Patricia May Zelle v. LLC (2012)

MEMORANDUM OF DECISION MOTION FOR SUMMARY JUDGMENT # 309, 310, 311

INTRODUCTION

This action was commenced by summons and complaint dated February 4, 2009 returnable on February 17, 2009.   The complaint named four defendants, three of which have been referred to as the Bayer defendants, Bayer Healthcare, LLC, Bayer Healthcare Pharmaceuticals, Inc., and Bayer Corporation.¹  The fourth defendant is Danbury Hospital.   The complaint was revised and thereafter a Second Amended Complaint dated May 19, 2010 was filed as a response to the decision of the court striking all counts except those pursuant to the Connecticut Products Liability Act against the Bayer defendants and Danbury Hospital.   The First count of the Second Amended Complaint contains the allegations against the Bayer defendants for a violation of C.G.S. § 52–572m(a).   On October 25, 2011, the Bayer defendants filed a motion for summary judgment as to the claims against each of them and filed a joint memorandum contending that the learned intermediary doctrine bars the plaintiff's allegations;  that two of the defendants are not product sellers pursuant to the statute and;  that the plaintiff has not provided any evidence to prove the claims that the Magnevist administered to her was in any way defective or the proximate cause of her injuries.   The plaintiff filed a memorandum in opposition to the motion dated December 9, 2011.   The Bayer defendants filed a reply on December 16, 2011.   The court heard argument on January 3, 2012.

FACTUAL BACKGROUND

The plaintiff, Patricia May Zelle, was admitted to Danbury Hospital on January 19, 2006 complaining of persistent numbness and heaviness on the right side of her body.   She was treated by the emergency physician, Dr. Bazuro, who requested a consult from a neurologist, Dr. Samuel Markind.   The physicians did an examination as well as take the medical history of the plaintiff and her family.   Because of Ms. Zelle's medical history and her family medical history including the fact that her mother had her first of three serious strokes at the age of 54, the physicians believed Ms. Zelle was suffering a stroke.   In an effort to accurately and quickly diagnose her, Dr. Markind ordered a magnetic reasonance imaging (“MRI”), one with and the other without the contrast agent, Magnevist.   Magnevist is a gadolinium based agent that is provided by one of the defendants to Danbury Hospital.   The physicians and nurses who were treating Ms. Zelle knew of the increased risks of potential serious reaction including a specific warned risk of an allergic reaction.   The Food and Drug Administration (FDA) approved the drug and a product labeling that identified the warnings, adverse reactions and precautions.   This product labeling was available to the physicians and MRI technician at Danbury Hospital.   Soon after injecting Ms. Zelle with the Magnevist agent for the MRI, she exhibited symptoms of an allergic reaction that resulted in respiratory arrest and hypotensive shock.   She was provided emergency treatment for this reaction and was placed in intensive care for observation.   The plaintiff was treated and released from the hospital.   As part of the procedure the hospital completed reports that were sent to Bayer who then reported to the FDA. (Defendants' Exh. 14.)

The product Magnevist is a contrast agent that was produced and sold by Bayer Healthcare Pharmaceuticals, Inc. (See Defendants' Exh. 7, Lopac affidavit, Exh. 12 and Exh. 14.)

The Second Amended complaint alleges the defendants are liable for varied claims of product defect.   The action is brought pursuant to the Connecticut Products Liability Statute, C.G.S. § 52–572m et seq.   The claim in count one against the Bayer defendants states that the defendants breached the duty of due care in that Bayer negligently prepared, inspected, fabricated or manufactured, handled, advertised or marketed designed and developed and failed to provide adequate warnings. (¶ 10a-l, ¶ 11a-g and ¶ 20a-f.)   The complaint alleges that as a result of the defective and unreasonably dangerous condition of the Magnevist and the failure to warn of the defective and unreasonably dangerous nature of the product and the breach of warranties and the negligence of Bayer, the plaintiff sustained serious and painful injuries. (¶ 23.)   The defendants have plead several special defenses including the learned intermediary doctrine.

