Blood tests revealed Bartlett was suffering from Stevens-Johnson Syndrome (which was rapidly evolving into a potentially fatal conditiontoxic epidermal necrolysis characterized by large lesions). Bartlett spent three months in the hospitaltwo of them in a medically-induced comma. When she woke up, she was suffering from permanent injuries that included blindness in one eye, esophageal burns, lung injuries, and a permanently scarred faceand also about 65% of the skin on her body deteriorated.. Fifty-five days of the three months Bartlett spent in the hospital was in a burn unit. She got to feel what people doused with kerosene and lit up like a Roman Candle feel like.
Sulindac®, the generic form of Clinoril, was approved by the FDA in 1991. Clinoril was approved in 1979. The Bartletts argued in their lawsuit that, following its approval by the Food and Drug Administration, Mutual Pharmaceuticals had an obligation to conduct post-approval safety surveillance for reports of adverse reactions to the drug that suggest the quality control of Sulindac® might not be what it should have been, or that nasty side-affects simply pop up like a blister or lesion after extended use. In addition, the Bartletts alleged that Mutual Pharmaceuticals had a moral responsibility to advise the end user of any potential serious side-affects including anything negative buried in the medical literature. And, was there anything in that literature that would have warned the physician thinking about prescribing it of the potential dangers which Karen Bartlett actually experienced?
The Bartlett lawsuit alleged seven problems. Onefailure to warn the market place of potential health hazards. Twoasserting product liability in a product that was inherently defective in design. Threefraud by omitting or concealing material facts about potential risks that existed from using Sulindac®. Fourbreach of an implied warranty. Fivebreach of express warranty that Sulindac® was safe. Sixnegligence in failing to use reasonable diligence in the marketing Sulindac® without making it clear to the medical community of the dangers of the drug which, apparently, was not bioequivalent of what should have been its clone . And finally, sevengross negligence based on all of the above.
The Bartletts filed their lawsuit based on those seven allegations. One by one, six of the causes of action were dismissed by summary judgment (or the Bartletts were forced to voluntarily withdraw them to keep the balance of their action alive) until only a single issue, design defect, remained alive. Finally, during fourteen days in late August and early September, 2009, Karen Bartlett had her "day in court." The Bartletts filed their action against Mutual Pharmaceuticals even though the FDA had never withdrawn its statutory "safe and effective" designation for Clinorilwhich continues to protect generic drug makers which manufacture sulindac, pretty much shielding Mutual Pharmaceuticals from successfully being sued although no medical patients taking Clinoril have ever suffered the type of reaction experienced by Karen Bartlett. In 2011 the Supreme Court ruled that pharmaceutical companies that make branded drugs are financially liable for inadequacies in safety warning labels. Their ruling deliberately did not impact generic copies of those medicines because it would raise the retail price of the cheaper alternatives. Again there was an assumption that the clone drug is precisely the same formulation as the branded drug it replicated. Mutual Pharmaceuticals, which is owned by Sun Pharmaceutical Industries, Limited, proved that's not necessarily true since the generic sulindac produced by them did not replicate what happens when you use the sulindac product produced by Merck & Co..
Which is why, when the jury in US District Court for New Hampshire awarded the Bartletts $21.6 million in compensatory damages in September, 2009. Mutual appealed that decision to the United States Court of Appeals for the First Circuit. Mutual Pharmaceuticals argued that the Food, Drug and Cosmetic Act pre-empted the State of New Hampshire's design-defect law because the Act requires generic drug makers to produce bioequivalent clone medications. Mutual was, in essence, arguing that the court was required to assume that regardless of the damage Sulindac® did to Karen Bartlett, it was legally bioequivalent to Clinoril, therefore it was immune from lawsuits because Sulindac® was approved by the FDAand, we all know that the FDA, being a completely non-political part of the nonpolitical federal bureaucracy, would never pander to political patronage and approve an inferior drug that should have been banned.
The Bartlett case hinged on two witnesses. A pharmacologist-toxicolgist and a burn surgeon. They used incident reports and other medical data to support their conclusion that Sulindac® was more likely to cause Stevens-Johnson Syndrome and toxic epidermal necrolysis [TEN] than other available drugs. The toxicologist testified that sulindac had a safety profile similar to other drugs that were deemed too dangerous to remain on the market. In 2005, because of the Bartlett case, the FDA ordered the labeling of all NSAIDs changed to contain a more explicit toxic epidermal necrolysis warning. The burn surgeon testified that sulindac had design defects, to which the defense lawyer objected and demanded a summary judgment for Mutual Pharmaceuticals. The State court judge ultimately denied the motion under the federal rule of civil procedure 59. The jury awarded the Bartletts $21.06 million. On appeal, the First Circuit Court of Appeals upheld the New Hampshire court's decision.
On July 31, 2012 Mutual Pharmaceuticals filed a writ of certiorari which the US Supreme Court granted on Nov. 30, 2012. The case was argued on March 10, 2013 and decided on June 24. The high court's decision was one of those five minute considerations based on politics and not on moral law. The high court ruled that under the Supremacy Clause of the Constitution (Article VI, paragraph 2), State laws that conflict with federal laws are "without effect." The justices said "...a state law may be impliedly pre-empted where it is impossible for a private party to comply with both State and federal requirements." In applying the Supremacy trump card, the high court never solved the problem. They simply buried it.
