Plaintiffs Assert no “Logical Basis” to Exclude Design Defect Claims from Fosamax Trials

Fosamax lawyers at Pintas & Mullins Law Firm report on the most current updates in the Fosamax federal injury trials. Plaintiffs recently filed a brief stating that a judge wrongfully used a U.S. Supreme Court ruling to preempt and deny claims of design defects against generic Fosamax manufacturers.

Specifically, the judge used the SCOTUS ruling in Pliva v. Mensing to preempt the design defects claim. Justices decided in this case that generic manufacturers could not be held liable for failure-to-warn because they are legally required to exactly match labels to those of brand-name drugs. Platiniffs are now asserting that their claims, which are filed as design defects, cannot be logically preempted by the Mensing ruling, which applied only to failure-to-warn.

In their brief plaintiffs affirm that their claims alleging design defects are in no way a “shot in the dark,” and that they purposefully made the distinction between failure-to-warn and designing and selling a drug manufacturers knew to be defective. More than 90 plaintiffs are involved in this particular filing, each claiming they suffered long and devastating bone injuries from their Fosamax use.

Fosamax is a popular drug prescribed, most often to postmenopausal woman, to treat and prevent osteoporosis. Unfortunately, in recent years, the drug has proven to actually have the opposite effect, causing atypical bone fractures in thigh bones and osteonecrosis (bone death) of the jaw. Active ingredients in Fosamax (bisphosphonates) implant in bones and, if patients take Fosamax for five years or longer, the bisphosphonates can impede the bone’s ability to self-repair.

The thigh bone is among the strongest in the body, and low-intensity atypical fractures (occurring during normal daily activities, such as walking or going down stairs) account for less than 1% of all hip and femur fractures overall. Importantly, atypical femur fractures are predominately reported in patients taking bisphosphonates.

Currently, about 900 Fosamax cases are consolidated in multidistrict litigation (MDL) concerning the drugs’ safety. In 2011, a New Jersey judge removed the above-mentioned 91 plaintiffs from the MDL due to the Pliva v. Mensing ruling. Plaintiffs appealed, arguing that Mensing did not apply to their claims of defective design.

In design defect cases courts must analyze whether the drugs’ manufacturer took a disproportional risk in selling a drug it knew, or reasonably should have known, was unsafe. Conversely, in failure-to-warn cases, courts only consider whether a manufacturer appropriately and legally warned users that the drug was potentially defective.

The 91 plaintiffs contend that their filings were carefully worded and drafted to allege that the manufacturers of generic Fosamax knew or reasonably should have known that they were selling an excessively dangerous drug, not that the drugs’ warnings were improperly labeled. Thus, their claims are “true” design claims, alleging the drugs’ risks outweigh the benefits.

The generic manufacturers named as defendants in these cases include Mylan Inc., Apotex Corp., and Teva Pharmaceuticals USA. Defendants are citing a federal law which states that generic drug manufacturers may not change a pharmaceutical’s design, and claim that they therefore cannot be held liable for it. This issue was recently illuminated in the SCOTUS case Mutual Pharmaceuticals v. Bartlett.

Fosamax attorneys at Pintas & Mullins Law Firm are currently reviewing and investigating cases of bone injuries caused by Fosamax use. If you or a loved one was prescribed to Fosamax and suffered an atypical thigh bone fracture, contact one of our knowledgeable pharmaceutical attorneys at soon as possible. We provide free, no-obligation consultations to potential clients from all 50 states.


Free Consultation
  • Please enter your first name.
  • Please enter your last name.
  • Please enter your email.
    This isn't a valid email address.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please make a selection.
  • Please make a selection.
  • Please enter your message.