Consumer Alert: Merck’s pharmaceutical osteoporosis drug, Fosamax, is associated with Dead Jaw (Jaw Necrosis)

The trial lawyers at Keefe Bartels, LLC continue to investigate potential injury claims about the prescription drug, Fosamax manufactured by Merck & Co., Inc. (“Merck”). Fosamax (or alendronate sodium) is a bisphosphonate drug, which has been on the market for over ten years. Fosamax generated 3.2 billion dollars in revenue from global sales in 2005; making it Merck’s second best selling drug that year.[1] Fosamax is generally prescribed for the prevention of bone loss, which is known as “osteoporosis,” and other bone diseases.

The Food and Drug Administration (“FDA”) previously found that Merck’s promotion of the drug Fosamax was both false and misleading to the public. In an FDA letter to Merck from July 1997, the Department of Health & Human Resources requested the immediate discontinuation of certain promotional materials directed at women to use Fosamax. (http://www.fda.gov/cder/warn/july97/fosamax.pdf). At the time, Merck’s marketing and promotional materials claimed that “Menopause [wa]s the single most important cause of Osteoporosis”; indicating menopausal and post-menopausal women should take the drug to prevent spine and hip bone fractures caused by osteoporosis.[2] The FDA found this statement to be false and misleading, because it overstated the amount of people, who should take the drug and would benefit from its use. Merck improperly implied that all women would develop osteoporosis because of menopause, when menopause alone did not cause osteoporosis.

Osteoporosis is caused by low calcium intake, acid/alkaline imbalance, malnutrition, being underweight, history of dieting, caffeine, nutritional deficiencies, inadequate peak bone mass, lack of exercise, over exercise, poor bone repair, high fat diets, junk food, sugar, stress, weak adrenals, weak digestion, tobacco, endocrine imbalance, irregular menstruation, onset of early menopause, eating disorders (especially anorexia nervosa), heavy alcohol consumption, kidney disease, certain genetic disorders, thyroid problems, diabetes, chronic liver disease, and low or no vitamin D in daily diet.[3]

In another FDA letter to Merck posted on July 30, 2001, the Department of Health and Human Services found that Merck objectionably overstated the benefits of Fosamax while minimizing the risks associated with the drug both on the company’s web site for the drug (www.Fosomax.com) and in promotional materials. (See June 2001 Fosamax link at http://www.fda.gov/CDER/warn/warn2001.htm).

In the late 1990s, the FDA began receiving reports that bisphosphonates users were experiencing osteonecrosis of the jaw (“ONJ”). ONJ is a severe bone disease of the jaw caused by a reduced local blood supply[4] [IV]. Jaw necrosis cases were also discovered in users of the drug Fosamax. Jaw necrosis or “jaw bone death” refers to the death of cells and living tissue in a person’s jaw due to the interference with the blood supply to the bone. Other Fosamax related side effects experienced by users included: esophagitis, upper gastrointestinal mucus, esophageal ulcers, esophageal erosions, esophageal stricture or perforation, uncontrollable heartburn, abdominal pain, acid regurgitation, bone and joint pain, constipation, diarrhea, gas, indigestion, muscle pain, nausea, skin rash, difficulty swallowing, bloated feeling, dyspepsia, gastritis, flatulence, and osteonecrosis of the jaw.[5]

On August 25, 2004 the FDA issued a Post Marketing Safety Report which included Fosamax and other bisphosphonates. (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4095B2_03_04-FDA-TAB3.pdf) The FDA’s report recommended changes to the drug’s label due to safety concerns with osteonecrosis associated with use of bisphosphonates including Fosamax.

An April 13, 2006 article in the Associated Press described the lawsuit filed in the U.S. District Court in Ft. Myers, Florida and highlighted that the FDA had previously directed Merck to include a warning label on Fosamax in August 2004 in order to disclose the risks and long term effects of the drug.[6] Merck replied that it did not receive a request from the FDA to update the label until January 2005. Merck waited another six months before updating the warning label in July 2005. In July 2005, Merck ultimately revised the label for Fosamax to include a warning about the reports of ONJ in users of the drug.

More than 100 related lawsuits have been filed since the end of 2006.[7] Merck previously allocated a reserve of $48 million for the future legal defense of Fosamax related litigation [VII]. Various Fosamax cases filed in federal court have also been consolidated by the Panel on Multidistrict Litigation. As of June 2008, the multidistrict litigation included over 550 actions.

By Order dated August 16, 2006 the Judicial Panel on Multidistrict Litigation (“JPML”) transferred approximately 18 cases from New York, Florida and Tennessee to Judge John F. Keenan in the Southern District on New York.[8] The JPML centralizes cases which involve common question of fact to serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. Contrary to Merck’s arguments against centralization, the JPML ordered the consolidation of these federal cases.

The extensive history of state and federal litigation concerning the danger and harms associated with Fosamax have prompted further investigations by various lawyers throughout the nation as well as responsive action by Merck.

