Product liability Claims involving Pharmaceutical Drugs



| Pharmaceutical Drugs | Product Liability

The FDA acknowledges the following risks associated with Celebrex and similar drugs: Heart attack. Stroke

The FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall. Drugs with harmful adverse events can be recalled by the FDA or pulled from the market by the manufacturer. (1)

Celebrex and Bextra are a type of NSAID (also called “Cox -2 inhibitors”) and are the commonly most prescribed drugs for arthritis, pain and stiffness. COX-2 inhibitors block COX-2 enzymes. There are 2 types of COX enzymes: COX-1 and COX-2. Both types produce prostaglandins; however, the main function of COX-1 enzymes is to produce baseline levels of prostaglandins that activate platelets that protect the lining of the gastrointestinal tract, whereas COX-2 enzymes are responsible for releasing prostaglandins after infection or injury. Prostaglandins have several different effects, one of which is to regulate inflammation. 

Side effects with these drugs are the concerns for the possible link between the drug and serious cardiovascular problems including heart attack and stroke and an increased risk of gastrointestinal bleeding and perforation. 

Cox-2 inhibitors are also prescribed for:

  • Back pain
  • Ankylosing spondylitis
  • Hereditary polyps of the colon
  • Juvenile rheumatoid arthritis in children aged from 2 years
  • Painful menstruation
  • Acute pain
  • Sports injuries

NSAIDS- (NonSteroidal Anti-Inflammatory DrugS) were the most frequently prescribed class of drugs for Rheumatoid Arthritis and Osteoarthritis

Bextra pulled off the market in 2005

Vioxx pulled off the market in 2004

Celebrex is still on the market but the FDA required the drug to include two “black box warnings” on all Celebrex labeling. Physicians ordering the medication need to apply the risk benefit for each patient and clearly inform patients of the risks. 

Osteoarthritis-is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of your bones wears down over time. Although osteoarthritis can damage any joint, the disorder most commonly affects joints in your hands, knees, hips, and spine.

Rheumatoid Arthritis– or RA, is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body. RA mainly attacks the joints, usually many joints at once.

Prostaglandins– are a group of lipids made at sites of tissue damage or infection that are involved in dealing with injury and illness. They control processes such as inflammation, blood flow, the formation of blood clots and the induction of labor in childbirth.   

Ankylosing spondylitis– is an inflammatory disease that, over time, can cause some of the small bones in your spine (vertebrae) to fuse. This fusing makes the spine less flexible and can result in a hunched-forward posture. If ribs are affected, it can be difficult to breathe deeply.

Black Box Warningmost serious warning that the FDA can provide short of having a drug recalled from the market. It is also called a “boxed statement” and is included at the top of the prescribing information in a box, enclosed by a thick, black border. The warning includes possible serious side effects, contraindications. are the strictest labeling requirements that the FDA can mandate for prescription drugs. First implemented in 1979, black box warnings highlight serious and sometimes life-threatening adverse drug reactions within the labeling of prescription drug products.

Glossary of Terms

Cobalt: a component of Vitamin B12 which supports production of red blood cells. Small amounts are needed for animals and humans to stay healthy. Cobalt is also found in other sources other than MoM implants: alloys, batteries, chemistry sets, crystal sets, glass, drill bits, saw blades, other machine tools, dyes, inks, and pigments (cobalt blue), magnets, tires. 

Cobalt and Chromium Toxicity: elevated levels can cause fever, inflammation, low thyroid levels, peripheral neuropathy, hearing and visual loss, cognitive decline, cardiac (arrhythmias) and cardiomyopathy and endocrine symptoms, dysgeusia (metallic taste); hand tremor, incoordination, depression, vertigo, ringing of the ears, thickening of the blood.

Blood Brain Barrier: the purpose of the BBB is to protect against circulating toxins or pathogens that could cause brain infections, while at the same time allowing vital nutrients to reach the brain.

Cardiomyopathy: an acquired or hereditary disease of heart muscle. This condition makes it hard for the heart to deliver blood to the body and can lead to heart failure. 

Osteolysis: a progressive condition where bone tissue is destroyed in this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker. In those who have had a hip replacement a key sign of periprosthetic osteolysis is an aseptic loosening of the joint (that is, a loosening of the implant without any indication of infection).

SPECT-CT: Single Photon emission computed tomography with bone scan are nuclear imaging techniques typically used together when viewing the spine. It is particularly useful in detecting metabolic abnormalities such as small changes in hard-to-see-bones, tumors, or blood flow patterns

Interesting facts about Cobalt: Cobalt was once used as a stabilizer in beer foam. It caused a condition called “beer drinker’s heart,” which resulted in heart muscle weakness. Cobalt can stimulate the production of red blood cells and has been used for the treatment of refractory anemia and by athletes to increase exercise performance, as an alternative to blood doping. (2)

What to look for in Labs and medical work up

Elevated Heavy metal blood levels

  • Cobalt 
  • Chromium

Increased levels in Urine:

  • Cobalt and Chromium
  • Creatinine 

Cerebrospinal fluid (CSF) -presence of these metals would indicate that the ions had crossed the blood brain barrier

  • Cobalt and Chromium

Other Important Imaging:

  • Xrays-osteolysis
  • EKG-various cardiac changes
  • MRI-brain-detection of both superficial and deep lesions and muscle atrophy, osteolysis
  • Ultrasound-identifying tendon abnormalities
  • CT -visualizing osteolysis if suspected on plain xrays
  • SPECT-CT-to detect abnormal metabolic abnormalities such as small changes in hard-to-see-bones, tumors, or blood flow patterns


(1) Naveed Saleh, MD, MS, for MDLinx | July 24, 2019

(2) Lippi G, Franchini M, Guidi GC. Blood doping by cobalt. Should we measure cobalt in athletes? J Occup Med Toxicol. 2006; 1:18. Doi:10. 1186/175-6673-1-18.

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