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A medical device case poses numerous pleading problems (see “Practice Tip: Pleading Medical Device Complaints,” LJN's Product Liability Law and Strategy, August, 2011). However, before one even reaches the pleading stage, there are major hurdles to consider.
If a firm is “lucky” enough to be retained on 100 such cases, the legal triage begins immediately. The major issue facing the plaintiff's lawyer during client intake is to decide which cases to file immediately and which cases can wait. This depends, of course, on the statute of limitations the lawyer determines will be applicable ' and that is no small task. Ever since the U.S. Supreme Court's decisions in Goodyear v. Brown, 131 S. Ct. 2846 (2011), and Daimler v. Bauman, 134 S. Ct. 746 (2014), jurisdiction over out-of-state manufacturers has become an unstable issue in every case where a plaintiff has been injured by a product designed and manufactured outside of the plaintiff's state of use. (See “Jurisdiction in Product Liability Cases after 2014,” LJN's Product Liability Law and Strategy, March, 2015.)
Jurisdiction
Prior to those two decisions, it was generally thought that a suit filed in the plaintiff's home state and/or the state where the product was implanted and used was the safest venue jurisdictionally. Such service depended upon that state's long-arm statute. Most states permit jurisdiction over an out-of-state manufacturer where the manufacturer is doing business in the state, or the foreign product causes injury in that state, if the defendant has business connections with the state. Those connections vary state to state, but include: 1) Solicitation of business; 2) A persistent course of conduct in getting business; 3) Getting substantial revenue from its goods used or consumed in the state; 4) Reasonably expecting any defective product to have consequences in the state; or 5) Deriving income from interstate or international commerce.
In Goodyear, the court held that the foreign defendant had to be “at home” in the state in order to get jurisdiction. Although both cases dealt with general jurisdiction, they gave rise to questions about the validity of long arm statutes where a corporation might not be doing much business in the particular state.
For example, suppose a medical device manufactured overseas is sold by the manufacturer's California sales office to a hospital in Wisconsin, where it is used by a surgeon and causes injury. Under most states' long-arm statutes, there would be jurisdiction in Wisconsin; however, Daimler and Goodyear seem to now require activities that are “purposefully directed” at the state. So if the foreign manufacturer and sales office claim they did not direct any advertising toward Wisconsin, there might not be any jurisdiction. But by the time this issue is litigated and finally adjudicated, the statute of limitations might have run. Perhaps it is better to sue the seller where it is located (which may also be subject to Daimler – Goodyear issues), or serve the overseas manufacturer under the Hague Convention (if that country is a signatory). Multiply this legal mess by 100 cases and you can see the problem.
Identify the Device, Defendant and Timing
Even before the lawyer has to decide the venue for the case, one must determine whether the device in question was even used and whose device it was, especially in those cases where there are almost identical devices manufactured by different possible defendants. Patients usually will not even know what devices were used in their surgeries, and even if they do, they would not know the identity of the manufacturer. Getting the medical records if the patient is alive is rather straightforward; however, if the patient is deceased, the HIPPA law requires that the lawyer proceed under local, state law to retrieve the records.
Some states require an estate to be set up and hospitals in those states will require one before they will release records. This means your firm may have to retain an estate lawyer just to get the medical records to learn the name of the manufacturer and decide whether the client has a case. Some states permit heirs to obtain medical records of decedents; however, affidavits under applicable state health codes or probate laws may be required.
Many times, the records do not reveal if the device was used, because the surgeon failed to note such information in the operative report. Also, the records may not note which manufacturer's device was utilized. Most surgeons we have asked do not recall the manufacturer of the devices they used. Sometimes, the identity of the defendant can be solved by “asking” the hospital if more than one manufacturer's device was used at the time of plaintiff's surgery. Other times, you can get the information from the list of materials used during the surgery (a “picklist”) and sometimes the hospital's purchasing office keeps such records; however, to get the hospital to divulge such information often requires the noticing of a deposition.
But if the case is not yet filed because you do not know the name of the defendant, you cannot notice a deposition except in those states that permit pre-action discovery to determine who is a proper party. (The Federal Rules do not permit a deposition in order to identify a defendant, FRCP 27). One way around this dilemma is to file suit against all of the possible manufacturers whose device it could have been. But this can be very costly, especially if there are foreign manufacturers of the device claimed to have been used. If your head is not already spinning from these issues, continue reading ' your problems are not over.
Statutes of Limitation
The cases have to be divided into statute of limitation categories to see which have to be filed first; which claims may expire in a few days; which in a few weeks; and which have several months or more left. The answer to these questions usually depends on the forum. Some states will “borrow” another state's statute of limitations, so research has to be done on that issue.
But even more important, many states have different triggers for the statutes of limitations. Some states will take the date of the device's use or date of surgery to commence the statute running, whereas other states may use either the date the injury is discovered, or the date the plaintiff learns the device is the cause of the injury. Therefore, while counsel is trying to retain estate lawyers in order to get the medical records, or is trying to get depositions of the hospital or surgeon to divulge the name of the manufacturer, he or she must also be researching the law of the possible jurisdictions that will entertain the case ' and determine when that forum's statute of limitations commences to run to decide which cases must be filed first.
Local Counsel
Next, you have to decide if you need to have local counsel on your case. If so, does counsel want his or her fee up front or is he/she willing to take a contingent retainer on the case? Recently, we filed in a state that did not require local counsel, but we had estate counsel; however, we soon learned that a summons and complaint must be court-certified before it is served on the defendant. The one we served was a nullity and we had to start over again. We quickly learned that local counsel is always a good idea, but that it should be someone who is a personal injury litigator, not an estate lawyer.
Conclusion
As we said in the beginning, if your firm is “lucky” enough to get retained on 100 cases, legal triage is a valid term to use. The real question is, do you have enough resources to undertake a mass tort medical device case?
Lawrence Goldhirsch and Michael Pederson are lawyers in the Drug and Medical Device Litigation practice of Weitz & Luxenberg, P.C.
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