Two years ago, the Supreme Court limited the conditions under which consumers of generic drugs could sue the manufacturers. In the case, Pliva v. Mensing the Court said the generic company did not have control over the warning labels insofar as what they said and therefore could not be sued for not warning patients about the risks of taking their drugs. Now another Plaintiff, who developed a rare but severe reaction to the anti-inflammatory drug Sulindac after a doctor prescribed it to treat shoulder pain in 2004, will have the Supreme Court decide whether her case will survive. Within weeks of taking the drug, the Plaintiff in that case had her skin begin to slough off. That continued until nearly two-thirds of her skin was gone. The Plaintiff spent almost two months in a burn unit, and months more in a medically induced coma. The reaction permanently damaged her lungs and esophagus and rendered her legally blind.
The Plaintiff sued Mutual Pharmaceutical Company, which made the drug she took, a generic pill, alleging that the drug’s design was dangerous and defective. The case was tried in 2010 in Federal District Court in Concord, N.H. During the trial, the Plaintiff’s burn surgeon described the woman’s experience as “hell on earth.” A jury awarded her $21 million and an appeals court upheld the verdict. The U.S. Supreme Court recently heard arguments on whether Mutual can be held responsible for the injuries.
Generic drugs now account for 80 percent of all prescriptions in the United States. This case is different because the Plaintiff did not claim that the drug’s warning label was inadequate. Instead, she contended that the drug itself was defective. But Mutual argues the rationale is the same. Like the label, the company says it has no control over the drug’s design. That argument should be very hard to justify since the company makes the drug even though it’s a generic.
Under federal law, generic companies are not allowed to deviate from the brand-name drug they are copying. Sulindac is the scientific name for Clinoril, a drug similar to ibuprofen that was approved by the Food and Drug Administration in 1978 and is sold by Merck. Like ibuprofen, Sulindac is in a class of drugs known as nonsteroidal anti-inflammatory drugs or NSAIDs, which are in widespread use.
Mutual is appealing the First Circuit Court of Appeals ruling that upheld the jury verdict. Even if Mutual could not have changed the drug’s design, it had no obligation to continue selling a defective product and could have taken the drug off the market. It’s hard to figure out what the federal government is thinking. It has sided with the generic drug makers in this case even though it opposed the industry in the Mensing case. Keith M. Jensen, a lawyer from Ft. Worth, Texas, with Jensen & Associates, who represents the Plaintiff, presented evidence at trial that patients taking the drug were more at risk of developing toxic epidermal necrolysis which is the condition that the Plaintiff contracted. The condition is a severe form of a related condition called Stevens-Johnson Syndrome.
Like all NSAIDs, Sulindac carried a notice on its label that patients could develop Stevens-Johnson Syndrome. But in 2005, after the Plaintiff’s reaction, the FDA required that all manufacturers of NSAIDs strengthen their labels by specifically listing the risk of developing the skin reactions in the “Warnings” section of the label. That same year, Pfizer removed the pain drug Bextra from the market after the FDA warned that patients were at a heightened risk for developing Stevens-Johnson Syndrome and other skin reactions.
The Alabama Supreme Court recently held that the brand name manufacturer could be held responsible for failing to warn in a case against a generic manufacturer. The Court reasoned that the brand name manufacturer’s duty to warn continues since they know the generics must rely on them to change the warning label. We will soon find out if generic manufacturers can sell a product for which they have no legal responsibility even though the product is defective and the warnings of risk inadequate. If justice is done, the public will be winners.
An editorial on generic drug manufacturers appeared in the New York Times on March 10, 2013. The writer of the editorial obviously understands the issue currently before the U.S. Supreme Court. In my opinion, the editorial hits the nail squarely on the head. Accountability in the drug industry is badly needed, and that shouldn’t come as much of a surprise. It has to include the generic drug industry. This editorial is set out below.
HOLD GENERIC DRUG MAKERS ACCOUNTABLE
A New Hampshire woman who was severely injured by a generic drug in 2004 is still struggling to hold the manufacturer liable. Her case will be argued this month before the Supreme Court, which has already severely limited the ability of consumers to sue generic manufacturers and may well limit it further. If so, some way must be found to compensate this Plaintiff, Karen Bartlett, and others who have been hurt by generic drugs, which account for 80 percent of all prescriptions in this country.
Ms. Bartlett suffered a rare but severe reaction to an anti-inflammatory drug, sulindac, a generic form of the drug a doctor prescribed to treat shoulder pain. The reaction permanently damaged her lungs and esophagus, disfigured her face and body, and left her legally blind. She sued the manufacturer, the Mutual Pharmaceutical Company, a subsidiary of an Indian drug maker, and was awarded $21 million by a Federal District Court jury in 2010. That amount included $16.5 million for pain and suffering, which Mutual challenged as excessive. A federal appeals court in Boston, however, upheld the verdict.
Mutual appealed to the Supreme Court, which ruled in 2011 that patients could not sue generic manufacturers for failing to warn them adequately about drug risks because, under existing laws and regulations, the generic makers cannot unilaterally change warning labels. In this case, Ms. Bartlett is not arguing that there was a failure to warn but that the drug’s design is defective. Mutual contends that it has no more control over the design, which must mimic the brand-name drug being copied, than over the warning labels. The appeals court noted that Mutual could have taken a dangerous product off the market.
Manufacturers should bear responsibility for making sure their drugs are safe and effective. The Food and Drug Administration plays an important role by approving drugs based on limited clinical trials and then monitoring what happens when the drugs are widely used. But lawsuits are important, too, as deterrents to negligence or wrongdoing. If the Supreme Court shields the makers of generic drugs from consumer suits, Congress ought to amend the laws.
It’s impossible to justify a court ruling – from either a legal or safety perspective – that would give virtual immunity to the manufacturers of generic drugs. This industry has an obligation to manufacture and sell drugs that are safe for use. The public also has a right to be warned when the drug is defective and dangerous. Hopefully, a majority of the U.S. Supreme Court will agree.
Source: New York Times
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