DISCUSSION

GENERAL STANDARD

“Practice Book § 17–49 provides that summary judgment shall be rendered forthwith if the pleadings, affidavits and other proof submitted show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.   In deciding a motion for summary judgment, the trial court must view the evidence in the light most favorable to the nonmoving party.”  (Internal quotation marks omitted.)  Provencher v. Enfield, 284 Conn. 772, 790–91, 936 A.2d 625 (2007).

“In ruling on a motion for summary judgment the court's function is not to decide issues of material fact, but rather to determine whether any such issues exist.”  Nolan v. Borkowski, 206 Conn. 495, 500, 538 A.2d 1031 (1988).  “In seeking summary judgment, it is the movant who has the burden of showing the nonexistence of any issue of fact.   The courts are in entire agreement that the moving party for summary judgment has the burden of showing the absence of any genuine issue as to all the material facts, which, under applicable principles of substantive law, entitle him to a judgment as a matter of law.”  (Internal quotation marks omitted.)  Ramirez v. Health Net of the Northeast, Inc., 285 Conn. 1, 10–11, 938 A.2d 576 (2008).   This means that the party moving for summary judgment, in this instance the Bayer defendants, must show that there is no genuine issue of material fact.  Strada v. Connecticut Newspapers, Inc., 193 Conn. 313, 317, 447 A.2d 1005 (1984).

“The courts hold the movant to a strict standard.   To satisfy his burden the movant must make a showing that it is quite clear what the truth is, and that excludes any real doubt as to the existence of any genuine issue of material fact ․ As the burden of proof is on the movant, the evidence must be viewed in the light most favorable to the opponent ․ When documents submitted in support of a motion for summary judgment fail to establish that there is no genuine issue of material fact, the nonmoving party has no obligation to submit documents establishing the existence of such an issue ․ Once the moving party has met its burden, however, the opposing party must present evidence that demonstrates the existence of some disputed factual issue.”  (Internal quotation marks omitted.)  Id., 11.   See also 2830 Whitney Ave. Corp. v. Heritage Canal Development Associates, Inc., 33 Conn.App. 563, 567, 636 A.2d 1377 (1994) (nonmoving party must show genuine issue of material fact by “counter affidavits and concrete evidence”).   The plaintiff in the instant action has not provided any counter affidavits or exhibits in opposition to the motion.   Instead the plaintiff has provided unsupported allegations in objection to the motion and argued that its position creates a genuine issue of fact.

“A motion for summary judgment shall be supported by such documents as may be appropriate, including but not limited to affidavits, certified transcripts of testimony under oath, disclosures, written admissions and the like.”   Practice Book § 17–45.  “[B]efore a document may be considered by the court in support of a motion for summary judgment, ‘there must be a preliminary showing of [the document's] genuineness, i.e., that the proffered item of evidence is what its proponent claims it to be.   The requirement of authentication applies to all types of evidence, including writings ․’ Conn.Code of Evid. § 9–1(a), commentary.   Documents in support of or in opposition to a motion for summary judgment may be authenticated in a variety of ways, including, but not limited to, a certified copy of a document or the addition of an affidavit by a person with personal knowledge that the offered evidence is a true and accurate representation of what its proponent claims it to be.”  New Haven v. Pantani, 89 Conn.App. 675, 679, 874 A.2d 849 (2005).

“[Section 17–46] sets forth three requirements necessary to permit the consideration of material contained in affidavits submitted in a summary judgment proceeding.   The material must:  (1) be based on personal knowledge;  (2) constitute facts that would be admissible at trial;  and (3) affirmatively show that the affiant is competent to testify to the matters stated in the affidavit.”  (Internal quotation marks omitted.)  Barrett v. Danbury Hospital, 232 Conn. 242, 251, 654 A.2d 748 (1995).   The court may consider not only the facts presented by the parties' affidavits and exhibits, but also the “inferences which could be reasonably and logically drawn from them ․” United Oil Co. v. Urban Redevelopment Commission, 158 Conn. 364, 381, 206 A.2d 596 (1969).

