versus civil case nevertheless the district court ruled that massachusetts did not does not recognize a claim for negligent design because of the state's adoption of comment k to restate in four zero two way back inclusion was incorrect for numerous reasons comment first massachusetts has long recognized a claim for negligent design it is consistently followed restate in sections three ninety five and three ninety eight which articulate the cause of action for negligent design and has consistently recognize such a claim it has applied to claim statement three ninety eight which as i said both both have been frequently adopted by the massachusetts courts can i become has a question certainly and it may well be the case that there the massachusetts courts have not firmly answered the question which justice souter put to you but here is what i understand state law require were to apply here you came up with no evidence and no argument and so your claim would have failed anyway you're right i would disagree  liability which massachusetts has messages its courts have not specifically referenced section six of the third restatement but they have frequently invoked the provisions of the restatement products  liability the third restatement distinguishes negligent design of drugs from negligent design of other products section two which concerns not other products requires proof of reasonable alternative design section six c or six which governs drugs in medical devices expressly does not require proof of a reasonable alternative design precisely for the reason that you can't simply redesign a drug what it says instead substitute a much stricter standard for liability which is that you must show that the risk is so great that a reasonable health care provider would never prescribe the drug to any category of patients and we are fully prepared to meet that stricter standard in this case indeed the f d a has already concluded that there are no patients for whom punishment is an appropriate drug but at the time this writer whose supply this is  mentions well the the answer on preemption your honor and i think again we're getting fairly far afield because these issues have not been fully bit below but the answer and i would suggest can be found in footnotes three and four to the bartl decision of this court is very familiar with bartlett since it decided the case on its way to the supreme court the supreme court in portland essentially said we're getting rid of the stop selling rationale you can't say it's not impossible because because they didn't have to sell the drug in the first place but the court included a very important cause in footnotes three and four footnote three says leaving aside the rare case in which state or federal law actually requires a product to be pulled from the market or preemption cases presume that a manufacturer's ability to stop selling does not turn and possibly the possibility and then put the forces the federal misbranding statute requires a manufacturer  any claim for design defect applies in the very narrow set of facts we're dealing with here in drug that was so dangerous that it was pulled from the market because there are no patients for whom it should be given its risks for it way its benefits and to go back to the comment then strict liability comment is not a prohibition on all designed the strict liability design defect claims against drugs it is only virtually all the cases in most states say you have to look on a case by case basis and determine whether a particular drug is unavoidably unsafe or whether it's unreasonably dangerous and it's only puts only that benefits outweigh its known risks can we say that it's unavoidabl unsafe and therefore there will be no design liability by definition if if a drug's risks outweigh its benefits it cannot be an unavoidably unsafe product and the defendant may be cases in this the brochure case in new hampshire and the custom yano case i'm sure in this pronouncing that in rhode island are both cases in which states within this jurisdiction have express lee is negligence was it negligent for y f to continue to sell this product long after it should have know it knew or should have known that it was unreasonably dangerous and should have pulled from the market you are correct such s in the modern era i've cited to at least four cases in which the massachusetts supreme judicial court has recognized a cause of action for negligent design including one case involving an f d a regulated medical device silicon breast implants  drugs and medical devices and they treat them as as the same because they're heavily regulated products that it's also important member the history here back in hundred seventy and going on when we when we used to have a pretty requirement so that you can only hold a perk a manufacturer liable if you bought the product wrecked me from one of the recognized exceptions in the law from the immunity from negligence likely than other products when historically drugs have had more and there's nothing in the case of nothing offensive cited that says that massachusetts doesn't abide by that normal understanding hasn't answered the question that the custard yano and brochure answer to whether they would apply comic a to strict liability on a case by case basis or on an across the board cases for all prescription drugs it doesn't affect this the outcome here because motion was argued to the court we cited this very law as a reason why what they're talking about is not negligent design they're talking about something new that's never been recognized by any massachusetts court which is th e manufacturer of properly manufactured f d a approved a prescription medicine who properly warns of the risks of the medicine communicates that warning to a physician who makes a decision to  prescribe it consultation with his patient that nonetheless a civil jury can declare that act illegal and that's something brand new under massachusetts law which  say look this is so outlandish you to stay courts have recognized the possible existence of these kinds sent least on a  certification because i think they're the court's analysis in east hampton savings sort of set forth the factors a court would consider and certification and then kluges is there controlling authority would be certified question the outcome determined and a host of factors that basically go to the practice fact of certification and first of all i would submit here we do have controlling authority and it's consistent with what your stearns rule this is but it's not made out of a negligent designed case here they haven't proved the basic elements that in come forward with evidence on summary judgment when they're required to do with the basic elements that that that  claim to the extent there they're trying to make new law there's no there's the only court that we could find that has faced this issue and in massachusetts what was good working in spray case in the district of massachusetts who's was asked to liability drug cases in massachusetts this is come up but in terms of whether he sort of fight question would be outcome deterred to terminate it the answer that question is also know whether plaintiffs theory is negligent design or whether it's new theory that no reasonable physician would have prescribed the drug at the time of the events in this case to any physician they did not come forward on summary judgment with a qualified expert to testify that they had not made the record so any sort of fight question would have to take into account the procedural status of the case and the absence of expert testimony from a qualified physician on that came out the same way so any any effort to forge a new law in this area would have to would but against a very strong preemption jurisdiction going the other way finally the the case goes to to a jury and of course after a story verdict from history to see any this is the would be a very poor case send a very poor message for certification here exceptional law we are i also think you have to remember this is exceptional circumstances here we're talking about a drug that has been deemed unsafe and or not effective and pulled off the market by the f d a and that is exactly the there's no reason to think they would not continue to do so here i also like to respond to the point of not having sought sort of a commission below the district court's ruling on summary judgment occurred on the trial historically drugs have been subject to greater tort liability than other products why is position in this case is that even if they sold a drug that they knew was going to kill everyone who took it so long as they sold