It's interestingly that the Hatch-Waxman Act allows generic drug makers to bypass extensive testing requirements and enter the market with clinical tests if they can show the FDA their generic drug is equivalent to the patented brand-name drug, and can carry the same product labeling. In PLOVA, Inc. v Mensing 131 S.Ct.2567 (2011) the Supreme Court ruled that the "sameness" requirement of the Hatch-Waxman Act pre-empted State law duties that imposed stricter labeling requirements on generic drugs. Mutual Pharmaceuticals argued before the Supreme Court that the design-defect law obstructed the purpose of federal law. Hatch-Waxman created the solution by providing an efficient procedure for inexpensive generic drugs to enter the marketplace simply by matching their branded counterparts. Simple. It solves the problem. The only problem is the Sulindac® didn't "match" Clinoril. Sulindac® failed to reach the safety threshold needed to enter the market place without jumping the hurdles.
During the appeals process, the 1st Circuit appeared to see what the the US Supreme Court failed to see. The question is, why didn't the Supreme Court see what the New Hampshire District Court saw, and what the United States 1st Circuit Court of Appeals saw? Clearly, the Supreme Court wasn't looking. The question is: why? Is it possible someone asked them not to? Who? Someone in the West Wing of the White House, perhaps. We can assume Karen Bartlett, maimed for life by Mutual's sulindac, didn't. So, let's go back to the West Wing and Obama's 2012 run for the rosesand the Democrats attempt to take back the House of Representatives. Prior to 2011 the largest pharmaceutical political briber through the use of campaign contributions was Pfizer. In 2011-12 Pfizer dropped to second place. Their legal bribes to political candidates totaled $1,814,766.00, dwarfed only by Mutual Pharmaceuticals who doled out $2,332,500.00 to purchase patronage. Merck & Co., who owns the Clinoril brand, dropped to number five, doling out a mere $1,297,771.00 in legal bribes to Democrats in the same time period.
Does anything suggest that Mutual Pharmaceuticals asked either the FDA or the West Wing to attempt to influence the United States Supreme Court? One thing suggests they did. On Feb. 20, 2013 the United States Solicitor General Donald B. Verrilli, Jr. (who replaced Elena Kagan, the only lesbian member of the high court) formally asked for a leave in order to submit a personal amicus brief to the high court on Mutual Pharmaceuticals v Bartlett. Verrilli petitioned the high court to allow him to participate in opening arguments. Verrilli did not get a response from the high court. The high court did not respond. On March 4, Verrilli resubmitted his request to participate in opening arguments. This time it was granted.
Two days later, on Feb. 22, 2013 the Justice Dept filed its own amicus brief. Like Verrilli's amicus curiae, the amicus brief filed for the United States was never publicly distributed. Why were there two of them from the Obama Administration? Could it be that one of themthe one from the Justice Departmentsided with the position of the Association of Trial Lawyers of America, favoring a change in the FDA's position to allow lawyers to sue drug company's like Mutual Pharmaceuticals. On Feb. 20, Sen. Tom Harkin [D-IA] and Congressman Henry Waxman [D-CA] insisted, in their amicus brief, that Congress never intended for the bureaucracy to interpret the Hatch-Waxman Act to preclude lawsuits against generic drug manufacturers. This is a key, bedrock Democratic position. After all, the Association of Trial Lawyers of America (now the American Association for Justice)paid legal bribes to federal legislators and Leadership PACs in 2011-12 to the tune of $5,168,041.00. In addition they paid another $6,910,000.00 to lobbyyou guessed itCongress during the same period. The official position of the Obama Administration and the Democrats as a whole is that lawyers should be allowed to sue pharmaceutical companies for defect designs in pharmaceutical products regardless if those drugs are branded or generic. When drug companies screw the pooch, they need to be held financially liable for the pain and suffering they cause. Exempting generic drug manufacturers from financial liability for marketing defective pharmaceuticals just to keep the cost of inferior drugs low is stupid because eliminating responsibility doesn't enhance quality control, it lessens it.
The facts aside, the strangest question arising from Mutual Pharmaceuticals v Bartlett is Solicitor General Donald B. Verrilli, Jr. requesting leave to prepare an amicus curiae to submit to the high court on Mutual v Bartlett, seeking permission to participate in open arguments. What is so unusual about that since the Solicitor General of the United States commonly participates in opening arguments before the Supreme Court, and presents the Administration's view on the matter before the court?
Only, this time the Solicitor GeneralVerrilliexcused himself from acting as the mouth piece of the West Wing when he submitted his own amicus curiae. Or, did he? Was he speaking for himself? Or, was he actually speaking for Obama? It may well be that was why Verrilli had to file his amicus brief twice before it was accepted. With the United States filing its amicus brief through the Justice Department, it may have confused the high court when both the Solicitor General and the Attorney General filed what the court would likely have viewed as the same amicus curiae. If that's true, then it's reasonable to assume Verrilli's amicus brief favored the plaintiff of the actionMutual Pharmaceuticals. Well, for whatever it's worth, once again, you have my two cents worth on this subject. Until next time...