In order to recover under C.G.S. § 52–572m the plaintiff must prove that:  “(1) the defendant was engaged in the business of selling the product;  (2) the product was in a defective condition unreasonably dangerous to the consumer or user;  (3) the defect caused the injury for which compensation was sought;  (4) the defect existed at the time of the sale;  and (5) the product was expected to and did reach the consumer without substantial change in its condition.”   Giglio v. Connecticut Light & Power Co., 180 Conn. 230, 234, 429 A.2d 486 (1980) citing Restatement (Second) of Torts, § 402A (1965).

PRODUCT SELLER

The court will first address the argument that at least two of the defendants do not fall within the statute as product sellers and thus judgment should be entered as to them.   This argument although not a resolution of all of the claims for all defendants does address the cause of action related to two of the defendants and is an argument that was not opposed by the plaintiff.

The defendants, Bayer Healthcare, LLC and Bayer Corporation argue that they are not product sellers pursuant to C.G.S. § 52–572m et seq. and thus are entitled to summary judgment.

The plaintiff's response to this argument is weak and almost non-existent.   She contends that because the defendants filed a motion to strike as to the exclusivity provisions of the Act, they have admitted to being product sellers.   Not only is this argument unsupported, but as stated above the court has already addressed the issue in a prior ruling when the plaintiff sought to reinstate the claims that were stricken.   Additionally, in the defendants' answer to the Second Amended Complaint, they specifically denied that they were product sellers.   The plaintiff must establish that the defendants “were engaged in the business of selling the product.”  Zichini v. Middlesex Memorial Hospital, 204 Conn. 399, 403, 528 A.2d 805 (1987).   The plaintiff provides no substantive argument to counter the defendants' contention other than the claim that there is an admission.   There is no genuine issue of fact as to this issue and thus summary judgment is granted as to the defendants Bayer Corporation and Bayer HealthCare, LLC because they are not product sellers.   The claims as to Bayer Healthcare Pharmaceuticals, Inc., f/k/a Berlex, Inc., f/k/a Berlex Laboratories, Inc. remain and the court addresses the argument that based upon other legal standards, summary judgment should be entered in its favor.

LEARNED INTERMEDIARY DOCTRINE

The court will next address the argument by all of the Bayer defendants in support of the affirmative defenses that the motion for summary judgment must be granted for each of the failure to warn claims because assuming they are product sellers there is no genuine issue of fact that the defendants satisfied the requirements of warnings to the physician and hospital employees as to the product Magnevist.   The defendants have each raised this defense of learned intermediary doctrine as their First Special Defense to the Second Amended Complaint.²

The learned intermediary doctrine provides that, “adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly.   The doctrine is based on the principle that prescribing physicians act as ‘learned intermediaries' between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient's needs and assess[the] risks and benefits of a particular course of treatment.”  Vitanza v. Upjohn Co., 48 F.Sup.2d 124, 127 (1999) citing Guevera v. Dorsey Laboratories, Division of Sandoz, Inc., 845 F.2d 364, 367 (1st Cir.1988).

The Second Amended Complaint consists of one count that alleges the cause of action against each of the three Bayer defendants.   The plaintiff does not distinguish in any manner the responsibility of each.   The plaintiff contends that the defendants failed to provide adequate warning as to the risk of the drug Magnevist.   The plaintiff also argued that the consent form provided by the defendants should not be a basis to determine that the plaintiff received warnings.  (Defendants' Exh. 10.)   The plaintiff's argument in this regard is not essential to the final decision of this court on this issue because the doctrine is applicable to the warnings being provided to the physicians and health care professionals and it is not relevant for purposes of this action whether the defendants provided specific warnings directly to the plaintiff.³  What the testimony and existence of the Consent Form does confirm is that the health care professionals had specific information concerning the adverse reactions as evidenced by the inclusion of these reactions within a form created by the hospital.   Therefore, the plaintiff's reliance upon the unsigned form to create a genuine issue of facts is misplaced.