On September 14, 2007 Merck issued a statement on the association of its drug Fosamax with osteonecrosis of the jaw most likely in reaction to the growing litigation surrounding this defective drug.[9] Merck’s statement emphasized that “ONJ is not well understood and may occur for a number of reasons.”

If you think you or a loved one may have been injured as a result of using the drug Fosamax, please contact the dangerous products lawyers at our law firm. Our trial attorneys are experienced in products liability injury cases and aggressively represent our clients.

Products liability law protects all consumers from the known, and oftentimes undisclosed, dangerous risks of harm and injury posed by defective products. If the continuing investigation reveals and confirms that the use of Fosamax caused jaw necrosis, then the manufacturer of this drug/product may be legally responsible for the injuries and harms caused by harmful and defective product.

The trial attorneys at Keefe Bartels, LLC are experienced in products liability law and the prosecution of such cases. The drug Fosamax may be dangerous/harmful due to a defect in the manufacturing and/or production process or because it is essentially unfit and not reasonably safe for use. Such a danger or defect is usually proven through direct evidence linking the dangerous drug to the harmful medical condition. In certain cases, proof may be inferred that there was a defect by reasoning from the circumstances and facts shown. Lastly, the jury may find from the evidence that there was no other cause for the harm/accident other than a manufacturing defect, and therefore properly conclude and find that a defect existed.

In a potential products liability action against the manufacturer, Merck, the lawyer for the individual injured as a result of the use of Fosamax would need to successful carry the burden of proof and persuasion for the jury to find that the plaintiff’s use of drug, Fosamax, led to osteonecrosis of the jaw (Dead jaw). Such a product liability case, if effective, also serves an important public interest by bring compensation to the victims of such dangerous drugs and deterring manufacturers from selling such products in the future. In pharmaceutical cases such as this, the unjust irony is that the individual who was supposed to medically benefit from the use of the drug, Fosamax, is often times the victim of a known and foreseeable harm and injury, which could have been prevented by the drug manufacturer taking reasonable action and measures.

The manufacturers and sellers of Fosamax may be found liable if the lawyer successfully proves that the product causing the harm was not reasonably safe for its intended purpose. Such proof would come by way of showing the drug was not reasonably safe for its intended purpose because of:

a. a manufacturing defect; or
b. a failure to adequately warn or instruct; or
c. a design defect.

The first theory a plaintiff may advance is that of a manufacturing defect. A manufacturing defect may be established by proof that, as a result of a defect or flaw which happened during production or while in defendant’s control, the product was unsafe and that unsafe aspect of the product was a substantial factor in causing plaintiff’s accident and/or injury. To establish his/her claim for a manufacturing defect, the plaintiff must prove all of the necessary elements by a preponderance (greater weight) of the credible evidence.

Plaintiff, through his or her trial lawyer, must prove that at the time the drug Fosamax was being used properly for its intended purposes and for an intended or reasonably foreseeable purpose. To prove this, plaintiff must show that the product was not being misused in a way that was neither intended nor was reasonably foreseeable. Plaintiff must also show that when he/she used the product, it had not been substantially altered since it left defendant’s control. A substantial alteration is a change or modification made to the product after it was manufactured or sold which both alters the design or function of the product and has a significant or meaningful effect on the product’s safety when used. In these pharmaceutical cases, a drug is not usually altered by the user, but the defendant may attempt to argue that the drug was carelessly taken by the individual in combination with another drug, alcohol or other substance.

The second theory a plaintiff may advance in a products liability case is a failure to adequately warn or instruct. This theory is a relatively straightforward approach which pins the manufactures liability for the harm caused by the drug on the basis of undisclosed information and/or the failure to warn consumers of potential or foreseeable dangers and/or a failure to instruct the user on how to properly use the drug.

The third theory a plaintiff may advance is that of a design defect. A design defect may be established by different methods. One method is the Consumer Expectations Test. Another method is applying the Reasonable Safer Design standard or the Risk-Utility Analysis. The Consumer Expectations Test typically applies where the product “like a bicycle whose brakes do not hold because of an improper design” is “self-evident(ly)…not reasonably suitable and safe and fails to perform, contrary to the user’s reasonable expectation that it would ‘safely do the jobs for which it was built'”. The design of a product is obviously defective when there are no relevant considerations which make the danger inherent in the product, or reasonably necessary to its functioning. In this respect, such defects are akin to manufacturing defect cases in which the defect is proven by circumstantial evidence. For such a product the usual Risk-Utility Analysis is unnecessary. The only material question is whether the product has been so designed that it poses a danger that is contrary to the user’s reasonable expectations.

A product falling within the Consumer Expectations Test category was a food slicing machine which was not equipped with an interlocked safety device to stop the blade from running after the guard was removed to wipe clean the blade. Mettinger, supra, note 1. The existence of a defect can be proven by circumstantial evidence. Myrlak v. Port Authority of New York and New Jersey et al., 157 N.J. 84 (1999) [adopting “Indeterminate Product Test” of section 3 of the Restatement (Third) of Torts: Products Liability].

