When Merck voluntarily withdrew Vioxx from the market in September 2004, it led to what has been described as a “feeding frenzy” by attorneys who sought clients allegedly harmed by the arthritis and pain medication. The move, which became a public relations nightmare for Merck, set off a flurry of lawsuits against the company and led to increased legislative activity aimed at full disclosure from drug manufacturers.
Moreover, Merck’s action increased concerns among other manufacturers over the possibility of lawsuits based on the safety of their products. Therefore, it is in product manufacturers’ best interests in general to prepare for lawsuits aimed at them.
Smart Business spoke to Kirk D. Willis, a partner at Godwin Pappas Langley Ronquillo, LLP, to determine what drug manufacturers and other companies can do to prepare for lawsuits regarding the safety of their products, and how they can respond to safety challenges and legislative changes that will increase regulators’ authority over specific industries.
How can manufacturers prepare for product liability litigation?
There are several ways, and the methods differ from manufacturer to manufacturer.
One suggestion is to retain qualified counsel to advise them how to lessen the possibility of product liability lawsuits. Counsel would have the capacity and experience to respond rapidly should lawsuits be filed. Choosing the right counsel keeps the corporate missions of manufacturers who have faced — or are facing — product liability matters.
Another is for a manufacturer to insure itself properly. Product manufacturers are advised to carry as much insurance as they deem advisable, taking into account deductibles and co-insurance.
A third is for a company to implement diverse pro-active managing, marketing and technological strategies aimed at ensuring product safety and addressing safety issues.
Another is to work with trade organizations to find out what they are doing to deal with product liability issues, and track regulatory and legislative changes to be prepared for possible changes that may be necessary to deal with potential lawsuits.
What strategies can product manufacturers employ to defend against product liability lawsuits should they be filed?
The available strategies should be carried out with an attorney’s assistance. The strategies might include filing actions in state courts to have cases transferred to a single judge in each state for coordinated proceedings, and filing motions to transfer to a single federal judge and consolidate for the purposes of all federal cases of similar nature alleging personal injury and /or economic loss relating to the purchase or use of a product named in a lawsuit.
Are there strategies that product manufacturers can develop to protect themselves in product liability litigation?
As in the case of preparation, different strategies apply to different cases. Again, manufacturers should follow the advice of their counsel. The strategies might include: procedurally challenging all frivolous lawsuits, fighting attempts to certify as ‘class action’ plaintiffs seeking medical monitoring, seeking attempts to dismiss claims based on the statutes of limitations, fighting discovery orders that involve products that are never used by consumers, challenging certifications in cases where it appears proposed plaintiffs have not suffered, attempting to recuse judges who might have used products involved in lawsuits, trying to move as many cases as possible to federal courts, and deleting the “proximate” from cause.
How is “proximate” cause relevant to product liability lawsuits?
The legal principle of proximate cause lies at the heart of product liability litigation. It simply means that there must be some reasonable connection between using a product and the “insult” that the plaintiff has allegedly suffered. In other words, for a manufacturer to be liable for a plaintiff’s injuries, the use of the product in question must be the proximate cause of plaintiff’s injuries.
Is deleting the “proximate” from the cause anything over which manufacturers have any control?
This takes us back to preparation. Merck took Vioxx off the market because the company recognized that consumers were being affected adversely. In fact, about 20 million users took Vioxx between 1999 and 2004. But a clinical trial showed increased cardiovascular risk in the patients using Vioxx beginning after 18 months of continuous use. The company acted immediately and appropriately to voluntarily withdraw Vioxx from the market, even though the FDA had approved it for treatment of pain and inflammation associated with osteoarthritis, menstruation and rheumatoid arthritis — and sales were generating $2.5 billion per year at the time the drug was withdrawn.
There is a lesson to be learned. If a manufacturer learns that its product is creating adverse effects on consumers, the best approach may be to withdraw it from the market. Doing so may invite a flurry of product liability lawsuits, but that is sometimes inevitable.
In the long run, deleting the “proximate” from the cause may work in the manufacturer’s best interests, especially if it is well prepared to deal with litigation, as we discussed earlier.
KIRK D. WILLIS is a partner and chair of the Personal Injury Trial Law section for Godwin Pappas Langley Ronquillo, LLP in its Dallas office. Reach him at (214) 939-4400 or [email protected].