The plaintiff fails to address the evidence and affidavits concerning the warnings that defendants have presented.   The defendants provided to the court an overabundance of deposition testimony and exhibits making it clear, unequivocal and uncontested that the product had FDA approved and appropriate warnings.   The defendants also provide the testimony of the health care professionals about their knowledge of the drug and the side effects or risks that may be part of the use of the drug.   The defendants included a copy of the prescribing information for Magnevist approved by the FDA which contains specific warnings as to adverse reactions.  (Defendants' Exh. 7, 7A and 7B.) ⁴ Additionally, the deposition testimony of Ms. Lore White indicates she was aware of the adverse reaction of a life threatening allergic reaction with the use of the Magnevist.  (Defendants' Exh. 8 at page 27.)   Dr. Markind, who scheduled the MRI with the contrast agent for the plaintiff, stated that he was aware that the contrast could cause a potentially life threatening allergic reaction whether it is anaphylactic or anaphylactoid.  (Defendants' Exh. 2 at 53–54.)   Dr. Newman, who is a radiologist at the MRI suite in the hospital, provided testimony in his deposition about the well known potential of Magnevist to cause life threatening reactions.   He referred to the FDA approved labeling that outlines the risks.   Dr. Newman confirmed the importance and appropriateness of the order for Ms. Zelle given her symptoms and history.   (Defendant's Exh. 11 at 29–31, 60–61.)   Lastly, Dr. Miller also agreed that even knowing of the risks, the MRI was necessary because Ms. Zelle may have been suffering from a stroke upon arrival at the hospital.

The deposition testimony of each of the physicians and the MRI technician leave no doubt that they were well aware of the possibility of adverse effects as noted in the FDA approved warnings and had for years been well aware of the specific risk of an anaphylactic reaction to the contrast agent.   Each confirmed that they had considered the risks versus the necessity to diagnose and treat a possible stroke and determined that the MRI with the contrast agent should be ordered.   The plaintiff does not present evidence or testimony that contradicts the adequacy of the warning, the nature of the warning, the approval by the FDA or the knowledge and understanding of the warnings by the treating physicians.   There is no genuine issue of fact in regard to the warnings as they pertain to the Magnevist and its use in providing testing for the plaintiff.   Therefore, the defendants' motion for summary judgment based upon the learned intermediary doctrine for claims of improper warnings pursuant to the statute is granted.

CLAIMS OF PRODUCT DEFECT AND PROXIMATE CAUSE

The defendants argue that the plaintiff has failed to provide any evidence or expert testimony to support her claim that the Magnevist was defective or was the proximate cause of her injuries.⁵

The plaintiff contends in her complaint that the defendants were negligent in that they negligently prepared the product, inspected the product, fabricated or manufactured the product, handled the product, tested the product, advertised or marketed the product, and made misrepresentations or omissions.   (Plaintiff's Second Amended Complaint, ¶ 10a-l.)   The plaintiff alleges the same acts in the next paragraph which specifies that the claim is pursuant to the CPLA. The claim as to the failure to provide proper warnings has been addressed above.   The remaining claims relate to the allegation of defective manufacture, fabricating, testing, inspections and marketing of the product.

As noted above, “[I]n any product action the plaintiff must plead and prove that the product was defective and that the defect was the proximate cause of the plaintiff's injuries.”  (Internal quotation marks omitted.)  Haesche v. Kissner, 229 Conn. 213, 218, 640 A.2d 89 (1994), See Faux v. Thomas Industries, Inc., Superior Court, J.D. of New Haven at Meriden, Docket Number CV 89–0233934 (October 8, 1992, Dorsey, J.) (7 C.S.C.R. 1209) (7 Conn. L. Rptr. 816).

