerous Defects or Side Effects

Actemra (arthritis)

May lead to increased risk of heart failure, stroke, pancreatitis, lung disease or gastrointestinal perforation.

Bard IVC Filter (embolism prevention)

Can potentially increase the risk of perforating the vena cava, a large vein in the heart.

Baycol (cholesterol)

Allegedly causes rhabdomyolysis, a disease that damages muscle tissues.

Belviq (weight loss)

May increase the risk of developing pancreatic, lung, or colorectal cancer.

Benicar (blood pressure)

Linked to severe gastrointestinal problems, including sprue-like enteropathy.

Elmiron (interstitial cystitis)

Potentially causes maculopathy, also known as macular degeneration, a disease of the eye that affects vision.

Surgical Staplers

Malfunctioning staplers used during medical procedures can cause fistulas (an abnormal connection between body parts), internal bleeding, infection, or organ damage.

Tasigna (chemotherapy)

Has been found to cause atherosclerosis (hardening of the arteries).

Truvada (HIV prevention)

Contains an unnecessary compound called tenofovir disoproxil fumarate which may cause kidney and bone problems.

Injectafer (iron replacement)

May cause hypophosphatemia (low phosphate levels), which is associated with bone pain, seizures, and death.

Lipitor (cholesterol)

Linked to an increased risk of developing diabetes.

Morcellator (hysterectomy and fibroid removal)

A medical tool that may spread uterine cancer.

Nexium (acid reflux, GERD, peptic ulcer disease)

Can increase the risk of developing a nutritional deficiency.

Paragard (IUD birth control)

Can break when removed, causing uterine damage requiring surgery.

Pradaxa (blood thinner)

May cause internal bleeding.

Valsartan (blood pressure)

Batches of the drug may have been contaminated with NDMA, a potential carcinogen linked to many types of cancer, including liver, kidney, colorectal, stomach, and bladder cancers.

Xarelto (blood thinner)

Associated with internal bleeding, wound leakage, and potentially infections.

Xeljanz (arthritis)

Allegedly causes blood clots, stroke, heart attack, heart failure, or cancer.

The Duty of Drug and Medical Device Companies

Pharmaceutical companies and medical device manufacturers have an obligation to put the safety of their customers above their own profits.

However, they sometimes fall short of that responsibility by not applying the highest level of care to clinical trials, failing to adequately warn consumers of known risks, not preventing products with manufacturing defects or contaminations from reaching consumers, or not recalling a product that is harming patients until it becomes financially necessary to.

Failure to Warn

Even if a product has received FDA approval, it may still pose serious health risks which aren’t discovered until months or years later. Drug and medical device companies can be held liable for the harm their products cause even if they are FDA approved and have been used according to the manufacturer’s instructions. Those instructions and other warning labels are sometimes inadequate. A health product’s labeling is defective when it fails to:

  • Provide clear and sufficient instruction for safe use
  • List all possible adverse reactions, drug interactions, and side effects
  • Inform patients of contraindications and preexisting conditions which increase the risk of harm

Deceptive Advertising

The marketing practices of drug companies and device manufacturers are also strictly regulated. They are not permitted to exaggerate the effectiveness of their products, downplay risks, or otherwise mislead consumers about the essential characteristics of medical products.

Some drugs or devices should simply never have been approved in the first place, and no amount of warnings or information can make them safe for human use. When dangerous drugs and devices cause injuries or even death, the companies that design, manufacture, test, and market them can be held responsible.

Statute of Limitations

In some states, patients injured by a drug or medical device have three years from the time they first were harmed (or became aware that they were) to file a claim against a drug or medical device company. In most states, though, including Pennsylvania, they have only two years to bring an action, or the court will most likely dismiss their claim.

Consult With A Drug and Medical Device Law Expert

Pharmaceutical companies and medical device manufacturers are large and powerful organizations that aggressively defend against legal claims regarding their products. Furthermore, these cases are complex and often require in-depth analysis of medical documents and expert testimony.

An experienced and knowledgeable prescription drug and defective medical product attorney is absolutely vital to winning the compensation injured patients and their families deserve.

If you were injured by a drug, supplement, medical device, or other medical product, contact Pond Lehocky Giordano for a free consultation to determine if you have a case. Call 1-800-568-7500 or fill out the form on this page.

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