Another method of proving the existence of a design defect is the Risk-Utility Analysis. There the defect is established by proof that the product’s risks or dangers outweigh its usefulness and therefore, a reasonably careful manufacturer or seller would not have sold the product at all in the form in which it was sold. This involves a balancing or weighing of a number of factors known as risk/utility factors.

In many or perhaps most cases the core issue is whether or not a Reasonable Safer Design would have reduced the risk or dangers of the product to the greatest extent possible consistent with the product’s continued utility, i.e., without impairing its usefulness and without making it too expensive for it to be reasonably marketable. In such cases, only the charge on reasonable safer design need be given. There, the plaintiff has only to show the existence of a safe and reasonably feasible alternative to the defendant’s product and that, in light of the omitted safer alternative, the product was not reasonably safe as manufactured or sold. The Restatement (Third) of Torts: Products Liability is fundamentally consistent with New Jersey’s products liability case law and statute regarding product defect.

There are three affirmative statutory defenses to certain design defect claims. They are: 1) there was not a practical and technically feasible alternative design, 2) the harm was caused by an unsafe aspect of the product that is an inherent characteristic of the product, and 3) the harm was caused by an unavoidably unsafe aspect of the product and the product was accompanied by an adequate warning or instruction. Our attorneys are prepared to counter such defenses if the manufacturer Merck should assert them.

In summary, to prevail on Fosamax case, the plaintiff in most states generally will have to show by the preponderance (greater weight) of the credible evidence that (1) the product as designed, manufactured or sold was defective, in that it was not reasonably safe for its intended or reasonably foreseeable uses, (2) the defect existed when the product left the hands and control of the defendant, (3) that at the time of the accident the product was being used for an intended or reasonably foreseeable purpose, that is, that it was not being misused or had not been substantially altered in a way that was not reasonably foreseeable, (4) that the defect caused injury to a direct or reasonably foreseeable user, or to a person who might reasonably be expected to come into contact with the product and (5) that the defect in the product was a proximate cause of the accident/injury. If plaintiff fails to establish any one of the just mentioned elements, then the defendant would probably win the case.

The product liability attorneys at Keefe Bartels are hard at work doing their part to protect people from harmful and dangerous drugs potentially exposing consumers to unreasonable risks of harm and injury which could have been prevented. If you or a loved one has used
or is using the drug Fosamax and have experienced any serious side effects, you may have a legal claim or lawsuit related to these defective products. Contact the trial attorneys at Keefe Bartels, LLC to see if they can help you in cases involving harmful and dangerous drugs.

 

[1] Merck Financial News – News:”Merck Announces Strong Full-Year and Fourth-Quarter 2005 Earnings; Reserves an Additional $295 Million for VIOXX Legal Defense Costs http://www.merck.com/newsroom/press_releases/financial/2006_0131.html

[2] Department of Health & Human Services: US Food and Drug Administration (1997). Fosamax Alendronate Sodium Tablets: Letter to Ellen Westrick, Senior Director of Legal/Medical Office, Merck & Co. http://www.fda.gov/cder/warn/july97/fosamax.pdf

[3] Susan Ott (2004). Osteoporosis and Bone Physiology. Dept. of Medicine: University of Washington: Seattle, Washington http://courses.washington.edu/bonephys/opdiagnosis.html

[4] Susan Ott (2004). Osteoporosis and Bone Physiology: Osteonecrosis the Jaw. Dept of Medicine: University of Washington: Seattle, Washington http://courses.washington.edu/bonephys/opjawON.html

[5] Merck & Co., Inc. (2000). Fosamax Tablets and Oral Solution Description Sheet. Whitehouse Station, NJ. http://www.fosamax.com/fosamax/shared/documents/english/pi.pdf

[6] Theresa Agovino. AP Business Writer (4/13/2006). Suit Alleges Merck Negligently Promoted Osteoporosis Drug Fosamax, Associated Press: NY, NY http://www.law.com/jsp/article.jsp

[7] Charles Toutant, (7/26/2007). Suits Grow Against Merck Alleging Fosamax Causes ‘Jaw Bone Death’. New Jersey Law Journal, NJ. http://www.law.com/jsp/nj/PubArticleNJ.jsp

[8] Transfer Order, In re Fosamax Products Liability Litigation, Docket No. 1789, http://www.jpml.uscourts.gov/Docket_Info/Products_Liability/MDL-1789/mdl-1789.html

[9] Merck.com, Product News – “Statement by Merck & Co., Inc. Regarding FOSAMAX┬« (alendronate sodium) and Rare Cases of Osteonecrosis of the Jaw”, September 14, 2007 http://www.merck.com/newsroom/press_releases/product/fosamax_statement.html