The defendants argue that the plaintiff fails to provide any testimony or evidence that the product was defective or that a defective product caused the injuries alleged.   The plaintiff counters with the response that there is a notation that the remaining Magnevist in the batch used for the testing of the plaintiff was removed and returned to Bayer after the incident.   The defendants contend that it is not certain that the remaining batch of Magnevist was sent back to Bayer.   The defendants provided exhibits from Danbury Hospital and Bayer that the remaining vials were not returned to Bayer.  (Defendant's Exhs. 18, 19, 20, 21, 22.)   The plaintiff argues that the notation in the hospital file about returning the remaining vials to Bayer provides conflicting evidence which is sufficient to create a genuine issue of fact.   However, the deposition testimony of the physician who supposedly made this comment is contrary to the plaintiff's assertions.   Dr. Newman testified at his deposition that he had “no idea” if the vials had been returned to Bayer.  (Defendants' Exh. 11 at 73–74.)   What is more troubling is that, other than the allegation that the vials were returned, there is no theory or explanation as to what consequence that has upon the allegations by this plaintiff that the Magnevist was defective.   The plaintiff has misconstrued the law in regard to a genuine issue of fact.   It is not simply arguing that there is a disagreement about an issue in a civil action but there must be a substantial or real issue.  “Moreover, [t]o establish the existence of a material fact, it is not enough for the party opposing summary judgment merely to assert the existence of a disputed issue ․ Such assertions are insufficient regardless of whether they are contained in a complaint or a brief.”  Da Graca v. Kowalsky Bros., Inc., 100 Conn.App. 781, 785–86, cert. denied, 283 Conn. 904 (2007) (Internal quotation marks omitted.)   Here, the claim about the return of the remaining batch in the present form is neither a substantial or real issue because the parties' allegations that the batch was returned or not returned does not sufficiently demonstrate or lead to a finding that the Magnevist was defective.   The plaintiff's reliance upon this difference of recollection and interpretation of an exhibit cannot create a genuine issue of material fact as to the defective nature of the Magnevist or the claims of failure in testing, inspecting, fabricating, and advertising before the product was placed in the consumer market.   In an action involving the complications of prescription medication, such as this action, where the claims are either scientific or medical, an expert opinion is required to discuss the development, manufacture, testing, handling and marketing of the product alleged to be defective.

There is no evidence produced by the plaintiff that the Magnevist was tested, and found defective or any action taken to confirm that it was defective.   The plaintiff continues in her argument to refer to the notation that the drug was removed from use but then takes a quantum leap in alleging that therefore the Magnevist was defective.   The plaintiff has not proffered any expert to testify at trial that the Magnevist used in the Zelle MRI was defective and that, if defective, it was the cause of the injuries she claims to have suffered.

“A product is defective when it is unreasonably dangerous to the consumer or user.”  (Internal quotation marks omitted.)  Battistoni v. Weather King Products, Inc., 41 Conn.App. 555, 562, 676 A.2d 890 (1996).  “Many products [however] cannot possibly be made entirely safe for all consumption, and any food or drug necessarily involves some risks ․ 2 Restatement (Second) Torts § 402 A, comment (k) (fn.10), see Vitanza v. Upjohn Co., 257 Conn. 365, 374 n.8, 778 A.2d 829 (2001).   Prescription drugs generally fall with the classification of “unavoidably unsafe” products.  Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir.1980) “[U]nlike most other products ․ prescription drugs may cause untoward side effects despite the fact that they have been carefully and properly manufactured.”  Wolfgruber v. Upjohn Co., 72 App.Div.2d 59, 61, 423 N.Y.S.2d 95 (1979) aff'd.  52 N.Y.2d 768, 417 N.W.2d 1002, 436 N.Y.S.2d 614 (1980).   Therefore, the plaintiff's allegations about the adverse effect of the drug which is noted in the product labeling information approved by the FDA does not, by itself, rise to the level of a defective product.   Many courts have recognized that prescription drugs can cause adverse effects but do not create liability in every instance where there is an adverse effect.   This is especially relevant for an action in which the plaintiff alleges she has suffered the adverse effects noted in the product labeling.   This recognition impacts the plaintiff's obligation to prove not only that there are adverse impacts but that the plaintiff suffered because the drug was defective and the defect caused other adverse impacts or heightened in some manner the adverse impacts already recognized and addressed through precautions or warnings.   The warnings contained in the FDA approved labeling specifically indicates that there could be an anaphylactic shock or other effects to some patients who utilize the Magnevist during the MRI procedure.   The technician for the MRI, Lori White, and the physician, Dr. Newman, provided deposition testimony that a crash cart is kept in the area where the MRI is administered specifically for this reason.  (Defendants' Exh. 8 p. 28 and Exh. 11 p. 39.)   This reaction, even assuming it is connected to the injection of the drug, does not create a defect.   Other than the notations in the hospital file of the physical condition of the plaintiff similar to the adverse reactions noted in the product warnings, there is questionable reaction to the Magnevist by the plaintiff.

Additionally, even if the remaining batch of the Magnevist was removed from further use at the hospital or returned to the defendant, this does not demonstrate that the product was defective.   There are a number of reasons that the drug may be removed including an abundance of caution or any hospital policy.   But the removal or return does not equate to establishing a defect.   The plaintiff has not provided any theory or basis as to what manufacturing, testing or fabrication process resulted in a defective product.   A finding of a defect in the drug is not within the common knowledge of an ordinary person.   Without an expert as to the allegations that the product was in some manner defective causing serious unexpected and unforeseen physical injuries, the plaintiff has not been able to forge a sufficient link in the causal chain that would assist a jury in reaching an educated finding that the injuries were caused by a defect in the Magnevist which was administered to her.   To make a finding that the Magnevist was defective, the jury would need to guess or speculate that the Magnevist given to the plaintiff was defective in some undefined manner, solely because the batch may have been removed from use for other patients.

The defendants also argue that if there is some unspecified defect, the plaintiff has failed to demonstrate that any of her alleged injuries were caused by the product defect.   The plaintiff has essentially argued that I took Magnevist as part of the MRI test, I suffered from an anaphylactic shock and other continuing injuries after being injected, therefore the Magnevist must have been defective and caused these physical injuries.   This argument cannot stand.   Of particular importance is the product labeling that recognized the possibility of this exact reaction from a non-defective drug.   Without expert testimony, to indicate that the Magnevist provided to the plaintiff contained a particular defect that caused the alleged damages, a jury cannot reasonably determine that there was a defective product and that the defective product caused her damages.   The plaintiff has provided as experts her treating physicians but has not disclosed them to provide expert testimony that she suffered injuries that were caused by the injection of defective Magnevist.

The plaintiff's failure to provide expert testimony on the issue regarding the allegations of defective testing, fabricating, manufacturing and marketing of the Magnevist as well as whether the alleged injuries were caused by the Magnevist are both fatal to the plaintiff's claims.   There are no genuine issues of fact relating to the claims of negligent design, development, preparation, production, testing, fabricating, marketing, advertising, and misrepresentations or omissions.   The motion for summary judgment is granted as to all defendants.

CONCLUSION

Based upon the above, the motion for summary judgment is granted as to motions by the defendants Bayer Healthcare, LLC and Bayer Corporation because there is no evidence that they were product sellers.   Summary judgment is granted as to all defendants based upon the learned intermediary doctrine and the failure to provide any factual issues in support of the claims that the Magnevist administered to her was defective in the manner alleged or was the proximate cause of her injures.

THE COURT

Brazzel–Massaro, J.

FOOTNOTES

FN1. The Bayer HealthCare Pharmaceuticals, Inc. includes f/k/a Berlex, Inc. and Berlex Laboratories, Inc..  FN1. The Bayer HealthCare Pharmaceuticals, Inc. includes f/k/a Berlex, Inc. and Berlex Laboratories, Inc.

FN2. The court has determined that neither Bayer Healthcare, LLC or Bayer Corporation are product sellers and thus summary judgment is appropriate as to them on this issue, however, the court includes them as to the learned intermediary doctrine because the defendants also contend that summary judgment is appropriate as to this legal argument..  FN2. The court has determined that neither Bayer Healthcare, LLC or Bayer Corporation are product sellers and thus summary judgment is appropriate as to them on this issue, however, the court includes them as to the learned intermediary doctrine because the defendants also contend that summary judgment is appropriate as to this legal argument.

FN3. Having recognized the plaintiff's argument in this regard, the court recognizes the strong testimony and exhibits about the care taken to inform Ms. Zelle about the drug prior to her MRI, but it is not necessary for the court to determine the validity, credibility and bearing of this evidence and testimony on this issue..  FN3. Having recognized the plaintiff's argument in this regard, the court recognizes the strong testimony and exhibits about the care taken to inform Ms. Zelle about the drug prior to her MRI, but it is not necessary for the court to determine the validity, credibility and bearing of this evidence and testimony on this issue.

FN4. The labeling for the Magnevist contains the following FDA approved warnings, risks, and adverse reactions:  ‘WARNINGS” ․ Patients with a history of allergy, drug reactions, or other hypersensitivity like disorders, should be closely observed during the procedure and for several hours after drug administration.”  “PRECAUTIONS” ․ “The possibility of a reaction, including serious, life-threatening, or fatal anaphylactoid or cardiovascular reactions or other idiosyncratic reactions (see Adverse Reactions), should always be considered, especially in those patients with a known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders.”  “ADVERSE REACTIONS” ․”The following additional adverse events occurred in fewer than 1% of the patients:  Body as a Whole ․ anaphylactoid reactions (characterized by cardiovascular, respiratory and cutaneous symptoms) rarely resulting in death.   Cardiovascular:  Hypotension, hypertension, arrhythmia, tachycardia, migraine, syncope, vasodilation, pallor, non-specific ECG changes, angina pectoris, death related to myocardial infarction or other undetermined causes ․”.  FN4. The labeling for the Magnevist contains the following FDA approved warnings, risks, and adverse reactions:  ‘WARNINGS” ․ Patients with a history of allergy, drug reactions, or other hypersensitivity like disorders, should be closely observed during the procedure and for several hours after drug administration.”  “PRECAUTIONS” ․ “The possibility of a reaction, including serious, life-threatening, or fatal anaphylactoid or cardiovascular reactions or other idiosyncratic reactions (see Adverse Reactions), should always be considered, especially in those patients with a known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders.”  “ADVERSE REACTIONS” ․”The following additional adverse events occurred in fewer than 1% of the patients:  Body as a Whole ․ anaphylactoid reactions (characterized by cardiovascular, respiratory and cutaneous symptoms) rarely resulting in death.   Cardiovascular:  Hypotension, hypertension, arrhythmia, tachycardia, migraine, syncope, vasodilation, pallor, non-specific ECG changes, angina pectoris, death related to myocardial infarction or other undetermined causes ․”

FN5. The only experts disclosed by the plaintiff are Dr. Samuel Markind and Dr. Arnold Newman who treated the plaintiff at Danbury Hospital but have made no disclosure that the product was defective in any manner, improperly marketed, or the cause of her alleged injuries..  FN5. The only experts disclosed by the plaintiff are Dr. Samuel Markind and Dr. Arnold Newman who treated the plaintiff at Danbury Hospital but have made no disclosure that the product was defective in any manner, improperly marketed, or the cause of her alleged injuries.

Brazzel–Massaro, Barbara, J.